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Case Details (Sorted by Age)

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VAERS ID:493511 (history)  Vaccinated:2013-05-23
Age:13.0  Onset:2013-05-23, Days after vaccination: 0
Gender:Female  Submitted:2013-06-06, Days after onset: 14
Location:Foreign  Entered:2013-06-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy
Preexisting Conditions: Influenza virus split virion 3v, Urticaria, 11 years old
Diagnostic Lab Data: 05/23/2013, Blood pressure diastolic, 114 mmHg; 05/23/2013, Blood pressure diastolic, 126 mmHg; 05/23/2013, Blood pressure systolic, 74 mmHg, 05/23/2013, Blood pressure systolic, 72 mmHg; 05/23/2013, Body temperature, 36; 05/23/2013, Heart rate, 72 /min; 05/23/2013, Heart rate, 54 /min; 05/23/2013, Oxygen saturation, 99%
CDC 'Split Type': WAES1306JPN000164
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN08R0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Convulsion, Fatigue, Stupor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic erythropenia (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)
Write-up: This spontaneous report as received from a health care professional refers to a 13 year old female patient. On 23-MAY-2013, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb (manufacturer unknown)(Lot number, expiry date and dose were not reported), intramuscularly. On 23-MAY-2013, the patient experienced syncope vasovagal. Approximately on an unknown date in May 2013, the event syncope vasovagal was recovered/resolved. The reporter considered syncope vasovagal to be related to quadrivalent Human papillomavirus (Types 6, 11, 16, 18) Recomb (manufacturer unknown). On 28-MAY-2013 follow up information was received. Initial information has been received from a physician via PMDA concerning a 13 year old female child who had an (adverse drug reaction)ADR history of urticaria following influenza vaccination at the age of 11 years old, and egg allergy was found by the examination at that time. On 23-MAY-2013, the patient was intramuscularly vaccinated with the first injection of GARDASIL (batch/lot # was reported as 9QN08R) (injection site not reported). No information on concomitant medications has been provided. On 23-MAY-2013, when she was sitting on the sofa after injection of GARDASIL at 16:25, suddenly she recurved her body with 10 seconds convulsion and was in a stupor of anemic condition. At 16:35, (blood pressure)BP was 126/74mmHgm and pulse was 54. Anemic condition decreased, and she came to herself. At 16:55, BP was 114/72mmHg, pulse was 72, and SpO2 was 99%. At 18:30, there was nothing special. She had recovered on the same day. On 24-MAY-2013, she had feeling of lassitude but attended school as usual. The reporting physician did not assess the causal relationship of syncope vasovagal and convulsion. The reporting physician considered that syncope vasovagal was non-serious, but did not assess the seriousness of convulsion. Upon internal review, convulsion was determined to be serious as an other important medical event. No further information is available.

VAERS ID:493518 (history)  Vaccinated:2013-05-14
Age:13.0  Onset:2013-05-14, Days after vaccination: 0
Gender:Female  Submitted:2013-06-06, Days after onset: 23
Location:Foreign  Entered:2013-06-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306GBR000747
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H019054 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Immediate post-injection reaction, Slow response to stimuli, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was received from the health authority on 27-May-2013. GB-MHRA-ADR 22116412. This case is medically confirmed as it was reported by a health care professional. A 13 year old female patient, with no medical history reported, received an injection of GARDASIL (batch number H019054, site of administration not reported) 0.5 mL intramuscularly on 14-May-2013 and experienced immediate faint following injection and was very slow to recover. The patient also complained of headache and was reluctant to open eyes, was slow to respond to questioning. It was a very unusual faint and paramedics were called and the patient was transferred to hospital. The onset dates for the adverse events were not reported by the MHRA but we suspected that all the events occurred on the same day of vaccine administration. At the time of reporting, the patient was not recovered. The MHRA considered that case serious due to be medically significant.

VAERS ID:496295 (history)  Vaccinated:2013-05-14
Age:13.0  Onset:2013-05-14, Days after vaccination: 0
Gender:Female  Submitted:2013-06-07, Days after onset: 24
Location:Foreign  Entered:2013-06-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: Underweight
Diagnostic Lab Data: Neurological examination, No anomalies not provided; Tilt table test, No anomalies not provided
CDC 'Split Type': WAES1306BEL002761
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Dysstasia, Gastritis, Heart rate decreased, Hypotension, Neurological examination normal, Presyncope, Tilt table test normal, Urinary incontinence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Serious case received from a healthcare professional (doctor) via the regulatory authority on 03-Jun-2013. Medically confirmed. A 13-year-old female patient had received the third dose of GARDASIL (batch number not reported) on 14-May-2013. The vaccine was administered at school following to the vaccination program. A few seconds later, the patient experienced a vagal reaction. The standard procedure (lay down the patient, feet up, surveillance of the vital parameters) was observed. After 10 minutes, the patient could sit up again, but 10 minutes later, she had another vagal reaction and sunk deeper away. Vaccinating doctor kept her conscious by talking to her. Her blood pressure remained low but normal (90/60), her pulse slowed down but did not fade away. As it was not possible to move her from one position to another without having another vagal reaction, the ambulance was called and she was hospitalised. During her stay at the hospital, she experienced the same deep vasovagal reaction several times, with urine loss, when trying to move her in her bed. This lasted for 2 days. Several examinations were performed (neurological and tilt test included), they did not show any anomalies. Patient was discharged on 16-May-2013, but on 17-May-2013, she experienced other vagal attacks and was hospitalised again until 23-May-2013. Attacks lessened and the hospital physicians'' hypothesis was: underweight with a possible psychological component and a slight inflammation of the stomach. Patient returned to school in the same week, for a while, but had to return back home because of abdominal pain, she could not stand up straight. Hospital physicians thought there was no link with the vaccination, but did not communicate this information to the parents. The vaccinating doctor reported that the patient has not been functional for 3 weeks following to the vaccination. Outcome for the vagal reaction, urine loss, slow pulse, low blood pressure, abdominal pain, stomach inflammation and suspicion of psychological component were not reported, but the reporter mentioned that the patient had not been functional following to the vaccination, without further details.

VAERS ID:493707 (history)  Vaccinated:2013-05-16
Age:13.0  Onset:2013-05-16, Days after vaccination: 0
Gender:Female  Submitted:2013-06-05, Days after onset: 20
Location:Foreign  Entered:2013-06-10, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sickle cell disease
Diagnostic Lab Data:
CDC 'Split Type': 2013168203
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF87971 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug interaction, Mobility decreased
SMQs:, Parkinson-like events (broad)
Write-up: This is a spontaneous report from a contactable nurse received via a company representative. A 13-years-old female patient received PREVENAR 13 0.5ml single dose via intramuscular route on 16May2013. Folic acid and ZINCOVIT tablets were reported as Interacting Products. Medical history included sickle cell anemia from 22Dec199 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced unable to raise up left arm (monoplegia) assessed as serious by reporter on 16May2013.

VAERS ID:494084 (history)  Vaccinated:2012-06-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-06-12
Location:Foreign  Entered:2013-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache
Preexisting Conditions: Cerebral concussion
Diagnostic Lab Data:
CDC 'Split Type': B0898058A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNAR
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Hypoaesthesia, Vertigo
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow)
Write-up: This case was reported by a physician and described the occurrence of vertigo in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cerebral concussion (April 2011). Concurrent medical conditions included headache since the cerebral concussion. Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline) given in April 2012. In June 2012, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). In 2012, between June and October, less than one year after vaccination with CERVARIX, the subject experienced vertigo. The subject was hospitalised due to the vertigo. In October 2012, 4 months after vaccination with CERVARIX, the subject experienced numbness. In 2012, less than one year after vaccination with CERVARIX, the subject appeared to have walking difficulty. At the time of reporting, the numbness was unresolved and the other events were unspecified. The subject received the 3rd dose of CERVARIX in December 2012 (unknown route and unknown deltoid). According to the physician, the numbness was related to the cerebral concussion.

VAERS ID:494138 (history)  Vaccinated:2013-03-13
Age:13.0  Onset:2013-03-14, Days after vaccination: 1
Gender:Unknown  Submitted:2013-06-14, Days after onset: 92
Location:Foreign  Entered:2013-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306IRL004548
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
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)
Write-up: This case was received from a physician in a foreign country on 06-Jun-2013 with additional information received on 07-Jun-2013. This case is medically confirmed. A 13 year old patient of unknown gender received dose three of GARDASIL (batch number not reported), route and site not reported, on 13-Mar-2013. On an unreported date, one day post vaccination, the patient experienced a seizure which is being investigated. The patient outcome was not reported. The reporter stated that the event had been reported to the IMB. Upon internal review the event was considered to be medically significant.

VAERS ID:494278 (history)  Vaccinated:2013-05-17
Age:13.0  Onset:2013-05-17, Days after vaccination: 0
Gender:Female  Submitted:2013-06-14, Days after onset: 28
Location:Foreign  Entered:2013-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Tonic clonic movements; GARDASIL, Syncope
Diagnostic Lab Data:
CDC 'Split Type': WAES1306IRl006324
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0131372IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Loss of consciousness, Opisthotonus, Tonic clonic movements
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), Convulsions (narrow), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was received from the health authority on 06-Jun-2013. REF 2013-017285. This case is medically confirmed as it was reported by a physician. A 13 year old female patient received her third dose of GARDASIL (batch number H013137, site of administration not reported) (Expiration date: 31-MAR-2015) 0.5 mL intramuscularly on 17-May-2013. The patient was reported to be well for 10 minutes post vaccine but became tonic after this and arched her back for approximately 10 seconds followed by tonic clonic movements of her limbs for a further 10 seconds with loss of consciousness. There was no tongue biting or no incontinence. The reporter indicated that the patient''s recovery was very protected with headache and fatigue and the patient was very weak and unable to sit without feeling faint for several hours. The reporter indicated that the patient was hospitalised, laid supine and observed for 30 hours and is due to have an EEG and further evaluation. "Epileptic seizure" was coded as an adverse event by regulatory authority. The patient experienced a previous syncope with tonic clonic movements post first dose of GARDASIL. At the time of reporting, the patient had made a complete recovery. The regulatory authority considered that case serious due to hospitalization.

VAERS ID:494396 (history)  Vaccinated:2013-06-07
Age:13.0  Onset:2013-06-07, Days after vaccination: 0
Gender:Female  Submitted:2013-06-17, Days after onset: 10
Location:Foreign  Entered:2013-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0899763A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Uterine haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This case was reported by a consumer and described the occurrence of uterine hemorrhage in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional had not verified this report. On 7 June 2013, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 7 June 2013, in the evening, within hours of vaccination with CERVARIX, the subject experienced uterine hemorrhage. The reporter considered the event was clinically significant (or requiring intervention). At the time of reporting, the outcome of the event was unspecified. No further information was expected. Case was closed.

VAERS ID:495002 (history)  Vaccinated:2013-02-25
Age:13.0  Onset:2013-03-13, Days after vaccination: 16
Gender:Female  Submitted:2013-06-25, Days after onset: 104
Location:Foreign  Entered:2013-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy; Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306JPN010870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN07R2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Epilepsy, Loss of consciousness
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 13 year old female patient who had a history of epilepsy on 25-FEB-2013 was intramuscularly vaccinated with GARDASIL (Lot No.: 9QN07R), 0.5mg once a day. Suspect therapy included ONON (oral, strength, totally daily dose and start date not reported) for the treatment of pollinosis (duration and dose were not reported). Other concomitant medications were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). On 25-FEB-2013, the patient was vaccinated with the third dose of GARDASIL. In the morning of 13-MAR-2013, she lost of consciousness due to epileptic seizure and admitted to other hospital. Epilepsy didn''t occurr until that time. Epilepsy also occurred on 08-APR-2013, 23-APR-2013, 27-MAY-2013 and 31-MAY-2013. At the time of the report, action taken with regard to pranlukast hydrate was unknown and the outcome of epileptic seizure was unknown. The physician''s comment: the patient didn''t visit the hospital after 25-FEB-2013, the relationship with GARDASIL was unknown. The reporting physician felt that the relationship between epileptic seizure and GARDASIL was unknown. Pranlukast hydrate was suspect drug. The reporting physician considered that the epileptic seizure was serious due to other important event. Additional information is not expected.

VAERS ID:495026 (history)  Vaccinated:2013-05-15
Age:13.0  Onset:2013-05-15, Days after vaccination: 0
Gender:Female  Submitted:2013-06-25, Days after onset: 41
Location:Foreign  Entered:2013-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306AUS011064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1682AA IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.G018445 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail report (reference number 319793), concerning a 13 year old female patient. The patient''s medical history was not reported. On 15-MAY-2013 the patient was vaccinated with GARDASIL, administered once, intramuscularly at a dose of 0.5 ml (Batch number G018445) and with HEPATITIS B VACCINE (manufacturer unknown), administered once, intramuscularly at a dose of 1 ml (Batch number 018409, lot number 1682AA). No other co-suspected medications and no concomitant medications were reported. On 15-MAY-2013, within 10 minutes of vaccination, the patient developed headache, felt dizzy and then 10 minutes later legs went numb and weak. Furthermore, the following was stated: assessed at emergency dept for 2 hours then discharged was walking independently when discharge no diagnosis. The outcome of headache, muscular weakness and dizziness was reported as unknown. Furthermore the three events were reported as serious with the serious criterion caused or prolonged inpatient hospitalisation. The reporter considered the adverse events to be possibly related to HEPATITIS B VACCINE (manufacturer unknown) and GARDASIL. The original reporting source was not provided. Additional information is not expected.

VAERS ID:495397 (history)  Vaccinated:2012-09-01
Age:13.0  Onset:2012-10-01, Days after vaccination: 30
Gender:Female  Submitted:2013-06-27, Days after onset: 269
Location:Foreign  Entered:2013-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0901777A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Hyperthermia, Joint swelling, Lymphadenopathy, Malaise, Oral mucosal erythema, Orthostatic intolerance, Pain in extremity
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of swollen wrist in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In September 2012 the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. In October 2012, 1 month after vaccination with CERVARIX, the subject experienced swollen wrist. In November 2012 the subject received 2nd dose of CERVARIX. In January 2013, 4 months after vaccination with 1st dose of CERVARIX, the subject experienced hyperthermia for 5 days, foot pain, abdominal pain, malaise, swollen lymph node, buccal erythema and orthostatic dysregulation. The subject was hospitalised. No information about hospitalisation was provided. At the time of reporting, the events were improved but malaise remained unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:495406 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-04-25, Days after vaccination: 24
Gender:Female  Submitted:2013-06-27, Days after onset: 63
Location:Foreign  Entered:2013-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance ima, Apr2013, no finding
CDC 'Split Type': B0902199A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA164AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Tremor
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: This case was reported by a healthcare professional via a regulatory authority (V13000310) and described the occurrence of Guillain Barre Syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 April 2013 the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 25 April 2013, 24 days after vaccination with CERVARIX, the subject experienced Guillain Barre syndrome, left hand tremor and grip strength decreased. The regulatory authority reported that the events were clinically significant (or requiring intervention). A nuclear magnetic resonance of brain was done and showed no abnormality. At the time of reporting, the symptoms tended to improve but still remained. Since the events occurred 3 weeks after the vaccination, the possibility that the subject had Guillain-Barre syndrome could not be ruled out considering the symptoms.

VAERS ID:495410 (history)  Vaccinated:2013-01-01
Age:13.0  Onset:2013-06-17, Days after vaccination: 167
Gender:Female  Submitted:2013-06-27, Days after onset: 10
Location:Foreign  Entered:2013-06-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0902200A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of facial palsy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In January 2013 the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 17 June 2013, 5 months after vaccination with CERVARIX, the subject experienced facial palsy. The pharmacist considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved.

VAERS ID:495530 (history)  Vaccinated:2012-11-06
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-06-28
Location:Foreign  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 10/16/2012, GARDASIL
Diagnostic Lab Data:
CDC 'Split Type': WAES1306GBR009870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0080411IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This misuse case was received from a health care professional on 05-Jun-2013. PIVOTAL 17062. This case was medically confirmed. A female patient received her second dose of GARDASIL (batch and lot number H008041) route and site of administration not reported, 3 weeks after the first injection of GARDASIL which is an inappropriate schedule of administration. No adverse effect at the time of administration was reported. Follow up received from the initial reporter on 19-Jun-2013: This case has been upgraded to serious. The patient was 13 years old and was not taking any other medication. The patient received the first dose of GARDASIL (batch number not reported), 0.5 mls, IM, on 16-Oct-2012, three weeks before the second dose. The patient received dose two of GARDASIL, 0.5 mls, IM, on 06-Nov-2012. The reporter considered the event to be serious as it was a clinically important medical event as it was an error by the school nurse team and that others may also have received vaccines on these dates. The reporter sought advice from PHE and was told not to repeat dose two but to carry on and give dose three.

VAERS ID:495536 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-06-28
Location:Foreign  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation, Headache
Diagnostic Lab Data: CT scan: Normal; MRI: Normal; Computerised tomogram, Normal; Nuclear magnetic resonance imaging, Normal;
CDC 'Split Type': WAES1306PRT014333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Balance disorder, Computerised tomogram normal, Dizziness, Gait disturbance, Headache, Nuclear magnetic resonance imaging normal, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from a consumer on 21-Jun-2013. Case not medically confirmed. A 13-year-old female patient experienced headache, dizziness and faint after she had received the second dose of GARDASIL (batch number not reported) on an unspecified date. The patient visited the primary care center and no anomaly was detected. After that, since the adverse event was still occurring, she visited the emergency room 3 times and she was referred to a central hospital. Some tests were performed such as CT-scan and laboratory tests, which found normal results. After hospitalisation the patient started to be limited in walking, showing imbalance and lack of strength for 4 weeks. An MRI was subsequently performed, which did not show any anomaly. The first dose of GARDASIL (batch number not reported) administered on an unspecified date had not been well tolerated since the patient started to experience headache and was treated with paracetamol. This was still ongoing at the time of the administration of the second dose. It is noteworthy that the reporter was a patient''s relative. At the time of reporting the patient had not recovered.

VAERS ID:495539 (history)  Vaccinated:2012-06-01
Age:13.0  Onset:2012-06-01, Days after vaccination: 0
Gender:Female  Submitted:2013-06-28, Days after onset: 392
Location:Foreign  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0902197A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fibromyalgia, Immediate post-injection reaction, Juvenile idiopathic arthritis, Pain
SMQs:, Hypersensitivity (narrow), Arthritis (narrow)
Write-up: This case was reported by a pharmacist and a physician and described the occurrence of fibromyalgia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given in April 2012. History of vaccination was not provided. In June 2012, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). In June 2012, immediately after vaccination with CERVARIX, the subject experienced generalized pain. The subject visited a medical institution where she was treated for suspected juvenile rheumatoid arthritis. At the time of reporting, the subject had visited departments of nephrology, rheumatology and collagen disease at medical center. Fibromyalgia was diagnosed. The reporters considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcomes of the events were unspecified.

VAERS ID:495796 (history)  Vaccinated:2013-03-21
Age:13.0  Onset:2013-03-21, Days after vaccination: 0
Gender:Male  Submitted:2013-06-28, Days after onset: 99
Location:Foreign  Entered:2013-06-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1306AUS013159
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0542AE0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.A70CC015A0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (OPR319726) concerning a 13 year old male patient. On 21-MAR-2013 the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) (manufacturer unknown) (lot number 1682AA, batch number H018644) dose 1, subcutaneous in the left arm, and with varicella virus (manufacturer unknown) dose 1, intramuscular in the right arm (batch number A70CC015A). On 21-MAR-2013, the patient fainted after receiving vaccinations and was briefly unconscious for 5 secs. The patient was pale but responded good. There were no signs of respiratory distress or urticaria. The patient recovered on 21-MAR-2013. The reporting agency considered the event to be possibly related to quadrivalent human papillomavirus (types 6, 11, 16, 18) (manufacturer unknown) and varicella virus (manufacturer unknown). Upon internal review, unconscious was considered medically significant. The original reporting source was a health department. Additional information is not expected.

VAERS ID:495659 (history)  Vaccinated:2013-05-27
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-01
Location:Foreign  Entered:2013-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cochlea implant; Mental disorder; Migraine
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0903991A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Headache, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included cochlea implant, mental disorder and migraine. On 27 May 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified date, less than one month after vaccination with CERVARIX, the subject experienced pain of lower extremities, abdominal pain and headache. The pain was generalized. The subject was hospitalised. At the time of reporting the events were unresolved.

VAERS ID:495782 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-04-25, Days after vaccination: 24
Gender:Female  Submitted:2013-07-02, Days after onset: 68
Location:Foreign  Entered:2013-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, no abnormalities; Nuclear magnetic resonance ima, no abnormalities
CDC 'Split Type': B0899308A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA164AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Grip strength decreased, Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging normal, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician and described the occurrence of weakness of limbs in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). Three weeks after vaccination with CERVARIX, the subject experienced weakness of the right hand and foot and left hand cramping. The weakness of the right hand and foot improved slightly and the subject gradually became able to put strength into them. At the time of reporting, the events were unresolved. The cramping in the middle, the ring and the little finger still persisted. Follow-up information received by a regulatory authority (V13000310) on 26 June 2013: This case was upgraded to serious. This case was identified as a duplicate of B0902199A. Case B0902199A was voided and all the future correspondence will be added to the present case which stands as case of record for this subject. On 1 April 2013, the subject received 3rd dose of CERVARIX. On 25 April 2013, 24 days after vaccination with CERVARIX, the subject experienced shaking of the left hand and decreased grip strength of hands. Although the symptoms gradually improved, the decreased grip strength of hands and shaking of the third to fifth fingers of the left hand as if she played volleyball persisted. On 17 July 2013, the symptoms tended to improve but still remained. The physician considered the events were clinically significant (or requiring intervention). Since the events occurred 3 weeks after the vaccination, the possibility that the subject had Guillain-Barre syndrome could not be ruled out considering the symptoms. At the time of reporting, the events were unresolved.

VAERS ID:495786 (history)  Vaccinated:2013-05-27
Age:13.0  Onset:2013-05-28, Days after vaccination: 1
Gender:Female  Submitted:2013-07-02, Days after onset: 35
Location:Foreign  Entered:2013-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0904333A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA164BB2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Headache, Pain in extremity
SMQs:
Write-up: This case was reported by a physician via a regulatory authority (V13000351) and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included chronic headaches. Subject''s body temperature before the vaccination was 36 deg. C. On 27 May 2013, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 28 May 2013, 1 day after vaccination with CERVARIX, the subject experienced headache and pain in extremity. On 29 May 2013, the subject visited a hospital for consultation. Analgesic medication was given but the symptoms didn''t improve. On 4 June 2013, the subject was referred to another hospital as headache persisted. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The causal relationship to CERVARIX was unassessable. The events were related to chronic headaches.

VAERS ID:495931 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2013-04-01
Gender:Female  Submitted:2013-07-04, Days after onset: 94
Location:Foreign  Entered:2013-07-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation; Hearing impaired
Preexisting Conditions:
Diagnostic Lab Data: Audiogram: Not reported
CDC 'Split Type': WAES1306GBR014611
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Audiogram, Condition aggravated, Deafness bilateral
SMQs:, Hearing impairment (narrow)
Write-up: This case was received from the health authority on 24-Jun-2013. GB-MHRA-ADR 22145701. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, with medical history of impaired hearing with regular check ups at hospital and was stable for 7 years, received in 2013 an injection of GARDASIL (batch number not reported), dose, route and site of administration not reported. In Apr-2013, the patient presented deafness of both ears. After vaccination, hearing loss dropped further and has had quite a bit big impact. The patient experienced hearing loss after injection, the hospital have the audiology graphs. At the time of reporting, the patient was not recovered. The regulatory authority considered that case serious due to be medically significant.

VAERS ID:495946 (history)  Vaccinated:2013-01-07
Age:13.0  Onset:2013-01-07, Days after vaccination: 0
Gender:Female  Submitted:2013-07-04, Days after onset: 177
Location:Foreign  Entered:2013-07-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
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)
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:496221 (history)  Vaccinated:2013-06-01
Age:13.0  Onset:2013-06-01, Days after vaccination: 0
Gender:Unknown  Submitted:2013-07-08, Days after onset: 37
Location:Foreign  Entered:2013-07-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307JPN002611
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
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)
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:496288 (history)  Vaccinated:2013-05-28
Age:13.0  Onset:2013-05-29, Days after vaccination: 1
Gender:Female  Submitted:2013-07-09, Days after onset: 41
Location:Foreign  Entered:2013-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307DEU004136
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0002820IMUN
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)
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:496305 (history)  Vaccinated:2012-03-19
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-09
Location:Foreign  Entered:2013-07-09
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0905720A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hernia, Hypoaesthesia, Ligament injury, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a physician and described the occurrence of myalgia of lower extremities in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline) 1st and 2nd dose given on 13 September 2011 and 11 October 2011. On 19 March 2012 the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown injection site). In March 2012, less than one month after vaccination with CERVARIX, the subject experienced myalgia of lower extremities and numbness. The subject visited several orthopedic departments but the cause of symptoms was not found. The subject also experienced ligament injury in the hip joint and leg and hernia. The physician considered the events were disabling. The subject was treated with LOXONIN with no improvement. At the time of reporting, myalgia and numbness were unresolved, the outcome of the other events was unspecified.

VAERS ID:496285 (history)  Vaccinated:2013-06-28
Age:13.0  Onset:2013-06-28, Days after vaccination: 0
Gender:Female  Submitted:2013-07-10, Days after onset: 12
Location:Foreign  Entered:2013-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307ITA004520
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
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)
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:496691 (history)  Vaccinated:2013-01-03
Age:13.0  Onset:2013-01-03, Days after vaccination: 0
Gender:Female  Submitted:2013-07-12, Days after onset: 189
Location:Foreign  Entered:2013-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vasovagal malaise
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0899129A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA135CB1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Inappropriate schedule of drug administration, Loss of consciousness, Malaise, Presyncope, Syncope
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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a pediatrician, via a GSK sales representative, and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Initial information received via sales representative on 12 June 2013 and follow-up received directly from pediatrician on 14 June 2013 were processed together. This case was linked to case B0899132A (same family twin sister, same reporter). Patient''s medical conditions included previous vasovagal malaise related to severe pain. On 03 January 2013, the subject received a 1st dose of CERVARIX (batch, route and injection site unknown). About 10 minutes after vaccination the subject had a syncope which lasted 2-3 seconds. On 10 June 2013, more than 1 month after the first dose (drug dose administration interval too long), the subject received a 2nd dose of CERVARIX (batch, route and injection site unknown). About 10 minutes later, while the subject was lying down, she had a syncope. At the time of reporting, the effects were resolved. The pediatrician considered the effects were probably related to vaccination with CERVARIX. Upon follow-up received on 04 July 2013: This case was upgraded to serious as it was considered by the pediatrician as clinically significant, intervention required. The subject weighed 51 kg and measured 161 cm. On 03 January 2013, the first dose of CERVARIX (batch AHPVA135CB) was administered intramuscularly in left deltoid. About 5 minutes later, with very short prodromes (a few seconds), the subject had a severe malaise with loss of consciousness for 2-3 seconds and fall corresponding to a clinical presentation of vagal malaise. The subject recovered totally and immediately. The subject was put in lay down position with legs raised. The second dose of CERVARIX (batch AHPVA135CB) was administered intramuscularly in left deltoid on 10 June 2013. The same reactions occurred with a brief loss of consciousness which resolved in a few seconds. At the time of reporting, all effects were resolved. The pediatrician considered the events as also possibly related to subject''s medical history of vagal malaise.

VAERS ID:496694 (history)  Vaccinated:2013-06-05
Age:13.0  Onset:2013-06-05, Days after vaccination: 0
Gender:Female  Submitted:2013-07-12, Days after onset: 37
Location:Foreign  Entered:2013-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307AUS005082
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0613AE1IMUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERA70CC318A0SCLA
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)
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:496811 (history)  Vaccinated:2013-06-05
Age:13.0  Onset:2013-06-05, Days after vaccination: 0
Gender:Female  Submitted:2013-07-14, Days after onset: 39
Location:Foreign  Entered:2013-07-14
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1307AUS004418
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0272AE IMUN
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)
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:496761 (history)  Vaccinated:2013-02-28
Age:13.0  Onset:2013-03-06, Days after vaccination: 6
Gender:Unknown  Submitted:2013-07-12, Days after onset: 127
Location:Foreign  Entered:2013-07-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Personal and family medical history: not reported.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201307675
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC4007AK4IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site reaction, Oedema, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Case received from the Health Authority (HA''s number PL-URPL-N259/2013) on 04 July 2013. A 5-year-old patient (gender not reported), with no reported medical history, had received intramuscularly the fifth dose of TRIPACEL (batch number C4007AK, expiration date: April 2014) in the left arm on 28 February 2013 at 9:30. On 06 March 2013 at 07:30, i.e 6 days post-vaccination, the patient presented severe injection site reaction at right arm expanding beyond the nearest joint, covering whole arm, lasting longer than 3 days, and allergic reaction: rash limited to certain areas of the skin also reported as rash in elbow area. At the time of reporting the patient was still treated at home. Reporter''s comments: "Oedema is still persisting." The HA coded "injection site reaction", "allergic reaction", "localized rash". The company coded "oedema". According to the Health Authority, the causal relationship between the events and the vaccine was considered as reasonable possibility. This case was considered as serious due to other medically important condition.

VAERS ID:496805 (history)  Vaccinated:2013-05-06
Age:13.0  Onset:2013-05-06, Days after vaccination: 0
Gender:Female  Submitted:2013-07-15, Days after onset: 70
Location:Foreign  Entered:2013-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
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
Diagnostic Lab Data:
CDC 'Split Type': WAES1307PRT006231
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0542AE0SCUN
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)
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:496957 (history)  Vaccinated:2013-02-25
Age:13.0  Onset:2013-02-25, Days after vaccination: 0
Gender:Female  Submitted:2013-07-15, Days after onset: 139
Location:Foreign  Entered:2013-07-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0907710A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162CA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Injected limb mobility decreased, Joint contracture, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: This case was reported by a physician via a regulatory authority (V13000419) and described the occurrence of contracture of joint of shoulder region in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 February 2013, the subject received 3rd dose of CERVARIX (intramuscular, left deltoid. on 25 February 2013 in the evening, less than one day after vaccination with CERVARIX, the subject experienced pain in joint involving shoulder region and brachialgia. On 26 February 2013, the symptoms still persisted. Therefore the subject visited an emergency outpatient department. In March 2013, 3 months after vaccination with CERVARIX, the subject experienced arm pain and injected limb mobility decreased. The subject was diagnosed with contracture of joint of shoulder region. The regulatory authority reported that the events were disabling. The subject was treated at the department of orthopaedics. At the time of reporting the events were unresolved.

VAERS ID:496966 (history)  Vaccinated:2011-07-25
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-15
Location:Foreign  Entered:2013-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomogram, Nov2011, normal; NMR, Nov2011, normal
CDC 'Split Type': B0907653A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Hypoaesthesia, Illusion, Muscular weakness, Nuclear magnetic resonance imaging normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13000415) and described the occurrence of perceptual disturbance in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 July 2011, the subject received 1st dose of CERVARIX (intramuscular, left deltoid). Lot number not provided. In August 2011, one month after vaccination with CERVARIX, the subject experienced perceptual disturbance, numbness in left fingers, which recently spread to the right fingers and the right-sided scalp. No abnormality was found in the consultation. On 2 September 2011, the subject received 2nd dose of CERVARIX (intramuscular, right arm). Lot number not provided. In November 2011, the subject underwent detailed examination such as computerized tomography (CT) and magnetic resonance imaging (MRI) in 2 hospitals, but no abnormality was found. The subject was informed that the cause of the numbness was unknown. Approximately in March 2012, numbness improved. On 16 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, left arm). Lot number not provided. In May 2013, numbness of the fingers recurred (which was more prominent in the left fingers than the right fingers). The subject also had attacks of weakness in the peripheral region from the left elbow. On 13 June 2013, the subject was referred to the department of neurology of a hospital. The subject was under detailed examination at the moment. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:496915 (history)  Vaccinated:2013-05-27
Age:13.0  Onset:2013-05-27, Days after vaccination: 0
Gender:Female  Submitted:2013-07-16, Days after onset: 50
Location:Foreign  Entered:2013-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: Anaphylactic reaction; KEFLEX, Hypersensitivity
Diagnostic Lab Data:
CDC 'Split Type': WAES1307AUS005139
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
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)
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)  Vaccinated:2012-07-25
Age:13.0  Onset:2012-08-01, Days after vaccination: 7
Gender:Female  Submitted:2013-07-16, Days after onset: 349
Location:Foreign  Entered:2013-07-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Familial risk factor; Juvenile idiopathic arthritis
Preexisting Conditions:
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN03R0IMUN
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)
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:497192 (history)  Vaccinated:2013-03-12
Age:13.0  Onset:2013-03-15, Days after vaccination: 3
Gender:Female  Submitted:2013-07-19, Days after onset: 126
Location:Foreign  Entered:2013-07-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GARDASIL
Diagnostic Lab Data:
CDC 'Split Type': WAES1307GBR010621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
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)
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:497272 (history)  Vaccinated:2012-02-13
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-19
Location:Foreign  Entered:2013-07-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
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:
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0108AA1IMUN
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)
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. (Cli

VAERS ID:497380 (history)  Vaccinated:2013-06-19
Age:13.0  Onset:2013-07-03, Days after vaccination: 14
Gender:Female  Submitted:2013-07-19, Days after onset: 16
Location:Foreign  Entered:2013-07-22, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: C-reactive protein normal, 2013, normal; CSF test, 2013, pending; Nuclear magnetic resonance ima, 2013, normal
CDC 'Split Type': D0080477A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA177DD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, C-reactive protein normal, CSF test, Headache, Muscular weakness, Nuclear magnetic resonance imaging normal, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012051922DE-PEI-PEI2013039648) and described the occurrence of sudden severe abdominal pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concomitant medication was not reported. On 19 June 2013 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown). Approximately 14 days post vaccination with CERVARIX, on 03 July 2013, the subject experienced sudden severe abdominal pain, followed by syncope; followed by headache, leg paresthesia and muscle weakness. The subject was hospitalised for an unknown period of time. Diagnosis was confirmed by normal magnetic resonance imaging (MRI) and normal C-reactive protein (CRP). The results from cerebrospinal fluid (CSF) test were pending. Headache and leg paresthesia lasted several days: After about 7 - 8 days, on 09 July 2013 to 10 July 2013 (date of reporting), all events were resolved. No further information will be available.

VAERS ID:497561 (history)  Vaccinated:2012-04-02
Age:13.0  Onset:2013-01-29, Days after vaccination: 302
Gender:Female  Submitted:2013-07-24, Days after onset: 175
Location:Foreign  Entered:2013-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prader-Willi Syndrome
Preexisting Conditions:
Diagnostic Lab Data: Grip strength, Jun2013, right: 5.1; left
CDC 'Split Type': B0909655A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162AA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Coordination abnormal, Diplegia, Dizziness, Eye pain, Femoral nerve palsy, Head discomfort, Hypoaesthesia, Muscular weakness, Pain in extremity, Paralysis, Vertigo, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow)
Write-up: This case was reported by a physician and then by the regulatory authority (V13000460) and described the occurrence of femoral nerve palsy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included a mild intellectual disability attribuable to Prader-Willi syndrome. The subject was walked with crutches. On 24 September 2011 and 29 October 2011, the subject received 1st and 2nd doses of CERVARIX (intramuscular, left and right deltoid respectively). On 2 April 2012, the subject received 3rd dose of CERVARIX (intramuscular, left deltoid). On 29 January 2013, 10 months after vaccination with CERVARIX, the subject experienced painful arms and pain in the right thigh. The subject had numbness of the left fingers and felt dizzy (especially when standing up). On the next day, she experienced swaying feeling, vertigo and eye pain. On 31 January 2013, the subject experienced heaviness of head. On 21 May 2013, right femoral palsy and right hand paralysis (reported as arm paralysis) as well as diplegia of upper limbs developed but the symptom of the left upper limb improved in the evening, and was considered as resolved with sequelae as the subject was not able to open the right hand anymore. On 25 May 2013, the subject had painful right forearm. On 26 May 2013, the subject also experienced astasia and weakness of right lower extremity. The subject was admitted to hospital but the causes of symptoms were unknown. On 08 June 2013, the subject was discharged from the hospital, the pain in the right thigh persisted. In June 2013, vertigo, swaying feeling, painful arm and pain in the thigh were reported as improved. The symptoms of the right hand improved in the middle of the month of June but the subject was able to lift chopsticks (grip strength of the right hand was 5.1 kg; and 21 kg for the left hand). At the time of reporting, the subject had no more pain, the weakness of the right lower extremity persisted, the outcome of the rest of the events was unspecified.

VAERS ID:497671 (history)  Vaccinated:2012-05-22
Age:13.0  Onset:2012-11-07, Days after vaccination: 169
Gender:Female  Submitted:2013-07-25, Days after onset: 259
Location:Foreign  Entered:2013-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 22May2012, 36.8Deg. C
CDC 'Split Type': B0909329A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Anxiety, Bone pain, Hypoaesthesia, Malaise, Pain, Visceral pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad)
Write-up: This case was reported by physician via a regulatory authority (# V13000446) and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 May 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). Before vaccination, subject''s body temperature 36.8 Deg. C. On 7 November 2012, 6 months after vaccination with CERVARIX, the subject experienced abdominal pain on the left side. In November 2012: The subject visited a hospital. In February 2013, the subject regularly visited the reporter''s department with complaints of gastralgia, abdominal pain, and numbness. The pains could be controlled with oral treatment with stomach medicine and an analgesic. In June 2013, the subject started to complain strongly of generalised aching. At the subject''s visit to the hospital in June 2013, the reporting physician was informed that the subject had occasionally complained of the gastralgia and visceral pain to the subject''s mother since approximately 1 year before and that the subject''s mother had not been very concerned about the symptoms at that time. The pains gradually intensified thereafter, and the subject frequently complained of the visceral pain and bone pain in the entire body in June 2013 and felt strong anxiety. The subject was hospitalised for 1 week and was observed. The symptoms other than the gastralgia had subsided during the hospitalisation but were aggravated again after the discharge from the hospital. At the time of reporting, the events were unresolved. The regulatory authority reported that the causal relationship between generalised aching, gastralgia and malaise, and vaccination with CERVARIX was unassessable.

VAERS ID:500171 (history)  Vaccinated:2013-05-08
Age:13.0  Onset:2013-05-08, Days after vaccination: 0
Gender:Male  Submitted:2013-07-25, Days after onset: 78
Location:Foreign  Entered:2013-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: Lab test (on 08-MAY-2013) results shown that RR 130/80 (also reported as "RR 13/80"), ASM 80/minute (also reported as "AMS 80/minute") and after observation in clinic for about 1 hour, the results were RR 110/80 and ASM 80/minute.
CDC 'Split Type': WAES1307POL012351
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H010334 IMUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER059081C IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Convulsion, Hypertonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Opisthotonus, Pain in extremity, Syncope, Urinary incontinence, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (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), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This spontaneous report as received from a physician via the agency (agency reference # PL-URPL-N651/2013) refers to a 13 years old male patient. On 08-MAY-2013 the patient was vaccinated with M-M-RVAXPRO (lot # H010334, Exp April 2014), 0.5 ml, intramuscularly. Other suspect therapies included TD-PUR (Batch# 059081C, Exp May 2015) 0.5 ml, intramuscularly. On reporting form of post-vaccine reaction other than BCG were noted following adverse events: non febrile seizures, hypertonia, RR 130/80, ASM 80/minute, hypotonic-hyporesponsive episode with loss of consciousness, arthralgia. In narrative part of reporting form physician reported: up to 5 minutes after vaccination, while patient was sitting faint went into 2-3 seconds incident of seizures (non-febrile), stress of the body with bend to the back, with urination. The symptoms have resolved without treatment with complete return of consciousness while patient was in horizontal position with raised legs. Observation in clinic for about 1 hour- without symptoms with RR 13/80, AMS 80/minute during incident and RR 110/80 and ASM 80/minute when patient was leaving on his own. Due to lack of symptoms patient''s mother decided not to observe child at hospital. On the following day about 24 hours after vaccination- urticaria, recovered after Calcium i.v. From 12-MAY-2013, hypertonia of lower limbs with knees and thighs pain (arthralgia) on 13-MAY-2013 referral to pediatric neurology department. According to reporting form reaction occurred on 08-MAY-2013 at 12:15. Medical outcome: full recovery. Sender''s comment: Muscle and joints pain are expected reaction after both TD-PUR and MMRVAXPRO. Urticaria is reaction expected for M-M-RVAXPRO and unexpected for TD-PUR. Whereas hypertonia, increased blood pressure, loss of consciousness and involuntary urination are for both vaccines unexpected reactions (involuntary urination could be an effect of loss of consciousness). WHO database since 2010 noted 6 cases of joint pain, 37 cases of loss of consciousness, 12 cases of hypertonia and 26 cases of seizures after M-M-RVAXPRO and 7 cases of joint pain, 1 case of loss of consciousness and 1 case of seizures for TD-PUR. These are known reactions. Temporal relationship suggests causal relationship. There was already reported hypotonic hyporesponsive episode after this batch number of M-M-RVAXPRO. All adverse events were considered as medically significant by the health authority. Additional information is not expected.

VAERS ID:497745 (history)  Vaccinated:2012-10-10
Age:13.0  Onset:2013-04-29, Days after vaccination: 201
Gender:Female  Submitted:2013-07-26, Days after onset: 88
Location:Foreign  Entered:2013-07-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Normal
CDC 'Split Type': B0909779A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia totalis, Autoimmune disorder, Blood test normal
SMQs:
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00102332) and described the occurrence of alopecia totalis in a 13-year-old female subject who was vaccinated with HPV vaccine. Concurrent medications included cetirizine hydrochloride. On 10 October 2012 the subject received unspecified dose of HPV vaccine. On 22 April 2013, the subject received the ''last'' dose of HPV vaccine. On 29 April 2013, 7 days after the last vaccination with HPV vaccine, the subject experienced alopecia totalis. A blood test came back as normal. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The consultant diagnosed a return of the alopecia most likely triggered by the immunisation although the causality was reported as unknown. Verbatim Text: Alopecia Areata totalis - autoimmune condition when immune system is triggered by something and overreacts and attacks hair follicles. Approximately 1 week after last immunisation, hair began to fall out in large amounts. Visited GP to rule out other causes for hair loss - blood tests done. When test came back normal she was referred to a consultant dermatologist. The consultant diagnosed a return of the alopecia most likely triggered by the immunisation. She had to take prednisolone 5mg for 3 weeks. She has lost most of her hair on her head. She is now on steroids for 3 days every other week and applying ELOCON scalp lotion and ETRIVEX shampoo daily. So far she has lost most of her scalp hair. Seek Advice Details: Her hair started falling out at a significant rate, bald patches appearing. Seeked doctors advice to check if any other cause for hair loss, when other reasons ruled out she was referred to a consultant.

VAERS ID:497853 (history)  Vaccinated:2008-02-13
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-26
Location:Foreign  Entered:2013-07-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy vagina, 11Jun2013, HSIL
CDC 'Split Type': B0910932A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA015CK0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy vagina abnormal, Cervical dysplasia, Smear cervix abnormal, Vaginal infection
SMQs:, Reproductive premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: This case was reported by a physician and described the occurrence of high-grade squamous intraepithelial lesion in a 19-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 February 2008, 2008 and 13 August 2008 the subject received 1st dose, 2nd dose and 3rd dose of CERVARIX (unknown route and site of injection). In February 2013, 5 years after vaccination with CERVARIX, the subject experienced first colpitis and was diagnosed with high-grade squamous intraepithelial lesion. On 11 June 2013, a pap biopsy was performed and the histological tests - results revealed mucosis from junctional area of cervix with plaques of squamous metaplasia mostly grade CIN 1, in minute section grade CIN 2. Immunochemical investigation revealed positivity p16 oncoprotein in the lower third of mucosis, in some places in the lower two-thirds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:497906 (history)  Vaccinated:2013-03-29
Age:13.0  Onset:2013-05-05, Days after vaccination: 37
Gender:Female  Submitted:2013-07-29, Days after onset: 85
Location:Foreign  Entered:2013-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Diagnostic Lab Data: Blood test, May2013, no abnormalities; Chemistry NOS, May2013, no abnormalities; Inflammation scan, May2013, no abnormalities
CDC 'Split Type': B0907195A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal tenderness, Arthralgia, Asthenia, Blood test normal, Complex regional pain syndrome, Facial pain, Inflammation scan, Laboratory test normal, Malaise, Migraine, Nausea, Pain, Scan normal, Swelling face, Tenderness, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of a possible complex regional pain syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In March 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site; lot number not provided). Around May 2013, 2 months after vaccination with CERVARIX, the subject experienced nonspecific symptoms: urticaria and multiple pains. The pains appeared to migrate. On 2 June 2013, 3 months after vaccination with CERVARIX, the subject experienced malaise. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 22 July 2013: This case was upgraded to serious. Concurrent medical conditions included epilepsy. Historic vaccination included CERVARIX; GlaxoSmithKline; intramuscular; given on August 2012 and October 2012. On 29 March 2013, the subject received 3rd dose of CERVARIX. On 5 May 2013, 37 days after vaccination with CERVARIX, the subject was admitted to hospital for urticarial where he was treated with an oral steroid. On 07 May 2013, the urticaria improved, and the subject was discharged from the hospital. On 08 May 2013, the subject visited the reporter''s hospital for the first time with complaints of face swelling and pain. The subject presented with pain and tenderness in both sides of the head, lower jaw, the back of the head, around the arms, and the back rib area. Adverse drug reactions caused by the oral steroids were suspected, and a drug for headache was prescribed. No abnormalities were noted in blood tests, blood plasma tests, general biochemical tests, and inflammatory reactions. The subject was euthyroid. On 16 May 2013, 48 days after vaccination with CERVARIX, the subject revisited the reporter''s hospital. The subject presented with urticaria in the nighttime and queasy persisting all day. The pain improved. An antihistamine and an analgesic were prescribed. In May 2013, 2 months after vaccination with CERVARIX, the subject experienced arthralgia. On 02 July 2013, 65 days after vaccination with CERVARIX, the subject experienced malaise. He revisited the reporter''s hospital where the complex regional pain syndrome (CRPS) was suspected. At an unspecified time after vaccination with CERVARIX, the subject experienced the subject experienced physical deconditioning, lower abdominal tenderness and migraine. At the time of reporting the outcome of pain, swelling of face, facial pain, tenderness, physical deconditioning, lower abdominal tenderness, migraine, lower jaw tenderness, tenderness of arm, tender back, arthralgia, headache, urticaria and queasy was unspecified. The complex regional pain syndrome and malaise were unresolved. The physician considered the complex regional pain syndrome was possibly related to vaccination with CERVARIX. Related to the effect of the steroid administered for treatment of the urticaria at another hospital and migraine.

VAERS ID:497910 (history)  Vaccinated:2012-03-09
Age:13.0  Onset:2012-03-11, Days after vaccination: 2
Gender:Female  Submitted:2013-07-29, Days after onset: 504
Location:Foreign  Entered:2013-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Iron Deficiency Anemia
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0911175A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Asthma, Colitis ulcerative, Condition aggravated, Dyspnoea exertional, Haematochezia, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician via a regulatory authority (V13000466) and described the occurrence of ulcerative colitis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included iron deficiency anemia. Historic medications included Ferromia. Concurrent medications included Fero-gradumet. Subject''s body temperature before the vaccination was 35.5 Deg. C. On 9 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 10 March 2012, the subject had queasy and difficulty in orally receiving his treatment for iron deficiency anaemia: Ferromia tablet. Accordingly, the medication was switched to Fero-Gradumet. On 11 March 2012, 2 days after vaccination with CERVARIX, the subject experienced exertional dyspnea and asthma-like attack during the club activity, for which she received inhalation treatment at hospital. The symptom improved. On 31 March 2012, 22 days after vaccination with CERVARIX, the subject experienced bloody stools. On 23 April 2012, 45 days after with CERVARIX, the subject was admitted to the hospital for aggravated anaemia. On 09 May 2012, the subject was hospitalised for suspected ulcerative colitis. A diagnosis of ulcerative colitis was made, for which she received treatment. On 25 June 2012, the subject was discharged from the hospital. On 16 July 2013, the exertional dyspnea, bloody stools improved. At the time of reporting the outcome of aggravated anaemia was unspecified and the outcome of ulcerative colitis was unresolved.

VAERS ID:497963 (history)  Vaccinated:2013-04-22
Age:13.0  Onset:2013-04-29, Days after vaccination: 7
Gender:Female  Submitted:2013-07-29, Days after onset: 91
Location:Foreign  Entered:2013-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 10/10/2012, HPV vaccine (unspecified), Immunisation
Diagnostic Lab Data: Blood test (Unknown date): Normal
CDC 'Split Type': WAES1307GBR014871
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia totalis, Blood test normal, Immune system disorder
SMQs:
Write-up: This case was received from the health authority on 22-Jul-2013. GB-MHRA-ADR 22176810. This case is not medically confirmed as it was reported by a consumer (Also reported as other health). A 13 year old female patient (weight: 57.15 kg), who already received a dose of HPV (manufacturer unknown) on 10-Oct-2012, received another case of HPV (manufacturer unknown, batch number not reported), dose, site and route of administration not reported on 22-Apr-2013. The patient was concomitantly treated with cetirizine hydrochloride, 1 dosage form once a day. On 29-Apr-2013, the patient experienced alopecia areata totalis, hair began to fall out in large amounts, bald patches appearing. The patient visited a general practitioner to rule out other causes for hair loss. Blood tests were done and came back normal. She was then referred to a consultant dermatologist. The consultant diagnosed a return of the alopecia (though alopecia was not coded in patient''s past medical history by agency) most likely triggered by the immunisation (autoimmune condition when immune system is triggered by something and attacks hair follicles). She had to take prednisolone 5 mg for 3 weeks. She had lost most of her hair on her head. At the time of reporting, the patient was on steroids for 3 days every other week and applying ELOCON scalp lotion and ETRIVEX shampoo. So far, she had lost most of her scalp hair. At the time of reporting, the patient was not recovered. The agency considered that case serious due to be medically significant.

VAERS ID:498077 (history)  Vaccinated:2013-07-03
Age:13.0  Onset:2013-07-03, Days after vaccination: 0
Gender:Male  Submitted:2013-07-30, Days after onset: 27
Location:Foreign  Entered:2013-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history; no medical history of seizures, movement disorders, head injury, other CNS conditions, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure or alcohol or drug abuse; no sign of a neurological lesion or infection which might have been the cause of the seizure; no intake of medication which is known to reduce the seizure threshold
Diagnostic Lab Data: UNK
CDC 'Split Type': B0905259A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Fatigue, Headache, Injection site pain, Malaise, Myoclonus, Nausea, Pallor, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of convulsion in a 13-year-old male subject who was vaccinated with HAVRIX 720 (GlaxoSmithKline). The subject had no relevant medical history. On an unspecified date, the subject received a 1st dose of HAVRIX 720 (batch, route and injection site unknown). After vaccination the subject experienced severe fatigue and nausea which resolved in unspecified times. On 03 July 2013, the subject received a 2nd dose of HAVRIX 720 (batch, route and injection site unknown). In doctor''s practice, the subject had convulsion which resolved spontaneously after about 20 seconds. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. Causality assessment was not provided. Upon follow-up received on 22 July 2013: The subject weighed 47.4 kg. The subject had no medical history of seizures, movement disorders, head injury, other CNS conditions, cerebral palsy, neurological handicap or congenital abnormality, diabetes, renal failure or alcohol or drug abuse. He did not receive any medication which is known to reduce the seizure threshold. There was no sign of a neurological lesion or infection which might have been the cause of the seizure and no abnormal serum electrolytes. After vaccination the subject had a feeling of malaise with injected arm pain followed by a myoclonus of upper limbs lasting for a few seconds while he was in sitting position. The subject was somnolent with headache, pallor and nausea for 15-30 minutes. During this episode, the subject had no urine or fecal incontinence. At the time of reporting, the events were resolved. Causality assessment was not provided.

VAERS ID:498190 (history)  Vaccinated:2004-03-16
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-01
Location:Foreign  Entered:2013-08-01
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GEN H-B-VAX K
Diagnostic Lab Data:
CDC 'Split Type': WAES1307DEU016104
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS 0UNAR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Autoimmune thyroiditis, Blood test, Compulsions, Hypothyroidism, Insomnia, Iron deficiency anaemia, Thyroid function test
SMQs:, Hypothyroidism (narrow), Hyperthyroidism (broad)
Write-up: Case received from the Health Authorities on 22-Jul-2013 (reference no. PEI2013041445). Case is medically confirmed. A 10-year-old female patient received the third dose of GEN H-B-VAX K (lot-no. R1430-1) into the upper arm on 29-May-2001. The patient received the first dose of PRIORIX (GSK, lot-no. 690174PD) into the upper arm and the first dose of ENCEPUR (Novartis Vaccines, lot-no. 061031A) into the upper arm on 16-Mar-2004 at the age of 13. On an unspecified date the patient developed compulsions, insomnia and iron deficiency anemia. In 2005 the patient developed Hashimoto''s disease and hypothyroidism. Blood test and examination of the thyroid were performed to confirm diagnoses (results not reported). At the time of reporting, the patient had not recovered and it was reported, that the patient was permanently disabled. The patient received D1 of GEN H-B-VAX K (lot-no. R1430-1) on 16-May-2000 and D2 (GEN H-B-VAX K (lot-no. R1430-1) on 04-Jul-2000. Toleration was not reported.

VAERS ID:498235 (history)  Vaccinated:2011-08-23
Age:13.0  Onset:2011-08-24, Days after vaccination: 1
Gender:Female  Submitted:2013-08-01, Days after onset: 708
Location:Foreign  Entered:2013-08-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Physical examination, 2011, normal
CDC 'Split Type': B0911863A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chronic fatigue syndrome, Gait disturbance, Malaise
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13000486) and described the occurrence of chronic fatigue syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 August 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). On 24 August 2011, 1 day after vaccination with CERVARIX, the subject experienced malaise. Even after that, the malaise persisted, and the subject mainly went to the school clinic while she was at school. At an unspecified date, after vaccination with CERVARIX, the subject experienced walking difficulty. On 24 October 2011 till 31 October 2011, the subject was hospitalised to the reporter''s hospital and from 31 October 2011 till 10 November 2011, the subject was admitted to a another hospital, where a detailed examination showed no problems. At an unspecified date, a diagnosis of chronic fatigue syndrome was made. At the time of reporting the outcome of the events was unspecified.

VAERS ID:498700 (history)  Vaccinated:2012-03-15
Age:13.0  Onset:2012-10-26, Days after vaccination: 225
Gender:Female  Submitted:2013-08-07, Days after onset: 285
Location:Foreign  Entered:2013-08-07
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance ima, 06Dec2012, normal
CDC 'Split Type': B0913548A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Musculoskeletal disorder, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician via a regulatory authority (V13000513) and described the occurrence of pain in right upper arm in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Before vaccination, her body temperature was 36.5 deg C. On 15 March 2012 the subject received 3rd dose of CERVARIX (intramuscular, left deltoid). On 26 October 2012, 7 months after vaccination with CERVARIX, the subject experienced pain and weakness in right upper arm. The regulatory authority reported that the events were disabling. The subject visited the hospital several times. On 6 December 2012, a MRI was done and was normal. At the time of reporting the events were unresolved. On 26 July 2013, the subject experienced severe pain when moving the right thumb and was not able to use the right arm.

VAERS ID:498709 (history)  Vaccinated:2012-11-01
Age:13.0  Onset:2013-07-30, Days after vaccination: 271
Gender:Female  Submitted:2013-08-07, Days after onset: 8
Location:Foreign  Entered:2013-08-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Retinopathy of Prematurity
Preexisting Conditions:
Diagnostic Lab Data: Electroencephalogram, 01Aug2013, Not provided; Nuclear magnetic resonance ima, 01Aug2013, Not provided
CDC 'Split Type': B0913178A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician and described the occurrence of tremor in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included retinopathy of prematurity. Concurrent vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on May 2012 and on an unspecified date. In November 2012, the subject received 3rd dose of CEVARIX (intramuscular, unknown injection site, batch number not provided). On 30 July 2013, 8 months after vaccination with CERVARIX, the subject experienced tremor of the right hand and both feet. On 1 August 2013, in the morning, the subject was hospitalised. Nuclear Magnetic Resonance Imaging and electroencephalogram were performed to detect whether the event was attributable to other diseases but results were not provided. At the time of reporting, the event was unresolved.

VAERS ID:499058 (history)  Vaccinated:2013-06-29
Age:13.0  Onset:2013-06-30, Days after vaccination: 1
Gender:Female  Submitted:2013-08-07, Days after onset: 38
Location:Foreign  Entered:2013-08-12, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no significant personal or family history. The patient''s concomitant medications were not reported.
Diagnostic Lab Data:
CDC 'Split Type': 201307698
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Joint swelling, Local swelling, Pain, Paraesthesia
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Initial report received from a healthcare professional on 01 July 2013. A 13-year-old female patient; who had no significant medical history and whose concomitant medications were not reported, had received first primary dose of MENACTRA (lot number: not reported) intramuscularly in left arm on 29 June 2013. On 30 June 2013; 24 hours after vaccination, the patient developed swelling in the left index finger. Left wrist was also swollen and painful on movement. Third left finger was starting to swell and the patient had tingling in fingers. There was no swelling or pain at the vaccination site. The patient''s complimentary investigations were not reported and the patient received ibuprofen (antalgics and anti-inflammatory) as corrective treatment. The outcome of the events was not reported. Relationship as per reporter: Yes. Documents held by sender: None.

VAERS ID:499177 (history)  Vaccinated:2010-01-22
Age:13.0  Onset:2010-01-22, Days after vaccination: 0
Gender:Male  Submitted:2013-08-12, Days after onset: 1297
Location:Foreign  Entered:2013-08-12
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness at time of Vaccine. He was fine, he started shaking, shivering as in shock immediately.
Preexisting Conditions: None - possible iodine allergy, fish allergy.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)GLAXOSMITHKLINE BIOLOGICALS 0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Haematochezia, Hallucination, Headache, Immediate post-injection reaction, Insomnia, Muscle spasms, Muscle twitching, Pain, Posture abnormal, Shock, Sleep apnoea syndrome, Tremor
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.

VAERS ID:499198 (history)  Vaccinated:2010-12-17
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-13
Location:Foreign  Entered:2013-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1107USA01744
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM466801UNUN
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)
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:499523 (history)  Vaccinated:1997-03-10
Age:13.0  Onset:2003-02-01, Days after vaccination: 2154
Gender:Female  Submitted:2013-08-15, Days after onset: 3847
Location:Foreign  Entered:2013-08-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0914549A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Disturbance in attention, Gait disturbance, Inappropriate affect, Memory impairment, Multiple sclerosis, Muscular weakness, Optic neuritis, Paraesthesia, Sensory disturbance, Sensory loss, VIIth nerve paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular infections (broad)
Write-up: This case was reported by the foreign Regulatory Authority (reference MA20131229) and described the occurrence of multiple sclerosis in a 19-year-old female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). The subject''s medical history and concomitant medications, if any, were not specified. Between 27 August 1996 and 10 March 1997, the subject received three primary doses of ENGERIX B pediatric (batch number, route and injection site unknown) through mandatory vaccination program at school. In February 2003, i.e. 06 years after vaccination with ENGERIX B pediatric, the subject presented with sensory disorder and lower limbs giving way. In April 2003, the patient experienced lower limbs paresthesia, walking disorder when she went straight and uncontrollable laughing fit. Sensory disorder remained. On 19 April 2003, multiple sclerosis was diagnosed. Later on, the subject experienced second flare-up with facial paralysis, optic neuritis, loss of balance and sensory loss. Paresthesia in lower and upper limbs remained. Loss of concentration and memory disorder was reported. The subject was followed-up for remittent multiple sclerosis. The regulatory authority reported that the event was disabling. At the time of reporting multiple sclerosis was unresolved. According to the agency, based on the foreign method of assessment, multiple sclerosis was dubiously related to ENGERIX B pediatric.

VAERS ID:500040 (history)  Vaccinated:2013-06-26
Age:13.0  Onset:2013-06-27, Days after vaccination: 1
Gender:Female  Submitted:2013-08-21, Days after onset: 55
Location:Foreign  Entered:2013-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation; Immunodeficiency common variable; Raynaud''s phenomenon
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 40.5; C-reactive protein, 140
CDC 'Split Type': WAES1308FIN008470
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Headache, Pain, Pyrexia, Vaccination site reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case was received from a physician via the Health Authorities on 13-Aug-2013 under the reference number (FI-FIMEA-20130862). Case is medically confirmed. A 13-year-old female patient, with a medical history of Raynaud''s syndrome and common variable immunodeficiency, received a dose of PNEUMOVAX23, lot-no. not reported) via intramuscular route into the left upper arm on 26-Jun-2013. One day later, on 27-Jun-2013, the patient developed pain throughout the body, headache, fever up to 40.5 and an intense vaccination site reaction. C-reactive protein was 140. The patient was hospitalised from 28-Jun-2013 to 02-Jul-2013. The patient had recovered from fever after 3 days, from vaccination site reaction after 4 days and at the time of reporting the patient had recovered completely.

VAERS ID:500105 (history)  Vaccinated:2011-09-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-22
Location:Foreign  Entered:2013-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 05/2011, GARDASIL, No adverse event
Diagnostic Lab Data:
CDC 'Split Type': WAES1308DEU009151
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
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)
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:500960 (history)  Vaccinated:2013-08-07
Age:13.0  Onset:2013-08-13, Days after vaccination: 6
Gender:Male  Submitted:2013-08-30, Days after onset: 17
Location:Foreign  Entered:2013-08-30
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1308GBR014319
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was received from the health authority in a foreign country on 23-Aug-2013. GB-MHRA-ADR 22214093. This case is not medically confirmed as it was reported by a consumer. A 13 year old male patient (weight: 31.75 kg) with no medical history reported, received on 07-Aug-2013 an injection of measles, mumps and rubella vaccine (MFR UNK, batch n. and site of administration not reported) intramuscularly and on 13-Aug-2013, he presented abdominal pain and very high temperature. At the time of reporting the patient had not recovered. The MHRA considered that case serious due to disability/incapacity.

VAERS ID:501092 (history)  Vaccinated:2013-01-31
Age:13.0  Onset:2013-03-01, Days after vaccination: 29
Gender:Female  Submitted:2013-08-30, Days after onset: 181
Location:Foreign  Entered:2013-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN07R2IMUN
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)
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:501433 (history)  Vaccinated:2012-02-25
Age:13.0  Onset:2012-07-01, Days after vaccination: 127
Gender:Female  Submitted:2013-09-04, Days after onset: 430
Location:Foreign  Entered:2013-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0917572A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dysmenorrhoea, Headache, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of painful periods in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st dose of CERVARIX (GlaxoSmithKline); (intramuscular, left deltoid) given on 27 August 2011 and 2nd dose of CERVARIX (GlaxoSmithKline); (intramuscular, right deltoid) given on 24 September 2011. On 25 February 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left deltoid). On an unspecified date in July 2012, 5 months after vaccination with CERVARIX, the subject experienced painful periods, numbness in hand and headache. At the time of reporting, numbness in hand was resolved but painful periods and headache were unresolved.

VAERS ID:501790 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-07
Location:Foreign  Entered:2013-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Pityriasis rosea; Rash; Infection
Diagnostic Lab Data: Further evaluation (date unspecified): documented seropositivity for ANA, anti-RNP, anti-Smith and anti-RO/SSA antibodies C-reactive protein, Normal; Complement factor C3, Decreased; Compliment factor C4, Decreased; Leukopenia, 2100 cells /mm3; Red blood cell sedimentation rate, increased
CDC 'Split Type': WAES1309ISR002035
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Biopsy kidney abnormal, C-reactive protein normal, Complement factor C3 decreased, Complement factor C4 decreased, Convulsion, Fatigue, Leukopenia, Local swelling, Lupus nephritis, Lymphadenopathy, Malaise, Mesangioproliferative glomerulonephritis, Periorbital oedema, Petechiae, Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, Thrombocytopenia, Weight decreased, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: This literature marketed report as received from a other health professional via a journalist concerning a 13 year old female patient. Her personal medical history was remarkable only for common infections, rash due to pityriasis rosea treated and resolved several months before vaccination. Her family history revealed several members of the family with autoimmune diseases including systemic lupus erythematosus (SLE). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient approached her general physician 3 weeks following the second dose of vaccination due to swelling of her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy as well as mild anemia. She was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2100 cells per cubic millimeter and mild thrombocytopenia. Further evaluation documented seropositivity for antinuclear rate (ESR). The C-reactive protein (CRP) level was normal. On an unknown date, the patient was diagnosed with systemic lupus erythematosus (SLE). The patient was treated with hydroxychloroquine and prednisone. Despite therapy, disease progression was documented with the appearance of CNS (i.e. seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. The outcome of the events was reported as resolving. The reporter considered SLE to be related to GARDASIL. The relatedness for seizures was unknown. It was reported that the highest relative risk for an individual autoimmune event was for systemic lupus erythematosus (SLE). A casual link between HPV vaccinations and onset or relapse of SLE is plausible. Upon internal review, systemic lupus erythematosus (SLE) and seizures were considered as medically significant. This is one of the several reports from the same source. Additional information has been requested.

VAERS ID:501791 (history)  Vaccinated:2012-02-20
Age:13.0  Onset:2012-02-20, Days after vaccination: 0
Gender:Female  Submitted:2013-09-01, Days after onset: 558
Location:Foreign  Entered:2013-09-09, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK299000IMUN
Administered by: Private     Purchased by: Public
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: Anaphylaxis - over 80 episodes requiring EPIPEN, ambulance, hospitalization. Under the care of hospital.

VAERS ID:502144 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-11
Location:Foreign  Entered:2013-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: Pityriasis rosea
Diagnostic Lab Data: White blood cell count: 2100 cell/mm3; Anti-SS-A antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody, Positive; Antinuclear antibody positive, Positive; C-reactive protein, Normal; Complement factor C3, Decreased, Low; Complement factor C4, Decreased; Erythrocyte sedimentation rate, Increased
CDC 'Split Type': WAES1309ITA004606
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Anaemia, Anti-SS-A antibody positive, Antinuclear antibody positive, Biopsy kidney abnormal, C-reactive protein normal, Complement factor C3 decreased, Complement factor C4 decreased, Convulsion, Fatigue, Leukopenia, Local swelling, Lupus nephritis, Lymphadenopathy, Malaise, Mesangioproliferative glomerulonephritis, Periorbital oedema, Petechiae, Pyrexia, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Renal disorder, Systemic lupus erythematosus, Thrombocytopenia, Weight decreased, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Case retrieved from the literature on 02-SEP-13. Case medically confirmed. The abstract initially received on 02-MAY-2013 was described in linked case E2013-03484 which was updated with information of patient n. 1. The other 4 patients reports of the article were described in linked cases E2013-06723; E2013-06725; E2013-06726 and E2013-06727 (same vaccine, similar events, different patients). This case concerns patient n. 6: a 13-year-old female approached her general physician 3 weeks following immunization with the second dose of GARDASIL due to swelling in her index finger and a rash. During the following couple of months, she developed erythematous rash on her face, fever, periorbital edema, weight loss, malaise, fatigue, cervical, axillary and inguinal lymphadenopathy, as well as mild anemia. At this stage, she was referred to a rheumatologist who noted that she had a petechial rash, alopecia, leucopenia of 2,100 cells/mm3, and mild thrombocytopenia. Further evaluation documented seropositivity for ANA, anti-RNP, anti-Smith and anti-RO/SSA antibodies as well as low C3 and C4, elevated ESR. The CRP level was normal. The patient was diagnosed with SLE. Hydroxychloroquine and prednisone treatment was started. Despite therapy, disease progression was documented with the appearance of CNS (i.e., seizures) and kidney involvement. Renal biopsy was compatible with mesangial proliferative glomerulonephritis, class II lupus nephritis. Thus, therapy was enhanced with high-dose steroids, cyclophosphamide, as well as antiepileptic medications. Under this therapy, there was gradual remission of the SLE. Notably, her personal medical history was remarkable only for common infections and a rash due to pityriasis rosea treated and resolved several months before immunization. Her family history revealed several members of the family with autoimmune diseases including SLE. The case is closed. The authors mentioned that based on the current available data, a causal link between HPV vaccine and onset or relapse of SLE is plausible. Upon internal review the Company assessed the case as serious.

VAERS ID:502378 (history)  Vaccinated:2013-09-09
Age:13.0  Onset:2013-09-09, Days after vaccination: 0
Gender:Female  Submitted:2013-09-13, Days after onset: 4
Location:Foreign  Entered:2013-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 09/09/2013, Body temperature, fever, fever raising in the evening not provided
CDC 'Split Type': WAES1309THA005040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Delirium febrile, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow)
Write-up: This spontaneous report as received from a pharmacist via company representative refers to a 13 year old female patient. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, strength, indication, route of administration not reported). On 09-SEP-2013 at around 10:00 AM (on an approximately 10:00 AM), the patient was vaccinated with second dose of GARDASIL (intramuscular, dose, strength, lot not reported). There was no concurrent conditions. After 1 hour from vaccination with GARDASIL (on an approximately 09-SEP-2013 at 11:00 AM), subject experienced fever and fever was raising in the evening (exact values and units not provided) had febrile delirium. Parent has cleaned subject''s body with water to make fever decreased and then subject was admitted in the hospital in the night of that day (09-SEP-2013). On the morning of 10-SEP-2013, subject was in the hospital and the event was resolving. Parent worried about the vaccination with GARDASIL, since the subject was healthy. The causality by pediatrician was not specified caused by vaccination with GARDASIL. It may be caused from other factors. The causality by gynecologist who was the consultant of vaccination with GARDASIL was not likely related to vaccination since subject has received second dose of GARDASIL, and no adverse event was reported for first dose of GARDASIL (date, dose, strength, indication, route of administration not reported). Pharmacist did not provide causality for GARDASIL. The parent worried and informed the hospital that the subject will receive third dose of GARDASIL in the hospital, not school for closely monitoring of adverse event in the hospital further. Additional information has been requested.

VAERS ID:503151 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-04-01, Days after vaccination: 0
Gender:Female  Submitted:2013-09-19, Days after onset: 171
Location:Foreign  Entered:2013-09-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 20Aug2013, 39Deg. C; Laboratory test, 22Aug2013, See text; X-ray, 22Aug2013, See text
CDC 'Split Type': B0918761A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Complex regional pain syndrome, Laboratory test normal, Pyrexia, Rheumatoid factor negative, X-ray normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of complex regional pain syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In April 2013, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown injection site and batch number). On 20 August 2013, 4 months after vaccination with CERVARIX, the subject experienced pyrexia (39 Deg.C) and arthralgia. The subject visited a practitioner and received non-steroidal anti-inflammatory (NSAID). She was placed under observation. Generalised joint pains involving the hands, shoulders, knees and elbows persisted and did not improve. The subject was able to walk, but unable to attend physical education classes. On 22 August 2013, since no improvement had been observed in the symptom, she visited the reporter''s hospital and no traumatic injury including fracture was noted. The possibility of complex regional pain syndrome (CRPS) could also not be ruled out. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 11 September 2013: Concurrent medical conditions included seasonal allergy. In April 2013, on the following day of the vaccination, the subject experienced pyrexia (39 Deg. C) and joint pains in both shoulders, both elbows, both hands, both knees, and both feet. On 22 August 2013, as the joint pains in the extremities did not improve, the subject visited the reporter''s hospital. The subject underwent tests for rheumatoid arthritis and systemic lupus erythematosus, which showed negative results. Radiography for the joints showed no fracture or no joint destruction. The subject began to receive other NSAIDs in place of the previous NSAIDs and was observed for a week, but NSAIDs were ineffective. On 29 August 2013, as NSAIDs were ineffective, the subject started to receive TRAMCET. The subject was hospitalised and the generalised joint pain was considered as disabling. Therefore, the case was upgraded to serious. At the time of reporting, the fever was resolved and the general joint pain was unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:503152 (history)  Vaccinated:2013-06-21
Age:13.0  Onset:2013-06-21, Days after vaccination: 0
Gender:Female  Submitted:2013-09-19, Days after onset: 90
Location:Foreign  Entered:2013-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Previously healthy.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0922129A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse drug reaction, Convulsion, Pain in extremity, Psychotic disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00103623) and described the occurrence of seizure in a 13-year-old female subject who was vaccinated with HPV vaccine. On 21 June 2013 the subject received an unspecified dose of HPV vaccine. On 21 June 2013, the same day as vaccination with HPV vaccine, the subject experienced seizure and pain in legs and arms. The subject was hospitalised for 2 weeks. The subject was given an anti-epileptic drug to which she experienced adverse effects. The subject was reported to be "psychotic and in a very bad way". At the time of reporting the events were unresolved. Verbatim Text: My daughter has been having seizures and achy legs and arms. Please could you look at this as a matter of urgency as my daughter was an above targets pupil. My daughter''s dance school now refuse to let her in and she cannot do her beloved drama. My daughter has spent two weeks in hospital most of which she was put to sleep as no one knew what to do and what was happening. My daughter was then given an anti-epileptic drug which she had adverse effects to. My daughter was psychotic and in a very bad way. I''m now left with a 13 year old that was healthy and happy to a poorly teenager who needs my constant attention in case she takes a turn for the worse. No one can tell me if or when this is going to stop. I am at my wits end and am thinking about seeking legal advice as no one can or is willing to help me out.

VAERS ID:503514 (history)  Vaccinated:2013-09-13
Age:13.0  Onset:2013-09-13, Days after vaccination: 0
Gender:Female  Submitted:2013-09-20, Days after onset: 7
Location:Foreign  Entered:2013-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0923854A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Cough, Dysstasia, Gait disturbance
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This case was reported by a physician and described the occurrence of cough in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In August 2013, in the middle of this month, the subject received first dose of CERVARIX (intramuscular, unknown site of injection and batch number). Ten minutes after vaccination with CERVARIX, the subject experienced cough and stumbling (difficulty in standing), for which the subject visited a hospital and received emergency treatment. On 13 September 2013, the subject received second dose of CERVARIX (intramuscular, unknown site of injection and batch number). On 13 September 2013, 20 minutes after the vaccination, the subject experienced cough. As the cough did not cease, ATARAX-P was administered. The cough ceased after the administration of ATARX-P, and the subject''s condition was stabilised with sleep. As the vaccination was performed in the evening, the subject was hospitalised for a night as a precautionary measure. The subject also presented with chest pain (which was considered attributable to the cough). It appeared that the subject presented with slight residual pain on the following day. The subject would revisit the hospital on 20 September 2013. At the time of reporting, the chest pain was improved and the outcome of difficulty standing was unknown. The physician considered that cough was related to vaccination with CERVARIX.

VAERS ID:503515 (history)  Vaccinated:2012-03-05
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-20
Location:Foreign  Entered:2013-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0923855A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Dizziness postural, Headache, Malaise, Orthostatic intolerance, Pyrexia, Somatoform disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13000649) and described the occurrence of orthostatic dysregulation in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline) given on an unspecified date. On 5 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). In June 2012, 3 months after vaccination with CERVARIX, the subject experienced malaise, dizziness, dizziness on standing up, fever and headache. The subject remained absent from school. The symptoms may have developed around May 2012 but became distinct in June 2012. The subject''s mother reported that such symptoms had not been observed before March 2012. On 7 September 2012, the subject visited hospital A for the first time. Counseling by a clinical psychotherapist and pharmacotherapy were continuously performed in view of orthostatic dysregulation and stress-related psychogenic reaction. Other contributing factors were orthostatic dysregulation and school refusal. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The causal relation to CERVARIX was unknown.

VAERS ID:503625 (history)  Vaccinated:2012-10-25
Age:13.0  Onset:2013-02-14, Days after vaccination: 112
Gender:Male  Submitted:2013-03-22, Days after onset: 35
Location:Foreign  Entered:2013-09-20, Days after submission: 182
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Influenza A virus test, positive
CDC 'Split Type': 2013SE19656
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AF2105 IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction
SMQs:
Write-up: A report was received from a physician via Regulatory Authority (PEI) concerning a 13 years old male patient. Medical history and concomitant medications were not reported. On 25-Dec-2012, patient received nasal FLUENZ vaccination. On 14-Feb-2013, despite the vaccination, patinet suffered from influenza A (PCR positive). After one week, the events resolved. The company physician assessed the events to be serious as an important medical event.

VAERS ID:503490 (history)  Vaccinated:2012-11-29
Age:13.0  Onset:2013-03-10, Days after vaccination: 101
Gender:Female  Submitted:2013-09-23, Days after onset: 196
Location:Foreign  Entered:2013-09-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: ECG: AV block 3rd degree, RBBB (right bundle branch block); 06/2013, Blood pressure, low; 06/2013, Electrocardiogram, AV block 3rd degree, Right bundle branch block, Abnormal; 06/2013, Heart rate, low; 06/2013, Liver function test, increased
CDC 'Split Type': WAES1309CZE007728
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Atrioventricular block complete, Blood pressure decreased, Bundle branch block right, Electrocardiogram abnormal, Eyelid oedema, Eyelid ptosis, Fatigue, Headache, Heart rate decreased, Hepatic enzyme increased, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow)
Write-up: Eyelid ptosis and oedema started on 10Mar2013 and persisted until the start of corticoids therapy, symptoms disappeared in June 2013. 30May2013 14 days lasting moderate fatigue, headache, increased levels of liver enzymes, blood pressure decreased, slow pulse. AV block 3rd degree with RBBB found. Child was sent to the hospital, corticosteroid therapy administered during hospitalization. OTHER INFO: AV block 3rd degree, RBBB (right bundle branch block). SUMMARY: 10th March, 2013 ptosis and eyelid oedema appeared, it disappeared after administration of steroids in June 2013. 30th May, 2013 About 14 days felt patient tired and had headaches. Increased liver tests, low blood pressure, low pulse rate, ptosis. ECG revealed AV block 3rd degree + RBBB. Patient was received to the hospital for medical examination and further hospitalisation with steroid treatment.

VAERS ID:503591 (history)  Vaccinated:2013-06-21
Age:13.0  Onset:2013-06-21, Days after vaccination: 0
Gender:Female  Submitted:2013-09-23, Days after onset: 94
Location:Foreign  Entered:2013-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1309GBR008326
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Adverse drug reaction, Convulsion, Pain in extremity, Psychotic disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was received from the health authority in a foreign country on 12-Sep-2013. GB-MHRA-ADR 22231350. This case is not medically confirmed as it was reported by a consumer. A 13-year-old female patient (weight: 63.96 kg), with no medical history reported, received on 21-Jun-2013 an injection of human papillomavirus vaccine (manufacturer unknown, batch number not reported), dose number, route and site of administration not reported. The patient''s mother reported her daughter has been having seizures and achy legs and arms. Her daughter''s dance school now refuse to let her in and she cannot do her beloved drama. The patient had the human papilloma virus vaccine and has been having seizures ever since. She has spent two weeks in hospital where she was put to sleep most of the time as no one knew what to do and what was happening. She was then given an anti-epileptic drug with which she had adverse affects too. She was psychotic and in a very bad way. The mother is now left with a 13 year old who was healthy and happy to a poorly teenager who needs her constant attention in case she takes a turn for the worse. The mother noticed no one can tell her if or when this is going to stop. The mother is at her wits end and is thinking about seeking legal advice as no one can or is willing to help her out. At the time of reporting, the patient has not recovered from seizures and pain of extremities. The patient''s outcome for psychosis was not reported. Upon internal review, the Company decided to code "psychosis" as an adverse event as it was noticed in the narrative but not coded by the MHRA. The MHRA considered that case serious due to the patient''s hospitalization.

VAERS ID:504043 (history)  Vaccinated:2011-12-28
Age:13.0  Onset:2012-03-01, Days after vaccination: 64
Gender:Female  Submitted:2013-09-25, Days after onset: 572
Location:Foreign  Entered:2013-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 05/26/2011, GARDASIL, Immunisation
Diagnostic Lab Data: Unknown date: Blood test: Myasthenia; Unknown date: CT scan: not provided; Unknown date: MRI: not provided; Unknown date: ECG: not provided; Unknown date: EMG: not provided
CDC 'Split Type': WAES1309DNK010595
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test abnormal, Computerised tomogram, Crying, Discomfort, Dyspnoea, Electrocardiogram, Electromyogram, Facial paresis, Fall, Fatigue, Feeling abnormal, Movement disorder, Muscular weakness, Myasthenia gravis, Nuclear magnetic resonance imaging, Speech disorder, Syncope, Thymectomy, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), 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), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 12-Sep-2013 under the references DK-DKMA-ADR 22237786 and DK-DKMA-EFO6815. Case is not medically confirmed. A 13-year-old female patient (weight 46 kg, height 165 cm) had received a dose of GARDASIL (batch no. not reported) via intramuscular route on 28-Dec-2011. On an unspecified, the patient began to faint. The patient said several times that she felt that her body was wrong. She woke up often and had difficulty breathing. She was very tired and cried often in spring 2012 after the vaccination because her body felt completely wrong. She said that she could not lie down and read because she was too weak in the arms to keep the book. She could not read for very long time because the text flowed. She began to smack when she ate, she bumped into things and had difficulty controlling movements, especially in the evening. Later in the year she presented to the doctor talking about her passing out more often. She felt uncomfortable. In January and February 2013, she began to fall when she walked, ran and biked. In March she could not smile anymore and her voice was so indistinct that others could not understand what she was saying. She began to drop food and water out of her mouth. The muscles were not longer working properly and she had difficulty seeing. She was so weak that she can not manage to bathe anymore. She was hospitalised first in May-2013 and diagnosed with myasthenia gravis through a blood test. Various blood tests were performed. In addition a CT scan, MRI, EMG, ECG and numerous neurological examinations as well as surgeries (removal of thymus) were done. Results were not further specified. At the time of reporting, the patient had not recovered from myasthenia gravis. The outcome of all other events were unknown. The patient received D1 of GARDASIL on 26-May-2011. Toleration was not reported. Noteworthy: Myasthenia gravis was diagnosed in May-2013, but Mar-2012 was reported as onset date by the HA.

VAERS ID:504223 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-25
Location:Foreign  Entered:2013-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Anti-cyclic citrullinated pept, 0.4; C-reactive protein, 3.22; Erythrocyte sedimentation rate, 24; Matrix metalloproteinase-3, 128; Rheumatoid factor, 2; Serum ferritin, 46.4
CDC 'Split Type': B0924244A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-cyclic citrullinated peptide antibody, C-reactive protein, Juvenile idiopathic arthritis, Matrix metalloproteinase-3, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Serum ferritin normal
SMQs:, Arthritis (narrow)
Write-up: This case was reported in a literature article and described the occurrence of juvenile idiopathic arthritis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; unknown given on an unspecified date. On an unspecified date, the subject received 3rd dose of CERVARIX (intramuscular, administration site unknown, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced juvenile idiopathic arthritis. The author considered the event was clinically significant (or requiring intervention). The subject was treated with methotrexate and tocilizumab. At the time of reporting, the outcome of the event was unspecified.

VAERS ID:504992 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-01
Location:Foreign  Entered:2013-10-01
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1309CAN013914
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Body temperature fluctuation, Confusional state, Dizziness, Headache, Hyperacusis, Hypoaesthesia, Irritable bowel syndrome, Menorrhagia, Migraine, Nausea, Night sweats, Pain, Photophobia, Rash, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad)
Write-up: Health Authority Report: this spontaneous report as received from a consumer or other non health professional refers to a 13 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, 1 DF, intramuscular. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced amenorrhoea (hospitalization, medically significant and disability), vomiting (hospitalization, medically significant and disability), syncope (hospitalization, medically significant and disability), rash (hospitalization, medically significant and disability), photophobia (hospitalization, medically significant and disability), pain (hospitalization, medically significant and disability), night sweats (hospitalization, medically significant and disability), nausea (hospitalization, medically significant and disability), migraine (hospitalization, medically significant and disability), menorrhagia (hospitalization, medically significant and disability), irritable bowel syndrome, (hospitalization, medically significant and disability), hypoaesthesia (hospitalization, medically significant and disability), hyperacusis (hospitalization, medically significant and disability), headache (hospitalization, medically significant and disability), dizziness (hospitalization, medically significant and disability), confusional state (hospitalization, medically significant and disability) and body temperature fluctuation (hospitalization, medically significant and disability). The outcome of amenorrhoea, vomiting, syncope, rash, photophobia, pain, night sweats, nausea, migraine, menorrhagia, irritable bowel syndrome, hypoaesthesia, hyperacusis, headache, dizziness, confusional state and body temperature fluctuation was reported as not recovered/not resolved. It is unknown if these events are related to GARDASIL. Additional information is not expected.

VAERS ID:505428 (history)  Vaccinated:2010-10-22
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-02
Location:Foreign  Entered:2013-10-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hay fever; Penicillin allergy
Preexisting Conditions: Previously extremely healthy spending her free time playing sport and dancing.
Diagnostic Lab Data: The subject was tested for glandular fever and full blood tests were performed which were all normal.
CDC 'Split Type': B0749391A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain lower, Activities of daily living impaired, Allergy to animal, Alopecia, Arthralgia, Blood iron decreased, Chills, Chronic fatigue syndrome, Contusion, Disturbance in attention, Dizziness, Dyspepsia, Dyspnoea, Emotional disorder, Fatigue, Food intolerance, Full blood count normal, Gastrooesophageal reflux disease, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Increased tendency to bruise, Influenza, Influenza like illness, Insomnia, Laboratory test, Lethargy, Malaise, Memory impairment, Menorrhagia, Menstrual disorder, Menstruation irregular, Mood altered, Myalgia, Nasopharyngitis, Nausea, Oropharyngeal pain, Paraesthesia, Peripheral coldness, Photophobia, Post viral fatigue syndrome, Postural orthostatic tachycardia syndrome, Pyrexia, Rash, Sensation of heaviness, Skin papilloma, Tachycardia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a consumer (mother of the subject) had described the occurrence of post viral fatigue in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hay fever. In October 2010, December 2010 and May 2011 the subject received 1st dose, 2nd dose and 3rd dose of CERVARIX (1 injection) respectively. The mother reported her daugther experienced heavy arm after each vaccination and more specfically after receiving the second dose of CERVARIX in December 2010. She also reported that her daughter was very ill for 2-3 weeks after the second dose, initially the mother thought the events were flu like illness as her daughter developed a fever, vomiting, abdominal pain, muscle aches, extreme fatigue, headache which she assumed was a flu. It was also reported her daughther was still having problems with fatigue and had been off school for 3 weeks and although she returned to school she would relapse with a period of exhaustion. These events were reported to the GP and the daugther was tested for glandular fever and full blood tests were performed which were all normal. After the 3rd dose of CERVARIX the subject experienced continual periods of fatigue, headaches which she never used to experience in the past, disruptive and extremely heavy menstrual cycle since December 2010. The daughter had also suddenly developed an allergy to their dog which they had for 10 years; she also developed a big wart on the cheek of her face and experienced a lot of muscle aches. 2 weeks after 3rd dose the subject went on holiday and she was lethargic and tired on holiday. The events remained unresolved at the time of reporting. The mother reported that on the last visit to her GP which was 6 weeks ago, the subject''s iron levels were on the low side of normal and she was prescribed iron tablets. The doctor had suggested the daughter was suffering with post viral fatigue. There was no further information available at the time of reporting. Follow-up information received from a journalist on 3 November 2011: The journalist stated that the patient had a CERVARIX vaccination in December 2010. At an unknown time after receiving this dose of CERVARIX, the patient experienced cold and flu symptoms. The events affected the patient''s ability to be as active as she was previously. It was reported the events had lasted for approximately ten months. As the time of reporting the events were resolved. Follow-up information received on 14 December 2011: It was reported that this case was initially reported via market research. Follow-up information received from a journalist on 14 December 2011: The journalist reported the subject was allergic to penicillin. After the 2nd CERVARIX dose the subject also experienced chills, sore throat and rash on her face torso and dizziness. Also after an unknown period after the vaccinations the subject also experienced join pain especially her knees. She was then diagnosed with chronic fatigue syndrome. After this she attended A and E as the subject had lost feeling in her rigth arm and right leg. It was also reported that the subject would get breathless from the slightest activity. Also whilst on holiday the subject had been emotional and moody. At the time of reporting the outcome of these events was unknown. Follow up information received from the regulatory authority on 24 September 2013: On 22 October 2010, 10 December 2010 and 23 May 2011 the subject received the 1st dose, 2nd dose and 3rd dose of CERVARIX (1 injection) respectively. In June 2011 the subject experienced lethargy. In September 2011 the patient experienced chronic fatigue syndrome, joint pain, breathlessness, acid indigestion and gastroesophageal reflux. On unknown dates the subject experienced chronic headaches, chronic sore throat, muscle pain, lower abdominal pain, menstrual cycle abnormal, pins and needl

VAERS ID:505598 (history)  Vaccinated:2009-05-07
Age:13.0  Onset:2009-11-01, Days after vaccination: 178
Gender:Female  Submitted:2013-10-03, Days after onset: 1432
Location:Foreign  Entered:2013-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: GARDASIL; GARDASIL, VIIth nerve paralysis; 10/15/2008, GARDASIL, Headache
Diagnostic Lab Data: Hearing test (March 2009): results not reported. MRI (March 2009): results not reported. Lumbar puncture (March 2009): results not reported. 10/2008, Acoustic stimulation tests, Normal not provided; 10/2008, Blood test, Normal not provided; 10/2008, Lumbar puncture, Normal not provided
CDC 'Split Type': WAES1310DNK001241
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0773X2SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Acoustic stimulation tests, Acoustic stimulation tests normal, Activities of daily living impaired, Arthralgia, Blood test normal, Chest discomfort, Depressed mood, Dizziness, Fatigue, Headache, Infection, Lumbar puncture normal, Lymphadenopathy, Malaise, Mouth haemorrhage, Myalgia, Nausea, Neck pain, Nuclear magnetic resonance imaging, Oral discomfort, Pain in extremity, Pyrexia, Swelling face, VIIth nerve paralysis, Wound complication
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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 meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Case received from non-healthcare professional and patient insurance company via health authority on 25-Sep-2013 under the reference number 13-5884 and 22249342. Case no medically confirmed. A 13-year-old female patient had received an injection of GARDASIL (batch number NK05560, dose 3) on 07-May-2009 and later on unspecified date in June 2009 she developed another left-sided facial paralysis (her third). In August 2009 she developed facial swelling at her cheek, that doesn''t decrease, as well as severe swelling of lymph. In November 2009 she developed another facial paralysis on her left side, which was later moved over to the right side like a big swelling that doesn''t disappear. Further she had, with a few weeks in between, severe discomfort in her mouth, painful wounds and red/blue/brown bleeding from the mucosa. Treatment at all occasions have been valaciclovir (3 x daily for 7 days), penicillin (several treatments), prednisolone (25 mg, 2 x daily for 2 days + 25 mg/day for 3 days), ZOVIR, and pain killers. For 11 months she was taking ZELETRIX (3 x daily) as preventive measure, without much effect. In between these events of paralysis she has had a lot of fever, infections, feeling generally unwell, nausea, dizziness, pain in all joints (pain in elbows and knees), tiredness, headache, pain in neck and chest pressure. The patient still suffers on a daily basis from pain in head and neck, generally unwell, tiredness, pain in fingers, elbows and knees, dizziness, nausea, fever, chest pressure, muscle pain and she is sad and resigned. The patient received the first dose of GARDASIL on 15-Oct-2008 (batch number NJ01850) and later on an unspecified date a few days later she developed severe pain behind both ears and on 19-Oct-2008 she developed left-sided facial paralysis (on the fourth day). Later on unspecified date in March 2009 she developed a right-sided facial paralysis. The patient received the second dose of GARDASIL (batch number NJ21220) on an unspecified date. At the time of reporting, the outcome of these events was unknown. The girl was hospitalized in October 2008 and many different examinations were performed, including blood tests, hearing tests and lumbar puncture, all tests were normal. After the second face paralysis in March 2009 she was again admitted to hospital with hearing test, MR scan and lumbar puncture (results not rep). According to the report, the events after the first dose was not assessed by the hospital as connected to the vaccination. The girl had been hospitalized in connection to the facial paralysis events (no details reported) and she has been out of school due to infections and fever. The outcome was reported as not recovered for facial swelling, fever, malaise, recurrent infection, nausea, dizziness, joint pain, chest pressure, pain in fingers, muscle pain, feeling sad and headache. Outcome for other events was unknown.

VAERS ID:506393 (history)  Vaccinated:2012-11-28
Age:13.0  Onset:2013-03-01, Days after vaccination: 93
Gender:Female  Submitted:2013-10-04, Days after onset: 216
Location:Foreign  Entered:2013-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Systolic pressure (??-MAR-2013): 100 mmHg, in the spine position; Diastolic pressure (??-MAR-2013): 60 mmHg, in the spine position; Systolic pressure (??-MAR-2013): 72 mmHg, when standing up; Systolic pressure (??-MAR-2013): 58 mmHg, when standing up
CDC 'Split Type': WAES1310JPN000196
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.9QN06R1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Fatigue, Headache, Loss of consciousness, Malaise, Orthostatic hypotension, Orthostatic intolerance, Somnolence
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial information has been received from a physician via the agency concerning a 13 year old female patient. The revaccination interview form (her underlying disease, allergy, past history of vaccination/disease during recent one month, concomitant medications, adverse drug reaction (ADR) history, status of growth) and her family history were not described. On 18-MAR-2013, she received the third injection of GARDASIL intramuscular injection drug (dose and injection site not reported) against cervical cancer. No concomitant medication was reported. On 24-SEP-2012, she received the first injection of GARDASIL (lot No. 9QN05R). On 28-NOV-2012, she received the second injection of GARDASIL (lot No. 9QN06R). On 18-MAR-2013, as stated above, she received the third injection of GARDASIL (Batch No. 9QN08R/lot No. 0989AA). In March 2013, the patient had generalized malaise, severe fatigue, headache, difficulty in awaking in the morning, strange sleepiness in the daytime, frequent absence from school, and orthostatic hypotension. Her blood pressure (BP) levels in the spine position and when standing up were 100/60 mmHg and 72/58 mmHg respectively. She lost her consciousness 3 minutes after her standing up. She developed orthostatic dysregulation. On 02-SEP-2013, the patient was recovering from the orthostatic dysregulation. Comment from the reporter: The orthostatic dysregulation can explain all the above symptoms. The reporting physician assessed that the orthostatic dysregulation was related to the GARDASIL. The physician assessed the orthostatic dysregulation as serious (other important medical event). Additional information is expected.

VAERS ID:506812 (history)  Vaccinated:2013-09-19
Age:13.0  Onset:2013-09-19, Days after vaccination: 0
Gender:Female  Submitted:2013-10-09, Days after onset: 20
Location:Foreign  Entered:2013-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 103/62 mmHg; Heart rate, 125 min
CDC 'Split Type': WAES1310POL002269
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J005992 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Dizziness, Erythema, Headache, Hypoaesthesia, Induration, Injection site reaction, Malaise, Nausea, Oedema peripheral, Pallor, Pyrexia, Skin swelling, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Patient female on 19 September 2013 at 10:00 AM was vaccinated wtih Silgard (volume 0.5 ml) intramuscular in left arm (lot# J005992/ exp 11/2015), On reporting form of post-vaccine reaction (other than BCG) were noted the following adverse events: fever above 40.5 Celsius degrees, up to 48 hours, chills, vomiting, numbness of limbs, severe injection site reactions with a diameter greater than 10 cm. In the narrative part of the form the physician reported: About 45 minutes after vaccination: dizziness. About 2 PM severe headache, later edema and redness of left arm with thick, linear ridge running vertically in the direction of the elbow. Numbness of left hand and right leg. About 6 PM severe chills fever initially 39 Celsius degrees, at 12 PM 40.6 Celsius degrees, at 4:30 AM 39.5 Celsius digress. At examination in physician office- state average, pale, hard, swollen skin, chills, blood pressure 103/62 mmHg, cor - 125. Headache, nausea, vomiting. Feeling generally unwell. The patient was directed to hospital. According to reporting form reaction occurred on 19-SEP-2013 at 11:00. Medical outcome: the child is still traded at home. Case comment: In the past the patient did not experience any post-vaccine reactions.

VAERS ID:506888 (history)  Vaccinated:2012-09-01
Age:13.0  Onset:2012-09-01, Days after vaccination: 0
Gender:Female  Submitted:2013-10-10, Days after onset: 404
Location:Foreign  Entered:2013-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 01Sep2012, Decreased; Blood pressure, 01Oct2012, Decreased; Blood pressure, 23Feb2013, Decreased; Blood test, No abnormalities; Ultrasound chest, No problems Orthostatic dysregulation tests including orthostatic test showed many relevant items.
CDC 'Split Type': B0925217A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162DA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood pressure decreased, Blood test normal, Chest pain, Convulsion, Headache, Laboratory test abnormal, Malaise, Oral allergy syndrome, Presyncope, Ultrasound chest, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a regulatory authority (V13000653) and described the occurrence of vasovagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 September 2012, the subject received 1st dose of CERVARIX (intramuscular, unknown site of injection). On 1 September 2012, within 30 minutes after vaccination, the subject experienced vasovagal reaction with decreased blood pressure but without syncope. At an unspecified time, the event was resolved. On 1 October 2012, the subject received 2nd dose of CERVARIX (intramuscular, unknown site of injection). On 1 October2012, within 30 minutes after vaccination, the subject experienced vasovagal reaction with decreased blood pressure but without syncope. At an unspecified time, the event was resolved. On 23 February 2013, the subject received 3rd dose of CERVARIX (intramuscular, unknown site of injection). On 23 February 2013, within 30 minutes after vaccination, the subject experienced vasovagal reaction with decreased blood pressure but without syncope. At an unspecified time after vaccination with 3rd dose of CERVARIX, the subject experienced headache, chest pain and malaise. On 4 September 2013, the subject visited the medical center. On an unspecified date, blood test and chest ultrasound were performed which revealed no particular problems. Orthostatic dysregulation (OD) tests including orthostatic test showed many relevant items. No myalgia, injection site pain, or tenderness was noted. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 03 October 2013. This case was upgraded to serious. At an unspecified time after vaccination with 3rd dose of CERVARIX, the subject experienced convulsion, abdominal pain, urticaria and oral allergy syndrome. The physician placed checkmarks on all the 5 categories of a classification for anaphylaxis, for which the present case was under investigation. On 12 September 2013, vasovagal reaction, chest pain and malaise were resolved. At the time of reporting, headache and abdominal pain was unresolved and the outcomes of convulsion, urticaria and oral allergy syndrome were unknown. The regulatory authority considered that the events were clinically significant (or requiring intervention). The regulatory authority reported that vasovagal reaction was related to vaccination with CERVARIX.

VAERS ID:507443 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-10
Location:Foreign  Entered:2013-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1301GBR007719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Optic neuritis, Pain, Viral infection
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad)
Write-up: This case was received from the Health Authority on 31-Dec-12 under the reference number GB-MHRA-ADR 21960925. This case is linked to E2012-11329 (same patient, same vaccine, events after second dose). 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 HPV vaccine (Manufacturer, batch number not reported) route and site not reported on an unreported date. On an unreported date, post vaccination (time to onset not reported) the patient experience viral type symptoms. The patient outcome is not reported. The patient subsequently received a second dose of HPV vaccine (Manufacturer unknown not reported) on an unreported date. On 23-Nov-12 (time to onset not reported) the patient experienced right optic neuritis. At the time of reporting the patient is recovering (E2012-11329). Follow-up information was received from the Health Authority on 02-Oct-2013. This case is now a serious case. One week post vaccination, the patient had viral type illness (generalised aches and pains). The batch number was unknown. Generalised aches and pains lasted one week and recovered. The reporter stated that, considering the temporal association with the HPV vaccine (one week after immunisation), it was possible that the reaction was immunisation related. The Regulatory Authority considered that case serious as an other significant medical reason.

VAERS ID:506968 (history)  Vaccinated:2013-10-05
Age:13.0  Onset:2013-10-06, Days after vaccination: 1
Gender:Female  Submitted:2013-10-11, Days after onset: 5
Location:Foreign  Entered:2013-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Laboratory test (unspecified) (06-OCT-2013): no abnormalities were found; 10/06/2013, Blood test, normal, no abnormalities N/A
CDC 'Split Type': WAES1310JPN005136
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0989AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Blood test normal, Cold sweat, Crying, Dysstasia, Gait disturbance, Headache, Hypoaesthesia, Insomnia, Laboratory test normal, Malaise, Pain, Sensory disturbance, X-ray normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Initial information has been received from a physician concerning a 13-year-old female patient with no underlying disease or medical history. On 05-OCT-2013, the patient received the third time vaccination with a GARDASIL IM injection drug (dose, injection site and not provided). No concomitant medication was reported. On an unspecified date, the patient received the first time vaccination with the GARDASIL ()batch number: 9QN07R, lot number: 0788AA, expiry date: 05-JUN-2014). On an unspecified date, the patient received the second time vaccination with the GARDASIL (batch number: 9QN08R, lot number: 0989AA, expiry date: 21-JUN-2014) at a nearby internal medicine clinic. One hour later, she had cold sweat and malaise. After she went home, she repeated 3-hour-sleep and waking up for strange sensation, but she had an appetite. On 06-OCT-2013, around 1:00 in the midnight, the patient had symptoms with numbness of four limbs (joints lower than elbow and knees). She also had headache, abdominal pain and malaise. She could not sleep because of pain, but the pain disappeared in the morning. She was seeing what''s happening and then became unable to stand up due to weakness. The headache and numbness reappeared around at 14:00 and 16:00, respectively. She then urgently visited and was admitted to the reporting physician''s hospital because frequency of these symptoms gradually increased. At presentation to the hospital, the patient seemed to have difficulty walking and to be crying and suffering. She received only drip infusion at admission. No abnormalities were found in blood tests or radiographic findings. On 07-OCT-2013, the malaise and numbness of four limbs (joints lower than elbows and knees improved. The outcome of the cold sweat, headache, abdominal pain, and weakness was unknown. Mild numbness of legs was still persisted in the morning then disappeared in the early evening. Reporter''s comment: none. The reporting physician did not assess the causal relationship of the malaise, numbness of four limbs (joints lower than elbows and knees) as serious (hospitalization) and did not assess the seriousness of the cold sweat, headache, abdominal pain and weakness. Additional information has been requested.

VAERS ID:507432 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2012-11-23
Gender:Female  Submitted:2013-10-11, Days after onset: 321
Location:Foreign  Entered:2013-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Color vision tests, Normal; Fundi examination, Swollen right op; Nuclear magnetic resonance ima, Normal; Ophthalmological examination, See additional i; Visual acuity tests, Right 6/6 -2 N5; Visual acuity tests, Normal in right; Visual field tests, See additional i; Her visual field testing showed significant superior and inferior field loss in her right eye. The field in the left eye was entirely full; Red desaturation and a right relative afferent pupillary defect although her colour vision was full
CDC 'Split Type': B0855943A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Colour vision tests normal, Eye pain, Fundoscopy abnormal, Headache, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination abnormal, Optic disc disorder, Optic neuritis, Pain, Pupillary reflex impaired, Visual acuity reduced, Visual acuity tests abnormal, Visual field defect, Visual field tests abnormal
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Glaucoma (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Ocular infections (broad)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00096507) and described the occurrence of optic neuritis in a 13-year-old female subject who was vaccinated with HPV2 (unknown manufacturer). On unspecified dates the subject received the 1st and 2nd dose of HPV2. It was reported the patient experienced viral symptoms after the 1st dose and after the 2nd dose, on 23 November 2012, the subject experienced right optic neuritis. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. Verbatim Text: Had viral-type symptoms after first dose and developed right optic neuritis after second dose of HPV vaccine. Follow up information received from the regulatory authority on 2 October 2013: Approximately 1 week after vaccination with HPV2, the subject experienced optic neuritis, painful eye movement, headache, decreased vision, relative afferent pupillary defect, visual field defect, optic disc disorder and generalized pain. Relevant test results included colour vision tests which were normal, fundi examination showed swollen right optic disc, an MRI of the brain was normal, visual acuity tests showed right 6/6 -2 N5 and left 6/6 N5 and were normal in the right eye. Ophthalmological examination and visual field tests showed her visual field testing showed significant superior and inferior field loss in her right eye. The field in the left eye was entirely full and red desaturation and a right relative afferent pupillary defect although her colour vision was full. At the time of reporting the events were resolved. Additional Verbatim Text: Patient attended the clinic for review having been seen by my colleague 3 weeks ago with a one week history of right eye pain on eye movement and associated headache and reduced vision. Her visual acuity was found to be normal in the right eye at that stage. She did, however, have red desaturation and a right relative afferent pupillary defect although her colour vision was full. Her visual field testing showed significant superior and inferior field loss in her right eye. The field in the left eye was entirely full. Fundal examination revealed a swollen right optic disc. A diagnosis of right optic neuritis was made. Considering the temporal association with her HPV vaccine (one week after immunisation) it is possible that it was immunisation related. She had a second dose of vaccine at that time. On questioning, she actually had quite a viral type illness (generalised aches and pains) a week after her first dose of vaccine and this lasted for a week. Thankfully her vision made a full recovery over a two month period. It is difficult to say for sure whether there is a definitive association with her vaccination. Following discussion, however, we have agreed that it is probably not in her best interest to get her 3rd vaccination done. An MRI of her brain was reported as normal.

VAERS ID:507852 (history)  Vaccinated:2013-03-25
Age:13.0  Onset:2013-03-26, Days after vaccination: 1
Gender:Female  Submitted:2013-10-14, Days after onset: 202
Location:Foreign  Entered:2013-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0929723A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA164AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Menorrhagia, Menstruation irregular, Pain, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13000707) and described the occurrence of generalized pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site; lot number not provided). Less than one month after vaccination with CERVARIX, the subject had her menstruation twice in a month which was described as an menstrual irregularity. Improvement in the menstrual irregularity was noted with treatment. On an unspecified date, the subject received the 2nd dose of CERVARIX (intramuscular, unknown injection site; lot number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced menostaxis. Subject''s body temperature prior to vaccination was of 36.6 Deg. C. On 25 March 2013, the subject received the 3rd dose of CERVARIX (intramuscular, unknown injection site). On 26 March 2013, 1 day after vaccination with CERVARIX, the subject experienced generalised aching, chronic pain and pain of lower extremities. It was difficult to identify the sites of pain. At an unspecified time after vaccination with CERVARIX, the subject experienced unceasing menstrual blood. Malaise also developed and persisted. The pain developed in the whole body from under the neck and pain of lower extremities was especially intense. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the subject presented with persistent chronic pain of unknown cause (generalised aching, chronic pain and pain of lower extremities) and malaise. The of metrorrhagia and menostaxis was improved. The regulatory authority reported that the generalised pain, chronic pain and pain of lower extremities were related to vaccination with CERVARIX.

VAERS ID:507870 (history)  Vaccinated:2009-08-03
Age:13.0  Onset:2009-08-04, Days after vaccination: 1
Gender:Female  Submitted:2013-10-15, Days after onset: 1533
Location:Foreign  Entered:2013-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 11/2010, Blood creatinine, $g450
CDC 'Split Type': WAES1310DNK006102
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Blood creatinine increased, Blood urine present, Chemotherapy, Glomerulonephritis, Plasmapheresis, Proteinuria, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Case of adverse event received from non health care professional via Health Authorities on 08-Oct-2013 under the reference number 22252552 and 13-5895. The primary reporter was a lawyer from patient insurance company (PIC). A 13 year old female patient had received the third dose of GARDASIL (batch number unknown) via not reported route of administration in not reported site of administration on 03-Aug-2009 and later on, 04-Aug-2009, she developed pain in back (around the kidney region), blood in urine, excretion of too much protein and chronic disease (Glomerulonephritis). HA received information from PIC on 17-Sep-2013, patient insurance number 13-5895, which was the patient''s initial notification to the PIC. PIC has not taken a decision on the case. Adverse reactions: Pain in the back (around the kidneys), chronic kidney disease (glomerulonephritis) which manifests in occasional compromised renal function with blood in the urine and excretion of too much protein. Vaccination: The first GARDASIL dose given on 15-Jan-2009, batch number is unknown to the patient''s physician, it has not been noted in the journal. Second GARDASIL vaccination is given on 26-Mar-2009 with batch number NJ38950. Third GARDASIL vaccine is given on 03-Aug-2009, batch number unknown to the patient''s physician, it has not been noted in the journal. Event around the adverse reactions: The patient was hospitalized from 22-Nov-2010 to 07-Dec-2010. The patient was hospitalized when her creatinine level was over 450. Patient was during her hospitalization treated with antibiotics, chemotherapy, plasmapheresis (seven times in 14 days), adrenal hormone and blood pressure lowering drugs to treat to kidneys. When the patient was discharged from the hospital she continued with blood pressure lowering drugs and adrenal hormone. The patient''s disease is currently stable but the disease is chronic and will under certain conditions (not specified) break out again at any time. Over the past three years, the patient has generally had high protein excretion, and blood in the urine for many times. The patient has recently stopped the blood pressure lowering medication. The patient has always been well and healthy. At the time of reporting, the patient had not recovered.

VAERS ID:507878 (history)  Vaccinated:2011-05-09
Age:13.0  Onset:2013-05-20, Days after vaccination: 742
Gender:Female  Submitted:2013-10-15, Days after onset: 148
Location:Foreign  Entered:2013-10-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 01/28/2011, GARDASIL, Drug Indication: Immunisation, batch number NN02290; 05/21/2010, GARDASIL, Drug Indication: Immunisation, batch number NL45420
Diagnostic Lab Data: A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date.
CDC 'Split Type': WAES1310DNK006354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Borrelia test negative, CSF test normal, Sudden hearing loss
SMQs:, Hearing impairment (narrow)
Write-up: Case received from health care professional via Health Authority in a foreign country on 04-Oct-2013 under the reference numbers 22256262 and EFO7020. The primary reporter was a physician. Case is medically confirmed. A 15 year old female patient (weight:52 kg; height: 160 cm), had received the third dose of GARDASIL (batch number NN02290) via intramuscular route of administration in not reported site of administration on 09-May-2011 and later on 20-May-2013 she developed sudden deafness on the right ear. The Health Authority was in contact with the physician on 26-Sep-2013. A negative borrelia test including a cerebrospinal fluid test was performed on an unspecified date. The patient had no other medications. The patient had a history of vaccination with the first and second dose of GARDASIL (batch number NL45420 and NN02290) respectively) via intramuscular route of administration and not reported site of administration on 21-May-2010 and 28-Jan-2011. At the time of reporting, the patient had not recovered.

VAERS ID:507914 (history)  Vaccinated:2009-01-19
Age:13.0  Onset:2009-03-21, Days after vaccination: 61
Gender:Female  Submitted:2013-10-15, Days after onset: 1669
Location:Foreign  Entered:2013-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 10/23/2008, GARDASIL
Diagnostic Lab Data: 01-OCT-2010: EEG (electroencephalography): widespread dominant activity of 8-10 Hz sometimes activity above 13 Hz and 5-7 Hz activity diffuse amplitude up to 4 uV, no hemisphere difference. No focal or paroxysmal. Hyperventilation and photo stimulation: Nothing further. Sleep Stage I: normal pattern. Electrocardiogram Regular heart rate of 56, no abnormality; On an unknown date, Computerised tomogram (CT) scan: No suspected breach of maxillary/infraorbitalis; On an unknown date, Computerised tomogram (CT) scan: Nothing abnormal and sinus abnormal; On an unknown date Systolic blood pressure, 95; On an unknown date, Tilt table test: normal; On 26-JAN-2010: Pulse decreased 68; On 02-FEB-2010; Holter monitoring: normal; On 01-OCT-2010, Electroe
CDC 'Split Type': WAES1310DNK004977
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1941U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Arrhythmia, Atrial septal defect, Atrial septal defect repair, Blood pressure decreased, Bone pain, Cardiac murmur, Cardiovascular disorder, Computerised tomogram abnormal, Concussion, Contusion, Cyanosis, Dizziness, Dizziness postural, Dysaesthesia, Echocardiogram abnormal, Electrocardiogram PQ interval, Electrocardiogram QT interval normal, Electrocardiogram abnormal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Electroencephalogram abnormal, Epistaxis, Erythema, Excoriation, Fall, Fatigue, Fundoscopy normal, Headache, Heart rate decreased, Hyperventilation, Local swelling, Loss of consciousness, Nasal inflammation, Nasopharyngitis, Nausea, Nuclear magnetic resonance imaging brain normal, Orthostatic hypotension, Paraesthesia, Periorbital contusion, Presyncope, Syncope, Tenderness, Tilt table test normal, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (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), Dementia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Case received from healthcare professional via Health Authority on 01-Oct-2013 and 02-Oct-2013 under the reference number 22256170. The primary reporter is a physician. Case is medically confirmed. A 13-year old female patient had received the second and third dose of GARDASIL (batch number NJ01850, Lot # 1941U, exp date 12-DEC-2010 and NK05560 Lot # 0773X, exp 16-JUN-2011, respectively) via intramuscular route of administration and not reported site of administration on 19-Jan-2009 and 09-Jun-2009 and later on 21-Mar 2009 she developed several times vision disturbance/blackened for the eyes, syncope, presyncope, headache and on one occasion she fell down the stairs, bruise on right cheek and forehead, right cheek red and swollen, mild indirect tenderness at the clenching and skin abrasion on her left leg, easy nausea and amnesia and on 08-Aug-2009 she experienced dizzy. On 23-Nov-2009 she was diagnosed with orthostatic hypotension on 16-Dec-2009 diagnosed with atrial septum defect (corresponding to the fossa ovalis), on 26-Jan-2010 diagnosed with suspected hyperventilation and on 20-May-2010 diagnosed with nasal mucosa seen inflamed bilateral. On an unspecified date in the end of Aug-/beginning of Sep-2010 the patient experienced commotio-cerebri symptoms and big bulge in the neck and on 11-May-2011 the patient developed tired and on unspecified dates cold and slightly cyanotic fingers. The HA has received additional information from the reporting physician on 02-Oct-2013. The reporting physician has a suspicion that the patient''s orthostatic hypotension may be due to the patient''s treatment with GARDASIL. Summary from epicrisis 21-Mar-2009. The girl experienced blackened for the eyes and the patient fainted and fell down the stairs. She was unconscious, probably around 1 minute. She is now bruised on the right cheek, forehead skin abrasion on her right leg. Has amnesia for the event. No dizziness or vomiting. Mild headache localized to the right side. Easy nausea. Right cheek is red and swollen, mild indirect tenderness at the clenching. CT shows no suspected breach of either maxillary or infraorbitalis. Treatment: None. Note medical record 30-Jul-2009: Persistent sore facial skeleton after the accident. CT scan showed nothing abnormal. Note medical record 01-Sep-2009: Superficial lesion of the head without any specification. In March lipothymia where the patient fell and hit the right half of the face. The patient has no functional face problems, but still sense mild dysesthesia on the right cheek and pressure tenderness around the ulnar infraorbitalis dexter. No difficulty swallowing. Sinus scan normal conditions in both jaw caves. Cranium/Face: Symmetric conditions. No conture leaps at orbital ridges. Os zygomaticus symmetric and stable on the two sides. Is sore over the right ulnar infraorbitalis. The skin quite unremarkable. No swelling or subcutaneous accumulations. Eyes: Free eye movements in all planes. Normal pupils. Anterior mouth and neck normal. Improvement may be seen up to a year after this. Wait and see how the situation develops. There can be no treatment. Medical record 01-Sep-2009: The mother reports that the patient on 08-Aug-2009 has been malaise and dizzy and she has the same symptoms today. Medical record 02-Sep-2009: Again "attack" of dizziness and malaise, not fainting. 23-Nov-2009, Outpatient Clinic, Hospital. 14 year old girl referral from a GP due to dizziness. The patient was over the past half year had attacks of dizziness, where it blackened for the eyes and she became malaise. The dizziness comes primarily when the patient must concentrate and if she is stressed. The patient has no palpitations, no sweating, no nausea. There has been no loss of consciousness or convulsions. The patient has sometimes headaches associated with the dizziness attacks, but not always, and may also have a headache when there is no dizziness. The headache does not affect the patient''s everyday life, and it is only bec

VAERS ID:508535 (history)  Vaccinated:2012-09-03
Age:13.0  Onset:2013-01-16, Days after vaccination: 135
Gender:Female  Submitted:2013-10-17, Days after onset: 273
Location:Foreign  Entered:2013-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0079647A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA150BE0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Orthostatic intolerance, Syncope, Vomiting
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of recurrent syncope / collapse episodes in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unknown date in fall 2012 the subject received the first dose of CERVARIX (0.5 ml, unknown). Approximately 3-4 months post vaccination with CERVARIX, on an unknown date in January 2013, the subject experienced recurrent syncope. At the time of reporting, on 29 April 2013, the event was unresolved. Follow-up information was received on 09 October 2013 from the reporting physician. The case was upgraded to serious. The subject had no underlying or concurrent medical conditions or other risk factors. The subject received no concomitant medication. On 03 September 2012 the subject received the first dose of CERVARIX (0.5 ml, intramuscular, left deltoid). Approximately four months (135 days) post vaccination with CERVARIX, on 16 January 2013, the subject experienced first collapse episodes, first episode of dizziness and vomiting for about two minutes. On the next day, on 17 January 2013, the subject experienced another collapse episode with dizziness and orthostatic dysregulation for about three minutes. The subject experienced other collapse episodes on 21 January 2013 and on 25 January 2013, two collapse episodes in March 2013, three collapse episodes in April 2013, three collapse episodes in May 2013 and one collapse episode in July 2013 which lasted only several minute, each. The subject was treated with EFFORTIL. Approximately 12 months post vaccination with CERVARIX, on 09 September 2013, the subject experienced a collapse episodes associated with loss of consciousness for about 40 minutes. The subject was hospitalised for four days from 09 September 2013 to 12 September 2013. Treatment included positioning of the subject into a recovery position, followed by infusion therapy. On an unknown date in September 2013 the subject started treatment with ASTONIN. Each single collapse episode was resolved but overall the collapse episodes may be unresolved. The vaccination course with CERVARIX was discontinued. The reporting physician considered that the events were unlikely related to vaccination with CERVARIX. The physician did not provide the answers to a GSK questionnaire asking for additional information in cases of loss of consciousness (psychogenic, due to syncope, due to seizure or due to anaphylaxis) post vaccination with CERVARIX. No further information will be available.

VAERS ID:508566 (history)  Vaccinated:2013-09-02
Age:13.0  Onset:2013-09-02, Days after vaccination: 0
Gender:Female  Submitted:2013-10-17, Days after onset: 45
Location:Foreign  Entered:2013-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1310GBR007134
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotonia, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261134. This case is medically confirmed. A 13 year old female patient, with no medical history reported, received on 02-Sep-2013 an injection of GARDASIL (batch number J005923) 0.5 mL intramuscularly, dose in series and site of administration not reported. She was also concomitantly treated by inhalation with RHINOCORT and VENTOLIN. Three to four minutes post vaccination, the patient became floppy but not unconscious with arm and head shakes. An ambulance was called and the patient had no concerning features from their assessment but was taken to hospital to be seen by a doctor. Within 30 minutes of the incident, the patient walked normally out to the ambulance and is back in school this afternoon. At the time of reporting the patient had fully recovered. The regulatory authority considered that case serious due to patient''s hospitalization.

VAERS ID:509005 (history)  Vaccinated:2013-09-25
Age:13.0  Onset:2013-09-26, Days after vaccination: 1
Gender:Female  Submitted:2013-10-23, Days after onset: 27
Location:Foreign  Entered:2013-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1310IRL009500
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0196330UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash pruritic, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was received from the health care authority on 16-Oct-2013. This case is not medically confirmed as it was reported by a consumer. A 13 year old female patient, with no medical history reported, received on 25-Sep-2013 a first dose of GARDASIL (batch number H019633), route and site of administration not reported. Within approximately 24 hours of vaccination, on 26-Sep-2013, the patient developed a rash that described as little spots (almost like chicken pox) first noticed on patient''s chest, then stomach, legs and on to her back. The spots were very itchy. Corrective treatment included ZYRTEC reported as ''ZIRTEX'', clarithromycin and EURAX Cream. At the time of reporting, the patient has not recovered. The agency considered that case serious due to be medically significant.

VAERS ID:509294 (history)  Vaccinated:2013-10-02
Age:13.0  Onset:2013-10-05, Days after vaccination: 3
Gender:Female  Submitted:2013-10-24, Days after onset: 19
Location:Foreign  Entered:2013-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1310MLT009773
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Benign intracranial hypertension
SMQs:
Write-up: This spontaneous report as received from a physician refers to a 13 year old female patient. Approximately on 02-OCT-2013 ("three days before adverse event") the patient vaccinated with first dose of SILGARD (lot#, expiration date, dose, indication, route not reported). Approximately on 05-OCT-2013 ("approximately 2 weeks ago"), the patient was diagnosed with benign intracerebral hypertension after administration of SILGARD. Patient was hospitalized 3 days after the first dose of SILGARD. The outcome of the event was unknown. Additional information has been requested.

VAERS ID:509485 (history)  Vaccinated:2013-09-27
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-25
Location:Foreign  Entered:2013-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1310IRL010809
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0131350IMUN
Administered by: Other     Purchased by: Other
Symptoms: Butterfly rash, Dizziness, Pallor, Rash macular
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was received from the health authority on 15-Oct-2013. REF 2013-018416. This case is medically confirmed as it was reported by a physician. A 13-year-old female patient, with no reported medical history, received on 27-Sep-2013 a first 0.5 mL dose of GARDASIL, (batch n. H013135) intramuscularly (site of administration not reported) and 45 minutes post-vaccination (date not reported) she experienced a confluent blanching macular rash on her upper chest and anterior shoulders. The patient also experienced dizziness, malar flush and pallor on an unreported date. Corrective treatment included PIRITON. The patient was referred to hospital for observation. At the time of reporting the patient had not recovered. The IMB considered the case to be serious as an other medically important condition because it required intervention.

VAERS ID:509596 (history)  Vaccinated:2013-10-07
Age:13.0  Onset:2013-10-07, Days after vaccination: 0
Gender:Female  Submitted:2013-10-25, Days after onset: 18
Location:Foreign  Entered:2013-10-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0931827A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-EYC 00104729) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with human papilloma type 16 + 18 vaccine. O 7 October 2013 the subject received unspecified dose of Human papilloma type 16 + 18 vaccine. That same day on 7 October 2013, after vaccination with Human papilloma type 16 + 18 vaccine, the subject experienced fever and sickness. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. MHRA Verbatim Text: Fever, sickness.

VAERS ID:510268 (history)  Vaccinated:2013-04-20
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-30
Location:Foreign  Entered:2013-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Computerised tomogram, Inspection myasthenia gravis and diagnosis
CDC 'Split Type': WAES1310JPN012866
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram abnormal, Myasthenia gravis
SMQs:
Write-up: Information has been received from a physician concerning a 13-year-old female patient with no underlying disease or medical history. On 20-APR-2013, the patient received the first vaccination of GARDASIL IM, 0.5 ml (injection site and lot number not reported). On 21-JUN-2013, the patient received the second vaccination with GARDASIL IM 0.5 ml (injection site and lot number not reported). On an unspecified date in 2013, myasthenia gravis developed in the patient after the vaccination. On an unspecified date, the patient underwent examinations at a hospital. On 24-SEP-2013, the patient was referred to the university hospital A. On an unspecified date, myasthenia gravis was diagnosed from the results of examinations such as CT. On 16-OCT-2013, the patient was transferred to the pediatric department. On 18-OCT-2013, the patient was admitted to the pediatric department. On 19-OCT-2013, treatment with an oral steroid drug was started, but her clinical course did not change. At the time of this report of 25-OCT-2013, the patient had not recovered from the myasthenia gravis. Reporter''s comment: The causal relationship between the myasthenia gravis and GARDASIL was unknown. The reporting physician assessed the myasthenia gravis as serious (hospitalization). Upon interval review, myasthenia gravis was considered to be an other important medical event. Additional information has been requested.

VAERS ID:510325 (history)  Vaccinated:2013-08-12
Age:13.0  Onset:2013-08-12, Days after vaccination: 0
Gender:Female  Submitted:2013-10-29, Days after onset: 78
Location:Foreign  Entered:2013-10-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: C-reactive protein, No increase was; Nuclear magnetic resonance ima, ADEM not suspect
CDC 'Split Type': B0917580A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein normal, Decreased appetite, Feeling abnormal, Hypoaesthesia, Malaise, Nausea, Nuclear magnetic resonance imaging, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of limb numbness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified date, at an unspecified time after vaccination with CERVARIX, the subject experienced limb numbness, feels poorly, malaise, appetite impaired and vomiting. At the time of reporting, the outcome of the events were unspecified. Follow-up information received on 23 August 2013: On 20 June 2013, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site and batch number). On an unspecified date, within a week after vaccination with CERVARIX, the subject experienced numbness of limbs which disappeared approximately 3 days after vaccination. On 12 August 2013, less than 1 day after vaccination with CERVARIX, the subject experienced queasy feeling, malaise and vomiting which resolved 2 days after. On 14 August 2013, although the vomiting resolved, the queasy feeling and malaise persisted. The subject presented with numbness of limbs. On 18 August 2013, the subject was referred to an hospital for examination. MRI showed no problems and complex regional pain syndrome (CRPS) was also negative. Neither swelling nor bump was noted on the vaccination site. The physician had the impression that the subject tended to fear injections. At the time of reporting, the outcome of feeling poorly and appetite impaired were unspecified and limb numbness, malaise, feeling queasy were unresolved. Case upgraded to serious upon follow-up information received on 24 October 2013: At an unspecified date after the 1st vaccination with CERVARIX, the subject experienced queasy feeling. On 12 August 2013, 1 month 23 days after vaccination with the 1st dose of CERVARIX, the subject received the 2nd dose of vaccine. This was considered as a drug dose administration interval too long. On 17 August 2013, 5 days after vaccination with the 2nd dose of CERVARIX, the subject was admitted and treated with ATARAX-P. The subject underwent examination and in the light of the clinical symptoms, Guillain-Barre syndrome was ruled out. On 20 August 2013, the subject was discharged from the hospital. On 22 August 2013, the numbness of limbs completely resolved. The physician assessed the feeling queasy was related to vaccination with the 2nd dose of CERVARIX.

VAERS ID:510834 (history)  Vaccinated:2012-09-01
Age:13.0  Onset:2013-04-01, Days after vaccination: 212
Gender:Female  Submitted:2013-10-31, Days after onset: 213
Location:Foreign  Entered:2013-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Platelet count, Low; Red blood cell count, Low; White blood cell count, Low Tests showed low platelets, red and white cells. These were repeated a few times and fluctuated each time.
CDC 'Split Type': B0935290A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Depression, Fatigue, Headache, Oropharyngeal pain, Platelet count decreased, Red blood cell count decreased, Weight decreased, White blood cell count decreased
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow)
Write-up: This case was reported by the regulatory authority (GB-MHRA-EYC 00104970) and described the occurrence of chronic fatigue in a 13-year-old female subject who was vaccinated with human papilloma type 16 and 18. In September 2012 the subject received an unspecified dose of human papilloma type 16 and 18. It was reported human papilloma type 16 and 18 was discontinued in April 2013. In April 2013, approximately less than 1 month after an unspecified dose of human papilloma type 16 and 18, the subject experienced headache. 1 month after vaccination, in May 2013, the subject experienced chronic fatigue, depression and weakness. 2 months after vaccination, in June 2013, the subject experienced sore throat and weight loss. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was taken to her GP who referred the subject to Child and Adolescent Mental Health Services (CAMHS) and a paediatrician. Tests revealed low platelet count, low red blood cell count and low white blood cell count. In August 2013, the weight loss and sore throat resolved. On an unknown date the weakness and depression resolved. At the time of reporting, the chronic fatigue was improved and the headache was unresolved. MHRA Verbatim Text: Chronic fatigue, depression, headache, sore throat, weakness and weight loss. Seek Advice Details: Took her to general practitioner who referred to Child and Adolescent Mental Health Services (CAMHS) and paediatrician. Barrage of tests, no conclusion.

VAERS ID:511272 (history)  Vaccinated:2013-04-01
Age:13.0  Onset:2013-05-01, Days after vaccination: 30
Gender:Female  Submitted:2013-11-04, Days after onset: 187
Location:Foreign  Entered:2013-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 09/2012, HPV vaccine (unspecified), Immunisation
Diagnostic Lab Data: Platelet count, Decreased; Red blood cell count, Decreased; White blood cell count, Decreased
CDC 'Split Type': WAES1310GBR015099
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Depression, Fatigue, Headache, Oropharyngeal pain, Platelet count decreased, Red blood cell count decreased, Weight decreased, White blood cell count decreased
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow)
Write-up: This case was received from the health authority on 24-Oct-2013. GB-MHRA-ADR 22282505. This case is not medically confirmed as it was reported by a consumer. A 13-year-old female patient (weight: 49.89 kg), with no reported medical history, was vaccinated in Apr-2013 with a dose of HPV (manufacturer unknown, batch n. not reported), route, dose, dose in series and site of administration not reported. In Apr-2013, she experienced headache. In May-2013, she experienced chronic fatigue, depression and weakness. In Jun-2013 she experienced sore throat and weight loss. The patient was taken to her general practitioner who referred to Child and Adolescent Mental Health Services and paediatrician. On unreported dates tests were performed and showed low platelets, red and white cells. These were repeated a few times and fluctuated each time. The patient had recovered from sore throat and weight loss both in Aug-2013. On an unreported date she had recovered from depression and weakness. At the time of reporting she was recovering from chronic fatigue and she had not recovered from headache. The patient had received a previous dose of HPV vaccine in Sep-2012. The regulatory authority considered this case to be serious as an other medically important condition.

VAERS ID:511762 (history)  Vaccinated:2013-09-09
Age:13.0  Onset:2013-09-09, Days after vaccination: 0
Gender:Female  Submitted:2013-11-06, Days after onset: 58
Location:Foreign  Entered:2013-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: 09-Sep-2013 pulse was 144bpm, respiratory rate was 16, her BP 138/80, oxygen saturation was 99% a repeat pulse was 122bpm and BP was 160/82. After another 15 minutes her pulse was reduced to 100bpm. On sitting up the patient''s pulse increased to 112bpm.
CDC 'Split Type': WAES1311IRL001878
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H013137 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Flushing, Headache, Heart rate increased, Heart rate irregular, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: This case was received from the health authority on 31-Oct-2013. REF 2013-018584. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication received an injection of GARDASIL (batch number H013137), IM, site not reported, 0.5 mls, on 09-Sep-2013. On 09-Sep-2013, approximately 25 minutes post vaccination, the patient complained of a frontal headache and was feeling flushed. The reporter indicated that the patient''s pulse was 144bpm which is irregular. The patient''s respiratory rate was 16, her BP 138/80 and oxygen saturation was 99%. The patient had no respiratory distress. A few minutes later the patient also complained of dizziness. The patient lay down with her legs elevated. A repeat pulse was 122bpm and BP was 160/82. After another 15 minutes the dizziness and flushing had improved, her pulse was reduced to 100bpm. The patient sat up and was given one tablet of paracetamol for her headache. On sitting up the patient''s pulse increased to 112bpm. The patient was transferred to A&E for persistent tachycardia. If any corrective treatment was provided it was no specified. The reporter indicated that the patient was discharged from A&E that day. The duration of the events was two hours and the patient made a complete recovery. The events were considered to be medically important by the health authority.

VAERS ID:511995 (history)  Vaccinated:2011-10-11
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2013-11-07
Location:Foreign  Entered:2013-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, no abnormalities
CDC 'Split Type': B0939567A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA076EC2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Blood test normal, Chest pain, Chronic fatigue syndrome, Fatigue, Hypersomnia, Influenza, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a consumer (subject''s mother) regulatory authority (# NL-LRB-161177) and described the occurrence of chronic fatigue syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no known medical history or past drug therapy. Former vaccinations in the routine childhood Immunisation programme went without any problems. There was no family history. Concomitant medication was not reported. On 11 October 2011, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). At an unspecified time after vaccination with CERVARIX, the subject became ill and experienced chronic fatigue. She slept a lot. Chronic fatigue increased and 3 months after vaccination, this became conspicuous. The subject also experienced pain on the chest. A general practitioner was visited and a heavy flu was suspected but it appeared to be muscle myalgia. Antibiotics were given but did not have effect. The subject was hospitalised during 1 month for check-up. Chronic fatigue syndrome was diagnosed. Later she was admitted to a rehabilitation centre for 4 months. According to subject''s mother, blood tests revealed no abnormalities. At the time of reporting the events were unresolved. She goes to school for 2 hours per day and does not play any sports anymore. The regulatory authority reported that the events were unlikely to be related to vaccination with CERVARIX.

VAERS ID:512730 (history)  Vaccinated:2013-06-01
Age:13.0  Onset:2013-07-08, Days after vaccination: 37
Gender:Female  Submitted:2013-11-12, Days after onset: 127
Location:Foreign  Entered:2013-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1311COL003754
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This spontaneous prospective pregnancy report as received from the National Institute of Health in a foreign country refers to a 13 year old female patient. An inadvertent GARDASIL vaccination was performed on 20-MAY-2013. In June 2013, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. The patient had a LMP of 29-APR-2013 and EDD of 03-FEB-2014. The exposure was during the first trimester. The pregnancy outcome was spontaneous abortion. On 08-JUL-2013, the patient experienced vaginal bleeding (hospitalization) and curettage (hospitalization). At the time of the onset of the symptoms, the patient was on the 10 week of gestation, and subsequent curettage. The patient had an analysis unit on department and final classification as a matching case. The outcome of vaginal bleeding and curettage was unknown. The action taken with GARDASIL was not provided. The reporter did not assess the relationship between the vaginal bleeding and curettage and GARDASIL. Additional information has been requested.

VAERS ID:512733 (history)  Vaccinated:2013-05-08
Age:13.0  Onset:2013-05-09, Days after vaccination: 1
Gender:Female  Submitted:2013-11-12, Days after onset: 187
Location:Foreign  Entered:2013-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1311COL003709
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This spontaneous report as received from a regulatory authority (#AE13CO0243) refers to a 13 year old female patient. No medical history provided. On 08-MAY-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular for prevention of cervical cancer. No concomitant medications were provided. On 09-MAY-2013 the patient experienced cellulitis, local pain and fever. She required hospitalization on 23-MAY-2013. The outcome of local pain, fever and cellulitis is unknown. Unknown whether the patient received the second (after two months) and third dose (after six months) of GARDASIL. Additional information has been requested.

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