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Found 573141 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

This is page 304 out of 574

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VAERS ID:434862 (history)  Vaccinated:2011-09-07
Age:13.0  Onset:2011-09-07, Days after vaccination: 0
Gender:Female  Submitted:2011-09-19, Days after onset: 12
Location:Foreign  Entered:2011-09-19
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, 07Sep2011, 110/62mmHg; Blood pressure, 07Sep2011, 110/65mmHg; Pulse rate, 07Sep2011, 65bpm; Pulse rate, 07Sep2011, 50bpm
CDC Split Type: B0746865A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Depressed level of consciousness, Muscular weakness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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 7 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 7 September 2011, 10 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, syncope, weakness of limbs and depressed level of consciousness. The physician considered the events were clinically significant (or requiring intervention). Blood pressure was 110/62 mmHg and pulse rate 50 bpm. The subject was treated with drip infusion and bed rest. The events improved. About 1 and a half hour later, blood pressure, and pulse rate became 110/65 mmHg and 65 bpm, respectively and the symptoms almost disappeared. On 7 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:435083 (history)  Vaccinated:2011-08-08
Age:13.0  Onset:2011-08-08, Days after vaccination: 0
Gender:Female  Submitted:2011-09-21, Days after onset: 44
Location:Foreign  Entered:2011-09-21
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: Blood pressure, 08Aug2011, 99/55mmHg; Blood pressure, 08Aug2011, 91/52mmHg; Oxygen saturation, 08Aug2011, 98%; Oxygen saturation, 08Aug2011, 99%; Pulse rate, 08Aug2011, 38bpm; Pulse rate, 08Aug2011, 57bpm; Pulse rate, 08Aug2011, 45bpm; Pulse rate, 08Aug2011, 58bpm
CDC Split Type: B0744134A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Asthenia, Bradycardia, Fall, Immediate post-injection reaction, 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
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 8 August 2011, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown). On 8 August 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). At the time of reporting, the event was resolved. The healthcare professional considered the event was related to vaccination with CERVARIX. Follow-up information received on 12 September 2011: No past history of loss of consciousness. No concomitant medication. The date of birth was provided. Injection site: left upper arm. The subject had no stimulus before the onset. Before vaccination, she was taking a nap. She was awakened by her parents and came to the hospital. (It was unknown whether this could be the predisposing factor). She had fear for the inoculation. She had no sign or warning regarding the episode. She didn''t sweat or had a warmth feeling. On 8 August 2011, immediately after vaccination with CERVARIX, the subject experienced weakness and loss of consciousness. When she was collapsing from her chair, a nurse supported her and went to a bed. She responded to calls. She didn''t remember when she lost consciousness. She neither had paralysis nor sensory aberrations. When she regained consciousness, it was slightly blurred but soon became lucid. A 5 pm, blood pressure was 99/55 mmHg, pulse rate: 38 bpm and oxygen saturation was 99%. After 5 minutes, blood pressure was 91/52 mmHg, pulse rate 45 bpm. After 15 minutes, pulse rate was 57 bpm and after 20 minutes, pulse rate was 58 bpm. Regarding the pulse, the reporter had an impression that it was about 60 bpm (by palpation). Subsequently, the pulse became bradycardiac and recovered again. She had neither pallor, cyanosis, nor flushing. She lost consciousness for a few seconds. The respiratory pattern was normal. She didn''t bite her tongue. The subject didn''t receive treatment. After recovery, no any symptom developed. The events didn''t recur. On 8 August 2011, the events were resolved.

VAERS ID:435084 (history)  Vaccinated:2011-08-12
Age:13.0  Onset:2011-08-12, Days after vaccination: 0
Gender:Female  Submitted:2011-09-21, Days after onset: 40
Location:Foreign  Entered:2011-09-21
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: Blood pressure, 12Aug2011, 110/60mmHg
CDC Split Type: B0742214A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Immediate post-injection reaction, 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (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 12 August 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 12 August 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 12 August 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 12 September 2011: The subject had no medical history, no past history of loss of consciousness and no particular predisposing factor. On 12 September 2011, before the onset of the event, the subject had a painful/emotional stimulus (unspecified), but she did not develop sweat or warmth feeling, she had no sign or warning regarding the episode. On 12 September 2011, immediately after vaccination with CERVARIX, the subject was in sitting position when she suddenly slid and fell from her chair, she was pale and completely lost of consciousness for several seconds. Her respiratory pattern was normal, no abnormal movements were observed, she did not bite her tongue. The blood pressure was 110/60. The subject did not undergo any special test. The subject did not received any medical treatment. The subject did not remember anything regarding loss of consciousness. The event did not recur. On 12 August 2011, the events were resolved.

VAERS ID:435090 (history)  Vaccinated:2011-09-08
Age:13.0  Onset:2011-09-09, Days after vaccination: 1
Gender:Female  Submitted:2011-09-21, Days after onset: 12
Location:Foreign  Entered:2011-09-21
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: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Oxygen saturation, Sep2011, 94%; Oxygen saturation, Sep2011, 40%
CDC Split Type: B0747988A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA IMAR
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Condition aggravated, Cyanosis, Depressed level of consciousness, Respiratory disorder, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of asthmatic attack in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On 8 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown deltoid). On 9 September 2011, 1 day after vaccination with CERVARIX, the subject experienced severe asthmatic attack during the night. She was taken to the hospital by ambulance. At the time of the arrival, she experienced cyanosis in the face and in the upper and lower extremities, respiratory discomfort, depressed level of consciousness and was unresponsive to verbal stimuli. The oxygen saturation measured by pulse oximetry (SpO2) was 40s %. The subject was treated with oxygen, unspecified inhalation, Intravenous steroids, Aminophylline drip and BOSMIN. The subject became able to respond to calls. SpO2 increased to 94 %. At the time of reporting the outcome of the severe asthmatic attack, cyanosis in the face and in the upper and lower extremities and respiratory discomfort was unspecified and the depressed level of consciousness and unresponsitivity to verbal stimuli were resolved. The patient was transferred to another hospital as a case of severe attack (which was much more severe than cases usually called severe attack). The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:435097 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-09-21
Location:Foreign  Entered:2011-09-21
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: B0748009A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Loss of consciousness, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of convulsion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced convulsion, loss of consciousness and pain. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events loss of consciousness and convulsion had resolved and the outcome of pain was unspecified.

VAERS ID:435274 (history)  Vaccinated:2011-09-06
Age:13.0  Onset:2011-09-07, Days after vaccination: 1
Gender:Female  Submitted:2011-09-22, Days after onset: 15
Location:Foreign  Entered:2011-09-22
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: B0748008A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA145AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of afebrile convulsion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 6 September 2011, the subject received an unspecified dose of CERVARIX (.5 ml, intramuscular, right arm). On 7 September 2011, 1 day after vaccination with CERVARIX, the subject experienced afebrile convulsion. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was improved.

VAERS ID:435277 (history)  Vaccinated:2011-09-05
Age:13.0  Onset:2011-09-08, Days after vaccination: 3
Gender:Female  Submitted:2011-09-22, Days after onset: 14
Location:Foreign  Entered:2011-09-22
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: Febrile convulsion
Diagnostic Lab Data: UNK
CDC Split Type: B0748813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA145AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Musculoskeletal pain, Neck pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included febrile convulsion. On 5 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left arm). On 8 September 2011, 3 days after vaccination with CERVARIX, the subject experienced decreased consciousness, vomiting, neck pain and shoulder pain. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were improved.

VAERS ID:435386 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2010-10-01
Gender:Female  Submitted:2011-09-22, Days after onset: 356
Location:Foreign  Entered:2011-09-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
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: WAES1109USA01346
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Activities of daily living impaired, Dizziness, Insomnia, Lethargy
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: This report was received from CSL and was assigned manufacturer report number 1000249840 (local reference number AUS-11-1130) concerning an approximately 13 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Since receiving her last dose of GARDASIL from the NIP school programme, in October 2010, the patient had ongoing dizziness, abdominal pains, lethargy and insomnia. The patient had had 20 days this year off school (unable to attend school) as a result of these symptoms. Reporter does not want this adverse event followed up and did not provide consent. Dizziness, abdominal pains, lethargy and insomnia were considered to be disabling since the patient had 20 days off school (unable to attend school) as a result of these symptoms. The original reporting source was not provided. No further information is available.

VAERS ID:435536 (history)  Vaccinated:2011-09-01
Age:13.0  Onset:2011-09-08, Days after vaccination: 7
Gender:Female  Submitted:2011-09-23, Days after onset: 15
Location:Foreign  Entered:2011-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0748853A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist via a physician and described the occurrence of convulsion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included epilepsy. On an unspecified date in September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown injection site, batch number not provided). On 8 September 2011, 1 week after vaccination with CERVARIX, the subject experienced convulsion. The pharmacist considered the event was clinically significant (or requiring intervention). On 8 September 2011, the event was resolved.

VAERS ID:435542 (history)  Vaccinated:2011-09-12
Age:13.0  Onset:2011-09-12, Days after vaccination: 0
Gender:Female  Submitted:2011-09-23, Days after onset: 11
Location:Foreign  Entered:2011-09-23
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: B0747977A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaemia
SMQs:, Haematopoietic erythropenia (broad)
Write-up: This case was reported by a physician and described the occurrence of anemia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included influenza virus vaccine (manufacturer unspecified; route and injection site unknown) given on an unspecified date. On 12 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 12 September 2011, 2 minutes after vaccination with CERVARIX, the subject experienced symptom of anaemia. She was immediately laid down on the bed. 4 minutes after the blood pressure was measured, the symptom of anaemia had improved. The physician considered the event was clinically significant (or requiring intervention). On 12 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:435549 (history)  Vaccinated:2011-08-16
Age:13.0  Onset:2011-08-16, Days after vaccination: 0
Gender:Female  Submitted:2011-09-23, Days after onset: 38
Location:Foreign  Entered:2011-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fear; Pollinosis
Preexisting Conditions: Food allergy; Seasonal allergy
Diagnostic Lab Data: Blood pressure diastolic, 16Aug2011, 38mmHg; Blood pressure diastolic, 16Aug2011, 34mmHg; Blood pressure systolic, 16Aug2011, 78mmHg; Blood pressure systolic, 16Aug2011, 74mmHg
CDC Split Type: B0742264A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Allergy test, Depressed level of consciousness, Fall, Malaise, 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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). The subject''s medical history included food allergy and seasonal allergy. on 16 August 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site). On 16 August 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). Blood pressure was taken at 2 different times and was 38/78 mm Hg and 34/74 mm Hg. On 16 August 2011, the event was resolved. Follow-up information received on 13 September 2011: Medical history included pollinosis, no concomitant medication was reported. On 16 August 2011, the subject received vaccination into the left deltoid. After the vaccination, a blood test was performed for an allergy test on the subject''s request. Approximately 7 - 8 minutes after the blood test, while subject was in a supine position, the subject complained about feeling sick. She experienced syncope, lost partially conscious (during 10 minutes) and fell down. She also presented facial pallor with a blood pressure of 78/38 mm Hg. She was placed in a bed to rest. The subject had no predisposition factor and no presence of signs of alarm regarding the episode. The subject did not experience any emotional or painful stimulation, and no sweating or warmth feeling was observed before the onset of the events but fear was reported as a triggering event. During the episode of syncope, subject was pale, respiratory pattern was normal, and no particular movement was observed. The subject did not bite her tongue. Her blood pressure at that time was of 78/38 mm Hg. The subject did not remember anything from her loss of consciousness. At the time of the recovery from the events, the subject was on supine or prone position. No other symptom was observed after the recovery of the event. No treatment was given and no special test was performed. Although she felt better after 15 minutes, her blood pressure did not show some changes (74/34 mm Hg). Later on, she was feeling good and went back home.

VAERS ID:435769 (history)  Vaccinated:2011-09-12
Age:13.0  Onset:2011-09-13, Days after vaccination: 1
Gender:Female  Submitted:2011-09-26, Days after onset: 13
Location:Foreign  Entered:2011-09-26
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: B0749155A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of platelets decreased in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site, batch number not provided) given on 12 August 2011. On 12 September 2011, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, unknown injection site, batch number not provided). On 13 September 2011, 1 day after vaccination with CERVARIX, the subject experienced fever. On 15 September 2011, 3 days after vaccination with CERVARIX, the subject experienced platelets decreased and CRP increased. The subject was hospitalised. At the time of reporting the outcome of the CRP increased was unspecified and the fever and platelets decreased were unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:435783 (history)  Vaccinated:2011-07-30
Age:13.0  Onset:2011-07-30, Days after vaccination: 0
Gender:Female  Submitted:2011-09-26, Days after onset: 58
Location:Foreign  Entered:2011-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Henoch Schonlein purpura
Diagnostic Lab Data: Blood pressure, 30Jul2011, 110/60mmHg; Body temperature, 30Jul2011, 40deg.C; C-reactive protein, 30Jul2011, No abnormalities; Oxygen saturation, 30Jul2011, 96%; Transaminases, 30Jul2011, No abnormalities
CDC Split Type: B0742796A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138AC0IMLA
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein normal, Dizziness, Fatigue, Feeling abnormal, Laboratory test normal, Malaise, Painful respiration, Pyrexia, Rhinorrhoea, Transaminases
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms 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). On 30 July 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 30 July 2011, 2 and half hours after vaccination with CERVARIX, the subject experienced fever (40 deg.C), feeling of dizziness, a lot of nasal discharge and feeling sick. At the time of reporting, fever was resolved and the outcome of the other events was unspecified. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 15 September 2011: On 30 July 2011, 3-4 hours after vaccination with CERVARIX, the subject visited the reporting physician''s hospital because she had severe light-headed feeling and was exhausted. She responded when called. She also complained of respiratory discomfort. The physician considered the events were clinically significant (or requiring intervention). The oxygen saturation measured by pulse oximetry (SpO2) was 96 % and blood pressure (BP) was 110/60 mmHg. C-reactive protein and transaminases did not show any abnormality. The subject was treated with oxygen was started at 2 L, REPLAS-1S 500 mL and SAXIZON 10 L was also started. Because pyrexia of 40 degrees Centigrade was observed, CALONAL one and a half tablets were orally administered. After that, the subject felt slightly better. On 1st August 2011, fever, feels poorly, swaying feeling and nasal discharge were resolved and the outcome of other events was improved. GSK case number B0743384A is a duplicate of this case. All future correspondence will be submitted to this case.

VAERS ID:435926 (history)  Vaccinated:2011-09-07
Age:13.0  Onset:2011-09-13, Days after vaccination: 6
Gender:Female  Submitted:2011-09-27, Days after onset: 14
Location:Foreign  Entered:2011-09-27
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: Atopic dermatitis
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomogram head, Sep2011, normal; Electrocardiogram, Sep2011, unknow
CDC Split Type: B0748901A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Cardiac disorder, Cardio-respiratory arrest, Cardiogenic shock, Computerised tomogram head, Computerised tomogram normal, Depressed level of consciousness, Electrocardiogram, Fall, Loss of consciousness, Mechanical ventilation, Postresuscitation encephalopathy, Resuscitation, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of cardiorespiratory arrest in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included atopic dermatitis. The subject had no regular medication. On 7 September 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). On 13 September 2011 at 16:00, 6 days after vaccination with CERVARIX, while the subject was running in a relay race at school, she experienced cardiorespiratory arrest and fell down. She was resuscitated at the hospital where she was carried to by ambulance. Subsequently, she was transferred to the reporting physician''s hospital. Treatment for cardiogenic shock and postresuscitation encephalopathy was being provided at the time of reporting. Cardio-respiratory arrest due to cardiac disease was suspected but, at the time of reporting, obvious reasons were not identified by past medical history, echography and electrocardiogram examination. On 16 September 2011, as of 19:00, the subject was being placed under artificial ventilator. Treatment with cardioactive drugs and sedatives (anaesthesia) was continued, and the patient was unconscious. Before treatment with an artificial ventilator, the patient had been in a state of clouding consciousness. The subject received no oral treatment. The general condition was severe. On an unspecified date, an ultrasound and electrocardiogram were performed with unspecified results. A head computerised tomogram showed no abnormalities. The subject was hospitalised and the physician considered the events were life threatening. At the time of reporting event cardiorespiratory arrest was unresolved and the outcome of the other events was unspecified. The physician reported that the causality was unassessable to CERVARIX and that the cardiorespiratory arrest was related to arrhythmia. Follow-up information received on 22 September 2011: On 21 September 2011, as of 19:00, the subject was removed from mechanical ventilation and had spontaneous respiration. The consciousness had not regained yet. It was informed that there was a strong possibility that she had brain disorder. The reporter informed that arrhythmia was considered in the first place as a causal factor for cardio-respiratory arrest caused by acute exercise. Because the patient was already in a condition of cardio-respiratory arrest, it was impossible to state that arrhythmia was the cause. The subject''s present illness was also unknown.

VAERS ID:436483 (history)  Vaccinated:2011-09-16
Age:13.0  Onset:2011-09-16, Days after vaccination: 0
Gender:Female  Submitted:2011-09-30, Days after onset: 14
Location:Foreign  Entered:2011-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 16Sep2011, 36.7deg. C.
CDC Split Type: B0749603A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146CB0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Injection site pain, Malaise, Presyncope, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of general malaise in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before vaccination was 36.7 degrees centigrade. On 16 September 2011, at 16:30, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, right upper arm). On 16 September 2011, at 16:35, 5 minutes after vaccination with CERVARIX, the subject experienced general malaise, presyncope and tinnitus. On the same day, at an unspecified time after vaccination, she also developed appetite impaired and injection site pain. On 16 September 2011, at night, pain and impaired appetite persisted. On 17 September 2011, the subject visited the reporting physician''s hospital again. the general malaise, although it improved slightly, persisted together with the impaired appetite. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of tinnitus was unspecified, the presyncope and the general malaise were improved and all the appetite impaired and injection site pain were unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:436910 (history)  Vaccinated:2011-09-21
Age:13.0  Onset:2011-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-10-05, Days after onset: 14
Location:Foreign  Entered:2011-10-05
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, 21Sep2011, 110/38mmHg
CDC Split Type: B0751688A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146DB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of abnormal consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 21 September 2011, at 17:40, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 21 September 2011, at 17:40, immediately after vaccination with CERVARIX, the subject experienced abnormal consciousness and syncope, possibly because of pain. The syncope was temporary and the subject''s consciousness had quickly improved. The subject''s blood pressure was 110/38 mmHg. No abnormality was found in her consciousness after 30-minutes bed rest and the subject returned home on foot. The physician considered the events were clinically significant (or requiring intervention). On 21 September 2011 the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.

VAERS ID:437101 (history)  Vaccinated:2011-09-16
Age:13.0  Onset:2011-09-16, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 20
Location:Foreign  Entered:2011-10-06
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: B0751250A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA079DB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chest discomfort, Disorientation, Dizziness, Dyspnoea, Feeling hot, Headache, Hyperhidrosis, Malaise, Pain in extremity, Petit mal epilepsy, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by the regulatory authority (GB-MHRA-EYC 00071774) and described the occurrence of absence attacks in a 13-year-old female subject who was vaccinated with CERVARIX. On 16 September 2011 the subject received unspecified dose of CERVARIX (intramuscular, Batch number AHPVA079DB). Approximately 15-20 minutes after vaccination with CERVARIX, the subject experienced absence attacks, was unresponsive to stimuli, chest tightness, sweating, headache, generalized weakness, feeling sick, arm pain, feeling faint, disorientated, difficulty breathing, feeling of warmth and dizzy episode. It was reported the patient had to be helped to lie down. The regulatory authority reported that the events were clinically significant (or requiring intervention). The healthcare professional asked the patient to get their blood sugar and thyroid levels checked by the GP. It was reported that the patient took at least half an hour to recover in the upright/sitting position. At the time of reporting the arm pain was improved, dizzy episode and feeling sick were resolved with sequelae and the unresponsive to stimuli, chest tightness, sweating, headache, generalized weakness, feeling faint, disorientated, difficulty breathing and feeling of warmth had resolved. MHRA Verbatim Text: Patient reaction wasn''t immediate; the reaction happened approximately 15-20 minutes after immunisation with the HPV vaccine, and patient had generally appeared well and relaxed before the immunisation! When the reaction started, the patient had to be helped to lie down on the spot due to general feeling of faint, weakness and dizziness, and there was a short spell where patient wasn''t responding, and seemed disorientated! She also complained of tight chest and appeared to have some minor breathing difficulties! She was noticibly sweaty and warm, and later complained of headache! She took at least half an hour to recover in upright/sitting position. Have asked patient to get blood sugar and thyroid levels checked with own GP.

VAERS ID:437111 (history)  Vaccinated:2011-08-11
Age:13.0  Onset:2011-08-11, Days after vaccination: 0
Gender:Female  Submitted:2011-10-06, Days after onset: 56
Location:Foreign  Entered:2011-10-06
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: B0751785A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Neurological examination normal, Paraesthesia, Presyncope
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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 11 August 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm, batch number not provided). On 11 August 2011, approximately 30 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction with numbness and tingling sensation of the fingertips of the left hand. There were no abnormalities in neurological findings, and the symptoms were observed and seemed to improve on the following day. The physician considered the events were clinically significant (or requiring intervention). On 12 August 2011, the events were resolved. The subject experienced no particular symptoms after receiving the second dose of CERVARIX.

VAERS ID:437408 (history)  Vaccinated:2011-09-26
Age:13.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 11
Location:Foreign  Entered:2011-10-07
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: B0751770A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Cold sweat, Depressed level of consciousness, Dizziness, Gaze palsy, Hyperthermia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 26 September 2011, 1 minute after vaccination with CERVARIX, the subject experienced decreased consciousness, eyeballs raised upward and cold sweat. On 26 September 2011, less than one day after vaccination with CERVARIX, the subject experienced decreased blood pressure, hyperthermia and giddiness. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, eyeballs raise upward and cold sweat were resolved, they lasted for 10 minutes. The outcome of the other events was unspecified.

VAERS ID:437412 (history)  Vaccinated:2011-09-26
Age:13.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-07, Days after onset: 11
Location:Foreign  Entered:2011-10-07
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: UNK
CDC Split Type: B0751751A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146CB IMRA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional via a physician and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, right deltoid). On 26 September 2011, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness and convulsion. The healthcare professional considered the events were clinically significant (or requiring intervention). On 26 September 2011, the events were resolved.

VAERS ID:437608 (history)  Vaccinated:2011-05-20
Age:13.0  Onset:2011-06-01, Days after vaccination: 12
Gender:Female  Submitted:2011-10-07, Days after onset: 128
Location:Foreign  Entered:2011-10-11, Days after submission: 4
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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: electromyography, Normal; physical examination, A non systematised motor and sensory deficiency was found (see narrative); dermatological examination, Cutaneous examination was normal, peripheral pulse well perceived; neurological examination, unremarkable
CDC Split Type: WAES1110USA00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Conversion disorder, Dermatologic examination normal, Electromyogram normal, Hypoaesthesia, Joint crepitation, Muscle fatigue, Neurological examination normal, Paraesthesia, Paralysis, Reflex test normal, Sensorimotor disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from Health Authorities on 27-SEP-2011 via identification number BX20111030 (BX1101166). Case medically confirmed. A 13-year-old female patient with no relevant medical history had received the first injection of GARDASIL (lot and batch number not reported) on 20-MAY-2011 and 3 weeks later, in June 2011, she experienced paresthesia with tingling and left arm and right foot paralysis episodes. A corrective treatment with analgesic, non steroidal anti-inflammatory drug and splint was prescribed. The patient was hospitalised from 22-AUG-2011 to 24-AUG-2011 for left upper limb motor and sensory deficiency following a vaccination with GARDASIL. Hospitalisation report: 3 weeks after vaccination with with GARDASIL, the patient experienced left upper limb paresthesia with motor deficiency. No infectious syndrome nor injection site inflammation were reported. During examination, a non systematised motor and sensory deficiency such as paresthesia, hypoesthesia, muscle fatigability and articular clicking was found. Symptoms were fluctuating depending on the physician. Cutaneous examination was normal. Peripheral pulse well perceived. Osteo-tendinous reflexes were normal. The rest of neurological and general examination was unremarkable. The electromyography (EMG) was normal. Without patient knowing, physicians constated, at several locations, that the patient used her arm spontaneously and normally. The diagnosis of conversion neurosis with non systematised motor and sensory deficiency of left upper limb with normal EMG following a vaccination with GARDASIL without traumatic triggering event was made. An external follow-up by a psychologist was proposed to the patient with hypnosis technique test. On 01-SEP-2011, the patient had not yet recovered although the symptoms improved. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 11) according to the foreign method of assessment. Other business partner number included: E2011-05729. No further information is available.

VAERS ID:437671 (history)  Vaccinated:2011-08-31
Age:13.0  Onset:2011-08-31, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 40
Location:Foreign  Entered:2011-10-11, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0752511A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143CA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of vasovagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 31 August 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 31 August 2011, 30 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction with decreased blood pressure and facial pallor. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved.

VAERS ID:437674 (history)  Vaccinated:2011-08-06
Age:13.0  Onset:2011-08-06, Days after vaccination: 0
Gender:Female  Submitted:2011-10-10, Days after onset: 65
Location:Foreign  Entered:2011-10-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Oxygen saturation, 06Aug2011, 92%
CDC Split Type: B0749065A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Hypoxia, Immediate post-injection reaction, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad)
Write-up: This case was reported by a physician and described the occurrence of hypoxemia in a 13-year-old female subject who was vaccinated with CERVARIX. On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced decreased oxygen saturation. At the time of reporting the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 27 September 2011: On 27 September 2011, this case was upgraded as serious. On 06 August 2011, the subject received the 1st dose of CERVARIX in the left arm. After vaccination, the subject immediately complained of chest distress. Oxygen saturation (SpO2) was measured revealing a decrease to 92%, for which she had inhalation treatment. The event immediately had resolved. She was referred to Hospital A for the second inoculation of CERVARIX. The circumstances at that time were unknown. The physician reported the events as clinically significant. The reporter considered the events as related to CERVARIX.

VAERS ID:437696 (history)  Vaccinated:2011-09-19
Age:13.0  Onset:2011-09-19, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 22
Location:Foreign  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No jerking with stiffness previously observed by parent.
Diagnostic Lab Data: UNK
CDC Split Type: B0752162A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA087AC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyskinesia, Loss of consciousness, Musculoskeletal stiffness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: This case was reported by the regulatory authority (GB-MHRA-ADR 21272696) and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX. No previous history of jerking with stiffness. On 19 September 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 19 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced loss of consciousness, stiffness of limb and jerky movements. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 19 September 2011, the events were resolved. Loss of consciousness, stiffness of upper limbs, jerking movements. Medically significant: child prone to fainting in stressful situations but no jerking with stiffness previously observed by parent.

VAERS ID:437697 (history)  Vaccinated:2011-09-28
Age:13.0  Onset:2011-09-28, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 13
Location:Foreign  Entered:2011-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0752515A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Blood pressure decreased, Nausea, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of unresponsive to verbal stimuli in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 September 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 28 September 2011, less than one day after vaccination with CERVARIX, the subject experienced syncopal attack. The physician considered the event was clinically significant (or requiring intervention). On 28 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 5 October 2011: On 28 September 2011, approximately 5 minutes after vaccination with CERVARIX, the subject experienced syncope attack with mild queasy feeling. She did not respond well to calls. Although mild decreased blood pressure was observed, she became able to respond well to calls approximately 10 minutes after she took bed rest in the supine position. The blood pressure returned to normal. Mild queasy feeling persisted, but disappeared 1 hour later.

VAERS ID:437835 (history)  Vaccinated:2011-08-26
Age:13.0  Onset:2011-08-26, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 46
Location:Foreign  Entered:2011-10-12, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201109687
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case report is part of a batch of TYPHIM VI reports that was received on 29 September 2011 by sanofi pasteur from the International Vaccine Institute (local case reference number NP-2011-026). During this vaccination campaign, a total of 35,354 students from 180 schools were vaccinated from 18 August 2011 to 19 September 2011. A 13-year-old female patient (school grade "8"), whose medical history and concomitant therapies were not reported, had received her dose of TYPHIM VI (batch number, route and anatomical site of administration not reported) on 26 August 2011 at 11:30 AM. On 26 August 2011, at 01:30 PM, the patient experienced headache and repeated vomiting which were reported as "non-serious". The patient was hospitalized on unspecified dates for observation. She received PARACETAMOL per os and METOCLOPRAMIDE per os as a corrective treatment. No active management was required. The outcome was not reported. Documents held by sender: none.

VAERS ID:437843 (history)  Vaccinated:2011-05-19
Age:13.0  Onset:2011-05-19, Days after vaccination: 0
Gender:Female  Submitted:2011-10-11, Days after onset: 145
Location:Foreign  Entered:2011-10-12, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201109692
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Injection site pain, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case report is part of a batch of TYPHIM VI reports that was received on 29 September 2011 by sanofi pasteur from the International Vaccine Institute (local case reference number NP-2011-045). During this vaccination campaign, a total of 35,354 students from 180 schools were vaccinated from 18 August 2011 to 19 September 2011. A 13-year-old female patient (school grade 6), whose medical history and concomitant therapies were not reported, had received her dose of TYPHIM VI (batch number, route and anatomical site of administration not reported) on 19 May 2011 at 01:15PM. On 19 May 2011 at 02:00PM, the patient experienced dizziness and vomiting, pain at injection site and was unconscious. The patient was not hospitalized. No seriousness criteria were reported for this case. However, this case was considered as serious as it was other medically important condition. She received glucose water to drink as a corrective treatment. The outcome was not reported. Documents held by sender: none.

VAERS ID:437957 (history)  Vaccinated:2011-09-05
Age:13.0  Onset:2011-09-06, Days after vaccination: 1
Gender:Female  Submitted:2011-10-12, Days after onset: 36
Location:Foreign  Entered:2011-10-12
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: B0747585A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Autonomic nervous system imbalance, Depression, Diarrhoea, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via another health professional and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, injection site unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced fever, diarrhea and headache. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, fever and diarrhea were unresolved and the outcome of headache was unspecified. The physician reported that the events were probably related to vaccination with CERVARIX. Follow-up information received on 27 September 2011: At an unspecified date after vaccination with CERVARIX, the subject also developed feeling queasy. At the time of reporting, the outcome of feeling queasy was unspecified and headache was resolved. GSK cases number B0750749A and B0750761A are duplicates of this case. All future correspondence will be submitted to this case. The duplicate cases included additional following information: Fever started on 6 September 2011, 1 day after vaccination with CERVARIX. Headache and feeling queasy started in September 2011, less than 1 month after vaccination with CERVARIX. Follow-up information received on 6 October 2011: At an unspecified time after vaccination with CERVARIX, the subject experienced autonomic nervous system imbalance and depression. The outcome of these events was unspecified.

VAERS ID:437998 (history)  Vaccinated:2011-09-29
Age:13.0  Onset:2011-09-29, Days after vaccination: 0
Gender:Female  Submitted:2011-10-12, Days after onset: 13
Location:Foreign  Entered:2011-10-13, 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: Unknown
Current Illness: Mass
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure measurement, 29Sep11, 90 mmHg, Systolic; Blood pressure measurement, 29Sep11, 70 mmHg, Systolic; Blood pressure measurement, 29Sep11, 52 mmHg, Diastolic; Blood pressure measurement, 29Sep11, 38 mmHg, Diastolic; Blood pressure measurement, 29Sep11, 99 mmHg, Systolic; Blood pressure measurement, 29Sep11, 56 mmHg, Diastolic; Total heartbeat count, 29Sep11, 72 /min; Total heartbeat count, 29Sep11, 60 /min; Total heartbeat count, 29Sep11, 78 /min
CDC Split Type: WAES1110USA00991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1336Z0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Cold sweat, Cyanosis, Malaise, Pallor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 13 year old and 10 month old female patient who had no history of allergy, underlying diseases, growth problem, vaccination within the past one month and other diseases. On 29-SEP-2011 (18:50) the patient was vaccinated with the first injection of GARDASIL, 0.5 ml, intramuscularly injected into left upper arm in the supine position (Lot number: 1336Z, batch number; 9QN01 R) of uterine cervical cancer. No other vaccine was injected at the same time. No information on concomitant medications had been provided. On 29-SEP-2011, before injection of GARDASIL, blood pressure was 90/52, pulse was 72/regular and consciousness was clear. (18:55) (also reported as 16:50), The vaccine was injected (as stated above). (18:55) after confirming that she felt all right after vaccination, she was transferred to the waiting room, and then she felt sick and sit down. Blood pressure was 70/38, pulse was 60/min, regular and the patient had facial pallor, cyanosis of lip and cold sweat on hands and feet. She was soon made to lie down in a recumbent position with her legs raised. Starting fluid SOLITA-T NO.1 200 mL was administered via drip infusion. (19:15) Blood pressure was 99/56, pulse was 78/regular, consciousness was clear and she went home without problem in standing position. The patient recovered from blood pressure decreased. The patient reporting physician felt that blood pressure decreased was definitely related to GARDASIL and judged that other factors (other diseases, etc.) were not related. The reporting physician considered blood pressure decreased to be serious as other important medical event. No further information is available.

VAERS ID:438235 (history)  Vaccinated:2011-09-21
Age:13.0  Onset:2011-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-10-13, Days after onset: 22
Location:Foreign  Entered:2011-10-14, 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: Unknown
Current Illness:
Preexisting Conditions: Cough; Nasopharyngitis
Diagnostic Lab Data: blood pressure measurement, fine; total heartbeat count, fine
CDC Split Type: WAES1110USA01159
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM33040 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: This case was received from the local Health Authority on 06-OCT-2011 under the reference number 2011006924. This case is medically confirmed. A 13 year old female patient with a history of a cough and cold in the days prior to the vaccination and nasopharyngitis and who was not receiving any concomitant medication received a dose of GARDASIL, (Lot number NM33040 is an invalid lot number for GARDASIL) and site not reported on 21-SEP-2011. On 21-SEP-2011, 10 minutes post vaccination, the patient experienced coughing profusely and throat tightness. The patients pulse and blood pressure were both fine. The patient was otherwise healthy. The patient received corrective treatment with PIRITON and hydrocortisone. The patient''s symptoms eased but she continued to cough intermittently and was advised to go to the hospital. She was admitted for observation and possibly further treatment. At the time of reporting the patient had not recovered. The local Medicine Board considered the events to be serious due to hospitalization and other medically important condition requiring intervention. Other business partner numbers included: E2011-05981. No further information was reported.

VAERS ID:438245 (history)  Vaccinated:2011-09-15
Age:13.0  Onset:2011-09-15, Days after vaccination: 0
Gender:Female  Submitted:2011-10-13, Days after onset: 28
Location:Foreign  Entered:2011-10-14, 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: Pre-vaccination medical history negative.
Diagnostic Lab Data:
CDC Split Type: E201105600
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNC: MENINGOCOCCAL (MENINGITEC)PFIZER/WYETHE63142 IMLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3750AD IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Clonus, Emotional disorder, Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, Presyncope, Syncope, Tachycardia, Tonic clonic movements, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Case received from Health Authority (case n. 148143) (local case n. IT377/11). Initial report received on 20-SEP-11. Case medically confirmed. A 13 year old female patient was vaccinated on 15-SEP-11 with one dose of TRIAXIS (batch n. C3750AD) i.m. and concomitantly with one dose of MENINGITEC (Mfr. Wyeth Lederle, batch n. E63142) i.m.. On the same day, a few seconds post-vaccination, she presented with a fainting spell with clonic contractions of the upper limbs that lasted a few seconds. The patient was held for monitoring for about 30 minutes. At the time of reporting her condition had improved. The final outcome was not reported. Upon medical review the Company judged relevant to code the adverse event "fainting spell" which was mentioned in the narrative but not coded by HA. The case is closed. Follow-up received from HA on 29-SEP-11: the patient was diagnosed with likely emotional vasovagal reaction, complicated by clonus of the upper limbs. No further information is available. The case is closed. Follow-up received from HA on 05-OCT-11: Pre-vaccination medical history negative. TRIAXIS was administered in right deltoid and MENINGITEC in the left deltoid while the patient was seated; when shifting to the standing position the patient suddenly presented with pallor, falling to the ground (without trauma as she was promptly rescued), loss of consciousness without response to stimuli and tonic-clonic contractions to the upper limbs and face, normal breathing. The symptoms resolved after a few seconds, the patient re-gained consciousness with sufficient spatial-temporal orientation, normal breathing, slight tachycardia, normal arterial blood pressure. She was held for monitoring in the horizontal position for a few minutes and then seated; forty minutes later the patient had almost completely recovered, pallor and slight alteration still persisted but she was taken home by her mother and advised to contact her pediatrician. The following day the parents were contacted by phone and they referred that the patient had presented with slight asthenia and one episode of vomiting in the evening following vaccination, but she had regularly attended school on the following day. The patient''s pediatrician confirmed of having evaluated her and finding her in good condition. An EEG was scheduled for the following weeks (results not reported). According to the reporter, the episode is to be considered as an emotionally based vaso-vagal reaction probably induced by the extreme heath and the age of the patient and complicated by brief loss of consciousness and tonic-clonic contractions. No further information is available. HA coded vasovagal reaction and clonic movements and did not upgrade the case. Upon medical internal review the case was upgraded to serious by Company. The outcome is recovered. The case is closed.

VAERS ID:438465 (history)  Vaccinated:2011-09-28
Age:13.0  Onset:2011-09-28, Days after vaccination: 0
Gender:Female  Submitted:2011-10-14, Days after onset: 16
Location:Foreign  Entered:2011-10-14
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: UNK
CDC Split Type: B0753670A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Injection site pain, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), 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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of shock in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 September 2011, the subject received 2nd dose of CERVARIX (0.5 ml, intramuscular, left deltoid). At an unspecified time after vaccination with CERVARIX, the subject experienced shock, facial pallor and injection site pain. On 28 September 2011, less than one day after vaccination with CERVARIX, the subject experienced dyspnea. The physician considered the events were clinically significant (or requiring intervention). 28 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:438755 (history)  Vaccinated:2011-09-30
Age:13.0  Onset:2011-09-30, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 17
Location:Foreign  Entered:2011-10-17
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, 30Sep2011, 80/40mmHg; Blood pressure, 30Sep2011, 110/70mmHg; Heart rate, 30Sep2011, 110bpm
CDC Split Type: B0753702A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Depressed level of consciousness, Pallor
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
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 30 September 2011 (at 18:10), the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 30 September 2011, 10 minutes after vaccination with CERVARIX, the subject experienced anaphylaxis, depressed level of consciousness and facial pallor. The physician considered the events were clinically significant (or requiring intervention). Blood pressure was 80/40 mmHg and heart rate was110 beats/minute. Although the subject responded to calls, decreased level of consciousness was obviously noted. SOLU-CORTEF was administered at 250 mg after securing the administration route and she was transported to the reporter''s hospital by ambulance. She was able to breathe on her own. On 30 September 2011 (around 18:20), the subject recovered her consciousness and was able to respond by the time the ambulance arrived at the hospital. Blood pressure recovered to 110/70 mmHg. On 1 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:438757 (history)  Vaccinated:2011-07-29
Age:13.0  Onset:2011-07-29, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 80
Location:Foreign  Entered:2011-10-17
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: B0750176A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138BA0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Feeling abnormal, Nausea, Pallor, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of vasovagal reaction in a 13-year-old female subject who was vaccinated with CERVARIX. On 29 July 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site and batch number). On 29 July 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced facial pallor, feels poorly, queasy and decreased blood pressure. On 29 July 2011, the events were resolved. Follow-up information received on 05 October 2011 by a physician: This case was upgraded to serious. The subject received the vaccination into the unspecified upper arm. On 29 July 2011, less than one day after vaccination with CERVARIX, the subject experienced the events. Transient feeling poorly and decreased blood pressure had developed and disappeared only with bed rest, so vasovagal reaction was suspected. The physician considered the events were clinically significant (or requiring intervention). No treatment was performed. The subject took a rest for approximately 30 minutes and left for home. The causal relationship was unknown.

VAERS ID:438806 (history)  Vaccinated:2011-10-11
Age:13.0  Onset:2011-10-11, Days after vaccination: 0
Gender:Female  Submitted:2011-10-17, Days after onset: 6
Location:Foreign  Entered:2011-10-17
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: B0755841A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Lip injury, Myoclonus, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of myoclonic jerks in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant previous medical history. On 11 October 2011, the subject received 1st dose of CERVARIX (unknown route of administration, unknown site of injection, batch number not provided). On 11 October 2011, 3 minutes after vaccination with CERVARIX, the subject fainted and experienced 3 myoclonic spasms which resolved within the next moment. In the fall, she also slightly injured her lip. This case was assessed as medically serious by GSK. On 11 October 2011, the events were resolved and the subject left the physician''s office in good condition. The physician considered the events were possibly related to vaccination with CERVARIX. Further details could not be obtained.

VAERS ID:438898 (history)  Vaccinated:2011-08-30
Age:13.0  Onset:2011-08-30, Days after vaccination: 0
Gender:Female  Submitted:2011-10-18, Days after onset: 49
Location:Foreign  Entered:2011-10-18
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, 106/60 mmHg; Blood pressure, 86/40 mmHg; Body temperature, 30Sep2011, 39Deg.C; Body temperature, 01Oct2011, 39Deg.C; C-reactive protein, 01Oct2011, more than 1
CDC Split Type: B0754271A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA143BA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Blood pressure decreased, C-reactive protein, Depressed level of consciousness, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased level of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown site of injection, batch number not provided). 9 minutes after vaccination with 1st dose of CERVARIX, the subject experienced mild decreased blood pressure (86/40 mmHg) and was placed in bed rest. It rapidly improved with leg elevation, and she went home with blood pressure of 106/60 mmHg. On 30 September 2011 at 16:49, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, right upper arm). On 30 September 2011 at 19:00, approximately 3 hours after vaccination with CERVARIX, the subject experienced pyrexia of 39.9 Deg.C and headache. She visited the emergency hospital, but was decided to be followed up and went home. On 1 October 2011, the subject visited the reporter''s hospital, and pyrexia of 39.0 Deg.C and C-reactive protein (CRP) of more than 1 were noted. On 3 October 2011, fever was resolved. At the time of reporting, the outcome of headache was unspecified. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 11 October 2011: The batch number and the site of injection for the 1st dose of CERVARIX were added. On 30 August 2011, the subject received the 1st dose of CERVARIX. On 30 August 2011, the subject also experienced depressed level of consciousness in addition to the previous reported events. The reporter considered the events as clinically significant (or intervention required). Headache was resolved on 1st October 2011.

VAERS ID:439193 (history)  Vaccinated:2011-09-07
Age:13.0  Onset:2011-09-07, Days after vaccination: 0
Gender:Female  Submitted:2011-10-19, Days after onset: 42
Location:Foreign  Entered:2011-10-19
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, 07Sep2011, 80/50mmHg; Oxygen saturation, 07Sep2011, 98%; Pulse rate, 07Sep2011, 38beats/min
CDC Split Type: B0746029A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure abnormal, Fall, Heart rate abnormal, 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), Accidents and injuries (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown deltoid, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 7 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 12 October 2011: The subject had no medical history and no family medical history, she did not have any past history of loss of consciousness. On 7 September 2011, the subject received unspecified dose of CERVARIX (intramuscular, left deltoid). Before the onset of the events, the subject did not have painful/emotional stimulus and she did not present sweat or warmth feeling. She had no predisposing factor, no triggering event and no sign or warning regarding the episode. On 7 September 2011, less than 1 days after vaccination with CERVARIX, when the subject was in the sitting position on a chair, she suddenly fainted and fell leaning towards her mother, with loss of consciousness, facial pallor and pale lips. The symptoms were considered to be attributed to vasovagal reflex. The loss of consciousness lasted for 5 to 10 seconds. Her respiratory pattern was normal and she did not bite her tongue. Vital signs were measured: blood pressure was 80/50 mmHg, pulse rate was 38 beats/minute and saturation of pulse oxymetry was 98%. After she was immediately taken to a bed and placed at rest, she gradually recovered. Her blood pressure and pulse rate returned to normal as well as her complexion for which she was sent home. She did not undergo any special test. The subject did not receive any medical treatment. On 7 September 2011, the events resolved. The subject did not develop any symptoms after she recovered from loss of consciousness and she did not remember anything regarding this episode. The events did not recur. The physician reported that the events were related to vaccination with CERVARIX.

VAERS ID:439322 (history)  Vaccinated:2011-10-12
Age:13.0  Onset:2011-10-12, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 8
Location:Foreign  Entered:2011-10-20
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: UNK
CDC Split Type: B0756078A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Blood pressure decreased, Headache, Immediate post-injection reaction, Pain, Presyncope, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (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 12 October 2011, at 18:00, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown deltoid, batch number not provided). On 12 October 2011, immediately after vaccination with CERVARIX, the subject complained of pain and waited in the waiting room. Disturbed consciousness and decreased blood pressure developed and inhalation of oxygen was performed. Headache and vomiting developed and SOLU-CORTEF was administered. The subject experienced somnolence and she returned home. On 12 October 2011, at 19:30, the subject experienced vomiting. On 12 October 2011, at 21:45, the subject experienced somnolence. On 13 October 2011, the subject stayed away from school. On 14 October 2011, the subject went back to school and recovered from the event. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with oxygen and SOLU-CORTEF. On 14 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:439325 (history)  Vaccinated:2011-10-11
Age:13.0  Onset:2011-10-11, Days after vaccination: 0
Gender:Female  Submitted:2011-10-20, Days after onset: 9
Location:Foreign  Entered:2011-10-20
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: Abdominal neoplasm; Surgery
Diagnostic Lab Data: Blood pressure, 11Oct2011, 96/50mmHg; Body temperature, 11Oct2011, 37.4deg.C; Pulse rate, 11Oct2011, 82bpm
CDC Split Type: B0755677A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Pallor, Presyncope, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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). The subject''s medical history included abdominal neoplasm and surgery. On 11 October 2011, at 16:22, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 11 October 2011, at 16:27, 5 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction, ill complexion, vomiting and queasy. The blood pressure was 96/50 mmHg and pulse rate was 82 bpm. The physician considered the events were clinically significant (or requiring intervention). On 11 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:439329 (history)  Vaccinated:2009-11-01
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-20
Location:Foreign  Entered:2011-10-20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: FORTISIP; Paracetamol; Ergocalciferol; Calcium salt; Potassium citrate
Current Illness: Unknown
Preexisting Conditions: Patient has a family history of renal stones.
Diagnostic Lab Data: Anti-thyroid antibody, 15Nov2010, elevated; Anti-thyroid antibody, 01Jan2011, 1201; Blood electrolytes, 22Jun2010, normal; Body height, 18May2010, 175.9cm; Body height, 22Jun2010, 176.3cm; Body height, 24Aug2010, 176.5cm; Body height, 21Sep2010, 176.5cm; Body height, 11May2011, 176cm; Body height, 14Jul2011, 177cm; Ceruloplasmin, Unknown; Electroencephalogram, 01Dec2009, normal; Electroencephalogram, 22Dec2009, within normal li; Electroencephalogram, 27Jan2010, increase in acti; Electroencephalogram, 01Jan2011, multiple focal s; Free T4, 01Jan2011, 12; Full blood count, 22Dec2009, normal; Full blood count, 22Jun2010, normal; Fundi, 01Dec2009, normal; Fundi, 22Jun2010, normal; Fundi, 15Nov2010, unremarkable; Lactate, Unknown; Liver function
CDC Split Type: B0754949A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aggression, Alopecia, Anti-thyroid antibody positive, Blood electrolytes normal, Blood lactic acid, Blood thyroid stimulating hormone increased, Blood urea normal, Ceruloplasmin, Coagulation test normal, Confusional arousal, Convulsion, Decreased appetite, Depressed mood, Disturbance in attention, Dyskinesia, Electroencephalogram abnormal, Epilepsy, Fall, Fatigue, Fluid intake reduced, Full blood count normal, Fundoscopy normal, Gaze palsy, Grand mal convulsion, Hashimoto's encephalopathy, Head lag, Headache, Heart rate increased, Listless, Liver function test normal, Malaise, Memory impairment, Nuclear magnetic resonance imaging normal, Partial seizures, Personality change, Platelet count decreased, Rash vesicular, Resting tremor, Slow speech, Somnolence, Thyroid function test normal, Thyroxine free normal, Ultrasound kidney normal, Unresponsive to stimuli, Vitamin A, Vitamin E, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (narrow), 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), Hostility/aggression (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via the foreign regulatory authority (# GB-MHRA-ADR 21252377) and described the occurrence of intractable epilepsy in a 13-year-old female subject who was vaccinated with HPV vaccine (unknown manufacturer). Concurrent medications included FORTISIP, paracetamol, ergocalciferol, Calcium and potassium citrate. In November 2009 the subject received unspecified dose of HPV vaccine. In November 2009, within 24 hours of vaccination with HPV vaccine, the subject experienced intractable epilepsy. In 2009 the subject experienced memory disturbance. On an unknown date the subject experienced tonic-clonic seizures. On 14 July 2011 the subject experienced Hashimoto''s encephalopathy. The subject was hospitalised and the regulatory authority reported that the events were disabling. It was reported that the subject presented to the on-call paediatric team with two generalised tonic-clonic seizures and parents report that subject has continued to have between four and five episodes per day of head and eye deviation in the context of remaining conscious. These episodes are very brief. They were deemed to represent focal seizures by the on-call paediatric team. the subject was treated with carbamazepine and CLOBAZAM. This has made the subject quite sleepy. On examination, the subject was extremely well. Subject did seem to be slightly sleepy from taking CLOBAZAM. Subject had no neurocutaneous stigmata and no dysmorphic features. Examination of the subject''s cranial nerves was unremarkable and fundi were normal. The medial temporal structures appeared normal. This potentially represents a focal seizure disorder, with some episodes of secondary generalisation. Subject had a worsening of seizures at night after starting carbamazepine. Carbamazepine stopped and sodium valproate 300 mg twice daily for three days commenced then increasing this to 500 mg twice daily for three days then increase to 700 mg twice daily for three days and a sleep. Electroencephalogram (EEG) recommended. Patient reviewed and was unwell over the weekend, seeming listless and vomiting but patient did not have a temperature. It was recommended that dose of sodium valproate be reduced to 500mg twice daily and patient is now better. Patient feels fine and back to normal. The small fits continue, predominantly at night time, but there are a few fits during the daytime. Patient to continue sodium valproate. Patient reviewed in clinic one month later and patient feels pretty much back to normal, but still gets tired quite quickly. There have been no clinical episodes at all on the last two nights, and the parents reported that there has been decreased frequency overall of the night time episodes. A prolonged EEG (Electroencephalogram) recording was performed in drowsiness and light sleep. During stage two sleep the subject awoke and fumbled with right hand, which she subsequently moved to the right side of head with eye deviation to the right before settling. The EEG changed a few seconds into this event, with a build up of 4-5c/s theta activity over the frontal regions initially, but no epileptiform features. There is also a slight increase in heart rate. The event was confirmed to be typical, and the semiology looks like a focal seizure. The evolution of EEG change would support the diagnosis of a seizure but there is no clear lateralizing or focal onset. The interictal EEG is within normal limits, without focal or epileptiform features. Conclusion: probable seizure. This sleep deprived Electroencephalogram (EEG) was very interesting, and is unusual, because there is subtle evidence of focal seizure disorder, without any epileptiform abnormalities. Subject to carry on treatment without change. Subject to be reviewed in one month. Subject continued to have clinical episodes, approximately twice during the daytime every day, most of which are in the evenings. Subject has not had an episode in school. The frequency of night time episodes is abou

VAERS ID:439473 (history)  Vaccinated:2011-10-04
Age:13.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-21, Days after onset: 17
Location:Foreign  Entered:2011-10-21
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: Asthma; Body mass index; No previous history
Diagnostic Lab Data: Blood pressure, Low
CDC Split Type: B0755319A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Blood pressure decreased, Grand mal convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by the agency (Regulatory Agency # GB-MHRA-ADR 21294378) and described the occurrence of faint in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included asthma and body mass index (low). Historic medications included SERETIDE and Salbutamol. On 4 October 2011 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular). Later that same day, on 4 October 2011, the subject experienced faint and tonic-clonic seizures twice, impending doom and decreased blood pressure. Diagnostic tests showed the subject had low blood pressure. The regulatory authority reported that the events were clinically significant (or requiring intervention). It was reported that the subject was taken to hospital by paramedics. On 4 October 2011, the events were resolved. Verbatim Text: Fainted twice. At both faints had tonic/clonic seizure. Had an impending sense of doom, low blood pressure and body mass index. No previous history. Medically significant: Removed to hospital by paramedics.

VAERS ID:439475 (history)  Vaccinated:2011-09-21
Age:13.0  Onset:2011-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-10-21, Days after onset: 30
Location:Foreign  Entered:2011-10-21
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: UNK
CDC Split Type: B0753703A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA129CA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, 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), Hypoglycaemia (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). Body temperature before vaccination was 35.8 deg. C. On 21 September 2011 (at 11:10), the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 21 September 2011, 5 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction and syncope. The physician considered the events were clinically significant (or requiring intervention). On 21 September 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow up information received on 13 October 2011: On 21 September 2011, the subject experienced also depressed level of consciousness.

VAERS ID:439476 (history)  Vaccinated:2011-06-14
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-21
Location:Foreign  Entered:2011-10-21
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: B0727919A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Flank pain, Pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer and described the occurrence of pain in extremity in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular) given on an unspecified date. On 14 June 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site). On an unspecified date in June 2011, less than one week after vaccination with CERVARIX, the subject experienced pain in extremity, flank pain and pain. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 11 October 2011: This case was upgraded from non-serious to serious because the subject was hospitalised. No further information was expected.

VAERS ID:439914 (history)  Vaccinated:2011-09-20
Age:13.0  Onset:2011-09-20, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 35
Location:Foreign  Entered:2011-10-25
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, 20Sep2011, 38deg. C.
CDC Split Type: B0757185A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Malaise, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer and described the occurrence of decreased consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 20 September 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). On 20 September 2011, less than one day after vaccination with CERVARIX, the subject experienced decreased consciousness (she fell into twilight state), fever (around 38 deg. C.) and feeling sick. She stayed away from school on the following date as a precaution measure. The consumer considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved.

VAERS ID:439915 (history)  Vaccinated:2011-10-04
Age:13.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-10-25, Days after onset: 21
Location:Foreign  Entered:2011-10-25
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, 04Oct2011, 102/70mmHg; Body temperature, 04Oct2011, 36.4deg.C
CDC Split Type: B0757207A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Orthostatic hypertension, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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). Historic medications included METLIGINE. On 4 October 2011, at 16:30, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, left shoulder). On 4 October 2011, at 16:35, 5 minutes after vaccination with CERVARIX, the subject experienced syncope, had complained that she had experienced poor feeling and her vision went dark. The subject was placed in recumbent position from a sitting position. The blood pressure was 102/70 mmHg. The subject''s body temperature before vaccine inoculation was 36.4 C?. The physician considered the events were clinically significant (or requiring intervention). On 4 October 2011, after she had laid down for 30 minutes, the events were resolved, and the subject went home. The physician reported the relationship between the events and the administration with CERVARIX as unassessable and considered the events were related to orthostatic hypertension.

VAERS ID:440244 (history)  Vaccinated:2011-09-14
Age:13.0  Onset:2011-09-16, Days after vaccination: 2
Gender:Female  Submitted:2011-10-26, Days after onset: 40
Location:Foreign  Entered:2011-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin Trihydrate
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0756109A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Lymphadenopathy, Nausea, Neck pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the foreign regulatory authority (Regulatory Agency # GB-MHRA-ADR 21294392) and described the occurrence of a high temperature in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included an ear infection. Concurrent medications included Amoxicillin. On 14 September 2011 the subject received an unspecified dose of CERVARIX (intramuscular, Batch number unknown). On 16 September 2011, two days after vaccination with CERVARIX, the subject experienced high temperature (reported as 35 degrees C), neck pain, headache, dizziness, nausea and a swollen left gland. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 20 September 2011, the events were resolved. MHRA Verbatim Text: High temperature (35 celcius). Neck pain, gland up left side, headache, dizzy, nausea.

VAERS ID:440347 (history)  Vaccinated:2011-09-20
Age:13.0  Onset:2011-09-21, Days after vaccination: 1
Gender:Female  Submitted:2011-10-26, Days after onset: 35
Location:Foreign  Entered:2011-10-27, 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: amoxicillin 14Sep11 - 21Sep11
Current Illness: Tonsillitis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM26350 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from a Health Authority on 17-OCT-2011 under the reference number 2011-007212. This case was medically confirmed. A 13 year old female patient with concurrent tonsillitis at the time of vaccination received a dose of GARDASIL (lot number NM26350, batch number NP26080) 0.5 ml intramuscularly, site not reported on 20-SEP-2011. On 21-SEP-2011, one day post vaccination, the patient experienced a macular rash and pyrexia. The patient had not past history of penicillin allergy and was receiving concomitant "PINAMOX" 250mg from 14-SEP-2011 to 21-SEP-2011. On 21-SEP-2011, one day post vaccination, in the morning, the patient experienced a macular rash on her trunk, arms and palms of her hands. The pyrexia developed on the night of 21-SEP-2011. The patient received corrective treatment with acetaminophen. The events resolved on 24-SEP-2011. At the time of reporting, the patient had recovered. The Health Authority considered the events to be serious due to other medically important condition which required intervention. Other business partner numbers include E2011-06302.

VAERS ID:440351 (history)  Vaccinated:2011-09-23
Age:13.0  Onset:2011-09-24, Days after vaccination: 1
Gender:Female  Submitted:2011-10-26, Days after onset: 32
Location:Foreign  Entered:2011-10-27, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03009
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from the Health Authority on 17-OCT-2011 under the reference number 2011007184. This case was medically confirmed. A 13 year old female patient who was healthy and had not history of human papillomavirus (HPV) lesions and was not receiving any concomitant medication received a dose of GARDASIL (lot and batch number not reported) 0.5 ml intramuscularly, site not reported on 23-SEP-2011. On 24-SEP-2011, one day post vaccination, the patient experienced an eruption on her soles of her feet and palms of her hands. No corrective treatment was reported. At the time of reporting, the patient had not recovered and the event was ongoing (also reported as unknown). Both the agency considered the event to be serious due to other medically important condition which required intervention. Other business partner number included: E2011-06307. No further information is available.

VAERS ID:440352 (history)  Vaccinated:2011-09-16
Age:13.0  Onset:2011-09-16, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 40
Location:Foreign  Entered:2011-10-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body temp, 16Sep11, 37.4
CDC Split Type: WAES1110USA03267
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100900IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Headache, Nasal congestion, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the agency on 14-OCT-2011, Ref: 2011-007163. This case is medically confirmed. A 13 year old female patient with no concomitant medications or medical history and no information available on risk factors, received GARDASIL, 0.5 ml, lot number: NM10090, batch NN40800 intramuscular dose 1 on 16-SEP-2011. On the same date as vaccination, 10 minutes post vaccination, the patient developed weakness and a headache. The patient also experienced nasal congestion after an unknown time. Two hours post vaccination, the patient developed a red rash on her neck, breasts, arms and face. The patient''s weakness persisted for 4 hours and the rash lasted 1 hour. According to the reporter the patient''s rash felt hot, her temperature was 37.4 at one point. The patient was sent to the accident and emergency department for observation. The rash reoccurred while the patient was there but settled again. Corrective treatment included PIRITON. At the time of reporting to the agency the patient fully recovered, date not reported. The agency considered the case to be serious as an other medically important condition requiring intervention. Other business partner number included: E2011-06283. No further information is available.

VAERS ID:441148 (history)  Vaccinated:2011-09-30
Age:13.0  Onset:2011-09-30, Days after vaccination: 0
Gender:Female  Submitted:2011-11-02, Days after onset: 33
Location:Foreign  Entered:2011-11-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0757932A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA085AF IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Inflammation, Muscular weakness, Nerve injury, Oedema peripheral, Pain in extremity, Paraesthesia, Soft tissue disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00073323) and described the occurrence of nerve damage in a 13-year-old female subject who was vaccinated with CERVARIX. On 30 September 2011 the subject received unspecified dose of CERVARIX (intramuscular, Batch number AHPVA085AF). On 30 September 2011, 30 minutes after vaccination with CERVARIX, the subject experienced numbness in finger and arm pain. Approximately 1-2 hours after vaccination, the pain in the upper arm extended to the mid forearm. On 30 September 2011 the patient also experienced nerve damage, soft tissue disorder, hand swelling and muscle weakness upper limb. The regulatory authority reported that the events were disabling. The patient was seen by their GP three times and went to accident and emergency twice. The patient was prescribed paracetamol and ibuprofen. At the time of reporting the events were improved. Verbatim Text: 30 minutes following HPV immunisation felt her arm numb 1-2 hrs later felt pain in upper arm extending down to mid forearm. Arm continues to feel weak with numbness and tingling in fingers. Symptoms persisting. Seen by GP on three occasions, and at A&E twice. Prescribed Paracetamol and Ibuprofen by GP. When seen by A&E, impression more likely to be inflammatory. Advised to rest arm. Reviewed in A&E again - symptoms improving.

VAERS ID:441154 (history)  Vaccinated:2011-09-29
Age:13.0  Onset:2011-09-29, Days after vaccination: 0
Gender:Female  Submitted:2011-11-02, Days after onset: 34
Location:Foreign  Entered:2011-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No known allergies.
Diagnostic Lab Data: UNK
CDC Split Type: B0757550A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA087AC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Muscle rigidity, Slow response to stimuli, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 21303184) and described the occurrence of faint in a 13-year-old female subject who was vaccinated with CERVARIX. On 29 September 2011 the subject received unspecified dose of CERVARIX (intramuscular). On 29 September 2011, three minutes after vaccination with CERVARIX, the subject became very rigid and fainted. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 29 September 2011, the events were resolved. Verbatim Text: After 3 minutes of receiving vaccine patient became very rigid and fainted. Slow to come round, was not aware of what had happened. Medically significant: faint, rigidity.

VAERS ID:441276 (history)  Vaccinated:2011-10-04
Age:13.0  Onset:2011-10-04, Days after vaccination: 0
Gender:Female  Submitted:2011-11-03, Days after onset: 30
Location:Foreign  Entered:2011-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methacholine
Current Illness: Respiratory distress; Respiratory tract malformation; Vocal cord dysfunction
Preexisting Conditions: Hospitalization
Diagnostic Lab Data: Pulmonary methacholine challen, 07Oct2011, 40% resistance
CDC Split Type: D0073156A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BN1UNAR
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Pulmonary function challenge test abnormal, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2011034395) and described the occurrence of exacerbation of respiratory distress in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included hospitalization in March 2010 for respiratory distress. Concurrent medical conditions included recurring respiratory distress from unknown cause since March 2010, possibly due to respiratory tract malformation or vocal cord dysfunction. At the time prior to vaccination respiratory distress was less often experienced. Sports and sleep were unaffected by respiratory distress. Previous vaccination with the first dose of CERVARIX (GlaxoSmithKline), given on 01 September 2011, was well tolerated. On 04 October 2011 the subject received the second dose of CERVARIX (0.5 ml, unknown, unknown deltoid). Approximately two hours post vaccination with the second dose of CERVARIX, on 04 October 2011, the subject experienced exacerbation of respiratory distress. This case was assessed as medically serious by GSK criteria. The subject was not hospitalised for the event. Pulmonary examinations, performed on 07 October 2011, were without pathologic findings. Post inhalation of methacholine for bronchial challenge test pulmonary resistance was increased by 40%. Auscultatory the lungs were free. No signs of dyspnea could be observed. By differential diagnosis other medications as cause of respiratory distress have been excluded. At the time of reporting, on 13 October 2011, the event was unresolved. The vaccination course with CERVARIX was discontinued. No further information will be available.

VAERS ID:441558 (history)  Vaccinated:2011-05-11
Age:13.0  Onset:2011-05-11, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 177
Location:Foreign  Entered:2011-11-07, 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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA04374
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site infection, Injection site pain, Injection site reaction, Pain, Scab, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 13 year old female patient who entered a study. The patient was vaccinated intramuscularly with the first dose of GARDASIL but did not return to complain since she thought some pain and some sight swelling was expected after a vaccination. There was no concomitant therapy. On 17-JUL-2011, a week after receiving the second dose of GARDASIL she came back to the clinic complaining of throbbing pain at the first injection site (left arm) but no pain on the right arm (2nd dose). Examination findings were negative and was advised warm compress. On 12-SEP-2011 the girl came back complaining of a small, 1 cm encrusted shallow lesion on the first dose (left arm) injection site managed with antibiotics and analgesics. The patient had not returned for follow up. The reporting investigator felt that the relationship between the injection site infection, left arm and the study therapy was unknown. The injection site infection, left arm was considered to be an other important medical event by the reporting investigator. No further information is available.

VAERS ID:441560 (history)  Vaccinated:2011-05-12
Age:13.0  Onset:2011-05-12, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 176
Location:Foreign  Entered:2011-11-07, 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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA04375
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site infection, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 13 year old female patient who entered a study. The patient was vaccinated intramuscularly with the first dose of GARDASIL (lot number not reported) and noted 2 days later on 14-MAY-2011 a slight swelling on left arm. On an unspecified day, the patient recovered from injection site infection, left arm-dose 1. However, she did not report/return until her second dose in June where the provider noted a small swelling and given antibiotics and analgesics. But she did not return to complain since she thought some pain and some slight swelling was expected after a vaccination. There was no concomitant therapy. The relationship between the injection site infection, left arm and the study therapy was unknown. The injection site infection, left arm was considered to be an other important medical event by the reporting investigator. Additional information has been requested.

VAERS ID:441709 (history)  Vaccinated:2011-11-01
Age:13.0  Onset:2011-11-01, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 6
Location:Foreign  Entered:2011-11-07
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, 01Nov2011, 110/80mmHg; Oxygen saturation, 01Nov2011, 78%; Oxygen saturation, 01Nov2011, 91%
CDC Split Type: B0760608A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Presyncope, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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 an unspecified date, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown injection site, batch number not provided). On an unspecified date, less than one day after vaccination with CERVARIX, the subject experienced slight fever. The event was recovered the next day. On 1 November 2011, at 17:18, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left arm). On 1 November 2011, at 17:21, 3 minutes after vaccination with CERVARIX, the subject experienced vasovagal reaction with facial pallor, jerkiness and loss of consciousness suddenly. Jerkiness and loss of consciousness lasted for several seconds. After the next vaccination with CERVARIX the fever did not recur. The blood pressure (BP) was 110/80 mmHg. Saturation measured by pulse oximetry (SpO2) was from 91% to 78%. The physician considered the events were clinically significant (or requiring intervention). On 1 November 2011, the events were resolved in several minutes. The physician considered the vasovagal reaction was related to vaccination with CERVARIX.

VAERS ID:441739 (history)  Vaccinated:2011-10-08
Age:13.0  Onset:2011-10-08, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 30
Location:Foreign  Entered:2011-11-07
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: B0759503A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of pneumonia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular) 1st dose given in September 2011. On 8 October 2011, the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). On 8 October 2011, less than one day after vaccination with CERVARIX, the subject experienced pneumonia and fever. The physician considered the events were clinically significant (or requiring intervention). On 11 October 2011, the subject went to hospital where she was prescribed unspecified treatment. At the time of reporting the events were unresolved.

VAERS ID:441748 (history)  Vaccinated:2011-09-13
Age:13.0  Onset:2011-09-20, Days after vaccination: 7
Gender:Female  Submitted:2011-11-07, Days after onset: 48
Location:Foreign  Entered:2011-11-08, 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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Serum C-reactive protein, =<6; serum rheumatoid factor, negative; erythrocyte sedimentation rate, 2; complete blood cell count, normal
CDC Split Type: WAES1111USA00406
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM100900IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein, Full blood count normal, Joint swelling, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was received from the health authority on 28-OCT-2011. Agency ref 2011-007676. This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medication received dose one of GARDASIL (lot # NM10090, batch number NN33040) 0.5ml, IM, on 13-SEP-2011. On 20 Sep-2011, one week post vaccination, the patient developed aches in the middle fingers of both hands with swelling of the distal interphalangeal joint of the right middle finger. The patient was seen by her GP who did bloods and they were all normal including erythrocyte sedimentation rate =2, C-reactive protein =<6, full blood count normal and rheumatoid factor negative. The patient received corrective treatment included non steroidal anti-inflammatories prn. At the time of reporting the patient had not yet recovered. The agency considered the events to be medically significant. Other business partner numbers included E2011-00060.

VAERS ID:441765 (history)  Vaccinated:2011-10-26
Age:13.0  Onset:2011-10-26, Days after vaccination: 0
Gender:Female  Submitted:2011-11-08, Days after onset: 13
Location:Foreign  Entered:2011-11-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pranlukast
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 27Oct2011, 297; Aspartate aminotransferase, 27Oct2011, 387; Aspartate aminotransferase, 01Nov2011, 60; Creatine phosphokinase, 27Oct2011, 111IU/L; Gamma glutamyl transpeptidase, 27Oct2011, 45; Lactate dehydrogenase, 27Oct2011, 405IU/L
CDC Split Type: B0759909A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase normal, Blood lactate dehydrogenase increased, Gamma-glutamyltransferase increased, Headache, Hepatic function abnormal, Musculoskeletal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of liver function disorder in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included asthma. Concurrent vaccination included CERVARIX; GlaxoSmithKline. Concurrent medications included ONON. On 26 October 2011, the subject received the 2nd dose of CERVARIX (0.5 ml, intramuscular, right upper arm). On 26 October 2011, less than one day after vaccination with CERVARIX, the subject experienced liver function disorder, shoulder pain, fever and headache. On 27 October 2011, the subject was admitted to the reporting physician''s hospital just to be on the safe side because abnormal hepatic function was observed. Only fluid therapy was performed. On 1 November 2011, because the subject''s hepatic function had improved, she was discharged from the hospital and the events were considered resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:441845 (history)  Vaccinated:2011-10-03
Age:13.0  Onset:2011-10-07, Days after vaccination: 4
Gender:Female  Submitted:2011-11-08, Days after onset: 32
Location:Foreign  Entered:2011-11-09, 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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory test, 10Oct11, blood test: normal
CDC Split Type: WAES1111USA00476
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124500IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Hypoaesthesia, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by the agency on 28-OCT-2011, Ref: 2011-007474. This case was medically confirmed. A 13 year old female patient with unreported medical history who was not taking any concomitant medications received dose 1 of GARDASIL (batch G005569; lot#NN12450), 0.5 mL intramuscularly on 03-OCT-2011 (side not reported). On 07-OCT-2011, 4 days post vaccination, the patient experienced numbness in the thumb and little finger and decreased power in the left arm. The patient underwent blood tests in hospital on 10-OCT-2011 and was informed that these were normal. At the time of reporting to the agency the patient still had decreased power in her left arm and had not recovered. The agency considered the case to be serious as an other medically important condition. Other business partner numbers include E2011-06671.

VAERS ID:441914 (history)  Vaccinated:2011-11-04
Age:13.0  Onset:2011-11-04, Days after vaccination: 0
Gender:Female  Submitted:2011-11-09, Days after onset: 5
Location:Foreign  Entered:2011-11-09
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: UNK
CDC Split Type: B0761065A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA1149AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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 4 November 2011, at 16:35, the subject received the 1st dose of CERVARIX (intramuscular, left deltoid). On 4 November 2011, at 16:38, 3 minutes after vaccination with CERVARIX, the subject had experienced facial pallor and fell into a state of syncope. She was laid down and was placed in observation with her legs elevated. She recovered in about 30 seconds. The physician considered the events were clinically significant (or requiring intervention). On 4 November 2011, the events were resolved. At passed 17:30, the subject went home. The physician considered the events were related to vaccination with CERVARIX and that the event was a typical episode of vasovagal reflex. Regarding the next inoculation, both the patient and her mother wished to receive it, so it was planned to be proceeded.

VAERS ID:442268 (history)  Vaccinated:2011-08-23
Age:13.0  Onset:2011-08-23, Days after vaccination: 0
Gender:Female  Submitted:2011-11-11, Days after onset: 80
Location:Foreign  Entered:2011-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 24Aug2011, 15U/L; Alanine aminotransferase, 26Aug2011, 15U/L; Alanine aminotransferase, 28Aug2011, 12U/L; alanine aminotransferase, 02Sep2011, 17U/L; aspartate aminotransferase, 24Aug211, 21U/L; aspartate aminotransferase, 26Aug2011, 20U/L; aspartate aminotransferase, 02Sep2011, 17U/L; body temperature, 24Aug2011, 40deg.C; C-reactive protein, 24Aug2011, 4.57mg/dl; C-reactive protein,28Aug2011, 0.43mg/dl; C-reactive protein, 02Sep2011, 0.07mg/dl; CSF cell count, 24Aug2011, 4/3mm3; cerebrospinal fluid glucose, 24Aug2011, 77.0; Cerebrospinal fluid protein, 24Aug2011, 16.0; Computerized tomogram abdomen, 26Aug2011, no problem, computerized tomogram head, 26Aug2011, no problem; hemoglobin, 24Aug2011, 13.0g/dL; hemoglob
CDC Split Type: B0742838A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Bacterial infection, Blood lactate dehydrogenase increased, C-reactive protein increased, CSF cell count normal, CSF glucose increased, CSF protein normal, Computerised tomogram abdomen normal, Computerised tomogram head normal, Culture negative, Feeling abnormal, Haemoglobin normal, Headache, Injection site pain, Neutrophil percentage decreased, Neutrophil percentage increased, Platelet count, Procalcitonin, Pyrexia, Vaccination complication, Vomiting, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
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). On 23 August 2011, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site and batch number). On 23 August 2011, less than one day after vaccination with CERVARIX, the subject experienced fever and headache. On 24 August 2011, the subject experienced vomiting. On 25 August 2011, fever and headache were resolved. On 26 August 2011, headache reoccurred. The subject was hospitalised. At the time of reporting, the outcome of vomiting was unspecified and headache was no resolved. Follow-up information received on 31 October 2011: At an unspecified dates, the subject received the 2 first inoculations with CERVARIX, and only injection pain was observed. On 23 August 2011, within hours after vaccination, the subject experienced feeling poorly, headache and pyrexia. On 24 August 2011, the symptoms persisted, and the subject experienced vomiting in the morning. She had pyrexia (40 deg. C) and headache. She was referred and admitted to the hospital. As some kind of bacteria infection was suspected, the subject was treated with CLAFORAN and CALOANAL. The lab results performed on that day were: Alanine aminotransferase: 15 U/L, aspartate aminotransferase: 21 U/L, C-reactive protein: 4.57 mg/dL (was considered as high value). Haemoglobin:13 g/dL, lactate dehydrogenase: 210 U/L, neutrophils:93 %, platelet count: 13.3 X10^4/mcL. White blood cells: 7800 /mcL. Cerebrospinal fluid examination was performed and results were normal (cell count 4/3 mm3, protein: 16.0, glucose: 77.0). On 25 August 2011, fever was resolved. On 26 August 2011, headache and vomiting were aggravated. Lab tests were performed and the results were: Alanine aminotransferase: 15 U/L, aspartate aminotransferase: 20 U/L, C-reactive protein: 1.6 mg/dL, haemoglobin: 14.1 g/dL, lactate dehydrogenase:203 U/L, neutrophils: 50 %, platelet count: 11.2 x10^4/mcL, white blood cells: 2600 /mcL. In addition, a head and a abdomen computed tomography''s were performed and showed no problem. On 27 August 2011, the symptoms (except decrease white blood cell) disappeared. Lab results were: Alanine aminotransferase: 12 U/L, aspartate aminotransferase: 17 U/L, C-reactive protein: 0.43 mg/dL, haemoglobin: 13 g/dL, lactate dehydrogenase: 160 U/L, neutrophils: 35. 2%, platelet count: 13.7 x10^4/mcL, white blood cells: 3000 /mcL. On 28 August 2011, the subject was discharged from the hospital. On 02 September 2011, decreased white blood cell was resolved. Lab results were: alanine aminotransferase: 17 U/L, aspartate aminotransferase: 17 U/L, C-reactive protein: 0.07 mg/dL, haemoglobin: 12.7 g/dL, lactate dehydrogenase: 177 U/L, neutrophils: 44.8 %, platelet count: 22.3 x10^4/mcL, white blood cells: 4800 /mcL. The reporter stated that pyrexia, headache and vomiting was related to CERVARIX and the causality between decreased white blood cell and CERVARIX was unknown. As the cell culture were all negative, the reporting physician judged that it was highly likely that the event was an adverse reaction to CERVARIX.

VAERS ID:442309 (history)  Vaccinated:2011-09-08
Age:13.0  Onset:2011-09-08, Days after vaccination: 0
Gender:Male  Submitted:2011-11-10, Days after onset: 63
Location:Foreign  Entered:2011-11-14, Days after submission: 4
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1110USA03967
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0893Z1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoacusis, Hypotension, Pallor, Pulse absent, Slow response to stimuli
SMQs:, Anaphylactic reaction (broad), 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), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from an agency via Public Case Detail (local reference # AUS/11/1451, OPR # 289126) concerning a 13 year old male who on 08-SEP-2011 was vaccinated with the second dose of RECOMBIVAX HB (lot # 668563/0893Z, batch # R3086). 14 minutes post vaccination the patient became pallor, slow response to voice, hypotensive- unable to locate pulse and stated he could not hear. The patient was laid on floor, Oxygen was administered, response slow and relapse when oxygen removed. The patient was taken to hospital. At the time of reporting, the patient had not yet recovered. The agency assessed the causality as possible. Follow-up information has been received from the agency. The event seriousness should be considered to be hospitalization. The original reporting source was not provided. No further information is available.

VAERS ID:442631 (history)  Vaccinated:2011-09-01
Age:13.0  Onset:2011-09-01, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 75
Location:Foreign  Entered:2011-11-15
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: Blood pressure, 01Sep2011, 80/40mmHg
CDC Split Type: B0761985A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, 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), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 September 2011, at 11:45, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left arm). On 1 September 2011, at 11:45, immediately after vaccination with CERVARIX, the subject experienced loss of consciousness. Her blood pressure was 80/40 mmHg. Tachycardia was not observed. She was placed at bed rest for around 10 minutes and regained consciousness, so she was sent home. The physician considered the event was clinically significant (or requiring intervention). On 1 September 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:443778 (history)  Vaccinated:2011-09-28
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-28
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, Nov2011, Negative finding; Urine culture, No anomaly; On 3 November 2011 a glandular fever screen was negative
CDC Split Type: B0763278A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Balance disorder, Blood test normal, Culture urine negative, Dizziness, Epstein-Barr virus test negative, Flushing, Hot flush, Nausea, Pollakiuria, Syncope, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of fainting in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 28 September 2011 the subject received an unspecified dose of CERVARIX (1 injection, intramuscular). On an unknown date, less than one month after vaccination with CERVARIX, the subject experienced nausea, imbalance and hot and cold flushes. On 24 October 2011 the patient''s mother reported the patient was missing school due to these events. The patient was treated with PARAMEX. On 31 October 2011 the patient''s mother called the general practitioner and reported the patient was still experiencing nausea and hot and cold flushes. The mother also reported that the patient had experienced dizziness. The patient had no abdominal pain or cough and the vital signs were normal. the patient had also experienced urinary frequency and therefore a diagnosis of a possible urinary infection was made. However a urine specimen was taken and this showed no anomalies. On 3 November 2011 a glandular fever screen was negative. On 4 November 2011, approximately 37 days after vaccination with CERVARIX, the patient presented to the general practitioner with feelings of weakness and fainting. The symptoms of nausea had improved since using PARAMEX. A blood test was performed but this showed ''negative findings''. On 10 November 2011 the patient was reviewed by her general practitioner; hot and cold flushes and fainting persisted but the nausea had improved. The patient was then prescribed STEMETIL for the nausea. This case was assessed as medically serious by GSK. At the time of reporting the nausea was improved but the outcome of the other events was unspecified.

VAERS ID:443815 (history)  Vaccinated:2011-10-17
Age:13.0  Onset:2011-10-18, Days after vaccination: 1
Gender:Female  Submitted:2011-11-28, Days after onset: 41
Location:Foreign  Entered:2011-11-28
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, 18Oct2011, 39.2deg.C
CDC Split Type: B0759496A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Eczema, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On 17 October 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 18 October 2011, 1 day after vaccination with CERVARIX, the subject experienced fever. At the time of reporting the outcome of the event was unspecified. Additional information received on 27 October 2011: Concomitant vaccination included 1st dose of CERVARIS, received on 16 September 2011. On 17 October 2011, the subject received the second dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number was provided). On 18 October 2011, 1 day after vaccination with CERVARIX, the subject experienced fever and arthralgia. On 19 October 2011, the event fever resolved. On 25 October 2011, 8 days after vaccination with CERVARIX, the subject experienced eczema. At time of reporting, the outcome of the events arthralgia and eczema was unknown. Additional information received on 11 November 2011: On 18 October 2011, in the morning, the subject experienced arthralgia. On 18 October 2011, in the afternoon, the subject presented with pyrexia of 39.2 degrees Centigrade. She took CALONAL at 300 mg (3 tablets x1/day, which was discontinued in 1 day because defervescence was obtained) and CLARITH at 200 mg each in the afternoon and the night. On 19 October 2011, defervescence was obtained and headache and arthralgia had resolved. On 25 October 2011, the subject visited the reporting physician''s hospital. She presented with eczema on the cheeks and inner sides of the knees. CLARITIN was prescribed. Because the subject did not visit the reporting physician''s hospital after 25 October 2011, the clinical course of the eczema was unknown. The reporter considered the events pyrexia, headache and arthralgia as related to CERVARIX. Additional information received on 18 November 2011: This case was upgraded from non serious to serious adverse event. On 17 October 2011, the subject received the second dose of CERVARIX in the left shoulder. The reporting physician considered the event as clinically significant/requiring intervention.

VAERS ID:443837 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 12
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CAT, 16Nov2011, Normal; Lumbar puncture, 16Nov2011, Normal; Neurological examination, 16Nov2011, Normal
CDC Split Type: B0764830A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Dizziness, Dyskinesia, Dysstasia, Gait disturbance, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle spasms, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (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), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by another health professional via a regulatory authority (# ES-AGEMED-608009345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history. On 16 November 2011, the subject received 1st dose of CERVARIX (intramuscular, injection site unknown). On 16 November 2011, less than one day after vaccination with CERVARIX, the subject experienced headache, dizziness and uncontrolled contracture in legs. The article mentioned seizures. The movements were described by the pharmacist as muscular spasms with tremor in legs and instability that was bigger when standing up. The regulatory authority added myalgia, fever, nausea and paresthesia which later involving in leg fasciculations. She had no loss of consciousness. The subject went to the emergency room. A neurological examination and brain CAT were performed and showed normal results and a lumbar puncture was also done where encephalitis was discharged. The subject was hospitalised on 18 November 2011 with cephalea, dizziness and uncontrolled movements of the legs. And the regulatory authority reported that the events were clinically significant (or requiring intervention). The events showed a good evolution. And the neurologist has not been able to see the movements of the legs in this subject. The subject was initially treated with RIVOTRIL (withdrawn), and after with paracetamol (1g/8h) and ibuprofen (600mg/8h) with good response. On 18 November 2011, headache, dizziness, leg fasciculation, paresthesias, fever, nausea and myalgia were resolved. On 23 November 2011, the other events were improved, but the subject vomited. At the time of reporting the outcome of vomiting was unspecified. The reporters described 2 other similar cases. Please see case B0764827A for details about the other subjects.

VAERS ID:443840 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 12
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Anorexia nervosa; Recurrent headache; Vaccine reaction
Diagnostic Lab Data: CAT, 16Nov2011, Normal; Lumbar puncture, 16Nov2011, Normal; Neurological examination, 16Nov2011, Normal
CDC Split Type: B0764827A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Coordination abnormal, Dizziness, Dyskinesia, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle contracture, Muscle spasms, Muscular weakness, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (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), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by another health professional via a regulatory authority (# ES-AGEMED-508008345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included anorexia nervosa, recurrent headache since the age of 4 years and reaction to the allergy vaccines. On 16 November 2011, the subject received 1st dose of CERVARIX (intramuscular, injection site unknown). On 16 November 2011, less than 1 day after vaccination with CERVARIX, the subject experienced heavy headaches, dizziness and uncontrolled movements in both legs. The physician reported bilateral muscular weakness and continuous muscular contracture in legs. The article mentioned seizures. The movements were described by the pharmacist as muscular spasms with tremor in legs and instability that was bigger when standing up. The regulatory authority added myalgia, fever, nausea and paresthesia which later involving in leg fasciculations. She had no loss of consciousness. The subject went to the emergency room. A neurological examination and brain CAT were performed and showed normal results and a lumbar puncture was also done where encephalitis was discharged. The subject was hospitalised on 18 November 2011 with cephalea, dizziness and uncontrolled movements of the legs. And the regulatory authority reported that the events were clinically significant (or requiring intervention). The events showed a good evolution. The subject was initially treated with RIVOTRIL (withdrawn), and after with paracetamol (1g/8h) and ibuprofen (600mg/8h). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the leg fasciculation, paresthesia, myalgia, fever and nausea were probably related to vaccination with CERVARIX. The reporters described 2 other similar cases. Please see cases B0764830A and B0764836A for details about the other subjects.

VAERS ID:443857 (history)  Vaccinated:2011-10-26
Age:13.0  Onset:2011-10-26, Days after vaccination: 0
Gender:Male  Submitted:2011-11-28, Days after onset: 33
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Electrocardiogram, 26Oct2011, Normal; Oxygen saturation, 26Oct2011, Normal; Pulse rate, 26Oct2011, Normal
CDC Split Type: B0763334A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB720AL IMUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure increased, Convulsion, Electrocardiogram normal, Heart rate normal, Oxygen saturation normal, Presyncope
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by another health professional via a regulatory authority (ES-AGEMED-724511341) and described the occurrence of vasovagal reaction in a 13-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), DIFTAVAX (non-gsk). On 26 October 2011, the subject received unspecified dose of ENGERIX B (.5 ml, intramuscular, injection site unknown) and unspecified dose of DIFTAVAX (intramuscular, injection site unknown). DIFTAVAX was administered 5 minutes before ENGERIX B. On 26 October 2011, 7 minutes after vaccination with DIFTAVAX and 2 minutes after vaccination with ENGERIX B, the subject experienced convulsion and elevated blood pressure which lasted 2 to 3 minutes. When he was being sit up, he experienced again convulsions, recovering in two minutes afterwards. He was referred to the emergency room where he was monitored. The regulatory authority reported that the events were clinically significant (or requiring intervention). Relevant tests were performed and showed normal pulse, normal electroencephalogram and normal oxygen saturation. The subject was diagnosed in the emergency room with vasovagal syndrome. At the time of reporting, 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:444130 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-30
Location:Foreign  Entered:2011-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: There were other psychosocial factors that may have contributed to the low mood and subsequent overdose. The vaccine was administered at school so I am unable to provide more information.
Diagnostic Lab Data: UNK
CDC Split Type: B0764842A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Intentional overdose, Mood altered, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Drug abuse and dependence (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by the regulatory authority (# GB-MHRA-EYC 00075517) and described the occurrence of an intentional overdose in a 13-year-old female subject who was vaccinated with papilloma type 16 + 18 vaccine. Previous vaccinations included the 1st dose of human papilloma type 16 + 18 vaccine given on an unspecified date. On an unspecified date the subject received the 2nd dose of human papilloma type 16 + 18 vaccine (manufacturer unknown). At an unspecified time after vaccination with human papilloma type 16 + 18 vaccine, the subjects experienced a rapid deterioration in mood. The patient then took a ''significant'' intentional overdose of medication in an attempted suicide. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. Following a 2nd Human Papilloma Virus vaccine the patient in question and her mother reported a rapid deterioration in her mood resulting in a significant overdose of medication intending to kill oneself.

VAERS ID:444536 (history)  Vaccinated:2011-08-25
Age:13.0  Onset:2011-09-26, Days after vaccination: 32
Gender:Female  Submitted:2011-12-05, Days after onset: 70
Location:Foreign  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pneumonia
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0766651A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146AA IMUN
JEVX: JAPANESE ENCEPHALITIS (NO BRAND NAME)UNKNOWN MANUFACTURERJR0861SCRA
Administered by: Other     Purchased by: Other
Symptoms: Antibody test positive, Asthenia, Blood test, CSF test, Gait disturbance, Guillain-Barre syndrome, Muscular weakness, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Vasculitis (broad), Hypersensitivity (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of Guillain Barre syndrome in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included pneumonia. On 25 August 2011, in the morning, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular). On 25 August 2011, in the morning, the subject simultaneously received the 2nd dose of vaccination of Japanese encephalitis vaccine (Biken; 0.5 ml, subcutaneous, right upper arm). On 26 September 2011, in the afternoon, 32 days after vaccination with CERVARIX and Japanese encephalitis vaccine, sudden weakness, difficulty in walking, muscle weakness of the extremities and sensory disturbance were observed. Judging from the results of blood test and cerebrospinal fluid examination, the reporting physician was negative in determining the events to be other diseases. Antiglycolipid antibody in blood showed positive and the physician reached a diagnosis of Guillain-Barre syndrome. On 27 September 2011, the subject was admitted to the hospital. The physician considered the events were disabling. At the time of reporting the outcome of the event Guillain-Barre syndrome was resolved with sequelae (difficulty in walking) and the outcome of the other events was unspecified. The physician considered the events were related to simultaneous vaccination with CERVARIX and Japanese encephalitis vaccine.

VAERS ID:444538 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-05, Days after onset: 19
Location:Foreign  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CAT, 18Nov2011, Normal; Lumbar puncture, 18Nov2011, Normal; Neurological examination, 18Nov2011, Normal
CDC Split Type: B0764836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Dizziness, Dyskinesia, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle contracture, Muscular weakness, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (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), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by a regulatory authority (# ES-AGEMED-608009345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history. On 16 November 2011, the subject received unspecified dose of CERVARIX (route and injection site unknown). On 16 November 2011, less than one day after vaccination with CERVARIX, the subject experienced headaches, dizziness and uncontrolled movements in both legs. The physician reported bilateral muscular weakness and continuous muscular contracture in legs. The article mentioned seizures. The regulatory authority added myalgia, fever, nausea, paresthesia and leg fasciculation. She did not loss of consciousness at any time. On 18 November 2011, the subject went to the emergency room: a neurological examination and brain CAT were performed and showed normal results. A lumbar puncture was also done: encephalitis was ruled out. The subject was treated with RIVOTRIL and paracetamol with good response and was discharged. On 18 November 2011, according to the regulatory authority leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were resolved. The subject was hospitalised on 22 November 2011 and the regulatory authority considered the events were clinically significant (or requiring intervention). However the events were improved (according to the pharmacist), the subject was hospitalised for assessment due to 2 similar cases reported. The neurologist has not been able to see the movements of the legs in this subject. At the time of reporting, leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were resolved and the other events were improved. Follow-up information received on 28 November 2011 from regulatory authority: At the time of follow-up, leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were unresolved. The reporters described 2 other similar cases. Please see case B0764827A for details about the other subjects.

VAERS ID:444541 (history)  Vaccinated:2009-05-12
Age:13.0  Onset:2009-05-12, Days after vaccination: 0
Gender:Female  Submitted:2011-12-05, Days after onset: 937
Location:Foreign  Entered:2011-12-05
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: B0766181A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: General physical health deterioration
SMQs:
Write-up: This case was reported by a consumer via a regulatory authority (# NL-LRB-129789) and described the occurrence of general health deteriorated in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concomitant medication was not reported. The subject had no known medical history or past drug therapy. On 12 May 2009, the subject received unspecified dose of CERVARIX (intramuscular, left upper arm, batch number not provided). On 12 May 2009, 60 minutes, after vaccination with CERVARIX, the subject experienced general health deteriorated. The subject was hospitalised. At the time of reporting the event was improved. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. There was no further information.

VAERS ID:444732 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-06
Location:Foreign  Entered:2011-12-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomogram, not provided; electroencephalogram, not provided
CDC Split Type: B0767241A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B056CB SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of seizure in a 13-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX (unknown route of administration, unknown site of injection, batch number not provided). At an unspecified time after vaccination with BOOSTRIX, the subject experienced seizure and fainting. The subject was hospitalised for 1 day. An electroencephalogram and a computerized tomogram scan were performed but no result was provided. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:444786 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-06
Location:Foreign  Entered:2011-12-07, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA00024
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depressed mood, Intentional overdose, Suicide attempt
SMQs:, Suicide/self-injury (narrow), Drug abuse and dependence (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: This case was received from the Health Authority on 24-NOV-2011 under the reference number ADR21362889. This case was medically confirmed. A 13 year old female patient with unreported medical history and concomitant medication received a second dose of GARDASIL (manufacturer unknown), (batch number not reported) on an unreported date. On an unreported date, post vaccination, the patient experienced a rapid deterioration in her mood resulting in a significant overdose of medication (unspecified) intending to kill herself. At the time of reporting, the patient had recovered on an unreported date. The regulatory authority considered the event to be serious due to other medically significant reason. Other business partner numbers included: E2011-07519. No further information is available.

VAERS ID:444895 (history)  Vaccinated:2011-09-21
Age:13.0  Onset:2011-10-02, Days after vaccination: 11
Gender:Female  Submitted:2011-12-07, Days after onset: 66
Location:Foreign  Entered:2011-12-07
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: UNK
CDC Split Type: B0765690A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA083EB IMAR
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority via a healthcare professional and described the occurrence of fit (non-epileptic) in a 13-year-old female subject who was vaccinated with CERVARIX. On 21 September 2011 and 16 October 2011 the subject received unspecified dose of CERVARIX (1 IU Axa, intramuscular). On 2 October 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced fit (non-epileptic) and faint. The healthcare professional considered the events were clinically significant (or requiring intervention). On 16 October 2011, the events were resolved. MHRA Verbatim Text: No known history of convulsions. First vaccine given and had first fit. Second vaccine given, fainted next day out for forty minutes. Had fit six days later. Now being investigated by Neurologist.

VAERS ID:444865 (history)  Vaccinated:2011-10-24
Age:13.0  Onset:2011-10-24, Days after vaccination: 0
Gender:Female  Submitted:2011-12-07, Days after onset: 44
Location:Foreign  Entered:2011-12-08, 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: Unknown
Preexisting Conditions: Fell from standing position
Diagnostic Lab Data: Blood pressure, 24Oct2011, 108/59mmHg; Pulse rate, 24Oct2011, 57bpm
CDC Split Type: B0759504A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Fall, Loss of consciousness, Malaise, Syncope, Visual impairment
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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 two unspecified dose of CERVARIX (intramuscular, unknown injection site, batch number not provided). At an unspecified time after unspecified vaccination with CERVARIX, the subject experienced syncope. 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 received on 30 November 2011: The subject''s medical history included fell from standing position when she was in elementary school although she did not remember what she was doing at that time (It was unknown whether it was loss of consciousness or not). The subject had no painful/emotional stimulus before the onset of the event. It was unknown if the subject had sweating before the onset of the event, but she probably did not sweat heavily. She did not feel warmth. The subject did not experience any abnormalities before the inoculation and did not complain of severe pain immediately after the inoculation. Concurrent vaccination included CERVARIX (GlaxoSmithKline, intramuscular, left arm, batch number not provided) given on 3 September 2011. No problem was noted. On 24 October 2011, around 16:10, the subject received 2nd dose of CERVARIX (intramuscular, left arm). Because the waiting room was crowded, the subject was waiting in the standing position. On 24 October 2011, approximately 5 minutes later, she noticed sickness and darkened vision and hunkered down. Immediately after she stood up again on her own. But she soon presented with disturbed consciousness and weakness with swaying feeling followed by fall. She experienced loss of consciousness for a few seconds. No convulsion was observed. Immediately after that, she regained her consciousness and was placed on a bed. Her consciousness became lucid and no paralysis of the hands or feet was observed. She did not present with vomiting. On 24 October 2011, at 16:20, blood pressure was 108/59 mmHg and pulse rate was 57 beats/minute (regular). Subsequently, she lay down on a bed and took a rest for approximately 30 minutes. She did not present with abnormalities at all and walked home. It was more likely that the event developed suddenly as the subject noticed sickness and darkened vision immediately before the onset of the event. The subject experienced swaying feeling and weakness followed by fall. The subject''s complexion was normal. The subject lost consciousness for several seconds. The subject''s respiratory pattern was normal. The subject''s movement was normal but at the time of the onset of the event weakness was noted. The subject had no tongue biting. It could not be confirmed if the subject completely lost her consciousness because the loss of consciousness lasted for a few seconds only. The subject did not receive any medical treatment or medication. The event resolve while the subject was placed on a bed. Blood pressure was 108/59 mmHg and pulse rate was 57 beats/minute. No symptom developed after the subject recovered from loss of consciousness. Regarding loss of consciousness, the subject remembered that she noticed sickness and darkened vision and subsequently experienced loss of consciousness. The subject did not undergo any special test. The event did not recur. The physician considered the events were clinically significant (or requiring intervention). On 24 October 2011, the events were resolved after 35 minutes. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:444912 (history)  Vaccinated:2011-01-17
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-07
Location:Foreign  Entered:2011-12-08, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body weight measurement, ??Jan11, Unusual weight loss
CDC Split Type: WAES1112USA00232
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abnormal loss of weight, Central nervous system lesion, Dizziness, Educational problem, Fatigue, Headache, Hyperhidrosis, Immediate post-injection reaction, Muscle spasms, Nausea, Paralysis, Photophobia, Photopsia, Visual impairment
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Case received from a lawyer on 30-NOV-2011. Case was not medically confirmed. A 13 year old female patient received a dose of GARDASIL (lot number, dose, injection route, and site not reported) on 17-JAN-2011. "Immediately after vaccination" she presented with dizziness, headache, abdominal cramps, nausea, vision abnormal, sweating attacks, muscle cramps in extremities, permanent fatigue, "paralysis in one side of the head", light sensitivity to eye, vision of flashes with black points, unusual weight loss and extreme decrease of school performance. Symptoms were ongoing at the time of reporting. The lawyer suggested that the vaccine would have caused a lesion of the central nervous system. All the events were considered as other important medical events by the reporter. Other business partner number included: E2011-07639. No further information is available.

VAERS ID:445241 (history)  Vaccinated:2011-06-14
Age:13.0  Onset:2011-06-14, Days after vaccination: 0
Gender:Female  Submitted:2011-12-12, Days after onset: 181
Location:Foreign  Entered:2011-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 15Jun2011, normal
CDC Split Type: B0732511A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA122AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Injection site erythema, Myalgia, Pain, Poor quality sleep, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of generalized pain in a 13-year-old female subject how was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 2 May 2011. On 14 June 2011, the subject received 2nd dose of CERVARIX (intramuscular, left arm). On 14 June 2011, at night, within hours of vaccination with CERVARIX, the subject experienced generalized paroxysmal pain. Pain sites were different every time such as trunk or thighs, and the patient subjectively felt a pain just like myalgia. The duration of the pain was short, lasting for a few seconds, and the pain was paroxysmal. On 15 June 2011, the subject visited the emergency room where a blood test was performed and showed no abnormalities. On 17 June 2011, 3 days after vaccination with CERVARIX, the subject experienced redness of 1 mm and needle mark at vaccination site. The subject complained that the frequency of the pain was high, and it occasionally occurred at intervals of approximately 3 minutes, to the point which it was so severe as to cause her to wake up at night. In the sites where the subject complained of pain, objective findings such as redness or tenderness were not observed. Since the subject''s parents were worried about whether she had fibromyalgia syndrome, she was referred to a pediatrician. The subject was treated with CALONAL, LOXONIN and DEPAS, which were ineffective. At the time of reporting the outcome of the events was unspecified. The physician considered the events were related to vaccination with CERVARIX. This case was upgraded to serious upon follow-up information received on 6 December 2011: On 14 June 2011, at 17:33, the subject received 2nd dose of CERVARIX (intramuscular, left arm). On 14 June 2011, around 21:00, paroxysmal pain was observed intermittently to the extent that it caused sleep disorder. Hardly any improvement of the symptom was observed using analgesic drugs. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the pain was unresolved and the outcome of the other events was unspecified.

VAERS ID:445453 (history)  Vaccinated:2011-09-12
Age:13.0  Onset:2011-09-12, Days after vaccination: 0
Gender:Female  Submitted:2011-12-14, Days after onset: 93
Location:Foreign  Entered:2011-12-14
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: UNK
CDC Split Type: B0768672A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by pharmacist and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 September 2011, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). On 12 September 2011, 4 to 5 minutes after vaccination with CERVARIX, the subject experienced syncope and loss of consciousness. One minute later, the subject regained consciousness. Subsequently, the subject was placed under observation for 30 minutes and no problem was observed. Therefore, she left for home. The pharmacist considered the events were clinically significant (or requiring intervention). On 12 September 2011, the events were resolved. The pharmacist considered the events were related to the action of injection of CERVARIX.

VAERS ID:445784 (history)  Vaccinated:2011-11-28
Age:13.0  Onset:2011-11-28, Days after vaccination: 0
Gender:Female  Submitted:2011-12-19, Days after onset: 21
Location:Foreign  Entered:2011-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Penicillin Allergy; Skin Sensitization; First dose CERVARIX received last month with no reaction
Diagnostic Lab Data: UNK
CDC Split Type: B0768118A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lip pain, Lip swelling, Nausea, Oral pain, Tongue disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-EYC 00076175) and described the occurrence of swollen lips in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included penicillin allergy and kin sensitization. The subject had received a 1st dose of CERVARIX. On 28 November 2011 the subject received a 2nd dose of CERVARIX. On 28 November 2011, 20 minutes after vaccination with CERVARIX, the subject experienced swollen lips and nausea. Throughout the day her mouth and lips felt sore and her tongue felt "thick" and she remained nauseated. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. MHRA Verbatim Text: Approximately 20 minutes after immunisation child felt swollen lips and nauseated. Throughout the day her mouth and lips felt sore and her tongue felt "thick" and she remained nauseated. Mum gave her a liquid antihistamine around 5pm and then later in the evening again.

VAERS ID:446014 (history)  Vaccinated:2008-10-13
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-21
Location:Foreign  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Celiac disease
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0596575A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA021BA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Alopecia, Aphonia, Arthralgia, Asocial behaviour, Balance disorder, Chronic fatigue syndrome, Crying, Dysphonia, Fall, Fatigue, Feeling abnormal, Frustration, Gait disturbance, Headache, Malaise, Neck pain, Oropharyngeal pain, Parosmia, Photophobia, Posture abnormal, Pyrexia, Viral infection, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer (patient''s mother) and described the occurrence of loss of balance in a 14-year-old female patient who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included celiac disease. On unspecified dates and in 2009 the patient received 1st dose, 2nd dose and 3rd dose of CERVARIX (1 injection, unknown). At an unspecified time after vaccination with 1st dose of CERVARIX, the patient felt unwell. At an unspecified time after vaccination with CERVARIX, the patient experienced loss of balance, hair loss, voice alteration ("to that of a horror movie actor, very scary"), constant headaches, walking difficulty and tiredness. It was reported that "the majority of her symptoms arose after the third dose was administered". It was reported that "the patient has seen a neurologist and a psychiatrist, visited hospital as an outpatient" but "the treating physicians were not able to diagnose her with anything". At the time of reporting the events were unresolved. Verbatim text received: On 5 th October 2009 a consumer reported that her daughter 14 years of age was administered a full course of CERVARIX and completed the three dose course at the beginning of 2009 (dates unknown). It was reported that after her first dose she felt unwell. The majority of her symptoms arose after the third dose was administered (dates unknown). The reporter explained that her daughter now suffers from a loss of balance; her voice has changed ''to that of a horror movie actor, very scary''. She still suffers from constant headaches, is always tired and due to the loss of balance she has difficulty in walking. It was also reported that she has also experienced substantial hair loss. It was reported that she has seen a neurologist, psychiatrist, visited hospital as an outpatient, but was not kept in overnight. The treating physicians were not able to diagnose her with anything. It was also reported that the patient suffers from Celiac disease. The symptoms reported have not been resolved. At the time of report, no further information was available. Follow up received on 23 October 2009: It was reported that the patient received first dose of CERVARIX (AHPVA 021BA) on 13 October 2008, second dose (batch number AHPVA 024BA) on 17 November 2009 and third dose (batch number AHPVA 057CA) on 31 March 2009. Follow up received on 14 December 2011 from the subject''s mother: Physical assessment of the patient prior to vaccination: -Very active child - Very communicative child - Very energetic child - Healthy (in 8 years saw the GP once) - Scooter, bicycle, roller blades, swimming - Beach lover - Walking lover - Horse ridding lover Psychological assessment of patient prior to vaccination: - Very social, with a wide group of friends (I used to take them to the beach with her) - Very communicative, expressing herself always in a gentle way - Very happy, always laughing and smiling - Very good sense of humor - Very popular with her friends - Very brave, hardly complaining about anything, hard working - High grades in school, her attendance was exemplar as her grades A star. The patient was born on 8 of October 1995, healthy baby, the baby every mums dreams about, no crying finishing her bottle in a blink, smiling all the time, grow up beautiful and loved by all of us, her development was perfectly normal, many friends following the patient everywhere, from bicycles, skates, roller skates, scooter, electric scooter, football, basketball, hockey, horse riding, trampoline, surf, swimming. The patient never stopped, always with a bunch of friends around her, sleepovers, her friends were from tinny ones to her age, always outside playing or making me drive them all around. The patient was like Duracell batteries, on and on and on, in full charge, in school she was a very hard work love by teachers and friends, great sense of humour with a very good us

VAERS ID:446018 (history)  Vaccinated:2011-09-22
Age:13.0  Onset:2011-09-22, Days after vaccination: 0
Gender:Female  Submitted:2011-12-21, Days after onset: 90
Location:Foreign  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: Diabetes
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0769370A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA082DC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Back pain, Blood glucose increased, Fatigue, Lethargy, Oropharyngeal pain, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00076495) and described the occurrence of increased blood sugar in a 13-year-old female subject who was vaccinated with CERVARIX. Concurrent medical conditions included diabetes. Concurrent medications included Insulin. On 22 September 2011 the subject received a dose of CERVARIX (0.5 ml, intramuscular). On 22 September 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced increased blood sugar, joint pain, sore back, sore throat, lethargy, weight decrease, feeling of total lack of energy and fatigue. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. Patient has had ongoing difficulties which their GP has told them is due to the vaccine, the patient has missed a lot of school due to ongoing feelings of fatigue. GP has undertaken numerous tests and has concluded that the vaccine has caused the problems. The patient is a known diabetic and has had very high blood sugars since having the vaccine. Parent has come to me as she was sent by her GP to ask me to fill out a yellow card. I am unaware of the sequence of events as patient has been seen by GP.

VAERS ID:446216 (history)  Vaccinated:2011-04-18
Age:13.0  Onset:2011-05-01, Days after vaccination: 13
Gender:Female  Submitted:2011-12-22, Days after onset: 235
Location:Foreign  Entered:2011-12-23, 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: Unknown
Current Illness:
Preexisting Conditions: Rash
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01902
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK443502IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema nodosum, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from the health authority on 13-DEC-2011 (REF 2011-008414). This is one of two linked cases concerning the same patient and vaccine and is linked with E2011-08070 (WAES # 1112USA01901). This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medications received the third dose of GARDASIL (lot # NK44350, batch number NN01990) IM on 18-APR-2011. On an unreported date, two weeks post vaccination, the patient experienced erythema nodosum. This persisted for a few weeks but relapsed in August 2011. Corrective treatment included antibiotics and analgesics. At the time of reporting the patient had recovered. The patient received the first dose of GARDASIL (lot # NK25010, batch number NM11420) IM, on 15-SEP-2010, and an unspecified time post vaccination, the patient experienced a rash. This persisted for a few weeks. The patient was treated with antibiotics and analgesics and recovered on an unreported date. Patient received the second dose of GARDASIL (lot # NK25010, batch number NM11420) IM on 20-DEC-2010. On an unreported date, an unspecified time post vaccination, the patient experienced a rash (captured in WAES # 1112USA01901). The patient was treated with antibiotics and analgesics and recovered on an unreported date. The event erythema nodosum was considered serious due to medically important condition which required intervention. Other business partner numbers include E2011-08071. No further information is available.

VAERS ID:446217 (history)  Vaccinated:2010-12-20
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-22
Location:Foreign  Entered:2011-12-23, 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: Unknown
Current Illness:
Preexisting Conditions: Rash
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01901
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK250101IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received from the health authority on 13-DEC-2011 (REF 201 1-008410 and REF 2011-008412). This is one of two linked cases concerning the same patient and vaccine and is linked with E2011-08071 (WAES # 1112USA01902). This case is medically confirmed. A 13 year old female patient with no medical history or concomitant medications received the second dose of GARDASIL (lot # NK25010, batch number NM11420) IM on 20-DEC-2010. On an unreported date, an unspecified time post vaccination, the patient experienced a rash. The patient received the first dose of GARDASIL (lot # NK25010, batch number NM11420) IM, on 15-SEP-2010, and an unspecified time post vaccination, the patient experienced a rash. This persisted for a few weeks. The patient was treated with antibiotics and analgesics and recovered on an unreported date. The rash persisted for a few weeks but relapsed in August 2011. Corrective treatment included antibiotics and analgesics. At the time of reporting the patient had recovered. The patient subsequently received the third dose of GARDASIL and experienced erythema nodosum (E2011-08071, WAES # 1112USA01902). The event was considered serious due to medically important condition which required intervention. Other business partner numbers include E2011-08070. No further information is available.

VAERS ID:446588 (history)  Vaccinated:2011-12-09
Age:13.0  Onset:2011-12-09, Days after vaccination: 0
Gender:Female  Submitted:2011-12-30, Days after onset: 21
Location:Foreign  Entered:2012-01-03, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure measurement, 09Dec11, 122 mmHg, Systolic pressure; Blood pressure measurement, 09Dec11, 70 mmHg, Diastolic pressure; Arterial blood PO [2), 09Dec11, 97; Total heartbeat count, 09Dec11, 86/min
CDC Split Type: WAES1112USA01809
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1336Z1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fall, Loss of consciousness, PO2 normal, Somnolence, Unresponsive to stimuli
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Initial and follow up information has been received from a physician concerning a 13 year old female patient with no primary disease/concurrent conditions or past medical history who on 09-DEC-2011 was vaccinated with the second dose of GARDASIL, 0.5 ml once a day, (batch number 9QN01R, lot number 1336Z), IM. No concomitant medication was reported. On 09-DEC-2011, the patient did not complain of pain, etc. at the time of injection, GARDASIL intramuscularly to right deltoid. Five minutes after injection, 15 seconds after she stood up to make her exit from a medical office, she suddenly fell forward (fortunately the patient fell to bed at face-position). She was laid down on bed but there was no consciousness. Consciousness loss occurred. Blood pressure was 112-70, arterial blood partial pressure of oxygen was 97 and pulse was 86. Although her breath was normal but there was no response. She had no pallor facial and after five minutes from the event she became making a motion with her hands gradually, after ten minutes from the event she became able to talk. After 30 minutes from the event, independent gait became possible. The patient recovered from consciousness loss. The patient described the event that she suddenly felt sleepiness and after that she didn''t remember anything. The reporting physician''s comment: It could be very dangerous situation; the patient smashed her face, if there was not a bed. The reporting physician considered that consciousness loss was serious as other important medical event. The reporting physician felt that consciousness loss was definitely related to GARDASIL. Additional information has been requested.

VAERS ID:446589 (history)  Vaccinated:2011-10-24
Age:13.0  Onset:2011-10-24, Days after vaccination: 0
Gender:Unknown  Submitted:2011-12-30, Days after onset: 67
Location:Foreign  Entered:2012-01-03, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement, 24Oct11, 80/60 mmHg; blood pressure measurement, 24Oct11, 108/70 mmHg; total heartbeat count, 24Oct11, 70 per minute, Pulse decreased; total heartbeat count, 24Oct11, 75 per minute
CDC Split Type: WAES1112POL00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.GOO6568 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Heart rate decreased, Hypotension, Loss of consciousness, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician via an Agency (Authority number: UR.DML.4401.N1032.2011.AN1; URPL paper id: N1032/2011) concerning a 13 year old patient who on 24-OCT-2011 was vaccinated with GARDASIL (Batch number: GOO6568). A while after vaccination the patient experienced syncope, loss of consciousness, muscle spasm (with the majority on the left side of the body), confused and hypotension (blood pressure 80/60 mmHg, after 15 minutes 108/70). Total heartbeat count revealed: 70 and 75 per minute. Syncope and loss of consciousness subsided after about 1 minute. After 20 minutes the patient recovered from muscle spasm, confused and hypotension. The patient was observed for about half hour and received oral liquids and glucose 40%. The reporter felt that syncope, loss of consciousness, muscle spasm, confused and hypotension were related to therapy with GARDASIL. The agency considered the events to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:446641 (history)  Vaccinated:2011-09-26
Age:13.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Female  Submitted:2011-12-27, Days after onset: 92
Location:Foreign  Entered:2012-01-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA02942
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM263500IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was received from the health authority on 16-DEC-2011. IMB REF 2011-008614. This case was medically confirmed. A 13 year old female patient with no medical history and no concomitant medications reported, received the first dose of GARDASIL (batch# NP26080; lot# NM26350), 0.5 mL, IM on 26-SEP-2011. On 26-SEP-2011, immediately the same day as vaccination, the patient experienced injection site soreness, tenderness, hot, red and swollen. The events persisted for seven days. The patient recovered on an unreported date. The events were reported when the patient attended for her second dose on 28-NOV-2011. The patient had no problem after the second dose. The events were considered to be medically important. Other business partner number included E2011-08199. Additional information has been requested.

VAERS ID:446645 (history)  Vaccinated:2011-12-05
Age:13.0  Onset:2011-12-05, Days after vaccination: 0
Gender:Female  Submitted:2011-12-27, Days after onset: 22
Location:Foreign  Entered:2012-01-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure measurement, 05Dec11, Stable; total heartbeat count, 05Dec11, Stable
CDC Split Type: WAES1112USA02717
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124501IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash maculo-papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the Health Authority on 16-DEC-2011, IMB Ref: 2011-008616. This case was medically confirmed. A 13 year old (also reported as 12 year old) female patient with no medical history, risk factors or concomitant medications, and who had previously received dose 1 of GARDASIL (batch not reported) on an unreported date, received dose 2 of GARDASIL (lot number: NN12450, batch G005669), intramuscularly on 05-DEC-2011. Within 5 minutes of receiving dose 2 the patient experienced a maculopapular rash on the chest and neck which was extremely itchy. According to the reporter the patient was given CHLORPHENAMINE 10mg intramuscularly however there was no response after 25 minutes and the patient was then given ZIRTECK 10mg orally. The patient then responded and the rash faded within 5 minutes and the patient was well. The overall reaction lasted about 45 minutes in total. The patient''s blood pressure and pulse were stable during the event and had no respiratory complications. At the time of reporting the patient had recovered. The IMB considered the case to be serious and other medically important condition that required intervention. Other business partner numbers included: E2011-08184. No further information is available.

VAERS ID:446694 (history)  Vaccinated:2011-10-14
Age:13.0  Onset:2011-10-14, Days after vaccination: 0
Gender:Female  Submitted:2012-01-03, Days after onset: 81
Location:Foreign  Entered:2012-01-04, 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: Co-dydramol
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0770645A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVAD82CC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Lethargy, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional, via the foreign regulatory authority, and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medications included Co-dydramol. On 14 October 2011 the subject received an unspecified dose of CERVARIX (0.5 ml, intramuscular, batch number AHPVAD82CC). On 14 October 2011, within 4 hours of vaccination with CERVARIX, the subject experienced a ''very high'' fever and sore throat. On the same day later, on 14 October 2011, the subject experienced lethargy, felt faint and unwell for several days. It was reported that the patient received a subsequent dose of CERVARIX approximately 6 weeks later. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 18 October 2011, the events were resolved. Verbatim Text: Very high fever within 4 hours and sore throat. Faint, lethargic, unwell for several days. Patient received subsequent dose of CERVARIX approximately six weeks later.

VAERS ID:446697 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2011-11-07
Gender:Female  Submitted:2012-01-03, Days after onset: 57
Location:Foreign  Entered:2012-01-04, 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: Unknown
Preexisting Conditions: Cystic fibrosis
Diagnostic Lab Data: UNK
CDC Split Type: B0770649A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Muscular weakness, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This case was reported by a healthcare professional, via the regulatory authority, and described the occurrence of chest pain in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cystic fibrosis. Previous vaccinations included the first dose of CERVARIX. On an unknown date the subject received the second dose of CERVARIX (0.5 ml, intramuscular, batch details unknown). On 7 November 2011, at an unspecified time ''following'' vaccination with CERVARIX, the subject experienced chest pain, throat '' feeling strange'' and weakness in the legs. It was reported that an ambulance was called. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. Following second vaccination they experienced chest pain, throat feeling strange and legs weak. They have a history of cystic fibrosis. An ambulance was called. Unable to contact Mum to find out outcome.

VAERS ID:447050 (history)  Vaccinated:2011-12-28
Age:13.0  Onset:2011-12-28, Days after vaccination: 0
Gender:Female  Submitted:2012-01-09, Days after onset: 12
Location:Foreign  Entered:2012-01-09
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: UNK
CDC Split Type: B0773779A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA148CB0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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 28 December 2011, at 14:10, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, right upper arm). On 28 December 2011, at 14:15, 5 minutes after vaccination with CERVARIX, the subject was resting in the sitting position. However, she began to feel poorly and presented with facial pallor. After she was placed under observation in the lying position for 30 minutes, the symptoms had improved, so she was allowed to leave for home. The physician considered the events were clinically significant. On 28 December 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:448147 (history)  Vaccinated:2008-12-15
Age:13.0  Onset:2009-04-01, Days after vaccination: 107
Gender:Male  Submitted:2012-01-26, Days after onset: 1030
Location:Foreign  Entered:2012-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Anti-cyclic citrullinated pept, Sep2009, NEGATIVE; Antinuclear antibody, Sep2009, NEGATIVE; Rheumatoid factor, Sep2009, NEGATIVE; Lab test performed on September 2009: HLA-B27: Positive
CDC Split Type: R0021005A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMAR
Administered by: Other     Purchased by: Other
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Anti-transglutaminase antibody, Antinuclear antibody negative, Back pain, Juvenile arthritis, Leukocyte antigen B-27 positive, Rheumatoid factor negative, Sacroiliitis, Synovitis, Ultrasound scan abnormal
SMQs:, Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This male subject was enrolled in a prophylactic study which is open or single blind according to communities. On 21 November 2008, 15 December 2008 and 04 May 2009, the subject received the 1st, 2nd and 3rd dose of HPV (IM deltoid). On April 2009, four months after the 2nd dose of HPV 16-18, this 13-year-old subject experienced juvenile rheumatoid arthritis. The subject was hospitalised. The subject was treated with methotrexate. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the juvenile rheumatoid arthritis may have been caused by HPV 16-18. Relevant Risk Factors: Suggestive family history of rheumatoid arthritis in mother''s side of the family as well as psoriasis. In addition her oldest sister has adrenal insufficiency. Investigator Comments: The subject was admitted to hospital because of morning back pain and was diagnosed in ultrasonography with synovitic knees and suspected sacroilitis. Microbial antibody tests, and sitrulline, transglutaminase, and anti-nuclear antibodies all negative as well as rheumatoid factor HLA-B27 positive. TREXAN 15mg/week was started. Suggestive family history for rheumatoid arthritis in mother''s side of the family as well as psoriasis. In addition her oldest sister has adrenal insufficiency. No relevant earlier medical history findings recorded. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. Juvenile rheumatoid arthritis is considered a chronic disease.

VAERS ID:448378 (history)  Vaccinated:2009-05-07
Age:13.0  Onset:2009-05-15, Days after vaccination: 8
Gender:Male  Submitted:2012-01-30, Days after onset: 990
Location:Foreign  Entered:2012-01-30
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: Blood Creatinine, 15Jun2009, 71; Blood Glucose, 15Jun2001, 30.7mmolL/L; Blood thyroid stimulating horm, 15Jun2009, 2.06; HbA1C, 15Jun2009, 10.6percent
CDC Split Type: R0006895A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Blood creatinine normal, Blood glucose increased, Blood thyroid stimulating hormone normal, Glycosylated haemoglobin increased, Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: This male subject was enrolled in the prophylactic study. On 07 May 2009, 28 May 2009 and 26 October 2009, the subject received the 1st, 2nd and 3rd dose of HPV type 16 and 18 vaccine (IM deltoid). On 15 May 2009, eight days after the 1st dose of HPV 16-18, this 13-year-old subject developed insulin-dependent diabetes mellitus type I. The subject was hospitalised. The subject was treated with intermediate/long-acting insulin and insulin. The event was unresolved at time of reporting and is considered as a chronic condition with no end date. The investigator considered that there was a reasonable possibility that the insulin-dependent diabetes mellitus type I may have been caused by HPV 16-18. Previously, this case has been considered as not related but on 24 January 2012, investigator has reviewed the case and considered it as related to study vaccine.

VAERS ID:448486 (history)  Vaccinated:2009-05-08
Age:13.0  Onset:2009-07-11, Days after vaccination: 64
Gender:Female  Submitted:2012-01-31, Days after onset: 934
Location:Foreign  Entered:2012-01-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Albumin, 12Jul2009, ++; Blood Basophils, 13Jul2009, 1.0%; Blood Eosinophils, 13Jul2009, 0.6%; Blood Glucose, 12Jul2009, 29MMOL/L; Blood Monocytes, 13Jul2009, 17.7%; Blood Neutrophils, 13Jul2009, 49.3%; Blood bicarbonate, 12Jul2009, 4MMOL/L; Blood carbon dioxide, 12Jul2009, 1.8KPA; Blood pH, 12Jul2009, 7.01; Erythrocyte sedimentation rate, 12Jul2009, 4.56E12/L; HbA1C, 13Jul2009, 14.4%; Lymphocytes, 13Jul2009, 31.4%; Plasma Glucose, 12Jul2009, 27.5MMOL/L; Platelet count, 12Jul2009, 338E9/L; Red blood cells urine, 12Jul2009, +; Serum calcium, 13Jul2009, 1.06MMOL/L; Serum chloride, 13Jul2009, 108MMOL/L; Serum sodium, 13Jul2009, 110MMOL/L; Urine Glucose, 12Jul2009, +++; White blood cell count, 12Jul2009, 13.7E9/L; 12 July 2009: Blood BE: -26 mmo
CDC Split Type: R0021026A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMAR
Administered by: Other     Purchased by: Other
Symptoms: Basophil percentage, Blood albumin increased, Blood bicarbonate decreased, Blood calcium decreased, Blood chloride normal, Blood glucose increased, Blood pH decreased, Blood sodium decreased, Carbon dioxide, Diabetic ketoacidosis, Glucose urine present, Glycosylated haemoglobin increased, Hypokalaemia, Lymphocyte percentage, Monocyte percentage increased, Neutrophil percentage increased, Platelet count normal, Red blood cell sedimentation rate, Red blood cells urine positive, Type 1 diabetes mellitus, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This female subject was enrolled in a prophylactic study which is open or single blind according to communities. On 25 November 2008, 16 December 2008 and 08 May 2009, the subject received the 1st, 2nd and 3rd dose of HPV 16-18 (IM deltoid). On 11 July 2009, 64 days after the 3rd dose of HPV 16-18, this 13-year-old subject developed type 1 diabetes mellitus. The subject was hospitalised. The subject was treated with intermediate/long-acting insulin, insulin aspart, prednisolone and prednisolone acetate. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the type 1 diabetes mellitus may have been caused by HPV 16-18. Investigator Comments: The subject was admitted because of ketoacidosis pH 7/01 due to acute type diabetes with blood glucose 29, HBA1C 143.4 and HCO3 4, CO2 1.8. Together with parenteral infusion therapy to substitute kypokalemia, LEVEMIR 12 + 12 IU and NOVORAPID 1.5 IU/10 g carbohydrate was started. For the treatment of concomitant non-serious iritis PRED-FORTE and Prednisolon 10 mgX1 had been applied since 09 July 2009. No family history or previous medical history suggestive for predisposing factors recorded. The reason for considering the case as "possibly related to the investigational product" is suggestive time interval and/or lack of other major causes. Diabetes is a chronic illness and will not be recovered.

VAERS ID:448512 (history)  Vaccinated:2010-01-27
Age:13.0  Onset:2010-09-01, Days after vaccination: 217
Gender:Female  Submitted:2012-01-31, Days after onset: 517
Location:Foreign  Entered:2012-02-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA02999
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1202U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cataplexy, Hallucination, auditory, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Case received from the Health Authorities on 19-JAN-2012, under the reference number PP20120009. Case was medically confirmed. A 13 year old female patient with no relevant medical history had received intramuscularly the first and second dose of GARDASIL on 27-JAN-2010 (Lot # 1202U, batch #NJ33350) and 16-JUN-2010 (Lot # NJ02700, batch # NJ49160) as well as a dose of PANDEMRIX, (other manufacturer, batch A81CA103A) on 04-DEC-2009. In September 2010, she felt asleep seven times in classroom. In December 2010, she experienced partial then complete cataplexy triggered off by laughing, and had a fit of somnolence every 1H 30. In 2011, she also developed auditory hallucination. She was given different treatments. Concerta was tried in 2011. At the time of reporting, the patient had not yet recovered. Upon medical review, the company judged relevant to code the adverse event hallucination auditory which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful according to the foreign method of assessment C1 S1 I1) GARDASIL and the dose of PANDEMRIX H1N1 and (C2 S1 I1) for the second dose of GARDASIL. Cataplexy, hallucination auditory and narcolepsy were considered by Health Authority to be disabling. Other business partner numbers include: E2012-00429. No further information is available.

VAERS ID:448738 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-01
Location:Foreign  Entered:2012-02-03, Days after submission: 2
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: No medical history reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201076
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Case retrieved form the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patient who displayed at least one ETAV after the administration of influenza A (H1N1) vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporarily criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine cases against influenza A (H1N1) and 18,442,171 doses against seasonal influenza vaccine were applied across the country. A total of 597 ETAV corresponding to the application of the antiinfluenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 13-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against influenza A (H1N1) (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not notified if vaccine contains adjuvant. On an unspecified date, the patient developed GBS (Guillain Barre syndrome) (reported as final diagnosis). The initial diagnosis was AFP (acute flaccid paralysis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The final outcome was not reported. It was specified that the patient was not died. This interval was reported as "50" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). According with the author, this case was assessed as serious due to medically important condition. Fourteen confirmed cases of GBS according to Brighton Criteria were reported. All were ruled as unrelated coincidental events, given that vaccination against A (H1N1) as an antecedent occurred in seven cases (50%); immunization against seasonal influenza occurred in four cases (28.5%), and the joint administration of both vaccines occurred in three cases (21.4%). Documents held by sender: none.

VAERS ID:448847 (history)  Vaccinated:2011-12-19
Age:13.0  Onset:2011-12-19, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 46
Location:Foreign  Entered:2012-02-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hemiparesis
Preexisting Conditions:
Diagnostic Lab Data: Electromyogram, Dec2011, Polyneuropathy A; Laboratory test, Dec2011, Polyneuropathy A
CDC Split Type: B0777961A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Electromyogram abnormal, Headache, Laboratory test abnormal, Myopathy, Nausea, Neck pain, Polyneuropathy, Tremor, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional via a regulatory authority and described the occurrence of polyneuropathy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included right hemiparesis. Historic vaccination included CERVARIX (GlaxoSmithKline, unknown route and injection site) given on 17 January 2011 without any adverse event. On 19 December 2011, the subject received 2nd dose of CERVARIX (intramuscular, left arm). On 19 December 2011, less than one day after vaccination with CERVARIX the subject experienced polyneuropathy, headache, nausea, blurred vision, neck pain, right arm tremor and myopathy. On 19 December, the subject went to emergency room and was treated with ibuprofen and Rivotril. The next day the subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). An electromyography and laboratory test were performed and revealed a polyneuropathy and myopathy. The event improved and the subject was discharged from hospital after 3 days. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX

VAERS ID:449009 (history)  Vaccinated:2011-05-12
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-03
Location:Foreign  Entered:2012-02-06, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201174
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3961A0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate, from the "Foreign Ministry of Health" through the distributor (local case reference number BR-BT2012-0191). A male patient whose medical history and concomitant therapies were not reported, had received his 1st dose of FLUZONE (batch number reported as 1104091 corresponding to Sanofi Pasteur''s batch number U3961AA, route and anatomical site of administration not reported) on 12 May 2011. On an unspecified date post-vaccination, the patient experienced afebrile seizure and other serious events and / or unusual. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The case was "indefinite" as per the Ministry of Health. The action with regards to the next vaccination was provided: "no conduct". Documents held by sender: none.

VAERS ID:449011 (history)  Vaccinated:2012-01-21
Age:13.0  Onset:2012-01-23, Days after vaccination: 2
Gender:Female  Submitted:2012-02-03, Days after onset: 11
Location:Foreign  Entered:2012-02-06, 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: computed axial tomography, 23Jan12, did not show any abnormal finding; diagnostic laboratory test, 23Jan12, Blood test did not show any abnormal finding; body temp, 21Jan12, 36.6 degrees C
CDC Split Type: WAES1201USA03464
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0108AA1SYRRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Initial and follow-up information has been received from a physician concerning a 13 year and 8 months old female patient who had no history of any medical history, allergy, underlying diseases, growth problem, vaccination within the past 1 month and other diseases or any adverse reaction by vaccination. On 21-JAN-2012 at AM 08:04, the patient was vaccinated with the second injection of GARDASIL, 0.5 ml once a day for the treatment of prophylaxis (injection site: right upper arm, batch #: 9QN02R, lot #: 0108AA). No other vaccine was injected at the same time. It seemed that the patient did not receive any other medication. On an unspecified date, the patient was vaccinated with the first injection. The patient did not develop any adverse reaction. On 21-JAN-2012 at 08:04, the patient visited the reporter''s hospital for the second vaccination. After a medical interview, the patient was vaccinated on right upper arm. The body temperature prior to the injection: 36.6. On 23-JAN-2012 around 06:00, the patient was taken to the city-hospital by ambulance as the patient developed convulsive seizure. It was her first time to develop convulsion (It was unknown if the patient was in absence status). Computed axial tomography (CT) or blood test did not show any abnormal finding. On the same day, it was reported that the patient was recovering from convulsion. Subsequent information was unknown as the patient did not visit the reporter''s hospital. Comment: As it was second injection of the vaccine and it seemed that the patient did not receive any other medication, this event was delayed adverse reaction caused by the vaccine. Physician was not going to vaccine the patient with the third. The reporting physician considered that the afebrile convulsion was non-serious. Upon internal review, the afebrile convulsion was determined to be serious as an other important medical event. The reporting physician stated that the event was related to the vaccine, and there was no other causality such as other disease. Additional information has been requested.

VAERS ID:449035 (history)  Vaccinated:2012-01-13
Age:13.0  Onset:2012-01-13, Days after vaccination: 0
Gender:Female  Submitted:2012-02-03, Days after onset: 21
Location:Foreign  Entered:2012-02-06, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA03465
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Fall, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a pharmacist and a physician concerning a 13 year 7 month old female patient who on 13-JAN-2012 was intramuscularly vaccinated with the second injection of GARDASIL, 0.5 mL, once a day (indication, injection site and lot number not reported). No information on concomitant medication was provided. On 13-JAN-2012, the patient was vaccinated with GARDASIL at another hospital (as stated above). At around one minute after vaccination, the patient lost her consciousness (for around 15 seconds). She almost fell over but a person nearby supported her and a fall was avoided. Thereafter, convulsion occurred. At the time of the report, the patient had recovered from syncope and convulsion. Physician''s comment: Casual relationship with vaccine was unknown. The reporting physician considered that syncope and convulsion were non-serious. The reporting physician felt that the causal relationship of syncope and convulsion to GARDASIL was unknown. Upon internal review, convulsion was determined to be serious as an other important medical event. Additional information has been requested.

VAERS ID:448975 (history)  Vaccinated:2011-05-10
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-06
Location:Foreign  Entered:2012-02-07, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201260
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER0908176 UNUN
RAB: RABIES (IMOVAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" through the distributor (local case reference number BR-BT2012-0237). A female patient, whose medical history and concomitant therapies were not reported, had received her 1st booster dose of dT (other manufacturer, batch number 0908176, route and anatomical site of administration not reported) concomitantly with her 1st dose of Rabies vaccine (manufactured by Sanofi Pasteur, batch number, route and anatomical site of administration not reported), on 01 May 2011. On an unspecified date post-vaccination, the patient experienced exanthema. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The status of this case was "Associated with more than 1 vaccine" as per the Ministry of Health. The action with regards to the next vaccination was provided: "no conduct". Documents held by sender: none.

VAERS ID:449075 (history)  Vaccinated:2011-12-01
Age:13.0  Onset:2011-12-01, Days after vaccination: 0
Gender:Female  Submitted:2012-02-06, Days after onset: 67
Location:Foreign  Entered:2012-02-07, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0779617A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B190DD UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
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 INFANRIX-IPV (GlaxoSmithKline). On 1 December 2011, the subject received unspecified dose of INFANRIX-IPV (unknown route of administration, unknown site of injection). On 1 December 2011, immediately after vaccination with INFANRIX-IPV, the subject experienced syncope. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified.

VAERS ID:449149 (history)  Vaccinated:2012-01-30
Age:13.0  Onset:2012-01-30, Days after vaccination: 0
Gender:Female  Submitted:2012-02-07, Days after onset: 8
Location:Foreign  Entered:2012-02-08, 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: Unknown
Preexisting Conditions: Facial pallor; Feeling queasy
Diagnostic Lab Data: Blood pressure, 30Jan2012, 103/35mmHg; Blood pressure, 30Jan2012, 98/70mmHg; Blood pressure, 30Jan2012, 101/63mmHg; Pulse rate, 30Jan2012, 85bpm; Pulse rate, 30Jan2012, 60pm; Pulse rate, 30Jan2012, 87bpm
CDC Split Type: B0779220A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149CA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Nausea, Pallor, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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). Before the vaccination, the blood pressure was at 98/70 mmHg and the pulse rate was at 60 bpm. On 30 January 2012, at 18:55, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 30 January 2012, at 18:57, 2 minutes after vaccination with CERVARIX, queasy feeling had gradually intensified and the subject felt poorly presenting with facial pallor. On 30 January 2012, at 19:02, seven minutes later, queasy feeling had subsided while the facial pallor still remained. On 30 January 2012, at 19:40, the facial pallor disappeared. The pulse was 85 beats/minute and the blood pressure was 101/63 mmHg. On 30 January 2012, at 19:45, the subject returned home. No treatment was especially given. The subject lay on the bed and rested. The physician considered the events were clinically significant. On 30 January 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Previously, the subject had experienced similar facial pallor and queasy feeling when having a blood test.

VAERS ID:449239 (history)  Vaccinated:2012-01-30
Age:13.0  Onset:2012-01-30, Days after vaccination: 0
Gender:Female  Submitted:2012-02-08, Days after onset: 9
Location:Foreign  Entered:2012-02-09, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0779378A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Vaccination site haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of vaccination site hemorrhage in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 30 January 2012, at 16:20, the subject received the 3rd dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 30 January 2012, during vaccination with CERVARIX, the needle was inserted, she experienced vaccination site haemorrhage. The needle was taken out and replaced with a 25g needle, which was inserted (injection of medicinal substance). Immediately after that, she experienced loss of consciousness (syncopal attack). She regained consciousness soon, but was in a condition of slight excitement. No abnormality was observe in blood pressure or pulse rate. Thirty minutes later, the patient''s condition became stable and she left for home. The physician considered the events were clinically significant. At the time of reporting the outcome of the event vaccination site hemorrhage was unspecified, the other events resolved on 30 January 2012. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:449270 (history)  Vaccinated:2009-05-18
Age:13.0  Onset:2010-05-31, Days after vaccination: 378
Gender:Male  Submitted:2012-02-09, Days after onset: 619
Location:Foreign  Entered:2012-02-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood calcium, 01Jun2010, 2.66; Blood Chloride, 01Jun2010, 97; Blood Glucose, 01Jun2010, 27.7MMOL/L; C-reactive protein, 01Jun2010, below 1; HbA1C, 01Jun2010, 13.4; White blood cell count, 01Jun2010, 6.6
CDC Split Type: R0021166A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood calcium normal, Blood chloride normal, Blood glucose increased, C-reactive protein normal, Diabetes mellitus, Glycosylated haemoglobin increased, White blood cell count normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: This male subject was enrolled in a study which is open or single blind according to communities. On 01 December 2008, 26 January 2009 and 18 May 2009, the subject received the 1st, 2nd and 3rd dose of ENGERIX B (10 mcg, IM deltoid). On 31 May 2012, 12 months after the 3rd dose of ENGERIX B, this 14-year-old subject developed diabetes mellitus. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with intermediate/long-acting insulin and insulin aspart. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the diabetes mellitus may have been caused by ENGERIX B.

VAERS ID:449344 (history)  Vaccinated:2012-01-26
Age:13.0  Onset:2012-01-26, Days after vaccination: 0
Gender:Male  Submitted:2012-02-10, Days after onset: 15
Location:Foreign  Entered:2012-02-10
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: Blood pressure, 26Jan2012, 90/60 - 100/60
CDC Split Type: B0778991A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B030DB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dizziness, Dizziness postural, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by another health professional via a regulatory authority (ES-AGEMED-524770341) and described the occurrence of vasovagal reaction in a 13-year-old male subject who was vaccinated with DITANRIX ADULT (GlaxoSmithKline). On 26 January 2012, the subject received an unspecified dose of DITANRIX ADULT (administration site and route unknown). On 26 January 2012, immediately after vaccination with DITANRIX ADULT, the subject experienced vasovagal reaction, convulsion, loss of consciousness, sweating and dizziness. No sphincter relaxation. Blood pressure was 90/60 and 100/60 10 minutes later. The subject was hospitalised. The subject was 2 hours in observation where the necessary laboratory test were performed. He was discharged after. The subject was treated with sweetened liquid. Due to remaining dizziness at the moment of stand up. After 30 seconds, the events were resolved. The outcome of dizziness was unspecified. The regulatory authority reported that the events were probably related to vaccination with DITANRIX ADULT. 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:449346 (history)  Vaccinated:2011-11-09
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-10
Location:Foreign  Entered:2012-02-10
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0780307A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Lethargy, Malaise
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-EYC 00079461) and described the occurrence of anaphylaxis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 9 November 2011 the subject received the 2nd dose of CERVARIX (intramuscular). At an unspecified time after vaccination with the 2nd dose of CERVARIX, the subject experienced anaphylaxis, lethargy and feeling unwell. The subject was hospitalised and the regulatory authority reported that the events were life threatening. The patient was treated with adrenaline. HPV vaccination would not be administered to the patient again in school and the patient was due to see a paediatrician for allergy testing. It was reported the patient felt generally unwell and lethargic for a few weeks following immunisation but at the time of reporting the events were resolved. Verbatim Text: Patient had an anaphylactic reaction following her second dose of HPV immunisation. She was treated in hospital with adrenaline. Patient felt generally unwell/lethargic for few weeks following immunisation. Patient to see paediatrician for allergy testing. HPV immunisation will not be given again in school.

VAERS ID:449556 (history)  Vaccinated:2012-02-04
Age:13.0  Onset:2012-02-04, Days after vaccination: 0
Gender:Female  Submitted:2012-02-14, Days after onset: 10
Location:Foreign  Entered:2012-02-14
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: UNK
CDC Split Type: B0780740A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Loss of consciousness, Presyncope
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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness (syncope) in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 4 February 2012, at 11:40, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 4 February 2012, during vaccination with CERVARIX, the subject experienced vasovagal reaction, fell forward and lost consciousness (syncope). She was left lying on the floor and then, she regained consciousness in approximately 20 seconds. The physician considered the events were clinically significant (or requiring intervention). On 4 February 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:449622 (history)  Vaccinated:2011-05-17
Age:13.0  Onset:2011-07-18, Days after vaccination: 62
Gender:Female  Submitted:2012-02-14, Days after onset: 211
Location:Foreign  Entered:2012-02-15, 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: Whole blood glycosylated hemoglobin, 18Jul11, 13%
CDC Split Type: WAES1202USA01351
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK068801IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Glycosylated haemoglobin increased, Thirst, Type 1 diabetes mellitus, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: This case was received from a healthcare professional via a company representative on 03-FEB-2012. Case was medically confirmed. A 13 year-old female patient with no underlying disease received D2 of GARDASIL (lot number: NK06880, batch number: NN20880) IM into upper arm on 17-MAY-2011. On 14-JUN-2011, the patient received a dose of NEISVAC-C (lot number: VN913060) IM into the upper arm. On 18-JUL-2011, two months after GARDASIL and one month after NEISVAC-C the patient prescribed with first manifestation of diabetes mellitus type 1 and this diagnosis was confirmed due to acute loss of weight, increased thirst and HbA1c of 13%. Therapy with insulin was initiated. There under diabetes was well adjusted at the lime of reporting. It was stated that the grandfather of the patient suffered from diabetes mellitus type II and it was underlined that the patient did not experience any infections prior to onset of diabetes symptoms. The physician reported the drug event relationship as not assessable. The patient had received D1 of GARDASIL (lot number: NK06880, batch number: NN20880) IM into the upper arm on 19-APR-2011, toleration was not reported. D3 of GARDASIL was not given. Case was closed. The company assessed the event to be medically significant. Other business partner numbers included: E2012-00715. No further information is available.

VAERS ID:449770 (history)  Vaccinated:2011-10-20
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-16
Location:Foreign  Entered:2012-02-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0074435A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Nervous system disorder
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of convulsive seizures in a 13-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 20 October 2011 the subject received the first dose of BOOSTRIX (0.5 ml, unknown). At an unspecified time post vaccination with BOOSTRIX, on an unknown date in 2011 or early in 2012, the subject experienced convulsive seizures with neurological disorder. This case was assessed as medically serious by GSK criteria. At the time of reporting, on 09 February 2012, the events were still unresolved. Follow-up information has been requested.

VAERS ID:449891 (history)  Vaccinated:2011-11-01
Age:13.0  Onset:2011-11-05, Days after vaccination: 4
Gender:Female  Submitted:2012-02-20, Days after onset: 107
Location:Foreign  Entered:2012-02-20
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: D0074457A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB448BH1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cutaneous sarcoidosis
SMQs:
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2012003861) and described the occurrence of lupus pernio in a 13-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). First vaccination with HAVRIX 720 pediatric on 23 December 2010 was well tolerated, as well as former vaccinations with PENTAVAC, GENHB vax pediatric, PRIORIX, BEGRIVAC, INFLUSPLIT and INFLUVAC, PANDEMRIX, INFANRIX and BOOSTRIX polio. On 1 November 2011 the subject received 2nd dose of HAVRIX 1440 (unknown, left arm). On 5 November 2011, 4 days after vaccination with HAVRIX 1440, the subject experienced lupus pernio. The subject was treated ambulatory and was hospitalised. At the time of reporting the event was unresolved. No further information will be available.

VAERS ID:449895 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:2010-09-01
Gender:Female  Submitted:2012-02-20, Days after onset: 537
Location:Foreign  Entered:2012-02-20
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: B0782620A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported the Ministry of Health via a regulatory authority (11-03-1283A) and described the occurrence of asthma in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of CERVARIX (unknown route of administration and batch number). At an unspecified time after vaccination with CERVARIX, the subject experienced asthma. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with CERVARIX. This report was received from a foreign Regulatory Authority as part of a line-listing of several hundred reports, each containing minimal information. No further information is expected.

VAERS ID:449945 (history)  Vaccinated:2011-12-20
Age:13.0  Onset:2011-12-20, Days after vaccination: 0
Gender:Female  Submitted:2012-02-20, Days after onset: 62
Location:Foreign  Entered:2012-02-21, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1202USA01845
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a nurse (Local reference# CA12-001489) concerning a 13 year old female who on 20-DEC-2011 was vaccinated with the second dose of GARDASIL (Lot#, dose and route not reported). In the evening of 20-DEC-2011 the patient had seizure for the first time ever in her life. As a result, she was brought to the hospital where they kept her in overnight, for observation but she had not had another seizure since that one the day she got vaccinated. The patient was fine within 1 day after having gotten vaccinated. The patient and the doctor were wondering if seizure was caused by vaccination. No further information is available.

VAERS ID:449959 (history)  Vaccinated:2012-01-03
Age:13.0  Onset:2012-01-03, Days after vaccination: 0
Gender:Female  Submitted:2012-02-20, Days after onset: 48
Location:Foreign  Entered:2012-02-21, 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: Unknown
Diagnostic Lab Data: physical examination, 03Jan12, unremarkable; electrocardiogram, 03Jan12, unremarkable; abdominal ultrasound, 03Jan12, unremarkable; fasting blood glucose, 03Jan12, unremarkable; serum lactose tolerance test, 03Jan12, unremarkable; serum fructose test, 03Jan12, unremarkable
CDC Split Type: WAES1201USA03732
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0120AAA0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Blood glucose normal, Diet refusal, Electrocardiogram normal, Enema administration, Fructose, Helicobacter test, Lactose tolerance test normal, Nausea, Radioallergosorbent test, Ultrasound abdomen normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was received from the Health Authorities on 16-JAN-2012 (PEI2012000781). The case was medically confirmed. A 13 year old female patient received dose o1 of MMR II (batch number: NP37960; lot number: 667966/0120AA) SC into the right upper arm on 03-JAN-2012. Later on the same day, she developed unspecified general symptoms. A clinical examination was unremarkable. At the time of the report to the HA on 09-JAN-2012, the events were persisting. Final outcome was not reported. Case was closed. Follow up information was received from the HA on 08-FEB-2012. Hospital discharge letter was provided. Seriousness criteria was changed to serious and new events of abdominal pain, nausea and diet refusal were added. "General symptoms NOS" was removed by the HA. On 16-JAN-2012, the patient with no underlying disease was hospitalized with abdominal pain, nausea and diet refusal persisting since 03-JAN-2012. On admission lab tests including lactose, fructose intolerance test, electrocardiogram, fasting blood glucose and abdominal ultrasound were all unremarkable. An enema was given whereupon the patient passed plenty to stool. Further course showed patient in stable general condition, the events resolved and she was discharged on 18-JAN-2012. At the time of discharge results for an electrocardiogram, C13 breath test, long term electrocardiogram and RAST for chicken protein were pending. Case was closed. Other business partner number included: E2012-00287. No further information is available.

VAERS ID:450067 (history)  Vaccinated:2011-12-13
Age:13.0  Onset:2011-12-14, Days after vaccination: 1
Gender:Female  Submitted:2012-02-12, Days after onset: 60
Location:Foreign  Entered:2012-02-22, Days after submission: 10
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: WAES1202USA02123
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124501IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash erythematous, Rash macular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was received by the Health Authority on 09-FEB-2012 under the reference number 2012-009481. This case was medically confirmed. A 13 year old female patient with no medical history, no concomitant medication and unreported risk factors received the second dose of GARDASIL (lot number: NN12450, batch number G005669) 0.5 ml intramuscularly, site not reported on 13-DEC-2011. On 14-DEC-2011, one day post vaccination, the patient experienced spotty rash, itchy and subsequently on 05-JAN-2012 an erythematous rash. Post vaccination, the patient developed spots on the thighs within 24-48 hours. This rash spread to the patient''s legs and buttocks over the next week and became itchy (start date reported as 14-DEC-2011). The following week the rash spread to the patient''s hands and abdomen and remained itchy. The patient was seen by the reporter on 05-JAN-2012 and was noted to have a erythematous rash on her chest and behind her ears. The patient was reviewed by a Consultant dermatologist and received treatment with BETNOVATE cream and PIRITON tablets. At the time of reporting, the patient had not recovered. The health authority coded the events of blotchy rash, itchy and erythematous rash and considered the events to be serious due to other medically important condition which required intervention. Other business partner numbers include # E2012-01019. No further information is available.

VAERS ID:450615 (history)  Vaccinated:2011-09-16
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-27
Location:Foreign  Entered:2012-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0783793A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Menstrual disorder, Menstruation irregular, Metrorrhagia, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of metrorrhagia in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 September 2011, the subject received 1st dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, batch number not provided). In September 2011, less than one month after vaccination with CERVARIX, the subject''s menstrual cycle was disturbed and she presented with abnormal vaginal bleeding twice in a month. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:450818 (history)  Vaccinated:2011-10-28
Age:13.0  Onset:2011-10-28, Days after vaccination: 0
Gender:Female  Submitted:2012-02-29, Days after onset: 124
Location:Foreign  Entered:2012-02-29
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, 28Oct2011, 90/40mmHg
CDC Split Type: B0784021A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Cold sweat, Feeling abnormal, Immediate post-injection reaction, Nausea, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (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 28 October 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left shoulder). On 28 October 2011, immediately after vaccination with CERVARIX, the subject experienced vasovagal reaction, feels poorly, nausea, cold sweat and decreased blood pressure (90/40 mmHg). The physician considered the events were clinically significant (or requiring intervention). On 28 October 2011, the events were resolved after the subject lay down for approximately 15 minutes. Then she went home. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:450931 (history)  Vaccinated:2012-02-01
Age:13.0  Onset:2012-02-01, Days after vaccination: 0
Gender:Female  Submitted:2012-03-01, Days after onset: 29
Location:Foreign  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0782855A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Paraesthesia oral, Tongue oedema, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by another health professional via a regulatory authority (ES-AGEMED-024811441) and described the occurrence of red face in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 1 February 2012, the subject received an unspecified dose of CERVARIX (administration site and route unknown). On 1 February 2012, within hours of vaccination with CERVARIX, the subject experienced red face, tongue edema and vaccination site tenderness. She went to the Emergency Room approximately 8 hours after vaccination. 4 hours after admission, the saturation level was 100%. On 2 February 2011, 1 day after vaccination with CERVARIX, the subject experienced tongue tingling and vaccination site pain. She returned back to the Emergency Room. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with SOLUMODERIN and cool compress. At the time of reporting, red face, tongue edema and vaccination site tenderness were unresolved. The outcome of tingling tongue was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.

VAERS ID:450944 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-01
Location:Foreign  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0783806A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia
SMQs:, Haematopoietic erythropenia (broad)
Write-up: This case was reported by a physician and described the occurrence of anemia 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 site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced anemia. 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:451261 (history)  Vaccinated:2011-10-29
Age:13.0  Onset:2011-10-29, Days after vaccination: 0
Gender:Female  Submitted:2012-03-07, Days after onset: 130
Location:Foreign  Entered:2012-03-07
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, 29Oct2011, 103/78mmHg; Blood pressure systolic, 29Oct2011, 88mmHg; Pulse rate, 29Oct2011, 38bpm; Pulse rate, 29Oct2011, 38bpm
CDC Split Type: B0785367A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA146BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, 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), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 29 October 2011, at 10:45, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, left arm). On 29 October 2011, the subject was waiting in the waiting room after vaccination. She presented with facial pallor and loss of consciousness, and was found leaning on her grandmother who was accompanied with her, at 11:03. Her blood pressure was 88 mmHg, and pulse rate was 38 bpm, which was bradycardia. The attending physician laid her down immediately, and her blood pressure became 103/78 mmHg and pulse rate was 38 bpm in 5 minutes. Drip infusion of SOLDEM 1 of 500 mL was started at 11:25. On 29 October 2012, she recovered from the symptoms and returned home at 12:15. The physician considered the events were clinically significant (or requiring intervention). On 29 October 2011, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. The subject was vaccinated for the second time on 03 December 2011. No abnormality was noted.

VAERS ID:451475 (history)  Vaccinated:2011-08-18
Age:13.0  Onset:2011-08-23, Days after vaccination: 5
Gender:Female  Submitted:2012-03-09, Days after onset: 199
Location:Foreign  Entered:2012-03-12, Days after submission: 2
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: magnetic resonance imaging, no abnormalities
CDC Split Type: WAES1203USA00293
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NK107700SYRUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CC488A1SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Encephalitis, Laboratory test normal, Nuclear magnetic resonance imaging normal, Psychotic disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a Health Care Professional via the Health Authorities on 28-FEB-2012 under the reference numbers DK-DKMA-ADR21515045, DK-DKMA-EFO2214. Case medically confirmed. A 13-year-old female patient (weight 85kg, height 162 cm) had received an injection of GARDASIL (dose 1, lot number NK10770, batch number NL48770, IM). Secondary suspect therapy included an injection of PRIORIX (other manufacturer, dose 2, batch number A69CC488A, SC) on 18-AUG-2011 and later on 23-AUG-2011, she developed fever and paranoid psychosis. The patient developed fever and altered behavior five days post vaccination. She was hospitalized psychotic on child psychiatric department on 04-SEP-2011. During hospitalization she was compulsory medicated (not specified). She was transferred to somatic department on suspicion of encephalitis which was rebutted by MR imaging (date not reported) which showed no abnormalities. Lab tests (not specified) were also normal. There was no information on whether or when the patient was discharged from the hospital. The patient had no relevant medical history or medication. She had previously received one dose PRIORIX on 20-SEP-1999. At the time of reporting, the outcome was recovering for paranoid psychosis (also reported as unknown) and recovered for fever (date not reported). No causality assessments were provided. Other business partner numbers included: E2012-01454.

VAERS ID:451570 (history)  Vaccinated:2009-04-27
Age:13.0  Onset:2009-05-01, Days after vaccination: 4
Gender:Female  Submitted:2012-03-12, Days after onset: 1046
Location:Foreign  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Behaviour problems; Psychosocial; Menarche
Preexisting Conditions: Febrile convulsion; Finger deformity; Inguinal hernia surgery; Psychiatric treatment
Diagnostic Lab Data: CAT, 2009, normal; Electroencephalogram, 2009, normal; Laboratory test, 2009, normal; Nuclear magnetic resonance ima, 2009, normal
CDC Split Type: B0785619A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ankle deformity, Anxiety, Aphasia, Back injury, Back pain, Chest discomfort, Chest pain, Computerised tomogram normal, Contusion, Diarrhoea, Diplopia, Dizziness, Dyspnoea, Dystonia, Dysuria, Elbow deformity, Electroencephalogram normal, Fall, Feeling abnormal, Finger deformity, Head injury, Headache, Hypertonia, Hyperventilation, Hypoaesthesia, Hypoglycaemia, Joint contracture, Joint injury, Laboratory test normal, Limb injury, Loss of consciousness, Mobility decreased, Muscle rigidity, Muscle spasms, Muscle tightness, Neck pain, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Polydipsia, Polyuria, Protrusion tongue, Somnolence, Stress, Suffocation feeling, Syncope, Tachycardia, Tenderness, Tetany, Tremor, Trigger finger, Urinary tract infection, VIIth nerve paralysis, Vision blurred, Vomiting, Wrist deformity
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Dystonia (narrow), Parkinson-like events (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (narrow), Hypoglycaemia (narrow)
Write-up: This case was reported by a lawyer and described the occurrence of loss of consciousness in a 13-year-old female subject who was vaccinated with HPV vaccine and Hepatitis B vaccine. The subject''s medical history included: febrile convulsions when the subject was 12 months old; hospitalization at 15 months due to non-febrile convulsions (treated with DEPAKIN); inguinal hernia surgery at the age of 2; evaluation in a pediatric psychiatric unit at the age of 8 due to low academic results and problems in the relations with her equals (verbal intelligence quotient: 88; manipulative intelligence quotient; 67; total intelligence quotient : 75; discharged after 4 months when the conflicts with their equals disappeared); menarche with irregular cycles at 12 years. The subject had neither drug allergies nor known allergies. The subject experienced pain, deformity and functional impotence of the 2nd finger of the left hand after trauma (a schoolmate twisted her finger). The 2nd finger of the left hand showed a deformity in neck of swan: proximal interphalanx joint with palmar deviation and distal interphalanx joint with dorsal deviation. It was painful to touch and movement (treated by immobilization and subcutaneous morphine chloride). Concurrent medical conditions included asthma (treated with PULMICORT, finger deformity of the 2nd finger of the left hand, psychological treatment due to behavior problems of teenager character and rivalry with their equals. The subject lived with her parents and 2 sisters and had low school results. Historic vaccination included included 1st dose of HPV vaccine (manufacturer unspecified) and 1st dose of Hepatitis B vaccine (manufacturer unspecified) given on 21 October 2008, 2nd dose of HPV vaccine (manufacturer unspecified) and 2nd dose of Hepatitis B vaccine (manufacturer unspecified) given on 2 December 2008. On 27 April 2009, the subject received 3th dose of HPV vaccine (unknown route and injection site, batch number not provided) and 3th dose of Hepatitis B vaccine (unknown route and injection site, batch number not provided). In May 2009, 1 month after vaccination with HPV vaccine and Hepatitis B vaccine, the subject experienced sudden deformity on 3rd and 4th finger of the right hand. In June 2009, 2 months after vaccination with HPV vaccine and Hepatitis B vaccine, the subject experienced contractures in the fingers of the left hand without apparent trigger. She started to be followed by a neurologist and metabolism pathologist. After the initial evaluation, the family referred that the episodes were coincident in some occasional with the sudden hyperventilation, suffocation feeling, tachycardia, precordial oppression and tingling in the hands. Due to compatibility with anxious chart, a paroxetine and anxiolytic''s treatment was started. On 19 June 2009, 53 days after vaccination with HPV vaccine and Hepatitis B vaccine, the subject experienced sudden deformity in neck of swan of the 2nd, 3rd and 4th finger of the left hand, left hand numbness (conserved palmar sensitivity.), left hand finger trigger (2nd, 3rd and 4th finger) associated with pain at palpation and rigidity in all joints. Pain didn''t relief with normal analgesics. No fever or inflammation. The mother observed that during the night the rigidity disappeared but not totally. On 20 June 2009, 54 days after vaccination with HPV vaccine and Hepatitis B vaccine, the subject experienced deformity of all the fingers of both hands (neck of the swan of the 2nd, 3rd and 4th finger of both hands, flexion of interphalanx joint of the 5th fingers), left wrist deformity and left elbow deformity. The subject went to emergency room, was hospitalized on 20 June 2009 and immobilized with a plaster. During the 1st hours she started to move the joint normally even the pain and the sensitivity alteration persisted. After 24 hour the joint of the hand were normal with no pain or sensitivity alteration. The symptoms reappeared once but only in the fingers

VAERS ID:451576 (history)  Vaccinated:2008-09-19
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-12
Location:Foreign  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine
Preexisting Conditions:
Diagnostic Lab Data: Audiometry, 2009, normal; Blood test, 2009, normal; Blood test, 2010, normal; Body temperature, Sep2008, 40Deg. C; Cytomegalovirus test, 2010, positive; Ear, nose and throat examinati, 2009, eardrum with cal; Electrocardiogram, 2008, normal; Electrocardiogram, 2008, normal; Electrocardiogram, 2009, normal; Electroencephalogram, 2009, normal; Epstein-Barr virus IgG antibod, 2010, positive; Laboratory test, 2008, normal; Nuclear magnetic resonance ima, 2009, normal
CDC Split Type: B0785445A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.VPHA1NG43220 SYRUN
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B019A SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Arthropathy, Asthenia, Audiogram normal, Blood test normal, Cytomegalovirus test positive, Dizziness, Ear pain, Electrocardiogram normal, Electroencephalogram normal, Electromyogram normal, Epstein-Barr virus antibody positive, Feeling hot, Gait disturbance, Headache, Hot flush, Injury, Migraine, Muscle spasms, Muscular weakness, Nausea, Nervousness, Nuclear magnetic resonance imaging brain normal, Odynophagia, Otitis media acute, Photophobia, Presyncope, Pyrexia, Sleep disorder, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a lawyer and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with DITANRIX (GlaxoSmithKline). Concurrent medical conditions included migraine. Subject''s father was under study due to a possible Brugada syndrome. Concurrent vaccination included HPV vaccine (non-gsk) (non-GSK manufacturer, unknown route and injection site) given on 19 September 2008. On 19 September 2008, the subject received unspecified dose of DITANRIX (unknown route and injection site). In September 2008, less than one week after vaccination with DITANRIX, the subject to the emergency room. She fever (40 Deg. C), odynophagia, left otalgia, migraine and frontal headache. Acute otitis media was diagnosed. The subject was treated with Amoxicillin, ibuprofen and DEXKETOPROFEN. According to the report of 17 October 2008, at an unspecified date, less than one month after vaccination with DITANRIX, the subject went to the school medical room and referred dizziness, vasovagal episode with shaky feeling and hot flash. Later she went to the otorhinolaryngologist due to dizziness. According to the report of 21 October 2008, at an unspecified date, less than one year after vaccination with DITANRIX, the subject went to the emergency room referring dizziness, photophobia, blurred vision, nausea and headache. An electrocardiogram performed. The results were normal. The subject was treated with PRIMPERAN. According to the report of 6 November 2008, lab tests were performed, the results were normal. According to the report of 18 November 2008, an electrocardiogram was performed. The results were normal. In January 2009, 4 months after vaccination with DITANRIX, the subject experienced syncope. In February 2009, 5 months after vaccination with DITANRIX, the subject experienced cramps in leg and possible restless leg syndrome. According to the report of 5 February 2009 to 10 February 2009, the subject experienced again syncope on 4 and 5 February 2009. Less than one year after vaccination with DITANRIX, the subject was admitted to the Hospital due to syncope and dizziness. Subject''s examination was normal. Oxygen administration for 40 minutes, the dizziness stopped. Syncope and migraine were diagnosed. The subject was treated with DIHYDROERGOTAMINE. She was discharged on 10 February 2009. According to the report of 18 February 2009, in February 2009, 5 months after vaccination with DITANRIX, the subject went to the emergency room due to dizziness with blurred vision, hot and nausea. According to the report of 19 February 2009 to 4 March 2009, less than 1 year after vaccination with DITANRIX, the subject was hospitalized due to dizziness and objects rotation sensation. She said that it happened every day. She also referred weakness in low limbs asthenia and instability. She didn''t feel the salted flavour neither hot sensation in skin. Subject''s examination was normal. Several tests were performed: electrocardiogram (normal), electroencephalogram (normal), brain magnetic resonance (normal), ORL (eardrum with calcareous plates, normal audiometry), blood test (normal), Brugada syndrome test (pending). The diagnosis was vasovagal instability. Heart disease was ruled out. The subject discharged on 4 March 2009. According to the report of 23 March 2009, less than 1 year after vaccination with DITANRIX, the subject went to the traumatologist due to an injury and arthropathy that didn''t improved after immobilization. According to the report of 22 October 2009, the subject went to the neurologist due to cramps in the legs for months that didn''t let her sleep. She presented asthenia and recurrent syncope. Possible relation with HPV vaccine. According to the report of 26 October 2009, the subject went to the emergency room due to the cramps in the legs for months that didn''t let her sleep. She presented asthenia and recurrent syncope. A blood test was performed (normal). According to the report of 3 November 2009, the subjec

VAERS ID:451820 (history)  Vaccinated:2012-03-06
Age:13.0  Onset:2012-03-06, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 7
Location:Foreign  Entered:2012-03-14
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: UNK
CDC Split Type: B0787162A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Depressed level of consciousness, Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of decreased consciousness in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included the 1st and 2nd doses of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection sites, batch numbers not provided) given on unspecified dates. No particular problem was observed after the 1st and the 2nd vaccinations with CERVARIX. On 6 March 2012, the subject received the 3rd dose of CERVARIX (0.5 ml, intramuscular, left upper arm). On 6 March 2011, immediately after vaccination with CERVARIX, the subject presented with convulsion-like symptoms in the hands and was losing consciousness, but soon she regained consciousness. After she was put on bed rest for a while, she returned home without complaining of particular symptoms. The physician considered that the events were not particularly serious, but this case was assessed as medically serious by GSK. On 6 March 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:451935 (history)  Vaccinated:2012-03-02
Age:13.0  Onset:2012-03-02, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 12
Location:Foreign  Entered:2012-03-15
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, 02Mar2012, 87/44; Electrocardiogram, 02Mar2012, No arrhythmia
CDC Split Type: B0787590A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Arrhythmia, Bradycardia, Electrocardiogram normal, Headache, Heart rate irregular
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylactic shock in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject reported that she had been receiving checkup for arrhythmia once a year up to the third grade of elementary school. Concurrent vaccination included first dose of CERVARIX (GlaxoSmithKline, intramuscular, left arm, batch number not provided) given on an unspecified date. On 2 March 2012, at 18h07, the subject received the 2nd dose of CERVARIX (0.5 ml, intramuscular, left upper arm, batch number not provided). The second dose was given on the same left arm as the first dose because the subject would have a pain in the arm when playing tennis. On 2 March 2012, during vaccination with CERVARIX, the patient complained of severe pain in the temple on the side of the vaccination. It was considered to be an anaphylactic shock. Irregular heart sounds and bradycardia were confirmed by auscultation. The subject''s blood pressure was 87/44. She was placed under observation with electrocardiogram for 3 hours. When the headache also subsided, no arrhythmia was seen and she left for home. This case was assessed as medically serious by GSK. The arrhythmia resolved on 2 March 2012, the anaphylactic shock and the headache resolved on 3 March 2012 and the outcome of the heart rate irregular and bradycardia was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:452043 (history)  Vaccinated:2009-06-16
Age:13.0  Onset:2009-06-17, Days after vaccination: 1
Gender:Female  Submitted:2012-03-16, Days after onset: 1003
Location:Foreign  Entered:2012-03-19, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Transaminases, 17Jun2009, Elevated
CDC Split Type: B0788435A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA059AD2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chromaturia, Headache, Pyrexia, Transaminases increased, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by subject''s mother via regulatory authority (160241) and described the occurrence of transaminases increased in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 June 2009, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 17 June 2009, 1 day after vaccination with CERVARIX, the subject experienced fever, headache, vomiting. On 18 June 2009, 2 days after vaccination with CERVARIX, the subject experienced orange urine. At unknown date, unspecified time after vaccination and after a pediatrician visit, a blood test was performed and revealed transaminases increased. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.

VAERS ID:452139 (history)  Vaccinated:2012-02-23
Age:13.0  Onset:2012-03-13, Days after vaccination: 19
Gender:Female  Submitted:2012-03-19, Days after onset: 6
Location:Foreign  Entered:2012-03-20, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CSF test, 13Mar2012, normal
CDC Split Type: D0074907A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BN UNUN
Administered by: Other     Purchased by: Other
Symptoms: CSF test normal, Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician and described the occurrence of facial paresis in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 February 2012 the subject received an unspecified dose of CERVARIX (0.5 ml, unknown). Approximately 19 days after vaccination with CERVARIX, on 13 March 2012, the subject experienced facial paresis. On 13 March 2012 he subject was hospitalised for two days. Cerebrospinal fluid (CSF) examinations showed no pathologic findings. At the time of reporting the outcome of the event was unspecified. Follow-up information has been requested.

VAERS ID:452175 (history)  Vaccinated:2012-01-14
Age:13.0  Onset:2012-01-14, Days after vaccination: 0
Gender:Female  Submitted:2012-03-20, Days after onset: 65
Location:Foreign  Entered:2012-03-20
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: UNK
CDC Split Type: B0789151A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Immediate post-injection reaction, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (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). The subject''s body temperature before vaccination was 35.7 degrees centigrade. On 14 January 2012, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, left upper arm). On 14 January 2012, immediately after vaccination with CERVARIX, the subject experienced vasovagal reaction with facial pallor and feeling poorly. She lay on a bed and the symptoms improved. This case was assessed as medically serious by GSK. On 14 January 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information has been requested.

VAERS ID:452437 (history)  Vaccinated:2012-03-02
Age:13.0  Onset:2012-03-17, Days after vaccination: 15
Gender:Female  Submitted:2012-03-26, Days after onset: 9
Location:Foreign  Entered:2012-03-26
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: CSF test, 18Mar2012, No abnormality; Nuclear magnetic resonance ima, 18Mar2012, No abnormality
CDC Split Type: B0790579A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA149BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: CSF test normal, Convulsion, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of convulsion in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 2 March 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left shoulder). On 17 March 2012, 15 days after vaccination with CERVARIX, the subject experienced convulsion and was transferred to the department of pediatrics of municipal hospital. She received steroid pulse therapy immediately. On 18 March 2012, magnetic resonance imaging and cerebrospinal fluid examination were performed, but there were no abnormalities. The administration of steroid was discontinued because the symptom subsided. As of 19 March 2012, although the symptom had been subsided, the subject was still in the hospital. No further information was available.

VAERS ID:452441 (history)  Vaccinated:2011-10-25
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-26
Location:Foreign  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Learning disability; No known allergies
Diagnostic Lab Data: UNK
CDC Split Type: B0789372A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Aggression, Decreased interest, Gastrooesophageal reflux disease, Hallucination, Insomnia, Lethargy, Vaccine positive rechallenge, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional, via the regulatory authority, and described the occurrence of hallucinations in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included epilepsy and a learning disability. It was reported that the subject had been seizure-free for 2 years and was now off medication. It was also reported that the patient attended a special needs school for learning difficulties. The subject had no known allergies. Previous vaccinations included the first dose of CERVARIX (GlaxoSmithKline) given on 20 September 2011. At an unknown time after vaccination with CERVARIX, the subject started vomiting and could not keep anything down for almost 2 weeks. She was lethargic, showed no interest in usual activities, was up all night for several nights and was ''not herself''. It was reported that things started to calm down slightly just as the second dose was due. On 25 October 2011 the subject received their 2nd dose of CERVARIX (1 injection, intramuscular, batch details unknown). It was reported that the events the subject had experienced after the 1st dose of CERVARIX, started again after the 2nd dose ''but seemed worse than the first time''. It was reported that the subject also experienced hallucinations and was occasionally aggressive (totally out of nature for the subject). This carried on for about 3 months and during that time the subject lost almost 2 stone in weight. The subject has now started to recover but appears to be left with reflux. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 23 February 2012 the vomiting, lethargy and sleeping difficulties had resolved with sequelae. At the time of reporting, the outcome of the hallucinations, aggression, weight loss, feeling abnormal and reduced interest in usual activities was improved. The gastroesophageal reflux was Unresolved. The first dose of CERVARIX, was given 6 months ago. The patient started vomiting and could not keep anything down for almost 2 weeks. She was lethargic, showed no interest in usual activities, was up all night for several nights and was "not herself". Things started to calm down slightly just as the second dose was due. The second dose of CERVARIX was given one month after the first. The above symptoms started again but seemed worse than the first time. The patient also suffered hallucinations and was occasionally aggressive (totally our of nature for the patient). This carried on for about 3 months and during that time she lost almost 2 stone in weight. She had now started to recover but appears to be left with reflux.

VAERS ID:452449 (history)  Vaccinated:2012-02-21
Age:13.0  Onset:2012-02-21, Days after vaccination: 0
Gender:Male  Submitted:2012-03-26, Days after onset: 33
Location:Foreign  Entered:2012-03-26
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, 21Feb2012, 38.5Deg. C
CDC Split Type: B0790812A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB870AJ UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Oropharyngeal pain, Pruritus, Pyrexia, Rash, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# AT-BASGAGES-120502) and described the occurrence of groggy in a 13-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), FSME IMMUN (non-gsk). No relevant medical history and no concomitant medications were reported. Previous vaccination included ENGERIX B (GlaxoSmithKline) and FSME IMMUN (non-gsk) given on unspecified dates. On 21 February 2012, the subject received unspecified dose of ENGERIX B (unknown route of administration, unknown site of injection) and unspecified dose of FSME IMMUN (unknown route of administration, unknown site of injection). On 21 February 2012, less than one day after vaccination with ENGERIX B and FSME IMMUN, the subject experienced groggy, tiredness, throat pain, small itching efflorescences on upper part of the body, faintness, fever (up to 38.5 Deg. C), lassitude, stomach pain and inappetence. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 2 March 2012, small itching efflorescences on upper part of the body were resolved and ambulant investigation at pediatric hospital was performed. On 13 March 2012, the other events were resolved. Follow-up information received on 26 March 2012: The subject experienced small itching efflorescences on upper part of the body on 25 February 2012 instead of on 21 February 2012.

VAERS ID:452519 (history)  Vaccinated:2012-02-23
Age:13.0  Onset:2012-02-23, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 32
Location:Foreign  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fear
Preexisting Conditions: Hyperventilation
Diagnostic Lab Data: Blood pressure, 23Feb2012, 90/50mmHg
CDC Split Type: B0785895A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Clonic convulsion, Fall, Headache, Loss of consciousness, Muscle twitching, Pallor, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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 23 February 2012, the subject received the 1st dose of CERVARIX (intramuscular, unknown shoulder, batch number not provided). On 23 February 2012, 15 minutes after vaccination with CERVARIX, the subject experienced syncope. The subject had particularly no sick feeling and was not scared at the time of vaccination. After the vaccination, the patient sat down on a chair and was followed. Approximately 15 minutes later, the patient suddenly suffered from syncope. Then, the patient became conscious immediately and had no problems, and thus was sent home. The physician considered the event was clinically significant (or requiring intervention). On 23 February 2012, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Additional information received on 21 March 2012. The subject had a past medical history of hyperventilation syndrome. On 23 February 2012, the subject received the intramuscular vaccination of CERVARIX in the left shoulder after she was given explanation on the vaccination. It seemed that she had slight fear during the explanation before the vaccination, but she did not cry or act violently in particular, and the vaccination was completed. When she was sitting in a sofa, taking a rest, approximately 15 minutes after the vaccination, clonic convulsion-like twitching of the whole body and ill complexion were suddenly noted and she lost consciousness completely for 2 to 3 minutes. Decreased blood pressure was noted, but the symptoms improved only with being placed at bed rest. The subject had no painful/emotional stimulus before the onset of the event, no sweat or warmth feeling before the event. She had a menstrual period. It seemed that the subject had fear of pain and syncope during the explanation on the vaccination. The event developed suddenly. The subject fell sideways as if she were slipping from a sofa. Her movement was clonic and lasted for several seconds. She was pale and she lost consciousness for 2 to 3 minutes. Her respiratory pattern was normal. Blood pressure was 90/50 mmHg. She experienced twitching in the face, arms and legs. There was no tongue biting. The subject did not receive any medical treatment and did not undergo any special test. The event resolved while the subject was in the supine position. After the subject recovered from loss of consciousness, she experienced headache. The subject did not remember anything regarding loss of consciousness, her vision suddenly became dark. The event did not recur.

VAERS ID:452627 (history)  Vaccinated:2012-02-29
Age:13.0  Onset:2012-03-02, Days after vaccination: 2
Gender:Female  Submitted:2012-03-28, Days after onset: 25
Location:Foreign  Entered:2012-03-29, 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: Unknown
Diagnostic Lab Data: hemoglobin, 03Mar12, 5.9 mg/dl; total plasma bilirubin, 03Mar12, 3.8 mg/dl; direct plasma bilirubin test, 03Mar12, 0.46 mg/dl
CDC Split Type: WAES1203USA03104
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURERBA3270A0IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1040M1SCUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURERG0457 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Haemoglobin decreased, Haemolytic anaemia, Packed red blood cell transfusion
SMQs:, Liver related investigations, signs and symptoms (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Biliary system related investigations, signs and symptoms (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from Health Authority (case n. 161330, local case n. IT135/12). Initial report received on 15-MAR-12. Case medically confirmed. A 13 year old female patient was vaccinated on 29-FEB-12 with a booster dose of DIFTAVAX ADULTI (batch n. G0457-1) IM in the left arm and concomitantly with the second dose of MMR II, IM, (dose not reported) (lot number 643834/1040M, batch n. G014794, W9570-4) in the right arm and with the first dose of MENJUGATE (batch n. BA3270A) IM in the right arm. All vaccines were reported as suspect. On 02-MAR-12 she presented with hemolitic anemia. She was hospitalized and received blood transfusions with concentrated RBC on 03, 04, 07, 08, 10, 11-MAR-12, on 09-MAR-12 she was also started on steroid therapy. Labwork performed: see lab comments screen. At the time of reporting she had not yet recovered (also reported as unknown). The final outcome was not reported. The case is closed. Other business partner numbers include E2012-01805. No further information is available.

VAERS ID:452802 (history)  Vaccinated:2011-07-30
Age:13.0  Onset:2011-07-30, Days after vaccination: 0
Gender:Female  Submitted:2011-08-16, Days after onset: 17
Location:Foreign  Entered:2012-04-02, Days after submission: 230
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, 30Jul2011, normal; Oxygen saturation, 30Jul2011, 98%
CDC Split Type: B0737410A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA138AB IMAR
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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 30 July 2011, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown deltoid). On 30 July 2011, less than one day after vaccination with CERVARIX, the subject experienced syncope. The physician considered the event was clinically significant (or requiring intervention). On 30 July 2011, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow-up information received on 9 August 2011: The subject had no family history or medical history of the following diseases: Cardiac disease, epilepsy, metabolic abnormality (e.g., diabetes mellitus), or allergy (e.g., vaccine induced allergy, vaccine component induced allergy, food allergy, allergic rhinitis, eczema, asthma etc.). The subject had no past medical history of loss of consciousness. No concomitant oral medication was reported. The subject was in a sit-down position when receiving the vaccine. The subject had painful/emotional stimulus before the onset of the event and possible predisposing factor because of fears. She also had triggering event because of fears. No Signs or warnings of the episode were observed. The subject was no sweating or feeling warm before the onset of the event. The event developed suddenly. The subject fell over with a loud noise and experienced slight facial pallor and loss of consciousness for approximately 5 seconds. There were no changes in the respiratory pattern. No changes in movement were observed. No movements related to the fall were observed. No tongue biting was reported. The events resolved in the supine or front position. The arterial oxygen saturation (SpO2) was 98%, and the blood pressure was unknown (the measured blood pressure seemed to be normal). No symptoms occurred after the recovery from the loss of consciousness. The subject did not remember about the unconsciousness. The subject did not undergo special examinations. The events did not recur. The fears at the time of vaccination and the fact that the subject had visited the hospital without a family member might have been responsible for the events.

VAERS ID:452887 (history)  Vaccinated:0000-00-00
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-03
Location:Foreign  Entered:2012-04-03
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: B0792109A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vasculitis
SMQs:, Vasculitis (narrow)
Write-up: This case was reported by a regulatory authority (GB-MHRA-EYC 00083098) and described the occurrence of vasculitis in a 13-year-old female subject who was vaccinated with CERVARIX. On an unspecified date the subject received unspecified dose of CERVARIX. At an unspecified time after vaccination with CERVARIX, the subject experienced vasculitis. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. MHRA Verbatim Text: Vasculitis. Other medically significant: reporter considers serious.

VAERS ID:452901 (history)  Vaccinated:2012-03-12
Age:13.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-04-03, Days after onset: 22
Location:Foreign  Entered:2012-04-03
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: B0792828A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Malaise, Nausea, Pallor, Presyncope, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer via a regulatory authority (NL-LRB-135863) and described the occurrence of presyncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 12 March 2012, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown arm, batch number not provided). The injection itself went well, although the subject was a bit nervous before. On 12 March 2012, about 5 minutes after vaccination with CERVARIX, the subject experienced presyncope and fainted: she turned white and went dizzy. Just in time she could lay down, with feet upwards. After another 5 minutes she could gradually recover, and went home by bicycle. At home, she did not feel well, and experienced injection site pain and mobility decreased of injected arm. In the evening, the subject experienced nausea with once vomiting. Next day the subject was recovering and went to school again. Injection site pain was diminishing. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved. The regulatory authority reported that presyncope was probably related to vaccination with CERVARIX. No further information could be obtained from the regulatory authority since all available information have been provided. Therefore, this case has been closed.

VAERS ID:453000 (history)  Vaccinated:2012-03-14
Age:13.0  Onset:2012-03-14, Days after vaccination: 0
Gender:Female  Submitted:2012-04-04, Days after onset: 21
Location:Foreign  Entered:2012-04-04
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: Allergy; Allergy to Nuts; Cat Allergy
Diagnostic Lab Data: UNK
CDC Split Type: B0792627A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVAO87CC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Feeling hot, Headache
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 21564963) and described the occurrence of headache in a 13-year-old female subject who was vaccinated with CERVARIX. The subject''s medical history included allergy to nuts and cat allergy. Historic medications included AMETOP. Concurrent medications included Loratadine and E45 Itch relief. On 14 March 2012 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular). On 14 March 2012, 10 minutes after vaccination with CERVARIX, the subject complained of a headache and redness all the way around both eyes and her face felt hot. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. MHRA Verbatim Text: CERVARIX given at 09:55. At 10:05 patient complained of a headache and redness all the way around both eyes, face felt hot. Medically significant: due to multiple allergies, carries Epipen.

VAERS ID:453092 (history)  Vaccinated:2012-03-12
Age:13.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-04-05, Days after onset: 24
Location:Foreign  Entered:2012-04-05
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, 12Mar2012, 102/50mmHg; Blood pressure, 12Mar2012, 99/57mmHg; Pulse rate, 12Mar2012, 43bpm; Pulse rate, 12Mar2012, 58bpm
CDC Split Type: B0789127A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA156BA2IMLA
Administered by: Other     Purchased by