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Found 44330 cases where Vaccine is HPV4

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VAERS ID: 495932 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-20
Onset:2013-05-21
   Days after vaccination:1
Submitted: 2013-07-04
   Days after onset:44
Entered: 2013-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Pain in extremity
SMQs:, Dementia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1306JPN013128

Write-up: Initial and Follow-up information has been received from a physician concerning a 12 year old female patient who on 20-MAY-2013 was vaccinated intramuscularly with GARDASIL (Batch/lot N: 9QN08R, Site: left arm), 0.5 ml once a day for the treatment. There was no concomitant medication. The patient''s background information: Underlying decease/concurrent condition: no. Family history: no. Allergy/vaccination or disease with recent a month/medicine being administered/past medical history/condition of development: no. Other vaccine vaccinated together with GARDASIL: no. On 21-MAY-2013, bout from 18:00, the patient felt sharp pain at knee, legs and ankle for about 1-3 hours. Pain of lower extremities was developed. As the pain mainly occurred in the evening and morning, the patient did not take leave from school, however she stopped going to school by bike and body exercise at school. The patient visited orthopedist and received therapy with wet cloth only. The patient had neither paralysis nor movement disorder. At this time of this report, the patient had not recovered from pain of lower extremities. The interval of pain prolonged recently. Whether the 2nd dose of GARDASIL should be vaccinated or not was under discussion. Additional information has been requested.


VAERS ID: 495945 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-06
Onset:2013-02-10
   Days after vaccination:4
Submitted: 2013-07-05
   Days after onset:144
Entered: 2013-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H014677 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dialysis, Neuromyelitis optica, Plasmapheresis, Sensory disturbance
SMQs:, Acute renal failure (narrow), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 2007, Optic neuritis; 2007, Blindness
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK000776

Write-up: Case received from patient/consumer via the Health Authorities in a foreign country on 25-Jun-2013 under the reference numbers DK-DKMA-ADR 22144047 and DK-DKMA-EFO6054. Case not medically confirmed. A 27 years old female patient had received an injection of GARDASIL (dose 2, lot number H014677, site-, route- and form of administration not reported) on 06-Feb-2013 and later on 10-Feb-2013 (date coded by HA but stated in the narratives as 4-7 days post-vaccination) she developed Neuromyelitis optica (not recovered outcome) and sensory impairment (unknown outcome). The patient received MEDROL and has been on dialysis (plasmapheresis) and has now IMUREL for the adverse reaction. According to the report the patient has been hospitalised due to the reactions. Patient does not have other medications. The patient has previously received an injection of GARDASIL (dose 1, batch number G007714, lot number NN12630, site-, form- and route of administration not reported) on 18-Sep-2012. Patient''s medical history includes loss of vision on one eye 2007 (the physician thought that time, that it was an optic nerve inflammation). At the time of reporting, the outcome was not recovered.


VAERS ID: 495946 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-07
Onset:2013-01-07
   Days after vaccination:0
Submitted: 2013-07-04
   Days after onset:177
Entered: 2013-07-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Pallor, Presyncope, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/07/2013, Blood pressure diastolic, 31 mmHg; 01/07/2013, Blood pressure systolic, 61 mmHg; 01/07/2013, Body temperature, 36.3 degrees C; 01/07/2013, Heart rate, 72 /min
CDC Split Type: WAES1306JPN014086

Write-up: Initial information has been received from a physician via Health Authority (PDA_2013/01, V13000342) concerning a thirteen year old female patient. According to medical history interview including underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, past history of ADR (adverse drug reaction), status of growth, the patient had no problem. The patient had no family history. The body temperature before vaccination was 36.3 C (on 07-JAN-2013). On 07-JAN-2013, she was vaccinated with the third dose of GARDASIL injection drug (intramuscularly, batch#9QN07R), (third time of vaccination)(dose, injection site or indication was not reported. No concomitant medications was reported. On an unspecified date, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch# 9QN04R, lot# 0308AA), (first time of vaccination). On an unspecified date, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch#9QN05R, lot# 0564AA), (second time of vaccination). On 07-JAN-2013, she was vaccinated with GARDASIL intramuscularly (IM) injection drug (batch# 9QN07R), (third time of vaccination). About five minutes later, she showed sign of shock and the face turned pale. The blood pressure was 61/31 (mmHg) and the pulse rate was 72 (/min). She lost consciousness. She was put on oxygen 6L/ min. for an hour. In one hour, she was recovered and walked to home. Reporter''s comments: none. The reporting physician felt that vasovagal reaction was related to GARDASIL. He did not assess the relationship of shock and loss of consciousness to the vaccine. Other possible causes was ruled-out. The reporting physician felt that vasovagal reaction was non-serious. He did not assess the seriousness of shock and loss of consciousness. Upon internal review, shock and loss of consciousness was determined as serious due to other important medical events. Additional information has been requested - for initial versions from banyu reports we always add this statement.


VAERS ID: 495989 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-11
Onset:2013-04-11
   Days after vaccination:0
Submitted: 2013-07-05
   Days after onset:85
Entered: 2013-07-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013055 / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Dysphagia, Dyspnoea, Headache, Nausea, Swelling face
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ethinyl estradiol; trimethoprim; DIFFERIN
Current Illness: Menstruation irregular; Skin disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307IRL002894

Write-up: This case was received from the health authority in a foreign country on 27-Jun-2013. IMB REF 2013-017433. This case is medically confirmed as it was reported by a physician. A 17 year old female patient received the third dose of GARDASIL (batch and lot number H013055), route of administration not reported, in left deltoid on 11-Apr-2013 and was concomitantly treated with trimethoprim and DIFFERIN for skin condition and Microlite for irregular menses. The patient had received a first dose of GARDASIL intramuscularly on 04-Oct-2012 and received the second dose of GARDASIL on 03-Dec-2012. On 11-APR-2013, 15-30 minutes post vaccination, the patient reported feeling nauseous with a headache and raised temperature. She was observed by the vaccination team and sent home to rest and avoid strenuous activity. The patient took paracetamol and went to bed. When the patient''s mother checked on the patient at 4 - 5 pm, the patient''s face was notably swollen with indentations from her spectacles on her temples and cheeks. The patient''s mother gave her liquid anti-histamine and took the patient to Accident and Emergency at 6.30 pm. The patient was seen by a doctor at 11.30 pm and her symptoms which had seemed to improve were worsening again at this stage, with increased facial swelling and difficulty breathing. The patient received corrective treatment with steroids. "Swallowing difficulty" was coded by IMB although not specified in the narratives. The patient fully recovered on an unreported date. The IMB considered that case serious due to be medically significant. Upon internal review, "difficulty breathing" was considered as an adverse event and was coded.


VAERS ID: 496161 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-09
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anogenital warts, Human papilloma virus test positive, Papilloma viral infection, Surgery
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Human papilloma virus test positive: HPV type 6, 40 and 42.
CDC Split Type: WAES1307SWE003073

Write-up: Case received from health care professional via the Health Authorities in a foreign country on 02-Jul-2013 under the reference number 132260. Case medically confirmed. A female patient had received an injection of GARDASIL (dose 3, batch number not reported, site and route of administration not reported) on unspecified date at 14 years old and later on during year 2013, at 19 years old, she developed condyloma. According to the reporter the patient received three doses of GARDASIL at 14 years of age and at 19 years of age she developed severe condyloma (onset during 2013). She was initially treated with podophyllotoxin, later with surgery. HPV typing showed HPV type 6, 40 and 42 (mixed infection; however notable with HPV 6). At the time of reporting, the outcome was not recovered. According to the health authority, the reaction was possible related to vaccination. The patient had previous received two doses of GARDASIL on unspecified dates at 14 years of age.


VAERS ID: 496221 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Unknown  
Location: Foreign  
Vaccinated:2013-06-01
Onset:2013-06-01
   Days after vaccination:0
Submitted: 2013-07-08
   Days after onset:37
Entered: 2013-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN002611

Write-up: Initial information has been received from a physician concerning a thirteen year old patient (gender unknown). In the beginning of June 2013, the patient was vaccinated with GARDASIL IM injection drug, 0.5milliliter (ml), 1 per day (time of vaccination, injection site or indication was not reported). No concomitant medications was reported. In the beginning of June 2013, after the vaccination, hypoaesthesia and tremor on the extremities developed. One month later, as of the reporting date, the symptoms persisted. The patient had not recovered from hypoaesthesia and tremor on the extremities. Tests such as electroencephalogram is scheduled. Reporter'' comment: none The reporting physician felt that hypoaesthesia and tremor on the extremities were related to GARDASIL. The reporting physician considered hypoaesthesia and tremor on the extremities as serious due to other important medical events. Additional information has been requested.


VAERS ID: 496285 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-28
Onset:2013-06-28
   Days after vaccination:0
Submitted: 2013-07-10
   Days after onset:12
Entered: 2013-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Exfoliative rash, Headache, Nuchal rigidity, Rash, Rash scarlatiniform, Trismus
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Dystonia (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307ITA004520

Write-up: Case received from Health Care Professional (physician) on 01-JUL-2013 through health authority (additional information received by e-mail on 03-JUL-13). Case medically confirmed. A 13 year old female patient was vaccinated on 28-JUN-2013 with the third dose of GARDASIL (batch n. not reported). On the same day, 3 hours post-vaccination, she presented with a scarlet fever-like rash on the face and neck, nuchal rigidity, trismus and headache. She went to the ER twice, were antihistamines were prescribed. At the time of reporting she had not yet recovered; she was complaining of marked asthenia and the rash was desquamating. The case is closed.


VAERS ID: 496286 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-10
Onset:2013-06-11
   Days after vaccination:1
Submitted: 2013-07-09
   Days after onset:28
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004473 / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Pruritus, Skin lesion, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307POL001758

Write-up: On 10/06/2013 at 13:30 the female child was vaccinated with SILGARD (0,5ml) intramuscular injection in arm. LOT# J004473 EXP 10/20/15). MAH MSD Ltd. On the form to report AE after vaccination other than BCG the following AE were noted: urticaria. In narrative part physician report generalized urticaria (skin lesions on the trunk, painful), hives on the face and upper and lower extremities with pruritus. Urticaria occurred about 14:00, pruritus occurred next day from morning hours. According to AE reporting form AE occurred 10-JUN-2013 at 14:00. Outcome: A full recovery.


VAERS ID: 496288 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-28
Onset:2013-05-29
   Days after vaccination:1
Submitted: 2013-07-09
   Days after onset:41
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000282 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Circulatory collapse, Fall, Loss of consciousness, Suture insertion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DEU004136

Write-up: Case received from a health care professional on 01-Jul-2013. Case medically confirmed. A 13-year-old female patient (weight 54,8 kg, height 161 cm) received the first dose of GARDASIL (lot-no. J000282) via intramuscular route on 28-May-2013 at 3 PM. PN 29-May-2013, at 10 AM, the patient developed circulatory collapse, unconsciousness and fell on her face. She was hospitalised and gingival suture was needed. At the time of reporting the ocutome was not reported. Corrective version created on 08-Jul-2013 in order to include the Health Authorities as reporter and to correct the reporters qualification in reporter screen. Case was received via Health Authorities on 01-Jul-2013 (ref. number PEI2013037039).


VAERS ID: 496289 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-16
Onset:2013-02-01
   Days after vaccination:77
Submitted: 2013-07-10
   Days after onset:158
Entered: 2013-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H006967 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Genital discomfort, Genital lesion, Genital pain, Hypothyroidism, Pruritus genital, Reproductive tract disorder, Vulvovaginal burning sensation
SMQs:, Hypothyroidism (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Prophylaxis
Preexisting Conditions: 09/14/2012, GARDASIL, Immunisation, dose 1, batch number H006967
Allergies:
Diagnostic Lab Data: On 25-Feb-2013 at a doctors appointment after sampling(blood test) hypothyroidism was discovered.
CDC Split Type: WAES1306SWE001859

Write-up: Case received from healthcare professional via company representative on 29-May-2013. Case medically confirmed. A female patient (age not reported) had received an injection of GARDASIL (dose 1, batch number unknown, route and administration not reported) on Sept-2012. The patient received an injection of GARDASIL (dose 2, batch number unknown, route and administration not reported) on Nov-2012. The patient developed unclear troubles with vulvovaginal burning sensation after the doses. She developed hyperthyroidism in Feb-2013. Patient medical history was not reported. At the time of reporting, the outcome was not provided. No more information is expected. Follow up information received from healthcare professional vial health authority on 02-JUL-2013. The following information was provided. A 10-year-old female patient was vaccinated with GARDASIL dose 1, 14-SEP-2012 (batch/lot number H006967) and dose 2, 16-Nov-2012 (batch number H912703). In September-October 2012 she develops genital pruritus and pain. She also developed lesion at two occasions. The girl is experience burning sensation and discomfort in the genital area. On 25-Feb-2013 at a doctors appointment after sampling hypothyroidism was discovered and LEVAXIN treatment was started. According to the initial report hyperthyroidism was reported which is a discrepancy with this follow up information. The report was classified as serious due to medical important event. The following events were coded by HA hypothyroidism, burning skin (coded as vulvovaginal burning sensation by company), pruritus (coded as pruritus vaginal female by company) and reproductive tract disorder NOS. Upon medical review it was decided to also code genital wounds and genital pain. The health authority assessed hypothyroidism, burning skin, pruritus and reproductive tract disorder NOS as possible related to the vaccination. At the time of reporting hypothyroidism, burning skin, pruritus and reproductive tract disorder NOS were not recovered and genital pain, genital discomfort and genital lesion not reported.


VAERS ID: 496291 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-01
Onset:2013-06-01
   Days after vaccination:0
Submitted: 2013-07-09
   Days after onset:38
Entered: 2013-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307COL002700

Write-up: Information has been received from a physician concerning a 12 year-old female patient enrolled in a patient support program, with no history of allergy to the vaccine, who in approximately January 2013, March 2013 and June 2013, was vaccinated with the first, second and third dose of GARDASIL 0.5ml, intramuscularly (lot # not provided). It was reported that in approximately June 2013, 24 hours after the vaccination, the patient experienced rash on the upper body and, on an unknown date, she was admitted to a hospital. The event was reported to a pediatrician who prescribed HIDERAX. The patient recovered from rash in 2013. The causality assigned by the physician was unknown. the patient''s rash was also considered to be medically significant by reporting physician. Additional information has been requested.


VAERS ID: 496426 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-07-22
Onset:2010-08-08
   Days after vaccination:17
Submitted: 2013-07-11
   Days after onset:1068
Entered: 2013-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Angiogram normal, CSF culture negative, Hypoglossal nerve paralysis, Nuclear magnetic resonance imaging brain normal, Serology normal, Tongue paralysis
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI angiography, Spinal fluid culture, MRI brain and Serology test were normal
CDC Split Type: WAES1307DNK004617

Write-up: Case received from a health care professional via the Health Authorities on 04-Jul-2013 under the references DK-DKMA-ADR 22156769 and DK-DKMA EFO6163. Case medically confirmed. A 12-year-old female patient had received the first injection of GARDASIL (batch number unknown, administration site not reported) via intramuscular route on 22-Jul-2010. On 08-Aug-2010, the patient developed right-side tongue deviation and paralysis of the hypoglossal nerve dexter. In Jun-2013, the patient had stationary function-failure of right nervus hypoglossus, localised at nerve nucleus. The patient was investigated with MRI of cerebrum and throat, MRI angiography, spinal fluid test and serological test for inflammation and neuro infection. All tests were without findings. At the time of reporting, the patient had not recovered.


VAERS ID: 496452 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-28
Onset:2013-06-28
   Days after vaccination:0
Submitted: 2013-07-10
   Days after onset:12
Entered: 2013-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H012525 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Presyncope, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307ITA004705

Write-up: Case reported by Health Authority (case n.209791) through health authority (local case n IT511/13). Initial report received on 03-JUL-2013. An 11 year old female was vaccinated on 28-JUN-13 with the first dose of GARDASIL (batch n. H012525) i.m. On the same day she presented with presyncope and tachycardia. She was hospitalized. The outcome is recovering/resolving. The case is closed.


VAERS ID: 496454 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-22
Onset:0000-00-00
Submitted: 2013-07-10
Entered: 2013-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000282 / 1 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Angina pectoris, Bursitis, Chest pain, Electrocardiogram normal, Injection site pain, Intercostal neuralgia, Ligament disorder, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Diagnostic tests including ECG were normal.
CDC Split Type: WAES1307DEU004726

Write-up: Case received from a health care professional on 03-Jul-2013. Case is medically received. This case is a cluster with case E2013-04201 (same reporter, same product, same lot-no., different reaction). A 15-year-old female patient received the first dose of GARDASIL (lot-no. J000282) into the left upper arm on 22-Apr-2013. 1-2 weeks after the vaccination, the patient developed anginal pain, retrosternal pain, shoulder pain left and pain upon movement of the left arm. She was hospitalised on 22-May-2013 and symptoms were associated with intercostal neuralgia. Diagnostic tests including ECG were normal. Due to ongoing symptoms she went to an orthopedist, who diagnosed a subacromial bursitis and ligament disorder. She was treated with physiotherapy. At the time of reporting, the patient had not recovered.


VAERS ID: 496458 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-11
Entered: 2013-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Pain in extremity, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK004741

Write-up: Case received from non-healthcare professional via company representative on 04-Jul-2013. Case not medically confirmed. A 24-year old (age at the time of reporting) female patient had received an injection of GARDASIL (dose, route, site and batch number not reported) on unspecified date and later on she developed absence of menstruation, severe pain in the leg and weight gain. It is reported that she has been hospitalised and that she has gained 15-20 kg despite a low fat and low carb diet. She is not able to exercise due to the severe pain in the leg. At the time of reporting, the outcome was not recovered. According to the reporter, the reaction was related to vaccination; but according to the reporter the patient''s gynecologist says this is not related to the vaccination. No further information expected.


VAERS ID: 496460 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-11
Onset:2013-02-01
   Days after vaccination:52
Submitted: 2013-07-11
   Days after onset:159
Entered: 2013-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Speech disorder, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307SWE004730

Write-up: Case received from a health care professional via the Health Authority in a foreign country on 04-Jul-2013 under the reference 132004. Case medically confirmed. A 15-year-old female patient, had received an injection of GARDASIL (batch number unknown, route, administration site not reported) on 11-Dec-2012. On an unspecified date in Feb-2013, the patient developed speech disorder, headache and vision abnormal. At the time of reporting the patient had recovered with in an unspecified timeframe. According to the Health Authority the events were possibly related to GARDASIL. The patient had received D1 of GARDASIL on 24-Oct-2012, toleration not reported.


VAERS ID: 496519 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-04-01
Onset:0000-00-00
Submitted: 2013-07-12
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Depression, Dizziness, Fatigue, Fibromyalgia, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisaton
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307FRA005417

Write-up: Case received from a pharmacy assistant on 02-Jul-2013. Case medically confirmed. The reporter was also the patient. An adult female patient had received the first dose of GARDASIL (batch number not reported) in Oct-2009. At the end of 2009-beginning of 2010, she developed legs pain. She consulted a podiatrist and a physiotherapist and consultations results were unremarkable. On a unspecified date in 2010, she consulted a rheumatologist who diagnosed fibromyalgia. For about 4 years, the patient was experiencing pain, chronic fatigue, nausea, dizziness and depressed state. Sometimes, she found herself incapacitated because of those symptoms. She was followed up every 3 months at hospital. To be noted that the patient had received the second dose of GARDASIL in Jan-2010 and the third dose in Apr-2010. At the time of reporting, the patient had not recovered.


VAERS ID: 496544 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-11
Onset:2013-04-12
   Days after vaccination:32
Submitted: 2013-07-12
   Days after onset:91
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H010092 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Adenovirus test, Blood glucose increased, Borrelia test negative, C-reactive protein normal, Coxsackie virus test negative, Cranial nerve disorder, Cytomegalovirus test negative, Echovirus test negative, Epstein-Barr virus test negative, Eyelid function disorder, Full blood count normal, Hepatitis viral test negative, Herpes simplex serology negative, Hyperglycaemia, Influenza virus test negative, Laboratory test normal, Lagophthalmos, Mastication disorder, Mycoplasma test, Neurological examination abnormal, Paraesthesia, Poliovirus test negative, Varicella virus test negative
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIBASE
Current Illness: Immunisation
Preexisting Conditions: Obesity; Varicella
Allergies:
Diagnostic Lab Data: On 12-APR-2013: neurological reaction time diminished. Labwork performed on 13-APR-13: CBC, blood glucose, C-reactive protein, serology for HSV, VZV, EBV, Borrelia, Coxsackie, Influenza, Polio, Parotitis, Hepatitis, Echovirus, Adenovirus, CMV, Mycoplasma all negative except for slight hyperglycemia (112 mg/dl). 12-APR-2013: Objective neurological exam all within normal limits, except for cranial nerves: right lagophthalmos and deficit in the oral fissure extension. Diagnostic conclusions: acute peripheral deficit of the VII cranial nerve.
CDC Split Type: WAES1307ITA006239

Write-up: Case received from Health Authority (case n. 210287) on 08-JUL-2013. Case initially reported by a patient. Case medically confirmed (neurological consultation records). An 11 year old female patient was vaccinated on 11-MAR-13 with the second dose of GARDASIL (batch n. H010092) i.m. Family History: The mother has suspected hiatal hernia. The father is being treated for hypertension. A maternal aunt has breast cancer. The maternal grandmother suffers from migraines, hypothyroidism, hypertension, type II diabetes, obesity and asthma. The maternal grandfather suffers from hypertension and cardiopathy. The paternal grandfather suffers from cardiopathy. Negative family history for neurological diseases. Patient History: the patient was born at 39 week gestation by C-section due to gestosis, peri-natal history normal, regular weight/height growth, regular psychomotor development. Started walking at age 12 months and uttering the first words at 10 months. No known allergies. She is concomitantly being treated with vitamin D DIBASE. Selective eating scarce on vegetables, fruits, fish. She attended middle school with some difficulty. No problems in reading-writing. Refers memory difficulties. Discrete socialization. Since October 2012 she is followed at a nutrition center for obesity, since then she has lost 8 kg. On 12-APR-13 in the morning, while in school, she presented with a tingling feeling in the right cheek, followed by the sensation of not being able to close well the right eye. No pain. No headache. Upon returning home for lunch she was not able to chew, no alterations of taste referred. On the same day, in the evening, she was seen in neurological consultation, no tick bites, infection episodes, no labial herpes referred. The patient had varicella as a child. She does not suffer from otitis. Objective neurological exam all within normal limits, except for cranial nerves: right lagophthalmos and deficit in the oral fissure extension. Diagnostic conclusions: acute peripheral deficit of the VII cranial nerve. She was prescribed therapy with DELTACORTENE 25mg., 2.5 tablets daily for 5 days tapering down to 1.5 tablets daily for another 5 days. Vitamin B12 (BENEXOL) 1 daily for 3 weeks, artificial tears and facial exercises. Labwork performed on 13-APR-13: see lab comments screen. The patient was also referred for an EMG to be performed only if symptoms do not resolve in 21 (follow-up check in 18 days). At the time of reporting the patient had not recovered. The case is closed.


VAERS ID: 496694 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-05
Onset:2013-06-05
   Days after vaccination:0
Submitted: 2013-07-12
   Days after onset:37
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0613AE / 2 UN / IM
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER A70CC318A / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Dyskinesia, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307AUS005082

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR321041) concerning a 13 years old female patient. On 05-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (batch number H019846, lot number 0613AE, exp. date 02-APR-2015) (1 dose unspecified, 1 time), intramuscular injection (given second) and the first dose of varicella virus vaccine live (manufacturer unknown) (lot number reported as A70CC318A) (1 dose unspecified, 1 time), subcutaneous (given first). Concomitant medications were not reported. On 05-JUN-2013, patient experienced loss of consciousness immediately post GARDASIL immunisation. Twitchy and jerky movements as regained consciousness. Pale and cyanotic lay in recovery position. Recovered quickly able to sit up after 15 minutes and have a drink. The relationship between GARDASIL and varicella virus vaccine live (manufacturer unknown), and the event was reported as possible. The original reporting source was the State/Territory Health Department. Upon internal review, loss of consciousness was considered to be medically significant. Additional information is not expected.


VAERS ID: 496695 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 2013-07-12
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Biopsy kidney abnormal, Blood creatinine increased, Blood test abnormal, C-reactive protein increased, Nausea, Pyrexia, Tubulointerstitial nephritis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/02/2013, GARDASIL, Arthralgia, Pyrexia, Myalgia, Oropharyngeal pain, Influenza like illness
Allergies:
Diagnostic Lab Data: 14-MAR-2013: Renal biopsy: Interstitial nephritis; Blood test NOS: Mild anaemia; Blood creatinine, 360 not provided; C-reactive protein, 86 not provided
CDC Split Type: WAES1307DNK005765

Write-up: Case received from a health care professional via the Health Authorities on 04-Jul-2013 under the references DK-DKMA-ADR 22158303 and DK-DKMA EFO6170. Case medically confirmed. This case is linked to case E2013-05179 (same patient, different dose, different reactions). A 20-year-old female patient had received the second injection of GARDASIL (lot and batch number H019870, administration site not reported) via intramuscular route on 01-Mar-2013. On an unspecified date in Mar-2013, the patient developed nephritis interstitial, nausea and fever. The patient was hospitalised. On admission creatinine was 360, CRP 86 and also a mild anemia was seen (6.5). Units and ranges were not reported. Renal biopsy on 14-Mar-2013 confirmed interstitial nephritis. At the time of reporting, the patient had not recovered from interstitial nephritis, the outcome for nausea and fever was unknown. The patient received D1 of GARDASIL on 02-Jan-2013. After vaccination, in Jan-2013, the patient developed influenza symptoms, throat pain, muscle pain, fever and joint pain.


VAERS ID: 496703 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-06-20
Onset:2013-06-21
   Days after vaccination:1
Submitted: 2013-07-12
   Days after onset:21
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Epilepsy, infantile spasms; Infantile spasms
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307AUS005102

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR322295) concerning a 15 year old male patient with history of uncontrolled epilepsy and infantile spasms. On 20-JUN-2013 the patient was vaccinated with the second dose of GARDASIL (Lot # not reported) intramuscular (dose not reported) 1 dose unspecified, 1 time. No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient had constant subclinical spikes/spasms but usually had a bigger cluster every second day or so. It was stated that the patient was ok for 24 hours post vaccination and the had increased in seizures, approximately 3 times usual amount. The general practitioner thought may have had a chest infection and prescribed antibiotics. Reports coming back to self now. The reported was worried about the third dose. The outcome of had increased in seizures was reported as recovered/resolved on 27-JUN-2013. The reporter considered had increased in seizures to be possible related to GARDASIL. Upon internal review of had increased in seizures was considered to be other important medical event. The original reporting source was state/territory health department. Additional information is not expected.


VAERS ID: 496708 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-12
Entered: 2013-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Carcinoma in situ
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307MEX005984

Write-up: This spontaneous report was received from a physician regarding a 19 year old female patient with unknown medical history. In 2010, (reported as "approximately 3 years ago") the patient received the complete GARDASIL vaccination schedule (lot number and expiration date not reported) (intramuscular, 0.5 ml). No other suspect therapies or concomitant medications were reported. Recently (unknown date) the patient was diagnosed with "cancer in situ" (unspecified anatomical region); the patient''s parents had scheduled an appointment with the physician in order to request an explanation about the cancer diagnosis. The outcome for cancer in situ was reported as not recovered/not resolved. No treatment information was provided. The reporting physician did not assess the causality between cancer in situ and GARDASIL. Upon internal review "cancer in situ" was considered a medically significant event. Additional information has been requested.


VAERS ID: 496805 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-06
Onset:2013-05-06
   Days after vaccination:0
Submitted: 2013-07-15
   Days after onset:70
Entered: 2013-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0542AE / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Generalised erythema, Localised oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Food allergy; Drug hypersensitivity; Asthma
Preexisting Conditions: Penicillin, Drug Reaction: Drug hypersensitivity; BUFREN, Drug Reaction: Dermatitis allergic; ATARAX, Drug Reaction: Dermatitis allergic
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307PRT006231

Write-up: Case received from the Health Authorities in a foreign country on 04-Jul-2013 under the reference number L201306-79 via the local site Sanofi Pasteur MSD. The primary reporter was a nurse. Case medically confirmed. A 13-year-old female patient experienced a localised oedema, difficulty in breathing and generalised erythema after she had received the first dose of GARDASIL (batch number H019462) subcutaneously on 06-May-2013. The patient had a family history of multiple allergies in her mother and her sister. She had a personal history of asthma (controlled) and several allergies including allergy to mucolytics and penicillin. She had experienced allergic rash after administration of ATARAX and BRUFEN. She was also allergic to spinach, French garlic, hazelnut, citrus, strawberry and seafood with the same cutaneous reactions. She was taking concomitant medication for asthma inhaled in SOS on an unknown start date. The localised oedema began shortly after vaccination and measured 2 cm in diameter. Difficulty in breathing and erythema occurred 8 hours and 12 hours post-vaccination respectively. She experienced no other manifestations. Difficulty in breathing resolved in a few minutes after the beginning of the events. Oedema and erythema lasted about 4 days. The patient received corrective treatment with inhaled bronchodilators and desloratadine in a dosage of 5 ml 6/6 hours for 3 days. The reporter did not suspect quality problems. The patient recovered. The Health Authorities assessed the causal relationship between the reported reactions (difficulty in breathing, generalised erythema) and vaccination as possible and between localised oedema and vaccinations as probable, according to the global introspection. The reporter assessed the causal relationship between the reported reactions and vaccination as probable according to an unknown assessment method.


VAERS ID: 496811 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-05
Onset:2013-06-05
   Days after vaccination:0
Submitted: 2013-07-14
   Days after onset:39
Entered: 2013-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0272AE / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307AUS004418

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR321453) concerning a 13 year old female patient. On 05-JUN-2013 the patient was vaccinated with a dose of GARDASIL lot # 0272AE, batch#H011498, expiring 02-MAR-2015, 0.5 ml, intramuscular. On 05-JUN-2013, the patient experienced difficulty breathing, feeling of upper airway and constriction. The outcome of the events was reported as unknown. It was administered adrenaline to the patient, as a treatment for the AE, and paramedics transferred her to emergency department. The agency considered the events to be life threatening. The agency considered the events to be possibly related to GARDASIL. The original reporting source was a state/territory health department. Additional information is not expected.


VAERS ID: 496888 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-16
Entered: 2013-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Fatigue, General physical condition abnormal, Loss of consciousness, Nausea, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DEU008161

Write-up: Case received from a consumer or other non health care professional on 05-Jul-2013. Case is not medically confirmed. This case is linked to case E2013-03274 (same reporter, same vaccine, same events). A female patient of unspecified age received a dose of GARDASIL (lot-no. not reported) on an unspecified date. On an unspecified date the patient developed weight loss, nausea, abdominal pain, unconsciousness, reduced physical condition, colics, fatigue and exhaustion. The outcome was not reported. Upon medical review the company considered the case as serious.


VAERS ID: 496893 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2013-07-16
Entered: 2013-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dysstasia, Gait disturbance, Hypotonia, Monoplegia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: Cartilage operation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307KOR006419

Write-up: This spontaneous report as received from a consumer, via a company representative, refers to a female patient of unknown age. 6 months before the vaccination, assumed in January 2013, the patient had knee cartilage surgery and at the time of vaccination the patient had no abnormal symptom. On 11-JUN-2013 the patient was vaccinated with GARDASIL injection vials (dosing information and route were not provided). The patient reported that 2 weeks after the vaccination, the patient felt like she lost her energy and felt like her leg was paralyzed and the leg muscle was lost. And the patient had symptom like gait disturbance so she could not stand up over 5 minutes. In June 2013 the patient experience also muscle pain. The patient reported that she did not receive any treatment for the symptoms yet. The outcome of felt like her leg was paralyzed, felt she lost her energy, muscle pain, felt like the leg muscle was lost, gait disturbance and hard to stand up over 5 minutes is unknown. No reporter causality provided. Upon internal review, felt like her leg was paralyzed was considered to be medically significant. The reporter did not want further follow up attempts. Additional information is not expected.


VAERS ID: 496914 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-05-22
Onset:2013-01-18
   Days after vaccination:241
Submitted: 2013-07-16
   Days after onset:178
Entered: 2013-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Arthralgia, Balance disorder, Crying, Dysstasia, Facial spasm, Laboratory test normal, Muscle spasms
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307KOR006507

Write-up: This spontaneous report as received from a consumer reporting about his daughter, a 12 year old patient. On 22-MAY-2012 the patient was vaccinated with GARDASIL dose 3 (route, dosage and lot number unknown). After the first vaccination the patient experienced knee pain, so the patient cried while sleeping. The reporter thought it was a growing pain so the patient only took a pain reliever at that time. The symptom got worse and on 18-JAN-2013 the patient could not stand up and walk (ataxia) and experienced body spasm and facial spasm. The patient visited emergency room and was told to go to a big hospital. The patient was hospitalized and several tests were performed but there was no abnormal finding. However, the symptoms persisted. The patient could not balance herself on one leg and the knee pain continued. The patient was taking steroid for the treatment. The outcome of knee pain and ataxia was reported as not recovered. The outcome of body and facial spasm was reported as unknown. Additional information is not expected.


VAERS ID: 496915 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-27
Onset:2013-05-27
   Days after vaccination:0
Submitted: 2013-07-16
   Days after onset:50
Entered: 2013-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Oral discomfort, Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Anaphylactic reaction; KEFLEX, Hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307AUS005139

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR # 320872) concerning a 13 year old female patient. The patient''s medical history included allergy to KEFLEX and idiopathic anaphylaxis with shellfish. On 27-MAY-2013, the patient was vaccinated with a second dose of intramuscular GARDASIL (dose and lot number were not provided). On 27-MAY-2013, 30 minutes later the patient felt faint and had a rash on the arm. Lips and throat were hot. The patient self-administered ZYRTEC. Ambulance was called and the patient was transferred to hospital, was observed and discharge. On 27-MAY-2013, the patient recovered from the adverse events. The adverse events were possible related to GARDASIL by the reporter. The original reporting source was State/Territory health department. Additional information is not expected.


VAERS ID: 496917 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-07-25
Onset:2012-08-01
   Days after vaccination:7
Submitted: 2013-07-16
   Days after onset:349
Entered: 2013-07-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0277AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Condition aggravated, Juvenile idiopathic arthritis, Matrix metalloproteinase-3 increased, Nuclear magnetic resonance imaging brain abnormal, Pain, Synovitis
SMQs:, Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate; HUMIRA; CELECOX
Current Illness: Familial risk factor; Juvenile idiopathic arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magnetic resonance imaging brain (date unknown): abnormal.; CRP (date unknown): increased.; Unknown date: MMP: 32 (normal range 17-59); August 2012: MMP: 116 (normal range 17-59); Around August 2012: MRI of synovitis aggravation; On an unspecified date, the finding of MRI showed aggravation and CRP was increased.
CDC Split Type: WAES1306JPN012517

Write-up: Initial and follow up information has been received from a physician concerning a 13 year old female patient with juvenile idiopathic arthritis who on 25-JUL-2012 was intramuscularly vaccinated with the first dose of GARDASIL (Lot number 9QN03R, dose not reported). Other concomitant medication included methotrexate, HUMIRA and CELECOX. The patient had an underlying disease of juvenile idiopathic arthritis and juvenile idiopathic arthritis was recovering with adalimumab (genetical recombination), methotrexate and CELECOX. On 25-JUL-2012, the patient was vaccinate with the first dose of the vaccine. Around August 2012, a month after the first dose, arthritis was aggravated with the change of matrix metalloproteinase (MMP) from 32 to 116 (NR: 17-59) and MRI finding of synovitis aggravation. While the patient complained of increase of pain, the vaccine was continued on request of herself or her parents. On 19-SEP-2012, the patient was vaccinated with the second dose of the vaccine (Lot number (9QN04R). After the second dose, the patient complained of increase of pain again. In addition, on an unspecified date, the finding of MRI showed aggravation and CRP was increased. In November 2012, the patient received steroid temporally. On 01-JUL-2013, the patient was recovering from juvenile idiopathic arthritis aggravation gradually. Comment: The physician considered the causality as unknown while the causality could not be ruled out. As her mother had experienced cervix cancer, she might have a risk. Therefore, she, her mother and her grandmother requested the third dose. The reporting physician considered that the juvenile idiopathis arthritis aggravated was serious due to other important medical event. The reporting physician felt that the relationship between juvenile idiopathic arthritis aggravated and GARDASIL was unknown. Additional information is not expected.


VAERS ID: 496948 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-11
Onset:2013-05-13
   Days after vaccination:2
Submitted: 2013-07-17
   Days after onset:65
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Injection site pain, Malaise, Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN007074

Write-up: Initial information has been received from a physician via the health authority concerning a 12-year-old female patient. No point to remember (underlying disease, allergy, the other vaccination or disease within the last 1 month, currently-taking mediation, past adverse reaction or growth status) on the patient was stated in the medical history interview. No information on family history and body temperature before vaccination was provided. On 11-MAY-2013, the patient received the first intramuscular injection of GARDASIL (lot No. 9QN08R) (dose and the site of the injection not reported). No concomitant medication was reported. On 11-MAY-2013, the patient received the first injection of the vaccine in the morning at Hospital A of obstetrics and gynecology. After the vaccination, the patient had injection site pain. On 13-MAY-2013, Guillain-Barre syndrome and peripheral nerve disorder developed. Pain in lower limbs, numbness and malaise also developed and got worse thereafter. On 20-MAY-2013, the patient had difficulty breathing and blowing at playing instruments. At the beginning of June 2013, the patient had tremor of upper limbs and weakness. On 22-JUN-2013, the patient was referred to the department of neurology of Hospital B. On 28-JUN-2013, the patient was referred to the reporting physician''s hospital because the decrease in the peripheral nerve conduction velocity was observed. On 01-JUL-2013, the patient was admitted to the reporter''s hospital for close examinations, and she underwent head and spinal MRT and also a peripheral nerve conduction test. On 05-JUL-2013, Guillain-Barre syndrome and peripheral nerve disorder were recovering, and the patient was discharged from the hospital. As of the same date, the outcome of injection site pain was unknown. Reporter''s Comment: The events developed after the vaccination although there was no marked abnormal examination result as there was a definite time lag between the events and the close examinations. Causal relationship is considered to be obvious. The reporting physician considered that Guillain-Barre syndrome and peripheral nerve disorder were related to GARDASIL and did not assessed the causal relationship between the vaccine and injection site pain. The reporting physician considered psychogenesis as the other possible cause of the events. The reporting physician assessed Guillain-Barre syndrome and peripheral nerve disorder as senous (hospitalization) and did not assess the seriousness of injection site pain. Upon internal review, Guillain-Barre syndrome was considered as other medically significant event. Additional information has been requested.


VAERS ID: 496953 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-03
Onset:2013-06-03
   Days after vaccination:0
Submitted: 2013-07-14
   Days after onset:41
Entered: 2013-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0613AE / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. A70FC14A / 1 RA / SC

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307AUS004922

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR number 320869) concerning a 12 year old female patient. On 03-JUN-2013 the patient was vaccinated with GARDASIL (Batch # H019846; lot #0613AE, expired date 02-APR-2015) (dose and injection site were not reported) (1st dose left arm) intramuscularly injection. Other suspect therapies included VARIVAX (Merck) (manufacturer unknown) (Batch/lot number was reported as A70FC14A) (expired date, dose and injection site were not reported) (1st dose, right arm) subcutaneously injection on 03-JUN-2013. On 03-JUN-2013 immediately post second vaccination student stiffened, became unconscious for 20 seconds. The patient was awaked at first confused then fully alert and conscious. Treatment was given as abservation, rest and fluid. The outcome was reported as recovered on 03-JUN-2013. The action taken was not provided. The agency felt that adverse events to be possibly related to GARDASIL and VARIVAX (Merck) (manufacturer unknown). Upon internal review, unconscious was considered as medically significant event. This was originally reported by the State/territory health department. Additional information is not expected.


VAERS ID: 497100 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-03-07
Onset:2012-03-07
   Days after vaccination:0
Submitted: 2013-07-17
   Days after onset:496
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB338AA / 3 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. G004524 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache, Hypoaesthesia, Inappropriate schedule of drug administration, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Vitamin D
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nuclear magentic resonance ima, 23Oct2012, multiple sclerosis; Vitamin D, 13Nov2012, 17.1ng/mL
CDC Split Type: B0864068A

Write-up: This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 15-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and GARDASIL (non-gsk). Historic vaccination included hepatitis B;GlaxoSmithKline;unknown given on an unspecified date. Concurrent vaccination included hpv vaccine (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 14 December 2011. On 7 March 2012, the subject received 3rd dose of ENGERIX B (administration site and route unknown, batch number not provided) and 2nd dose of GARDASIL (unknown). The 1st and 2nd doses of ENGERIX B were given 5 years earlier. The vaccination schedule was therefore lengthened. By the end of March 2012, less than one month after vaccination with GARDASIL and ENGERIX B, the subject experienced numbness in the lower limbs extended to hip. Hospital diagnoses were inconclusive. The healthcare professional considered the events were clinically significant (or requiring intervention). On October 2012, a magnetic resonance imaging brain was performed. Multiple sclerosis was suspected. Later on, this diagnosis was confirmed. At the time of reporting, multiple sclerosis was unresolved. The healthcare professional considered multiple sclerosis was possibly related to vaccination with ENGERIX B and GARDASIL. Follow-up information received on 6 March 2013: The DOB and patient''s initials were provided. The lot number of ENGERIX B was provided. The healthcare professional no more considered the case as clinically significant (or requiring intervention) but aw disabling. In March 2012, in addition to the above mentioned events, the subject experienced leg paresthesia. Multiple sclerosis was the hypothesis diagnosis. Follow-up information received on 16 April 2013: In October 2012, multiple sclerosis was diagnosed. Follow-up information received on 22 April 2013: This case was also reported by a physician via a regulatory authority (PT-INFARMED-S201304-63). In March 2012, 3 weeks after vaccination with GARDASIL and ENGERIX B, the subject experienced leg paresthesia and headache. The regulatory authority considered the events were clinically significant (or requiring intervention). Despite treatment, the events were unresolved. Follow-up information received on 21 June 2013: The magnetic resonance imaging brain performed on 23 October 2012 detected multiple dispersed lesions in the white substance of the cerebral tissue. Multiple sclerosis could be present before or after vaccination. The regulatory authority considered multiple sclerosis and leg paresthesia were unlikely related to vaccination with ENGERIX B and GARDASIL. Headache was possibly related. Follow-up information received on 8 July 2013: The regulatory authority considered multiple sclerosis and leg paresthesia were possibly related to vaccination with ENGERIX B and GARDASIL.


VAERS ID: 497102 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-26
Onset:0000-00-00
Submitted: 2013-07-17
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019718 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Disturbance in attention, Gait disturbance, Hypoaesthesia, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging normal, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 06/08/2012, GARDASIL, Immunisation, No adverse event, Dose 2; 04/17/2012, GARDASIL, Immunisation, No adverse event, Dose 1
Allergies:
Diagnostic Lab Data: MRI knee: Normal; Blood test, Normal; Neurological examination, Normal; Ultrasound scan, Normal
CDC Split Type: WAES1307DEU007255

Write-up: Case received from a consumer (patient''s father) on 10-Jul-2013 and medically confirmed on 11-Jul-2013 by a physician. A 15-year-old female patient received the third dose of GARDASIL (lot-no H019718) on 26-Apr-2013. Four weeks post vaccination she developed numbness up to the knee for one time lasting about 5-6 hours. Additionally she developed leg weakness and concentration impaired. The patient had difficulties walking upstairs. She was hospitalised for three days. Blood analysis, MRI of knee and sonography were normal as well as neurological examination. At the time of reporting leg weakness and concentration impaired were ongoing. An examination by a psychologist was planned on 11-Jul-2013. To be noted that the physician underlined that the girl has "family problems". D1 and D2 of GARDASIL (batch-no. for both G017722, lot-no NP00860), given on 17-Apr-2012 and 08-Jun-2012, respectively, were well tolerated.


VAERS ID: 497114 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-11
Onset:0000-00-00
Submitted: 2013-07-17
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 01/2012, Fibromyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN006957

Write-up: Initial information has been received from a physician via the PMDA concerning a 15-year-old female patient with a concomitant disease of fibromyalgia syndrome (diagnosed on January 2012). On 11-APR-2012, the patient received an intramuscular injection (0.5 ml) of GARDASIL (lot No. 9QN03R). No concomitant medication was reported. In January 2012, the patient was given a diagnosis of fibromyalgia syndrome, and she had been visiting the pediatrics department of the hospital of the reporting physician since then. On 11-APR-2012, the patient received the vaccine as described above. As of the beginning of April 2013, symptoms (mainly pain), which had developed after the vaccination, were exacerbated. On an unspecified date, the patient had episodes such like syncope. On 10-JUN-2013, the patient had generalized aching. As of this date, the outcome of the exacerbated pain was not recovered, and that of the syncope was not provided. Reporter''s comments: This report was a request from the patient''s family, although the relationship between the vaccination and the exacerbation of the patient''s currently having disease was unknown. The patient have not been seen for many times. The reporting physician considered that the causal relationship between the exacerbated pain and GARDASIL was unknown. The reporting physician did not report the causal relationship between the syncope and the vaccine. The reporting physician considered that the other possible cause of the exacerbated pain was the exacerbation of the patient''s concomitant disease. The reporting physician assessed the exacerbated pain as serious (disability) and did not assess the seriousness of the syncope. Additional information has been requested.


VAERS ID: 497115 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2012-12-20
Onset:2013-02-12
   Days after vaccination:54
Submitted: 2013-07-17
   Days after onset:154
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H018411 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cleft lip and palate, Foetal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACICLODAN
Current Illness: Maternal exposure timing unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK009149

Write-up: Case was received by a physician via the Health Authorities in a foreign country on 08-Jul-2013 under the reference number DK-DKMA-ADR 22160156 and DK-DKMA-EFO6185. Case medically confirmed. This case is linked to case E2013-05274 (patient''s mother, same vaccine). A foetus had received the first dose of GARDASIL (batch/lot number H018411) via transplacental route on 20-Dec-2012 as the mother of the patient had been vaccinated with GARDASIL (D2) at 6 weeks gestation. The patient received ACICLODAN via transplacental route on 18-Dec-2012 as the mother had received a dose on 18-Dec-2012. On 12-Feb-2013, the patient was diagnosed with cleft lip and palate. At the time of reporting, the outcome of was unknown.


VAERS ID: 497118 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-24
Onset:0000-00-00
Submitted: 2013-07-18
Entered: 2013-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diplegia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307KOR008904

Write-up: This spontaneous report was received from a nurse via a business partner concerning a 36 year old female patient. On 24-APR-2013, the patient was vaccinated with the first dose of GARDASIL injection (vials) (lot number, expiry date, dose and route unspecified). The patient was planned to be vaccinated with the second dose in June but she did not visit the clinic. No concomitant medications were reported. On 11-JUL-2013, the patient visited the clinic. Approximately on an unknown date in 2013, the patient experienced tingling and paralysis symptoms in arms and legs. The patient did not receive any treatment for the symptoms when she visited the clinic. Outcome of the evevnts was unkown. The relatedness for the events was unkonwn for GARDASIL injection (vials). Upon internal review the paralysis symptoms in arms and legs were considered as medically significant. Additional information is not expected.


VAERS ID: 497126 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-25
Onset:0000-00-00
Submitted: 2013-07-17
Entered: 2013-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erysipelas, Lymphoedema
SMQs:, Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 04/14/2008, 06/14/2008, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307FRA008165

Write-up: Case received from a physician on 10-Jul-2013. Case medically confirmed. An adult female patient (age not reported) had received the third dose of GARDASIL (batch number not reported) on 25-Oct-2008. In Feb or Mar-2011 she experienced sudden onset of primary lymphedema in the region of leg. In May-2011 she developed erysipelas also in the region of the leg. She was given amoxicillin as corrective treatment for erysipelas and recovered on an unspecified date. The patient was hospitalized (dates not reported). She was seen by a specialist at the reference center for vascular disease. Primary lymphedema was diagnosed. On 08-Jul-2013 the patient, and her parents, was seen by the reporter. To be noted that the parents were convinced that there was a causal relationship between the adverse reactions and the vaccination with GARDASIL. They were planning on filling a compensation claim. The patient had received the first dose of GARDASIL (batch number not reported) on 14-Apr-2008 and the second dose (batch number not reported) on 14-Jun-2008. She did not have any wound prior to the onset of the events. She did not have any risk factor. At the time of reporting, she was about 20 years old. She had not recovered. Upon medical review the company judged relevant to assess the case as serious due to the "Hospitalization" criterion.


VAERS ID: 497184 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-26
Onset:2013-04-01
   Days after vaccination:65
Submitted: 2013-07-18
   Days after onset:108
Entered: 2013-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Balance disorder, Convulsion, Dyscalculia, Dyspnoea, Fall, Gait disturbance, Headache, Hypoacusis, Illusion, Memory impairment, Menstruation irregular, Migraine, Salivary hypersecretion, Visual acuity reduced
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN009146

Write-up: Initial information has been received from the father of a 12-year-old female patient concerning the patient (his daughter). No information on her concomitant disease and medical history was provided. On 26-JUL-2012, the patient received the first injection of GARDASIL intramuscular drug (lot No., injection site and indication not reported). No information on concomitant medication was reported. Around July 2012, the patient had had headache since around the first vaccination, she thought it was migraine. On 29-SEP-2012, she received the second injection of GARDASIL intramuscular drug (lot No., injection site and indication not reported). On 26-JAN-2013, she received the third injection of GARDASIL intramuscular drug (lot No., injection site and indication not reported). On an unspecified date, a surgeon on A hospital considered the patient''s symptom to be psychological and prescribed BRUFEN and an antiepileptic drug (unspecified). The patient, however, complained that she wanted to die more than before, and her father stopped her from taking those drugs and decided not to go to the A hospital again. On an unspecified date, the patient received close examinations at B clinic, but the physician of the hospital said that the cause was still unknown even though he/she checked many medical books. On an unspecified date, a pediatrician of C hospital, where the patient had visited many times since she was little, recognized vaccination, but none of examinations could prove rationale. Around April 2013, the patient presented to the pediatrics department of D hospital, which she visited when she was little, but nothing was found even though inner blood vessel was examined. As the patient''s symptoms, the attending pediatrician reported fall, dyscalculia, memory impairment, convulsion, perceptual disturbance, visual acuity reduced, hypoacusis, balance disorder, difficulty in walking, dyspnea, arthralgia, salivary hyposecretion and menstrual irregularity. The pediatrician, however, told the patient''s father that her symptoms were due to the vaccination but there was no data which prove it. The patient was referred to E hospital because the hospital treats patients in a serious condition, can obtain any information quickly and can response to an emergency. On an unspecified date, the patient presented to the E hospital, where symptoms of the patient were considered to be psychological. The attending physician said that it would take years, at least a few years, for recovery. On an unspecified date, the patient fell over for headache, and then she was sent to hospital by ambulance because of a 2 to 3-hour convulsion (From April 2013, the patient''s falling frequency was increasing). She could not go to school although she used to run in the playground as member of kendo club before. She felt as if she was falling down stairs. At the time of this report, the outcome of all the reported events (headache, fall, dyscalculia, memory impairment, convulsion, perceptual disturbance, visual acuity reduced, hypoacusis, balance disorder, difficulty in walking, dyspnea, arthralgia, salivary hyposecretion and menstrual irregularity) was unknown. Reporter''s comment: The father thought that the hospital E had no inadequate skill or facility. The reporter (the patient''s father) did not assess the seriousness of the events (headache, fall, dyscalculia, memory impairment, convulsion, perceptual disturbance, visual acuity reduced, hypoacusis, balance disorder, difficulty in walking, dyspnea, arthralgia, salivary hyposecretion and menstrual irregularity). Upon internal review, convulsion and hypoacusis were determined as serious (other clinically important events). The reporter (the patient''s father) did not assess the causal relationship of the events (headache, fall, dyscalculia, memory impairment, convulsion, perceptual disturbance, visual acuity reduced, hypoacusis, balance disorder, difficulty in walking, dyspnea, arthralgia, salivary hyposecretion and menstrual irregularity) to GARDASIL. No further information is available.


VAERS ID: 497189 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-04
Onset:0000-00-00
Submitted: 2013-07-18
Entered: 2013-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0788AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram head normal, Seizure like phenomena, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unspecified date Cerebral CT examination showed no abnormality.
CDC Split Type: WAES1307JPN006950

Write-up: Initial information has been received from a physician concerning a female (age unknown). The patient had no concurrent conditions or past medical history. On an unspecified date, she was vaccinated with GARDASIL, intramuscular injection drug (1st time). On an unspecified date, she was vaccinated with GARDASIL, intramuscular injection drug (2nd time). On an unspecified date, she was vaccinated with GARDASIL, intramuscular injection drug (3rd time). No concomitant medications was reported. On an unspecified date, when the vaccination, syncope developed. On an unspecified date, after the vaccination, the patient experienced epileptic seizure-like symptoms. Cerebral CT examination showed no abnormality. As of reporting date, the outcome of syncope was unknown. The outcome of epileptic seizure was not recovered. Reporter''s comments: none The reporting physician felt that epileptic seizure was serious due to other important medical events and that is was related to GARDASIL. The reporting physician did not assess the seriousness of syncope or its relationship to GARDASIL. Additional information has been requested.


VAERS ID: 497192 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-03-15
   Days after vaccination:3
Submitted: 2013-07-19
   Days after onset:126
Entered: 2013-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Nausea, Rash, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307GBR010621

Write-up: This case was received from the health authority on 12-Jul-2013. GB-MHRA-ADR 2166575. This case is medically confirmed as it was reported by a pharmacist. A 13 year old female (weight: 57kg) patient received on 12-Mar-2013 an injection of GARDASIL, (batch number not reported) intramuscularly, dose and site of administration not reported and on 15-Mar-2013 the patient experienced nausea, blurred vision, dizziness, rash, severe headache, lasting 2.5 weeks. She attended A&E twice and also the GP six times. The patient already received a pervious dose of GARDASIL in the past. The patient fully recovered on an unreported date. The MHRA considered that case serious due to be medically significant as the symptoms lasted over 2 weeks.


VAERS ID: 497193 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2013-01-03
Onset:0000-00-00
Submitted: 2013-07-18
Entered: 2013-07-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Congenital absence of cranial vault, Congenital adrenal gland hypoplasia, Congenital diaphragmatic hernia, Death, Foetal exposure during pregnancy, Pulmonary hypoplasia
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Maternal exposure timing unspecified
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK009995

Write-up: Case was received by a physician via the Health Authorities on 08-Jul-2013 under the reference DK-DKMA-ADR 22166169. Case medically confirmed. This case is linked to case E2013-05277 (patient''s mother, same vaccine). A foetus had received the second dose of GARDASIL (batch number not reported) via transplacental route on 03-Jan-2013 as the mother of the patient had been vaccinated with GARDASIL. On an unspecified date the patient developed absence of cranial vault, congenital diaphragmatic hernia, congenital adrenal gland hypoplasia and pulmonary hypoplasia. Abortion was induced. The patient died on 11-Mar-2013. Autopsy was determined. It was reported that the mother was 19 gestation week at the time of the events but it was not specified whether it was at the time of vaccination, at the time of induced abortion or at the time of congenital anomalies diagnosis. The mother received D1 of GARDASIL on 06-Nov-2012, toleration not reported.


VAERS ID: 497268 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-06-28
Onset:0000-00-00
Submitted: 2013-07-22
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H001930 / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test normal, Mechanical urticaria, Rash generalised, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, Normal
CDC Split Type: WAES1305SWE009609

Write-up: Case received from a Health Care Professional on 18-Mar-2013. Case medically confirmed. A 14-year-old female patient had received an injection of GARASIL (dose 1, batch number unk) in later April 2012 and 1-2 weeks p-v she developed general itchy rash, dermographia which was not atopic. Symtoms most present during the nights. She received treatment with cetirizin with some effect. The patient received GARDASIL dose 2 (batch number unk.) on 28-Jun-2012 and after this vaccination the symptoms aggravated. The symptoms now also appeared more in daytime. She was referred to the children''s allergist with pronounced dermographia. She was also prescribed ATARAX and SINGULAIR. Phototherapy was planned. At the time of reporting, the outcome was not recovered. According to the reporter, the reaction was possible related to vaccination. Follow-up information received from health care professional via health authority on 16-Jul-2013. The patient refused third GARDASIL vaccination. According to the reporter the patient was diagnosed with dermagraphia and urticaria factitia (onset date unspecified in Apr-2012). HA received information on 17-Jun-2013: Pruritus and urticaria came and went. The patient used cetirizin and MINIDERM x 2, she experienced now that it was no longer helping. Laboratory tests were normal. She was referred to an allergy department. Batch number of GARDASIL dose 1 was G009842. Seriousness was upgraded to serious due to medical important event. Batch number of GARDASIL dose 2 was H001930. HA MedDra coded: Urticaria, dermographia and pruritus. The events assessed by HA as possible related to vaccination.


VAERS ID: 497269 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-06-05
Onset:2012-07-01
   Days after vaccination:26
Submitted: 2013-07-19
   Days after onset:383
Entered: 2013-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN04R / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Agitation, Anxiety, Back pain, Convulsion, Crying, Electroencephalogram abnormal, Epilepsy, Headache, Inferiority complex, Malaise, Memory impairment, Pain in extremity, Somatoform disorder, X-ray limb normal
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-Ray examination results (03JUL2012): showed no abnormality on the right upper limb. Unspecified test: showed that patient''s brain waves were found to be normal. Unspecified test: Final brain wave examination, showed epileptic abnormal waves. 10/16/2012, Body temperature, 36.2 degrees C; 03/05/2013, Body temperature, 36.2 degrees C; 06/05/2013, Body temperature, 36.5 degrees C
CDC Split Type: WAES1307JPN006704

Write-up: Initial information has been received from a physician via the concerning a 12 year old female with no family history. On 05-JUN-2012, she was vaccinated with GARDASIL IM injection drug 0.5 ml (lot No. 9QN04R), (first time vaccination) in the left upper limb. No concomitant medication was provided. On 05-JUN-2012, her body temperature before the vaccination was 36.5 C, and no important point on the patient was stated in the vaccination coupon. The patient received the vaccination as described above. On 01-JUL-2012, at around 12:30, the patient had generalised convulsion and pain in right upper limb (vaccination in the left upper limb). On 03-JUL-2012, the pain in right upper limb improved. X-ray examination showed no abnormality on the right upper limb. On an unspecified date, the patient still sometimes had low back pain of unknown origin. On an unspecified date, the convulsion still appeared sporadically, and epilepsy was diagnosed by a physician of a nearby hospital (her brain waves were found to be normal). The patient started to take oral TEGRETOL, which was ineffective. On an unspecified date, carbamazepine was switched to EXCEGRAN, and frequency of the convulsion decreased, meanwhile the patient developed somatoform disorder-like symptoms (such like temporary memory disorder, sudden cry, and sudden excitement) and their frequency increased. At school, she had the convulsion and somatoform disorder-like symptoms with anxiety, feeling of inferiority, and headache and malaise of unknown origin; she could not to go to school because of the symptoms. On 16-OCT-2012, the patient was vaccinated with GARDASIL (Lot # 9QN04R) injection drug (second time) during the clinical course observation. Her body temperature before the vaccination was 36.2 C. On 05-MAR-2013, the patient was vaccinated with GARDASIL (Lot # 9QN07R) injection drug (third time) during the clinical course observation. The body temperature before the vaccination was 36.2 C. On an unspecified date, the final brain wave examination showed epileptic abnormal waves. As of 03-JUL-2013, the patient had not recovered from the generalised convulsion, pain in right upper limb, low back pain, epilepsy, malaise, headache or somatoform disorder. Comment from the reporting physician: Epileptic abnormality waves were found in our final brain wave examination, which implied epilepsy-related abnormality. Meanwhile, the patient had other symptoms, and these events and the vaccination were at the same; the causal relationship between the GARDASIL and these events cannot be ruled out. The reporting physician considered that the generalised convulsion, pain in right upper limb, low back pain, epilepsy, malaise, headache and somatoform disorder were related to the vaccine. The reporting physician considered that the other possible cause of these events was the epilepsy that had developed at the same time as the vaccination. The reporting physician assessed the generalised convulsion pain in right upper limb, low back pain epilepsy, malaise headache and somatoform disorder as all serious (other medically important events). Additional information is not available.


VAERS ID: 497270 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-02
Onset:2013-07-02
   Days after vaccination:0
Submitted: 2013-07-19
   Days after onset:17
Entered: 2013-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J004473 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Fall, Head injury, Headache, Hypertonia, Lip haemorrhage, Loss of consciousness, Somnolence, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307POL009121

Write-up: Patient (girl) was on 02-JUL-2013 at 18:15 vaccinated with SILGARD (volume: 0.5 ml), injection site: left arm, route of administration: i.m. (lot and batch: J004473, exp 10/2015), MAH Ltd. On reporting form of post-vaccine reaction other than BCG was noted: seizures first episode. In narrative section physician reported: after administration of the vaccine loss of consciousness, non-febrile seizures first episode. The child fell on the floor and hit her head on the floor. Increased muscle tone loss of consciousness for 15-20 seconds. Bite of tongue. After the fall headache, somnolence and battered. Pulse 68/minute, heart rate regular, RR 110/80. Due to head injury and bleeding from the lip patient referred to the hospital. According to form post-vaccine reaction occurred on 02-JUL-2013 at 18:15. Medical outcome: the child is still treated at hospital.


VAERS ID: 497272 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-02-13
Onset:0000-00-00
Submitted: 2013-07-19
Entered: 2013-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0108AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse drug reaction, Amino acid level normal, Asthenia, Blood pyruvic acid normal, Bronchitis, Circadian rhythm sleep disorder, Condition aggravated, Depressed level of consciousness, Depression, Dizziness, Educational problem, Headache, Hypersomnia, Imaging procedure, Laboratory test normal, Malaise, Musculoskeletal pain, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging thoracic abnormal, Organic acid analysis, Orthodontic appliance user, Orthostatic intolerance, Pharyngeal erythema, Presyncope, Somnolence, Unresponsive to stimuli, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Abnormal symptom; Familial risk factor, Migraine (Father and mother) and Hypotension (father); 04/--/2012, Headache; 04/--/2012, Orthostatic intolerance
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 06/--/2012, Amino acid level, normal; 06/--/2012, Blood pyruvic acid, normal; 06/--/2012, Imaging procedure; 2012, Imaging procedure, Normal, Results were normal except for mild bronchitis; 2012, Nuclear magnetic resonance imaging, brain, normal; 06/--/2012, Organic acid analysis, normal
CDC Split Type: WAES1307JPN007078

Write-up: Initial information has been received from a physician via PMDA concerning a 13 years old female patient. Orthostatic dysregulation was stated in the medical history interview as a point to remember on the patient. The patient had a family history of migraine (her father and mother) and hypotension (her father). In the afternoon 16-DEC-2011, the patient received the first injection of GARDASIL (batch # 9QN01R, also reported as 9QN02R) (injection site, dose not provided) intramuscularly. Her body temperature before the vaccination was 36.5 C. In the afternoon 13-FEB-2012, the patient received the second injection of GARDASIL (batch #9QN02R, lot#0108AA) intramuscularly (injection site, dose not provided) in the afternoon. Her body temperature before the vaccination was 36.8 C. No concomitant medication was reported. Since April 2010, the patient had been visiting the department of pediatric of another hospital as an outpatient for orthostatic dysregulation, chronic headaches, etc. Around February 2012, headache, queasy, vomiting, sleepiness and generally unwell developed in the patient. On 14-FEB-2012, one day after the second vaccine, the patient had felt headache and pain in shoulder strongly, but she went to school after taking loxoprofen (painkiller). On 22-FEB-2012, the headache and queasy became severe, and the patient visited the reporter''s hospital as an outpatient. Blood and imaging tests were performed, and the patient was to be allowed followed up with medication as aggravation of orthostatic dysregulation. From 14-MAR-2012 to 18-MAR-2012, the patient was hospitalized because of worsening of abdominal symptoms, physical decondition and headache (first hospitalization). These symptoms got better and worse thereafter, Around May 2012 (also reported as June 2012), the patient started to skip school because of worsening of headache, queasy, etc. From 09-MAY-2012 to 12-MAY-2012, the patient was hospitalized (second time). In June 2012, the symptoms were worsened. The patient told that sumatriptan succinate was ineffective, loxoprofen was effective a little and ibuprofen was low in effectiveness; she had orally been receiving Hange-byakujutu-tenmato (Chines herbal medicine). On 21-JUN-2012, she was depressed. On 22-JUN-2012, the patient visited the reporter''s hospital. From 22-JUN-2012 to 25-JUN-2012, the patient was hospitalized (third time) and underwent close examinations. (Examination results) No marked abnormality was found in the imaging or biochemistry. Acidum lacticum, pyruvic acid and amino acid analysis was normal. (Clinical course during hospitalization) The patient was closely watched with transfusion with cyproheptadine hydrochloride hydrate, amezinium metilsulfate (orally), loxoprofen (as needed). On 22-JUN-2012, the day the patient was admitted to the hospital, the patient was watching TV sitting on the bed, eating snacks and chatting with others pleasantly in the afternoon. On 23-JUN-2012, the patient was sleeping all the time in the morning. On 24-JUN-2012, drip infusion was discontinued because the patient was energetic. On 25-JUN-2012, the patient left the hospital cheerfully. The patient had been followed up as an outpatient since then. On 10-NOV-2012, frequency of headache was increasing probably because of the patient''s bad habit (sleeping, diet, etc.) those days. On 20-NOV-2012, the patient showed no response at all in the morning when the patient''s mother went into the patient''s room, and her mother called the outpatient department of the reporter''s hospital. It was considered to be transient consciousness clouding. From 20-NOV-2012, to 10-DEC-2012, the patient was hospitalized (fourth time) for headache, close examinations and to improve generally unwell through improvement of daily habit. (Status at admission) The patient''s consciousness was clear, and there was not neurological abnormality. Mild redness of pharynx was observed. Imaging test results were all normal except for mild bronchitis. (Clinical course) There was no abnormality which was considered to be the cause of loss of consciousness in none of examinations; the event was considered to be due to vagal reaction associated with the orthostatic dysregulation. The patient had continuously been taking amezinium metilsulfate and Hange-byakujutu-tenmato for orthostatic dysregulation. The patient''s daily habit was bad (especially on sleep) just before the admission, for which zolpidem tartrate (bed time dosing) was started, but the drug was discontinued within a day because the patient had symptoms like giddiness and light-headed feeling. The patient was then instructed to keep regular hours. The patient took ibuprofen and loxoprofen as needed because of her chronic headaches. The braces on her teeth were transiently removed at the dental clinic. Head MRI was performed, which resulted in normal. Continuous oral treatment with Gorei-san (Chinese herbal medicine, pediatric medication for migraine) (three times a day) was started to control chronic headaches. Also, treatment plan for headache was changed: at the time of headache, Shakuyaku-kanzo-to (Chinese herbal medicine) was first administered for pain relief, and ibuprofen and loxoprofen were next administered orally only when the headache did not improve. During the hospitalization, the patient sometimes stayed at home as an attempt to improve the daily habit at home, and then she tried to go to school as trial after improvement or her daily habit. On 10-DEC-2012, the patient was discharged from the hospital as the patient became able to be followed up as outpatient. The patient''s clinical course was then followed up at the outpatient department. She scarcely attended the school because of continuous headache and physical deconditioning in the morning. She slept mostly in the morning and sometimes felt better in the afternoon. The patient was continuously observed closely at the outpatient department, and headache queasy, sleepiness, generally unwell and school failure were persisting. On an unspecified date, the patient changed the private junior high school to a public junior high school because of difficulty in commuting. When the patient had strong sleepiness, especially in February and March 2013, she reportedly stayed in the bed for 17-18 hours a day. She stayed almost all day in the bed every day because of disturbance of sleep-wake rhythm after amezinium metilsulfate was changed to midodrine hydrochloride, but she complained of strong headache and generally unwell after the drug was switched back to amezinium metilsulfate. The drug was then changed to etilefrine hydrochloride, and the patient''s condition became stable. Loxoprofen and ibuprofen were still used for continuous headache. On 25-MAY-2013, the patient was referred to the psychiatric hospital because of no improvement of the symptoms (headache, queasy, sleepiness, generally unwell, school failure) despite the long-term treatment. Reporter''s comment: Based on the recent adverse reaction reports on cervical cancer vaccine, exacerbation of the patient''s symptoms and their continuous appearance are considered to have a strong relationship to GARDASIL. The reporting physician considered that headache, queasy, vomiting, sleepiness, generally unwell and school failure were related to GARDASIL and also considered orthostatic dysregulation as the other possible cause of the events. The reporting physician did not assess the causal relationship of worsening abdominal symptom, transient consciousness clouding, mild bronchitis to the vaccine. Reporting physician assessed headache, queasy, vomiting, sleepiness, generally unwell, school failure, worsening abdominal symptom, transient consciousness clouding as serious (hospitalization) and did not assess the seriousness of the mild bronchitis. Follow up information has been received, concerning the batch validation for the first dose (Batch # 9QN01R with a valid lot number 1336Z) and for the second dose (Batch # 9QN02R with a valid lot number 0108AA) GARDASIL. Additional information has been requested.


VAERS ID: 497275 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-25
Onset:0000-00-00
Submitted: 2013-07-22
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Vaccination site nodule, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307SWE010449

Write-up: Case received from a Health Care professional via the Health Authorities on 16-Jul-2013 under the reference no. MPA 132256. Case medically confirmed. An 11-year-old female patient, had received the third dose of GARDASIL (batch no. not reported) on 25-Apr-2013. The patient developed pain and skin nodule at the vaccination site (2x2 cm) tender, around 1 cm deep, well defined. The side effect was shown to the reporter on 16-May-2013. At the time of reporting, the patient had not yet recovered. The Health Authority assessed the events as possibly related to GARDASIL. D1 and 2 of GARDASIL were given on unspecified dates, toleration not reported.


VAERS ID: 497279 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-24
Onset:2013-06-29
   Days after vaccination:5
Submitted: 2013-07-22
   Days after onset:23
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002122 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune thrombocytopenia, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Thrombocyte count (date unknown): 0.
CDC Split Type: WAES1307DNK010539

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Jul-2013 under the references DK-DKMA-ADR 22166999 and DK-DKMA-EFO6241. Case medically confirmed. A 22-year-old female patient had received the second dose of GARDASIL (lot-no. J002122) via intramuscular route on 24-Jun-2013. On 29-Jun-2013, the patient developed severe immune thrombocytopenia purpura (ITP) with thrombocyte count 0. At the time of reporting, the patient had not recovered. The patient received D1 of GARDASIL on 25-Apr-2013 (batch no. J000160), toleration was not reported.


VAERS ID: 497411 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-16
Onset:2012-11-16
   Days after vaccination:0
Submitted: 2013-07-22
   Days after onset:247
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015182 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Headache, Laboratory test, Lymphadenitis, Malaise, Menstruation irregular, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Fertility disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 08/30/2012, GARDASIL, Dose 1, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307DNK010012

Write-up: Case received from a health care professional via the Health Authorities on 15-Jul-2013 under the references DK-DKMA-ADR 22169345 and DK-DKMA-EFO6255. Case medically confirmed. A 23-year-old female patient, with a medical history of diffuse symptoms 10 days prior vaccination, had received the second dose of GARDASIL (lot-no. H015182, Expiration Date 28-FEB-2015) via intramuscular route on 16-Nov-2012. On the same day the patient developed malaise, swelling of lymph nodes, rash, headache, irregular menstruation and pain in leg. The patient was hospitalised. Investigations and laboratory tests were performed (not further specified). The patient recovered with sequelae on 01-Jun-2013. The patient received D1 of GARDASIL on 30-Aug-2012, toleration was not reported.


VAERS ID: 497416 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-05-11
Onset:2011-05-12
   Days after vaccination:1
Submitted: 2013-07-22
   Days after onset:802
Entered: 2013-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Fatigue, Malaise, Musculoskeletal chest pain, Pain in extremity, Pain in jaw, Palpitations, Paraesthesia, Presyncope
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline; MYSOLINE; KESTIN
Current Illness: Immunisation
Preexisting Conditions: 2011, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307FRA010023

Write-up: Case received from a pharmacist on 17-May-2011. Case medically confirmed. A 15-year-old female patient had received the second dose of GARDASIL (batch number not reported) in the right side on 12-May-2011 and 12 hours later, she experienced a vasovagal malaise. On an unspecified date she also complained of tingling in the hands and intercostal pain radiating to the jaw and the arm. The patient was taking concomitantly an anti-acne treatment and apparently one week earlier she was given MYSOLINE and doxycycline (to be confirmed). Five days after vaccination the patient had residual intercostal pains. She visited her physician who gave her corrective treatment with ibuprofen. The patient had no relevant medical history. She had received the first dose of GARDASIL (batch number not reported) uneventfully on an unspecified date. At the time of reporting the patient had recovered from vasovagal malaise and had not recovered from intercostal pain and tingling in the hands. Follow-up information received from the health authorities on 08-Jun-2011 under the reference number BX20110604: Case upgraded to serious by the Health Authorities. The patient had received the dose of GARDASIL (batch number not reported) on 11-May-2011 (instead of 12-May previously reported) at 7 pm. On the following morning she presented with vagal malaise and intercostal pain irradiating at the level of the back, the arm and the jaw with tingling in the fingertips of the left hand. The evolution was reported as favorable 5 days after vaccination although intercostal pain were still present. The patient was concomitantly taking doxycycline and KESTIN. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as possible (C2 S2 I2) according to the country''s method of assessment. To be noted that Health Authority coded "Intercostal pain" and "Malaise". Additional information received from the initial pharmacist reporter on 09-Jun-2011: The vaccine was administered in the deltoid. It was reported that the patient was not taking any concomitant treatment at the moment of the injection nor in the following days. Twelve hours after vaccination, she presented with vagal malaise which resolved within a few seconds, and pain in arm and shoulder associated with tingling in the hand opposite to the injection side. At the time of reporting, the patient still presented with fatigue and "morning palpitations", associated with chest discomfort of spikes type, with dorsal irradiation. The final outcome was not reported. The reporter did not provide any seriousness assessment. Follow-up information received on 25-May-2012: Everything was back to normal. There was no further recurrence. Follow-up information received from the pharmacist on 12-Jul-2013. Upon request from the Health Authorities, the reporter was contacted to update the documentation of the case. The pharmacist reported that pain lasted for 15 days. He did not deliver the third dose of GARDASIL and did not know whether or not the patient had received this third dose. Dose 1 was delivered in Jan-2011. He did not have medical reports and did not know if exams were performed or not. Final outcome was recovered without sequelae. Upon internal review, anti-acne treatment was removed as already captured with doxycycline. On 16-Jul-2013: Case replaces case E2011-03112 which will be deleted and nullified due to technical error (misrouting). This case, E2013-05414 will be the new referent case.


VAERS ID: 497429 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-31
Onset:0000-00-00
Submitted: 2013-07-23
Entered: 2013-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN08R / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 36.4 degrees C
CDC Split Type: WAES1306JPN005106

Write-up: This spontaneous report as received from an other health professional refers to a 14 year old female patient. On 31-MAY-2013 the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11,16,18) (manufacturer unknown), intramuscular. She was also vaccinated with quadrivalent human papillomavirus (manufacturer unknown) on two unknown dates. On 31-MAY-2013 the patient experienced syncope. The outcome of syncope was reported as recovering/resolving. The reporter considered syncope to be related to quadrivalent human papillomavirus (types 6, 11, 16, 18) (manufacturer unknown). Follow up information has been received from a physician and a pharmacist via the PMDA concerning a 14-year-old female patient. There was no special point to attention (e.g.: underlying disease, past medical history, allergy, past history of vaccination within recent one month, past ADR history, growth status) on the patient in the vaccination coupon. The body temperature before the vaccination was 36.4 C. On 31-MAY-2013, the patient received the third injection of syringe-type GARDASIL intramuscular (IM) drug (lot No. reported as 9QN08R, exp. date not reported) (injection site and indication not provided). The patient had been taking no concomitant drug. On an unspecified date, the patient received the first vaccination of GARDASIL. On an unspecified date, the patient received the second vaccination of GARDASIL. On 31-MAY-2013, at 14:55, the patient received the third vaccination of GARDASIL. After the vaccination, the patient suddenly lost consciousness and had respiratory arrest. Also, vasovagal syncope developed. The patient recovered from the symptoms on 31-MAY-2013 with oxygen. Reporting pharmacist''s comment: The syncope developed after the third vaccination in the patient. The reporter was surprised at this because the reporter heard the symptom tended to occur after the first vaccination of the vaccine. The reporting physician considered vasovagal syncope, loss of consciousness and respiratory arrest serious (life threatening). The reporting physician assessed vasovagal syncope, loss of consciousness and respiratory arrest as definitely related to GARDASIL and considered reflex response to pain to be other possible cause of the events. Upon internal review, loss of consciousness and respiratory arrest were considered to be medically significant. Additional information has been requested.


VAERS ID: 497430 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-23
Entered: 2013-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307KOR012208

Write-up: This spontaneous report was received via a company representative from a physician concerning a female patient of unknown age. On an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL (batch#, expiry not reported). On an unknown date in 2011, the patient experienced convulsion after GARDASIL vaccination in 2011 and the patient''s parents reported the event to local HA. At the time of report, the patient was taking steroid (unspecified). The outcome of convulsion was unknown. Upon internal review the event convulsion was considered to medically significant. Additional information is not expected.


VAERS ID: 497501 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-19
Onset:2013-06-20
   Days after vaccination:1
Submitted: 2013-07-24
   Days after onset:34
Entered: 2013-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019078 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bone pain, Gait disturbance, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Post viral fatigue syndrome; Eczema; Chronic fatigue syndrome; Asthma
Preexisting Conditions: Measle and rubella vaccine live, vomiting; Measles and rubella vaccine live, malaise; Measles and rubella vaccine live, rash; Measles and rubella vaccine live, febrile convulsion
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307GBR012103

Write-up: This case was received from the health authority on 15-Jul-2013. GB-MHRA-ADR 22168718. The case is linked with E2013-05463 (same patient, different vaccine and events). This case is medically confirmed as it was reported by a healthcare professional. A female patient (age unspecified) received on 19-Jun-2013 an injection of GARDASIL (batch number H019078) 0,5 mL intramuscularly, dose in series and site of administration not reported and on 20-Jun-2013 experienced severe pain in legs (down to the bone), difficulty in walking. The patient didn''t receive corrective treatment. Her condition was improving 6 days later. The patient''s medical history included asthma, chronic fatigue syndrome, eczema and myalgic encephalomyelitis. The patient was previously vaccinated with MMR (manufacturer unknown) and experienced febrile convulsion, rash, vomiting and felt unwell (see linked case). At the time of reporting, the patient was recovering. The MHRA considered that case serious due to be medically significant.


VAERS ID: 497535 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-24
Entered: 2013-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cyanosis, Electrocardiogram normal, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: Loss of consciousness, Once when she was having dinner
Allergies:
Diagnostic Lab Data: Electrocardiogram, Normal
CDC Split Type: WAES1307LBN011852

Write-up: This spontaneous report as received from a physician refers to a 12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1 (route, dose and lot number not provided) and a minute after the dose was administered the patient lost her conscious and turned blue. She remained in this condition for around 80 seconds and then woke up normally. The girl''s mother said that this happened to her once when she was having dinner. The physician asked her to do analysis tests that included an electrocardiogram, and said everything was normal. The causal relationship was not reported. It was noted that the patient''s mother was afraid now of giving her the therapy second dose. Upon internal review loss of consciousness was considered to be medically significant. Additional information has been requested.


VAERS ID: 497587 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-29
Onset:2013-07-01
   Days after vaccination:2
Submitted: 2013-07-24
   Days after onset:23
Entered: 2013-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 06/29/2013, Body temperature, 36.1 degrees C
CDC Split Type: WAES1307JPN010774

Write-up: Initial information has been received from a physician via PMDA concerning a twelve year old female. According to medical history interview including underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, past history of ADR, status of growth, the patient had no problem. The patient had no problems. The patient had no family history. The body temperature before vaccination was 36.1 C. On 29-JUN-2013 10:30 am, she was vaccinated with GARDASIL for intramuscular injection (batch No. 9QN08R, lot No. 0989AA, exp 21-JUN-2014), (1st time of vaccination) (dose, injection site or indication was not reported). No concomitant medications was reported. Then for 1-2 days she avoid strenuous exercise. 2-3 days after the vaccination, about 01-JUL-2013, pain around the injection site and left arm mobility decreased developed. On the morning 01-JUL-2013, she had difficulty in raising the left arm. Later it became improving, but movement of the left arm was restricted due to pain. At the time of the report, pain around the injection site and left arm mobility decreased persisted. Reporter''s comments: None. The reporting physician felt that pain around the injection site and mobility decreased were related to GARDASIL intramuscular injection. The reporting physician felt that pain around the injection site and mobility decreased was serious (possible disability). Pain around the injection site and mobility decreased were considered to be medically significant. Additional information has been requested.


VAERS ID: 497616 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-25
Entered: 2013-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN013477

Write-up: Initial information has been received from a physician (also reported pharmacist) concerning a female patient (age unknown), who received a GARDASIL intramuscular (IM) injection drug (third time) (vaccination date, lot No, dose, injection site and indication not provided). No concomitant medication was reported. On an unspecified date, the patient received a GARDASIL IM injection drug (first time) (vaccination date, lot No, dose, injection site and indication not provided). On an unspecified date, the patient received a GARDASIL IM injection drug (second time) (vaccination date, lot No, dose, injection site and indication not provided). On an unspecified date, the patient received the third vaccine as described above and had syncope and convulsion after the vaccination. At the time of this report, the outcome of the syncope and convulsion was unknown. The reporting physician did not assess the causal relationship of the syncope and convulsion to GARDASIL. The reporting physician did not assess the seriousness of the syncope and convulsion. Upon internal review, convulsion was determined as serious (other important medical event). No further information is available.


VAERS ID: 497660 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-07-25
Entered: 2013-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307HKG012891

Write-up: This spontaneous report was received from a consumer who read on a newspaper concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (doses, route of administration and lot # not reported). On an unknown date, the patient was diagnosed with some sort of blood cancer 1 year after receiving GARDASIL. At time of reporting, the patient''s outcome of blood cancer was unknown. This is one report of two reports from the same reporter. By internal review this event was considered to be medically significant. Additional information is not expected.


VAERS ID: 497739 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-20
Onset:0000-00-00
Submitted: 2013-07-26
Entered: 2013-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abortion spontaneous, Fatigue, Uterine dilation and curettage
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307CAN013706

Write-up: This spontaneous pregnancy report as received from a nurse refers to a 28 year old female patient. On 17-JAN-2013 (dose #1) the patient was vaccinated with GARDASIL, on 13-MAR-2013 (dose #2) and 20-JUL-2013 (dose #3). The patient received her 1st dose on 17-JAN-2013, her second dose on 13-MAR-2013. On 01-JUN-2013, she got the confirmation that she was pregnant. On 10-JUN-2013, she lost the baby (medically significant). Her third dose was given on 20-JUL-2013. Lot number provided for dose #3 is: H015796. The outcome is unknown. It is unknown if the event "abortion spontaneous" is related to GARDASIL. On 25-JUL-2013, response to a follow-up request received from the nurse. Lot number was provided: H015796, expiry date: 21-NOV-2014. The patient was due for her third dose and since the clinic was closed that day, and the nurse is the patient''s neighbor, the nurse agreed to administer the vaccine. Before doing so, the nurse went on Merck''s website to get all the information necessary on the product. Dose was well tolerated. The nurse reported stated that the patient had a miscarriage recently; a pregnancy test was done on 01-JUN-2013, no method of contraception was used. The patient experienced abdominal discomfort and significant fatigue for approximately 10 days following the pregnancy test. She went to the hospital (date not provided), she lost the baby, no fetal heart as per patient. A curettage was needed. No further information can be provided.


VAERS ID: 497848 (history)  
Form: Version 1.0  
Age: 29.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-11
Onset:2013-03-27
   Days after vaccination:16
Submitted: 2013-07-29
   Days after onset:124
Entered: 2013-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019870 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Biopsy kidney abnormal, Biopsy skin, Henoch-Schonlein purpura, IgA nephropathy, Leukocytoclastic vasculitis, Protein urine present, Proteinuria, Rash macular, Skin ulcer, Type 2 diabetes mellitus
SMQs:, Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 05-Apr-2013 the dermatologist made a skin biopsy and the patient is inserted on Prednisolone therapy. On 09-Apr-2013 the patient was found having proteinuria 1.8 g and a renal biopsy was made which showed IgA-nephropathy/Schoenlein-Henoch.
CDC Split Type: WAES1307DNK014839

Write-up: Case received from a physician (specialist) via the Health Authorities on 23-Jul-2013 under the reference number DK-DKMA-ADR 22187135 and DK-DKMA-EFO6378. Case medically confirmed. A 30-year-old female patient had received an injection of GARDASIL (dose 1, 0.5 ml, batch number H019870, intramuscular route of administration, site- and form of administration not reported) on 11-Mar-2013 and later on the 27-Mar-2013 she developed Leukocytoclastic vasculitis (Schoenlein-Henoch purpura), skin ulcers and dark red splotches. The patient was hospitalized 31-Mar-2013 because of the vasculitis. On 05-Apr-2013 the dermatologist made a skin biopsy and the patient was initiated with Prednisolone therapy (other manufacturer, dose not reported, batch number not reported, site-, route- and form of administration not reported). On 09-Apr-2013 the patient was found having proteinuria 1.8 g and a renal biopsy was made which showed IgA-nephropathy-Schoenlein-Henoch. The patient received during hospitalization (on 10-Apr-2013) the diagnosis of diabetes mellitus type 2, which the reporter considered as medical history and not as an adverse reaction to GARDASIL. The patient was discharged from the hospital on 10-Apr-2013. The last patient examination has revealed healing of skin ulcers and now improvement on the dark red splotches. The reporter also states that the biochemical parameters are improving. Prednisolone dose has been reduced to 2.5 mg. The patient has no other vaccines or medications. HA coded diabetes as medical history. Physician (the primary reporter) had assessed diabetes as medical history and not related to GARDASIL and it is unknown whether it is continuing (coded by HA). Upon medical review the company judged relevant to code the following adverse event: IgA nephropathy which was mentioned by the HA in the narrative, but not coded. At the time of reporting, the outcome was recovering.


VAERS ID: 497956 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-04-01
Onset:2013-06-01
   Days after vaccination:61
Submitted: 2013-07-30
   Days after onset:59
Entered: 2013-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Haematemesis, Hypoaesthesia, Laboratory test normal
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, Negative
CDC Split Type: WAES1307JPN015269

Write-up: Initial information has been received from a physician via the PMDA concerning a 16-year-old female patient. In APR-2013, the patient received GARDASIL IM (third time) (lot no, dose, injection site not provided). No concomitant medication was reported. In SEP-2012, the patient received GARDASIL IM (first time) (lot no, dose, injection site not provided). In NOV-2012, the patient received a GARDASIL IM (second time) (lot no, dose, injection site not provided). In APR-2013, the patient received a GARDASIL IM (third time) as above. Around JUN-2013, a few months after the vaccination, the patient had persistent haematemesis, chest pain and numbness in feet, and she was admitted to a hospital due to the strong chest pain of the left side. Various examinations resulted in negative. At the time of this report, the outcome of the events had not been provided. Reporter''s comment: Although I did not think that the events were likely related to GARDASIL intramuscular, I reported this case because the parents of the patient suspected through recent news that the events were due to the vaccine. The reporting physician did not assess the causal relationship of the chest pain of the left side, haematemesis, and numbness in feet to GARDASIL. The reporting physician assessed the chest pain of the left side as serious due to hospitalization. The reporting physician did not assess the serious criteria of the haematemesis and numbness in feet. Additional information has been requested.


VAERS ID: 498022 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-03-12
Onset:2013-03-12
   Days after vaccination:0
Submitted: 2013-07-30
   Days after onset:140
Entered: 2013-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H013055 / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site pain, Sensation of heaviness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307IRL015737

Write-up: This case was received from the health authority on 23-Jul-2013. IMB REF 2013-017672. This case is medically confirmed as it was reported by a hospital physician (also reported as other health care professional). A 17 year old female patient, with no medical history, received on 12-Mar-2013 an injection of GARDASIL, (batch and lot number H013055), 0.5 mL intramuscularly on the left upper arm, dose in series not reported. Immediately following the vaccination, the patient experienced painful and heavy left upper arm at injection site. The Company judged relevant to code heavy upper arm that was mentioned in the narratives but not coded by the HA. No corrective treatment was given. At the time of reporting, the patient was not recovered. The IMB considered that case serious due to be medically significant.


VAERS ID: 498082 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-16
Onset:2012-04-01
   Days after vaccination:198
Submitted: 2013-07-31
   Days after onset:486
Entered: 2013-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1336Z / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Back pain, Diarrhoea, Dizziness, Dizziness postural, Eye pruritus, Feeling abnormal, Gastroenteritis, Muscular weakness, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain, Pyrexia, Restless legs syndrome, Rhinorrhoea, Seasonal allergy, Sensory disturbance, Somatic delusion, Tonsillitis, Upper respiratory tract inflammation, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Conjunctival disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Familial risk factor; Paternal grandfather: hypertension. Paternal grandmother: DM; Maternal grandmother: hypertension. Father: pollinosis.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray examination of low back and feet(21-JUL-2012): no abnormal results. On 08-DEC-2012, at B hospital, MRI of feet showed no abnormal finding, and Ekbom syndrome was diagnosed. The patient also underwent examinations and got prescription at C hospital and the department of neurology of 2 hospitals, but nothing improved her symptoms. On 21-JUN-2013. Head MRI showed no abnormality. Restless legs syndrome and psychosomatic disease were diagnosed. 09/16/2011, Body temperature, 36.6 degrees C; 11/18/2011, Body temperature, 36.2 degrees C; 03/12/2012, Body temperature, 37.6 degrees C; 03/31/2012, Body temperature, 36.6 degrees C; 05/30/2013, Body temperature, 37.8 degrees C; 06/01/2013, Body temperature, 37.8 degrees C
CDC Split Type: WAES1307JPN011443

Write-up: This spontaneous report as received from a healthcare professional refers to a patient of unknown age. On unspecified date of 2011, 31-MAR-2012 and unspecified date of 2011, the patient was vaccinated with three doses of quadrivalent human papillomavirus recomb. vaccine(manufacturer unknown). In 2012 the patient experienced restless legs syndrome and muscular weakness. In May 2013 the patient experienced slight fever, giddiness, diarrhoea, dizziness on standing up and feeling queasy. In June 2013 the patient experienced feeling strange. On an unknown date the patient experienced psychosomatic disease and upper respiratory tract inflammation. The outcome of restless legs syndrome, muscular weakness, feeling strange, slight fever, giddiness, dizziness on standing up, feeling queasy and psychosomatic disease was reported as not recovered/not resolved. The outcome of diarrhoea and upper respiratory tract inflammation was unknown. The reporter considered the adverse events to be related to Quadrivalent Human Papillomavirus Recomb. Vaccine(manufacturer unknown). Follow-up information has been received from a physician of A hospital via the agency concerning a 12-year-old female patient with a family history (hypertension for paternal grandmother and maternal grandmother, diabetes mellitus for paternal grandmother and pollinosis for father). On 18-NOV-2011, at 17:30, the patient received a GARDASIL IM injection drug (lot No. 9QN02R) (second time) (dose, injection site and indication not reported). Her body temperature before the vaccination was 36.2 C. No concomitant medication was reported. At 17:15 of 16-SEP-2011, the patient received GARDASIL injection drug (lot No. 9QN01 R) (first time). The body temperature before vaccination was 36.6 C. On 18-NOV-2011, the patient received the second GARDASIL injection drug as above. On 19-NOV-2011M low back pain developed around 9:00. Around 2012, muscular weakness developed. Around March 2012, the patient was given a diagnosis of pollinosis as she had itchy eyes and nasal discharge, and ALLEGRA 60 mg (1 tablet x 2/day) and PATANOL (Ophthalmic Solution) were prescribed. On 12-MAR-2012, tonsillitis and gastroenteritis(were diagnosed due to symptoms of a 37.6 C fever and nausea). Following drugs were thus prescribed for 4 days: CLARICID 200 mg (1 tablet x2/ day), antibiotics-resistant lactic acid bacteriae (BIOFERMIN-R) (3 tablets/ day), NAUZELIN 10 mg (3 tablets/ day) and RECTOS 10 mg (2 tablets x 3/ day). On 31-MAR-2012, at 11:00, the patient received a GARDASIL injection drug Clot No. 9QN02R (third time). The body temperature before the vaccination was 36.6 C. On 01-APR-2012, round 9:00, the patient had pain and strange sensation in left ankle and came to kick the left ankle with her right foot. On 21-JUL-2012, she received X-ray examination of low back and feet, with no abnormal results. On 08-DEC-2012, at B hospital, MRI of feet showed no abnormal finding, and Ekbom syndrome was diagnosed. The patient also underwent examinations and got prescriptions at C hospital and the department of neurology of 2 hospitals, but nothing improved her symptoms. Around MAY-2013, dizziness on standing up developed. On 29-MAY-2013, diarrhea developed. On 30-MAY-2013, the patient presented to A hospital for pain pharynx, giddiness, nausea and a 37.8 C fever. Upper respiratory tract inflammation and gastroenteritis were diagnosed. On 01-JUN-2013, the fever went down, but the patient then had a fever of 37.8 C and giddiness on 07, 13 and 14-JUN-2013. Her parents wanted to visit to D hospital. On 18-JUN-2013, the patient visited the D hospital, where no abnormality was found in blood tests or head CT. On 21-JUN-2013, the patient was finally admitted to a hospital due to continuous symptoms. Head MRI showed no abnormality. Restless legs syndrome and psychosomatic disease were diagnosed. On 07-JUL-2013, the patient was discharged from the hospital. The symptoms dis not Improve thereafter. On 08-JUL-2013, wrist pain also developed. At the time of this report, the outcome of all the reported events was not recovered. Reporter''s comment: The patient''s family and the patient herself did not complain low back pain or left ankle pain to me, and no abnormal finding was found. The vaccination was, thus performed with the consent of the patient herself and her mother. I heard for the first time on 31-MAY-2013 about the above symptoms and her visiting to other hospitals. Although the causal relationship between the symptoms and the vaccination was unknown, I agreed to report this case at the strong request from the patient''s parents as they suspected all the symptoms to be due to the vaccination. Reporting physician did not assess the causal relationship of the muscular weakness and dizziness on standing up to GARDASIL. Reporting physician assessed the causal relationship of restless legs syndrome (pain and strange sensation in left ankle, and Ekbom syndrome), low back pain, wrist pain, gastroenteritis, upper respiratory tract inflammation, giddiness, nausea, psychosomatic disease, pollinosis, tonsillitis, gastroenteritis and pain pharynx to GARDASIL as unknown. Reporting physician considered restless legs syndrome as other possible factor of the events. Reporting physician assessed the restless legs syndrome (pain and strange sensation in left ankle, and Ekbom syndrome), low back pain, gastroenteritis, upper respiratory tract inflammation, giddiness, nausea, psychosomatic disease, pollinosis, tonsilitis, gastroenteritis and pain pharynx as serious due to hospitalization. Reporting physician did not assess the seriousness of the wrist pain, muscular weakness and dizziness on standing up. Further information has been requested.


VAERS ID: 498091 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-31
Onset:0000-00-00
Submitted: 2013-07-30
Entered: 2013-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007022 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Intervertebral disc protrusion, Nuclear magnetic resonance imaging spinal abnormal
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 06-Dec-2012 MRI was carried out and herniated disc L5/S1 was diagnosed. A further MRI on 27-Jun-2013 confirmed the diagnosis.
CDC Split Type: WAES1307DEU016095

Write-up: Case was received from a consumer on 25-Jul-2013. Case is not medically confirmed. It was reported from a mother that her daughter of unspecified age ("pupil") received a first dose of GARDASIL, (lot-no. H007022) on 31-Aug-2012. One day later she developed severe joint pain (localisation not specified) which lead to pronounced relieving posture. She was treated with "strong analgesics". On 06-Dec-2012 MRI was carried out and herniated disc L5/S1 was diagnosed. A further MRI on 27-Jun-2013 confirmed the diagnosis. The patient was hospitalised on an unspecified date. The patient''s mother assumes a causal relation to the vaccine.


VAERS ID: 498094 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-04
Onset:2013-07-08
   Days after vaccination:4
Submitted: 2013-07-30
   Days after onset:22
Entered: 2013-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram normal, Loss of consciousness, Nuclear magnetic resonance imaging normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Tic; 2013, Muscle Twitching
Allergies:
Diagnostic Lab Data: 04/2013, Electroencephalogram, Slight general changes, Normal; Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1307DEU016097

Write-up: Case received from a health care professional on 22-Jul-2013. Case medically confirmed. A 12-year-old female patient (reporter''s daughter, weight 48.5 kg, height 161 cm) had received the first dose of GARDASIL, (lot-no. not reported) IM on 04-Jul-2013. 4 days later, on 08-Jul-2013, the patient developed a seizure with unconsciousness during a car ride. The patient recovered within 2-3 minutes after some water had been thrown in her face. The reporter pointed out that it had been quite hot in the car and the girl had only eaten and drunken little. There was no tongue bite nor enuresis. The girl was completely responsive afterwards. Diagnosis of convulsive syncope was also considered. The patient was hospitalised. EEG showed slight general changes. MRI was normal. Results of CT scan and EEG were not provided. The patient was treated with anticonvulsants. The patient has a medical history of recurrent facial twitching in the beginning of 2013. EEG performed in Apr-2013 was normal. "Tic" was suspected. According to the reporter a causal relation to the vaccine was possible.


VAERS ID: 498287 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-18
Onset:2013-06-26
   Days after vaccination:8
Submitted: 2013-08-01
   Days after onset:36
Entered: 2013-08-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000282 / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood alkaline phosphatase normal, Blood thyroid stimulating hormone normal, Bundle branch block right, Electrocardiogram abnormal, Electroencephalogram abnormal, Epistaxis, Gaze palsy, Loss of consciousness, Malaise, Musculoskeletal stiffness, Ophthalmological examination normal, Thyroxine free normal, Tremor, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARISTELLE
Current Illness: Unknown
Preexisting Conditions: Vomiting; Syncope
Allergies:
Diagnostic Lab Data: 06/26/2013, Blood alkaline phosphatase, 0.65 SI; 06/26/2013, Blood thyroid stimulating hormone, 5.01 SI; Electrocardiogram, Uncomplete right bundle branch block N/A; Electroencephalogram, Centralised spike potential N/A; 06/26/2013, Electrocardiogram, Increased, Increased cerebral susceptibility to seizures N/A; 06/26/2013, Thyroxine free, 21.2 SI
CDC Split Type: WAES1307DEU015738

Write-up: Case was received from the Health Authorities in a foriegn country on 25-Jul-2013 (reference no. PEI2013042492). Case is medically confirmed. A 16-year-old female patient with a medical history of relapsing syncopes including vomiting during menstruation since 2011, received a third dose of GARDASIL (batch and lot-no. J000282) IM into the left upper arm on 18-Jun-2013. Eight days prior to vaccination, on 10-Jun-2013 use of hormonal contraceptive (ARISTELLE) was started. Eight days p.v., on 26-Jun-2013 in the morning, she developed severe nose bleeding and felt unwell. Subsequently her mother found her lying on the floor, stiff and trembling. Her eyes rolled upwards. Symptoms resolved after one minute and she slowly regained consciousness but was still not responsive. On arrival of the emergency doctor she had completely recovered, was awake and responsive again. She was hospitalised on the same day. Examination at admission showed no pathological findings. Lab test was normal except for alkaline phosphatase 0.65 SI (normal: 0.82-5.50), TSH 5.01 SI (normal: 0.27-4.2), free T4 21.2 SI (normal: 12.6-21.0). EEG showed evidence for increased cerebral susceptibility to seizures on temporoparietal right side. Sleep-deprivded EEG showed centralised spike potential. ECG revealed an uncomplete right bundel branch block. Ophthalmological examination showed normal results. A first "questionable seizure" was diagnosed. She was discharge in a good general condition on 28-Jun-2013. The patient had received D1 of GARDASIL, batch and lot-no. H009962, on 10-Sep-2012 and D2 of GARDASIL, batch and lot-no. H019318, on 12-Feb-2013. Both does were given IM into the left upper arm and well tolerated. Upon medical review the company added the following AE, which was mentioned in the hospital report but not coded by HA: severe nose bleed.


VAERS ID: 498288 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-01
Onset:2013-07-01
   Days after vaccination:150
Submitted: 2013-08-02
   Days after onset:32
Entered: 2013-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Condition aggravated, Hypoaesthesia, Muscle disorder, Pain, Paralysis, Quadriplegia, Stupor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Pain; Quadriplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1307JPN017304

Write-up: This spontaneous report as received from a 14 year old female consumer refers to herself. In February 2013 the patient was vaccinated with GARDASIL, injection, intramuscular. In July 2013 the patient was hospitalized for quadriplegia and pain. The patient originally had quadriplegia and pain but then had numbness of limbs (right upper and lower limbs), stupor and paralysis complaining that she could not put some muscle at all. During observation period on her hospital stay, she could not walk because of difficulty in using muscles of right lower limb although she was gradually becoming able to use muscle of upper limbs. Quadriplegia, pain in extremity and numbness of limbs (right upper and lower limbs) were not recovered. Reporter''s comment: The symptoms are unlikely due to an organic disease but likely adverse drug reactions or psychogenetic. The reporting physician did not assess the causal relationship of the quadriplegia, pain in extremity and numbness of limbs (right upper and lower limbs) to GARDASIL. The reporting physician considered the quadriplegia and pain in extremity as serious (hospitalization). The reporting physician did not assess the seriousness of the numbness of limbs (right upper and lower limbs). Additional information is not expected.


VAERS ID: 498399 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-18
Onset:2013-06-06
   Days after vaccination:19
Submitted: 2013-08-02
   Days after onset:57
Entered: 2013-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Convulsion, Hypoaesthesia, Muscle disorder, Pain, Pain in extremity, Paralysis, Quadriplegia, Stupor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN000128

Write-up: Initial information has been received from a physician concerning a female (age unknown), who on 18-MAY-2013 received the second injection of recombinant quadrivalent human papillomavirus vaccine IM (dose, injection site and indication not provided). No concomitant medication was reported. On 21-MAR-2013, the patient received the first injection of recombinant quadrivalent human papillomavirus vaccine IM (dose, injection site and indication not provided). On 06-JUN-2013, seizure developed in the patient. On an unspecified date, the seizure developed secondly. The event was being treated with an antiepileptic drug. At the time of this report, the outcome of the seizure was unknown. Reporter''s comment: The patient has been taking the anti epileptic drug as she had a continuous series of two seizure. At this moment, this drug is planned to be continued at least until the end of AUG-2013. The reporting physician considered that the seizure was related to recombinant quadrivalent human papillomavirus vaccine. The reporting physician did not assess the seriousness of the seizure. Upon internal review, the seizure was determined to be serious due to other important medical report. No further information is expected. Follow-up information has been received from a 14-year-old female patient, who in FEB-2013 received an injection of recombinant quadrivalent human papillomavirus vaccine (formulation unknown) IM (dose, injection site and indication not provided). No concomitant medication was provided. In FEB-2013, the patient received the injection of recombinant quadrivalent human papillomavirus as mentioned above. As of JUL-2013, the patient was hospitalized for quadriplegia (estesia, motion) and pain. The patient originally had quadriplegia and pain but then had numbness of limbs (right upper and lower limbs), stupor and paralysis complaining that she could not put some muscle at all. During observation period on her hospital stay, she could not walk because of difficulty in using muscles of right lower limb although she was gradually becoming able to use muscles of upper limbs. Quadriplegia (estesia, motion), pain in extremity and numbness of limbs (right upper and lower limbs) were not recovered. Reporter''s comment: The symptoms are unlikely due to an organic disease but likely adverse drug reactions or psychogenetic. The reporting physician did not assess the causal relationship of the quadriplegia (estesia, motion), pain in extremity and numbness of limbs (right upper and lower limbs) to recombinant quadrivalent human papillomavirus. The reporting physician considered the quadriplegia (estesia, motion) and pain in extremity as serious (hospitalization). The reporting physician did not assess the seriousness of the numbness of limbs (right upper and lower limbs). Additional information was requested.


VAERS ID: 498530 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-12-01
Onset:0000-00-00
Submitted: 2013-08-06
Entered: 2013-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Muscle spasms, Pain, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate; ORENCIA
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1306JPN013994

Write-up: This spontaneous report was received from a other health professional concerning a 39 year old female patient. On an unknown date in December 2012, the patient was vaccinated with a dose of quadrivalent Human Papillomavirus (manufacturer unknown) (lot number, expiry date and dose unspecified), intramuscularly. On an unknown date, the patient was vaccinated with other two doses of Quadrivalent Human Papillomavirus (manufacturer unknown) (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. On an unknown date, in February 2013, the patient experienced foot cramps. Approximately on an unknown date in 2013, the patient recovered from foot cramps. The reporter considered foot cramps to be related to Quadrivalent Human Papillomavirus (manufacturer unknown). Follow-up information has been received from a health professional concerning the 39 year-old female patient vaccinated with Quadrivalent Human Papillomavirus (manufacturer unknown). It was reported that, on an unknown date, the patient experienced generalised aching and numbness. The outcome for generalised aching and numbness was unknown. The reporter considered generalised aching and numbness to be related to Quadrivalent Human Papillomavirus (manufacturer unknown). Follow-up information has been received from a physician (gynecologist) concerning a 39-year-old female patient with a concurrent disease of rheumatism, who in December 2012 received a third dose of GARDASIL IM injection drug 0.5 ml once a day (third time) (injection site not reported). Her concomitant medication included: methotrexate (manufacturer unknown) (daily dose, route and indication were unknown) and ORENCIA (daily dose unknown, injection parenteral) for rheumatoid arthritis. On an unspecified date, the patient received the first dose of GARDASIL intramuscular (IM) injection drug (first time) (dose and injection sire not reported). On an unspecified date, the patient received a second dose of GARDASIL intramuscular (IM) injection drug (second time) (dose and injection site not reported). Around September 2012, sensory disturbance developed. In December 2012, the patient received the third dose of GARDASIL intramuscular (IM) injection drug 0.5 ml once a day (third time) (injection site not reported) as stated above. In February 2013, foot cramps (in both legs) developed. On an unspecified date, the foot cramps resolved. On an unspecified date, generalized aching and numbness developed. At the time of this report, the patient had not recovered from the generalized aching or numbness. Comment of the reporting physician: As tot he foot cramps, this was unlikely related to GARDASIL because there was a rime lag between the vaccination and the development of the event. The patient just worried about it from the vaccine article on the newspaper. The physician considered this event was due to psychogenetic. as the sensory disturbance, the physician recommended the patient to consult with a neurologist but she did not want to do it. The physician heard that she contacted the victims association of the vaccine by herself and was said that vaccine should be detoxed, etc. The reporting physician assessed the foot cramps as unrelated to GARDASIL and the sensory disturbance as related to the vaccine. The reporting physician did not assess the relationship of the generalised aching and the numbness to GARDASIL. The reporting physician assessed the sensory disturbance as serious (disability) and did not assess the seriousness of the foot cramps, generalized aching and numbness. Additional information is not expected.


VAERS ID: 498650 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-06
Entered: 2013-08-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diabetes insipidus, Hypophysitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DEU002147

Write-up: Case received from a health care professional in a foreign country on 01-Aug-2013. Case medically confirmed. An 18-year-old female patient received the second dose of GARDASIL (lot-no. not reported) on an unspecified date. On an unspecified date, the patient developed hypophysitis with diabetes insipidus. The final outcome was not reported. D1 of GARDASIL (lot-no. not reported) was given on an unspecified date, toleration was not reported.


VAERS ID: 498809 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-13
Onset:2012-05-01
   Days after vaccination:109
Submitted: 2013-08-08
   Days after onset:464
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Retinal vasculitis, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Vasculitis (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK001951

Write-up: Case received from a health care professional via the Health Authorities on 01-Aug-2013 under the reference DK-DKMA-ADR 22199493 and DK-DKMA EFO6450. Case is medically confirmed. A 41-year-old female patient (weight 85 kg, height 168 cm) had received the third injection of GARDASIL (batch number not reported) via intramuscular route on 13-Jan-2012. 16 weeks later, on 01-May-2012, the patient developed visual disorders and retinal vasculitis. The patient was examined for arthritis and connective tissue disorders without finding the cause. The patient was monitored every two months in rheumatology clinic and eye clinic, because the symptoms could be long termed, progressive and leading to visual disabilities. At the time of reporting, the patient had not recovered. Previous doses of GARDASIL were given on 24-Nov-2010 (D1) and on 11-Feb-2011) (D2), toleration was not reported.


VAERS ID: 498891 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-03
Onset:0000-00-00
Submitted: 2013-08-08
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Demyelination, Nuclear magnetic resonance imaging brain abnormal, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Nuclear magnetic resonance imaging brain, demyelination of optic chiasm
CDC Split Type: WAES1308GRC003572

Write-up: Case received from paediatrician on 15-Jul-2013 via the contractual partner VIANEX under the reference number SPV13031. Case medically confirmed. A 12-year-old female patient had received the first dose of GARDASIL, (batch number not reported) 6 weeks before 15-Jul-2013 and 3 weeks post-vaccination, she developed decreased visual acuity. Brain MRI revealed demyelination foci in the area of optic chiasm. The patient''s status remained stable up to now. No treatment was administered. The patient had no relevant medical history, no concurrent medication were administered. The patient had a family history of demyelinating disorder. The reporting paediatrician considered the case as possibly related to vaccination.


VAERS ID: 498902 (history)  
Form: Version 1.0  
Age: 27.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-16
Onset:2012-10-16
   Days after vaccination:0
Submitted: 2013-08-08
   Days after onset:296
Entered: 2013-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood glucose, Disturbance in attention, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache, Hypoaesthesia, Memory impairment, Metabolic function test, Myalgia, Nausea, Oral herpes, Paraesthesia, Rash, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERDOLECT; ABILIFY; EFEXOR DEPOT; METFORMIN ACTAVIS; ELTROXIN
Current Illness: Polycystic ovaries; Social phobia; Myxoedema; Schizophrenia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, ECG; Metabolic function test and Ultrasound scan: Not reported
CDC Split Type: WAES1308DNK001938

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 30-Jul-2013 under the references DK-DKMA-ADR 22196072 and DK-DKMA EFO6424. Case not medically confirmed. A 27-year-old female patient (weight 114 kg, height 170 cm) with a medical history of schizophrenia, social phobia, myxoedema and polycystic ovarian syndrome, had received an injection of GARDASIL (batch number not reported) on 16-Oct-2012. On the same day, the patient developed headache, concentration impaired, difficulty breathing, dizziness, joint pain, memory impairment, muscle pain, nausea, fainting, tiredness, numbness and tingling in the feet and hands, spotting and herpes outbreaks in the mouth. The patient was hospitalised. Laboratory and diagnostic tests included metabolic function test, blood glucose, ECG and ultrasound of the heart. Results were not provided. Concomitant medication included SERDOLECT since 2007 for schizophrenia, ABILIFY since 2011 for schizophrenia, EFEXOR DEPOT since 2005 for social phobia, METFORMIN ACTAVIS since 2010 for polycystic ovarian syndrome and ELTROXIN since 2010 for myxoedema. The patient was treated with IBUMETIN, PANODIL and asthma inhaler. The patient received a further injection of GARDAIL on 20-APR-2013, toleration was not reported. At the time of reporting, the patient had not recovered.


VAERS ID: 498932 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-17
Onset:2013-07-17
   Days after vaccination:0
Submitted: 2013-08-09
   Days after onset:23
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J000731 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose normal, Feeling hot, Gaze palsy, Headache, Hypertension, Loss of consciousness, Pallor, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Syncope, Medical history of vasovagal syncope since childhood fuelled by strong emotions.
Allergies:
Diagnostic Lab Data: Physical examination was normal. Blood pressure was at 77/33 (hypertension), heart rate at 45 and blood glucose normal at 0.8g/L.
CDC Split Type: WAES1308FRA003336

Write-up: Case received from the Health Authorities under reference number PB20130699 on 02-Aug-2013. Case medically confirmed. A 12-year-old female patient with a medical history of vasovagal syncope since childhood fuelled by strong emotions, had received a dose of GARDASIL (batch/lot number J000731, exp 30-JUN-2015) via intramuscular route on 17-Jul-2013. Five minutes post-vaccination she experienced prodroma such as feeling of warmth, cephalgia, blur vision, pallor and then loss of consciousness for less than 1 minute. She had a fixed gaze. She did not have any abnormal movements. Blood pressure was at 77/33 (hypertension), heart rate at 45 and blood glucose normal at 0.8 g/L. The patient gradually recovered and physical examination was normal. Upon medical review, the company considered the case as serious due to other medically important condition: loss of consciousness. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (C2 S1 B3 l1) according to the updated method of assessment.


VAERS ID: 498933 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-02-16
Onset:2013-04-14
   Days after vaccination:57
Submitted: 2013-08-09
   Days after onset:117
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Asthenia, Atrophy, Convulsion, Dyskinesia, Electroencephalogram normal, Epilepsy, Fatigue, Grand mal convulsion, Hypoacusis, Nuclear magnetic resonance imaging brain abnormal, Tinnitus, Tongue biting, Unresponsive to stimuli, Urinary incontinence, Urticaria, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADROSTAT; PROVAMES
Current Illness: Immunisation
Preexisting Conditions: Polycystic ovaries; Dyspraxia; GARDASIL, She had received the first dose of GARDASIL (batch number not reported) via intramuscular route on 22-Dec-2012.
Allergies:
Diagnostic Lab Data: MRI recently performed evidenced a slight atrophy of the biparietal region. EEG: no anomaly
CDC Split Type: WAES1308FRA003339

Write-up: Case received from the Health Authorities under reference number NT20130961 and NT20130960 on 02-Aug-2013. Case medically confirmed. To be noted that case NT20130960 was considered as non serious by the Health Authorities. But as the adverse event reported in NT20130960 occurred after the same dose and upon internal review, the company judged relevant to merge both cases in one. Case is considered as serious. A 17-year-old female patient had received the second dose of GARDASIL (batch number not reported) via intramuscular route on 16-Feb-2013. On an unspecified time to onset, in Feb-2013, the patient experienced asthenia, which resolved within a few days. On 14-Apr-2013, while at home, she experienced a first seizure with abnormal movements, suffocation for few minutes without cyanosis, tongue biting and urine loss inducing her hospitalization. Tonic-clonic seizure recurred, which resolved with RIVOTRIL. Since Apr-2013, the patient had experienced several seizures, which seemed to be generalized tonic-clonic seizure of typical course in 3 phases with tongue biting and urine loss. The patient experienced times to times ear buzzing for 1 or 2 minutes with sudden onset and sudden disappearance. Therefore, it was difficult to distinguish between generalized epilepsy and a partial secondary generalization seizure. Sometimes the patient had visual disorder and the feeling that noises faded away for several minutes but always within a context of fatigue. When the patient was last seen in the neurology department, she had a generalized seizure and might have had a partial seizure as she broke contact during 1 minute: she did not answer to her mother and was wild-eyes. This fit started with an ear buzzing. MRI recently performed evidenced a slight atrophy of the biparietal region. No other relevant abnormality was noticed. The patient was on LAMICTAL twice but urticarial-like cutaneous reaction occurred each time. Corrective treatment with KEPPRA was then initiated. Dosage started at 250mg twice a day (morning and evening) for 1 week, and increased to 500mg twice a day (morning and evening). The patient was also on URBANYL but treatment was scheduled to be tapered. Neurological follow-up was on-going. The patient had a medical history of visospacial dyspraxia and polycystic ovarian syndrome. She had received the first dose of GARDASIL (batch number not reported) via intramuscular route on 22-Dec-2012. ANDROCUR and PROVAMES were taken as long-term treatments. At the time of reporting, the patient had not recovered from epilepsy. The Health Authority assessed the causal relationship between epilepsy and vaccination as doubtful (C1 S1 l1 B4 Nl2) according to the updated method of assessment. The Health Authority assessed the causal relationship between asthenia and vaccination as doubtful (C2 S1 B3 l1) according to the updated method of assessment.


VAERS ID: 498934 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-16
Onset:0000-00-00
Submitted: 2013-08-09
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Colonoscopy normal, Diarrhoea, Endoscopy upper gastrointestinal tract normal, Enteroclysis, Epilepsy, Erythema, Gastrointestinal disorder, Inflammation, Inflammatory marker increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Hypersensitivity; Epilepsy; GARDASIL, Vomiting; GARDASIL, Diarrhoea; 09/07/2012, GARDASIL, Abdominal pain; 07/12/2012, GARDASIL, Abdominal pain
Allergies:
Diagnostic Lab Data: Exams performed while hospitalized evidenced a slight inflammatory syndrome. Gastroscopy and colonoscopy performed in Mar-2013 were normal.
CDC Split Type: WAES1308FRA003343

Write-up: Case received from the Health Authorities under reference number MP20130792 on 02-Aug-2013. Case medically confirmed. A 17-year-old female patient with a medical history of epilepsy and allergy had received the third dose of GARDASIL (batch number not reported) via intramuscular route on 16-Jan-2013. A 0, 2, 6 month vaccination schedule was followed. She received the first dose on 12-Jul-2012 and the second dose on 07-Sept-2013 (batch numbers not reported) both via intramuscular route. Between the first and second injection she experienced 2 fits with abdominal pain, diarrhea and vomiting. The second one was stronger. Between the second and third injection she experienced fit once a month with similar symptoms. One month after the third dose, fit recurred, which lasted for 12 hours leading to hospitalization. Exams performed while hospitalized evidenced a slight inflammatory syndrome. Gastroscopy and colonoscopy performed in Mar-2013 were normal. In Apr-2013 fit recurred 3 times. In addition to digestive symptoms she experienced erythema on 2 of those fits. On 19-May-2013, i.e. 4 months after the third dose, the patient had another fit. CT enteroclysis performed on an unspecified date was unremarkable. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the adverse event: "erythema" which was mentioned by the CA in the narrative but not coded. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 498943 (history)  
Form: Version 1.0  
Age: 28.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-20
Onset:2013-06-06
   Days after vaccination:17
Submitted: 2013-08-09
   Days after onset:64
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Electroencephalogram, Extremity contracture, Hypotension, Muscle spasms, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Tetany, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Low blood pressure
CDC Split Type: WAES1308KOR000497

Write-up: This spontaneous report as received from a nurse via company representative refers to a 28 year old female patient (inappropriate age). On 20-MAY-2013 the patient was vaccinated with a dose of GARDASIL (route, dose and lot # were unknown). The patient drank alcohol on the day before the vaccination. Subsequently, the patient experienced limbs shrinking, low blood pressure, and twistered tongue on an unspecified date in June 2013, and body tetany on an unspecified date in 2013. The patient experienced body tingling and body paralysis on 06-JUN-2013 and recovered on the same day. She had muscle spasm and body paralysis on 13-JUN-2013 and recovered on the same day. She went to a hospital and Magnetic Resonance Imaging (MRI) and electroencephalograph (EEG) were performed with no result provided. Also, she received treatment at the neurology department. The outcome of other events was reported as recovered/resolved on an unspecified date in 2013. Upon internal review, both episodes of body paralysis were considered to be medically significant events. Additional information is not expected.


VAERS ID: 498962 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-26
Onset:2012-02-01
   Days after vaccination:6
Submitted: 2013-08-09
   Days after onset:554
Entered: 2013-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1336Z / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Electroencephalogram abnormal, Epilepsy, Metamorphopsia
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Retinal disorders (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN001820

Write-up: Initial information has been received from a physician via agency (2012/01) concerning a 16 year old female patient. Medical history interview including underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, past history of ADR, status of growth, were not reported. On 26-JAN-2012, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (batch number 9QN01R, Lot # 1336Z) IM. No concomitant medications were reported. Around February 2012, metamorphopsia and epilepsy developed. On 29-MAR-2013, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (batch number 9QN01R, Lot # 1336Z) IM. On 15-JUN-2012, the patient visited the reporting physician''s hospital where she was admitted for investigation. Prior to 15-JUN-2012, she had visited a hospital and psychosomatic medicine of hospital. Abnormal brain wave was observed and epilepsy was suspected. On an unspecified date she was referred to psychiatry medicine of hospital. On 19-OCT-2012, the patient was recovering from metamorphopsia. The outcome of epilepsy was unknown. Upon internal review epilepsy was considered to be medically significant. Reporter''s comment: none. The reporter did not assess the relationship of metamorphopsia to GARDASIL. Other possible causes were ruled out. He considered metamorphopsia and epilepsy as serious (hospitalization). Additional information has been requested.


VAERS ID: 499055 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-14
Onset:2013-06-18
   Days after vaccination:4
Submitted: 2013-08-12
   Days after onset:55
Entered: 2013-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Back pain, Blood bicarbonate decreased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Metabolic acidosis, Metabolic function test abnormal, Renal colic, Renal failure, Renal function test normal, Spinal pain, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Arthritis (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CEBUTID; Meteospasmyl; Acetaminophen
Current Illness: Immunisation; Back pain
Preexisting Conditions: Back pain; 11/2012, Renal failure; 11/2012, Pyelonephritis acute
Allergies:
Diagnostic Lab Data: Ultrasound scan: no lithiasis. Lab test on 14-JUN-2013: renal insufficiency and metabolic acidosis. 06/14/2013, Blood bicarbonate, 22.6 mmol/l; 06/20/2013, Blood bicarbonate, 19.9 mmol/l; 06/25/2013, Blood bicarbonate, 25.8; 06/14/2013, Blood creatinine, 123 umol/l; 06/20/2013, Blood creatinine, 111 umol/l; 06/25/2013, Blood creatinine, 17.3; 06/20/2013, Blood potassium, 5.21 mmol/l; 06/25/2013, Blood potassium, 5.44; 06/25/2013, Blood urea, 2.4; 06/14/2013, Laboratory test, renal sufficiency and metabolic acidosis; Ultrasound scan, no lithiasis
CDC Split Type: WAES1308FRA003970

Write-up: Case received from the Health Authorities under reference number CF20130358 on 02-Aug-2013. Case medically confirmed. A 14-year-old female patient, who went to see her physician on 11-Jun-2013 due to lumbago, had received a dose of GARDASIL (batch number not reported) via intramuscular route on the same day. She was given CEBUTID 100 (twice a day) from 11-Jun-2013 to 14-Jun-2013 per os and paracetamol as corrective treatment for lumbago. Three days post-vaccination she experienced abdominal pain and went back to see her physician. She was given METOSPAMYL per os from 14-Jun-2013 to 18-Jun-2013 and paracetamol as corrective treatment. The patient went to the ER due to too intensive pain and was hospitalized on 18-Jun-2013. Upon admission, laboratory tests performed showed renal insufficiency and metabolic acidosis. Bicarbonate level was at 22.6 mmo/l and creatinine was at 123umol/l. Renal colic was evoked to explain the lumbar pain but ultrasound performed did not evidence any abnormalities, in particular no urolithiasis. The patient did not make any wrong moves. She had right spinal pain. It was concluded that lumbar pain was not a symptom of the renal insufficiency. On 20-Jun-2013 lab data showed: Potassium at 5.21 mmol/l; Bicarbonate level at 19.9 mmol/l; Creatinine at 111umol/l; On 25-Jun-2013 lab data showed: Urea at 2.4; Potassium at 5.44; Bicarbonate level at 25.8; Creatinine at 17.3; She had a medical history of acute pyelonephritis of infectious origin associated with renal insufficiency in Nov-2012. At the time of reporting the patient had recovered. Upon medical review the company judged relevant to code the adverse event: "lumbar pain" which was mentioned by the CA in the narrative but not coded. To be noted that CEBUTID 100 and Meteospasmyl were also considered as suspect by the Health Authorities. The Health Authorities assessed the causal relationship between the reported reaction(s) and both medications as doubtful (C2 S1 l1) according to the method of assessment. The Health Authorities assessed the causal relationship between the reported reaction(s) and GARDASIL as doubtful (C1 S1 l1) according to the method of assessment.


VAERS ID: 499086 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-12
Entered: 2013-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dizziness, Headache, Laboratory test normal, Nerve conduction studies normal, Paraesthesia, Paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examination for sclerosis, calcifications, nerve function, thrombosis, cardio etc. were performed there (on unspecified dates) with negative results. Brain tumor (Unknown date): Negative
CDC Split Type: WAES1308DNK003736

Write-up: Case received from patient via the Health Authorities on 05-Aug-2013 under the reference number DK-DKMA-ADR 22197565 and DK-DKMA-EFO6429. A 19-year-old female patient had received an injection of GARDASIL (dose not reported, batch number not reported, site-, route- and form of administration not reported) on unspecified date in 2006 and later on shortly p-v she developed daily headache, abdominal pain, paralysis in body parts, dizziness, vomiting and constant tingling in the body. The adverse reactions have been unchanged. The patient states that she has in vain visited a private physician on several occasions (on unspecified dates) for her symptoms, therefore she contact her private insurance company who sent her on to a private clinic. Examination for sclerosis, calcifications, nerve function, thrombosis, cardio etc. were performed there (on unspecified dates) with negative results. The patient has not been hospitalized due to the adverse reactions. The patient has no other medications. The patient has in general no other health problems. The agency has requested a medical confirmation on the case and awaits an answer. At the time of reporting, the outcome was not recovered.


VAERS ID: 499198 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-12-17
Onset:0000-00-00
Submitted: 2013-08-13
Entered: 2013-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NM46680 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Delivery, Exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1107USA01744

Write-up: This pregnancy follow up case was received from Health Authority on 07-Jul-11 under the reference number 2011-004740. This case is medically confirmed. A 13 year old female patient with an unreported medical history and concomitant medication received the first dose of a GARDASIL, (NM46680) route and site not reported on 06-Jun-10 and subsequently received the second dose of a GARDASIL on 17-Dec-10. The patient was due to received the third dose on 20-May-11 but this dose was not given because the patient had a baby the previous day on 19-May-11. No further information was reported. The IMB considered the pregnancy to be serious due to other medically important condition which required intervention. Follow up received from the IMB on 29-Aug-11. According to the reporter the duration of the patient''s pregnancy was 39 weeks. The weight of the infant was 2.910 kilograms. There were no complications at birth, a normal spontaneous vaginal delivery. The mother is breast feeding and the baby is doing fine so far. Follow up received from the IMB on 06-Aug-2013: The IMB coded the event of no adverse reaction to better capture the outcome of the pregnancy.


VAERS ID: 499312 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-24
Onset:2008-08-01
   Days after vaccination:69
Submitted: 2013-08-14
   Days after onset:1839
Entered: 2013-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Blood test, Colitis ulcerative, Functional gastrointestinal disorder, Hemiplegia, Hypoaesthesia, Melaena, Micturition disorder, Paraesthesia, Sensory disturbance
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation; 11/08/2007, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood samples had been taken, but results were not provided.
CDC Split Type: WAES1308DNK005318

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 06-Aug-2013 under the references DK-DKMA-ADR 22202249 and DK-DKMA EFO6483. A 21-year old female patient (weight 64 kg, height 170 cm) had received the third injection of GARDASIL (batch number not reported) via not reported route and site of administration on 24-May-2008. Approximately 2 months later, on 01-Aug-2008, the patient developed stomach pain, melena and ulcerative colitis. On an unspecified date, later that year, the patient developed sensory disorders in the left arm, leg and abdomen, paralysis on the right side (both arm and leg), urination problems, bowel problems, numbness in extremity and tingling sensations in extremities. The patient was hospitalised. Blood samples had been taken, but results were not provided. The patient received drug therapy for ulcerative colitis, and medical care and rehabilitation for paralysis. At the time of reporting, the patient had not recovered from stomach pain, melena, ulcerative colitis, sensory disorders in the left arm, leg and abdomen, numbness in extremities and tingling sensations in extremities. The outcome of paralysis on the right side, urination problems and bowel problems was unknown. Previous dose of GARDASIL was given on 08-Nov-2007 (D1). The patient received D2 on an unspecified date. Toleration of the vaccinations was not reported. Noteworthy: The company corrected the patient''s age at onset of events to 21 years, HA reported 26 years (patient was born in 1987)


VAERS ID: 499424 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-19
Onset:0000-00-00
Submitted: 2013-08-15
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP00860 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Vacuum extractor delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212IRL008959

Write-up: This case was received from the health authority on 13-Dec-2012. Ref 2012-015659. This case is medically confirmed. The primary reporter is a nurse. A 17-year-old female patient, with no reported medical history or concomitant medication, received an injection of GARDASIL (batch no. G019345, dose in series and site of administration not reported) 0.5 mL intramuscularly on 19-Sep-2012. Post vaccination the patient discovered she was pregnant. The reporter indicated that the patient was approximately 3 months into the pregnancy at the time of reporting and the baby was due in Jun-2013. At the time of reporting the outcome was unknown. The agency considered this case to be serious as an other medically important condition. Follow up received from the agency on 07-Aug-2013: The reporter indicated that the patient had a baby girl on 12-Jun-2013 at 40 weeks +2 days, weighing 7lb 4oz, by vacuum delivery. Both baby and mother were doing well. The agency coded the event of no adverse reaction.


VAERS ID: 499427 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-18
Onset:2012-04-18
   Days after vaccination:0
Submitted: 2013-08-15
   Days after onset:484
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NN43380 / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Nasal congestion, The patient was taking concomitant nasal spray (unspecified) for a blocked nose.
Preexisting Conditions: 12/08/2011, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210IRL001044

Write-up: This pregnancy follow-up case was received from the health authority on 13-Sep-2012. Ref 2012-013856. This case is medically confirmed. A 16 year old female patient received the second dose of GARDASIL (batch number G014502, lot number NN43380, expiry 11-2013), route and site not reported, on 18-Apr-2012. The patient was subsequently found to be pregnant at the time of the second dose. Her LMP was 01-Apr-2012 and her EDD was 27-Nov-2012. The patient received her first dose of GARDASIL (batch number NN33040, lot number NN43380, expiry 01-2013) on 08-Dec-2011. The patient was taking concomitant nasal spray (unspecified) for a blocked nose. At the time of reporting the patient outcome was unknown. The agency considered that case serious due to be medically significant. Follow-up information was received from the reporting physician on 07-Aug-2013: The patient gave birth to a baby girl weighing 3.06 kg on 18-Nov-2012. She was 38 +/-5 gestation weeks and the baby''s Apgar was 9/9. The reporter indicated that there has been no complications or worries since. The delivery was vaginal vacuum delivery. It was reported that the patient experienced no adverse effect. According to agency coding, the patient was recovered.


VAERS ID: 499570 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-30
Onset:2013-07-30
   Days after vaccination:0
Submitted: 2013-08-16
   Days after onset:17
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Areflexia, Arthralgia, Blood test normal, CSF test normal, Dysphagia, Injected limb mobility decreased, Injection site pain, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01-AUG-2013: Deep reflex was not observed. At admission: no clear abnormal finding was found in blood tests or cerebrospinal fluid examination. In head MRI, high intensity area with small wave-like pattern was found in the white matter of the right frontal lobe on the T2 and FLAIR. 07/30/2013, Body temperature, 36.7 degrees C
CDC Split Type: WAES1308JPN005025

Write-up: Initial and follow-up information have been received from a physician via the agency concerning a 12-year-old female patient with no family history. No important point (underlying disease, allergy, past vaccination/disease during recent one month, concomitant medications, past ADR history or status of growth) on the patient was described on the vaccination coupon. Her body temperature before the vaccination was 36.7 degrees C. On 30-JUL-2013, the patient received the second (syringe-type) GARDASIL IM injection drug (lot No. 0989AA, batch No. 9QN08R, expiring on 21-JUN-2014) on the right upper arm (dose and indication not reported). No concomitant medication was reported. On an unspecified date, the patient received the first GARDASIL IM injection drug. On an unspecified date, myalgia developed, and also she complained of pain in arms and legs. On an unspecified date, around 3 weeks after the development, the myalgia resolved. On 30-JUL-2013, at 15:00, the patient received the second GARDASIL IM injection drug (lot No. 0989AA, batch No. 9QN08R, expiring on 21-JUN-2014) in the right upper arm. Just after the vaccination, the patient had difficulty raising her right upper limb. She complained of injection site pain, and about 2 hours later, she had difficulty raising the arm up above the shoulder. In that night, she complained that she could not go upstairs due to pain legs. On 01-AUG-2013, the patient had difficulty swallowing solid food, gonalgia and difficulty going up and down stairs. She visited a nearby hospital and then was referred and admitted to the hospital of the reporting physician since deep reflex was not observed. At admission, no clear abnormal finding was found in blood tests or cerebrospinal fluid examination. In head MRI, high intensity area with small wave-like pattern was found in the white matter of the right frontal lobe on the T2 and FLAIR. On 02-AUG-2013 (next day of the admission), the difficulty swallowing and difficulty raising the right upper limb resolved. The patient became able to go up and down stairs thereafter. On 05-AUG-2013, the myalgia, gonalgia and muscle weakness of lower limbs improved, and the patient was discharged from the hospital. Reporter''s comment: (physician who vaccinated) It was revealed after the second vaccination that the patient thought the myalgia which had developed after the first vaccination was a muscle pain by her club activity. (physician who treated) Considering clinical course and examination results, it is unlikely that the adverse events were due to other factor other than the vaccination. The physician assessed that the myalgia, gonalgia, muscle weakness of lower limbs, difficulty swallowing and difficulty raising right upper limb were serious (hospitalization) and related GARDASIL. The physician did not consider there was other possible cause of the events. The physician did not assess the seriousness of the myalgia (which developed after the first vaccination) or the causal relationship between the event GARDASIL. Additional information has been requested.


VAERS ID: 499571 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-01-23
Onset:2013-04-01
   Days after vaccination:434
Submitted: 2013-08-15
   Days after onset:136
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NP23380 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Dizziness, Fatigue, Multiple sclerosis relapse, Nausea, Nuclear magnetic resonance imaging abnormal, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypothyroidism; Immunisation
Preexisting Conditions: 11/11/2011 GARDASIL; Drug Indication: Immunisation
Allergies:
Diagnostic Lab Data: MRI (11-APR-2012): Diagnosis of multiple sclerosis; 04/11/2012, Nuclear magnetic resonance imaging, diagnosis of multiple sclerosis N/A
CDC Split Type: WAES1308FRA006268

Write-up: Case received from the Health Authorities on 06-Aug-2013 under the reference number MA20131385. Case not medically confirmed (also reported as other health professional as primary source). Source reported by the patient. A 20-year-old female patient had received a dose of Meningo A+C, (batch number F25172, exp date: Sep-2012) via intramuscular route on 19-Dec-2011 and on 23-Jan-2012, she received a second dose of GARDASIL (batch/lot number NP23380, exp date: Apr-2012) and a dose of ENGERIX B20, (other manufacturer, batch number AHBV060AE, exp date: Feb-2014) via intramuscular route. About 5 days later, the patient experienced fatigue, nausea and dizziness, and ten days later, she experienced paresthesia in limbs. To be noted that she received the first dose of GARDASIL (batch/lot number NP39110, exp date: Apr-2012) on 11-Nov-2011, i-e two months before the second dose. In March 2012, she consulted as these symptoms were persisting. On 11-APR-2012, she was hospitalized. An MRI was performed and the diagnosis of multiple sclerosis was made. She received corrective treatment with corticoids with SOLUMEDROL as per 1g/day during 3 days. On 24-May-20121, she was administered the third dose of GARDASIL (batch number HO02423- exp date: June 2014), i-e six months after the administration of the second dose. A multiple sclerosis relapsing occurred in May 2012 (no precise date). Homecare treatment with oral corticotherapy was set up. A third relapsing occurred in August 2013 with hospitalization. All in all, in July 2013, since the first hospitalization in April 2012, the patient experienced 7 MS-relapsing from which 4 with hospitalization and 3 treated as outpatient. The patient had not recovered. Outcome for limbs paresthesia was unknown. To be noted that the patient had no medical history of neurological disorder except a hypothyroidism treated by levothyrox 75ug since the age of 15. The patient grand-mother was diabetic. Upon internal review, the company judged relevant to code the adverse reactions "fatigue", "nausea" and "dizziness" which were mentioned by the health Authorities in the narrative but not coded. The Health Authorities assessed the casual relationship between the reported reactions ans vaccinations as doubtful (C2 S1 l1) according to the method of assessment.


VAERS ID: 499573 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-29
Onset:2013-07-29
   Days after vaccination:0
Submitted: 2013-08-16
   Days after onset:18
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Fall, Head injury, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308ITA006395

Write-up: Case received from Health Authority (case n. 213727) on 09-AUG-13. Case initially reported by a Health Care professional. Case medically confirmed. A 12 year old female patient with no medical history reported was vaccinated on 29-JUL-13 with GARDASIL (batch n. not reported), 0.5 ml, intramuscularly and the same day on 29-JUL-13 she presented with lipothymic episode preceded by blurred vision, she fall to the ground and presented an head trauma. The patient''s outcome was not reported. Upon medical review, the company judged relevant to add the adverse event "head injury" which was mentioned in the narrative but not coded by HA. HA performed causality assessment for suspect products through an algorithm for vaccines on 09-AUG-2013, that results as "possibly related".


VAERS ID: 499582 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-01
Onset:2012-12-24
   Days after vaccination:114
Submitted: 2013-08-15
   Days after onset:233
Entered: 2013-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood test abnormal, Blood thyroid stimulating hormone increased, Cervical conisation, Cervical dysplasia, Dizziness postural, Hypothyroidism, VIIth nerve paralysis
SMQs:, Reproductive premalignant disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Hearing impairment (broad), Uterine and fallopian tube malignant tumours (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; 08/16/2011, Fatigue; 08/16/2011, Anaemia; 01/2012, Cervical dysplasia
Preexisting Conditions: 05/2012, GARDASIL, Second dose, Immunisation; 03/2012, GARDASIL, First dose, Immunisation
Allergies:
Diagnostic Lab Data: Blood test: Abnormal; TSH: Increased
CDC Split Type: WAES1308ESP006740

Write-up: Case received from a consumer and from a physician on 06-AUG-2013 and 12-AUG-2013. Case medically confirmed. A 30-year-old female patient had received three doses of a GARDASIL (batch number not reported, route and site not reported), she received the first dose on MAR-2012 (exact date not reported), the second dose of GARDASIL on 30 or 31-MAY-2012 and the third dose of GARDASIL was administered on SEP-2012, batch numbers, route and site of administration not reported. Before vaccination, a cytology was performed on JAN-2012 and on FEB or MAR-2012 the results showed a cervical intraepithelial neoplasia III. A conization was performed on 29 or 30-MAY-2012. According to the patient she was healthy until vaccination. According to the patient, she gave birth on 16-AUG-2011 and since this moment she felt tired, she had anemia and strange values of iodine. According to the physician the patient had increased TSH (start date not reported), she was diagnosed with hypothyroidism (date not reported), she will start the treatment to treat it (EUTHYROX, dosage not reported). According to the patient on 24-DEC-2012 she had facial paralysis (confirmed by the physician) in both sides of the face during 2-3 weeks. Also, she presented with dizziness when she stand up from seat, loss of strength of knees and alterations in blood tests (onset dates not reported). According to the patient she was healthy until vaccination. The patient did not know whether she considered these events as related to vaccination, she could not remember dates of onset but she thought she should be recovered after giving birth and she was not. Therefore the company did not know whether the adverse events were part of the patient''s medical history. Clarifications have been requested to both, the patient and the physician. According to the physician, the patient went to the specialists and they considered the picture as not related with the vaccination. At the time of reporting the patient had not recovered. Upon internal review the company considered the case as serious with other medically important condition as criteria. No further vaccination was reported.


VAERS ID: 499634 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-18
Onset:2013-06-26
   Days after vaccination:8
Submitted: 2013-08-16
   Days after onset:51
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Burning sensation, Dizziness, Fatigue, Headache, Muscle contractions involuntary, Muscular weakness, Neuritis, Pain in extremity, Palpitations, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 01/18/2013, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Blood test, Normal
CDC Split Type: WAES1308DNK006725

Write-up: Case received from health care professional via the Health Authorities on 08-Aug-2013 under the reference number DK-DKMA-ADR 22205026 and DK-DKMA-EFO6514. Case medically confirmed. A 24-year old female patient had received an injection of GARDASIL (batch number not reported, intramuscular route of administration, form and site of administration not reported) on 18-Feb-2013 and later on the same day she developed discrete nervous system symptoms in form of heart palpitations, tingling in the left arm and pain in the left arm. These symptoms decreased slightly until she received the third injection of GARDASIL (dose 3, batch number not reported, route, form, and site of administration not reported) on 18-Jun-2013 and later on 26-Jun-2013, one week post-vaccination, she developed severe symptoms from the nervous system. The patient had headaches, tingling and tickling under the skin, burning sensation that goes down the neck, neuritis, nerve fasciculation''s, involuntary muscle contractions from the neck and legs in a severe form of nature, fatigue, dizziness and muscle weakness. Blood tests were performed on unspecified date and all the results were normal. The patient was hospitalized (reported by HA) on unspecified date. No further information on this occasion has been specified. The patient''s medical history includes an injection of GARDASIL (dose 1, batch number not reported, form, route and site of administration not reported) on 18-Jan-2013. At the time of reporting, the outcome was not recovered.


VAERS ID: 499718 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-03
Onset:2012-08-01
   Days after vaccination:120
Submitted: 2013-08-18
   Days after onset:382
Entered: 2013-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Affect lability, Asthenia, Dizziness, Fear, Hallucination, auditory, Head injury, Hyperventilation, Hypoaesthesia, Irritability, Memory impairment, Pain, Pain in extremity, Tinnitus
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN005262

Write-up: Initial information has been received from a physician concerning a 15-year-old female patient with no underlying/concurrent disease or medical history. On 01-OCT-2011, 01-DEC-2011, 03-APR-2012, the patient respectively received the first, the second and the third doses of GARDASIL (IM injection 0.5 ml once, lot# not reported). Concomitant therapy included Japanese encephalitis virus vaccine. Nothing happened to the patient at time of the vaccination. Around July 2012, 3 months after the third vaccination, the patient had loss of energy. Around August 2012 (4 months after the vaccination), the patient had auditory hallucination. Around October 2012 (6 months after the vaccination), the patient had pain in feet. Around November 2012, during the school test period, she could not concentrate on study because of emotional instability. She got yelled by her father for that and had hyperpnoea. She then saw a psychotherapist, who judged there was no problem with her. On unspecified dates, tinnitus, giddiness, pain in feet, forgetfulness, irritation, fear feeling, swaying and body pain subsequently developed in the patient, and she hit her over the head against the floor and slap her body by herself because of the body pain. On 25-MAR-2013, the patient received a Japanese encephalitis virus vaccine at the reporter''s clinic, when she told nothing about her symptoms at all. In August 2013, no abnormality was found at an orthopedic department where the patient visited for numbness in feet. At the time of this report, the patient had not recovered from the loss of energy, auditory hallucination, or pain in feet. The outcome the emotional instability, hyperpnoea, tinnitus, giddiness, forgetfulness, irritation, fear feeling, swaying, body pain and numbness in feet was unknown. Reporter''s comment: It was unknown about the casual relationship of these events to the GARDASIL, because the development of the events was too late for inactivated vaccine-induced events. The patient''s parent wanted to have her examined by a specialist and would refer to another hospital. The name of hospitals (departments of psychological and orthopedic) the patient visited was unknown. The patient did not complain of anything at the time of Japanese encephalitis virus vaccine. The patient would not revisit the physician after she was referred to the hospital. The reporting physician did not assess the causal relationship of the loss of energy, auditory hallucination, pain in feet, emotional instability, hyperpnoea, tinnitus, giddiness, body pain, forgetfulness, irritation, fear feeling, swaying and numbness in feet to GARDASIL. The reporting physician assessed the loss of energy, auditory hallucination and pain in feet as serious due to other important medical events, and did not assess the seriousness of the emotional instability, hyperpnoea, tinnitus, giddiness, body pain, forgetfulness, irritation, fear feeling, swaying and numbness in feet. Additional information is not expected.


VAERS ID: 499720 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-19
Entered: 2013-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, dose 1, batch number not reported route and site of administration not reported on unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK007007

Write-up: Case received from a non-health care professional via the Health Authorities on 12-Aug-2013 under the reference number DK-DKMA-ADR 22210953. Case not medically confirmed. An adolescent female patient (birth date and initials not reported) had received an injection of GARDASIL (dose 2, batch number not reported, route and site of administration not reported) on unknown date (onset date not reported) and later on she developed sclerosis. HA has received the report from the patient''s mother. Her daughter has received the HPV-vaccine 2 times on unknown dates and has subsequently been diagnosed with sclerosis (onset dates not reported). Patient''s medical history includes: GARDASIL, dose 1, batch number not reported route and site of administration not reported on unknown date. The patient was diagnosed with sclerosis (coded by HA as multiple sclerosis). At the time of reporting, the outcome was not recovered.


VAERS ID: 499724 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-16
Entered: 2013-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Feeling abnormal, Hypoaesthesia, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN007222

Write-up: Initial information has been received from a physician (also reported as pharmacist) concerning a female patient of an unknown age who on an unknown date, was vaccinated intramuscularly with a dose of GARDASIL (dose, injection site and lot number not reported). No concomitant medication was reported. On an unspecified date, the patient received GARDASIL and after vaccination, the patient experienced nausea, floating feeling, giddiness and numbness of 4 limbs. The patient was observed for a while, and then she underwent examinations after admission to hospital. There was no abnormality in vital and no hyperventilation. The next day (date unknown), the patient was discharged from the hospital because she had recovered from the nausea, floating feeling, giddiness and numbness of limbs. I consider that there was some causal relationship between the adverse events and the GARDASIL because the patient''s condition changed just after the vaccination, but I could not identify the cause of the events at the moment. The reporting physician assessed that the nausea, floating feeling, giddiness and numbness of limbs were related to GARDASIL. The reporting physician assessed the nausea, floating feeling, giddiness and numbness of limbs as serious due hospitalization. Additional information has been requested.


VAERS ID: 499887 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-23
Onset:2013-07-23
   Days after vaccination:0
Submitted: 2013-08-20
   Days after onset:28
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness postural, Lip discolouration, Lip swelling, Paraesthesia, Rash, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Dizziness, with the first vaccine of GARDASIL
Allergies:
Diagnostic Lab Data: 07/23/2013, Heart rate, 96 not provided; 07/23/2013, Heart rate, 88 not provided; 07/23/2013, Respiratory rate, 32 not provided; 07/23/2013, Respiratory rate, 26-30 not provided
CDC Split Type: WAES1308AUS007892

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 12 year old female patient. On 23-JUL-2013 the patient was vaccinated with GARDASIL (batch # reported as H016666) dose 2, intramuscular. The patient was administered second dose of GARDASIL at approximately 10:10-10:15. She had felt dizzy with her first vaccine so we had her wait in close proximity to us sitting up. She remained sitting for approximately 15 minutes and checked on throughout. When she stood up to leave she felt dizzy so she was asked to stay and laid down with legs elevated. By 10:30 she had developed a fine rash on her inner forearm (itchy) and within a few minutes a welt like rash on her right side forehead/scalp. Pulse (P) was 96 Respiratory rate (RR) was 32. The patient was alert and talking feeling "ok". By 10:40 the HCP noted colour change of lips and slight swelling of lips, tingling sensation. She remained alert, no increased work of breathing (WOB) and strong regular pulse P88, RR 26-30. Rash began to subside and no further change in appearance (adrenalin was drawn up). Ambulance was called. The patient was assessed and monitored by paramedics and transferred to medical centre for further management. Subsequently, the patient was hospitalized. The patient said she was given some medications and observed and sent home later that day. Her mother does not speak the language so she was unable to further explain treatment given in emergency department (ED). The outcome of the events was unknown. The agency considered the events to be possibly related to GARDASIL. The original reporting source was State/Territory Health Department. Additional information is not expected.


VAERS ID: 499932 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-07-25
Onset:2013-07-27
   Days after vaccination:2
Submitted: 2013-08-20
   Days after onset:24
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, General physical health deterioration, Gianotti-Crosti syndrome, Malaise, Pyrexia, Rash, Rash macular
SMQs:, Liver infections (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, $g39 degree
CDC Split Type: WAES1308DEU008646

Write-up: Case was received from the Health Authorities on 13-Aug-2013 (reference no. PEI2013046128). Case is medically confirmed. A 26-year-old male patient received the first dose of GARDASIL (lot-no. not reported) IM on 25-Jul-2013. On 27-Jul-2013, the patient developed Gianotti-Crosti syndrome (all over skin multiple ($g200) disseminated, non itching erythematous maculae with central vesicula and normal mucosa), exanthem, feeling sick, fever ($g39 degrees C) and weakness. On 28-Jul-2013, patient presented to the emergency unit due to deterioration of his condition. The patient refused the recommended hospitalization. At the time of reporting the patient had not recovered. The case was assessed by HA as serious (other medical important condition).


VAERS ID: 500026 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-02-22
Onset:2013-02-28
   Days after vaccination:6
Submitted: 2013-08-20
   Days after onset:172
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. RN39011 / 1 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H001349 / 1 UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC378078AH / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS008096

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning to a 12 years old male patient. On 22-FEB-2013 the patient was vaccinated with the first dose of GARDASIL batch# H001349 (exp. 28-JUN-2014), the first adult dose of HBVAX II batch# G005881 (valid as lot# RN39011, exp. 16-NOV-2013), and the first dose of BOOSTRIX batch# AC378078AH. No administration route was provided. On 28-FEB-2013, the patient developed a rash and welts on inner thighs and under arms 6 days post vaccination. Patient attended to emergency department (ED) on 03-MAR-2013. ED discharge notes was requested and would be forwarded. The was recovered from rash on 11-MAR-2013. The reporter considered rash to be possible related to GARDASIL, HBVAX II and BOOSTRIX. The original reporting source was State/Territory Health Dep. Additional information is not expected.


VAERS ID: 500035 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-23
Onset:2012-07-01
   Days after vaccination:69
Submitted: 2013-08-20
   Days after onset:415
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Confusional state, Convulsion, Electroencephalogram normal, Muscle twitching, Musculoskeletal stiffness
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electroencephalograph (EEG): 12-FEB-2013: no abnormality detected
CDC Split Type: WAES1308AUS007332

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR323758) concerning a 12 year old female patient. On 29-FEB-2012, 23-APR-2012, and on approximately 30-JUN-2012 the patient was vaccinated with his first, second and third doses of GARDASIL respectively, intramuscularly (doses, and lot numbers not provided). The day after vaccinations, on 01-JUL-2012, the patient''s father found her having seizure and stiff twitching movements of all body. It lasted a few minutes. The patient was confused for some time afterwards. The patient backed to normal after some time. The patient recovered after 4 hours. On 12-FEB-2013, an electroencephalograph (EEG) showed no abnormality detected (NAD). The agency considered the events to be possibly related to GARDASIL. The original reporting source was State/territory Health Department. Upon internal review convulsion was considered medically significant. Additional information is not expected.


VAERS ID: 500036 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Foreign  
Vaccinated:2013-06-24
Onset:2013-06-24
   Days after vaccination:0
Submitted: 2013-08-20
   Days after onset:57
Entered: 2013-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0613AE / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Hypoaesthesia, Loss of consciousness, Loss of control of legs, Restlessness, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS007335

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR322400) concerning a 12 year old male patient. On 13-FEB-2013 the patient was vaccinated with his first dose of GARDASIL (dose, route and lot number not provided). On 24-JUN-2013 the patient was vaccinated with his second dose of GARDASIL lot # 0613AE, batch H019846, expiring 02-APR-2015, intramuscular (dose and site not provided). On 24-JUN-2013, at approximately 13:00 hours the patient presented at sick bay, was unable to walk properly, his legs were ''twisting'', he was ''blanking out'' but easily roused. The patient experienced numbness of left face. The patient was taken to the Hospital at 15:00 hrs by his parents. The patient presented with shakiness, restlessness and possible syncope. The patient complained of shortness of breath and was given VENTOLIN prn. On 25-JUN-2013 the patient was still feeling weak and limping left leg, and stayed home from school. On 26-JUN-2013, the patient still was not fully recovered, and remained weak. The patient was advised by Hospital to go to GP and consider follow up with Paediatric Neurologist if any symptoms persist. (Also reported as: The outcome of the events was reported as recovered (27-JUN-2013). The agency considered the events to be possibly related to GARDASIL. The original reporting source was state/territory health department. Additional information is not expected.


VAERS ID: 500039 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-21
Entered: 2013-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008260 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Contusion, Dizziness, Face injury, Fall, Lip injury, Lymphadenopathy, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308GBR008475

Write-up: This case was received from the health authority in a foreign country on 13-Aug-2013. GB-MHRA-ADR 22203313. This case is medically confirmed. A 12-year-old patient (gender unknown), with no reported medical history, was vaccinated on an unreported date with an injection of GARDASIL (batch n. H008260; dose, dose in series, route and site of administration not reported). The patient fainted 5 minutes after the vaccination, hit face when falling and had sustained bruising, swelling to node and cut lip. She felt nauseated and dizzy and was collected from school. The patient returned to school on the following day. At the time of reporting the patient had recovered from dizziness, fainting and nausea (date of recovery not reported). The outcome was not reported for hit face when falling, sustaining bruising, swelling to node and cut lip. Upon internal review the company decided to add the adverse events "hit face when falling", "sustaining bruising", "swelling to node" and "cut lip" which were mentioned but not coded by HA. The events were considered to be serious as an other medically important condition.


VAERS ID: 500104 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-09-05
Onset:2012-09-15
   Days after vaccination:10
Submitted: 2013-08-21
   Days after onset:340
Entered: 2013-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H001349 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Immunoglobulin therapy, Neuropathy peripheral, Plasmapheresis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308AUS008137

Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 14 year old female patient. On 05-SEP-2012 the patient was vaccinated with a dose of GARDASIL (lot # H001349, 0.5 ml, intramuscular). On 15-SEP-2012, the patient experienced sensory predominant acute inflammatory neuropathy (almost complete loss of posterior column function). Steroids/ivig/plasmapheresis was ongoing. 20 days hospital admissions in all, as a work up for treatment +intravenous immunoglobulin (IVIG) and plasma exchange. The outcome of sensory predominant acute inflammatory neuropathy was reported as not recovered/not resolved. The reporter considered sensory predominant acute inflammatory neuropathy to be Incapacity/disability and to be possibly related to GARDASIL. The original reporting source was an other health professional. Additional information is not expected.


VAERS ID: 500105 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2011-09-01
Onset:0000-00-00
Submitted: 2013-08-22
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Dissociative disorder, Nonspecific reaction, Pyrexia, Syncope, Tonic clonic movements, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 05/2011, GARDASIL, No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DEU009151

Write-up: Case was received from the Health Authorities on 14-Aug-2013 (reference no. PEI2013046170). Case is medically confirmed. A 13-year-old female patient received the second dose of GARDASIL (lot-no. not reported) IM on an unspecified date in Sep-2011. Following the vaccination, the patient developed fever and a severe general reaction lasting for one week. Two months after vaccination, the patient experienced poor concentration and general ill feeling. Patient missed school on a regular basis. Eight months after vaccination, the patient developed tremor, syncopes and tonic-clonic jerks in terms of dissociative seizures requiring several hospital stays. At the time of reporting to local HA on 21-Mar-2013, the outcome was unknown. D1 of GARDASIL (lot-no. not provided) given in May-2011 was well tolerated.


VAERS ID: 500106 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-25
Onset:2012-10-25
   Days after vaccination:0
Submitted: 2013-08-22
   Days after onset:301
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H006967 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Nausea, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: BRICANYL
Current Illness: Immunisation; Asthma exercise induced
Preexisting Conditions: GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308SWE009122

Write-up: Case received from a health care professional via Health Authority on 14-Aug-2013 under reference number 132806. Case serious and medically confirmed. A 14 year old female patient had received an injection of GARDASIL (dose 2, batch number H006967, route intramuscular and site not reported) on 25-Oct-2012 and later on, the vaccination day, (onset date: 25-Oct-2012) she developed an anaphylactic reaction, heavy breathing, dizziness, nausea, shaking, red rash. According to the reporter the patient received the GARDASIL vaccination at 11:30 am, shortly post vaccination she developed dizziness, nausea, shaking and red rash. She received 0, 15 mg ANAPEN (mfr other) with successful effect. At 12:00 pm she also received BETAPRED (mfr other) 5 mg and TAVEGYL (mfr other) 1 mg by the ambulance team and when she arrived at the hospital she was no longer heavy breathing but she was still feeling dizzy and shaky. She was hospitalized for observation. At 21:00 pm she was discharged from hospital and returned to her home, at that time she was completely recovered and stable circulatory and respiratory. The patient has previously been vaccinated with GARDASIL (batch number, route and site not reported), date of vaccination not reported. The patient also has a disease history of asthma exercise induced, ongoing. Upon medical review the company judged relevant to code the following adverse events: dizziness, nausea, shaking, red rash and heavy breathing which were mentioned by the HA in the narrative, but not coded. At the time of reporting, the outcome was recovered.


VAERS ID: 500112 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-04-27
Onset:2012-05-28
   Days after vaccination:31
Submitted: 2013-08-22
   Days after onset:451
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythromelalgia, Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site pain, Nerve block, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Mumps
Allergies:
Diagnostic Lab Data: Body temperature, 36.6 degrees C; 04/27/2012, Body temperature, 36.2 degrees C; 06/30/2012, Body temperature, 36.5 degrees C
CDC Split Type: WAES1308JPN008438

Write-up: Initial information has been received from a physician via the PMDA concerning a 12-year-old female patient, who on 27-APR-2012 received a GARDASIL (Lot # 9QN03R) intramuscular (IM) injection for the first time (dose and injection site not provided). In the immunization questionnaire (about underlying disease, allergy, past history of vaccination/ disease during recent one month, concomitant medications, past history of adverse drug reaction (ADR) and status of growth), it was reported that the patient had a history of mumps and no family history. Her body temperature before the vaccination was 36.2 C. No concomitant medication was reported. On 27-APR-2012, the patient received the GARDASIL injection drug (Lot# 9QN03R) for the first time as mentioned above. She then immediately had only injection site pain and redness. On 28-MAY-2012, the patient had pain in the soles of both feet and had to walk on her toes. The pain increased when they touched hot water. At the beginning of June 2012, the patient visited a department of dermatology and was given a diagnosis of erythromelalgia. The painkiller prescribed was ineffective. In the middle of June 2012, the patient had a nerve block at a pain clinic, which was ineffective. On 30-JUN-2012, the patient received the type GARDASIL (Lot # 9QN03R) for the second time. On 08-AUG-2012, the patient was admitted to the department of neurology of a hospital and had close examinations. She received medical treatment but did not improve. On 17-AUG-2012, the patient was discharged from the hospital. On an unspecified date, the patient received the GARDASIL (Lot # 9QN06R) for the third time. As of 05-JUL-2013, the patient still had pain of erythromelalgia, and it had slightly been affecting her daily and school like. Reporter comment: Nothing particular. The reporting physician assessed the causal relationship between the erythromelalgia and GARDASIL as unknown and did not assess the relationship of the injection site pain and injection site redness to the GARDASIL. The physician did not consider there was other possible cause (such as some disease) of the events. The reporting physician assessed the erythromelalgia as serious (hospitalization) and did not assess the seriousness of the injection site pain and the injection site redness. Additional information has been requested.


VAERS ID: 500211 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-02
Onset:2009-04-14
   Days after vaccination:12
Submitted: 2013-08-22
   Days after onset:1591
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cataplexy, Hypersomnia
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK009140

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22209766 and DK-DKMA-EFO6547. Case medically confirmed. A 14-year old female patient had received an injection of GARDASIL (dose 3, batch number not reported, intramuscular route, site not reported) on 02-Apr-2009 and later on 14-Apr-2013 (ie 12 days p-v) she developed hypersomnia and cataplexy. The patient was hospitalized first time with attack on 14-Apr-2009 (date discharged not reported). Other vaccines: no. Other medications: no. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, route and site of administration not reported) on 09-Oct-2008. Second GARDASIL vaccination (dose 2, batch number not reported, route and site of administration not reported) on 11-Dec-2008. At the time of reporting, the outcome was not recovered.


VAERS ID: 500212 (history)  
Form: Version 1.0  
Age: 42.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-12
Onset:2013-06-26
   Days after vaccination:14
Submitted: 2013-08-22
   Days after onset:57
Entered: 2013-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H016574 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Computerised tomogram head abnormal, Confusional state, Depressed mood, Disturbance in attention, Dizziness, Impaired work ability, Libido decreased, Mental status changes, Musculoskeletal disorder, Myalgia, Nausea, Speech disorder, Stress, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT (cerebral) was performed on an unspecified date with nothing abnormal as result.
CDC Split Type: WAES1308DNK009746

Write-up: Case received from a health care professional via the Health Authorities in a foreign country on 15-Aug-2013 under the reference number DK-DKMA-ADR 22208286 and DK-DKMA-EFO6541. Case medically confirmed. A 42 year old female patient (height 174 cm, weight 85 kilogram) had received an injection of GARDASIL (dose 2, batch number H016574, intramuscular route, site of administration not reported) on 12-Jun-2013 and later on 26-Jun-2013 (i.e. 14 days p-v) she developed Transient Cerebral Ischaemia (TCI), difficulty speaking and difficulty controlling right arm and leg. The patient was hospitalized due to the events. CT (cerebral) was performed on an unspecified date with nothing abnormal as a result. The patient''s medical history includes: First GARDASIL vaccination (dose 1, batch number not reported, site and route of administration not reported) on 06-Mar-2013. Previously healthy patient. At the time of reporting, the outcome was unknown. Additional information received from health authority on 19-Aug-2013. Additional reference number received: DK-DKMA-ADR 22213488 and DK-DKMA-EFO6584. HA received information from the patient. Patient initials, height: 165 cm, weight 89 kilogram updated and changed. According to the patient, she developed speech impairment, confusion, dizziness, nausea, concentration impaired, TCI/blood clots, tiredness, tender muscles, mentally unstable, anxiety, sadness, quickly stress, decreased sex drive. Due to these symptoms the patient was absent from work for 5 weeks and had to start seeing a psychologist. She is very sad all the time. The patient received the following treatment for the side effect: clopidogrel (other MFR) and simvastatin (other MFR). HA added AE with outcome and onset as follows: quickly stress: unknown (onset not reported), sadness: unknown (onset not reported), anxiety: unknown (onset not reported), decreased sex drive: unknown (onset not reported), confusion: not recovered (onset 26-Jun-2013), concentration impaired: not recovered (onset 26-Jun-2013), tender muscles: unknown (onset not reported), mentally unstable: unknown (onset not reported), dizziness: not recovered (onset 26-Jun-2013), tiredness: unknown (onset not reported), nausea: not recovered (onset 26-Jun-2013).


VAERS ID: 500389 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-25
Onset:2013-03-20
   Days after vaccination:54
Submitted: 2013-08-25
   Days after onset:158
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H017284 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Borrelia test negative, Computerised tomogram normal, Dizziness, Fatigue, Headache, Hypoaesthesia, Lumbar puncture normal, Malaise, Nuclear magnetic resonance imaging normal, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerised tomogram, No TIA/stroke, multiple sclerosis or Borrelia; Lumbar puncture, No TIA/stroke, multiple sclerosis or Borrelia; Nuclear magnetic resonance imaging, No TIA/stroke, multiple sclerosis or Borrelia
CDC Split Type: WAES1308DNK010428

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22210977 and DK-DKMA EFO6556. Case is not medically confirmed. A 38-year-old female patient (weight 60 kg, height 174 cm), had received an injection of GARDASIL (dose not reported, batch number not reported) via not reported route on 25-Jan-2013. On 20-Mar-2013, the patient developed headache, sensory disturbance and numbness in the right side of the body. On 21-Mar-2013, the patient developed general malaise. On an unspecified date the patient also developed sporadic dizziness and general fatigue. The patient was hospitalised. Lumbar puncture, MRI and CT scan were performed. No TIA/strike, multiple sclerosis or Borrelia were detected. In July 2013, the patient developed the same feelings in his left hand and foot. At the time of reporting, the patient had not recovered from headache, sensory disturbance and numbness in the right side of the body. The outcome of general malaise, sporadic dizziness and general fatigue was unknown. Noteworthy: The HA reported that the patient had received a previous dose in Apr-2013 which is not consistent with the suspect dose. Additional information received from a health care professional via Health Authority in a foreign country on 20-Aug-2013 under reference numbers DKMA 2214207 and DKMA EFO6596. Case is medically confirmed. The following information has been added/changed. Patient''s height is changed to 175. Batch number H017284 added for GARDASIL dose administered on 25-Jan-2013. Adverse event PARESTHESIA IN ENTIRE RIGHT SIDE added with start date 21-Mar-2013, outcome not recovered. On 03-Apr-2013 the patient received an injection of GARDASIL (dose not reported, batch number J0003947, route intramuscular and site not reported). On 11-Jul-2013 the patient developed a deterioration shown as paresthesias in left side of the body and face. After GARDASIL vaccination received on 25-Jan-2013 the patient develops paresthesia in the entire right side. She was hospitalized on a neurological department, apoplectical observation and disseminated sclerosis observation, neither existed. No signs of neurological infection. After GARDASIL vaccination received 03-Apr-2013 the patient developed a deterioration shown as paresthesias in left side of the body ad face, in addition, dizziness and fatigue. At the time of reporting the outcome for deterioration shown as paresthesias in left side of the body and face was not recovered.


VAERS ID: 500390 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-22
Onset:2013-07-22
   Days after vaccination:0
Submitted: 2013-08-25
   Days after onset:34
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Cold sweat, Depressed level of consciousness, Disturbance in attention, Dizziness, Dysgraphia, Dyspnoea, Fatigue, Headache, Hearing impaired, Heart rate increased, Hot flush, Hyporesponsive to stimuli, Influenza like illness, Libido decreased, Memory impairment, Monoplegia, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Palpitations, Paraesthesia, Sensory disturbance, Speech disorder, Spinal pain, Tremor, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 05/27/2013, GARDASIL, Drug Reaction: Influenza like illness; 05/27/2013, GARDASIL, Drug Reaction: Anogenital warts
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK010420

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22213485 and DK-DKMA EFO6581. Case is not medically confirmed. A 31-year-old female patient (weight 56 kg, height 161 cm) had received the second injection of GARDASIL (batch number not reported) via not reported route on 22-Jul-2013. On the same day, the patient developed breathing problems, flu-like symptoms, cold sweat, sensory disturbances, visual disturbances, writing difficulty with pencil, difficulty in speaking, headache, dizziness, consciousness clouding (was in bubble), hearing impaired, nausea, pain in joints, pain in muscles, tiredness and difficulty getting out of the bed despite the fact that she was sleeping around 7 hours each night, difficulty concentrating, memory impairment, tremors in the legs and arms, high pulse, poor response, hot flush, decreased libido, heart palpitations, leg paralysis for short periods, severe pain in the upper neck, sleeping feet, pain in lumbar region and neck stiffness. Blood tests were performed, but results were not provided. At the time of reporting, the patient had not recovered. Previous dose of GARDASIL (D1) was given on 27-May-2013. On the same day, the patient developed flu-like symptoms. On an unspecified date in May-2013, the patient also developed genital warts and bumps in the vagina introitus.


VAERS ID: 500392 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-30
Onset:2013-06-23
   Days after vaccination:144
Submitted: 2013-08-23
   Days after onset:61
Entered: 2013-08-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H019411 / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram normal, Diplopia, Headache, Hypoaesthesia, Neck pain, Nuclear magnetic resonance imaging normal, Paraesthesia, Subarachnoid haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Tension headache; MIgraine; 10/22/2012, GARDASIL, Immunisation, Dose 2. Batch number H007797; 09/17/2012, GARDASIL, Dose 1. Batch number G020674.
Allergies:
Diagnostic Lab Data: CT and MMR was normal. MMR or molecular MR is MRI with molecular imaging. 06/23/2013, Computerised tomogram, normal; 06/23/2013, Nuclear magnetic resonance imaging, Normal
CDC Split Type: WAES1308DNK008876

Write-up: Case received from a health care professional via company representative on 14-Aug-2013. Case medically confirmed. A 21 year old female patient had received an injection of GARDASIL (dose 3, batch number H019411, site and route of administration not reported) on 30-Jan-2013 and later about 5 months p-v, on 23-Jun-2013, she developed severe neck pain and was hospitalized with suspected arachnoidal hemorrhage. After half a day occurs diplopia and numbness in the arm from the elbow down. CT and MMR were normal and the patient was discharged the same evening (23-Jun-2013). She still has tingling in the right cheek and headache. To be noted that MMR or molecular MR is MRI with molecular imaging. Patient''s medical history includes: First vaccination with GARDASIL (Dose 1, Batch number G020674, lot number NP00860, site and route of administration not reported) on 17-Sep-2012. Second vaccination with GARDASIL (Dose 2, Batch number H007797, site and route of administration not reported) on 22-Oct-2012. Patient had previously suffered from migraine and tension headaches. At the time if reporting, the outcome was not reported for severe neck pain, suspected arachnoidal bleeding, diplopia and numbness in arm. Outcome of tingling in the right cheek and headache was not recovered.


VAERS ID: 500393 (history)  
Form: Version 1.0  
Age: 36.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-15
Onset:2013-01-20
   Days after vaccination:5
Submitted: 2013-08-25
   Days after onset:216
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Blood test, Computerised tomogram, Dizziness, Ear, nose and throat examination, Fatigue, Headache, Hemiplegia, Impaired work ability, Memory impairment, Metabolic function test abnormal, Neurological examination, Nuclear magnetic resonance imaging spinal, Oedema peripheral, Sensory disturbance, Somnolence, Tic, VIIth nerve paralysis, Visual impairment
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT scan, MRI of spinal fluid, neurological tests and ear, nose and throat tests were performed. Results were not provided. Blood test, tabolism parameters were rising N/A
CDC Split Type: WAES1308DNK010406

Write-up: Case received from a consumer or other non health care professional via the Health Authorities in a foreign country on 19-Aug-2013 under the references DK-DKMA-ADR 22210979 and DK-DKMA EFO6558. Case is not medically confirmed. A 38-year-old female patient (weight 98 kg, height 176 cm) had received the first injection of GARDASIL (batch number not reported) via not reported route on 15-Jan-2013. 5 days later, on 20-Jan-2013, the patient developed headache, dizziness, paralysis/stunned face, left arm and leg, pain in joints, fatigue, feeling of grogginess, memory impaired, visual disturbances, tics and disturbances in fingers and water in the left leg. The symptoms were increasing and on 05-Aug-2013, the patient found it difficult to do her job. The patient was hospitalised. Blood tests showed that metabolism parameters were rising. CT scan, MRI of spinal fluid, neurological tests and ear, nose and throat tests were performed. Results were not provided. The patient was treated with metabolic medicine due to water in the legs and headache. The patient was also treated with cranio-sacral therapy and reflexology. At the time of this report, the patient had not recovered.


VAERS ID: 500534 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-25
Entered: 2013-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Acne, Computerised tomogram, Infertility female, Menstruation irregular, Metabolic function test abnormal, Neurological examination, Nuclear magnetic resonance imaging
SMQs:, Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerized tomogram, MRI, Neurological examination and Ear, nose and throat examination performed, results not provided; Blood test, metabolism parameters were rising
CDC Split Type: WAES1308DNK010417

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 19-Aug-2013 under the references DK-DKMA-ADR 22210163 and DK-DKMA EFO6550. Case is not medically confirmed. A female patient, (weight 62 kg, height 170 cm), had received an injection of GARDASIL (batch number not reported) via not reported route on an unspecified date in 2005. On an unspecified date in 2005, the patient developed blemished skin, irregular menstruations and decreased fertility (cannot get pregnant). The patient had been rarely sick before the vaccination with GARDASIL, but since vaccination, the patient experienced approximately two episodes of sick leave per year. At the time of reporting, the patient had not recovered.


VAERS ID: 500640 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2010-03-01
Onset:2010-04-01
   Days after vaccination:31
Submitted: 2013-08-27
   Days after onset:1244
Entered: 2013-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis autoimmune, General physical health deterioration, Headache, Immunoglobulin therapy, Intensive care, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308ISR009992

Write-up: This spontaneous report as received from a gynecologist refers to a 22 year old female patient with no history of sexual activity who was married with a young male with no history of sexual activity, both were not at risk group for HPV. In March 2010, the patient was possibly vaccinated with the first dose of GARDASIL (Lot # not reported, expiration date and route not specified). The physician reported that in April 2010, after one month of vaccination, following a day of hiking the patient complained to her husband at the evening about a headache and within a short time the patient lost consciousness. The patient was hospitalized at the intensive care unit under the diagnosis of autoimmune inflammation of the brain. Despite intensive treatments that included immunoglobulin therapy and wide and global consultations the patient''s condition deteriorated and the patient passed away after several days in April 2010. No post-mortem autopsy was performed. The physician felt that severe autoimmune inflammation of the brain was not related to vaccination with GARDASIL. The physician stated that hospital''s physicians did not relate the event to vaccination with GARDASIL and it was never raised as a cause. The reporter stated that the patient''s sister mentioned at one point that might be the patient was not vaccinated with GARDASIL after all and only had a prescription at that time. Additional information has been requested.


VAERS ID: 500815 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-03-01
Submitted: 2013-08-28
   Days after onset:179
Entered: 2013-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Dysmenorrhoea, Hypomenorrhoea, Menstrual disorder, Menstruation delayed, Polymenorrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Rhinitis allergic, no medicinal treatment
Preexisting Conditions: Cardiac disorder, abnormality was pointed out in a high-school medical checkup, but no specific disease was diagnosed in a close examination, and she had been receiving no medical treatment; Diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxo, Pyrexia
Allergies:
Diagnostic Lab Data: 03/2013, Body temperature, 36.2 degrees C
CDC Split Type: WAES1308JPN004077

Write-up: Initial and follow up information was received from physician concerning a 16-year-old female patient. The following were revealed in the patient from the pre-vaccination medical history interview (such as underlying disease, allergy, past history of vaccination/ disease during recent one month, concomitant medications, past history of ADR and status of growth): the patient had allergic rhinitis with no medical treatment; abnormality in heart (abnormality was pointed out in a high-school medical checkup, but no specific disease was diagnosed in a close examination, and she had been receiving no medical treatment and having no regular medical checkup); and she had a fever at the time of the DPT vaccine. She had no specific family history. Her body temperature before the vaccination of GARDASIL IM injection drug was 36.2 C. On 16-MAR-2013, the patient received the GARDASIL IM injection drug (0.5 ml once a day) (third time) (injection site not provided). No concomitant medication was reported. On an unspecified date, the patient received the first GARDASIL IM injection drug (lot number and injection site not provided). On an unspecified date, the patient received the second GARDASIL IM injection drug (lot number and injection site not provided). On 16-MAR-2013, as mentioned above, the patient received the third GARDASIL (lot no. 9QN07R) (injection site not provided). Her menstruation had been stable with a 1-week period and a 4-week interval since her first menstruation was started when she was in the 6th grade of primary school, but the volume and the frequency decreased since after the third vaccination. She began to have severe abdominal pain and delayed menstruation (oligomenorrhoea) in MAR-2013 and started to receive a painkiller. On an unspecified date, her most recent menstruation lasted only for a few days with a small amount of bleeding, but she had a severe menstrual pain. Reporter''s comment: The causal relationship between the events and the recombinant quadrivalent human papillomavirus vlp vaccine was unknown. Thee physician was very dissatisfied with the country and the pharmaceutical company of the vaccine because they did not properly announce adverse reactions due to the vaccine and would not stop the use of the vaccine. The reporting physician did not assess the causal relationship of the abnormal menstruation (light periods, painful menses) and oligomenorrhoea to the recombinant quadrivalent human papillomavirus vlp vaccine. The physician considered that other cause of the events (such as any disease) was unknown as her symptoms had been checked by a department of gynecology. The outcome for menstruation abnormal (light periods, menses painful) and menstruation abnormal (light periods, menses painful) were not recovered and oligomenorrhoea was unknown. The reporting physician assessed the abnormal menstruation (light periods, painful menses) as serious and the oligomenorrhoea as non-serious. The events of menstruation abnormal (light periods, menses painful) and menstruation abnormal (light periods, menses painful) were considered as medically significant. Additional information has been requested. Narrative, products, patient and event were updated.


VAERS ID: 500854 (history)  
Form: Version 1.0  
Age: 21.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-08
Onset:0000-00-00
Submitted: 2013-08-28
Entered: 2013-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Back pain, Blood test normal, Condition aggravated, Disturbance in attention, Dizziness, Fall, Fatigue, Feeling abnormal, Formication, Headache, Hyperhidrosis, Mobility decreased, Muscle spasms, Muscular weakness, Myalgia, Nausea, Paralysis, Visual impairment, Vomiting, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Cardiac disorder; Asthma; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2013, Blood test, Normal
CDC Split Type: WAES1308DNK011875

Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 19-Aug-2013 under the references DK-DKMA-ADR 22213484 and DK-DKMA EFO6580. Case is not medically confirmed. A 21-year-old female patient (weight 67 kg, height 165 cm) with a medical history of asthma and unstable heart had received an injection of GARDASIL (batch number not reported) via not reported route and site of administration on 14-Feb-2013. On an unspecified date, the patient developed headache, paralysis (could not feel or move her legs or arms), cramps, vomiting, difficulty concentrating, severe pain in the back and constant back pain, sweating, nausea, weight loss (lost 10 kg in 1 month) and formication. On 08-Jul-2013 the patient received another injection of GARDASIL (batch number not reported) via not reported route and site of administration. After this vaccination the symptoms that the patient had experienced after the previous dose, aggravated. In addition, the patient developed spontaneous abortion, insane fatigue, decreased muscle strength, feeling abnormal (to be present and still not), dizziness (could not travel without being so dizzy that she was falling because everything grew dark before her eyes) and sore muscles on an unspecified date. Blood samples were normal. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the event "Condition aggravated".


VAERS ID: 500894 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-08-29
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Laboratory test normal, Local swelling, Mobility decreased, Nerve conduction studies normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Peripheral coldness, Somatosensory evoked potentials, Ultrasound scan normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown date: MRI: R. arm and brachial plexus: no nerve injury; Nerve conduction studies, Normal; Somatosensory evoked potentials, Normal; Ultrasound scan, Normal
CDC Split Type: WAES1308DEU013656

Write-up: Case retrieved from the literature on 19-Aug-2013. Case is medically confirmed. A 14-year old girl received her first dose of GARDASIL (lot-no. not reported) IM into the right deltoid muscle on an unspecified date. Within 24 hours she developed severe pain, swelling, numbness, and coldness of the right arm and hand. Additionally she developed "lack of function" on an unknown date. Diagnostics with ultrasound, nerve conduction, and sensory evoked potentials were normal. The MRI scan of the right arm and brachial plexus showed no nerve injury. The symptoms improved under physical and occupational therapy. After 2 months skin temperature was normal and swelling reduced. Pain and lack of function were ongoing. The case was assessed as serious by the company (medical judgment).


VAERS ID: 500904 (history)  
Form: Version 1.0  
Age: 43.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-17
Onset:2013-08-18
   Days after vaccination:1
Submitted: 2013-08-29
   Days after onset:11
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ocular hyperaemia, Rash generalised, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hepatitis C; Colitis ulcerative
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308JPN012005

Write-up: Initial information has been received from a physician concerning a 43-year-old female patient with underlying diseases of ulcerative colitis and hepatitis C. On 17-AUG-2013, the patient received the second dose of GARDASIL intramuscularly, injection drug 0.5 ml (injection site and indication not provided). Information of concomitant medication was not obtained. On 17-JUN-2013, the patient received the first dose of GARDASIL intramuscularly, injection drug, dose: 0.5ml, batch # 9QN09R, lot # 0989AA (indication not provided). Nothing happened in the patient at that time. Around 10 days before the second vaccination, the patient visited the reporting physician''s hospital for cystitis and received antibiotic. On 17-AUG-2013, at 12:00, the patient received the second dose of GARDASIL, intramuscularly, injection drug, batch # 9QN08R, lot # 0989AA expiration date: 21-JUN-2014 (Indication not provided) as mentioned above. On 18-AUG-2013, around 7:00, the following events developed (chronologically): Rash on right foot which expanded to generalized exanthema, swelling face, and ocular hyperaemia. On that day, the patient was in a foreign city on business and thus visited a hospital because the symptoms were the worst at that night. She was told at the hospital that the symptoms were due to the vaccination and she should visit the physician of the vaccination. No treatment or prescription was given to her. On 21-AUG-2013, the patient presented to the reporting physician''s hospital, where she received SOLULACT, ascorbic acid and VIT AMEDIN, and prescription of TATHION and oral RESTAMIN KOWA. On 22-AUG-2013, the reporting physician called the patient to check her conditions. She would be getting improvement but she could be hardly clearly recovered. So, she was recovering from generalized exanthema, swelling face and ocular hyperaemia. It was decided after the talk with the patient that the third vaccination would not be conducted, action taken regarding to GARDASIL was reported as withdrawn. Comment: This patient received the CERVARIX in February, March and August 2011 and then wanted to receive also the GARDASIL. She thus started to receive the vaccine after the consultation with hospital A. She also receives flu vaccine every year. Reporting physician assessed the generalized exanthema, swelling face and ocular hyperaemia as serious (other important medical events). Reporting physician assessed that the generalized exanthema, swelling face and ocular hyperaemia were related to the GARDASIL. Additional information has been requested.


VAERS ID: 500933 (history)  
Form: Version 1.0  
Age: 22.0  
Gender: Female  
Location: Foreign  
Vaccinated:2004-01-01
Onset:2005-01-01
   Days after vaccination:366
Submitted: 2013-08-29
   Days after onset:3161
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amenorrhoea, Arthralgia, Decreased activity, Dizziness, Dizziness postural, Hormone level abnormal, Immune system disorder, Loss of consciousness, Lymphadenopathy, Menstruation irregular, Muscle spasms, Myalgia, Neuropathy peripheral, Paraesthesia, Sensory disturbance, Skin burning sensation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1308DNK009477

Write-up: Case received from a non-health professional via other company in a foreign country on 08-Aug-2013. Case not medically confirmed. A 32-year-old female patient had received 3 doses of GARDASIL (batch numbers not reported, site and route not reported) on unspecified dates in 2004/2005 and later on unspecified date she developed various disorders; sensory disturbances, blackouts, muscle pain and joint pain. Exact information regarding the various disorders is missing. The patient''s medical history includes: Participation in a GARDASIL study which started on unspecified date in 2002 (end date not reported), where she received a placebo vaccine (no further information specified). The patient received the 3 doses of GARDASIL immediately after a study stop. At the time of reporting, the outcome was not provided. Follow-up information received from a health care professional via Health Authorities in a foreign country on 19-Aug-2013 under the reference number DK-DKMA-ADR 22203120 and DK-DKMA-EFO6503. According to HA, the patient participated in a clinical study with GARDASIL between 2002-2006 (exact start and end date not reported). She received placebo-injections on unspecified dates in 2002-2003 and active vaccines on unspecified dates in 2004-2006. HA coded GARDASIL given patient on 01-Jan-2004 (batch number unknown, intramuscular route) as suspected dose. The company presumes it was the first dose since HA has started GARDASIL not previously given. In the beginning of 2005 the patient began to have blackouts (onset date coded by HA as 01-Jan-2005)/fainting (onset in the beginning of 2005), but did not link it with the vaccine because she had been told that it did not give adverse reactions. Her menstrual cycles were also irregular (onset date not reported) and she started to feel dizzy (onset date 01-Jan-2005). In 2011 the patient''s symptoms began to worsen and she was on sick leave from her school almost the entire year of 2011. After 4 months of very low activity (onset date not reported), she gradually started to get better, but she was unable to work full time. She has continued dizziness (onset date 01-Jan-2005), muscle cramps (01-Jan-2011), severe muscle pain (onset date 01-Jan-2011), burning in the skin (onset date not reported), tingling in fingers and toes (onset date not reported), constantly swollen lymph nodes (onset date not reported), absent menstruation. HA has coded the adverse reactions: immune disorder (onset date 01-Jan-2011), neuropathy (onset date 01-Jan-2011) and hormonal imbalance (onset date 01-Jan-2005) but no further information is specified. The patient has had many questions for the emergency and for her own physician without them being able to explain her condition. According to HA th patient had not taken any other vaccines. It is unknown whether the patient had concomitant medications. The patient''s birth date and age at the time of event has been updated by HA. Patient''s date of birth is coded but age at the time of event is coded as 23 years (presumably a type failure of the age). Height (175 cm) and weight (75 kg) of the patient have also been updated. The company coded fainting and low activity (not coded by HA). At the time of reporting the outcome was not reported for fainting, low activity, sensory disturbances and joint pain and not recovered for blackouts, dizziness on standing up, cramp muscle, muscle pain, immune disorder (NOS), neuropathy, menstrual cycle also irregular/absent, burning in the skin, tingling in fingers and toes, hormonal imbalance and constantly swollen lymph nodes.


VAERS ID: 500935 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-12-01
Submitted: 2013-08-29
   Days after onset:270
Entered: 2013-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Asthenia, Autoantibody negative, Borrelia test negative, Brucella test negative, Coxiella test, Cytomegalovirus test negative, Epstein-Barr virus antigen positive, Headache, Hepatitis B test negative, Hepatitis C test negative, Laboratory test normal, Lumbar puncture normal, Meningeal disorder, Mononucleosis heterophile test, Nausea, Nuclear magnetic resonance imaging brain normal, Periarticular disorder, Pyrexia, Serology test, Toxoplasma serology negative
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Gastrooesophageal reflux disease, since childhood; Immunisation
Preexisting Conditions: Urinary tract infection; GARDASIL
Allergies:
Diagnostic Lab Data: Autoantibody test, Negative; Body temperature, 38 degrees C; Borrelia test, Negative, serology negative; Brucella test, Negative; Coxiella test, Negative, serology negative; Cytomegalovirus test, Negative; Epstein-Barr virus test, former infection; Hepatitis B virus test, Negative, serology negative; Hepatitis C virus test, Negative, serology negative; Lumbar puncture, Normal; Nuclear magnetic resonance imaging brain, Normal; Serology test, Negative, Bartonella: negative; Toxoplasma serology, Negative; Viral test, infectious mononucleosis: non conclusive
CDC Split Type: WAES1308FRA013830

Write-up: Case received from the Health Authorities under reference number TO20131488 on 22-Aug-2013. Case medically confirmed. Case linked with non serious case E2013-06314 (same vaccine, similar adverse reactions). A 15-year-old female patient had received the second dose of GARDASIL (batch number unknown) via intramuscular route in autumn 2012. On 01-DEC-2012, at the approximate schedule date for the third dose, she experienced non specified meningeal syndrome including asthenia, headache, arthralgia and fever. Lumbar puncture, MRI and infectious mononucleosis viral test were non conclusive. In Feb-2013 asthenia and headache were persisting and were accompanied by abdominal pain, periarticular pain and nausea. Laboratory tests were normal. Relatives of the patient were also affected by similar symptoms, including her sister, who was also recently vaccinated with GARDASIL (batch number not reported). This was consistent with infectious origin. She was given as symptomatic treatment for headache with SOLUPRED, paracetamol, MYOLASTAN and LAROXYL. Headache regressed. In Jun-2013 symptoms were still persisting. Infectious or autoimmune origins were ruled out. Functional origin was favored. Viral context with fever up to 38 degrees C, infectious mononucleosis and flu infection were suspected as 2 other patient''s relative experienced similar symptoms. Lumbar puncture and brain MRI were normal. Serology for HBV, HCV, CMV, Bartonella, Toxoplasma and Brucella were negative. Borrelia and Coxiella tests were also negative. Epstein-Barr virus serology was consistent with a former infection. Autoantibody test screening was also negative. Therefore non drug-induced etiology was ruled out. The patient had a medical history of persisting gastroesophageal reflux disease since childhood and recurrent urinary tract infection. She had received the first dose of GARDASIL (batch number not reported) on an unspecified date. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the following adverse events: "arthralgia", "abdominal pain", "fever" and "nausea" which were mentioned by the CA in the narrative but not coded. The Health Authorities considered the case as serious due to "hospitalization" criterion. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment.


VAERS ID: 500941 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-06-22
Onset:2012-08-21
   Days after vaccination:60
Submitted: 2013-08-30
   Days after onset:374
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN03R / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Blood pressure inadequately controlled, Body temperature fluctuation, CSF test abnormal, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Myalgia, Nasopharyngitis, Nerve conduction studies, Pneumonia aspiration, Pyrexia, Reflex test normal, Tracheostomy
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Head computerised tomography (CT) (22-AUG-2012): no abnormality; The test on neurotransmission and spinal fluid (24-AUG-2012): Guillain-Barre syndrome was diagnosed; 08/22/2012, Computerised tomogram head, Normal
CDC Split Type: WAES1308JPN011255

Write-up: This spontaneous report as received from a pharmacist refers to a 34 year old female patient with no underlying disease or medical history. On 22-JUN-2012 the patient received the first GARDASIL, (lot # 9QN03R), 0.5 ml, intramuscular (injection site not reported). No concomitant medication was reported. On 21-AUG-2012, the patient felt numbness of limbs and hypoaesthesia. On 22-AUG-2012, the patient visited a nearby department of internal medicine, where head computed tomography (CT) showed no abnormality. The patient felt she had caught her child''s common cold. On 23-AUG-2012, the patient felt muscle pain and difficulty in walking, and then visited a department of neurology. She had normal neural reflex. At this night, she had to walk along the wall because of worsening of the symptoms. On 24-AUG-2012, the patient re-visited and was admitted to the department of neurology. Guillain-Barre syndrome was diagnosed after the tests on neurotransmission and spinal fluid. She received immune globulin for 5 days. She then had pneumonia aspiration and received temporal tracheostomy for treatment of respiratory impairment. She had difficulty in adjusting body temperature due to autonomic nervous system imbalance, for which her fever persisted. Blood pressure had also been controlled poorly. Therapy with GARDASIL was discontinued. On an unknown date in October 2012, the outcome of Guillain-Barre syndrome(numbness, hypoaesthesia) was recovering (also reported that the event stop date was in October 2012). The patient was discharged from hospital, and she then began rehabilitation. Around March 2013, the patient returned to part-time job. The outcome of temporal tracheostomy, pneumonia aspiration and autonomic nervous system imbalance was unknown. Reporter''s comment: The physician of the vaccination seems to consider that the events are unlikely related to the GARDASIL since the events developed long time after the vaccination. The reporting pharmacist assessed the Guillain-Barre syndrome(numbness, hypoaesthesia) as serious due to hospitalization. The reporting pharmacist did not assess the seriousness of the temporal tracheostomy, the pneumonia aspiration and autonomic nervous system imbalance. Upon internal review, the temporal tracheostomy and the review Guillain-Barre syndrome was decided as serious due to other important medical event. The reporting pharmacist assessed that the Guillain-Barre syndrome (numbness, hypoaesthesia) was unrelated to GARDASIL. The reporting pharmacist did not assess the causal relationship of the temporal tracheostomy, the pneumonia aspiration and autonomic nervous system imbalance to GARDASIL. This is amended report. The temporal tracheostomy was added as serious AE due to other important medical event. The outcome of temporal tracheostomy, pneumonia aspiration and autonomic nervous system imbalance was changed from" recovering" to "unknown". Additional information has been requested.


VAERS ID: 501084 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-08-03
Onset:0000-00-00
Submitted: 2013-08-30
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022181 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein normal, Headache, Liver function test normal, Musculoskeletal stiffness, Nausea, Pharyngeal erythema, Pyrexia, Urticaria, Viral infection, Vomiting, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Urticaria
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: White blood (Unknown date): 4200; C-reactive protein (Unknown date): <1; Liver function tests: Normal
CDC Split Type: WAES1308FRA014252

Write-up: Case received from the Health Authorities under reference number MA20131596 on 12-Aug-2013 via our contractual partner Sanofi Pasteur. Case medically confirmed. An 11-year-old female patient with a medical history of 2 episodes of unexplained generalized urticaria, had received the first dose of GARDASIL (batch number H022181) via intramuscular route on 03-Aug-2013. Four hours post-vaccination she experienced nausea, vomiting, headache and fever. The patient went to the ER. She had mild neck stiffness nut no hepatosplenomegaly, no rash or adenopathy. She had mild pharynx redness. Lab tests performed showed white blood cell count was at 4200, C-reactive protein less than 1 and liver function test normal. Virosis was suspected. She was given paracetamol and VOGALENE as corrective treatment. The patient''s treating physician decided to discontinue the vaccination. On 07-Aug-2013 vomiting and headache had resolved. According to the patient''s mother, fever was persisting. To be noted that the patient was not seen again by her physician. At the time of reporting, the patient was recovering. Upon medical review the company judged relevant code the following adverse events: "virosis", "nausea" and "neck stiffness" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the case as serious due to "Other medically important condition" criterion. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as probable (C3 S1 I3) according to the method of assessment.


VAERS ID: 501092 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-01-31
Onset:2013-03-01
   Days after vaccination:29
Submitted: 2013-08-30
   Days after onset:181
Entered: 2013-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9QN07R / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Endocrine test normal, Endoscopy normal, Epilepsy, Hemiparesis, Myoclonus, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Positron emission tomogram normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 37 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Around March 2013, Results of head MRI were normal. In July 2013, brain imaging showed normal brain waves, and also normal results in MRI of head, thoracic spine and neck. MRI performed for possible spinal myoclonus, and it was normal. Possibility of infection was excluded in blood tests, and collagen disorder was also denied. MRI, contrast CT and PET also denied the malignant tumor. No abnormality in hormone system. An endoscope revealed no abnormality on Behcet''s disease or mixed collagen disorder. 2012, Body temperature, about 39, 39 degrees C; 2012, Body temperature, 38 degrees C; 06/19/2012, Body temperature, 36.9 degrees C; 07/02/2012, Body temperature, about 39, 39 degrees C; 12/2012, Body temperature, 37 degrees C
CDC Split Type: WAES1308JPN014199

Write-up: Information has been received from a physician via the agency concerning a 13-year-old female patient. According to the pre-vaccination interview about underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, ADR history and status of growth, the patient had no problem. The patient had no family history. Her body temperature before the vaccination was 36.9 C. On 19-JUN-2012 at 11:40, the patient received the syringe-type first GARDASIL intramuscular injection drug (Lot number 9QN03R) (dose was not provided). No concomitant medication was reported. On 02-JUL-2012, the patient had pyrexia of 39 C at 8:00, and pyrexia of around 39 C continued thereafter. Possibility of infection was excluded in blood tests, and collagen disorder was also denied. MRI, contract CT and PET also denied the malignant tumor. No abnormality in hormone system. An endoscope revealed no abnormality on Behcet''s disease or mixed collagen disorder. The pyrexia was judged to be psychogenic pyrexia, and her clinical course was being followed up. On 23-AUG-2012, the patient was admitted to hospital. In autumn of 2012, the patient''s body temperature had been 38 C. On 27-SEP-2012, the patient received the second dose of GARDASIL intramuscular injection drug (lot No. 9QN06R) (dose was not provided). On 28-SEP-2012, the patient was discharged from hospital. At the end of December 2012, the temperature went down to 37 C. On 31-JAN-2013, the patient received the third dose of GARDASIL intramuscular injection drug (lot No. 9QN07R) (dose was not provided). Around March 2013, the patient had convulsion-like myoclonus during night sleep and weakness of right side of body in the daytime. Results of head MRI were normal, while sharp waves were observed at the right parietal region. During an observation period, the patient had had the myoclonic-like involuntary movements during sleep-time and the wakeful weakness in the daytime continuously. In July 2013, brain imaging showed normal brain waves, and also normal results in MRI of head, thoracic spine and neck. Valproic acid was administered for suspected epilepsy but did not improve her conditions. MRI performed for possible spinal myoclonus, and it was normal. As of 16-AUG-2013, the patient had not recovered from the myoclonic-like involuntary movements or pyrexia. Clonazepam had been administered for the myoclonic-like involuntary movements. The outcome of the weakness of right side of body was unknown. Reporter''s comment: The patient had pyrexia of 39 C of unknown origin since 02-JUL-2012 after the first vaccination on 19-JUN-2012. At the beginning, I had never thought that the event was due to the GARDASIL, and I judged that it was psychogenic pyrexia from the head examination results. I then came to think that the relation to the vaccine could completely not be denied from the fact that the myoclonic-like involuntary movements appeared in March 2013 after the second and third vaccinations. The reporting physician considered that the causal relationship of the myoclonic-like involuntary movements and pyrexia to GARDASIL was unassessable, and also considered that other possible causes of the event were epilepsy, spinal myoclonus, psychogenesis, etc. The reporting physician did not assess the causal relationship of the weakness of right side body to the vaccine. The reporting physician assessed the myoclonic-like involuntary movements as serious (possible disability) (also reported as medically significant) and pyrexia as serious (possible disability (also reported as medically significant) and hospitalization). The reporting physician did not assess the seriousness of the weakness of right side of body. Remarks: Serious (possible disability) is entered as serious OME due to internal procedures. Additional information has been requested.


VAERS ID: 501102 (history)  
Form: Version 1.0  
Age: 10.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-27
Onset:0000-00-00
Submitted: 2013-09-02
Entered: 2013-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Gait disturbance, Hypoaesthesia, Laboratory test normal, Muscular weakness, Nasopharyngitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unspecified examination in a brain surgery department and a prefectural hospital (date unknown): no abnormality was found
CDC Split Type: WAES1308JPN014926

Write-up: Initial information has been received from a physician concerning a female patient in her 10''s. On 27-AUG-2012, she received the third GARDASIL intramuscular (IM) injection drug (injection site and lot number not provided). No concomitant medication was reported. On 29-SEP-2011, the patient received the first GARDASIL IM injection drug (at A hospital). On an unspecified date, the patient received the second GARDASIL IM injection drug (at A hospital). On 27-AUG-2012 as mentioned above, the patient received the third GARDASIL IM injection drug (at A hospital). On an unspecified date, 5 days after the third vaccination, the patient had cold symptoms and then numbness, gait disturbance and weakness of limbs. On an unspecified date, the patient visited a department of brain surgery and a prefectural hospital, where no abnormality was found. The patient then left the symptoms untreated. In NOV-2012, the patient complained of only cold symptoms at A hospital. In APR-2013, the patient presented to B hospital because symptoms such as numbness, gait disturbance and weakness of limbs appeared again. At the time of this report, the outcome of the numbness gait disturbance, cold symptoms and weakness of limbs was unknown. Reporter''s comment: A hospital: I did not know details about the patient''s symptoms because she complained of only cold symptoms when visited our hospital in NOV-2012. Her symptoms (numbness, gait disturbance and weakness of limbs) were reported by the B hospital after her 3 vaccinations. I have never seen her symptoms, so I can do nothing about them. B hospital: The GARDASIL is suspected to be related to the symptoms. The reporting physician assessed that the numbness, gait disturbance and weakness of limbs were related to GARDASIL. The reporting physician did not assess the causal relationship of the cold symptoms with GARDASIL. The reporting physician assessed the numbness, gait disturbance and weakness of limbs as serious (disability). The reporting physician did not assess the seriousness of the cold symptoms. Further information has been requested.


VAERS ID: 501300 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-01-07
Onset:0000-00-00
Submitted: 2013-09-04
Entered: 2013-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Candida infection, Chills, Drug administered to patient of inappropriate age, Headache, Hyperhidrosis, Immune system disorder, Influenza like illness, Pain, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309GBR000546

Write-up: This case was received from a non health care professional on 23-Aug-2013. This case is not medically confirmed as it was reported by a member of the public. This case is linked to E2012-04561. A 34 year old male patient, with no medical history reported, received in Jan-2012 (exact date: 07-Jan-2012 according initial version of the linked case) the first dose of GARDASIL (batch number not reported), route and site of administration not reported. Vaccine was administered at private clinic/hospital and the patient was aware to be outside of recommended age for vaccine. It was reported the patient experienced flu-like symptoms (sweating, shivering, headache and aches/pains) 6-7 weeks later vaccination and also developed thrush and a rash on his body. The patient went to doctors who believed its vaccine was related to the adverse events but also believed that the patient''s immune system/body became stressed and hence caused his body to react. The patient was referred to neurologist by his doctor for investigations. No seriousness criterion was provided and the company considered that case serious and choose the "other medically important condition" criterion. The patient''s outcome was not reported. This case is one of the two linked cases (same patient, same reporter, same product, number of dose in series different).


VAERS ID: 501328 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-06
Onset:2012-11-01
   Days after vaccination:87
Submitted: 2013-09-03
   Days after onset:306
Entered: 2013-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0308AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase increased, Hypoaesthesia, Muscle spasms, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: Familial risk factor, Paternal grandfather; Familial risk factor, Maternal grandmother
Allergies:
Diagnostic Lab Data: 01/2013, Blood creatine phosphokinase, Increased, Temporal, not provided
CDC Split Type: WAES1309JPN000540

Write-up: Initial information has been received from a physician via the agency concerning a 12-year-old female patient. According to pre-vaccination interview about underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, ADR history and status of growth, the patient had no problem. She had a family history of ALS (paternal grandfather) and leukaemia (maternal grandmother). On 06-AUG-2012, she received the second vaccination of the syringe-type recombinant with GARDASIL IM injection drug (dose and injection site not reported). No concomitant medication was reported. On 11-JUN-2012, the patient received the first vaccination with GARDASIL injection drug (Batch No. 9QN04R and Lot # 0308AA). On 06-AUG-2012, the patient received the second vaccination of the GARDASIL injection drug (Batch No. 9QN04R and Lot # 0308AA), as mentioned above. Around November 2012, pain in upper and lower limbs, weakness of upper and lower limbs (cramp-like symptom) and numbness of upper and lower limbs developed. On 17-DEC-2012, the patient received the third vaccination of GARDASIL injection drug (Batch No. 9QN06R and Lot # 0700AA). In January 2013, a temporal increase in blood creatine phosphokinase was observed. In April 2013, the pain in upper and lower limbs, numbness in upper and lower limbs, weakness in upper and lower limbs by which she could not move some muscle (because of cramp-like symptom) got worse. At the time of this report, the patient had recovered from the "blood creatine phosphokinase increased" (the level had returned to normal) but had not from the pain in upper and lower limbs, weakness of upper and lower limbs (cramp-like symptom) and numbness of upper and lower limbs. The symptoms of upper limbs were improving, but those of lower limbs were continuing, and the continuing symptoms were disturbing her daily life. Her clinical course had been observed. Reporter''s comment: Myositis and fasciitis after the vaccination of GARDASIL have been reported overseas. These symptoms are similar to those of this patient, but I still cannot judge whether or not this case is actually applicable to the overseas cases. The reporting physician assessed the causal relationship of the pain in upper and lower limbs and weakness of upper and lower limbs (cramp-like symptom) to GARDASIL as unassessable. The physician considered that it was unknown about the other possible cause (such as other disease) of the events. The physician did not assess the causal relationship of the "blood creatine phosphokinase increased" and numbness of upper and lower limbs to the vaccine. The reporting physician assessed the pain in upper and lower limbs and weakness in upper and lower limbs (cramp-like symptom) as serious (other important medical events) and did not assess the seriousness of the "blood creatine phosphokinase increased" and numbness of upper and lower limbs. Pain in upper and lower limbs and weakness in upper and lower limbs (cramp-like symptom) were considered to be other important medical event by the reporter. Additional information has been requested.


VAERS ID: 501481 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-08-27
Onset:2012-09-03
   Days after vaccination:7
Submitted: 2013-09-04
   Days after onset:366
Entered: 2013-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Lumbar puncture normal, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal
SMQs:, Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MALONETTA
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis.
CDC Split Type: WAES1309DNK001381

Write-up: Case received from health care professional via the Health Authorities on 26-Aug-2013 under the reference number 22218521 and EFO6612. Case medically confirmed. A 23 year old female patient had received an injection of GARDASIL (dose 1, batch number not reported, intramuscular route, site not reported) on 27-Aug-2012. She had also concomitant medication MALONETTA (other MFR) and later on (03-Sep-2012) she developed myelitis transverse. The patient was hospitalized due to the adverse event (dates not reported). She went through vaccination program without any further problems. Examinations and laboratory tests: MRI showed myelitis to TH6-TH8. Lumbar puncture showed no signs of sclerosis. No relevant medical history reported. At the time of reporting, the outcome was recovering.


VAERS ID: 501487 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-07-15
Onset:2009-08-01
   Days after vaccination:17
Submitted: 2013-09-05
   Days after onset:1496
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. NJ28270 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Cardiovascular evaluation, Dizziness, Headache, Laboratory test normal, Nausea, Neurological examination normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 03/10/2009, GARDASIL, immunisation; 01/12/2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: Cardiological examination and neurological examination have been performed on non-specified dates, withoit any findings.
CDC Split Type: WAES1309DNK001226

Write-up: Case received from a patient/consumer via a Health Authority on 27-Aug-2013 under reference numbers EFO6643 and 22222039. Case not medically confirmed. A 12 year old female patient had received an injection of GARDASIL (dose 3, batch number NK14370, route and site not reported) on 15-Jun-2009 and later on an unspecified date in Aug-2009 she developed dizziness, fainting, abdominal pain, nausea and headache. The patient has not been treated for the events and she has no other medication. The HA is awaiting answer for requested medical confirmation. Cardiological examination and neurological examination have been performed on non-specified dates, without any findings. The patient was previously vaccinated with GARDASIL (batch number NJ38950, route and site not reported) on 12-Jan-2009 and GARDASIL (batch number NJ50800, route and site not reported) on 10-Mar-2009. The patient has no other health problems. At the time of reporting, the outcome was not recovered.


VAERS ID: 501488 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-04-01
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0773X / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood cortisol, Blood immunoglobulin A decreased, Blood immunoglobulin G decreased, Cortisol free urine, Depressed mood, Dizziness, Ear pain, Electrocardiogram, Fatigue, Haematochezia, Headache, Heart rate increased, Hot flush, Hypoaesthesia, Hypotension, Infection, Lymphadenopathy, Memory impairment, Mood swings, Oropharyngeal pain, Ultrasound abdomen, Ultrasound urinary system, Urinary tract disorder, Visual impairment, Vitamin D decreased, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 2009, GARDASIL, Immunisation
Allergies:
Diagnostic Lab Data: The patient describes the following test: Various routine blood tests (unspecified(, urine test of cortisol, ECG, ultrasound scanning of urinary tract and ultrasound scan of lower abdomen. Results not reported. Blood cortisol, not reported; Blood immunoglobulin A, low; Blood immunoglobulin G, low; Electrocardiogram, not reported; Vitamin D, low
CDC Split Type: WAES1305DNK015645

Write-up: Case received from a health care professional via Health Authority on 17-May-2013 under reference numbers EFO5812 and 22116364. Case medically confirmed. A 14 year old female patient had received on injection of GARDASIL (dose 3, batch number NK36120, route intramuscular, site not reported) on 01-Apr-2009 and later on 01-Nov-2009 she developed neck pain, ear pain, adenopathy, frequent infections, lack of energy, weight gain, abdominal pains and daily headache. On an unspecified date pv in 2009 she also developed sadness and mood swings. Upon medical review the company judged relevant to code the following adverse events: sadness and mood swings which were mentioned by the HA in the narrative, but not coded. The patient has low levels of Vitamine D, IgA and IgG, but the levels have now been normalized. The patient was previously vaccinated with GARDASIL Dose 1 on an unspecified date ( batch number NK14370, route intramuscular, site not reported) and GARDASIL dose 2 on an unspecified date (batch number NK05560, route intramuscula, site not reported). At the time of reporting, the outcome was not reported for sadness and mood swings and not recovered for the other events. Follow up information received on 29-Aug-2013 from patient via the health authority. Adverse reaction from patient reported to HA: headache, dizziness, bloody stool, pointwise numbness in legs, little finger completely numb, continuous infections, no feeling during urination, periodic high resting heart rate, pointwise numbness in legs, memory impaired, fatigue, low blood pressure, numbness in feet, visual disturbance, dizziness, little finger completely numb and sudden hot flushes. Onset date for these AE is unspecified during 2010. Outcome for all AE not recovered. Vaccination date changed to 24-Apr-2013. All three vaccinations received during 2009. HA coded onset age 18 years but it should be 14 years and onset date in 2009. The patient describes the following test: various routine blood rests (unspecified), urine test of cortisol, ECG, ultrasound scanning of urinary tract and ultrasound scan of lower abdomen. Results not reported. An error was discovered upon review: The company has previously coded "neck pain" as and adverse event but it was discovered that HA had coded "throat pain". The company coded "throat pain" instead. HA changed upgraded this case to serious / other medically significant event.


VAERS ID: 501498 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-19
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002122 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Muscular weakness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK000531

Write-up: Case received from a patient/consumer and a health care professional via company representative on 14-Aug-2013. Case medically confirmed. A 12 year old female patient had received an injection of GARDASIL (dose 1, batch and lot number J002122, exp. 31-AUG-2015, route intramuscular, site not reported) on 19-Jun-2013 and later on 3-4 days post vaccination (date not specified) she experienced paralyzed hand with a duration of 1 minute, 2-4 weeks post vaccination (date not specified) she experienced feeble legs during walks. Upon medical review the company decided to assess the case as serious on 30-Aug-2013 (due to reported event "paralyzed hand"). At the time of reporting, the outcome was recovered.


VAERS ID: 501595 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-03
Onset:2013-05-04
   Days after vaccination:1
Submitted: 2013-09-05
   Days after onset:124
Entered: 2013-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H015737 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Blood glucose normal, C-reactive protein increased, Headache, Inflammatory marker increased, Meningeal disorder, Nausea, Neutrophil count normal, Photophobia, Pyrexia, Red blood cell sedimentation rate increased, Renal function test normal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 02/2013, GARDASIL 1
Allergies:
Diagnostic Lab Data: 05/07/2013, Blood glucose, 4.87 mmol/l; Body temperature, 38 degrees C; 05/07/2013, C-reactive protein, 100 not provided; 05/10/2013, C-reactive protein, 23.5 not provided; 05/07/2013, Neutrophil count, 7771/mm3; 05/10/2013, Neutrophil count, 5575/mm3; Red blood cell sedimentation rate, 63 for 1st hour/106 for 2nd hour min; 05/07/2013, Renal function test, Normal; 05/07/2013, White blood cell count, 9900/mm3; 05/10/2013, White blood cell count, 7700/mm3
CDC Split Type: WAES1309FRA000554

Write-up: Case received from the Health Authorities under reference number BS20130614 on 27-Aug-2013. Case medically confirmed. A 15-year-old female patient with no relevant medical history had received the second dose of GARDASIL (batch number H015737) via intramuscular route on 03-Aug-2013. To be noted that she had received the first dose (batch number not reported) in Feb-2013. Therefore the second dose was late according to the recommendation. On 04-May-2013 in the evening she experienced headaches, which evolved into a meningeal syndrome with nausea, vomiting, fever at 38 degrees C and photophobia. Laboratory tests performed on 07-May-2013 evidenced an inflammatory syndrome with neutrophil count at 7771/mm3, C-reactive protein at 100. Circulating anticoagulant was suspected. Renal function test was normal. White blood cell count was at 9900/mm3 and blood glucose at 4.87 mmol/L. She was given as corrective treatment SOLUPRED 20mg per day for 3 days. The patient recovered from headaches, meningeal syndrome, nausea, vomiting, fever at 38 degrees C and photophobia. On 10-May-2013 C-reactive protein was at 23.5 and erythrocyte sedimentation rate was still above the norm with 63 minutes for the first hour and 106 minutes for the second hour. Neutrophil count was at 5575/mm3 and white blood cell count was at 7700/mm3. The patient did not go to school for 1 week. To be noted that she was not taken to the hospital as her father was anesthesiologist. At the time of reporting, the patient had not recovered from inflammatory syndrome according to the lab data dated 10-May-2013. Upon medical review the company judged relevant to code the following adverse events: "meningeal disorder", "nausea" and "inflammatory marker increased" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C2 S1 I1) according to the method of assessment.


VAERS ID: 501599 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-07-01
Onset:0000-00-00
Submitted: 2013-09-05
Entered: 2013-09-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H022294 / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia, Respiratory distress, Sensation of foreign body, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Sensation of foreign body; GARDASIL, Anxiety; GARDASIL, Respiratory distress; 11/2012, GARDASIL, Dose 1, Urticaria
Allergies:
Diagnostic Lab Data: At a re-visit to the doctor on 10-Jul-f2013 she did not present any symptoms. General appearance: no remarks, Heart and breathing: normal, saturation: 100%, mouth and throat: no remarks and skin: no remarks. 07/10/2013, Oxygen saturation, normal
CDC Split Type: WAES1307SWE012561

Write-up: Case received from a patient/consumer via health care professional on 05-Jul-2013. Case medically confirmed. This case is liked to E2013-05237 (coded AE after dose 1). Two cases were created as the patient had not developed the same symptoms after Dose 1 and Dose 2. A 18 year old female patient had received an injection of GARDASIL (dose 2, valid lot/batch number H016923, route and site not reported) on 01-Mar-2013 and later the same day (as the vaccination day, 01-Mar-2013) she developed numbness in cheek. On an unspecified date pv she also developed respiratory distress, anxiety and a feeling of a lump in the throat (rechallenge positive). According to the reporter she recovered from numbness in cheek but the respiratory distress gets worse after dose 2. Outcome of anxiety and feeling of a lump in the throat not reported after dose 2. On 01-Jul-2013 the patient also received an injection of GARDASIL (dose 3 valid lot/batch number H022294, route and site not reported). Before dose 3 vaccination she has almost recovered from the events, but after dose 3 the respiratory distress, anxiety and a feeling of lump in the throat got worse (rechallenge positive). According to the reporter the outcome was not recovered. The reactions come and go. The patient was previously vaccinated with dose 1, GARDASIL (valid lot/batch number H013250, route and site not reported) on an unspecified date in Nov-2012. Later on pv she developed urticaria all over the body, respiratory distress, anxiety and a feeling of a lump in the throat. According to the reporter the patient has never been afraid of needles, no disease history and the patients does not have any concomitant medication. The patient has a scheduled doctors visit within a week (approx 10-Jul-2013). Follow-up information received from health care professional via the HA on 29-Aug-2013 under the reference number 132811. HA coded Dyspnoea and Anxiety after dose 2 and dose 3 (date of onset in 2013 not rep). HA coded the dyspnoea as serious, due to a medically important event. The patient experienced short episodes of breathing difficulties with simultaneous anxiety several times daily, especially in the evening. She improved gradually, but was not fully recovered before receiving the third dose on 01-Jul-2013. After this she experienced more pronounced symptoms again. At a re-visit to the doctor on 10-Jul-f2013 she did not present any symptoms. General appearance: no remarks, Heart and breathing: normal, saturation: 100%, mouth and throat: no remarks and skin: no remarks. The patient received all three vaccinations intramuscular route. According to HA, the dyspnoea and anxiety was possibly related to vaccination. The final outcome coded by HA was not recovered.


VAERS ID: 501603 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-15
Onset:2012-11-15
   Days after vaccination:0
Submitted: 2013-09-06
   Days after onset:294
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Dizziness, Epilepsy, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELOTROXIN; lamotrigine; KALEORID; CENTYL; GESTONETTE
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK001380

Write-up: Case received from consumer via the Health Authorities in a foreign country on 26-Aug-2013 under the reference number 22219015 and EFO6616. Case not medically confirmed. A 26 year old female patient (weight 120 kg and height 175 cm) had received an injection of GARDASIL (dose 1, batch number not reported, site and route of administration not reported) on 15-Nov-2012 and later on, the same day, she developed increased frequency of seizures. Concomitant drugs at the time of vaccination: ELTROXIN, Lamotrigin, KALEORID, CENTYL, GESTONETTE. The patient is suffering from epilepsy and prior to vaccination she had only one attack every 12 months. After the first vaccination (15-Nov-2012) with GARDASIL, she developed her first epileptic seizure since several months back. This time worse than ever. On 19-Nov-2012 (HA reported 19-Nov-2013, presumably type wrong) she developed malaise and again seizures. Now more than 6 months later, the seizure is still not under complete control and the patient is on sick leave. The patient was unsure whether she should receive the second vaccination. She then chose to receive it (GARDASIL, dose 2, batch number not reported, site and route of administration not reported, vaccination date unspecified in 2013) in order to clarify whether the seizure was worsening because of the vaccine (and according to patient it could actually be worse). Subsequently, she got rashes and dizziness as well as several attacks (even though she had experienced it previously). After the third vaccination (GARDASIL, dose 3, batch number not reported, site and route of administration not reported, vaccination date not reported) the symptom was not quite as bad. The patient has received the following treatment for the side effect: Epilepsy medication (product name not reported). The patient had not been hospitalised because of adverse reaction. The HA has requested medical confirmation and reply is awaited. HA has reported rechallenged. The patient thinks that the adverse events are related to vaccination but no one takes her seriously. The patient has a history of hypothyroidism and epilepsy. At the time of reporting, the outcome was recovering for increased frequency for seizures and unknown for dizziness, rash and malaise.


VAERS ID: 501605 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-25
   Days after vaccination:13
Submitted: 2013-09-06
   Days after onset:316
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H007022 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fibromyalgia, Hypoaesthesia, Paraesthesia, Tendonitis, Tension
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALDOXAN
Current Illness: Immunisation
Preexisting Conditions: Muscle tightness; Tendonitis; Fibromyalgia; Dose 2, batch number H000245, Immunisation; GARDASIL, Dose 1, batch number G006099, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK001825

Write-up: Case received from health care professional via the Health Authorities on 28-Aug-2013 under the reference number 22220892 and EFO6629. Case medically confirmed. A 39 year old female patient had received an injection of GARDASIL (dose 3, batch/lot number H007022, site and route of administration not reported) on 12-Oct-2012 and later on (25-Oct-2012) she developed paraesthesia and reduced sensation in the face, front of the neck, arms and legs. The patient had concomitant drug VALDOXAN (antidepressant, other mfr) at the time of reactions. She was hospitalised at hospital for investigation. At first, the reduce sensation was suspected to be an adverse reaction of VALDOXAN treatment (which started 2 weeks earlier). But then concluded that the severe tension/tendinitis/fibromyalgia was the cause of the problem. The patient now (after the media attention of the vaccine) raised the suspicion of possible side effect of the vaccine. The doctor does not think that the reaction is related to the vaccination, but she does not have enough knowledge to be able to exclude a connection. Hospital was probably not aware that the patient had completed GARDASIL vaccination''s schedule. The patient''s medical history includes: Dose 1 (batch number G006099, lot number NN12610, exp 20-SEP-2013, site and route of administration not reported) on 16-Apr-2012. Dose 2 (batch number H000245, lot number NN51680 site and route of administration not reported) on 15-Jun-2012. Tension/tendinitis/fibromyalgia (no further information specified). At the time of reporting, the outcome was not recovered.


VAERS ID: 501670 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-05-14
Onset:2013-06-18
   Days after vaccination:35
Submitted: 2013-09-06
   Days after onset:80
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0989AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase normal, Blood fibrinogen increased, C-reactive protein increased, Chills, Cushing's syndrome, Cushingoid, Fibrin D dimer, Fibrin degradation products, Juvenile idiopathic arthritis, Liver function test normal, Pyrexia, Sensation of heaviness, Serum ferritin normal, Thyroid function test normal, Urine analysis, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 68 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature; 20-JUN-2013, the patient had fever of 39 degree C with chills in the midnight; Body temperature; 22-JUN-2013, the patient''s body temperature went up to 39''s degree C and down repeatedly in the afternoon; Hepatic function; 27-JUN-2013, her hepatic function had showed no abnormality from 24-JUN-2013 to this date; 06/24/2013, Alanine aminotransferase, 9 IU/l, Normal; 06/26/2013, Blood fibrinogen, 412.3 mg/dL, Increased; 06/18/2013, Body temperature, 39.3 degrees C; 06/19/2013, Body temperature, 38-39 degrees C; 06/20/2013, Body temperature, 36 (daytime) degrees C; 06/20/2013, Body temperature, 39 (daytime) degrees C; 06/20/2013, Body temperature, 39 (midnight) degrees C; 06/22/2013, Body temperature, It is upper and lower up to 39 degrees C; 06/23/2013, Body temperature, 39 (at AM 2:00) degrees C; 06/24/2013, Body temperature, 36s-36.9 degrees C; 06/25/2013, Body temperature, 40.5 degrees C; 06/26/2013, Body temperature, 40s degrees C; 06/27/2013, Body temperature, 40s degrees C; 06/24/2013, C-reactive protein, 3.04 mg/dL, Increased; 06/26/2013, C-reactive protein, 2.56 mg/dL, Increased; 06/24/2013, Fibrin D dimer, 6.7 not provided, Increased; 06/26/2013, Fibrin D dimer, 6.2 not provided, Increased; 06/24/2013, Fibrin degradation products, 12.7 ug/l, Increased; 06/26/2013, Fibrin degradation products, 12.2 ug/l, Increased; 06/24/2013, Serum ferritin, 83.0 ng/mL, Increased; 06/26/2013, Serum ferritin, 87.0 ng/mL, Increased; 06/24/2013, White blood cell count, 6200/uL, Normal; 06/26/2013, White blood cell count, 3400/uL, Decreased
CDC Split Type: WAES1306JPN014033

Write-up: Follow-up information has been received from a physician concerning a 12-year-old female. The patient had no concomitant disease or medical history. On 14-MAY-2013, she was vaccinated with GARDASIL (lot No. 9QN08R), 0.5 ml one dose (number of times of vaccination, injection site or indication was not reported). No concomitant medication was reported. On 14-MAY-2013, the vaccination was performed at another clinic. On 18-JUN-2013, the patient felt heavy all the time at school and then had fever with 39.3 degree C after she went home. On 19-JUN-2013, the fever of 38''s-39''s degree C persisted, and the patient received drip infusion, BRUFEN, BIOFERMIN tablet and SESDEN at a nearby hospital. On 20-JUN-2013, the patient had fever of 39 degree C with chills in the midnight, 36''s degree C in the daytime, and 39 degree C with chills around noon. On 21-JUN-2013, the patient urgently visited the reporting physician''s hospital as the same symptoms were persisting. FIOMOX tablet, TSUMURA KAKKONTO and CALONAL 250 tablet were administered for treatment. On 22-JUN-2013, the patient''s body temperature went up to 39''s degree C and down repeatedly in the afternoon. On 23-JUN-2013 (Sunday), the body temperature was 39 degree C at 2:00, and the patient visited the physician''s hospital again, when her CRP and WBC were 2.67 and 7200, respectively. She also underwent urine tests. On 24-JUN-2013, she had spike fever twice (during daytime and midnight), however, the other time the body temperature was kept at 36''s degree C. Fever persisted, and she visited the pediatric department of the reporting physician''s hospital for the first time. No redness of the pharynx or change in lips was observed; the cause of the fever was not found. She was admitted to the hospital for follow-up as that day was the sixth day of the fever. On 27-JUN-2013, her hepatic and thyroid functions had showed no abnormality from 24-JUN-2013 to this date. Her CRP and WBC were 3.04 mg/dl and 6200, respectively. The patient had been observed with ferritin 83 ng/dl and FLUMARIN (drip infusion), but she had chills and shivering in the early evening and then had a spike fever of 40 degree C repeatedly. The patient had received MYNOMYCIN since 25-JUN-2013 but did not respond to this antibiotic drug. On 27-JUN-2013, she had a high fever (40''s degree C) again, and she was referred to another hospital. Reportedly her WBCs had gone up and down between 3000 and 7000 during her hospital stay. On an unspecified date, at the hospital, treatment was started on the basis that the relationship of the pyrexia to the HPV vaccine was unlikely. Spike fever persisted thereafter, and juvenile rheumatoid arthritis (JRA) was suspected; therapy with prednisolone 1 mg/kg/day was started. Then the spike fever subsided, and the patient had a diagnosis of JRA. On 30-AUG-2013, the pyrexia resolved. Her clinical course during the hospital stay had been good although she had steroid-induced adverse reactions such as moon face. She was discharged from the hospital. Steroid dose had been decreased to 18 mg/day with good controlling of the JRA. JRA; fever was recovering. At the time of this report, outcome of the moon face was unknown. Reporting physician''s comments: Pyrexia was probably not related to the vaccination. Patient''s parents became anxious seeing the news and I had an inquiry to know if there had been any patient reported who had pyrexia a week or more after the vaccination, and also to know the interval from the vaccination to the pyrexia and its outcome (if there was such the patient). Drug-induced pyrexia come in sight in the another hospital. The reporting physician felt that the JRA; fever was serious due to hospitalization. The reporting physician did not assess the serious criteria of moon face. The reporting physician did not assess the causal relationship of the JRA; fever to the GARDASIL. The reporting physician considered that the moon face was definitely not related to the GARDASIL, but definitely related to the steroid. Additional information is not expected.


VAERS ID: 501779 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antinuclear antibody positive, Antiphospholipid antibodies positive, Arthralgia, Asthenia, Bacterial test negative, C-reactive protein increased, Influenza, Laboratory test abnormal, Lupus-like syndrome, Normochromic normocytic anaemia, Pyrexia, Red blood cell sedimentation rate increased, Skin lesion, Urine analysis normal, Viral test negative
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Raynaud''s phenomenon, Family History
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Extensive bacterial and viral screening (date unspecified): negative; Autoantibodies profile (date unspecified): revealed seropositivity for ANA and lupus anticoagulant (LAC); Laboratory examinations (date unspecified): revealed normochromic normocytic anemia with elevated CRP and ESR; Body temperature, 39.5 degrees C; C-reactive protein, Increased; Red blood cell sedimentation rate, Increased; Urine analysis, Normal
CDC Split Type: WAES1309ISR001862

Write-up: This literature marketed report was received from a other health professional refers to a 16 year old female patient. Her current and family histories were remarkable for Raynaud''s phenomenon while her maternal aunt was diagnosed with systemic sclerosis. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient was admitted to the Infectious Diseases Department because of high-grade fever (39.5 degree Celsius (C)), generalized asthenia, diffuse polyarthralgia, and, multiple erythematous annular cutaneous lesions on the face, trunk, and lower limbs which occurred 8 days after the first dose of GARDASIL. While she received the vaccine, she developed low-grade fever, which was interpreted as viral flu syndrome. Laboratory examinations revealed normochromic normocytic anemia with elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), an extensive bacterial and viral screening was negative and her urine sediment was normal. Autoantibodies profile revealed seropositivity for antinuclear antibody (ANA) and lupus anticoagulant (LAC). On an unknown date, a diagnosis of lupus-like syndrome was determined and the patient was treated with intravenous high-dose methylprednisolone followed by oral prednisone (PDN). Following initiation of treatment, her blood temperature normalized and her skin lesions significantly improved with almost complete resolution in a month, while receiving 50 milligrams (mg) of PDN. The latter was tapered down within 6 months, and at 1 year following vaccination the patient was in good health. The reporter considered the event to be related to GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A causal link between HPV vaccination and onset or relapse of SLE is plausible. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501782 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2013-06-11
Onset:0000-00-00
Submitted: 2013-09-06
Entered: 2013-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident, Condition aggravated, Laboratory test, Migraine, Paraesthesia, Sensory disturbance, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MINULET
Current Illness: Immunisation; Oral contraception
Preexisting Conditions: Migraine; GARDASIL, Paraesthesia; GARDASIL, Sensory disturbance; GARDASIL, Visual impairment; 03/13/2013, GARDASIL, Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1309DNK002708

Write-up: Case received from health care professional via the Health Authorities on 27-Aug-2013 under the reference number DK-DKMA-ADR 22212511 and DK-DKMA-EFO6569. Case medically confirmed. A 26 year old female patient (weight 86 kg, height 174 cm) had received an injection of GARDASIL (dose 2, batch number not reported, site and route of administration not reported) on 11-Jun-2013 and later on 17-Jun-2013 she developed migraine, visual disturbance, sensory disturbance on the right side, paresthesia and on a non-specified date she developed "suspected apoplexy". Cessation date for "migraine", "visual disturbance", "sensory disturbance on the right side" and "paresthesia" reported as 30-Jun-2013 (AE duration of 13 days). According to the reporter the patient had concomitant contraceptive treatment with MINULET (other mfr) started on 17-Mar-2013 and discontinued on 29-Mar-2013 (duration of 12 days). The patient did not receive other concomitant vaccinations. On 03-Jul-2013 the patient was hospitalized at a neurology ward. The reporter mentioned that examinations/laboratory tests were performed (no dates specified). The patient was diagnosed with apoplexy during hospitalisation. No further information was specified. The patient has a medical history of known migraine once a month but with other character. The patient was previously vaccinated with an injection of GARDASIL (dose 1, batch/lot number J000160, Expiration Date 30-Jun-2015, intramuscular route, site not reported) on 13-Mar-2013 and later on 16-Mar-2013 she developed similar symptoms as after the second dose, migraine, visual disturbance, sensory disturbance on the right side and paresthesia. Cessation date 23-Mar-2013. The HA mentioned in lab test that the patient had been hospitalized in neuro on 3-Jul-2013 and obs apoplexy was also reported. Base on this information the Company assumed that the patient had been hospitalized for evaluation of apoplexy. The case was therefore upgraded to serious. The company coded "apoplexy" and "sensory disturbance on the right side" (although mentioned in the narrative but not coded by HA). HA coded dose 1 as suspected and the following reactions as non-serious: migraine, visual disturbance, sensory disturbance on the right side and paresthesia. At the time of reporting, the outcome for "apoplexy" was not reported and recovered for "migraine", "visual disturbance", "sensory disturbance on the right side" and "paresthesia".


VAERS ID: 501783 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antiphospholipid antibodies positive, Arthralgia, Arthritis, Butterfly rash, Cardiolipin antibody positive, Chest X-ray normal, Complement factor C4 decreased, Condition aggravated, Double stranded DNA antibody positive, Dyspnoea, Laboratory test abnormal, Leukopenia, Lymphadenopathy, Normochromic normocytic anaemia, Nuclear magnetic resonance imaging brain normal, Rash, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Systemic lupus erythematosus rash
SMQs:, Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Systemic lupus erythematosus, Diagnosed 4 years prior
Preexisting Conditions: Hydroxychloroquine sulfate, Systemic lupus erythematosus; Corticosteroids, Systemic lupus erythematosus
Allergies:
Diagnostic Lab Data: Chest x-ray, Normal, no abnormalities; Complement factor, Decreased; Red blood cell sedimentation rate, Increased
CDC Split Type: WAES1309ISR001989

Write-up: This literature marketed report was received from a other health professional via a journalist concerning a 19 year old female patient. Current condition of the patient included systemic lupus erythematosus (SLE) diagnosed on an unknown date in 4 years prior due to the appearance of malar rash typical SLE skin rash, arthritis, positive serology for antinuclear antibody (ANA) and anti-dsDNA antibodies, as well as very low C4 complement levels. She was treated with corticosteroid and hydroxychloroquine (HCQ) and achieved a full clinical remission with normalization of complement and anti-dsDNA antibodies levels. Her maintenance therapy included low-dose HCQ and vitamins D. On an unknown date, the patient was vaccinated with the first and second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Following the first dose of vaccine, she experienced mild arthralgia, dyspnea (with no abnormalities on her chest x-ray), cervical lymphadenopathy, and skin rash. Treatment with prednisone (PDN) 40 milligrams/day was commenced with good response and the dose was slowly tapered down. Although otherwise advised, the patient decided to receive the second boost of the vaccine. This time SLE-symptoms were more pronounced with very notable malar rash, severe skin rash, cervical lymphadenopathy of more than 3 centimeter (cm), alopecia, leucopenia, elevated erythrocyte sedimentation rate (ESR), and decreased complement levels. Corticosteroids dose was increased, and following discussions with the patient, therapy with belimumab (anti-BLyS) was commenced, which induced an improvement. The reporter considered the event to be relate to GARDASIL. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccination and onset or relapse of SLE is plausible. Upon internal review, SLE flare was considered as medially significant. This is one of the several reports from the same source. Additional information has been requested.


VAERS ID: 501789 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-09-07
Entered: 2013-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Aphthous stomatitis, Arthralgia,