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Case Details (Sorted by Age)

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VAERS ID:409197 (history)  Vaccinated:2010-05-19
Age:13.0  Onset:2010-05-19, Days after vaccination: 0
Gender:Female  Submitted:2010-11-17, Days after onset: 182
Location:Foreign  Entered:2010-11-18, 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
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure measurement, 22Sep10, 100/60; Total heart beat count, 19May10, 84 and regular; Vital sign, 22Sep10, normal; Total heart beat count, 22Sep10, 80 and regular
CDC Split Type: WAES1010USA00716
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oedema peripheral, Similar reaction on previous exposure to drug, Soft tissue disorder
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was received from a health care professional on 23-SEP-2010. This case is medically confirmed. A 13 year old female patient with a medical history of an aunt who died of motor neuron disease, received the first dose of GARDASIL on an unspecified date and experienced swelling on the dorsum of the hand - this was not documented. The patient received dose 2 of GARDASIL (lot number NK25010; batch number NM11420) on 22-SEP-2010 in the left deltoid at about 2:00 pm. The patient was kept behind for observation. On 22-SEP-2010 the reporter asked the patient what was the matter and the patient replied that her left hand was swollen. The reporter looked at the left hand and it looked essentially normal but there was some soft tissue swelling on the dorsum of the left hand between the thumb and index finger; it looked slightly puffy. There was no mottling. The patient looked well post vaccination. The reporter advised the patient''s mother about using perhaps an antihistamine. The puffiness resolved by the evening, the patient was never in any danger. No shortness of breath, no lip or tongue swelling and no rash. The reporter had informed the IMB. Follow up information has been received on indication that on 22-SEP-2010, the patient received intramuscularly the second dose of GARDASIL at 14:35 hours. At 16:34 hours on 22-SEP-2010, according to documentation, the patient informed the staff that her left hand was swollen. Her vital signs were normal. She had no evidence of airway difficulties and no swelling of the lips or tongue and no swelling elsewhere. Her blood pressure was 100/60 and pulse 80 and regular. The reporter noticed the patient sitting in the observation area and pointed to the back of her left hand thenar eminence (dorsal aspect) and said it was swollen. The reporter looked at both hands to compare and the area on the left hand appeared to be a little puffier compared to the right. There was no redness and no rash. There was no swelling for her fingers or above the wrists in either hand. The patient informed the reporter on 22-SEP-2010, that she had a similar swelling after her first dose of GARDASIL (Lot # NK25010; Batch# NM1420) (Expiration date: 20-APR-2010) on 19-MAY-2010, she experienced swelling on the dorsum of the hand (this was not documented). The reporter confirmed that the patient had returned to the observation area at 12:17 with swollen fingers. Finger and elbow exercise were given. A pulse was recorded at 84 and regular. On 22-SEP-2010, the patient was kept under observation until she was collected by her mother at 16:00 hours. The reporter spoke to the mother and advised corrective treatment with an antihistamine for one to two days and to seek medical assistance at any stage if she was unhappy. The reporter suggested that the patient''s mother be present at the time of administration of the third dose of GARDASIL. On the evening of 22-SEP-2010, the mother confirmed that the patient''s left hand was satisfactory but the reporter omitted to confirm whether the patient had taken antihistamine. This case had been upgraded to serious by the agency on 05-NOV-2010 (reference number 2010-000073) for other important medical event. Other business partner numbers include: E2010-05710. No further information is available

VAERS ID:409208 (history)  Vaccinated:2010-10-16
Age:13.0  Onset:2010-10-18, Days after vaccination: 2
Gender:Male  Submitted:2010-11-17, Days after onset: 30
Location:Foreign  Entered:2010-11-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous vaccinations were generally well tolerated.
Diagnostic Lab Data:
CDC Split Type: E201006746
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURERC3124AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Injection site erythema, Lymphadenitis, Lymphadenopathy, Pyrexia, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Case received from the Health Authorities in a foreign country on 05-Nov-2010 (PEI2010031269). Case medically confirmed. A 13-year-old male patient had received an injection of Td-vaccine (lot-no. C3124AA) IM in the left deltoid muscle on 16-Oct-2010. Two days later, on 18-Oct-2010, he developed fever, axillary lymphadenitis and distinctive "painful inflammatory vaccination reaction with redness and swelling" of the left upper arm leading to hospitalisation on the same day. Axillary lymph nodes were enlarged up to 17 mm diameter. CRP was increased (15mg/l). Symptoms improved under corrective treatment with cefuroxim, FENISTIL, and "aseptic compresses". The boy completely recovered from fever (duration not reported). The patient was discharged on 22-Oct-2010 with ongoing residual redness and swelling and enlarged axillary lymph nodes. The final outcome was not reported. Upon medical review the company added the following AEs, which were mentioned in the hospital report but not coded by HA: Axillary lymphadenitis, fever, localised erythema, pain localised, localised swelling. FILE CLOSED.

VAERS ID:409677 (history)  Vaccinated:2010-09-27
Age:13.0  Onset:2010-10-02, Days after vaccination: 5
Gender:Female  Submitted:2010-11-19, Days after onset: 48
Location:Foreign  Entered:2010-11-22, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA01311
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK25010 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Nausea, Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: This case was received from the health authority on 05-NOV-2010. Agency ref 2010-000052. This case was medically confirmed. A 13 year female patient with no risk factors or concomitant medications available received an injection of GARDASIL (Batch # NM11420, Lot # NK25010) on 27-SEP-2010. On 02-OCT-2010, five days post vaccination, the patient developed an itchy red rash on her arms and legs. On 03-OCT-2010 the patient attended accident and emergency as the rash had worsened. The patient was given AUGMENTIN, PIRITON and prednisolone for five days. On the 04-OCT-2010 the patient contacted the clinic with worsening rash all over the body and itching. On the 06-OCT-2010 the rash had almost gone but the patient was experiencing nausea. No other medications were used. At the time of reporting the patient had not yet recovered. The agency considered the case serious as it required intervention. Other business partner numbers included E2010-06791. No further information is available.

VAERS ID:410338 (history)  Vaccinated:2010-11-02
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2010-11-29
Location:Foreign  Entered:2010-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: DIABETIC
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 118/68; Blood pressure, 110/64; Glucose, 15.1mmol; Glucose, 19mmol; Pulse rate, 88; Pulse rate, 78
CDC Split Type: B0685423A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA091CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Dizziness, Slow response to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad)
Write-up: This case was reported by a healthcare professional via the regulatory authority (GB-MHRA-ADR 20742761) and described the occurrence of dizziness in a 13-year-old female subject who was vaccinated with CERVARIX. Concurrent medical conditions included diabetes. Concurrent medications included INSULIN. On 2 November 2010 the subject received an unspecified dose of CERVARIX (1 IU Axa, intramuscular). At an unspecified time after vaccination with CERVARIX, the subject experienced light headedness, dizziness and increased blood sugar. It was felt that slow reaction was probably a result of increased blood sugars. It was reported that the subject was seen in accident and emergency and was discharged home later that day. The regulatory authority reported that the events were clinically significant (or requiring intervention). Relevant test results included blood sugars ''19 mmol to 15.1 mmol''. At the time of reporting the events were resolved and the subject was fully recovered. Returned to session feeling light headed and dizzy. Diabetic on insulin pump. Blood sugars 19 mmol to 15.1 mmol. Breathing and swallowing okay. It is felt that slow reaction was probably a result of increased blood sugars. Seen in accident and emergency and discharged home later that day. Patient is now fully recovered. Other medically significant: slow to recover; sent to accident and emergency.

VAERS ID:410342 (history)  Vaccinated:2010-11-06
Age:13.0  Onset:2010-11-06, Days after vaccination: 0
Gender:Female  Submitted:2010-11-29, Days after onset: 23
Location:Foreign  Entered:2010-11-29
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: B0685742A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site movement impairment, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a physician and described the occurrence of injection site impairment in a 13-year-old female subject who was vaccinated with CERVARIX. On 6 November 2010 the subject received unspecified dose of CERVARIX (intramuscular), lot number not provided. On 6 November 2010, the day of vaccination with CERVARIX, the subject experienced injection site pain and injection site movement impairment. the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:410673 (history)  Vaccinated:2010-09-13
Age:13.0  Onset:2010-11-15, Days after vaccination: 63
Gender:Female  Submitted:2010-11-29, Days after onset: 14
Location:Foreign  Entered:2010-11-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood pressure measurement, 15Nov10, 120/45; Blood pressure measurement, 15Nov10, 130/60; Blood pressure measurement, 15Nov10, 135/65; Total heartbeat count, 15Nov10, 160 bpm; Total heartbeat count, 15Nov10, 110 bpm; Total heartbeat count, 15Nov10, 120 bpm
CDC Split Type: WAES1011USA02151
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cough, Cyanosis central, Dizziness, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: Information has been received from the health authority on 16-NOV-2010, agency ref 2010-000791. This is one of a cluster of four cases after vaccination with GARDASIL (same batch and three of the cases occurred in the same area of the country) and is linked with WAES # 1010USA00699, 1010USA00700 and 1011USA02143. This case was medically confirmed. A female patient of unknown age was vaccinated with the second dose of GARDASIL (lot # NK25010, batch # NM31130) on an unreported date. On an unspecified date, post vaccination, the patient experienced an anaphylactic reaction. The patient had received the first dose of GARDASIL (batch # not reported) on an unreported date with no adverse effect. The patient outcome was not reported. Follow-up information was received from agency on 22-NOV-2010: The patient was aged 13 years old. She had no medical history of note and was not taking any concomitant medication. There were no risk factors available. The patient was vaccinated with the first dose of GARDASIL on 13-SEP-2010. The patient was vaccinated IM with the second 0.5 ml dose of GARDASIL at 14:20 on 15-NOV-2010. On 15-NOV-2010, six minutes post vaccination, the patient complained of throat tightness and dizziness. Her pulse was 160bpm and regular, and her blood pressure (BP) was 120/45. An urticarial rash was noticed on both upper limbs. The patient lay down but there was no improvement. At 14:55 the patient complained of throat tightness and a cough. There was no tongue swelling but a marked central cyanosis of her tongue. Adrenaline 0.5 ml 1 in 1000 was given in her right anterolateral upper thigh. Her vital signs were reported and showed a pulse of 110bpm and a BP of 130/60. There was no improvement in the urticarial rash. At 15:08 the patient complained again of throat tightness and a cough. Adrenaline 0.5 mls 1 in 1000 was given into her right anterolateral upper thigh. Overall the patient improved with a pulse of 120 bpm and BP 135/65. The patient was then taken by ambulance and transferred to the Accident and Emergency department for overnight observation. The patient outcome was not reported. The events were considered serious for hospitalization and medically important condition (required intervention). Other business partner numbers include E2010-07042. Additional information has been requested.

VAERS ID:411216 (history)  Vaccinated:2010-09-14
Age:13.0  Onset:2010-11-16, Days after vaccination: 63
Gender:Female  Submitted:2010-12-01, Days after onset: 15
Location:Foreign  Entered:2010-12-02, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure measurement, 16Nov10, hard to detect; test or measurement, 16Nov10, pulse rate: 104 bpm, weak; respiratory rate measurement, 16Nov10, 44
CDC Split Type: WAES1011USA02143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Dizziness, General physical health deterioration, Mouth breathing, Pallor, Pulse absent, Pulse pressure decreased, Stridor, Tachycardia, Tachypnoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (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), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: This case was received from the health authority. This is one of a cluster of four cases after vaccination with GARDASIL (same batch and three of the cases occurred in the same area of the country) and is linked with E2010-05963, E1010-05968 and E1010-07042. This case is medically confirmed. A female patient of unknown age received the second dose of GARDASIL (batch number NM31130, lot # NK25010, expiry 04/2012) on an unreported date. On an unspecified date, post vaccination, the patient experienced an anaphylactic reaction. The patient had received the first dose of GARDASIL (batch number not reported) on an unreported date with no adverse effect. The patient outcome was not reported. Anaphylactic reaction was considered to be an other important medical event. Follow-up received from the agency (ref 2010-000652): The patient was aged 13 years. The patient received the first dose on 14-SEP-2010. The patient had no medical history and no risk factors were available. Concomitant medication information was not available. The patient received the second dose IM 0.5mls on 16-NOV-2010. On 16-Nov-2010, within a few minutes of vaccination, the patient felt dizzy, faint and looked pale. She lay down and was comfortable but tachycardic at 104. The patient was observed and her BP and pulse rechecked and they were normal but she was noted to have pursed lip breathing and tachypnea. The patient seemed distressed but had no complaints of chest tightness, rash or throat tightness. She was wheezy on auscultation and it was decided to give ADRENALINE. While the ADRENALINE was being drawn up the patient deteriorated further with a weak pulse and hard to detect blood pressure. The first dose of ADRENALINE was given and there was some improvement in the pulse and blood pressure but a worsening stridor and wheeze. Therefore a second dose of ADRENALINE was given. The blood pressure and pulse improved briefly after this. PIRITON 10mg, IM, VENTOLIN via a spacer were also given. The patient''s pulse and blood pressure were again barely palpable and the patient was distressed with worsening stridor and a respiratory rate of 44. Therefore a third dose of ADRENALINE was given as per the local protocol. The patient was then taken by ambulance to the emergency department. The patient was admitted to the hospital in a stable condition. The patient recovered and by that evening was stable and later that night was well. The reporter stated that the staff involved felt that the events were a life-threatening reaction. The patient needed the maximum amount of medicine that was allowed to be given and her pulse was barely palpable and was momentarily unpalpable. Her BP was unrecordable. The reporter felt that the patient was pre-arrest. The events were considered serious for hospitalisation, life-threatening and other medically important event (required intervention). A standard lot check investigation has been finalized. All in-process quality checks for the [Due to memory limitations, the remainder of this text could not be compared.] s for the lot number (lot # NK25010) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the bath prior to release met all release specifications. Other business partner numbers include: E2010-07046.

VAERS ID:411217 (history)  Vaccinated:2009-10-14
Age:13.0  Onset:2010-04-01, Days after vaccination: 169
Gender:Female  Submitted:2010-12-01, Days after onset: 244
Location:Foreign  Entered:2010-12-02, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Tonsillitis recurrent; Recurrent respiratory tract infections
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA02671
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Encephalitis, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from health authority on 18-NOV-2010 (under the reference number NO-NOMAADVRE-FHI-2010-11424 and NIPH 10/2377). Case medically confirmed. A 13 year old female patient on 14-OCT-2009 was vaccinated with a first dose of GARDASIL (Batch number unknown) and later on she received a dose of PANDEMRIX H1N1 (Batch number unknown) on 24-NOV-2009. She also received a second dose of GARDASIL (Batch number unknown) on 06-JAN-2010, but this was not coded as suspected from health authority. Health authority coded adverse experiences meningoencephalitis (onset on April 2010) and status epilepticus (onset on 06-APR-2010). The girl developed meningoencephalitis with status epilepticus about a half year after the first dose of GARDASIL, 5 months post vaccine PANDEMRIX H1N1 and 3 months after second dose of GARDASIL. The girl received penicillin (date, dose of manufacturer not reported) in April 2010. Medical history of the patient included recurrent tonsillitis (with positive test for Streptococcus) and recurrent upper respiratory tract infections. Health authority assessed that the causal relationship with vaccines was unlikely. At the time of reporting, the outcome was recovered. Health authority considered the meningoencephalitis and status epilepticus to be immediately life-threatening. Other business partner numbers include: E2010-07118. Additional information is not expected.

VAERS ID:411424 (history)  Vaccinated:2010-11-17
Age:13.0  Onset:2010-11-18, Days after vaccination: 1
Gender:Female  Submitted:2010-12-02, Days after onset: 14
Location:Foreign  Entered:2010-12-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Flu
Preexisting Conditions: Epigastric pain
Diagnostic Lab Data: Diagnostic laboratory test, ??10, blood clotting was normal; Diagnostic laboratory test, ??10, transaminase values are decreasing; Diagnostic laboratory test, ??10, acute hepatitis; Total plasma bilirubin, ??10, high values; Plasma alanine aminotransferase test, 18Nov10, around 900; Plasma aspartate aminotransferase test, 18Nov10, around 500
CDC Split Type: WAES1011USA03052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Coagulation test normal, Hepatitis acute, Intensive care, Laboratory test abnormal, Thrombin time normal, Transaminases decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (narrow), Biliary system related investigations, signs and symptoms (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Case received from a physician on 19-NOV-2010. Case medically confirmed. A 13 year old female patient had received the third dose of GARDASIL (batch number, site of administration not reported) via intramuscular route on 17-NOV-2010. She experienced epigastralgy 30 minutes p-v. On 18-NOV-2010 she visited the emergency room and she was hospitalized. High transaminase analytical values (ALT around 900 and AST around 500) were reported. One week before the administration of the vaccine, the patient had flu and specific treatment with BEN-U-RON) and ibuprofen was administered during 5 days. The patient was transferred to a paediatric hospital and the blood clotting was normal, bilirubin still has high values, transaminase values are decreasing. The pain had relieved with administration of "CETROLAC". Outcome: still occurring. Follow up information received on 24-NOV-2010: The hospital was contacted on 24-NOV-2010 and had informed that the patient was transferred from the ICU to the gastroenterology unit. On 25-NOV-2010, the gastroenterology unit and the doctor had specified that the patient was discharged from the hospital on 23-NOV-2010 and her condition was improving. According to the physician, the epigastralgy experienced by the patient 30 minutes p-v, was not linked to the administration of the vaccine, since the patient had had the same symptoms 1 month before the administration of the third dose of the vaccine and she had no problem after the administration of the previous doses. The results of the analytical tests showed that the patient had an acute hepatitis probably linked to the administration of azithromycin and not linked to the administration of GARDASIL. Other business partner numbers include E2010-07217. More information is expected next week after the patient visit the doctor on 30-NOV-2010. At the time of the report, the patient was recovering.

VAERS ID:411654 (history)  Vaccinated:2010-10-05
Age:13.0  Onset:2010-10-06, Days after vaccination: 1
Gender:Female  Submitted:2010-12-03, Days after onset: 58
Location:Foreign  Entered:2010-12-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Nocturnal enuresis; Constipation; Abdominal pain; glue ear; Nasal congestion; Eosinophilia; Overactive bladder
Diagnostic Lab Data: hospital observation; 14Oct10; No toxemia, no meningism, no collapse; abdominal computed axial tomography; 14Oct10; normal; abdominal ultrasound; 14Oct10; Echo abdominal: normal; X-ray; 14Oct10;Rx Thorax: normal; urological examination; 14Oct10; urogenital: normal; pulmonary function test; 14Oct10; Lung: normal; dental examination; 14Oct10; one small hole; physical examination; 14Oct10; Abdominal pain: between navel and symphysis, not peritoneal; ophthalmological exam; 14Oct10; ophtalmo: normal; ears, nose, and throat examination; 14Oct10; ENT: normal; dermatological examination; 14Oct10; Dermato: normal; WBC count; 22Mar10; 11.380; eosinophil count; 22Mar10; 11%; WBC count; 11Oct10; 29.8; eosinophil count; 11Oct10; 37%; WBC count; 13Oct10
CDC Split Type: WAES1011USA03331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Biopsy bone marrow, Chest X-ray, Computerised tomogram abdomen abnormal, Condition aggravated, Culture stool, Dental examination abnormal, Dermatologic examination normal, Ear, nose and throat examination normal, Echography normal, Eosinophil percentage increased, Eosinophilia, Leukocytosis, Lymphadenitis, Ophthalmological examination normal, Peritoneal disorder, Pulmonary function test normal, Sleep disorder, Ultrasound abdomen normal, Urological examination normal, White blood cell count increased, X-ray normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Serious case received from the health authorities on 22-NOV-2010. Case medically confirmed. case reported as serious by the health authorities. The primary reporter had reported the case as serious. A 13-year-old female patient with a medical history of mentioned "correct" general condition (sic) and no dependence. The patient had presented with nocturnal enuresis till 10 year because of overactive bladder. In March 2010, she had had constipation due to diet issue (no vegetables/fruit) and had presented with abdominal pain for which DICLOFENAC 2x25mg was given for 3 days. Eosinophilia which was minimally present about 7 months before. In September 2010, she had had serous otitis and congested nose treated with DAFALGAN with or without NUROFEN. The patient was frequently on holiday in another country. It was also mentioned that the patient''s mother had a history of hay fever. On 05-OCT-2010 she had received a dose of GARDASIL (Lot and batch# not reported). She experienced abdominal pain and increasing leukocytosis with clear eosinophilia and mesenteric lymph glands. On 06-OCT-2010, the patient developed progressive "++" abdominal pain and had mild peritoneal irritation. She did not have fever. Her night sleep was disturbed by pain. Menses were unclear. No medication was prescribed. Laboratory test were performed included: On 22-MAR-2010: white blood cells: 11.380 Eosinophiles 11%. On 11-OCT-2010: white blood cells: 29.8 (eosinophiles: 37%). On 13-OCT-2010: white blood cells: 30.58 (eosinophiles: 53.2%). On 14-OCT-2010, the patient was in observation at the hospital. No toxemia, no neningism, no collapse was observed. Abdominal computed axial tomography showed increased mesenteric glands. Abdominal pain was found between navel and symphysis, not peritoneal. Rx thorax and Echo abdomen were normal. Dermatological, urogenital and ophthalmological examinations were normal. Lungs were normal. Dentist examination found one small hole. Ears, nose, and throat examination was normal. Bone marrow examination and coproculture. These tests were mentioned without results. It was specified that the adverse event was in evolution. Treatment: expectatio armata. The health care professional wondered about the influence of the vaccination on eosinophilia which was minimally present about 7 months before and escalated in October in such a way that hospital admission was needed. Other business partner numbers include: E2010-07211. No further information is available.

VAERS ID:411900 (history)  Vaccinated:2010-11-15
Age:13.0  Onset:2010-11-15, Days after vaccination: 0
Gender:Female  Submitted:2010-12-06, Days after onset: 21
Location:Foreign  Entered:2010-12-07, 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: Chronic headaches
Preexisting Conditions: Arteriovenous malformation; Convulsion
Diagnostic Lab Data: Blood pressure measurement, 15Nov10, 11/60; Total heartbeat count, 15Nov10, 64 bpm; Respiratory rate measurement, 15Nov10, 12 /min
CDC Split Type: WAES1011USA03488
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Feeling abnormal, Headache, Hypoaesthesia, Migraine, Nausea, Photophobia, Pulse pressure decreased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Information has been received from a Health Authority on 23-NOV-2010 under the reference number 2010-000792. This case is medically confirmed. A 13 year old female patient with a medical history of convulsion, arteriovenous malformation and a headache experienced migraine, felt faint, lifeless, nauseated, numbness, weak pulse and photophobia after she received a dose of GARDASIL (batch number NM31130; lot number: NK25010) intramuscularly, site not reported on 15-NOV-2010. The patient had a history of arteriovenous malfonnation, a seizure activity three months ago, which is under investigation and chronic headaches which are also under investigation. She experienced no adverse reaction to her first dose of GARDASIL. On 15-NOV-2010, a few minutes post vaccination, the patient complained of a severe headache, was faint-like and lifeless. Her blood pressure was reported as 11/60, pulse 64 bpm and respiration rate 12/min. On lying down the patient improved slightly. On standing and walking she became very faint-like, dizzy, nauseated and complained of a worsening headache with numbness in her hands and feet. The patient also experienced photophobia and power 3/5 of all four limbs and reflexes were present. The patient was transferred to a day ward for observation. She was discharged home later with a diagnosis of severe migraine. Patient''s outcome had not been reported. The report is considered for other medically significant condition requiring intervention. Following internal review the onset date of severe headache was amended from 15-OCT-2010 TO 15-NOV2010. Other business partner numbers include: E2010-07280.

VAERS ID:412916 (history)  Vaccinated:2009-03-06
Age:13.0  Onset:2009-03-19, Days after vaccination: 13
Gender:Female  Submitted:2010-12-09, Days after onset: 630
Location:Foreign  Entered:2010-12-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0571031A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA059BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Dizziness, Hyperventilation, Hypotonia, Influenza like illness, Pain, Syncope, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (# NL-LRB-86540) and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history and no concomitant medication. On 19 March 2009, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). On 19 March 2009, less than one day after vaccination with CERVARIX, the subject experienced localized pain, unconscious partial, hypotonia and dizziness. One day after vaccination, the subject experienced syncope. And 2 days after vaccination, she developed upper respiratory infection. The subject was hospitalized for observation. Some tests were performed and the results were pending. After discharge, she developed considerable flu-like symptoms. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. Follow up information on 11 June 2009: The lot number of vaccine was provided. No further information could be obtained from the Regulatory Authority; therefore the case has been closed. Follow up information received on 2 December 2010: This case was reported by a regulatory authority (# NL-LRB-111553). On 6 March 2009, the subject received 1st dose of CERVARIX. On 19 March 2009, 13 days after vaccination with CERVARIX, the subject experienced syncope, unconscious partial, localized pain, hypotonia and dizziness. One month after discharge, the subject was still experiencing dizziness. Pediatrician suspected hyperventilation for which breathing therapy was suggested.

VAERS ID:412950 (history)  Vaccinated:2010-11-17
Age:13.0  Onset:2010-11-17, Days after vaccination: 0
Gender:Female  Submitted:2010-12-15, Days after onset: 28
Location:Foreign  Entered:2010-12-16, 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:
Preexisting Conditions: Migraine
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA01338
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Flushing, Headache
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a Health Authority (reference # 2010-000962) concerning a 13 year old female patient with a history of migraine and no concomitant medication who on 17-NOV-2010, was vaccinated IM with the second dose of GARDASIL (Lot # NK25010, Batch # NM11420) (site not reported) and later the same day, the patient experienced a severe headache and facial flushing. This case was medically confirmed. The headache lasted for three to four hours and the facial flushing for nine to ten hours. The patient received corrective treatment with NUROFEN and PANADOL. At the time of reporting, the patient was recovered. The agency considered the events to be due to other medically condition which required intervention. Other business partner numbers include E2010-07595. Additional information is not expected.

VAERS ID:413011 (history)  Vaccinated:2010-11-27
Age:13.0  Onset:2010-11-27, Days after vaccination: 0
Gender:Female  Submitted:2010-12-17, Days after onset: 20
Location:Foreign  Entered:2010-12-17
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: Blood pressure, 27Nov2010, 116/80mmHg; C-reactive protein, 27Nov2010, 0; Eosinophils, 27Nov2010, 3%; Haematocrit, 27Nov2010, 38.4%; Haemoglobin, 27Nov2010, 12.8g/dL; Lymphocytes, 27Nov2010, 17%; Monocytes, 27Nov2010, 2%; Neutrophils, 27Nov2010, 78%; Platelet count, 27Nov2010, 17.1 x10^4/mm3; Red blood cell count, 27Nov2010, 449x10^4/mm3; White blood cells, 27Nov2010, 7600cells/mm3
CDC Split Type: B0689215A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Adverse reaction, C-reactive protein normal, Chills, Eosinophil percentage, Feeling abnormal, Haematocrit normal, Haemoglobin normal, Headache, Lymphocyte percentage decreased, Monocyte percentage, Neutrophil percentage increased, Pallor, Peripheral coldness, Platelet count decreased, Red blood cell count, Shock, White blood cell count normal
SMQs:, Anaphylactic reaction (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Dystonia (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock like symptom in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination included CERVARIX GlaxoSmithKline intramuscular given on 30 October 2010. She had nothing particular. On 27 November 2010 the subject received 2nd dose of CERVARIX (.5 ml, intramuscular). On 27 November 2010, 20 minutes after vaccination with CERVARIX, the subject experienced unusual reaction. Immediately after arriving home, she started to complaint of strange feeling and was brought back to hospital. The subject experienced shock like symptom, cold extremities, facial pallor and chills, shivering. The physician considered the events were clinically significant (or requiring intervention). Relevant test results included on 27 November 2010 blood pressure 116/80 mmHg, eosinophils 3%, hematocrit 38.4%, hemoglobin 12.8 g/dl, lymphocytes 17%, monocytes 2%, neutrophils 78%, platelets count 17.1x 10^4/mm3, red blood cell count 449 x 10^4/mm3, white blood cells 7600 cells/mm3. The subject was treated with strong neo minophagen C 20 ml and intravenous drip infusion of fluid 200ml were provided. In approximately 30 min she was able to respond. But she complaint of headache and was unable to walk. She spent another 1 hour at hospital for follow-up observation and then went home. At the time of reporting shock like symptoms improved and the outcome for the rest of the events was unspecified. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:413043 (history)  Vaccinated:2010-09-21
Age:13.0  Onset:2010-09-22, Days after vaccination: 1
Gender:Female  Submitted:2010-12-16, Days after onset: 85
Location:Foreign  Entered:2010-12-17, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA02096
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250100IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was received from health authority on 09-DEC-2010 under the reference number 2010-001195. This case was medically confirmed. A 13 year old female patient with an unreported medical history and non concomitant medication received the first dose of GARDASIL (batch number NM11420, lot number NK25010) on 21-SEP-2010 and on 22-SEP-2010, 24 hours later, the patient experienced an urticarial rash and severe whole body itch. The patient received corrective treatment with ZIRTEK 10 mg. The event lasted for two days. At the time of reporting, the patient has recovered. The agency considered the events were serious due to other medically important condition which required intervention. Other business partner numbers include E2010-07723. No further information is available.

VAERS ID:413363 (history)  Vaccinated:2010-10-22
Age:13.0  Onset:2010-10-23, Days after vaccination: 1
Gender:Female  Submitted:2010-12-21, Days after onset: 59
Location:Foreign  Entered:2010-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0689905A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA074BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Intensive care, Platelet count decreased, Platelet transfusion, Rash
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of idiopathic thrombocytopenic purpura in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 October 2010 the subject received unspecified dose of CERVARIX (unknown). On 23 October 2010, 1 day after vaccination with CERVARIX, the subject was brought to the intensive care unit due to rash lasting till 05 October 2010. The diagnosis of idiopathic thrombocytopenic purpura and platelets decreased was made on 24 September 2010. The subject was hospitalised. The subject was treated with hydrocortisone (intravenous), immunoglobulin (intravenous) and 4 pints of platelets transfusion. At the time of reporting the events were resolved.

VAERS ID:413364 (history)  Vaccinated:2010-07-05
Age:13.0  Onset:2010-07-07, Days after vaccination: 2
Gender:Female  Submitted:2010-12-21, Days after onset: 167
Location:Foreign  Entered:2010-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0689253A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Proteinuria, Pruritus, Rash, Upper respiratory tract infection
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: This case was reported by a sales representative and described the occurrence of rash in a 13-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 5 July 2010 the subject received unspecified dose of ENGERIX B (intramuscular), lot number not provided. On 7 July 2010, 2 days after vaccination with ENGERIX B, the subject experienced rash and itching. At unspecified time the subject had proteinuria and upper respiratory tract infection. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The sales representative reported that rash and itching were possibly related to vaccination with ENGERIX B. Proteinuria and upper respiratory tract infection were unrelated to vaccination with ENGERIX B.

VAERS ID:413441 (history)  Vaccinated:2010-09-28
Age:13.0  Onset:2010-09-29, Days after vaccination: 1
Gender:Female  Submitted:2010-12-20, Days after onset: 82
Location:Foreign  Entered:2010-12-22, Days after submission: 2
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA02095
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250100IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis allergic, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was received by the Health Authority on 09-DEC-2010 under the reference number 2010-001211. This case is medically confirmed. A 13 year old female patient with no medical history and no concomitant received the first dose of GARDASIL (batch # NM31130, lot # NK25010) intramuscularly, site not reported on 28-SEP-2010. 24 hour later on 29-SEP-2010, the patient experienced an allergic type skin reaction with urticaria and was itchy. The patient received corrective treatment with cortrophin 1% cream. The events persisted for six days. At the time of reporting, the patient has recovered on 06-OCT-2010. The agency considered the events to be serious for other medically important condition which required intervention. The patient was due for second dose on 30-NOV-2010 when the reaction was reported. The second dose was deferred whilst the reporter was awaiting guidelines. Other business partner numbers include E2010-07720.

VAERS ID:413569 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2010-12-23
Location:Foreign  Entered:2010-12-27, Days after submission: 4
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03528
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Cough, Nervousness, Pruritus generalised
SMQs:, Anaphylactic reaction (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a female nurse concerning a 13 year old female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (lot# not reported). The nurse stated that within half an hour of receiving the vaccine the patient was very, very anxious, she felt she was itchy all over but she did not have a rash and had a bit of cough. So as a precaution an epipen was given. The nurse who gave the shot said that the girl was very anxious and nervous. The patient only got 2 doses instead of the recommended 3. At the time of the report, the patient''s outcome was unknown. The relation ship between bit of cough, felt she was itchy all over but did not have a rash, nervous, very anxious and GARDASIL was unknown. Upon internal review, cough, felt she was itchy all over but did not have a rash, nervous, and very anxious were determined to be an other important medical event due to the patient was treated with an epipen. This is one of several reports received from the same source. No further information is available.

VAERS ID:413695 (history)  Vaccinated:2010-10-05
Age:13.0  Onset:2010-10-18, Days after vaccination: 13
Gender:Female  Submitted:2010-12-28, Days after onset: 71
Location:Foreign  Entered:2010-12-29, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03369
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250100IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)
Write-up: Information has been received from a Health Authority on 16-DEC-2010, reference 2010-001387. This case was medically confirmed. A 13 year old female patient who was not taking any concomitant medications and had no medical history or concurrent conditions and no risk factors available, received the first dose of GARDASIL (Batch # NM31130, Lot # NK25010), on 05-OCT-2010, 0.5 mL, intramuscularly. On 18-OCT-2010, thirteen days post vaccination, the patient experienced right lower limb deep vein thrombosis and bilateral pulmonary embolism. Corrective treatment included anticoagulation therapy. At the time of reporting the patient outcome was unknown. The health authority considered the case to be serious as an other medically important condition that required intervention. Other business partner numbers included E2010-07881. No further information is available.

VAERS ID:413696 (history)  Vaccinated:2010-09-22
Age:13.0  Onset:2010-09-22, Days after vaccination: 0
Gender:Female  Submitted:2010-12-28, Days after onset: 97
Location:Foreign  Entered:2010-12-29, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Body temp, 22Sep10, 102 degree F, 14:00
CDC Split Type: WAES1012USA02810
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1334X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Body temperature increased, Headache, Lethargy, Local reaction
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from the Health Authority (IMB ref 2010-001219). This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication and risk factors not available, received the first dose of GARDASIL (lot number 1334X, batch number NL31810) IM on 22-SEP-2010, ten minutes post vaccination, the patient experienced severe lethargy and headache and was observed for an extended period in the recovery area. The patient did not require any treatment in the recovery area but was very weak and had to be assisted to her mother''s car. Soon after arriving home at approximately 14:00 the patient''s mother checked her temperature which was 102 degrees F. The headache and the lethargy persisted and the patient slept almost continually until the next morning. There were no other symptoms of intercurrent illness. By the next morning the patient had developed a severe local reaction extending from the top of her shoulder to halfway down her upper arm. Corrective treatment administered was analgesics. The patient recovered on an unreported date. The events were considered medically important as they required intervention. Upon internal review the event of raised temperature was coded. This term was mentioned in the narrative but not coded. Other business partner numbers include: E2010-07841. No further information is available.

VAERS ID:413727 (history)  Vaccinated:2010-05-26
Age:13.0  Onset:2010-05-26, Days after vaccination: 0
Gender:Female  Submitted:2010-12-29, Days after onset: 217
Location:Foreign  Entered:2010-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0069816A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA019CI2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bone pain, Central nervous system lymphoma, Cervix neoplasm, Mediastinum neoplasm, Myalgia, Non-Hodgkin's lymphoma, Pain, Paresis
SMQs:, Rhabdomyolysis/myopathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteonecrosis (broad), Malignant tumours (narrow), Tumours of unspecified malignancy (narrow), Uterine and fallopian tube tumours of unspecified malignancy (narrow), Malignant lymphomas (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of complicated Non-Hodgkin''s lymphoma in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Former vaccinations included CERVARIX on 16 April and 18 May 2009. On 26 May 2010 the subject received 3rd dose of CERVARIX (unknown route and application site). On 26 May 2010, less than one day after vaccination with CERVARIX, the subject experienced neck myalgia and pain in cervical spine. On 14 June 2010 the subject had severe pain in cervical spine. The subject was hospitalised on 07 July 2010 with severe pain and increasing paresis of the right arm. On 13 July 2010 the subject was transferred to another unit with the diagnosis of metastinal and cervical tumour. After further diagnostics the subject was diagnosed with complicated Non-Hodgkin''s lymphoma with affecting the central nervous system and infiltrating the cerebral membrane. At the time of reporting the outcome of the events was unspecified. The subject''s father, who is a microbiologist was convinced the event was caused by vaccination with CERVARIX. Follow-up information has been requested.

VAERS ID:413745 (history)  Vaccinated:2010-12-06
Age:13.0  Onset:2010-12-06, Days after vaccination: 0
Gender:Female  Submitted:2010-12-29, Days after onset: 23
Location:Foreign  Entered:2010-12-30, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA02813
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK44350 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oropharyngeal pain, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from the Health Authority (HA), reference 2010-001362. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medications and no available data or risk factors, received GARDASIL batch number NN01990, lot number NK44350, 0.5 ml intramuscularly on 06-DEC-2010. Fifteen to thirteen minutes post vaccination, the patient experienced a sore throat and a swollen tongue that persisted for two to three hours. Corrective treatment included chlorphenamine (G). The patient went home with her parents after three hours and went back to school the next day, the patient was recovered at the time of reporting. The IMB considered the case to be serious and an other important medically important condition because the event required intervention. Other business partner numbers include: E2010-07854. No further information is available.

VAERS ID:413746 (history)  Vaccinated:2010-10-13
Age:13.0  Onset:2010-10-14, Days after vaccination: 1
Gender:Female  Submitted:2010-12-29, Days after onset: 76
Location:Foreign  Entered:2010-12-30, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03553
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.MN395102IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (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)
Write-up: Case received from Health Authority on 17-DEC-2010, reference number C201012-479. Case medically confirmed. A 13 year old female patient had experienced two episodes of faint and excessive somnolence after the administration of the third dose of GARDASIL (batch n. MN39510, site of administration not reported) 0.5mL, 1 unit, indicated against papillomavirus, via intramuscular route on 13-OCT-2010. The two episodes had occurred 16 hours after vaccination and the patient had quickly recovered consciousness. One hour after the faint episodes, the patient was observed in the primary care unit and the regular clinical observation showed a normal result. During the day after the vaccination, the patient experienced excessive somnolence. The patient had completely recovered from the adverse event on the second day. Unknown previous adverse reactions to the suspected drug or to any other drugs. Case is closed. No further information is available. Other business partner numbers include E2010-07950.

VAERS ID:413748 (history)  Vaccinated:2010-11-16
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2010-12-29
Location:Foreign  Entered:2010-12-30, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03705
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM311301IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site induration, Injection site reaction, Local reaction, Pain in extremity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was received from the health authority on 21-DEC-2010. Company ref 2010-001391. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication and no risk factors available, received the second dose of GARDASIL (batch number: NM31130) IM 0.5 ml on 16-NOV-2010. On an unreported date post vaccination, the patient experienced local reaction, muscle at site got hard, painful arm, red spots and urticaria/wheals on upper arm. Corrective treatment included ibuprofen and acetaminophen. At the time of reporting the patient''s outcome was unknown. The event was considered serious as it was medically important. Other business partner numbers include E2010-07979.

VAERS ID:413891 (history)  Vaccinated:2010-11-16
Age:13.0  Onset:2010-11-16, Days after vaccination: 0
Gender:Female  Submitted:2010-12-30, Days after onset: 44
Location:Foreign  Entered:2011-01-03, Days after submission: 4
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03717
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Lethargy, Malaise, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by the Health Authority on 22-DEC-2010, reference number 2010-001532. This case is medically confirmed. A 13 year old female patient with unknown medical history and no concomitant medication, received GARDASIL (lot number NK25010, batch number NM31130) intramuscularly, dose 2 on 16-NOV-2010. On the same day post vaccination, the patient experienced feeling sick and that evening lost feeling in her left arm and developed a high temperature and vomiting and lethargy. The patient was seen in the evening by the doctor, no corrective treatment was given by the general practitioner. The duration of the reaction was approximately 12 hours. At the time of reporting, the patient outcome was unknown. The company considered the case to be serious as an other medically important condition with required intervention. No further information is available.

VAERS ID:413893 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2010-12-30
Location:Foreign  Entered:2011-01-03, Days after submission: 4
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03711
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK25010 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Pallor, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from the health authority on 22-DEC-2010, reference 2010-01436. This case is medically confirmed. A 13 year old female patient with unknown medical history and risk factors not available and no concomitant medication received an injection of IM GARDASIL (batch # NM31130, lot # NK25010) on an unreported date. On an unreported date, post vaccination, the patient complained of feeling faint associated with blurred vision and poor colour. The patient was placed lying down and allowed to recover slowly. Her observations were stable and she was observed in recovery for one hour. The patient was discharged with her friends. The final patient outcome was not reported. The events were considered medically important as they required intervention. Other business partner numbers include E2010-7997.

VAERS ID:413894 (history)  Vaccinated:2010-09-29
Age:13.0  Onset:2010-09-29, Days after vaccination: 0
Gender:Female  Submitted:2010-12-30, Days after onset: 92
Location:Foreign  Entered:2011-01-03, Days after submission: 4
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: None
Diagnostic Lab Data: Blood pressure measurement, 29Sep10, 94/65, at 11:30 am; Total heartbeat count, 29Sep10, 68 bpm, at 11:30 am
CDC Split Type: WAES1012USA03702
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK25010 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depressed level of consciousness, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: The case was received from the health authority on 21-DEC-2010. Agency ref 2010-001514. This case is medically confirmed. A 13 year old female patient with no medical history had no risk factors available and no concomitant medication received an injection of GARDASIL (batch number: NM11420; lot number: NK25010) 0.5mL IM in the left deltoid on 29-SEP-2010. On 29-SEP-2010, ten minutes post vaccination, the patient experienced a vasovagal reaction and a momentary consciousness decreased. The patient was observed sliding from the chair and was assisted to the floor. Her feet were elevated. The patient''s blood pressure was 94/65 and pulse 68 bpm at 11:30 am. The patient recovered within 20 seconds. The event was considered serious as it was medically important and required intervention. Other business partner numbers include E2010-07975.

VAERS ID:413902 (history)  Vaccinated:2010-11-29
Age:13.0  Onset:2010-12-03, Days after vaccination: 4
Gender:Female  Submitted:2010-12-30, Days after onset: 27
Location:Foreign  Entered:2011-01-03, Days after submission: 4
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1012USA03700
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK443501IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Grand mal 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: Information has been received from the health authority on 22-DEC-2010, reference 2010-001525. This case is medically confirmed. A 13 year old female who had no underlying conditions and was a healthy young girl with no concomitant medications received the second dose of GARDASIL (batch # NN01990, lot # NK44350), intramuscularly on 29-NOV-2010. On 03-DEC-2010 4 days post vaccination, the patient experienced a grand mal seizure lasting 3 minutes. The patient was given first aid and admitted to hospital overnight, at the time of reporting to the health authority the patient was recovered. The health authority considered the case to be serious as an other medically important condition that required intervention. Other business partner numbers include E2010-08006.

VAERS ID:414122 (history)  Vaccinated:2010-12-07
Age:13.0  Onset:2010-12-09, Days after vaccination: 2
Gender:Female  Submitted:2011-01-05, Days after onset: 27
Location:Foreign  Entered:2011-01-05
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: B0691860A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB482F IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERE46273 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Motor dysfunction, Nuchal rigidity, Oropharyngeal pain, Paralysis flaccid
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a regulatory authority (130722) and described the occurrence of flaccid paralysis in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), MENINGITEC. Previous vaccinations (NOS) had been uneventful. The patient did not receive other vaccines or drugs during the previous month. On 7 December 2010 the subject received unspecified dose of HAVRIX (intramuscular, unknown), unspecified dose of MENINGITEC (intramuscular, unknown). On 9 December 2010, 2 days after vaccination with HAVRIX and MENINGITEC, the subject experienced flaccid paralysis of the left hemisoma and motor deficiency. On 19 December 2010, she experienced intermittent headache, nuchal rigidity and pharyngodynia. The regulatory authority reported that the events were disabling. The subject was treated with antibiotics, anti-inflammatory and hydrocortisone. At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX and MENINGITEC.

VAERS ID:414369 (history)  Vaccinated:2010-10-05
Age:13.0  Onset:2010-10-05, Days after vaccination: 0
Gender:Male  Submitted:2011-01-07, Days after onset: 94
Location:Foreign  Entered:2011-01-10, Days after submission: 3
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: Not reported
Diagnostic Lab Data:
CDC Split Type: 201100006
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3244AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphonia, Eye pruritus, Hypoaesthesia facial, Malaise, Ocular hyperaemia, Paraesthesia, Pruritus, Swollen tongue, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Hypersensitivity (narrow)
Write-up: A line listing of 16 cases was received on 31 December 2010 from a physician at the Public Health Agency in response to a follow-up request for additional information concerning a report of some cases of anaphylaxis following the administration of ADACEL (lot number C3244AA). The line listing contained 16 cases of anaphylaxis following the administration of ADACEL (various lot numbers). ADACEL had been administered between 2002 and 2010, in unspecified provinces. The reference number for this case is V1006996 and it had been reported by a nurse. A 13 year old male patient, whose medical history was not reported, received a left arm intramuscular 0.5 ml injection of ADACEL (lot number C3244AA) on 05 October 2010. After 15 minutes, the patient returned to class and reported to his teacher "the shot made me sick". Thirty minutes after vaccination, the patient was assessed by the nurse and presented the following: generalized hives, itchiness (without rash), red itchy eyes, upper airway swelling (tongue), numbness/tingling on the right side of the face. The patient was given one intramuscular dose of epinephrine (0.5 ml 1:1000). His pulse was 96 and respiration was 24. Symptoms progressed to include hoarse voice and sensation of throat closure. A second intramuscular dose of epinephrine (0.5 ml 1:1000) was administered. His pulse was 128 and respiration was 32. The patient expressed relief of sensation of throat closure soon after the second dose. The patient was then transported to the emergency room by paramedics. The patient was assessed and later sent home for observation. There was no recurrence of the reaction in the 24 hours post-immunization. The patient fully recovered. The other 15 cases in the line listing are captured in cases 2010-07027, 2011-00002 through 2011-00005, and 2011-00007 through 2011-00016.

VAERS ID:414409 (history)  Vaccinated:2010-10-13
Age:13.0  Onset:2010-10-13, Days after vaccination: 0
Gender:Female  Submitted:2011-01-07, Days after onset: 86
Location:Foreign  Entered:2011-01-10, Days after submission: 3
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: Not reported.
Diagnostic Lab Data:
CDC Split Type: 201100003
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3244AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Nausea, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: A line listing of 16 cases was received on 31 December 2010 from a physician at the Public Health Agency in response to a follow-up request for additional information concerning a report of some cases of anaphylaxis following the administration of ADACEL (lot number C3244AA). The line listing contained 16 cases of anaphylaxis following the administration of ADACEL (various lot numbers). ADACEL had been administered between 2002 and 2010, in unspecified provinces. The reference number for this case is V1006975 and it had been reported by a nurse. A 13 year old female patient, whose medical history was not reported, received a left arm intramuscular 0.5 ml injection of ADACEL (lot number C3244AA) on 13 October 2010. Fifteen minutes after vaccination, the patient became lightheaded, nauseated, and shaking. Thirty minutes later, she began to complain of being short of breath and having difficulties breathing. Epinephrine given and she was transferred to emergency via ambulance. The duration of the events was two hours. The patient fully recovered. The other 15 cases in the line listing are captured in cases 2010-07027, 2010-00002, and 2011-00004 through 2011-00016.

VAERS ID:414546 (history)  Vaccinated:2008-09-01
Age:13.0  Onset:2008-09-01, Days after vaccination: 0
Gender:Female  Submitted:2011-01-12, Days after onset: 863
Location:Foreign  Entered:2011-01-12
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: B0588850A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Laboratory test normal, Lethargy, Local reaction, Myalgia, Nausea, Walking aid user, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the Foreign regulatory authority and described the occurrence of joint pain in a 13-year-old female patient who received CERVARIX (GlaxoSmithKline). Concurrent vaccination included 2 doses of CERVARIX (GlaxoSmithKline) given in November 2008 and March 2009. In September 2008 the subject was vaccinated with CERVARIX. In September 2008, the subject experienced joint pain, muscle pain, lethargy, nausea, weakness and local reaction. The regulatory authority reported that the events were disabling as the subject was using crutches and a wheel chair and was not attending school. Numerous tests were unremarkable. At the time of reporting, the events were unresolved and the subject was being referred to a tertiary centre. Patient experienced general joint and muscular aches, severe lethargy, nausea, weakness and local arm reaction. Numerous tests back as unremarkable. Being referred to tertiary centre. Involved persistent or significant disability or incapacity: Currently requiring crutches and wheel chair. Not attending school etc. B0588850A is a duplicate of B0573288. All future correspondence will be submitted to B0573288A.

VAERS ID:414547 (history)  Vaccinated:2008-09-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-01-12
Location:Foreign  Entered:2011-01-12
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: Asthma; No known allergies. No history of eczema or psoriasis. No family history of juvenile idiopathic arthritis or other forms of arthritis or connective tissue disease. Patient denies any other symptoms such as inflammatory bowel disease.
Diagnostic Lab Data: Blood pressure, 136/74; Blood test, normal; C-reactive protein, Normal; Calcium, Normal; Creatine kinase, Normal; Erythrocyte sedimentation rate, Normal; Full blood count, Normal; Glucose normal, Normal; Heart rate, 91bpm; Liver function test, Normal; Neurological examination, normal; Oxygen saturation, 97%; Rheumatoid factor, Normal; Thyroid function test, Normal. On examination appeared well, rather tall but no Marfanoid features or other connective tissue disease signs. She has normal respiratory, cardiovascular system and abdominal examination. Neurological examination: normal range of the cervical spine, shoulders, elbow, wrist, hip, knee joints and ankles. However, there was some tenderness on both knees with some mild degree of sublu
CDC Split Type: B0573288A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA021BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Blood calcium normal, Blood creatine phosphokinase normal, Blood electrolytes normal, Blood glucose normal, Blood test normal, Blood urea normal, C-reactive protein normal, Chronic fatigue syndrome, Fatigue, Full blood count normal, Gait disturbance, Headache, Immunology test normal, Joint dislocation, Lethargy, Liver function test normal, Local reaction, Malaise, Myalgia, Nausea, Neurological examination normal, Oedema peripheral, Pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Tenderness, Thyroid function test normal, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the agency (GB-MHRA-ADR 20422703) and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX. Concurrent medications included SALBUTAMOL and SERETIDE. On an unknown date in September 2008 the subject received unspecified dose of CERVARIX (intramuscular). Approximately few week after vaccination with CERVARIX, the subject experienced headache, joint pain and walking difficulty. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. Joint pain, headache and they unable to walk upstairs. Started a few weeks after first injection and is ongoing. Two further doses of CERVARIX given 2 and 6 months after first dose. Usually plays tournament tennis but has been unable to do so. Follow up received on 26 August 2009: The subject''s medical history included asthma. Concurrent medications included BRUFEN. At an unspecified time after vaccination with CERVARIX, the subject also experienced generalized pain. Diagnostic details were updated. At the time of reporting the event; generalized pain was unresolved. Subsequent to first lot of new vaccine she started complaining of painful knees and was generally run down. Previously she was well and full of energy and very sporty. Her symptoms exacerbated further when she had her booster. She is now aching generally but mainly her knee joints but her symptoms vary in severity with days worse than others. She has missed a lot of school and over the last few months or so she has only attended 3 days, but she is now using crutches as an aid in order to help her walk and her knees are very painful. However, there have been no other features of arthropathy such as swelling of the joints and no associated fever, skin rash or sweating. Examination and blood tests were all normal. Follow-up information received on 28 August 2009: The subject experienced chronic fatigue syndrome on an unknown date. At the time of reporting the outcome of the event was unresolved. Follow-up information received on 05 January 2011: B0588850A is a duplicate of B0573288. All future correspondence will be submitted to B0573288A. The subject received 1st dose of CERVARIX in September 2008. Few weeks after receiving the 1st dose of CERVARIX, the subject experienced general joint and muscular aches, severe lethargy, nausea (September 2008), weakness, local reaction (September 2008), headache and the subject was unable to walk upstairs. It was reported that the events were ongoing. The subject received the 2nd dose of CERVARIX in November 2008. At an unknown time after receiving the second dose of CERVARIX the subject experienced arm swelling. Despite this the nurse gave a 3rd dose of CERVARIX to the subject in March 2009. At an unknown time after vaccination with the 3rd dose of CERVARIX, joint pains worsened and the subject experienced nausea, severe fatigue and chronic fatigue syndrome. It was reported that ''she will need graduated rest and activity program as some of these features may be related to her chronic fatigue but also a link between vaccine and arthralgia is really well established.

VAERS ID:414720 (history)  Vaccinated:2010-12-15
Age:13.0  Onset:2010-12-15, Days after vaccination: 0
Gender:Female  Submitted:2011-01-13, Days after onset: 29
Location:Foreign  Entered:2011-01-14, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA00667
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK44350 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dermatitis allergic, Pruritus, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from health authority on 04-JAN-2011, reference 2010-001610. This case is medically confirmed. A 13 year old female patient with no medical history and no concomitant medication received GARDASIL (batch # NN01990, lot # NK44350) intramuscularly on 15-DEC-2010. On the same date the patient experienced an allergic red rash and pruritis in both arm for 6 hours. Corrective treatment included PIRITON orally. At the same time of reporting the patient had recovered. The health authority considered the case to be serious and for other medically significant reasons. Other business partner numbers include E2010-00050.

VAERS ID:414929 (history)  Vaccinated:2010-10-01
Age:13.0  Onset:2010-10-01, Days after vaccination: 0
Gender:Female  Submitted:2011-01-14, Days after onset: 105
Location:Foreign  Entered:2011-01-18, Days after submission: 4
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA00663
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the health authority on 01-JAN-2011, reference 2010-001617. This case was medically confirmed. A 13 year old female patient with no medical history received the first dose of GARDASIL (batch number not reported) intramuscularly 0.5 ml in October 2010, exact date not reported. 1 week post vaccination the patient experienced a rash, headache and urticaria lasting for 10 days and the patient then recovered. Corrective treatment included generic steroids. The IMB considered the case to be serious for other medically significant reasons. Other business partner numbers include E2011-00051. No further information is available.

VAERS ID:415122 (history)  Vaccinated:2010-12-14
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-01-20
Location:Foreign  Entered:2011-01-20
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: B0694043A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNAR
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, Vaccination site haemorrhage, Vaccination site induration, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This case was reported by a physician and described the occurrence of injection site bleeding in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 October 2010, the subject received 1st dose of CERVARIX (unknown route of administration, given slightly lower than upper deltoid region, lot number not provided). On 14 December 2010 the subject received 2nd dose of CERVARIX (unknown route, unknown deltoid, lot number not provided). In 2010, at an unspecified time after vaccination with CERVARIX, the subject experienced vaccination site hemorrhage, vaccination site pain, vaccination site induration and incorrect route of drug administration. The physician considered the events were clinically significant (or requiring intervention). Injection site pain after 2nd vaccination lasted for 6 days, the outcome of the other events was unspecified.

VAERS ID:415149 (history)  Vaccinated:2010-12-29
Age:13.0  Onset:2010-12-29, Days after vaccination: 0
Gender:Unknown  Submitted:2011-01-21, Days after onset: 23
Location:Foreign  Entered:2011-01-21
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: Body temperature, 29Dec2010, 39.2deg.C
CDC Split Type: B0693349A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA020BO IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site extravasation, Injection site inflammation, Injection site oedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# PL-URPL-OCR-2011-0112006) and described the occurrence of injection site inflammation in a 13-year-old subject of unspecified gender who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 December 2010, the subject received unspecified dose of CERVARIX (intramuscular, injection site unknown). On 29 December 2010, less than one day after vaccination with CERVARIX, the subject experienced injection site inflammatory infiltration with edema (diameter 5x10 cm) and fever (39.2 deg. C). The regulatory authority reported that the events were clinically significant (or requiring intervention). The events lasted 4 days and at the time of reporting, they were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.

VAERS ID:415631 (history)  Vaccinated:2010-11-12
Age:13.0  Onset:2010-11-12, Days after vaccination: 0
Gender:Female  Submitted:2011-01-27, Days after onset: 76
Location:Foreign  Entered:2011-01-27
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: UNK
CDC Split Type: B0695553A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHAPVA088AE UNUN
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 reported by a regulatory authority and described the occurrence of fit (nos) in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 November 2010, at 10.30 am, the subject received an unspecified dose of CERVARIX (administration site and route unknown, batch number not provided). On 12 November 2010, at 4 pm, 6 hours after vaccination with CERVARIX, the subject experienced one episode of fit (nos). This case was assessed as medically serious by GSK. No treatment was given. At the time of reporting, the event was resolved. Follow-up information received on 24 January 2011: The batch number provided.

VAERS ID:415636 (history)  Vaccinated:2011-01-15
Age:13.0  Onset:2011-01-15, Days after vaccination: 0
Gender:Female  Submitted:2011-01-27, Days after onset: 12
Location:Foreign  Entered:2011-01-27
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: UNK
CDC Split Type: B0695318A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA100BB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Daydreaming, Depressed level of consciousness, Fall, Presyncope, Pulse absent
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 15 January 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 15 January 2011, approximately 1 minute after vaccination with CERVARIX, the subject experienced vasovagal reaction. She became absent-minded with decreased consciousness and finally fell down in the waiting room. The subject, however was able to respond, but her pulse was not palpable temporarily. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with SAXIZON. On 15 January 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:415836 (history)  Vaccinated:2010-09-27
Age:13.0  Onset:2010-09-27, Days after vaccination: 0
Gender:Female  Submitted:2011-01-27, Days after onset: 122
Location:Foreign  Entered:2011-01-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA02443
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK25010 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Headache, Influenza like illness
SMQs:, Guillain-Barre syndrome (broad)
Write-up: This case was reported by a Health Authority on 19-JAN-2011, reference 2011-001714, this case is medically confirmed. A 13 year old female patient who was not taking any concomitant medications received GARDASIL (lot # NK25010, batch # NM31130, 0.5ml intramuscularly on 27-SEP-2010. A few hours post vaccination on 27-SEP-2010 the patient experienced a headache, flu like symptoms and weakness. The patient received corrective treatment with paracetamol. At the time of reporting to the regulatory authority the patient had not yet recovered. The regulatory authority considered the case to be serious and other medically significant due to required intervention. Other business partner numbers included: E2011-00400. No further information is available.

VAERS ID:416033 (history)  Vaccinated:2010-10-27
Age:13.0  Onset:2010-12-21, Days after vaccination: 55
Gender:Female  Submitted:2011-02-01, Days after onset: 42
Location:Foreign  Entered:2011-02-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Vomiting; Abdominal pain; Hospitalisation
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA02693
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Similar reaction on previous exposure to drug, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was received from the health authority on 20-JAN-2011. IMB ref. 2011-001729 and 2011-001755. This case is medically confirmed. A 13 year old female patient received the second dose of GARDASIL (Batch # not reported) on 17-DEC-2010. On 21-DEC-2010, four days post vaccination, the patient experienced abdominal pain and vomiting. The patient had no significant medical history as well. There were no risk factors available. The patient received the first dose of GARDASIL (batch # not reported) on 27-Oct-2010 and three days post vaccination experienced abdominal pain and vomiting requiring hospital admission. Any corrective treatment and the patient outcome were unknown. The patient was hospitalized and treated with IV fluids ZOFRAN, morphine for pain (PRN) and BUSCOPAN PRN. At the time of the reporting, the patient had not recovered. Other business partner numbers include E2011-00432. No further information is available.

VAERS ID:416090 (history)  Vaccinated:2010-10-04
Age:13.0  Onset:2010-10-08, Days after vaccination: 4
Gender:Female  Submitted:2010-12-10, Days after onset: 63
Location:Foreign  Entered:2011-02-03, Days after submission: 55
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: Unknown
Diagnostic Lab Data: Serum multiallergen radioallergosorbent, 20Oct10, nothing abnormal detected; serum immunoglobulin E test, 20Oct10, nothing abnormal detected
CDC Split Type: WAES1011USA00288
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood immunoglobulin E normal, Hypersensitivity, Pruritus, Radioallergosorbent test negative, Skin reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was received from a physician. This case is medically confirmed. A 14 year old female patient born in 1996 with an unreported medical history and concomitant medications, received the first dose of GARDASIL (Batch# not reported), route and site not reported, three weeks prior to reporting in October 2010 and four days later experienced an allergic reaction with wheals and hives. The patient went to the hospital and received corrective treatment with PIRITON tablets and CHLORPHENAMINE injections. The patient recovered and there was no overnight stay. The physician arranged for an allergy test one week later and the results showed that the patient was allergic to nothing and the physician thought that the patient had a reaction to GARDASIL. The patient was not to continue with the course of GARDASIL. Follow up information received from the initial reporter on 02-DEC-2010. The patient was 13 year old (not 14 as initially reported). The patient had no history of note, no reaction to previous vaccines or drugs and was not taking any concomitant medication. The patient received the GARDASIL IM in the left arm on 04-OCT-2010. 08-OCT-2010, four days post vaccination, the patient experienced a skin reaction and allergy. The patient had hives and was itching ++. The patient was given antihistamines and steroids for five days and recovered on 12-OCT-2010. On 20-OCT-2010 the patient had IgE and radioallergosorbent (RAST) test both of which were nothing abnormal detected (NAD). The reporter stated that the events were moderate in severity, non-serious and probably caused by vaccination. Upon internal medical review the events were considered serious. Relevant Test/Laboratory Data on 20-OCT-2010: IgE - NAD, RAST - NAD. Other business partner numbers included: E2010-06543. No further information is available.

VAERS ID:416300 (history)  Vaccinated:2010-12-30
Age:13.0  Onset:2010-12-31, Days after vaccination: 1
Gender:Female  Submitted:2011-02-04, Days after onset: 35
Location:Foreign  Entered:2011-02-07, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported.
Diagnostic Lab Data:
CDC Split Type: E201100476
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURD0871 IMUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER080702 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Intensive care, Paralysis flaccid, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Case received from Health Authority (case n. 133048) (local case n. IT034/11). Initial report received on 25-JAN-11. Case medically confirmed. A 13 year old female patient was vaccinated on 30-DEC-10 with one dose of IMOVAX POLIO (batch n. D0871-7) i.m. and concomitantly with one dose of DIF-TET-ALL (Mfr. Novartis, batch n. 080702). On 31-DEC-10 she presented with persistent fever, the symptoms (NOS) worsened until flaccid paralysis of the limb with involvement of the cerebral trunk. She was admitted to the hospital in pediatrics and then transferred to neuro-intensive care. The duration and outcome were not reported. No further information is available. The case is closed.

VAERS ID:416358 (history)  Vaccinated:2010-11-22
Age:13.0  Onset:2010-11-22, Days after vaccination: 0
Gender:Female  Submitted:2011-02-07, Days after onset: 77
Location:Foreign  Entered:2011-02-08, 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: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Pulse oximetry, 22Nov10, 80, regular and strong.
CDC Split Type: WAES1102USA00153
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK44350 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Dizziness, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This case was received from a health authority on 27-JAN-2011. Agency ref 2011-001791. This case is medically confirmed. A 13 year old female patient with a medical history of being asthmatic and no risk factors available and with no concomitant medication received an IM 0.5 ml injection of GARDASIL (batch# NN01990; lot# NK44350) in the left deltoid on 22-NOV-2010, post vaccination, the patient experienced slight chest tightness, dizziness and nausea. No inhaler was used to treat the patient''s slight chest tightness. The patient was given a glucose drink and biscuit and was put lying on the mat with her legs elevated. The patient was seen by assistant medical officer (AMO) for the slight chest tightness. The patient''s color was normal, there was no distress, respiratory rate was normal, chest was clear and there was no wheeze. The patient''s pulse was 80 regular and strong. The patient was reassured and returned to class well. At the time of reporting the patient had recovered. The events were considered medically significant as they required intervention. Other business partner numbers included: E2011-00553. No further information is available.

VAERS ID:416362 (history)  Vaccinated:2010-11-16
Age:13.0  Onset:2011-01-17, Days after vaccination: 62
Gender:Female  Submitted:2011-02-07, Days after onset: 21
Location:Foreign  Entered:2011-02-08, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA02680
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250100UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Vaccine positive rechallenge
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician via phone concerning a female patient who on unspecified dates, was vaccinated with the first and the second dose of GARDASIL (lot# not reported) respectively. The patient got GARDASIL twice. After the administration of first vaccinate, the patient had allergic reaction in site of administration. After second vaccine administration the again moderate allergic reaction occurred, antihistamine therapy by orally was required. At the time of reporting, the outcome of the event was unknown. Follow-up information has been received from the physician via e-mail concerning the 13 year old female patient who on 17-JAN-2011 the patient was vaccinated with the second dose of GARDASIL (batch# NN4410). Concomitant therapy included DITHIADEN. After the administration of first vaccinate of GARDASIL (batch# NM10370), the patient had allergic reaction in site of administration - erythema of the skin in the administration site, after second vaccine administration - erythema of the skin (diameter about 10 cm) on 17-JAN-2011. No systemic allergic reaction occurred. On 20-JAN-2011, the patient was placed on therapy with ZODAC 10 mg once a day and triamcinolone cream for treatment of the local allergic reaction. All described symptoms disappeared in approximately 5 days on 22-JAN-2011. It was unspecified if the patient sought medical attention. The reporter considered that allergic reactions in site of administration were related to therapy with GARDASIL. The allergic reaction in site of administration was considered to be an other important medical event by the physician. No further information expected.

VAERS ID:416842 (history)  Vaccinated:2011-01-22
Age:13.0  Onset:2011-01-22, Days after vaccination: 0
Gender:Female  Submitted:2011-02-14, Days after onset: 23
Location:Foreign  Entered:2011-02-14
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: Blood pressure, 22Jan2011, 100/51mm Hg; Pulse rate, 22Jan2011, 70beats/min
CDC Split Type: B0695954A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA100BB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Memory impairment, 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 January 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). The batch number was not provided. On 22 January 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The healthcare professional considered the event was clinically significant (or requiring intervention). On 22 January 2011, the event was resolved. The healthcare professional considered the event was related to vaccination with CERVARIX. Follow up information received on 03 February 2011 reported by a physician: No previous episode of loss of consciousness was reported. On 22 January 2011, around 11am, the subject received CERVARIX vaccine into the left upper deltoid. Immediately after vaccination, while she was sitting, the subject experienced syncope. She suddenly slid down from a chair and loss consciousness for a few seconds. No painful or emotional stimuli, and no sign of alarm were observed before the event, no sweating or warmth feeling was observed. It is unknown if the subject has some predisposition for that kind of event. The subject could have been mentally stressed before injection. During the occurrence of the events, no specific movements as no tongue biting were observed, breathing pattern was normal. The subject did not remember that she was unconscious. During the events, the subject was carried to a bed and she regained consciousness. At the time of the recovery, she was on prone position. The blood pressure was 100/51 mm Hg and pulse rate was regular and around 70 beats/min. The subject was lucid, and complexion was good. No other symptom was observed after the recovery. No treatment was given. No special test was performed. The events were not anaphylaxis, but it could have been a vasovagal attack. The relationship between vaccination and events was unspecified.

VAERS ID:417187 (history)  Vaccinated:2011-01-26
Age:13.0  Onset:2011-02-02, Days after vaccination: 7
Gender:Female  Submitted:2011-02-18, Days after onset: 16
Location:Foreign  Entered:2011-02-18
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: B0699146A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLL
Administered by: Other     Purchased by: Other
Symptoms: Ulcerative keratitis
SMQs:, Corneal disorders (narrow), Ocular infections (broad)
Write-up: This case was reported by a physician and described the occurrence of corneal ulcer in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 January 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, injection site unknown, batch number not provided). On 2 February 2011, 7 days after vaccination with CERVARIX, the subject experienced corneal ulcer. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.

VAERS ID:417602 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-02-24
Location:Foreign  Entered:2011-02-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Neurological examination, revealed decreased muscle strength of lower limbs, hyporeflexia of patellar and Achilles tendons; diagnostic laboratory test, PCR for herpes virus was negative; electromyography, showed motor and sensory potentials in both upper and lower limbs within the normal; magnetic resonance imaging, Vertebro-medullary MRI: showed no alteration; electromyography, showed no alteration; magnetic resonance imaging, Brain and spinal cord MRI: normal; diagnostic laboratory test, Analytical evaluation was negative; Epstein-Barr virus antibodies, negative; enterovirus PCR, negative; serum ANA, revealed no alteration; serum ANCA, revealed no alteration; serum B19 virus IgG antibody, negative; serum Campylobacter jejuni Ab, negative;
CDC Split Type: WAES1102USA02452
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Asthenia, Back pain, C-reactive protein normal, CSF glucose normal, CSF protein normal, CSF test abnormal, Chlamydia test negative, Cytomegalovirus test negative, Electromyogram normal, Enterovirus test negative, Epstein-Barr virus antibody negative, Headache, Herpes simplex serology negative, Hyporeflexia, Laboratory test normal, Legionella test, Liver function test normal, Muscular weakness, Mycoplasma test, Myelitis transverse, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Parvovirus B19 test negative, Pleocytosis, Polymerase chain reaction, Pyrexia, Red blood cell sedimentation rate increased, Renal function test normal, Toxoplasma serology negative, Viral test negative, Walking disability
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Case received from a physician and literature on 14-FEB-2011. Case medically confirmed. A 13-year-old female patient had received the second dose of GARDASIL (manufacturer unknown, Batch#, site of administration and route not reported) at unspecified date and 16 days post vaccination, the patient experienced fever that lasted a week, lower limb pain and lower back pain with disability in locomotion. The AE had started one month before admission and during this period, the patient had visited the emergency room for two times having been treated symptomatically with paracetamol and non steroid anti-inflammatory drugs, since no change in the regular clinical observation was detected. At admission, the patient experienced headache and partial improvement on the other algic complaints, while maintaining functional disability of lower limbs. The patient did not make reference to previous trauma and no other relevant personal or family history was reported. Neurologic examination revealed decreased muscle strength of lower limbs, hyporeflexia of patellar and Achilles tendons, cutaneous plantar reflex indifferent bilaterally, T10 no algic sensory level and inability to walk. Without meningeal signs, no changes of sphincters control and no other major changes to the regular clinical observation. The analytical evaluation that included complete blood count, biochemical renal function, hepatic and C-reactive protein was negative. The sedimentation rate was 25 mm/lh. Serology for Campylobacter jejuni, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumoniae ser 1, toxoplasmosis wright reaction, cytomegalovirus, herpes simplex virus I and II, parvovirus and Epstein-Barr virus were negative. Analysis of the cerebrospinal fluid showed mild pleocytosis (7 Leuc/ul), with normal glucose and protein, and bacteriological and virus search for Polymerase Chain Reaction Technique for enterovirus and herpes virus were negative. Immunologic studies with assay of immunoglobulins, complement, ANA and ANCA had revealed no alteration. It was performed a brain and spinal cord MRI which results were normal. The electromyography showed motor and sensory potentials in both upper and lower limbs within the normal, abdominal muscle activation in tibialis anterior and vastus lateralis with normal recruitment and potential of motor unit with normal characteristics, suggesting proximal lesion (medullary/preganglionic). During hospitalization, there was a gradual improvement in motor disability of lower limbs. Specific treatment with gabapentin (600 mg, Tid) was administered, with significant improvement in pain, allowing the patient to have autonomous march, at the time of the discharge (8 days after admission). At this time of discharge, she was able to walk. After discharge, the patient began a program of physiotherapy rehabilitation, keeping the gabapentin therapy at home. Two months later, the patient was asymptomatic and with normal neurological exam and she began a gradual reduction of medication. The patient had repeated a brain and vertebro-medullary MRI and the electromyography that showed no alteration. Ten months later the patient remains without neurological sequelae. Clinical evolution and diagnostic tests were consistent with the hypothesis of transverse myelitis. Note: According to the author''s conclusions, although they could not find en etiological factor, the history of fever and the clinical evolution without sequelae suggest a post-infectious etiology. There is also the possibility of a post-vaccinal immunological process. At the time of reporting, the patient had fully recovered. Other business partner numbers include: E2011-01151. No further information is available.

VAERS ID:417762 (history)  Vaccinated:2010-09-22
Age:13.0  Onset:2010-11-01, Days after vaccination: 40
Gender:Female  Submitted:2011-02-28, Days after onset: 119
Location:Foreign  Entered:2011-03-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Computed axial tomography, ??Nov10, Normal; Electroencephalography, ??Feb11, Normal; Blood pressure measurement, ??Feb11, 108/65; Total heartbeat count, ??Feb11, 84, and regular
CDC Split Type: WAES1102USA02964
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250100UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Computerised tomogram normal, Confusional state, Dyskinesia, Electroencephalogram normal, Epilepsy, Eye movement disorder, Flank pain, Headache, Loss of consciousness, Migraine, Photophobia, Psychosomatic disease, Trance, Unresponsive to stimuli
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), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician on 18-FEB-2011. This case was linked to E2011-001187 (WAES # 1102USA02965; same patient, same reporter, same vaccine, events after second dose). This case was medically confirmed. A 13 year old female patient with an unreported medical history and concomitant medication received the first dose of GARDASIL (lot number NK25010, batch number NM11420) route not reported in the left deltoid on 22-SEP-2010. On 21-NOV-2010, two months post vaccination the patient experienced a sore head, confusion and a few days pain in the left side and abdominal migraine was suspected. On 21-NOV-2010, the patient experienced the first episode where the patient got up from bed complaining of a sore head and became confused. The GP on call was contacted and the patient was taken the accident and emergency department by ambulance. The patient was discharged after two days. A few days later, the patient complained of pain in her side and was seen by the GP who took bloods. The patient then became confused and was taken by ambulance to hospital and admitted for two days. A CAT scan was normal and abdominal migraine was queried. In November, the patient''s parents were called into school after the patient experienced what look like an epileptic fit and was again confused. The patient was seen by the General Practitioner. In December a week before Christmas the patient went into a trance in school, there was no jerking but was not responding. This episode continued for about 40 minutes. Afterwards the patient was not confused or drowsy and was taken to accident and emergency and was admitted. The patient was last seen by the consultant on 10-JAN-2011 and was due to be seen again in three months time. On 03-FEB-2011, the patient again complained of a sore head and went to the schools office to sit down where she blanked out for 15 minutes and then went home. The patient was not normally tired or upset after episodes. The patient always complained of headaches in the region of the left occiput prior to the episodes, did not like bright lights and these bring on a trance. The patient was at a Christmas pantomime recently where there were lots of flashing lights but this did not bring on an episode. The patient received the second dose of GARDASIL (lot number NK25010, batch number NM311130) route not reported in the left deltoid on 04-FEB-2011. On 04-FEB-2011, whilst the patient was in the nurses room after receiving the vaccine, the patient had suddenly gone into a trance. Her colour was good, she did not respond to any questions. The parents informed the physician at this time, that the patient had been having these episodes since 22-SEP-2010 but they had not expected her to have an episode that day. The patient was taken to the couch and was lying flat. Her colour continued to be good and her blood pressure was 108/65, pulse was 84 and regular. From the time of the vaccine on 15.25 pm and 15.54 hours the patient remained lying on her back on the couch and did not respond to any questions or commands. On one occasion the patient partially opened her eye and the physician noted coarse jerking of both eyes for a short period. She occasionally appeared to come what look frightened and the shudder and then close her eyes again. At 15.45 hours she was noted to be alert and talkative. The patient was transferred but to the chair and after a short time appeared to go back into a trance where she held both eyes closed. The patient had two more episodes lasting about 5 minutes each. The patient went home with her family at 16.45 hours, she was conscious at this time and they walked her out to the car. The parents refused to take the patient to the emergency department. The father confirmed that the patient had been investigated for these episodes and a CAT scan was normal and the patient was waiting for an EEG which had been booked but was not considered urgent. The parents had arranged an urgent appointment at a clinic

VAERS ID:418477 (history)  Vaccinated:2011-01-06
Age:13.0  Onset:2011-01-24, Days after vaccination: 18
Gender:Female  Submitted:2011-03-11, Days after onset: 46
Location:Foreign  Entered:2011-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Great Toe Pain
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0703179A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Exostosis, Nail operation
SMQs:
Write-up: This female subject was enrolled in the local post-marketing surveillance study (HPV). On 06 January 2011, she received the 1st dose of CERVARIX (IM non-dominant deltoid). Medical conditions at the time of the event included great toe pain. On 25 January 2011, 19 days after the 1st dose of CERVARIX, this 13-year-old subject experienced exostosis. The subject was hospitalised. The event resolved on 26 January 2011. The investigator reported the exostosis as unlikely to be related to CERVARIX and that the event was possibly due to previous disease (pincer nail). Investigator comments: This patient has had left great toe pain without any trauma since December 2010. She was diagnosed with exostosis, left great toe and she had follow-up at the Office Surgery. On 06 January 2011, X-ray showed subungual exostosis. Left great toe nail extraction due to pincer nail was planned. Then, she was operated on 25 January 2011. The patient discharged on 26 January 2011 (operation site wound was clear).

VAERS ID:419093 (history)  Vaccinated:2011-02-26
Age:13.0  Onset:2011-02-26, Days after vaccination: 0
Gender:Female  Submitted:2011-03-18, Days after onset: 19
Location:Foreign  Entered:2011-03-18
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: Blood pressure, 26Feb2011, 102/65IU; Heart rate, 26Feb2011, 49bpm
CDC Split Type: B0704960A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Clonic convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 February 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, left deltoid). The subject was sitting on bed with her older sister to rest. On 26 February 2011, less than one day after vaccination with CERVARIX, upon seeing her sister experiencing syncope, the subject also experienced syncope for a few seconds with clonic convulsion. She was immediately laid down and the event was resolved. Immediately after she was laid down, bradycardia was observed with blood pressure of 102/65 and heart rate of 49 bpm. She was laid down for 30 minutes. After she was recovered, she walked home. The physician considered the events were clinically significant (or requiring intervention). On 26 February 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:419934 (history)  Vaccinated:2010-10-05
Age:13.0  Onset:2010-10-28, Days after vaccination: 23
Gender:Female  Submitted:2011-03-29, Days after onset: 152
Location:Foreign  Entered:2011-03-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Obesity
Diagnostic Lab Data: Magnetic resonance imaging, 05Nov10, right shoulder revealed bursitis subacrominal; Serum creatine kinase, 05Nov10, 154 U/L, Elevated
CDC Split Type: WAES1103USA03007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NG312500IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, Bursitis, Expired drug administered, Injected limb mobility decreased, Injection site pain, Motor dysfunction, Muscular weakness, Neuralgic amyotrophy, Neurological examination normal, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal, Paresis, Peripheral nerve injury, Radiculitis brachial, Sleep disorder, Winged scapula
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Case received from the Health Authorities on 18-MAR-2011 (reference number PEI2011007698). This was a case of misuse due to expired vaccine used. Case medically confirmed. A 13 year old female patient with a medical history of adipositas had received the first dose of GARDASIL (batch# NJ11450, lot# NG31250, expiry date September 2010) IM into the right upper arm on 05-OCT-2010. On 28-OCT-2010, she experienced brachial neuritis/neuralgic amyotrophy leading to hospitalization on 05-NOV-2010. Anamnesis and examination revealed pain and weakness in the right upper arm, decreased mobility of this arm upon elevation and scapula alata tight at elevation. It was reported that the patient always slept on the elevate arm. Laboratory data showed an elevated CK level at 154 U/L, MRI of the right shoulder on 05-NOV-2010 revealed bursitis subacomial. At that time mechanical irritation of right thoracicus longus nerve due to atypical sleeping position an hereditary neuropathy with a tendency of pressure paresis were suspected, differential diagnosis was early stated of right neuralgic shoulder amyotrophy. The patient was treated with ibuprofen leading to improvement of pain, the motoric weakness persisted. The patient was discharged on 06-NOV-2010. On 22-NOV-2010, the patient was followed-up in the neuropediatric ambulance unit. Neurological examination revealed no pain and an improved but still existing scapula alata right. There was no motoric deficiency. The patient was diagnosed with neuralgic amyotrophy (plexus neuritis of unknown etiology). Causal relationship with the vaccination was not excluded although other unspecified causes (infections) could be the trigger. There were no signs of a hereditary form. The patient was treated with prednisone. On 30-NOV-2010, the patient received the second dose of GARDASIL and did not experience any adverse events. On 23-FEB-2011 the patient was again followed-up in the neuropediatric unit. The paresis had completely resolved under prednisone therapy. Upon internal review the company considered relevant to code expired vaccine used which was not coded by HA. Other business partner numbers included: E2011-01919. Case is closed. No further information is available.

VAERS ID:420131 (history)  Vaccinated:2011-03-25
Age:13.0  Onset:2011-03-25, Days after vaccination: 0
Gender:Female  Submitted:2011-04-01, Days after onset: 7
Location:Foreign  Entered:2011-04-01
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: UNK
CDC Split Type: B0708603A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Angioedema, Lip swelling, Paraesthesia, Type IV hypersensitivity reaction
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of angioedema in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included epilepsy. Previous vaccinations included 2 CERVARIX vaccine given on an unspecified dates. Concurrent medications included Epilim. On 25 March 2011 the subject received 3rd dose of CERVARIX (1 injection, intramuscular). On 25 March 2011, less than one day after vaccination with CERVARIX, the subject experienced delayed hypersensitivity reaction with mild angioedema characterised by swelling of the lips and tingling of hands. This case was assessed as medically serious by GSK. At the time of reporting the events were improved. Verbatim text: On 25th March 2011, a physician reported that a 13 year old female patient was administered on the 25th March 2011 their third CERVARIX injection (batch number and expiry unknown) and experienced a delayed hypersensitivity reaction with mild angioedema characterised by swelling of the lips and tingling of hands. Concurrent medical conditions included Epilepsy treated with Epilim. At the time of reporting the events were improved. No further information available at the time of reporting.

VAERS ID:420185 (history)  Vaccinated:2010-05-26
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-01
Location:Foreign  Entered:2011-04-04, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Varicella
Diagnostic Lab Data: ultrasound, 12Jul10, no signs of typical malignant lymphoma; electrocardiogram, 12Jul10, normal; computed axial tomography, 14Jul10, soft tissue formations laterocervical right, in upper mediastinum possibly consistent with M. Hodgki; electroencephalography, 14Jul10, generalized function disorder, no clear epileptic-like potential; chest computed axial tomography, 15Jul10, suspect lymphoma-like formations cervical, mediastinal and left axillar; echocardiography, 15Jul10, no pathological findings; magnetic resonance imaging, 15Jul10, no sign of brain metastasis, evidence of suspect multilocular of suspect multilocular focus cervical; bone marrow biopsy, 23Jul10, conventional-morphologically and immunohistologically no signs of infiltration o
CDC Split Type: WAES1103USA03679
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anal fissure, B-cell lymphoma, Back pain, Biopsy bone marrow normal, Biopsy lymph gland, Blood fibrinogen increased, C-reactive protein increased, Catheter placement, Central nervous system lesion, Chemotherapy, Chest X-ray normal, Clostridium colitis, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Culture urine positive, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram abnormal, Electronystagmogram abnormal, Escherichia test positive, Febrile neutropenia, Fibrin D dimer increased, Gastroenteritis norovirus, General physical health deterioration, Genital herpes, Grip strength decreased, Hyporeflexia, Mediastinal disorder, Menorrhagia, Monoparesis, Mucosal inflammation, Muscular weakness, Neutropenic sepsis, Night sweats, Nodule, Non-Hodgkin's lymphoma, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging thoracic, Pain in extremity, Peripheral nerve lesion, Positron emission tomogram abnormal, Proctoscopy abnormal, Swelling, Ultrasound scan normal, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Agranulocytosis (narrow), Angioedema (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Malignant tumours (narrow), Malignant lymphomas (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Case received from the Health Authorities on 24-MAR-2011 (reference number PEI2010038739). Case medically confirmed. A 13 year old female patient with a medical history of varicella at kindergarten-age, had received all three doses of GARDASIL (manufacturer, dates of administration for first and second dose, site and route not reported), third dose on 26-MAY-2010. The same day, on 26-MAY-2010, the patient presented to the ambulance unit and complained of back pain, irradiating to the right arm, pain relief therapy with indomethacine and ointment was initiated. In the future course strength weakness and reduction of reflex in the right arm developed, which was unsuccessfully treated with physiotherapy. In addition, the patient experienced a weight loss of about 3 kg within 3 weeks and night sweats. From 07-JUL-2010 to 12-JUL-2010 the patient was hospitalized for further investigations. Upon admission she reported that she had been suffering from back pain for over three months. Neurological examination including neurography showed radicular lesion at level C7 and C8. Thoracic x-ray revealed a clear broadened mediastinum. MRI of 09-JUL-2010 showed an extensive process on the right from the neck area up to the upper thoracic aperture with nodular structures. On 12-JUL-2010, the patient was transferred to the hematological-oncological unit. Clinical examination on admission showed reduced general health state of patient, with right arm paresis, drop hand, weakness by closing the first and infraclavicular solid swelling. Laboratory values data: 12-JUL-2010: CRP slight increased at 12.2mg/l, fibrinogen 4.72 g/l (norm 2.0 - 4.0), D-dimer 0.7 mg FEU/1 (norm: < 0/.5 mg FEU/l), complex sonography : no signs of typical malignant lymphoma; ECG normal 14-JUL-2010: PET-CT : soft tissue formations laterocervical right, in upper mediastinum possibly consistent with M. Hodgkin, ECG generalized function disorder, no clear epileptic-like potential 15-JUL-2010: MRI cranial/spinal : no sign of brain metastasis, evidence of suspect multilocular of suspect multilocular focus cervical and thoracic bilateral. CT thorax: suspect lymphoma-like formations cervical, mediastinal and left axillar. Echocardiography: no pathological findings. 16-JUL-2010: Tc-scintiscanning no evidence of bone marrow or osseo participation. 23-JUL-2010/06-AUG-2010: histopathological finding: left axilla, diffuse large B-cell lymphoma 23-JUL-2010: bone marrow biopsy : conventional-morphologically and immunohistologically no signs of infiltration of the B-cell lymphoma. 30-JUL-2010: MRI cranial/spinal : regression 02-AUG-2010: liquor cytology: blast/tumor cell free liquor. 23-AUG-2010: MRI neck/pharynx/ thorax /mediastinum : size regression of lymphoma. 24-AUG-2010: ENG: evidence of regression of paresis in C5, C6 and C7 core muscles. 20-OCT-2010: MRI cranial/spinal : minimal tumor residuum, regressive changes under chemotherapy. 20-OCT-2010: cervical / thoracic: minimal further regression. 17-DEC-2010: evidence of E. coli in urine culture. 13-JAN-2011: MRI cranial : no pathological lymphoma-suspected parechym enhancement. 13-JAN-2011: MRI spinal: no evidence of further lymphoma-suspected enrichments. 14-JAN-2011: MRI neck/ thorax/ mediastinum pharynx: evidence of T2 signal lifting in the area of right cervical / supraclavicular in the upper thoracic aperture 14-JAN-2011: X ray thorax: no pathological finding. Several examinations (e.g. MRIs, CTs, and axillary biopsy on 20-JUL-2010) led to the diagnosis of B-Non-lymphoma (B-NHL) including infiltration of right brachial plexus. B-NHL was treated with polychemotherapy including cyclophosphamide, cytarabine, vincristine sulfate, vindesine, etoposide, doxorubicin, methotrexate, dexamethasone (manufacturer unknown), prednisolone and ifosfamide. During / after chemotherapy following events occurred: neutropenic sepsis (14-AUG-2010), neutropenic fever (14-AUG-2010), clostridium enterocolitis (14-AUG-2010), Norovirus gastroenteritis

VAERS ID:420258 (history)  Vaccinated:2011-02-12
Age:13.0  Onset:2011-02-12, Days after vaccination: 0
Gender:Female  Submitted:2011-04-04, Days after onset: 50
Location:Foreign  Entered:2011-04-04
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: UNK
CDC Split Type: B0709008A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Pain, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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 consciousness disturbed in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 February 2011, the subject received unspecified dose of CERVARIX (intramuscular, left deltoid). On 12 February 2011, less than one day after vaccination with CERVARIX, the subject experienced consciousness disturbed, fever and generalized pain. The physician considered the events were clinically significant (or requiring intervention). On 12 February 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:420267 (history)  Vaccinated:2011-03-11
Age:13.0  Onset:2011-03-11, Days after vaccination: 0
Gender:Female  Submitted:2011-04-04, Days after onset: 23
Location:Foreign  Entered:2011-04-04
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: Anaphylactic shock due to peanuts
Diagnostic Lab Data: Pulse rate, 84
CDC Split Type: B0708523A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA0946D2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Paraesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: This case was reported by the foreign regulatory authority Healthcare products Regulatory Agency (# GB-MHRA-ADR 20973876) and described the occurrence of tingling of lip in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included anaphylactic shock due to peanuts. Concurrent medications included Seretide. On 11 March 2011 the subject received the third dose of CERVARIX (.5 ml, intramuscular) at 9.35am. On 11 March 2011, at 10.50am, the subject experienced tingling of lip. Patient has an anaphylactic reaction to peanuts and had had a brownie to eat at 10.15am. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. Agency Verbatim Text : Third vaccine given at 9.35am. Patient returned at 10.50am with tingling lips. No breathing difficulties. Pulse 84. Colour good. Patient has an anaphylactic reaction to peanuts and had had a brownie to eat at 10.15am. Medically significant due to potential anaphylaxis.

VAERS ID:420280 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-04
Location:Foreign  Entered:2011-04-05, 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:
Preexisting Conditions: Cold; Body temperature increased; Pallor; Tiredness
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1103USA03823
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Balance disorder, Body temperature increased, Chronic fatigue syndrome, Condition aggravated, Crying, Dysstasia, Fatigue, Gait disturbance, Nasopharyngitis, Oropharyngeal pain, Pain, Pallor, Speech disorder, Viral infection, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: This case was identified from an article in a magazine on 25-MAR-2011. This was one of a cluster of three linked cases from the same article involving the same vaccine and was linked with E2011-02052 and E201102061. This case is not medically confirmed. A 13 year old female patient received the third dose of GARDASIL (manufacturer and batch number not reported) on an unreported date. On an unreported date, post vaccination, the patient was diagnosed with chronic fatigue syndrome (ME). The patient had the first dose of GARDASIL (manufacturer and batch number not reported) on an unreported date with no adverse effect reported. The patient received the second dose of GARDASIL (manufacturer and batch number not reported) on an unreported date and the same day the patient stated that she thought she was getting a cold and had a raised temperature, was pale and tired. The outcome was not reported. The day after the patient''s third dose her temperature soared, she had trouble walking because of the pain in her joints and her throat was so sore she could hardly speak. In the weeks that followed the patient saw the doctor many times and went to the hospital and kept getting told it was a virus. The patient was too ill to go to school and had to have home tuition. She was so weak she couldn''t get up the stairs and had to sleep in the living room at night. The patient''s mother slept in the same room to keep an eye on her as she became deathly pale and began to cry out in pain. The patient lost three stone in weight and struggled to keep her balance when she was standing up. Almost two years after the vaccinations the patient was diagnosed with chronic fatigue syndrome (ME). The patient had physiotherapy and hydrotherapy every week and she hoped to go into remission. She only left the house for hospital appointments or to attend school if she was well enough. At the time of reporting the patient had not yet recovered. Upon internal medical review the events were considered medically significant. Other business partner numbers include E2011-02049.

VAERS ID:420405 (history)  Vaccinated:2011-02-25
Age:13.0  Onset:2011-02-26, Days after vaccination: 1
Gender:Female  Submitted:2011-04-06, Days after onset: 38
Location:Foreign  Entered:2011-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 2011, negative for bac; CSF bacteria test, 2011, negativeUnits
CDC Split Type: B0709634A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B047AE UNLA
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test negative, Blood test normal, CSF test normal, Headache, Meningitis, Musculoskeletal stiffness, Pyrexia, Viral test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Arthritis (broad)
Write-up: This case was reported by a regulatory authority (# 136785) and described the occurrence of meningitis in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 25 February 2011, the subject received an unspecified dose of BOOSTRIX (administration site and route unknown). On 26 February 2011, 1 day after vaccination with BOOSTRIX, the subject experienced meningitis, high fever, headache and stiff neck. The subject was hospitalised for 19 days, from 28 February to 18 March 2011. She was only discharged on 18 March 2011 because the epidemiological investigation revealed a diagnosis of serious meningitis. The meningitis was without signs of brain involvement. Tests performed on blood and liquor (clear) were negative for bacteria and virus specific. On 5 March 2011, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX. The doctors have not found correlation between pathology and the administration of the vaccine.

VAERS ID:420492 (history)  Vaccinated:2011-03-25
Age:13.0  Onset:2011-03-25, Days after vaccination: 0
Gender:Female  Submitted:2011-04-07, Days after onset: 13
Location:Foreign  Entered:2011-04-07
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: Blood pressure, 25Mar2011, 105/51 IU
CDC Split Type: B0709709A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA123AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Loss of consciousness, Pallor, 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), Cardiomyopathy (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 vasovagal reflex in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Body temperature before vaccination: 37.0 deg. C. No simultaneous vaccination was performed. On 25 March 2011 (at 15:15), the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 25 March 2011 (at 15:20), 5 minutes after vaccination with CERVARIX, the subject was reading a book on a chair and then, all the sudden she experienced blackout and collapsed. Blood pressures were 105/51. She presented with facial pallor but not urticaria or dyspnea. When she was laid down on bed rest, the event was improved. Thereby, the reporting physician made a diagnosis of vasovagal reflex. The physician considered the events were clinically significant (or requiring intervention). On 25 March 2011, the events were resolved.

VAERS ID:420613 (history)  Vaccinated:2011-01-27
Age:13.0  Onset:2011-01-27, Days after vaccination: 0
Gender:Unknown  Submitted:2011-04-08, Days after onset: 70
Location:Foreign  Entered:2011-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0711231A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083BD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Face oedema, Lacrimation increased, Nasopharyngitis, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# PL-URPL-OCR-20110318004) and described the occurrence of face edema in a 13-year-old subject of unspecified gender who was vaccinated with CERVARIX, (GlaxoSmithKline). Concurrent medical conditions included allergy. No any contraindications for vaccination. On 27 January 2011, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown). On 27 January 2011, within hours of vaccination with CERVARIX, the subject experienced slight face edema, lacrimation, itching, red face and catarrh. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with anti-allergic drug. A consultation in vaccination clinic has been recommended. After 3 days, the events were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.

VAERS ID:420672 (history)  Vaccinated:2010-11-04
Age:13.0  Onset:2010-11-04, Days after vaccination: 0
Gender:Female  Submitted:2011-04-08, Days after onset: 155
Location:Foreign  Entered:2011-04-08
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: UNK
CDC Split Type: B0711545A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA0702AB2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Dizziness, Headache, Hyperhidrosis, Hypotonia, Pain, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (# NL-LRB-116900) and described the occurrence of unconscious partial in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). No concomitant medication or relevant medical condition was reported. Family history included easy fainting after vaccinations. On 4 November 2010, the subject received 3rd dose of CERVARIX (unknown route of administration). On 4 November 2010, 5 minutes after vaccination with CERVARIX, the subject experienced pain leading to fainting. Symptoms consisted of headache, pallor, dizziness, sweating unconscious partial and hypotonia nos. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with CERVARIX. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. The case has been closed.

VAERS ID:421178 (history)  Vaccinated:2011-04-05
Age:13.0  Onset:2011-04-05, Days after vaccination: 0
Gender:Female  Submitted:2011-04-15, Days after onset: 10
Location:Foreign  Entered:2011-04-15
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: UNK
CDC Split Type: B0711925A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Anaphylactic reaction, Body temperature decreased, Dizziness, Feeling abnormal, Pallor, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 April 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). The subject returned home and was resting because of sleepiness. On 5 April 2011, approximately 2 hours after vaccination with CERVARIX, the subject experienced ill complexion, vomiting, decreased body temperature, feels poorly, giddiness and abdominal pain. Because worsening of general condition was observed, an ambulance was requested and the subject visited the reporting physician''s hospital. When the subject was transported to the reporting physician''s hospital, the consciousness was almost clear and the complexion also recovered. However, based on the clinical course of the symptoms, it was judged to be anaphylaxis. The subject received oxygen and fluid replacement with LACTEC D. Secure vascular route was obtained and BOSMIN was administered (SC) and Hydrocortone and ATARAX-P were administered (IV). After the subject was observed on rest, the general condition improved. The physician considered the events were clinically significant (or requiring intervention). On 5 April 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:421225 (history)  Vaccinated:2011-03-21
Age:13.0  Onset:2011-03-21, Days after vaccination: 0
Gender:Male  Submitted:2011-04-15, Days after onset: 25
Location:Foreign  Entered:2011-04-18, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES1104USA01526
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Feeling abnormal, Headache, Pain, Pallor, Pulse abnormal, Rash pruritic, Sensation of foreign body, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the agency via a public case details form concerning a 13 year old male who on 21-MAR-2011 was vaccinated intramuscularly with a dose of RECOMBIVAX HB. (Lot number and dose were not reported). On 21-MAR-2011, 10 minutes post vaccine the patient developed itchy rash on hand with point pain in knuckles and fingers, itchy burning rash also on side of neck, burning pain from armpits up to neck area, headache, feeling weird, pale, thready pulse, feeling of lump and itchy in the throat and unsteady on feet. The patient received treatment with adrenaline, ambulance arrived and the patient was transferred to emergency and required hospitalization. At the time of the report on 23-MAR-2011, the outcome of the patient was recovered. The agency considered that all the symptoms were possibly related to therapy with RECOMBIVAX HB. The original reporting source was not provided. No further information is available.

VAERS ID:421227 (history)  Vaccinated:2011-03-14
Age:13.0  Onset:2011-03-15, Days after vaccination: 1
Gender:Female  Submitted:2011-04-15, Days after onset: 31
Location:Foreign  Entered:2011-04-18, 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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA00797
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Complex regional pain syndrome, Cyanosis, Oedema peripheral, Pain in extremity, Peripheral coldness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was received from the health authority on 05-APR-2011. IBM ref 2011-002901. This case was medically confirmed. A 13 year old female patient with no medical history or risk factors available and no concomitant medications, received the second dose of GARDASIL (lot number not reported) on 14-MAR-2011. On 15-MAR-2011, one day post vaccination, the patient experienced pain and swelling in her arm distal to the injection site. There was no swelling or tenderness at the injection site. She had purplish discolouration of the hand and her hand felt colder than contra lateral hand. The reported stated that is was clinically a reflex sympathetic dystrophic-type reaction. The patient was seen at A&E and referred to the pediatric clinic. At the time of reporting the patient''s symptoms were persistent. The events were considered serious as they were medically significant and required intervention. Other business partner numbers include 2011-02233. No further information is available.

VAERS ID:421375 (history)  Vaccinated:2011-03-14
Age:13.0  Onset:2011-03-15, Days after vaccination: 1
Gender:Female  Submitted:2011-04-18, Days after onset: 34
Location:Foreign  Entered:2011-04-19, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA01823
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250102IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Decreased appetite, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was received from the Health Authority (Agency ref 2011-002919). This case was medically confirmed. A 13 year old female patient with no history of significant concomitant illness or previous drug reaction and no risk factors reported an no concomitant medications received the third dose of GARDASIL (batch# NM31130, lot# NK25010) IM on 14-MAR-2011. On 15-MAR-2011, one day post vaccination, the patient was shivery. She also vomited once and was not eating. The patient was seen by the general practitioner and the doctor on call and went to A&E. At the time of reporting the patient had not yet recovered (also reported as unknown). The events were considered to be medically significant. Other business partner numbers included: E2011-02332. No further information is available.

VAERS ID:421392 (history)  Vaccinated:2011-02-23
Age:13.0  Onset:2011-02-23, Days after vaccination: 0
Gender:Female  Submitted:2011-04-19, Days after onset: 54
Location:Foreign  Entered:2011-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0704958A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122BA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, Cough, Gait disturbance, Headache, Hypoaesthesia, Muscular weakness, Nerve conduction studies abnormal, Neuron-specific enolase, Neuropathy peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (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 peripheral neuropathy 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, lot number not provided). On 27 February 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced peripheral neuropathy. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with CERVARIX. Follow up information received on 08 April 2011 (case upgraded to serious): Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline; intramuscular; unknown deltoid) given on 26 January 2011. On 23 February 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown deltoid). On 23February 2011, less than one day after vaccination with 2nd dose of CERVARIX, the subject experienced headache. On 26 February 2011, the subject experienced peripheral neuropathy. Tendency toward aggravated headache was noted. Cough also developed. Therefore, the subject visited a nearby hospital. She received a prescription and returned home. The subject began to take Chinese herbal medicinel pack x3/day and Loxonin, 1 tablet until 28 February 2011. On 26 February 2011 (in the evening), numbness developed in the left hand. On 27 February 2011, numbness developed in both feet. The subject visited the reporting hospital. On 28 February 2011, the subject had difficulty in walking due to numbness. Manual muscle testing (MMT) was performed and showed level 2. The subject was admitted to the hospital for treatment and placed under observation to follow-up clinical course taking oral drugs and rest. The symptoms showed tendency toward gradual improvement thereafter. On 28 February 2011, lab tests were performed and showed the following: Blood test: Neuron-specific enolase, anti-GMl immunoglobulin (Ig), monoclonal antibodies (MAb) and anti-GQlbIgMAb were all negative. Nerve conduction velocity was performed and decrease was noted. Anti-GMlIgG antibody: 0.009; Anti-GQlbIgG antibody: 0.061. On 10 March 2011, the conditions of numbness and muscular weakness improved, and the subject returned home. On 11 March 2011, the events were resolved. The physician considered the events were possibly related to vaccination with CERVARIX.

VAERS ID:421470 (history)  Vaccinated:2011-04-04
Age:13.0  Onset:2011-04-05, Days after vaccination: 1
Gender:Female  Submitted:2011-04-20, Days after onset: 15
Location:Foreign  Entered:2011-04-20
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: Alanine aminotransferase, 21Dec2005, 14IU/L; Alanine aminotransferase, 06Apr2011, 18IU/L; Aspartate aminotransferase, 21Dec2005, 28IU/L; Aspartate aminotransferase, 06Apr2011, 20IU/L; Blood test, 06Apr2011, Normal; Blood urea nitrogen, 21Dec2005, 12.7mg/dL; Blood urea nitrogen, 06Apr2011, 12mg/dL; C-reactive protein, 21Dec2005, 0.0IU/L; Chloride, 21Dec2005, 101mEq/L; Chloride, 06Apr2011, 101mEq/L; Creatine phosphokinase, 06Apr2011, 98IU/L; Creatinine, 21Dec2005, 0.37mg/dL; Creatinine, 06Apr2011, 0.55mg/dL; Electrocardiogram, 06Apr2011, Normal; GGT, 21Dec2005, 12IU/L; GGT, 06Apr2011, 13IU/L; Hematocrit, 21Dec2005, 45.1%; Hematocrit, 06Apr2011, 38.6%; Hemoglobin, 21Dec2005, 15.1g/dL; Hemoglobin, 06Apr2011, 13.1g/dL; Iron, 06Apr2011, 65mcg/dL;
CDC Split Type: B0711695A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood iron normal, Blood ketone body absent, Blood lactate dehydrogenase increased, Blood pH decreased, Blood potassium normal, Blood sodium normal, Blood test normal, Blood urea normal, C-reactive protein normal, Electrocardiogram normal, Gamma-glutamyltransferase normal, Haematocrit normal, Haemoglobin normal, Headache, Hypoaesthesia, Iron binding capacity total normal, Loss of consciousness, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Occult blood negative, Platelet count normal, Protein urine present, Red blood cell count normal, Syncope, Urine analysis normal, Urine ketone body present, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad)
Write-up: This case was reported by a consumer and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 4 April 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, deltoid muscle of the left upper arm). On 5 April 2011, 1 day after vaccination with CERVARIX, the subject experienced syncope, headache, limb numbness and head numbness. On 5 April 2011, the events were resolved. Follow up information received on 08 April 2011: The subject received no simultaneous vaccination. On 04 April 2011 (at 15:35), the subject received the 1st vaccination with CERVARIX. On 05 April 2011 (at 17:20), syncope occurred after taking a bath and the subject regained consciousness a while later (about 1 minute). The subject experienced slight numbness followed by headache. The symptoms resolved 15 minutes later. On 06 April 2011, lab test were performed and showed the following: ECG: No abnormalities, Blood test: No abnormalities; Urine analysis: No abnormalities; Alanine aminotransferase: 18 IU/L (normal range: 5-40); Aspartate aminotransferase: 20 IU/L (normal range: 10-40); Blood urea nitrogen: 12mg/dL (normal range: 8-22); Chloride: 105mEq/L (normal range: 98-109); Creatine phosphokinase: 98 IU/L (normal range: 45-163); Creatinine: 0.55mg/dL (normal range: 0.47-0.79); GGT: 13 IU/L (normal range: 0-30); Hematocrit: 38.6% (normal range: 33.4-44.9); Hemoglobin: 13.1g/dL (normal range: 11.3-15.2); Iron: 65mcg/dL (normal range: 48-154); Ketone bodies: negative; Lactate dehydrogenase: 129 IU/L (normal range: 115-245); Mean cell haemoglobin: 30.5pg (normal range: 26.3-34.3); Mean cell hemoglobin concentration: 33.9g/dL (normal range: 30.7-36.6); Mean cell volume: 90.1 fL (normal range: 79-100); Occult blood: negative; Platelet count: 22.8 cells/mm3 (normal range: 13-36.9); Potassium: 3.7mEq/L (normal range: 3.6-5); Protein: positive; Red blood cell count: 429 cells/mm3 (normal range: 376-500); Sodium: 144mEq/L (normal range: 136-147); Total iron binding capacity: 316 mcg/dL (normal range: 246-410); White blood cells: 7000 cells/mm3 (3500-9100); pH: 7.

VAERS ID:421476 (history)  Vaccinated:2011-04-13
Age:13.0  Onset:2011-04-13, Days after vaccination: 0
Gender:Female  Submitted:2011-04-20, Days after onset: 7
Location:Foreign  Entered:2011-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Influenza
Diagnostic Lab Data: UNK
CDC Split Type: B0714082A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included influenza. On 13 April 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 13 April 2011, less than one day after vaccination with CERVARIX, the subject experienced fever and headache. The subject was hospitalised. On 14 April 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:421509 (history)  Vaccinated:2011-03-30
Age:13.0  Onset:2011-03-30, Days after vaccination: 0
Gender:Female  Submitted:2011-04-20, Days after onset: 21
Location:Foreign  Entered:2011-04-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sinusitis
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02141
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Decreased appetite, Headache, Listless, Malaise, Nuclear magnetic resonance imaging, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a Health Authority on 11-APR-2011 under the reference number NO-NOMAADVRE-FHI-2011-12235 and 11/681. Case medically confirmed. A 13 year old female patient had received an injection of one dose of GARDASIL (batch number not reported) on 30-MAR-2011 and a few hours later she developed listlessness, near syncope, chills, headache, appetite impaired and feeling unwell. It was reported that the girl was near syncope in the evening of the vaccination day. the next morning she collapsed and was pale. She was hospitalized for observation a day and a night (Dates not reported). Patient had a history of sinusitis (not reported as an AE after vaccination) started on 30-MAR-2011 to 01-APR-2011. MR caput performed on 31-MAR-2011, no results provided. The girl had previously received 2 doses of GARDASIL. At the time of reporting the outcome was recovered. According to the reporter, the reactions were possibly related to vaccination. Other business partner numbers include E2011-02336. No further information is expected.

VAERS ID:421552 (history)  Vaccinated:2011-04-01
Age:13.0  Onset:2011-04-01, Days after vaccination: 0
Gender:Female  Submitted:2011-04-21, Days after onset: 20
Location:Foreign  Entered:2011-04-21
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Wheal
Diagnostic Lab Data: Diastolic blood pressure, 01Apr2011, 70mmHg; Systolic blood pressure, 01Apr2011, 120mmHg
CDC Split Type: D0071080B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB901CC1IMRA
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA098AD1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Fatigue, Injection site urticaria, Pallor, Sneezing, Throat irritation, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority vaccines, biologicals) # DE-PEI-PEI2011011263) and described the occurrence of wheal in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) and ENGERIX B pediatric. On 24 January 2011 the subject received 1st dose of CERVARIX (intramuscular, right arm) and 1st dose of ENGERIX B pediatric (intramuscular, left arm). On 29 January 2011, 5 days after vaccination with CERVARIX and ENGERIX B pediatric, the subject experienced local wheal on the right upper arm. After one to two days the event was resolved. After the next vaccination with CERVARIX the event recurred. For another case from the same patient please see D0071080B (serious). This case was reported by a regulatory authority (foreign Regulatory Authority (vaccines, biologicals) # DE-PEI-PEI2011010564) and described the occurrence of anaphylactic reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) and ENGERIX B pediatric. The subject''s medical history included wheal on 29 January 2011 after vaccination with CERVARIX (GlaxoSmithKline) and ENGERIX B pediatric on 24 January 2011. (For additional information please see case D0071080A (non-serious). On 1 April 2011 the subject received 2nd dose of CERVARIX (intramuscular, left arm) and 2nd dose of ENGERIX B pediatric (intramuscular, right arm). On 1 April 2011, 10 minutes after vaccination with CERVARIX and ENGERIX B pediatric, the subject experienced anaphylactic reaction with urticarial wheals (left upper arm), then tiredness, pallor, sneezing and clearance of throat. The subject was treated with Prednisolon and CLEMASTIN. Under this regression of urticarial wheals and improving of sneezing and clearance of throat. Blood pressure was stable (120/70 mmHg). After 1.5 hours the subject was discharged home. Three days after vaccination the subject experienced wheals on the right upper arm without general symptoms. The subject was treated with CETRIZIN. The reporting physician reported that the events were life threatening. Latest at the time of reporting, on 05 April 2011, the events were resolved. No further information will be available. For another case from the same patient please see case D0071080A (non-serious).

VAERS ID:421583 (history)  Vaccinated:2011-03-28
Age:13.0  Onset:2011-03-28, Days after vaccination: 0
Gender:Female  Submitted:2011-04-21, Days after onset: 24
Location:Foreign  Entered:2011-04-22, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02330
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100902IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactoid reaction, Asthenia, Dyspnoea, Hypotension, Nausea, Tachycardia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was received from the health authority on 13-APR-2011, agency ref 2011-003104. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication reported received the third dose of GARDASIL (batch number NN40800, lot # NM10090, 0.5mls, IM, on 28-MAR-2011. On 28-MAR-2011, post vaccination, the patient experienced an anaphylactoid reaction including hypotension, tachycardia, nausea, weakness, dyspnoea and tightness of throat. The event persisted for one hour. The patient was treated with adrenaline 0.5mg, chlorphenamine 10mg and hydrocortisone 100mg. The patient recovered on an unreported date. The events were considered to be medically significant. Other business partner numbers included E2011-02384.

VAERS ID:421584 (history)  Vaccinated:2010-09-29
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-21
Location:Foreign  Entered:2011-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA02544
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK44350 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This case was received from the health authority on 14-APR-2011, agency ref 2011-003122. This case was medically confirmed. A 13 year old female patient with no medical history and no concomitant medication received an injection of GARDASIL (batch number NN01990, lot number NK44350) IM, 0.5 ml on 29-SEP-2010. On an unreported date, four days post vaccination, the patient experienced chest pain and dyspnoea persisting for 3-4 days and requiring hospitalisation. No further vaccinations were given and the patient recovered on an unreported date. Other business partner numbers include E2011-02420.

VAERS ID:421835 (history)  Vaccinated:2011-02-28
Age:13.0  Onset:2011-02-28, Days after vaccination: 0
Gender:Female  Submitted:2011-04-27, Days after onset: 57
Location:Foreign  Entered:2011-04-27
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: Blood pressure, 28Feb2011, 120/80mmHg; Blood pressure, 28Feb2011, 95/64mmHg; Heart rate, 28Feb2011, 61bpm
CDC Split Type: B0703341A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Injection site pain, Loss of consciousness, 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), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (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 syncopal attack in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 February 2011, at 15:47, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left upper deltoid). On 28 February 2011, at 15:50, 3 minutes after vaccination with CERVARIX, the subject experienced syncopal attack. She laid down in bed immediately. Vital signs were stable with blood pressure 120/80. One later, blood pressure was 95/64 but the subject had no discomfort. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information was received on 22 April 2011: The subject was in sitting position. The subject had activity after the inoculation. The subject had painful/emotional stimuli before the onset of the event. The triggering event was pain due to the injection. The subject had no predisposing factor. The subject did not have any sign or warning responsible for the episode. The subject was not sweating or feeling warm before the event. The event developed suddenly. The subject fell backward. Nothing abnormal was observed at movement, complexion and respiratory pattern. The loss of consciousness lasted for seconds. The subject made no movement in association with the fall. The subject had no tongue biting. The subject did not lose consciousness completely. The subject received no medical treatment. The event resolved while the patient was in the supine position. After vaccination, blood pressure was 120/80 and pulse rate was 61beats/min. No symptoms developed after the patient recovered from loss of consciousness. The subject did not remember anything regarding to loss of consciousness. The subject had no family history or her own medical history such as heart disorder, epilepsy, metabolic abnormality (such as diabetes mellitus), or allergy (such as vaccine, vaccine-component-induced allergy, food allergy, allergic rhinitis, eczema, or asthma). The subject had no past history of loss of consciousness. No special test was performed. The event did not recur. The subject did not receive any medication.

VAERS ID:421839 (history)  Vaccinated:2011-04-01
Age:13.0  Onset:2011-04-05, Days after vaccination: 4
Gender:Female  Submitted:2011-04-27, Days after onset: 22
Location:Foreign  Entered:2011-04-28, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA03198
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100902IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the Health Authority on 20-APR-2011, reference number: 2011-003255. This case was medically confirmed. A 13 year old female patient with no available risk factor data and no history of hives or allergic reaction to foods, medicines or to other substances who had previously received 2 doses of GARDASIL on unreported dates received a third dose of GARDASIL (Lot number: NM10090, dose not reported) intramuscularly on 04 or 05-APR-2011. Within 24 hours of vaccination, on 05-APR-2011, the patient experienced hives localised to the upper part of the lower limbs and to the nasal area and itching. The patient was otherwise well. At the time of reporting to the Health Authority the hives were still present and itchy. The patient had not recovered. The Health Authority considered the case to be serious as an other medically important condition with required intervention. Other business partner numbers included: E2011-02536. No further information is available.

VAERS ID:421873 (history)  Vaccinated:2011-03-25
Age:13.0  Onset:2011-03-25, Days after vaccination: 0
Gender:Female  Submitted:2011-04-28, Days after onset: 34
Location:Foreign  Entered:2011-04-28
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: UNK
CDC Split Type: B0714682A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, Malaise, Oedema mouth, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the foreign regulatory authority (GB-MHRA-ADR 21013877) and described the occurrence of a swollen mouth in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 March 2011 the subject received the 2nd dose of CERVARIX (0.5 ml, intramuscular). On that same day later, on 25 March 2011, the subject experienced a swollen mouth, rash, feeling unwell and lip swelling. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 27 March 2011, the events were resolved. MHRA Verbatim Text : Seen by General Practitioner, reported by mother. Medically significant: Swelling of mouth/lips, rash, unwell.

VAERS ID:422107 (history)  Vaccinated:2011-03-31
Age:13.0  Onset:2011-03-31, Days after vaccination: 0
Gender:Female  Submitted:2011-05-02, Days after onset: 32
Location:Foreign  Entered:2011-05-03, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA03197
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK443502IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was received from the Health Authority on 20-APR-2011, under the reference number: 2011-003276. This case was medically confirmed. A 13 year old female patient with no medical history and no concomitant medication received the third dose of GARDASIL (Lot number: NK01990) 0.5 mL intramuscularly, site not reported on 31-MAR-2011. The same day as the vaccination, the patient felt dizzy and had to lie down and one day later experienced fever, chills, nausea, headache and on 03-APR-2011, generalised body rash. The patient felt dizzy and had to lie down after the first dose of GARDASIL but had no reaction after the second dose. The patient was self limited. The patient received corrective treatment with paracetamol. At the time of reporting, the patient was better and recovered on an unreported date. Both the reporter and the agency considered the events to be serious due to other medically important condition which required intervention. Other business partner numbers included E2011-02538. Additional information has been requested.

VAERS ID:422109 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-05-02
Location:Foreign  Entered:2011-05-03, 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: Swollen glands; Sore throat; Shivering; Tiredness; Headache; Nausea
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA03898
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Feeling hot, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a Health Authority under the reference number 2011-003081 and IE-1577272925, concerning a 13 year old generally healthy female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported) in the left deltoid and three weeks later experienced swollen glands, sore throat and shivery feeling on exercise for several months for which she was treated with AUGMENTIN (E2011-02373-WAES# 1104USA02142). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not reported) in the left deltoid and was tired, had a headache and was nauseous a few weeks later (E2011-02591-WAES# 1104USA03897). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL (lot # not reported) in the left deltoid. No concomitant medications were reported. Subsequently, on an unreported date, within 24 hours post-vaccination, the patient experienced an itchy rash, was feeling hot and weak. All these events were still ongoing. The events of itchy rash, feeling hot and weak were considered to be medically important. This case was medically confirmed. Other business partner numbers include E2011-02592. Further information is not available.

VAERS ID:422211 (history)  Vaccinated:2010-07-17
Age:13.0  Onset:2011-01-29, Days after vaccination: 196
Gender:Female  Submitted:2011-05-04, Days after onset: 94
Location:Foreign  Entered:2011-05-04
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: Body temperature, 31Jan2011, 38.1deg C; C-reactive protein, 31Jan2011, 5.7; Eosinophils, 31Jan2011, 2%; Lymphocytes, 31Jan2011, 5%; Monocytes, 31Jan2011, 5%; Neutrophils, 31Jan2011, 88%; White blood cells, 31Jan2011, 12600/mm3
CDC Split Type: B0700991A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA079BA2IMAR
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein normal, Eosinophil percentage, Erythema induratum, Erythema nodosum, Hypophagia, Lymphocyte percentage decreased, Malaise, Monocyte percentage, Neutrophil percentage increased, Pruritus, Pyrexia, Rash, Rhinitis, Viral infection, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of erythema nodosum in a 13-year-old female subject who was vaccinated with CERVARIX. Previous vaccination included CERVARIX 1st and 2nd doses given on 17 July 2010 and on unspecified date. On 22 January 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown deltoid). Lot number not provided. On 30 January 2011, 8 days after vaccination with CERVARIX, the subject experienced erythema nodosum. At the time of reporting the outcome of the events was unspecified. The physician considered the events were related to vaccination with CERVARIX. Follow-up information was received on 6 April 2011. This case was upgraded to serious. On 17 July 2010 and on an unspecified date, the subject received 1st dose and 2nd dose of CERVARIX (intramuscular, unknown deltoid). According to the subject and her family, skin eruption was observed unspecified time after the first and the second dose of vaccine but the course was mild. After the next vaccination with CERVARIX the events recurred. On 22 January 2011, the subject received 3rd dose of CERVARIX (intramuscular, unknown deltoid). Lot number provided. On 28 January 2011, 7 days after vaccination with CERVARIX, the subject experienced rhinitis symptoms. The subject was treated with Alesion. On 29 January 2011, the subject developed fever and skin eruption. On 30 January 2011, the subject visited the reporting physician''s hospital. The temperature was 37.6 deg C. Skin eruption was observed over the whole body. On 31 January 2011, fever was 38.1 deg C, skin eruption showed a tendency to fuse each other. Itching was remarkable. The patient visited the department of dermatology and was suspected viral infection. Thereafter the patient was followed up under observation at the department of dermatology. A diagnosis of erythema nodosum tuberculous was given. The physician considered the events were clinically significant (or requiring intervention). On 31 January 2011, relevant test results included: CRP: 5.7; Eosinophils: 2%; Lymphocytes: 5%; Monocytes: 5% Neutrophils: 88%; WBC: 12600 cells/mm3. On 15 February 2011, the subject experienced malaise and skin eruptions were limited in the areas of the feet and the frontal lower legs. The temperature was 37.6 deg C. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 28 Apr 2011. Vaccine details were provided (lot number, injection sites). On 17 July 2010, 23 August 2010 and 22 January 2011 the subject received 1st dose, 2nd dose and 3rd dose of CERVARIX (intramuscular, unknown deltoid). In July 2010 and in August 2010, less than one month after vaccination with 1st and 2nd dose of CERVARIX, the subject experienced skin eruption which resolved. On 29 January 2011, 7 days after vaccination with CERVARIX, the subject experienced erythema nodosum, rhinitis symptoms, itching, possible viral infection, fever and malaise. The subject was treated with Levocetirizine on 30 January 2011. Rhinitis symptoms resolved on 15 February 2011, malaise resolved on 1 March 2011. At the time of reporting the events were improved. Pruritus and fever caused difficulty in the dietary intake. The state of the whole body was not good.

VAERS ID:422379 (history)  Vaccinated:2011-03-05
Age:13.0  Onset:2011-03-05, Days after vaccination: 0
Gender:Female  Submitted:2011-05-06, Days after onset: 61
Location:Foreign  Entered:2011-05-06
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: Blood pressure, 05Mar2011, 100/52IU; Pulse rate, 05Mar2011, 53IU
CDC Split Type: B0705394A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122BA0IMRA
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: This case was reported by a physician and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 March 2011 (at 10:10), the subject and her older sister (see case B0705392A) visited the reporting physician''s hospital to receive CERVARIX; the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown deltoid) before her sister. On 5 March 2011 (at 10:25), 15 minutes after vaccination with CERVARIX, the subject saw her sister receive CERVARIX, standing there. Her sister presented with syncope when standing up, and was placed under observation for a few minutes. When her sister was made to sit and had the blood pressure measured the subject also experienced syncope. The subject was about to collapse, but she was supported and made to lie down. The subject rested for a few minutes and had no problem in both sitting and standing positions. The subject rested in recumbent position until her sister finished receiving intravenous fluids and returned home. The physician considered the event was clinically significant (or requiring intervention). On 5 March 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow up information received on 11 March 2011: Lot number was provided. Follow up information received on 26 April 2011: Injection site: The deltoid muscle in the right upper arm. Position: Standing position. Activities: The subject was waiting for her elder sister''s vaccination to be finished in the standing position after receiving the same vaccination and saw the sister fell when she stood up. After the sister recovered and sat down on her chair, the subject fell just like her sister. The subject had no painful or emotional stimuli before the onset of the event. The subject had no predisposing factor. Triggering event: The subject saw her sister fell after receiving the same vaccination. The subject had no signs or warnings responsible for the episode. The subject was not sweating or feeling warm before the onset of the event. The event occurred suddenly. The subject almost collapsed and was supported immediately. Complexion: pallor. Loss of consciousness lasted around 20 seconds. Respiratory pattern was normal. Movements: Collapsed. The subject had no tongue biting. The subject did not lost consciousness completely. No oral medication was used. The event resolved in the supine position. Vital signs: Blood pressure and pulse rate in the supine position were 100/52 and 53, respectively. No symptoms occurred after the recovery from the loss of consciousness. The subject did not remember about the unconsciousness. The subject had no family history or personal medical history. The subject had no past medical history of loss of consciousness. The event did not recur. No oral medication was used.

VAERS ID:422382 (history)  Vaccinated:2011-03-29
Age:13.0  Onset:2011-03-29, Days after vaccination: 0
Gender:Female  Submitted:2011-05-06, Days after onset: 38
Location:Foreign  Entered:2011-05-06
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: UNK
CDC Split Type: B0716715A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Muscle twitching, Musculoskeletal stiffness, Pallor, Syncope, Unresponsive to stimuli, Urinary incontinence, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00062275) and described the occurrence of seizure in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccinations included two doses of CERVARIX on unknown dates. It was reported the subject fainted on two previous vaccinations with CERVARIX. On 29 March 2011 the subject received the 3rd dose of CERVARIX (intramuscular). On that same day later, on 29 March 2011 the subject experienced a seizure. The subject fainted and had twitching of the arms and legs, stiffening of the body, pale colour and was unresponsive. The seizure activity stopped but recommenced after a few minutes, lasting less than a minute. The subject was also incontinent of urine during the episode. The regulatory authority reported that the event was clinically significant (or requiring intervention). After approximately 5 minutes, on 29 March 2011, the event was resolved. The subject''s colour improved and she became fully responsive. MHRA Verbatim Text : This young girl fainted on previous two vaccinations for HPV, this time she fainted and had twitching of arms and legs, stiffening of body, colour pale and unresponsive. The seizure activity stopped but recommenced after a few minutes, lasting less than a minute. She recovered after approximately 5 minutes, colour improved and became fully responsive. She was sent home into the care of her mother who reported no previous incidents like this. When they got home Mother contacted school health to report that when her daughter got changed she realised she had been incontinent of urine during episode.

VAERS ID:422443 (history)  Vaccinated:2011-03-14
Age:13.0  Onset:2011-03-14, Days after vaccination: 0
Gender:Female  Submitted:2011-05-06, Days after onset: 53
Location:Foreign  Entered:2011-05-09, Days after submission: 3
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: Asthma
Diagnostic Lab Data: blood pressure measurement, 14Mar11, 100/65; PVC/total heartbeat ratio, 14Mar11, 76
CDC Split Type: WAES1104USA04119
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK443502IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This case was received from the health authority on 27-APR-2011. Agency ref: 2011-003355. This case was medically confirmed. A 13 year old female patient with a history of asthma and receiving concomitant VENTOLIN EVOHALER received the third dose of GARDASIL (lot number: NK44350, batch number: NN01990) intramuscularly on 14-MAR-2011. On 14-MAR-2011, 15 minutes (also reported as 30 minutes) post vaccination, the patient began to feel faint and breathless. The patient''s blood pressure was 100/65 and her pulse was 76. The patient was treated with VENTOLIN (2 puffs). The patient recovered on an unreported date. The events were considered to be medically important as they required intervention. Other business partner numbers include: E2011-02614. No further information is available.

VAERS ID:422480 (history)  Vaccinated:2011-04-13
Age:13.0  Onset:2011-04-13, Days after vaccination: 0
Gender:Female  Submitted:2011-05-09, Days after onset: 26
Location:Foreign  Entered:2011-05-09
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: Body temperature, 13Apr2011, 38Deg.C
CDC Split Type: B0714810A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA123AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Decreased appetite, Feeling cold, Hypoaesthesia, Injection site discolouration, Injection site pain, Pyrexia, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of skin discoloration in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 April 2011 the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 13 April 2011, less than one day after vaccination with CERVARIX, the subject experienced skin discoloration and fever. On 16 April 2011, the subject experienced anorexia. At the time of reporting, the events were improved. Follow-up information received on 27 April 2011: Previous and/or concurrent vaccination included CERVARIX (GlaxoSmithKline) given on 9 March 2011. Site of injection (left upper arm) was added. On 13 April 2011, during vaccination with CERVARIX, when the needle was intramuscularly inserted in the left upper arm, the subject had no numbness or no backflow of blood. But when the drug was infused, she experienced pain which was moderate. After coming back home, the subject experienced numbness, cold feeling, turning purple in the overall left upper limb (to the fingertips). The fingertips in the right hand also turned purple. During the night of 13 April 2011, the subject experienced pyrexia (38 Deg.C). On 13 April 2011, the subject also experienced anorexia. The physician considered the events were clinically significant (or requiring intervention). On 14 April 2011, the subject was afebrile, and the color of the limbs became normal. Between 16 April 2011 and 18 April 2011, as the subject persistently had anorexia, Sulpiride was administered. At the time of reporting, all the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 2 May 2011: The batch number was added.

VAERS ID:422579 (history)  Vaccinated:2011-04-06
Age:13.0  Onset:2011-04-06, Days after vaccination: 0
Gender:Female  Submitted:2011-05-09, Days after onset: 33
Location:Foreign  Entered:2011-05-10, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA04123
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100902IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the agency on 28-APR-2011, reference 2011-003358. This case was medically confirmed. A 13 year old female patient who had no available risk factors, no relevant history/concurrent conditions and was not on any concomitant medication who had previously received two doses of GARDASIL on unreported dates, received the third dose of GARDASIL (batch# NN33040, lot# NM10090, 0.5 ml intramuscularly) on 06-APR-2011. The same evening following vaccination, the patient experienced a sore arm. The event lasted for two days and the patient recovered on 08-APR-2011, the patient received corrective treatment with an ice pack and generic analgesics. The agency felt event was serious as an other medically important condition with required intervention. Other business partner numbers included: E2011-02633. No further information is available.

VAERS ID:422601 (history)  Vaccinated:2011-02-26
Age:13.0  Onset:2011-02-26, Days after vaccination: 0
Gender:Female  Submitted:2011-05-10, Days after onset: 72
Location:Foreign  Entered:2011-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Tension
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0704669A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Nausea, Syncope
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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 syncope 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). At an unspecified time after vaccination with CERVARIX, the subject experienced nausea and feels poorly. At the time of reporting the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 18 March 2010: Case upgraded to serious (clinically significant). Concurrent medical conditions included tension. On 26 February 2011, the subject received 1st dose of CERVARIX (intramuscular, left upper deltoid). On 26 February 2011, 5-10 minutes after vaccination with CERVARIX, while the subject was sitting in a sofa in the waiting room, the subject felt poorly. She experienced syncope, lost conscious and fell down on her way to bed. She did not experienced traumatic injury because she was supported. Blood pressure and pulse rate were normal. The physician considered the events were clinically significant (or requiring intervention). The subject regained conscious in about 30 min. During that time (or more), she was laid down as precautionary measure. On 26 February 2011, the events were resolved. The subject was in a totally normal state without any problems. For the physician, feel poorly and nausea were related to CERVARIX, syncope was also related to the vaccine but also to a slight touch of tension. Follow-up received on 28 April 2011: No relevant medical history or concomitant medication was reported. The subject was not fat. Before the onset of the syncope, the subject was sitting in a sofa, taking a rest. The subject did not present any prior sign of alarm, any sweating or warmth feeling before the onset of syncope. A possible cause could be the resolution of the tension prior the vaccination. The syncope and loss of consciousness occurred gradually. The subject fell down on her way to bed, she was supported by another person and then sank down to the floor. The subject totally lost conscious during 30 seconds. During the event, there were no abnormal movement (lax movements), no tongue biting. The skin coloration and breathing pattern were normal. At the recovery time, the subject was in a lying position. No other events occurred after the recovery of consciousness. The subject remembered that she was unconscious. No treatment was given.

VAERS ID:422668 (history)  Vaccinated:2011-04-14
Age:13.0  Onset:2011-04-14, Days after vaccination: 0
Gender:Female  Submitted:2011-05-11, Days after onset: 27
Location:Foreign  Entered:2011-05-11
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: Blood pressure, 106/67mmHg; Pulse rate, 113bpm
CDC Split Type: B0713864A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Convulsion, Immediate post-injection reaction, Pallor, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a Nurse and described the occurrence of anaphylactic reaction in a 13-year-old female subject who was vaccinated with AMBIRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of AMBIRIX (1 injection, Batch number and Exp date unknown). At an unspecified time after vaccination with AMBIRIX, the subject experienced anaphylactic reaction and vomiting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unknown. Verbatim text received: On 14th April 2011 a nurse reported that a 13 year old female patient was administered AMBIRIX (batch number and expiry date unknown). At an unknown time later the patient experienced anaphylactic reaction and vomiting. The outcome of events was unknown and at the time of reporting no further information was available. Follow-up information received on 5 May 2011: On 14 April 2011 the subject received an unspecified dose of TYPHERIX (GlaxoSmithKline, intramuscular). On 14 April 2011, 30 minutes after vaccination with TYPHERIX, the subject received an unspecified dose of AMBIRIX (GlaxoSmithKline). Immediately after vaccination with AMBIRIX, and approximately 30 minutes after vaccination with TYPHERIX, the subject experienced a ''brief fit'' (convulsion), looked pale, vomiting and anaphylactic reaction. The subject''s blood pressure was 106/67mmHg and pulse rate was 113bpm but regular. On 14 April 2011 the subject recovered from the convulsive state rapidly but at the time of reporting the outcome of the vomiting, paleness and anaphylactic reaction was unknown.

VAERS ID:422669 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-05-11
Location:Foreign  Entered:2011-05-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0716940A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chronic fatigue syndrome
SMQs:
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00062969) and described the occurrence of chronic fatigue syndrome in a 13-year-old female subject who was vaccinated with CERVARIX. On unspecified dates the subject received a 1st and 2nd dose of CERVARIX. At an unspecified time after vaccinations with CERVARIX, the subject experienced transient symptoms of chronic fatigue syndrome. On an unspecified date the subject received a 3rd dose of CERVARIX. Within a week to 10 days of receiving the 3rd dose of CERVARIX, the subject developed very profound symptoms. The subject was hospitalised. At the time of reporting the event was unresolved. MHRA Verbatim Text : This girl now has a two year history of very profound Chronic Fatigue Syndrome, being either hospitalised or housebound - developed mild and transient symptoms after first two doses of CERVARIX, but following the third dose she developed very profound symptoms within a week to 10 days. This could be coincidence but is not the only case that I have seen with this pattern.

VAERS ID:422670 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-05-11
Location:Foreign  Entered:2011-05-11
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: B0716941A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chronic fatigue syndrome
SMQs:, Dementia (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00062968) and described the occurrence of chronic fatigue syndrome in a 13-year-old female subject who was vaccinated with CERVARIX. On an unspecified date the subject received a 3rd dose of CERVARIX. Within a week of vaccination with CERVARIX, the subject experienced chronic fatigue syndrome. The regulatory authority reported that the event was disabling. At the time of reporting the event was resolved with sequelae. It was reported that the subject continues to have significant symptoms despite implementation of NICE Guideline approaches to management. At present she was only able to attend school on a very limited basis. MHRA Verbatim Text : This patient developed symptoms of Chronic Fatigue Syndrome very shortly (within a week) of third CERVARIX immunisation - she continues to have significant symptoms despite implementations of NICE Guideline approaches to management. At present they are only able to attend school on a very limited basis. This could be coincidence but is the second case I have encountered in a 3 month period - this case also reported.

VAERS ID:422952 (history)  Vaccinated:2010-11-01
Age:13.0  Onset:2010-11-12, Days after vaccination: 11
Gender:Female  Submitted:2011-05-16, Days after onset: 184
Location:Foreign  Entered:2011-05-16
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: UNK
CDC Split Type: B0718928A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNLA
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 reported by a regulatory authority (# 10-12-6753A) and described the occurrence of fit in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In November 2010, the subject received 2nd dose of CERVARIX (unknown route of administration, unknown site of injection, batch number not provided). On 12 November 2010, 12 hours after vaccination with CERVARIX, the subject experienced fits. This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. This report was received from the Foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:422953 (history)  Vaccinated:2010-09-20
Age:13.0  Onset:2010-09-20, Days after vaccination: 0
Gender:Female  Submitted:2011-05-16, Days after onset: 238
Location:Foreign  Entered:2011-05-16
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: UNK
CDC Split Type: B0718937A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (# 10-11-6466A) and described the occurrence of blackout in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 20 September 2010, the subject received unspecified dose of CERVARIX (.5 ml, unknown route of administration, unknown site of injection, batch number not provided). On 20 September 2010, less than one day after vaccination with CERVARIX, the subject experienced blackout (not amnesia) and giddiness. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. This report was received from the Foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:422954 (history)  Vaccinated:2010-09-20
Age:13.0  Onset:2010-09-20, Days after vaccination: 0
Gender:Female  Submitted:2011-05-16, Days after onset: 238
Location:Foreign  Entered:2011-05-16
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: UNK
CDC Split Type: B0718942A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (# 10-10-6303A) and described the occurrence of blackout in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 20 September 2010, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown site of injection, batch number not provided). On 20 September 2010, 5-10 minutes after vaccination with CERVARIX, the subject experienced blackout (not amnesia). This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. This report was received from the Foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:422955 (history)  Vaccinated:2010-09-22
Age:13.0  Onset:2010-09-22, Days after vaccination: 0
Gender:Female  Submitted:2011-05-16, Days after onset: 236
Location:Foreign  Entered:2011-05-16
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: UNK
CDC Split Type: B0718944A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (# 10-10-6003A) and described the occurrence of blackout in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 22 September 2010, the subject received unspecified dose of CERVARIX (.5 ml, unknown route of administration, unknown site of injection, batch number not provided). On 22 September 2010, 10 minutes after vaccination with CERVARIX, the subject experienced blackout (not amnesia) and pallor. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. This report was received from the Foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:422956 (history)  Vaccinated:2010-09-21
Age:13.0  Onset:2010-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-05-16, Days after onset: 237
Location:Foreign  Entered:2011-05-16
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: UNK
CDC Split Type: B0718949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (# 10-10-6032A) and described the occurrence of blackout in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 September 2010, the subject received unspecified dose of CERVARIX (.5 ml, unknown route of administration, unknown site of injection, batch number not provided). On 21 September 2010, 15 minutes after vaccination with CERVARIX, the subject experienced blackout (not amnesia) and giddiness. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. This report was received from the Foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:423060 (history)  Vaccinated:2011-05-10
Age:13.0  Onset:2011-05-11, Days after vaccination: 1
Gender:Female  Submitted:2011-05-17, Days after onset: 6
Location:Foreign  Entered:2011-05-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Double outlet right ventricle
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA02271
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.NN232000SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Clonus, Convulsion, Enuresis
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: Case received from a healthcare professional (physician) on 11-MAY-2011. Case medically confirmed. A 13-year-old female patient with a medical history of vitium cordis (double outlet right ventricle), had received a first dose of VARIVAX (Merck) (lot-no. NN23200) SC in the left upper arm on 10-MAY-2011. One day later, on 11-MAY-2011, she developed seizure with clonic movements and enuresis during physical education at school. The patient was hospitalized. The outcome was not reported. Additional information has been requested. Other business partner number included: E2011-02854.

VAERS ID:423065 (history)  Vaccinated:2010-09-28
Age:13.0  Onset:2011-01-13, Days after vaccination: 107
Gender:Female  Submitted:2011-05-17, Days after onset: 123
Location:Foreign  Entered:2011-05-18, 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:
Preexisting Conditions: Flu-like symptoms
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA01776
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza like illness, Vaccine positive rechallenge
SMQs:
Write-up: This case was reported by the health authority - agency on 06-MAY-2011, reference number 2011-003509. This case was medically confirmed. A 13 year old female patient with unreported risk factors received dose 2 of GARDASIL (batch number: NN01990, lot number: NK44350) 0.5 ml intramuscularly on 11-JAN-2011. Two days post-vaccination, on 13-JAN-2011, the patient experienced flu-like symptoms which lasted for 4 days. The patient received unspecified analgesics and recovered. The patient refused to have the third dose. The patient had received the first dose of GARDASIL (batch number: NM31130, lot number: NK25010) on 28-SEP-2010, intramuscularly 0.5 mls and 2 days later on 30-SEP-2010, the patient experienced flu-like symptoms and recovered after 4 days. The agency considered the case to be serious and an other medically important condition which required intervention. Other business partner number included: E2011-02826. No further information is available.

VAERS ID:423202 (history)  Vaccinated:2011-03-29
Age:13.0  Onset:2011-03-29, Days after vaccination: 0
Gender:Female  Submitted:2011-05-18, Days after onset: 50
Location:Foreign  Entered:2011-05-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA01773
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK050700IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fall, Head injury, Laceration, Loss of consciousness, 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), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case received from a pediatrician on 06-MAY-2011. Case medically confirmed. A 13 year old female patient with no relevant medical history had received the first dose of GARDASIL (lot number:NN04460; Batch number: NN04460) IM in the deltoid muscle on 29-MAR-2011, 10 minutes post vaccination she had a syncope, fell down and was unconscious for 2 minutes. When falling, the patient experienced a craniocerebral trauma with head laceration. She was hospitalized for observation during 2 days with no complications and recovered. Other business partner numbers included E2011-02788. The case is closed. No further information is available.

VAERS ID:423852 (history)  Vaccinated:2011-05-03
Age:13.0  Onset:2011-05-03, Days after vaccination: 0
Gender:Female  Submitted:2011-05-23, Days after onset: 20
Location:Foreign  Entered:2011-05-24, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA02684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK443502IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Peripheral coldness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by the agency on 12-MAY-2011, reference 2011-003712. This case was medically confirmed. A 13 year old female patient with no medical history of note and no concomitant medication, who had previously received 2 doses of GARDASIL within the past 6 months received the 3rd dose of GARDASIL (batch# NN01990, lot# NK44350) intramuscularly 0.5 ml on 03-MAY-2011. Within 10 minutes the patient experienced a numb and cold left arm that persisted for 6 hours. The patient went home from school and rested, her symptoms resolved completely by the next day. The patient received no corrective treatment. The agency considered the events to be serious as an other medically important condition requiring intervention. Other business partner numbers included: E2011-02922. No further information is available.

VAERS ID:423853 (history)  Vaccinated:2011-02-15
Age:13.0  Onset:2011-02-15, Days after vaccination: 0
Gender:Female  Submitted:2011-05-23, Days after onset: 96
Location:Foreign  Entered:2011-05-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA02573
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0098Z IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1612X UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Pyrexia, Rash, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Information was obtained on request by the company from the agency via public case detail Form (local reference # 2011MSDA0836, OPR 281080) regarding a 13 year old female who on 15-FEB-2011 was vaccinated with a dose of GARDASIL, 1 dose, 1 time (lot #662963/1612X, batch number:N0467). Secondary suspect therapy included a dose of RECOMBIVAX HB (MSD) (Lot # 667012/0098Z, batch # R1279) 1 dose, 1 time, i.m. A few minutes after vaccination patient developed shortness of breath, facial swelling and rash to face, neck and upper chest, and mild fever. Subsequently, the patient recovered from the symptoms. The agency considered that shortness of breath, facial swelling, mild fever and rash to face, neck and upper chest were possibly related to therapy with GARDASIL and RECOMBIVAX HB. The original reporting source was not provided. Additional Information is not expected.

VAERS ID:423877 (history)  Vaccinated:2011-04-27
Age:13.0  Onset:2011-04-27, Days after vaccination: 0
Gender:Female  Submitted:2011-05-24, Days after onset: 27
Location:Foreign  Entered:2011-05-24
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: Asthma
Diagnostic Lab Data: UNK
CDC Split Type: B0719451A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Headache, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 21052015) and described the occurrence of lethargy in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included asthma. On 27 April 2011 the subject received a 3rd dose of CERVARIX (intramuscular). On 27 April 2011, 9 hours after vaccination with CERVARIX, the subject experienced lethargy, fever, rigors and headache. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with oral citirazine and paracetamol/ibuprofen. At the time of reporting the events were improved. MHRA Verbatim Text : Nine hours after vaccination - lethargy, headache, fever, rigors. Was given oral citirazine and paracetamol/ibuprofen.

VAERS ID:424206 (history)  Vaccinated:2011-02-01
Age:13.0  Onset:2011-02-28, Days after vaccination: 27
Gender:Female  Submitted:2011-05-27, Days after onset: 87
Location:Foreign  Entered:2011-05-27
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: UNK
CDC Split Type: B0721028A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the MHRA (# GB-MHRA-EYC 00063760) and described the occurrence of allergic reaction in a 13-year-old female subject who was vaccinated with CERVARIX. Previous vaccinations included CERVARIX. In February 2011 the subject received second dose of CERVARIX (intramuscular). On 28 February 2011, a few hours after vaccination with CERVARIX, the subject experienced allergic reaction, and swelling of face. The following morning (1 March 2011) the patient experienced hives all over her body, including the face lips and feet which remained for 3 weeks. The regulatory authority reported that the events were clinically significant (or requiring intervention). In 2011, the events were resolved. A few hours following the second vaccination, the patient developed swelling to the face. The following morning they developed hives all over her body, including face, lips and feet, which remained for 3 weeks.

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