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Found 468972 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

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VAERS ID:331162 (history)  Vaccinated:2008-07-30
Age:25.0  Onset:2008-07-30, Days after vaccination: 0
Gender:Male  Submitted:2008-11-03, Days after onset: 96
Location:Foreign  Entered:2008-11-03
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: Blood pressure, 30Jul2008, 110/70; Pulse rate, 30Jul2008, 84per min
CDC 'Split Type': D0059259A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURA05810IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB115EA0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA05810IMLA
Administered by: Other     Purchased by: Other
Symptoms: Circulatory collapse, Dizziness, Heart rate
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (foreign regulatory authority # DE-PEI-PEI2008015851) and described the occurrence of circulatory collapse in a 25-year-old male subject who was vaccinated with TWINRIX adult, (GlaxoSmithKline). Co-suspect vaccine included REPEVAX (Sanofi Pasteur MSD). On 30 July 2008 the subject received 1st dose of TWINRIX adult (intramuscular, right deltoid), 1st dose of REPEVAX (intramuscular, left deltoid). On 30 July 2008, less than one day after vaccination with REPEVAX and TWINRIX adult, the subject experienced circulatory collapse and persisting dizziness. This case was assessed as medically serious by GSK. The patient had a blood pressure of 110/70 and a pulse of 84 per minute. Ambulatory treatment was necessary. After four days the events were resolved. No further information will be available.

VAERS ID:332346 (history)  Vaccinated:2008-04-07
Age:25.0  Onset:2008-04-29, Days after vaccination: 22
Gender:Female  Submitted:2008-11-13, Days after onset: 198
Location:Foreign  Entered:2008-11-14, 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: hormonal contraceptives (unspecified)
Current Illness: Hypothyroidism
Preexisting Conditions:
Diagnostic Lab Data: magnetic resonance imaging, 29Apr08, Cranial MRI: normal NMR tomography of cranium, no indication of lesions typical of multiple sclerosis; cardiac electrophysiology, 02May08, SEP of median nerve (bilateral) normal findings; visual evoked p
CDC 'Split Type': WAES0811USA00926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Albumin CSF normal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood thyroid stimulating hormone increased, Borrelia burgdorferi serology negative, CSF cell count normal, CSF glucose normal, CSF lactate abnormal, CSF oligoclonal band absent, CSF protein normal, Cardiac electrophysiologic study, Dizziness, Electrocardiogram normal, Hypoaesthesia, Hypoaesthesia facial, Hypothyroidism, Immunology test, Laboratory test normal, Neurological examination abnormal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain normal, Post lumbar puncture syndrome, Red blood cells CSF positive, Ultrasound thyroid normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad)
Write-up: Information has been received from a gynaecologist concerning a 25 year old female patient who was vaccinated with a second dose of GARDASIL (Lot #, site and route not reported) on 07-APR-2008. Concomitant medication included unspecified hormonal contraceptives. On 29-APR-2008, she was hospitalized for numbness of the left arm and face (left half) for 6 days. Additionally, she complained of dizziness. Neurological findings showed hypoesthesia of the left half of the face and the left arm. Overall clinical examination was normal. Lab findings revealed TSH: 6.26 uIE/ml. Routine laboratory findings showed normal results. Thyroid sonography was normal. Diagnosis of latent hypothyroidism was established. CSF puncture on 30-APR-2008: cell count: 1/3, glucose 63 mg/dL, protein: 21 mg/dL, lactate: 1.7 mmol/L. Albumin and IgG/IgA/IgM (CSF and serum) showed normal values. TPHA screening procedure was negative, specific IgG and IgM antibodies to borrelia (CSF and serum) were negative. No oligoclonal bands detectable. No CSF-blood barrier disorder. ECG showed normal results. Cranial MRI on 29-APR-2008: Normal NMR tomography of the cranium, no indication of lesions typical for multiple sclerosis. Electrophysiology on 02-MAY-2008, SEP of median nerve (bilateral): normal findings. VEP on 05-MAY-2008: normal findings. MEP (arms) on 05-MAY-2008: normal findings. MEP (legs) on 05-MAY-2008: normal findings. On 01-MAY-2008, the patient experienced headache caused by lumbar puncture. The patient''s condition improved under treatment with infusions, Ibuprofen and caffeine tablets and at discharge on 05-MAY-2008 she had completely recovered from headache. Outcome from hemihypaesthesia was not reported. The first dose of GARDASIL (Lot # not reported) was administered on an unspecified date and was well tolerated. Other business partner numbers included: E2008-10187. Additional information has been requested.

VAERS ID:333548 (history)  Vaccinated:2008-10-21
Age:25.0  Onset:2008-10-21, Days after vaccination: 0
Gender:Female  Submitted:2008-12-01, Days after onset: 41
Location:Foreign  Entered:2008-12-01
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': B0547253A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Neck pain, Somnolence, Vertigo
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), Arthritis (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of neck pain in a 25-year-old female subject who was vaccinated with TEDIVAX PRO ADULTO (GlaxoSmithKline). Co-suspect medication included YASMIN started in 2006. ON 21 October 2008, the subject received booster dose of TEDIVAX PRO ADULTO (intramuscular, unknown deltoid), lot number not provided. On 21 October 2008, less than one day after vaccination with TEDIVAX PRO ADULTO, the subject experienced neck pain with somnolence, vertigo feeling, swelling and pain at injection site. 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.

VAERS ID:335153 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-11
Location:Foreign  Entered:2008-12-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
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': WAES0812AUS00124
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Immediate post-injection reaction
SMQs:, Hypersensitivity (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 25 year old female, who has never had a history of anxiety problems before who was vaccinated with 3 doses of GARDASIL. Subsequently after vaccination with the first dose of GARDASIL, the patient developed anxiety. It was described as severe anxiety symptoms immediately after the first dose of GARDASIL, which continued until approximately 4 months after the last (third) dose. The patient was treated with psychological therapy. At the time of reporting to the agency on 29-SEP-2008, the patient had recovered from the anxiety. The agency considered that anxiety was possibly related to therapy with GARDASIL. The original reporting source was not provided. The adverse event of anxiety was considered to be disabling by the reporting agency. Additional information is not expected.

VAERS ID:335485 (history)  Vaccinated:2008-11-12
Age:25.0  Onset:2008-11-16, Days after vaccination: 4
Gender:Female  Submitted:2008-12-16, Days after onset: 30
Location:Foreign  Entered:2008-12-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ethinyl estradiol (+) levonorgestrel
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: biopsy, ??Nov08, serum sickness; body temp, ??Nov08, 38-39 degree C
CDC 'Split Type': WAES0812AUS00218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Biopsy, Body temperature increased, Chills, Feeling hot, Pain, Rash, Rash generalised, Serum sickness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a physician as part of a business agreement (manufacturer control # GARD 2008 12 12 001) concerning a 25 year old female who on 12-NOV-2008 was vaccinated with GARDASIL. Concomitant therapy included MICROGYNON. On 16-NOV-2008, 84 hours after vaccination with GARDASIL, the patient developed serum sickness. It was described that the patient developed a rash on the lower trunk which spread over several hours. The patient the developed chills and felt worse when she was hot. Two days later, on approximately 18-NOV-2008 the rash became generalised and the patient was admitted to the hospital with a possible diagnosis of scarlet fever. The patient was aching all over and her temperature was 38-39 degree C. A biopsy was done which revealed serum sickness. Subsequently, the patient recovered from the serum sickness. Additional information is not expected.

VAERS ID:336354 (history)  Vaccinated:2008-11-01
Age:25.0  Onset:2008-11-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 60
Location:Foreign  Entered:2009-01-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Injection site oedema
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA04467
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.N1027802IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Discomfort, Hypersensitivity, Injected limb mobility decreased, Injection site oedema, Pain, Vaccine positive rechallenge
SMQs:, Angioedema (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist on 12-DEC-2008 concerning a 26 year old female patient with a history of injection site oedema who was vaccinated with the third dose of GARDASIL (batch # not reported) in her arm on an unspecified date. One to two days later she developed an arm oedema of severe intensity with arm movements constraint. She had recovered in two to three days with PARACETAMOL. The patient had no adverse effect after the first dose of GARDASIL (unspecified date) and she had a slight injection site oedema after the second dose of GARDASIL (unspecified date). The case was closed. Follow up information received on 24-DEC-2008: The case was upgraded to serious due to another seriousness criterion, movement discomfort. It was reported that the patient was 25 years at the time of adverse reactions. The GARDASIL (Batch # NJ02780) was administered in November 2008 via the intramuscular route in the right arm. One or two days post-vaccination the patient experienced oedema, discomfort when moving and local pain during 3 or 4 days, and asthenia during a few days. The reactions were considered as moderate and non serious except for movement discomfort which was moderate and serious. The patient was prescribed corrective treatment for pain with PARACETAMOL 1g three times per day and local disinfection. The patient was diagnosed with allergic reaction to vaccination. The patient recovered. The reporter considered the case as non serious but discomfort was highlighted. The case was closed. The reporter considered injection site movement impairment to be an other important medical event. Other business partner numbers include E2008-11702. No further information is available.

VAERS ID:336771 (history)  Vaccinated:2008-11-04
Age:25.0  Onset:2008-11-04, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 64
Location:Foreign  Entered:2009-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Had drug abuse history
Diagnostic Lab Data: Hepatitis C PCR, negative
CDC 'Split Type': 200914494
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hepatitis C test negative, Influenza like illness, Jaundice, Mobility decreased, Musculoskeletal stiffness, Pain, Pneumonia, Polymerase chain reaction
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Report received from Healthcare Products Regulatory Agency. (No.: GB-MHRA-ADR20355736). A 25-year-old female patient (initials and date of birth unknown) was vaccinated with ENZIRA (lot unknown on 04-Nov-2008. Concomitant medication included Methadone 90mL since 08-Feb-2006 for drug abuse, and Mirtazepine 45 mg since 18-Jul-2007 for depression. On 04-Nov-2008, the patient experienced muscle stiffness, pain, reduced mobility and flu-like presentation - treated as such. Pneumonia and jaundice developed on 02-Dec-2008 and patient was hospitalised. The patient''s outcome was unknown at the time of reporting. Serious criterion: hospitalisation. The company considered events from this ADR report does not change the current safety profile of FLUVAX.

VAERS ID:338228 (history)  Vaccinated:2008-09-10
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-23
Location:Foreign  Entered:2009-01-26, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, ??08, 38-39 degrees celsius, febrile
CDC 'Split Type': WAES0901AUS00078
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER72CA458 IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER72CA458 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Injection site reaction, Injection site swelling, Injection site vesicles, Pain, Pyrexia, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information was obtained on request by the company from the agency, via a case line listing and public case details form, concerning a 25 year old female who on 10-SEP-2008 was vaccinated with PNEUMOVAX 23, subcutaneously. Other suspect therapy included Tdap (+) HIB, intramuscularly, which was also administered on 10-SEP-2008 (batch No. 72CA458). Subsequently, after vaccination with PNEUMOVAX 23 and Tdap (+) HIB the patient developed injection site swelling, injection site reaction and skin exfoliation and was hospitalised. It was described that the patient developed redness/swelling and pain, was febrile at 38-39, and developed blisters around the injection site, which were weeping. She also developed peeling skin. The patient was treated with IV antibiotics. At the time of reporting to the agency on 9-OCT-2008, the patient had not yet recovered from injection site swelling, injection site and skin exfoliation. The agency considered that injection site swelling, injection site reaction and skin exfoliation were possibly related to therapy with PNEUMOVAX 23 and/or Tdap (+) HIB (unspecified carrier. The original reporting source was not provided. Additional information is not expected.

VAERS ID:338378 (history)  Vaccinated:2008-11-01
Age:25.0  Onset:2008-11-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-26, Days after onset: 86
Location:Foreign  Entered:2009-01-27, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood pressure measurement, 01Nov08, 110/70, units not specified; Respiratory rate measurement, 01Nov08, low - bradypnoea
CDC 'Split Type': WAES0901AUS00105
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradypnoea, Hypotonia, Loss of consciousness, Respiratory rate decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information was obtained on request by the Company from the agency, via a Case Line Listing and Public Case Details form, concerning a 25 year old female who on 01-NOV-2008 was vaccinated with her third dose of GARDASIL. Subsequently, on 01-NOV-2008 the patient experienced loss of consciousness and bradypnoea and was hospitalised. It was described that the patient was vaccinated with her third dose of GARDASIL at 10:52 am without any obvious side effects. At approximately 11:20 am the patient''s husband brought her back to the physician''s waiting room in a limp, unconscious state. The patient had collapsed 30 minutes after injection. The physician could not feel a pulse, however, a more senior physician could, and the patient''s blood pressure was 110/70 and her respiratory rate was low. The patient was taken to the emergency department of hospital, where she was treated with oxygen. She was observed for a few hours and then discharged. On 01-NOV-2008 the patient recovered from loss of consciousness and bradypnoea. The agency considered that loss of consciousness and bradypnoea were probably related to therapy with GARDASIL. Additional information is not expected.

VAERS ID:340904 (history)  Vaccinated:2009-01-16
Age:25.0  Onset:2009-01-16, Days after vaccination: 0
Gender:Female  Submitted:2009-02-27, Days after onset: 42
Location:Foreign  Entered:2009-03-02, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement, 16Jan09, Arterial pressure was a little low
CDC 'Split Type': WAES0902USA04447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1647U0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood pressure decreased, Convulsion, Feeling hot, Gaze palsy, Immediate post-injection reaction, Loss of consciousness, Syncope
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health care professional concerning a 25 year old female who on 16-JAN-2009 was vaccinated with the first dose of GARDASIL (lot# 1647U, batch# NH52670) route and site not reported. It is reported that the patient presented with convulsions, immediately after vaccine administration, these convulsions started from the abdomen and went up. The patient experienced a loss of consciousness and eye deviation. These events lasted for a few seconds or a few minutes. The patient was placed with her legs up, her arterial pressure was measured and a glycemic test was performed. Arterial pressure was a little low. The patient sat. She felt general weakness during chat afternoon and a warm/hot sensation right after she was vaccinated. The patient recovered. No further information has been requested. Additional information obtained on 18-FEB-2009: When the reporter was asked for a more detail description of the adverse event, she clarified that it was not a real convulsion but a convulsive syncope that lasted seconds (less than 1 minute) and resolved spontaneously. The event was defined as non serious by the reporter. Upon internal review, "convulsive syncope" was determined to be an other important medical event. Other business partner numbers include: E2009-01408. No further information is available. The case is closed.

VAERS ID:341192 (history)  Vaccinated:1993-01-11
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2009-03-05
Location:Foreign  Entered:2009-03-05
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: Scan, 1996, diagnosis of multiple sclerosis.
CDC 'Split Type': B0562418A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS954B6 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Multiple sclerosis, Scan abnormal
SMQs:, Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by a consumer and described the occurrence of multiple sclerosis in a 25-year-old male subject who was vaccinated with ENGERIX B, GENHEVAC B. A physician or other health care professional has not verified this report. Subject''s medical conditions were unspecified. Concurrent medications were unknown. On 10 November 1992, the subject received a first dose of ENGERIX B (20mcg, injection site and batch unknown). On 10 December 1992, the subject received a second dose of ENGERIX B (20mcg, injection site unknown, batch number 955B6). On 11 January 1993, the subject received a third dose of ENGERIX B (20mcg, injection site unknown, batch number 954B6). On 28 February 1994, the subject received a dose of GENHEVAC B (injection site and batch unknown). In 1996, 2 years after vaccination with GENHEVAC B and 3 years after last vaccination with ENGERIX B, the subject experienced inability to walk. Then in 1996, a scan was performed: multiple sclerosis was diagnosed (NOS). This case was assessed as medically serious by GSK. At the time of reporting, multiple sclerosis was unresolved. Outcome of inability to walk was unknown.

VAERS ID:341207 (history)  Vaccinated:2008-12-01
Age:25.0  Onset:2008-12-01, Days after vaccination: 0
Gender:Female  Submitted:2009-03-05, Days after onset: 94
Location:Foreign  Entered:2009-03-06, 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: Unknown
CDC 'Split Type': WAES0902ISR00023
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Monoplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a physician concerning a 25 year old female who in December 2008, was vaccinated with GARDASIL first dose. In December 2008, the patient experienced arm paralysis for two weeks. Subsequently, the patient recovered from arm paralysis. The physician indicated that the consumer (the patient''s mother) reported to her about the event approximately one and half month posts the event by phone call. The adverse event was termed by the consumer as an "arm paralysis" and "could not move her hand". The reporting consumer indicated that the patient did not refer to a physician for examination at the time of the event. The physician advised the patient to refer for examination however the patient was not examined by the time of this report. The physician felt that the relation of arm paralysis to therapy with GARDASIL first dose is unknown. The physician raised the possibility that the event was not paralysis per se but rather pain from the injection however since the patient was not examined the physician could not determined that. Upon internal review, monoplegia was considered to be an other important medical event. Additional information is not expected.

VAERS ID:342492 (history)  Vaccinated:2008-02-01
Age:25.0  Onset:2008-07-23, Days after vaccination: 173
Gender:Female  Submitted:2009-03-23, Days after onset: 243
Location:Foreign  Entered:2009-03-24, 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: diagnostic laboratory test, 03Sep08, a CCT showed no pathologies
CDC 'Split Type': WAES0903USA00144
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0510U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache, Laboratory test normal, Nausea, Paraesthesia, Vertigo
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Information has been received from a gynaecologist concerning a 25 year old female who was vaccinated with a third dose of GARDASIL (lot# 0467U, batch# NG14290) into the deltoid muscle on an unspecified date. Four to six weeks post vaccination, the patient developed dizziness. The patient was hospitalized for clarification and diagnosis on an unspecified date. The patient had not recovered at the time of this reporting. The first dose of GARDASIL (lot# 0510U, batch# NG20180) was administered on 01-FEB-2008 and the second dose of GARDASIL (lot# not reported) was administered on an unspecified date. Toleration of the 1st and 2nd doses was not reported. Follow-up information was received on 12-MAR-2009. The reporting form and the hospital report were provided. On the reporting form only 2 doses of GARDASIL were mentioned. The second dose of GARDASIL, (lot# 0467U, batch# NG14290) was administered IM into the upper arm on 13-MAY-2008. On 03-SEP-2008 the patient was admitted to hospital because of prolonged vestibular vertigo with nausea and right-sided headache of unknown origin since about 6 weeks. A few days prior to hospitalization vertigo and nausea worsened. At admission neurological and orthopaedical investigation had been performed and showed normal results. On 03-SEP-2008 a CCT showed no pathologies. On 08-SEP-2008 the ears, nose, and throat investigation as a thermic examination of the external ear canal showed a transient slight reduced excitability of the right horizontal semicircular canal with complete central nerve system compensation. On 16-SEP-2008 a cardiological consultation was normal. Under treatment with rheological infusions including cortisone and pentoxifyllin (Pentoxifylline), the symptoms improved. For a short time the patient complained of paraesthesia of cheeks and lower extremities but a neurological examination showed no pathological findings. The patient denied further investigations to clarify the symptoms. The diagnosis of phobic vertigo and transient slight reduced excitability of the

VAERS ID:342590 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2009-03-24
Location:Foreign  Entered:2009-03-25, 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:
Diagnostic Lab Data:
CDC 'Split Type': 200914810
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDB0906 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Malaise, Nausea, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Report received from a physiotherapist via a company representative on 19-MAR-2009. A male patient received FLUVAX (batch number unknown) on unknown date. No information provided regarding medical history or concomitant medications. The patient received FLUVAX on the Wednesday, and subsequently developed a sore arm, felt unwell, dizzy and vomiting. Exact time to onset not specified. The patient continued to be sick until Monday and was admitted to hospital overnight for nausea and vomiting. The patient was discharged from the hospital on Tuesday. It is not known whether the patient received any treatment for the events. This case was assessed as serious due to hospitalisation. The company assessed the events as conditional in relation to the suspect drug, pending further follow-up information. Information derived from this AE report does not change the safety profile of FLUVAX.

VAERS ID:342705 (history)  Vaccinated:2009-03-16
Age:25.0  Onset:2009-03-16, Days after vaccination: 0
Gender:Female  Submitted:2009-03-25, Days after onset: 9
Location:Foreign  Entered:2009-03-26, 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: Drug Hypersensitivity
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0903USA03704
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Intensive care, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (narrow)
Write-up: Information has been received from a physician concerning a 25 year old female with a history of drug hypersensitivity (chest tightness and dyspnea) of unknown drug name who on 16-MAR-2009 at 10:00 was vaccinated IM with the first 0.5 mL dose of GARDASIL. On 16-MAR-2009 at 14:00, the patient experienced dyspnea and chest tightness and was hospitalized. She felt mild dyspnea and chest tightness. At 17:00, she felt severe dyspnea, chest tightness and vertigo. Therefore she came to the ICU of the general hospital and was treated with DEMEROL and DEPO MEDROL and oxygen until 21:00. The patient was completely conscious when she came to the ICU. After that, the patient''s condition was better and the hospital let her come home, but she still felt tired and asked to stay in the hospital, so she stayed in the ICU. The patient was then transferred to an internal department for follow up. The patient was discharged recovered at 02:00 17-MAR-2009. The physician reported that it was unknown if the patient''s dyspnea and chest tightness were related to therapy. The reporting physician considered dyspnea and chest tightness were other important medical events. Additional information has been requested.

VAERS ID:342793 (history)  Vaccinated:1996-07-30
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2009-03-26
Location:Foreign  Entered:2009-03-26
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: No history of multiple sclerosis.
Diagnostic Lab Data: Unk
CDC 'Split Type': B0566321A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Multiple sclerosis, Nervous system disorder
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by GSK Legal Department and described the occurrence of multiple sclerosis in an adult male subject (25-year-old at the time of vaccination) who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of multiple sclerosis. In 1995, on unspecified date, the subject received first dose of ENGERIX B (injection site and batch unknown). On 15 January 1996, the subject received a second dose of ENGERIX B (injection site and batch unknown). On 30 July 1996, the subject received a third dose of ENGERIX B (injection site and batch unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced neurological disorder (NOS). At the beginning of 1998, less than two years after last vaccination with ENGERIX B, multiple sclerosis was diagnosed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Causality assessment to vaccination with ENGERIX B was not provided.

VAERS ID:344610 (history)  Vaccinated:2007-02-01
Age:25.0  Onset:2009-02-01, Days after vaccination: 731
Gender:Female  Submitted:2009-04-21, Days after onset: 78
Location:Foreign  Entered:2009-04-22, Days after submission: 1
Life Threatening? Yes
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: Unknown
CDC 'Split Type': WAES0904USA02350
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427U IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical dysplasia, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a health authority on 14-APR-2009 under HA reference no. PEI2009007080. It was reported that a 25 year old female patient was vaccinated with a dose of GARDASIL (batch number NH15200, lot number 1427U) IM into the left upper arm in February 2007, In February 2009 a cervical PAP smear showed PAP IIID. The reporter assessed the event as "life-threatening" (as documented), but the patient was not hospitalized. Previous vaccination with GARDASIL, lot number not reported, was administered on an unspecified date. Toleration was not reported. Final outcome was unknown. Case closed. Other business partner numbers included E200903271. No further information is available.

VAERS ID:345139 (history)  Vaccinated:2008-12-19
Age:25.0  Onset:2008-12-30, Days after vaccination: 11
Gender:Female  Submitted:2009-04-28, Days after onset: 118
Location:Foreign  Entered:2009-04-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVLEN ED
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test, pit:1; diagnostic laboratory test, viral and immune disease screen non-contributory; WBC count, 9.1; hemoglobin, 140; neutrophil count, 7.76
CDC 'Split Type': WAES0904USA03855
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Differential white blood cell count normal, Haemoglobin increased, Laboratory test, Neutrophil count decreased, Petechiae
SMQs:, Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Information was obtained on request by the company from the agency, via a Public Case Details forms, concerning a 25 year old female who on 19-DEC-2008 was vaccinated with GARDASIL IM (therapy dose, site and lot # unknown). Concomitant therapy included LEVLEN ED. On 30-DEC-2008 the patient experienced petechial rash on legs and was hospitalized. Laboratory investigations included Hemoglobin of 14.0, "pit" of 1, WCC of 9.1, Neutrophils of 7.76, and viral and immune disease screen non-contributory. The patient was given PREDNISOLONE 50mg daily. Subsequently, on 04-JAN-2009 the patient recovered. The reporter felt that petechial rash on legs was possibly related to therapy with GARDASIL. The original reporting source was not provided. Additional information has been requested.

VAERS ID:346688 (history)  Vaccinated:2009-01-22
Age:25.0  Onset:2009-01-22, Days after vaccination: 0
Gender:Female  Submitted:2009-05-19, Days after onset: 116
Location:Foreign  Entered:2009-05-20, 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: No information reported. Vaccination certificate missing / no vaccination documented.
Diagnostic Lab Data: Laboratory findings showed leukocytosis on an unknown date.
CDC 'Split Type': E200902713
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURD0653 IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0842 IMLL
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CB556A SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC29699A IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardiovascular disorder, Dizziness, Hyperhidrosis, Laboratory test abnormal, Leukocytosis, Nausea, Photosensitivity reaction, Pyrexia, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Case received from a health care professional on 27-Mar-2009. It was reported that a 25-year-old female patient was vaccinated concomitantly with booster doses of ADACEL (lot-no. not reported) IM and IPOL (lot-no. not reported) IM, a dose of FLUZONE (lot-no. not reported) IM and a dose of PRIORIX (Man. GSK, lot-no. not reported) SC on 22-Jan-2009. To be noted that the patient had no vaccination certificate (no vaccination documented). The following night the patient experienced dizziness, nausea, sweating and "circulatory problems". She recovered within an unspecified time. Short time later all symptoms reoccurred, she additionally developed fever. Since then the symptoms relapse ever and anon. The patient presented at the outpatient department of the hospital 3 times. A blood sample showed increased leukocytes. No diagnosis was established so far. Follow-up information received on 04-May-2009. The reporting form was sent: The patient was vaccinated with a booster dose of COVAXIS, lot # C2699AA, into the left deltoid muscle on 22-Jan-2009. On the same day she was vaccinated with a dose of IMV MERIEUX, lot# A0842-2, IM into the left thigh, a dose of MUTAGRIP, lot# D0653-1, IM into the right thigh and with PRIORIX, Man. GSK, lot# A69CB556A SC into the right upper arm. On 22-Jan-2009 the patient developed the before-mentioned events, plus photosensitivity. The fever increased up to 39.5 deg. C. Laboratory findings showed leukocytosis on an unknown date. Under treatment with antibiotics and unspecified drops of stabilizing the circulation the patient recovered on an unspecified date. Case Closed. Upon medical review the company upgraded the case to serious because of the duration of atypical events reported and the reoccurrence of the events. Case Closed.

VAERS ID:348568 (history)  Vaccinated:2009-03-27
Age:25.0  Onset:2009-04-30, Days after vaccination: 34
Gender:Female  Submitted:2009-06-04, Days after onset: 35
Location:Foreign  Entered:2009-06-05, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Oral contraception
Preexisting Conditions:
Diagnostic Lab Data: angiography, 06May09, 1800 MICROGRAM/ML
CDC 'Split Type': WAES0905TUR00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiogram, Fibrin D dimer increased, Pulmonary embolism
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow)
Write-up: Information has been received from a physician concerning a 25 year old female with oral contraception who on 27-MAR-2009 was vaccinated with GARDASIL. Concomitant therapy included JASMINE for 4 months. On 30-APR-2009 the patient experienced pulmoner emboli and was hospitalized. On the angiography, there was pulmoner emboli in dextra inferior lob; invasive lesions in sinistra. D-dimer value was 1800 microgram/ml. Subsequently, on 6th May 2009 the patient recovered from pulmoner emboli. On 16th of May 2009 the patient was discharged from hospital. The reporter felt that pulmoner emboli was not related to therapy with GARDASIL. Therapy with human papillomavirus was discontinued. Pulmoner emboli was considered to be immediately life-threatening. Additional information is not expected.

VAERS ID:349512 (history)  Vaccinated:2009-04-28
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-18
Location:Foreign  Entered:2009-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic; Diabetes NOS; Tomato Allergy
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0578953A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Lip swelling, Oedema mouth, Rash generalised, Swelling face, Swollen tongue, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer (subject) and described the occurrence of nettle rash in a 25-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). The subject had no previous allergies (has, however, reacted to antibiotics and tomato). The subject has diabetes. On 28 April 2009, the subject received 1st dose of TWINRIX ADULT (unknown route of administration, left arm, lot number not provided). In 2009, 2-3 days after vaccination with TWINRIX ADULT, the subject experienced nettle rash, which began on the elbows then spread to the arms and legs and later on the face that became swollen. On 05 May 2009, the subject went to the hospital because the nettle-rash had spread throughout the body. On 15 May 2009, the subject was hospitalised, because the eyes, mouth, lips and tongue swelled. On 22 May 2009, the subject was hospitalised again, because the eyes, mouth, lips and tongue swelled. The subject received an adrenaline syringe to take home if it would happen again. The subject received treatment with various allergy tablets, currently she was treated with AERIUS tablets, BETAPRED and TAVEGYL as necessary. At time of reporting, the problems were better, but they were not completely resolved. In the afternoon, it may come back dots along her arms and her lips may be swollen.

VAERS ID:349870 (history)  Vaccinated:2009-05-01
Age:25.0  Onset:2009-05-01, Days after vaccination: 0
Gender:Male  Submitted:2009-06-23, Days after onset: 53
Location:Foreign  Entered:2009-06-23
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: Body temperature, May2009, 39deg C
CDC 'Split Type': B0579589A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B016A1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Hyperthermia
SMQs:, Neuroleptic malignant syndrome (broad), Accidents and injuries (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-119408344) and described the occurrence of hyperthermia in a 25-year-old male subject who was vaccinated with (DITANRIX, GlaxoSmithKline). In May 2009 the subject received unspecified dose of DITANRIX (intramuscular). In May 2009, less than one month after vaccination with DITANRIX, the subject experienced hyperthermia 39 Deg C for 3 days, somewhat resistant to antipyretics. The regulatory authority reported that the event was clinically significant (or requiring intervention). The regulatory authority reported that the event was probably related to vaccination with DITANRIX. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:351187 (history)  Vaccinated:2009-03-23
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-13
Location:Foreign  Entered:2009-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance ima, 29Apr2009, Negative
CDC 'Split Type': B0582222A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthritis reactive, Asthenia, Discomfort, Ear infection, Ear pain, Ear pruritus, Facial palsy, Hypoaesthesia, Hypoaesthesia facial, Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (narrow)
Write-up: This case was reported by a regulatory authority (#NO-NOMAADVRE-FHI-2009-7871) and described the occurrence of Bell''s palsy in a 25-Year-old female subject who was vaccinated with TWINRIX adult, GlaxoSmithKline. On 23 March 2009, the subject received 1st dose of TWINRIX adult (unknown route of administration, lot number not provided). In March 2009, less than one week after vaccination with 1st dose TWINRIX adult, the subject felt some discomfort and prickling in fingers. She consulted a physician because of extremely pain and itching in outer auditory canal. Journal notes from 23 March 2009 reported that she was diagnosed with "acute inflammation of the left outer auditory canal" and she was treated with Imacillin. On 20 April 2009, the subject received 2nd dose of TWINRIX adult (parenteral, unknown injection site). On 22 April 2009, 2 days after vaccination with 2nd dose of TWINRIX adult, the subject experienced pain in left arm and powerful neck. Journal notes from 29 April 2009 (medical center) reported that the subject came with a week of feeling numbness in the left side of the face and the numbness feeling in the entire left arm, also reduced the strength of the left arm. She was diagnosed with Bell''s palsy. On 29 April 2009, MRI of brain was performed and showed no obvious pathology. Later journal notes from May and June 2009 reported that she was still struggling with symptoms of radiation and numbness in the left part of the face and left arm. The local Doctor had diagnosed arthritis reactive after vaccination. The regulatory authority reported that events were clinically significant (or requiring intervention). Status on 18 June 2009: Still pain in left arm. Prescription of treatment at a pain treatment clinics. At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with TWINRIX adult. Cessation of third dose of TWINRIX.

VAERS ID:351742 (history)  Vaccinated:2008-05-08
Age:25.0  Onset:2008-05-08, Days after vaccination: 0
Gender:Male  Submitted:2009-07-17, Days after onset: 435
Location:Foreign  Entered:2009-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Family history of colon cancer; Family history of diabetes mellitus; Hemorrhoid surgery; Nasal septum surgery
Diagnostic Lab Data: CSF test, 08Jun2009, normal; Examinations: Clinical examination when admitted on 19 May 2009: Reduced general condition, cachexic nutritional condition, small macular exanthema with pustules on back, red throat, tachycardia heart sounds, el
CDC 'Split Type': D0062258A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B027BH IMLA
Administered by: Other     Purchased by: Other
Symptoms: Acne, Anorexia, Asthenia, Bronchitis, Bronchoscopy abnormal, CSF test normal, Cachexia, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram thorax normal, Conversion disorder, Depression, Dermatologic examination abnormal, Dizziness, Dry mouth, Dysgeusia, Dyspnoea, Dyspnoea exertional, Ear, nose and throat examination abnormal, Electromyogram abnormal, Fatigue, Fibromyalgia, General physical health deterioration, Hyperhidrosis, Hyperlipidaemia, Hypersensitivity, Injection site haematoma, Insomnia, Intervertebral disc protrusion, Migraine, Myalgia, Nuclear magnetic resonance imaging abnormal, Odynophagia, Oropharyngeal pain, Pain in extremity, Performance status decreased, Pharyngeal erythema, Pharyngitis, Pulmonary arterial hypertension, Radiculopathy, Rash maculo-papular, Rash pustular, Rickettsiosis, Sputum discoloured, Tachycardia, Thrombophlebitis, Tonsillectomy, Tonsillitis, Tremor, Vitamin D deficiency, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (broad), Dyslipidaemia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of allergic reaction in a 25-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 8 May 2008 the subject received 1st dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site) as a booster. On 8 May 2008, at an unspecified time after vaccination with BOOSTRIX, the subject experienced orthostatic problems and hematoma injection site. Additionally the subject developed reduced performance. The physician provided a hospital report. The subject was hospitalised for 25 days and the physician considered the events were clinically significant (or requiring intervention). The subject''s family history included colon cancer and diabetes mellitus. There were no cardiovascular risks or infections. The subject''s medical history included hemorrhoid surgery and nasal septum surgery. The subject was dosing a lot of sports. He consumed no nicotine, alcohol or coffeine. There was history of allergies or transfusion. The subject was hospitalised from 19 May 2009 to 12 June 2009, because of worsening complaints. At the time the subject had exertional dyspnea, muscle and limb pain of multiple body regions, reduced performance with weakness, dizziness and sweating attacks. The subject had developed possible allergic reaction after vaccination in May 2008 and since then the symptoms were worsening. Possible intravasal administration of vaccine was suspected (intramuscular formulation administered by other route). Concurrently the subject was in traineeship in a sewage work besides his studies. In hospital it became clear that the symptoms were rather beginning after traineeship than after vaccination. The subject complained about throat pain and pain when swallowing, green-yellowish sputum and diffuse taste disorder, Recurrent purulent throat angina (tonsillitis) was suspected and the subject underwent tonsillectomy in March 2009. The subject had lack of appetite in the last months before hospitalization and weight loss by 11 kg within 6 m

VAERS ID:352520 (history)  Vaccinated:1994-12-01
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-27
Location:Foreign  Entered:2009-07-27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Lumbar puncture, 12Feb1998, sterile; Nuclear magnetic resonance ima, 10Feb1998; On 10February 1998, MRI evidenced many peri-ventricle hypersignals, and white matter involvement on both hemispheres, T2 hypersignal in favour of inflammation.
CDC 'Split Type': B0584586A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Balance disorder, CSF lymphocyte count, CSF monocyte count, CSF test abnormal, Cerebellar syndrome, Clonus, Demyelination, Depression, Disability, Fatigue, Gait deviation, Gait disturbance, Hypoaesthesia, Lumbar puncture normal, Motor dysfunction, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Red blood cells CSF positive, Reflexes abnormal, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by GSK Legal Department and described the occurrence of multiple sclerosis in a 28-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline). Medical conditions were unspecified. On 15 November 1994, the subject received a first dose of ENGERIX B (injection site and batch unknown). At the end of 1997, about 3 years after vaccination with ENGERIX B, the subject presented with peri - buccal paresthesia, left upper limb sensory disorders and walking trouble. Since 07 February 1998, the subject experienced balance disorders, associated with tongue and hemiface paresthesia, spreading to left hemibody. About 2 days later, the subject reported left upper and lower limbs numbness. On 10 February 1998, a MRI evidenced many T2 hypersignals and white matter involvement on both hemispheres. These results were in favour of inflammation. From 12 February to 18 February 1998, the subject was hospitalised Clinical examination revealed left side gait deviation, left hemibody thermoalgic tactile hypoesthesia, including face. The subject presented with left limbs proprioceptive attack, left kinetic cerebellar syndrome, moderate left distal motor deficiency. Left plantar reflex extension (coded abnormal reflex), and left foot clonus were also evidenced. All these symptoms evoked a probable demyelinating disease of central nervous system (coded demyelination). On 13 February 1998, during hospitalisation, a lumbar puncture was sterile. A treatment with RIVOTRIL was initiated. From 20 to 23 August 1999, the subject was hospitalised: multiple sclerosis was diagnosed. From February 1998 to October 2008, the subject had many sick leaves due to her health status. On 20 February 2005, the subject received a third dose of ENGERIX B (injection site and batch unknown). In September 2000, October 2003, February 2004 and in September 2008, the subject experienced multiple sclerosis flare up. Because of fatigue and handicap (NOS) issued from each multiple sclerosis flare up, the subjec

VAERS ID:352612 (history)  Vaccinated:2009-07-13
Age:25.0  Onset:2009-07-13, Days after vaccination: 0
Gender:Female  Submitted:2009-07-27, Days after onset: 14
Location:Foreign  Entered:2009-07-28, 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': WAES0907CAN00057
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0695X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia facial, Localised oedema, Paraesthesia
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a nurse concerning a 25 year old female who on 13-JUL-2009 was vaccinated with the first dose of GARDASIL, batch # NJ17110/lot # 661046/0695X. On 13-JUL-2009 the patient experienced numbness right side of chin, tingling near the navel and right sided chin edema (there was no redness or skin eruption). On approximately 14-JUL-2009 the patient recovered from numbness right side of chin, tingling near the navel and right sided chin edema (the nurse reported that the symptoms resolved within 12 hours). Numbness right side of chin and tingling near the navel were determined to be important medical events based on foreign agency requirements. No further information is available.

VAERS ID:354262 (history)  Vaccinated:2009-07-08
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-14
Location:Foreign  Entered:2009-08-14
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: Examinations: Electrocardiogram (ECG) in July 2009: No ischemia, no hypertrophy, no repolarisation disorder; Sonogram of abdomen in July 2009: No acute appendicitis, no colitic wall thickening, no free liquid, normal ovary, else uneventful;
CDC 'Split Type': D0062617A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB143AA0UNRA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39B022BF0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B022BF0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Asthenia, Diarrhoea, Electrocardiogram normal, Gastrointestinal infection, Immunisation reaction, Nausea, Neurological examination normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Sleep disorder, Tremor, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2009017153) and described the occurrence of immunization reaction in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), TWINRIX adult. On 8 July 2009 the subject received 1st dose of BOOSTRIX-polio (unknown route, left arm), 1st dose of TWINRIX adult (unknown route, right arm). BOOSTRIX was reported, but the lot number clearly identified BOOSTRIX-polio. In July 2009, at an unspecified time after vaccination with BOOSTRIX-polio and TWINRIX adult, the subject experienced prolonged immunization reaction. The subject was hospitalised. At the time of reporting the events were resolved. A hospital report was provided. The subject was hospitalised on 21 July 2009 and because of persisting symptoms again from 25 to 27 May 2009. The subject had no relevant medical history and took no medication. The subject was diagnosed with gastrointestinal infection and prolonged immunization reaction. When first hospitalised on 21 July 2009 subject had recurrent diarrhea for two weeks, with mushy stools four to five times daily, which were not bloody. There was no tenesmus. Stool examination showed no enteropathogenic germs. Additionally the subject had recurrent sleep disorder for two and a half weeks (difficulty to get to sleep and sleep through the night). There was generalized tremor, loss of appetite, loss of strength, nausea without vomiting and recurrent paresthesia of the right arm. Clinical examination and laboratory test were normal. Electroencephalogram (EEG), abdominal sonogram, cerebral magnetic resonance tomogram (MRT) and neurological examination were without pathological findings. There were no signs for colitic wall thickening, acute appendicitis, neurological deficit or GUILLAIN-BARRE syndrome. The subject was treated with REMERGIL. The hospital physician reported this case as a suspect prolonged reaction to vaccination to the regulatory authority. No further information will be available.

VAERS ID:356008 (history)  Vaccinated:2009-03-01
Age:25.0  Onset:2009-03-15, Days after vaccination: 14
Gender:Female  Submitted:2009-08-28, Days after onset: 166
Location:Foreign  Entered:2009-08-31, 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: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0908USA04187
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0747X1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Asthenia, Histiocytic necrotising lymphadenitis, Histology abnormal, Leukopenia, Lymphadenopathy, Pyrexia
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Case received from the Foreign Health Authorities on 24-AUG-2009 under the reference number S200908-671 and transmitted by the foreign agency. A 25 year female patient received the second dose of GARDASIL (lot # 0747X, batch # NJ40530) via intramuscular route on 01-MAR-2009. On 15-MAR-2009, the patient developed fever during 3 weeks and asthenia during 4 weeks, and on 31-MAR-2009 she developed asthenia, leucopenia and cervical adenopathy during 4 weeks. The histological diagnosis revealed histiocytic necrotizing lymphadenopathy (Kikuchi-Fujimoto disease). The patient was treated with METAMIZOL and PARACETAMOL. She was not taking any concomitant medication at the time of the administration of the second dose of GARDASIL, nor between the date of administration and the occurrence of the adverse reaction. It was unknown whether the patient had a history reaction to other medicine. At the time of the reporting, the patient had recovered. To be noted in the adverse event field, the Health Authorities described the following adverse events: Fever, lymphadenopathy cervical, asthenia, leucopenia, anaemia and Kikuchi disease, by this order. However in the narrative, there was neither information about anaemia nor any dates of the histological diagnosis of Kikuchi disease. Other business partner numbers include E2009-08174. No further information is available.

VAERS ID:356193 (history)  Vaccinated:2008-08-02
Age:25.0  Onset:2008-08-02, Days after vaccination: 0
Gender:Female  Submitted:2009-08-31, Days after onset: 394
Location:Foreign  Entered:2009-09-01, 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: magnetic resonance imaging, no changes on MRI study to indicate multiple sclerosis; cerebrospinal fluid analysis, no changes on CSF study to indicate multiple sclerosis
CDC 'Split Type': WAES0908USA04367
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ataxia, CSF test normal, Central nervous system lesion, Cerebellar syndrome, Dysarthria, Nuclear magnetic resonance imaging normal, Saccadic eye movement
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow)
Write-up: Information was obtained on request by the company from the agency via a public case details form concerning a 25 year old female who on 02-AUG-2008 was vaccinated with a dose of GARDASIL. On 02-AUG-2008, the patient experienced severe gait ataxia, moderate dysarthria, ocular dysmetria, slowed saccades, and marked dysmetria and dysdiadochokinesia of the limbs, right more than left onset over 2 weeks in September 2008. The findings were consistent with cerebellar outflow tract lesion. No changes on MRI or CSF studies to indicate multiple sclerosis. No clear response to IV METHYLPREDNISOLONE. The symptoms were improving gradually but had significant ongoing disability. The agency considered that the adverse experiences were possibly related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.

VAERS ID:356199 (history)  Vaccinated:2009-04-09
Age:25.0  Onset:2009-04-09, Days after vaccination: 0
Gender:Female  Submitted:2009-08-31, Days after onset: 144
Location:Foreign  Entered:2009-09-01, 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': WAES0908USA04331
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEURDE173 IJUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Nausea, Nystagmus
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 25 year old female who on 09-APR-2009 was vaccinated with GARDASIL (lot# 1208U, batch# NH30330). Other suspect therapy included VAXIGRIP (lot# DE173). On 09-APR-2009 the patient experienced nausea, dizziness and nystagmus and was hospitalized. It was reported that one hour after vaccination, the patient felt faint and nauseated. Nystagmus developed soon after. The patient was treated with STEMETIL, ondansetron and IV fluids. Subsequently, the patient recovered from nausea, dizziness and nystagmus. The agency considered that nausea, dizziness and nystagmus were possibly related to therapy with GARDASIL and VAXIGRIP. The original reporting source was not provided. No further information is available.

VAERS ID:356348 (history)  Vaccinated:2005-10-25
Age:25.0  Onset:2005-12-01, Days after vaccination: 37
Gender:Female  Submitted:2009-09-02, Days after onset: 1370
Location:Foreign  Entered:2009-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OLANZAPINE; YASMIN (Ethinyloestradiol + Progesterone)
Current Illness: Endometriosis; Stress
Preexisting Conditions: Bipolar Depression
Diagnostic Lab Data: Diagnostic ultrasound, 07Dec2005, missed abort
CDC 'Split Type': B0401517A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSDHAVA002A0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abortion missed, Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This 25-year-old subject was enrolled in a blinded study (208141 039) for the prophylaxis of genital herpes in healthy young females. The subject received intramuscular investigational product single dose on 25 october 2005. Site of injection was the right deltoid. On 25 October 2005, the subject received the 1st intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of HAVRIX vaccine containing 720 ELISA units of hepatitis A antigen and 500 ug Al (OH) 3. Lot number DHAVA002A. The subject''s past medical history included two previous full-term pregnancies. The mother had endometriosis since 1995. In 2001, she had a laparoscopic surgery. She had also a bipolar depression which was treated with ZYPREXA from 01 October 2005 until 30 october 2005. She had a lot of personal stress in her life because her baby son has a brain tumor that has recurred requiring resurgery, chemo and radiotherapy. There was no info available about the partner of the subject. On 23 November 2005, approximately one month after the 1st dose of blinded vaccine, this 25-year-old subject was reported to be pregnant. Her last menstrual period was uncertain. The estimated delivery date was unknown. On 01 December 2005, 37 days after the 1st dose of Blinded vaccine, this 25-year-old subject developed abdominal cramping and went to the emergency department. From 1 December 2005 to 7 December 2005, the subject experienced vaginal bleeding. On 06 December 2005, she saw her doctor. On 07 December 2005, a diagnostic ultrasound was done and showed a missed abortion at a gestational age of 7.5 weeks by biometry. On 08 December, the subject had a spontaneous abortion. On 12 December 2005, Dilation and Curettage was performed. This event has been considered to be medically important. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by investigatio

VAERS ID:356984 (history)  Vaccinated:2007-07-25
Age:25.0  Onset:2009-08-28, Days after vaccination: 765
Gender:Female  Submitted:2009-09-10, Days after onset: 13
Location:Foreign  Entered:2009-09-11, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: cervical smear, 25Jul07, clear; cervical smear, 25Jul08, clear; cervical smear, 28Aug09, REVEALED CIN III
CDC 'Split Type': WAES0909USA00600
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical dysplasia, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a physician concerning a 25 year old female who on 25-JUL-2007 was vaccinated with the first dose of GARDASIL. On 25-SEP-2007 was vaccinated with the second dose and on 25-JAN-2008 was vaccinated with the third dose (lot numbers not reported). The physician reported that on 25-JUL-2007 before vaccination, the patient had a Pap smear that was clear and on 25-JUL-2008 six months following the completion of vaccination, another Pap smear that was also clear. On 28-AUG-2009 the patient had a Pap smear grade III. The physician reported that a biopsy and a colposcopy would be done. At the time of reporting the outcome was unknown. Pap smear grade III was considered to be another important medical event by the reporting physician. Additional information has been requested.

VAERS ID:357906 (history)  Vaccinated:2009-06-29
Age:25.0  Onset:2009-06-29, Days after vaccination: 0
Gender:Female  Submitted:2009-09-21, Days after onset: 84
Location:Foreign  Entered:2009-09-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0909USA01933
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0772X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blindness transient, Malaise, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from the Health Authority concerning a 25 year old female with no history of adverse reaction to any drug, who on 29-JUN-2009 was vaccinated with her first dose of GARDASIL (lot # 0772X, Batch # NK13910/0772X). IM. Concomitant therapy included hormonal contraceptives (unspecified). Ten minutes after the vaccination, the patient experienced general malaise defined by nausea, fainting and temporary vision loss. Approximately 24 hours later, the event regressed and the vital signs stabilized. At the time of the report, the patient had recovered. Health Authorities considered the case as other medically important condition. Other business partner numbers included E2009-08678.

VAERS ID:363350 (history)  Vaccinated:2009-05-15
Age:25.0  Onset:2009-05-15, Days after vaccination: 0
Gender:Female  Submitted:2009-10-27, Days after onset: 165
Location:Foreign  Entered:2009-10-28, 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: ophthalmological exam, 16May09, vision normal; head computed axial tomography, 16May09, normal; magnetic resonance imaging, 16May09, normal
CDC 'Split Type': WAES0909USA00830
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from a physician via CSL as part of a business agreement (manufacturer control number 20090907JV2) concerning a 25 year old patient who on 15-MAY-2009 was vaccinated with the first dose of GARDASIL (lot number not reported). On 16-MAY-2009 the patient developed headache and left side numbness without weakness. The patient''s vision was normal. The patient was transferred to a hospital Emergency Department. Head computed axial tomography (CT) was performed and the result was normal. Magnetic resonance imaging (MRI) was performed and the result was normal. The patient was diagnosed with questionable migraine. It was noted that the symptoms lasted for a few hours and got better on its own. The patient was discharged home. The patient was not given the second dose of GARDASIL. Follow-up information has been received from the physician concerning the 25 year old female patient. On 15-MAY-2009 (previously reported as 16-MAY-2009) the patient developed headache, numbness on the left side and was hospitalised. On 16-MAY-2009 Head CT and MRI were performed and nothing abnormal detected. On an unspecified date, the patient recovered. No further information is available.

VAERS ID:363897 (history)  Vaccinated:2009-10-08
Age:25.0  Onset:2009-10-15, Days after vaccination: 7
Gender:Female  Submitted:2009-10-29, Days after onset: 14
Location:Foreign  Entered:2009-10-30, 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: lamivudine (+) zidovudine; lopinavir (+) ritonavir
Current Illness:
Preexisting Conditions: Pregnancy; Delivery
Diagnostic Lab Data: magnetic resonance imaging, 16Oct09, brain: see narrative; blood CD4 count, ??Jul09, 600; serum blood urea nitrogen, 02Jul09, normal; serum creatine, 02Jul09, normal; complete blood cell count, 02Jul09, normal; hepatic function tests, 02Jul
CDC 'Split Type': WAES0910CAN00081
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blood creatine normal, Blood urea normal, CD4 lymphocytes, Cerebral infarction, Encephalopathy, Full blood count normal, Gait disturbance, Hemiparesis, Hyperreflexia, Liver function test normal, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic cerebrovascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Chronic kidney disease (broad)
Write-up: Information has been received from a Study concerning a 25 year old female with a history of pregnancy and delivery who entered a study. In July 2009: blood helper/inducer cell lymphocyte count was 600 (no units provided). On 02-JUL-2009, complete blood cell count, hepatic function tests, serum blood nitrogen test and serum creatine test were normal. On October 2009: blood helper/inducer cell lymphocyte count was 600 (no units provided). In 08-OCT-2009 the patient was vaccinated with the first dose of GARDASIL, lot # not available. Concomitant therapy included KALETRA (dates unknown) and COMBIVIR (dates unknown). It was reported that other concomitant medications were unknown. On 15-OCT-2009 the patient presented with post vaccine encephalomyelopathy. It was reported that the patient presented with mild weakness and hyper reflexia on right side, right foot dragging and patient complaining of difficulty holding baby. On 16-OCT-2009 an MRI of the brain showed acute perforator infarction in the territory of the short circumferential arteries in the pontomesencephalic region on the left side presumably due to periventricular inflammation with significant amount of leptomeningeal contrast enhancement present in the contrast-enhanced scans. In addition to these findings, T1 and FLAIR hyperintensities were present in the periventricular white matter. These may be related to HIV encephalopathy, progressive multifocal leukoencephalopathy or post-vaccination encephalitis. The patient''s post vaccine encephalomyelopathy persisted. It was reported that the vaccine was discontinued. It was reported that there was no treatment to date. The investigator commented that differential diagnosis included PML, HIV encephalopathy (that are unlikely given current CD4 and use of HAART), TB meningitis in differential diagnosis and vaccine induced multiple sclerosis also a consideration. The reporting investigator felt that post vaccine encephalomyelopathy was probably related to study therapy. Post vaccine encephalomyelopathy was consider

VAERS ID:365938 (history)  Vaccinated:2009-06-30
Age:25.0  Onset:2009-07-16, Days after vaccination: 16
Gender:Female  Submitted:2009-11-06, Days after onset: 113
Location:Foreign  Entered:2009-11-06
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': B0602071A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Typhoid fever
SMQs:
Write-up: This female subject was enrolled in a post-marketing surveillance open study 108160. On 29 January 2009, 03 March 2009 and 30 June 2009, she received the 1st, 2nd and 3rd dose of CERVARIX (IM deltoid) On 16 July 2009, 16 days after the 3rd dose of CERVARIX, this 25-year-old subject developed typhoid fever. The subject was hospitalised. The event resolved on 27 July 2009. The investigator considered that there was no reasonable possibility that the typhoid fever may have been caused by CERVARIX.

VAERS ID:365995 (history)  Vaccinated:2007-07-02
Age:25.0  Onset:2008-01-01, Days after vaccination: 183
Gender:Female  Submitted:2009-11-06, Days after onset: 675
Location:Foreign  Entered:2009-11-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Polycystic ovarian syndrome
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory test, ??/Jan?09, Arthritis test: normal
CDC 'Split Type': WAES0910USA04142
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Erythema, Laboratory test normal, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a consumer via CSL as part of a business agreement (manufacturer control #20091030KH2) concerning a 25 year old female patient with polycystic ovarian syndrome who on 02-Jul-2007 was vaccinated with the first dose of GARDASIL, on 28-Sep-2007, received her second dose of GARDASIL and on 12-Mar-2008 received her third dose of GARDASIL (Lot numbers not reported). There was on concomitant medication. In approximately January 2008 (reported as beginning of 2008), the patient experienced itchiness and red spots/rash near scalp between cheeks and eyes (developed itchiness and red spots on forehead and underneath eyes) after the administration of GARDASIL. The itchiness went away but redness remained after a while. The patient also experienced joint pain in ankles and wrists. In the beginning of 2009 an arthritis test was done and the results were normal. At the time of reporting on 30-Oct-2009, the patient''s joint pain in ankles and wrists and itchiness and red spots persisted. The patient had many treatments, not specified, to no avail. The reporter felt that there was a reasonable possibility that joint pain in ankles and wrists, itchiness and red spots were caused by the therapy with GARDASIL. Joint pain in ankles and wrists were considered to be disabling as it impeded her everyday life. Joint pain in ankles and wrists, itchiness and red spots were considered as other important medical events by the reporter. Additional information has been requested.

VAERS ID:367066 (history)  Vaccinated:2005-10-18
Age:25.0  Onset:2005-10-20, Days after vaccination: 2
Gender:Female  Submitted:2009-11-12, Days after onset: 1484
Location:Foreign  Entered:2009-11-13, 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: None
Current Illness: Multiple sclerosis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0512USA02175
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0710P0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bed rest, Condition aggravated, Hypoaesthesia, Multiple sclerosis, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a health professional concerning a 25 year old adult female medicine student with a history of multiple sclerosis who on 18-Oct-2005, was vaccinated with an intramuscular first dose in the left deltoid of RECOMBIVAX HB (Batch# NA30060/Lot# 649880/0710P). It was noted that prior to vaccination the patient reported to the health care professional that she had a history of multiple sclerosis and that she was afraid for symptoms to return. Her neurologist had advised her to get vaccinated for hepatitis B, and that there was no cause for concern. "Three days after vaccination" in approximately October 2005, the patient''s feet felt numb. It was reported that she stayed in bed for 2 weeks. Subsequently she recovered. More information is expected. Follow-up information from a health professional indicated that the patient''s symptoms occurred 2 days after vaccination, on 20-Oct-2005. After two weeks bed rest, the symptoms reoccurred and the neurologist advised to hospitalize her and to start a course of prednisone for 5 days. The patient recovered. Upon internal review on 18-Sept-2009, it was detected that follow-up information had been received from the agency on 03-Jan-2006. All data available (initial information received from (nurse) on 15-Nov-2005, follow-up information received from HCP (physician) on 20-Dec-2005, and follow-up information received on 03-Jan-2006 from the agency were reviewed, corrected, completed and synthesized below. This synthesis replaces the information of all previous narratives. This case was upgraded to serious on 20-Dec-2005 due to the patient''s hospitalization. It was reported that a 25- or 26-year-old female medicine student with a medical history of multiple sclerosis received a dose of RECOMBIVAX HB (1st in series, IM, left deltoid muscle, batch number NA 30060) on 18-Oct-2005. Prior to vaccination, she was completely symptom-free. She reported to the HCP that she had a history of multiple sclerosis and that she was afraid for symptoms to return. Her

VAERS ID:367170 (history)  Vaccinated:2009-10-27
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2009-11-13
Location:Foreign  Entered:2009-11-13
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': B0602827A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy, Flushing, Monoplegia
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad)
Write-up: This case was reported by a patient via sales representative and described the occurrence of facial paralysis in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 27 October 2009, the subject received unspecified dose of CERVARIX (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced facial paralysis, arm paralysis and injection site flushing. This case was assessed as medically serious by GSK. At the time of reporting, flushing at injection site was unresolved and the outcome of the remaining events (paralysis) was unspecified.

VAERS ID:367176 (history)  Vaccinated:2009-10-20
Age:25.0  Onset:2009-10-20, Days after vaccination: 0
Gender:Female  Submitted:2009-11-13, Days after onset: 24
Location:Foreign  Entered:2009-11-13
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, 20Oct2009, 132/85; Heart rate, 20Oct2009, 86
CDC 'Split Type': B0602639A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB283AG0UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39B020C1 UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B020C1 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Headache, Paraesthesia oral, Pharyngeal oedema, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (NO-NOMAADVRE-FHI-2009-8423) and described the occurrence of tongue paresthesia in a 25-year-old female subject who was vaccinated with BOOSTRIX-POLIO (GlaxoSmithKline), HAVRIX ADULT. On 20 October 2009, the subject received unspecified dose of BOOSTRIX-POLIO (parenteral, unknown injection site), 1st dose of HAVRIX ADULT (parenteral, unknown injection site). On 20 October 2009, 10 minutes after vaccination with BOOSTRIX-POLIO and HAVRIX ADULT, the subject experienced tongue paresthesia. On the same day, she developed throat swelling, throat tightness, discomfort and headache. The subject was hospitalised. Heart rate: 86; Blood pressure: 132/85. The subject was treated with PREDNISOLON and adrenaline. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX-POLIO and HAVRIX ADULT. No additional information has been requested; the case has been closed.

VAERS ID:367207 (history)  Vaccinated:2009-09-24
Age:25.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-11-13, Days after onset: 50
Location:Foreign  Entered:2009-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hep B vaccine (Non-GSK)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0601811A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bradycardia, Chest pain, Dizziness, Flushing, Hypertension, Hypotension, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: This case was reported a regulatory authority (#GB-MHRA-ADR 20517850) and described the occurrence of feeling faint in a 25-year-old female subject who was vaccinated with ENGERIX B, GlaxoSmithKline. Concurrent medications included (Non-GSK) HBvaxPRO. On 24 September 2009, the subject received a single dose of ENGERIX B (20 mcg, intramuscular). On 24 September 2009, 10 minutes after the vaccination with ENGERIX B, the subject felt faint, had hypotension and bradycardia. One hour later the subject experienced chest pain. Hypertension and tachycardia. The blood pressure and pulse settled 90 minutes after the injection. How ever, the subject then developed facial flushing and felt faint. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was assessed by accident and emergency as the reaction was prolonged (two hours). At the time of reporting the outcome of the events were was unspecified. Verbatim text: Faint, hypotension and bradycardia ten minutes following injection. One hour later chest pain; hypertension; tachycardia. Blood pressure and pulse settled 90 minutes after injection, then facial flushing and faint. Required Accident and Emergency assessment as the reaction was prolonged (two hours).

VAERS ID:367659 (history)  Vaccinated:2009-09-24
Age:25.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-11-13, Days after onset: 50
Location:Foreign  Entered:2009-11-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0911USA01750
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Chest pain, Flushing, Hypertension, Hypotension, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: This case was initially reported to Health authority, ref # 20517850 on 05-NOV-2009. This case concerns a 25 year old female patient. Details of the patient''s medical history and concomitant medication were not reported. On 19-AUG-2009 the patient received a dose of RECOMBIVAX HB thimerosal free, 10 micrograms, intramuscularly (batch number and site not reported). On 24-SEP-2009 the patient received another dose of ENGERIX, 20 micrograms, intramuscularly. On 24-SEP-2009, 10 minutes following vaccination with ENGERIX and five weeks after receiving RECOMBIVAX HB thimerosal free, the patient experienced a faint, hypotension and bradycardia. one hour later, the patient experienced chest pain, hypertension, tachycardia. The blood pressure and pulse settled 90 min after the injection. The patient then experienced facial flushing and faint. The patient was transferred to the accident and emergency department as the reaction was prolonged (over two hours). The patient''s outcome has not been reported. Other business partner numbers include E2009-10386. Additional information has been requested.

VAERS ID:370779 (history)  Vaccinated:2009-08-01
Age:25.0  Onset:2009-08-01, Days after vaccination: 0
Gender:Female  Submitted:2009-11-30, Days after onset: 121
Location:Foreign  Entered:2009-12-01, 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: Unknown
CDC 'Split Type': WAES0911PHL00033
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)
Write-up: Information has been received from a physician concerning an approximately 25 year old female who in June 2009, was vaccinated with first dose of GARDASIL. The second dose was received on August 2009. There were no concomitant medications at the time of the vaccination. In approximately August 2009, the patient experienced an adverse effect. The patient consulted with a rheumatologist and was advised that she experienced drug induced SLE. Subsequently, the patient recovered from drug induced SLE. The patient refused to receive the third dose due to the event. The relationship of drug induced SLE to therapy with GARDASIL was unknown by both the rheumatologist and the reporter. The rheumatologist, however, advised the patient that although SLE can caused by other factors, drug induced SLE may be ascribed to the vaccine. The patient requested the reporter for a certification that she received two doses of the suspect therapy. Upon internal medical review, drug induced SLE was considered an other important medical event. Additional information is not expected.

VAERS ID:371857 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:2009-11-01
Gender:Female  Submitted:2009-12-04, Days after onset: 33
Location:Foreign  Entered:2009-12-07, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0911CZE00001
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical dysplasia
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Information has been received from a physician concerning a 25 year old female who in December 2008, February 2009 and July 2009 was vaccinated with 3 doses GARDASIL. In November 2009, the patient experienced cervical high grade intraepithelial lesion (C1N3). Additional information is not expected.

VAERS ID:372970 (history)  Vaccinated:2007-01-11
Age:25.0  Onset:2009-11-17, Days after vaccination: 1041
Gender:Female  Submitted:2009-12-13, Days after onset: 26
Location:Foreign  Entered:2009-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NIL
Preexisting Conditions: Hypo-thyroid congential - however treated.
Diagnostic Lab Data: Positive for MS in Blood Test, MRI, subsequent MRI scans and 2 x Lumbar Punctures.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Private     Purchased by: Public
Symptoms: Blood test abnormal, Gaze palsy, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging, Paralysis, Relapsing-remitting multiple sclerosis, Speech disorder
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow)
Write-up: I awoke with palsy on my right arm, right side of face, numbness in right leg and difficulty talking and keeping my gaze. Has since been diagnosed with relapsing-remitting MS - NIL symptoms of this before my Gardasil vaccine.

VAERS ID:377734 (history)  Vaccinated:2009-12-25
Age:25.0  Onset:2009-12-25, Days after vaccination: 0
Gender:Male  Submitted:2010-01-21, Days after onset: 27
Location:Foreign  Entered:2010-01-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0838620A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLL
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Convulsion, Feeling hot, Loss of consciousness, Sudden onset of sleep, Tremor
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), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a nurse and described the occurrence of convulsion in a 25-year-old male subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). On 25 December 2009 the subject received unspecified dose of TWINRIX ADULT (unknown). On 25 December 2009, the nurse stated that she administered the vaccine to the subject and turned around to dispose of the needle and when she turned back the subject was lying on his side, his eyes wide open. He was breathing. When he came to he had no recollection of receiving the dose he stated that he felt a warm feeling originating in his arm and to his chest before he fell asleep. The mother of the subject stated that she saw him shake and have convulse like seizure before he slumped over onto his side. The subject did not receive any treatment, his pulse was fine. The subject suffered no ill effects from the experience. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.

VAERS ID:379558 (history)  Vaccinated:2006-03-17
Age:25.0  Onset:2009-10-02, Days after vaccination: 1295
Gender:Female  Submitted:2010-02-04, Days after onset: 125
Location:Foreign  Entered:2010-02-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood culture, 02Oct09, positive for streptococcal pneumonia serotype 8
CDC 'Split Type': WAES1001USA03861
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Drug ineffective, Pneumonia streptococcal
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail form concerning a 25 year old female patient who on 17-MAR-2006 was vaccinated SQ with PNEUMOVAX (lot # not reported). It was reported that on 02-OCT-2009, the patient developed pneumonia with blood culture positive for streptococcal pneumonia serotype 8 and was hospitalized. The patient was 1 day in treatment in hospital. On an unspecified date, the patient recovered. The agency considered that streptococcal pneumonia and drug ineffective was possibly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. No further information is available.

VAERS ID:380545 (history)  Vaccinated:2009-04-21
Age:25.0  Onset:2009-05-22, Days after vaccination: 31
Gender:Female  Submitted:2010-02-16, Days after onset: 270
Location:Foreign  Entered:2010-02-17, 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: Pregnancy NOS (LMP = 10Apr09)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp), 19May09, positive pregnant
CDC 'Split Type': WAES0906USA00463
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1172U1IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a gynecologist for GARDASIL, concerning a 25-year-old female patient (with child wish) who was vaccinated with the first dose of GARDASIL (lot # 11472U, batch # NH13130) on 24-FEB-2009 and was well tolerated. The patient was vaccinated with the second dose of GARDASIL vaccine (lot # 1172U, batch # NH13130) IM into the deltoid muscle on 21-APR-2009. Pregnancy test was positive on 19-MAY-2009. At that time the patient was in the 6th week of pregnancy. Last menstrual period was 10-APR-2009 (estimated delivery date was 15-JAN-2010). No adverse effect occurred at the time of reporting. Additional information received on 01-FEB-2010 which led to upgrade of the case to serious. It was reported that the patient had a spontaneous abortion on 22-MAY-2009. The patient''s spontaneous abortion was considered an other important medical event. Case is closed. Other business partner numbers included: E2009-04325.

VAERS ID:380971 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2010-02-19
Location:Foreign  Entered:2010-02-22, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1002USA02281
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: Information has been received from a physician concerning a 25 year old female patient with no relevant history reported, who "approximately 3 years before the report", in approximately 2007, was vaccinated with the first dose of GARDASIL (route and lot # unknown). Subsequently, on an unspecified date, the patient experienced type 1 diabetes. The remaining doses were not administered by the reporting physician, who considered that the event was related to vaccination. The outcome was not reported. Type 1 diabetes mellitus was considered to be an other important medical event by the physician. Other business partner numbers include E2010-00973. No further information is available.

VAERS ID:382523 (history)  Vaccinated:2009-03-01
Age:25.0  Onset:2009-03-01, Days after vaccination: 0
Gender:Female  Submitted:2010-03-11, Days after onset: 375
Location:Foreign  Entered:2010-03-12, 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: Pregnancy NOS (LMP = 03Feb09)
Preexisting Conditions:
Diagnostic Lab Data: Urine iron test, dosage in iron was a little low
CDC 'Split Type': WAES0908USA00671
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Breast feeding, Breech presentation, Caesarean section, Drug exposure during pregnancy, Urine iron decreased
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female with no relevant medical history who was vaccinated with the second dose of GARDASIL (batch number not reported) in March 2009 as she was pregnant. Her latest Menstrual Period dated back to 03-FEB-2009 and the date of delivery was estimated for 17-NOV-2009. Her dosage in iron was a little low. The pregnancy was spontaneous. Follow up information received on 09-MAR-2010 by telephone: The case which was not medically confirmed was upgraded to serious due to the seriousness criterion "other medically relevant", i.e. caesarean section. The patient''s pregnancy was uneventful. She gave birth to a female baby on 18-NOV-2009 by caesarean section due to breech presentation. The baby was doing fine. She was breastfed. The patient had had no previous pregnancy. The third injection of GARDASIL was scheduled soon. No further information expected. Other business partner numbers include E200906179.

VAERS ID:382889 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2010-03-16
Location:Foreign  Entered:2010-03-17, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC 'Split Type': 201001507
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)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: Initial report received on 08 March 2010 from a Health Authority in a foreign country via a sanofi pasteur local correspondent. This report, which was primarily associated with Influenza A H1N1 pandemic vaccine and/or seasonal Influenza vaccine, contained a line listing of cases ranging from an unspecified date up to 19 February 2010. A 25-year-old male patient, whose medical history was not reported, received a dose of influenza vaccine (manufacturer and lot number not reported) on an unspecified date. The final diagnosis was Guillain-Barre syndrome. The patient was recovering. No additional information was reported.

VAERS ID:383862 (history)  Vaccinated:1997-07-24
Age:25.0  Onset:2007-08-01, Days after vaccination: 3660
Gender:Male  Submitted:2010-03-30, Days after onset: 972
Location:Foreign  Entered:2010-03-30
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthenia; dizziness; knee pain; liver disorder; memory difficulty; migraine
Preexisting Conditions: The subject medical conditions included occasion alcohol consumption, and no tabagism. The subject had no family history of neurological disorder. In 2010, medical conditions included asthenia, dizziness and memory difficulty, related to treatment with natalizumab (Tysabri).
Diagnostic Lab Data: Lumbar puncture, Mar1998, normal; Nuclear magnetic resonance ima, Mar1998, abnormal; Nuclear magnetic resonance ima, 2001, abnormal; Nuclear magnetic resonance ima, 2007, abnormal; March 1998: MRI showed protuberancial T2 hypersignals. Unspecified evoked potentials and biological tests were normal. Early 2001: MRI showed protuberantial lesions. March 2007: MRI showed more lesions than on last MRI (NOS).
CDC 'Split Type': B0642295A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acute vestibular syndrome, Amimia, Asthenia, Ataxia, Balance disorder, Central nervous system lesion, Cerebellar syndrome, Condition aggravated, Dizziness, Dysarthria, Dysgraphia, Dysphagia, Extraocular muscle paresis, Fatigue, Gait disturbance, Hypoaesthesia, Hypoaesthesia facial, Limb malformation, Liver disorder, Lumbar puncture normal, Memory impairment, Motor dysfunction, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Oscillopsia, Paraesthesia, Paresis, Sensory disturbance, Tremor
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Ocular motility disorders (narrow)
Write-up: This case was reported by GSK legal department and described the occurrence of multiple sclerosis in a 25-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included depression when he was 16-year-old and meniscus removal around 1989. Concurrent medical conditions included right knee pain in October 2004, migraine for about 15 years, occasional alcohol consumption, and no tabagism. Concurrent medications included treatment with Zoloft and Xanax started when he was 16-year-old. The subject had no family history of neurological disorder, the subject''s father presented with diabetes. On 24 July 1997 the subject received a first and single dose of ENGERIX B (route, injection site and batch unknown). In August 1997, about 1 month after vaccination with ENGERIX B, the subject presented with left peribuccal paresthesia. In January 1998, 6 months after vaccination with ENGERIX B, the subject experienced oscillopsia, right hemiface paresthesia and left hemibody hypoesthesia. From 19 to 26 March 1998, he was hospitalized in neurological unit for examination: a MRI showed protuberancial T2 hypersignals. Lumber puncture was normal, as unspecified evoked potentials and common biological tests. Last February 2001, the subject experienced a second episode with dysphagia, dysarthria, action tremor and right upper limb motor difficulties (while writing). He was hospitalized from 26 February 2001 to 02 March 2001: neurological examination found cerebellar syndrome, left lower limb and right upper limb deficiency. MRI showed protuberantial lesions. The patient was treated with 3 courses of Solumederol. A treatment with Avonex was also initiated. On 22 November 2004, the subject presented with paresthesia, left hypoesthesia and experienced fatigue. He received a course of Solumedrol during hospitalization. In January 2005, treatment with interferon was discontinued due to liver disorder (incidental event). In November 2006, the subject experienced flare-up with sensory disorders and ataxia. His health status improved during few weeks. Early 2007, symptoms worsened. On 11 February 2007, an ophthalmological exam evidenced paresis of right rectus medialis oculi muscle without visual acuity disorder. At that time, the subject presented with worsening balance disorder. On 13 March 2007, the subject presented with vestibular syndrome with left gait disorder (deviation) without evidenced of motor symptoms. He also presented with left hemibody sensory disorder, especially on trunk and face with cardboard-like skin feeling, bilateral face numbness and amimia difficulty. A MRI showed more lesions than on last MRI. In April 2007, treatment with natalizunab (Tysabri) was initiated. On 30 March 2009, the subject was treated with Tysabri, Zoloft 2 capsules, Xanax half a tablet and had two physical therapy sessions a week. Neurological examination found action tremor, balance disorder in unipodal stance, and mild ataxia on aerialist walk. Asthenia, dizziness and memory difficulty were reported, related treatment with Tysabri. Events wee considered as disabling for the subject. On unspecified date diagnosis of multiple sclerosis was made. At the time of reporting, multiple sclerosis was unresolved. The law expert physician considered multiple sclerosis as possibly related to vaccination with ENGERIX B.

VAERS ID:384113 (history)  Vaccinated:2009-09-30
Age:25.0  Onset:2009-09-30, Days after vaccination: 0
Gender:Female  Submitted:2010-04-01, Days after onset: 183
Location:Foreign  Entered:2010-04-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement, ok; arterial blood O2 saturation, ok
CDC 'Split Type': WAES1003USA04263
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1590X IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure normal, Oxygen saturation normal, Paraesthesia, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Initial case was reported as non-serious case on 24-MAR-2010 by Health Authority (HA reference # FI-FIMEA-20091360), this case was updated to serious due to internal criteria of the company. It was reported that a 25 year old female on 30-SEP-2009 was vaccinated with a dose of PNEUMOVAX (batch # NK44680, lot # 663827/1590X, IM, # in series not reported) in her right arm. About 10-15 minutes post vaccination the patient experienced tingling in her throat and feeling of felling of the throat. She was administered antihistamine (trade name, dosage and route of administration not reported) and SOLU-CORTEF (dosage not reported) IV. The condition became slightly better. After a while the patient experienced tingling in her neck and urticaria. She was administered 0.3mg adrenalin IM. (trade name not reported). Her condition became better. The blood pressure and oxygen saturation were good and her breathing was free and there was no sign of obstruction. She was administered 20mg PREDNISOLON orally. After 2 hours from acute phase she experienced tingling in her neck and in hands. SOLU-MEDROL (125mg) and AERIUS (5mg) for home treatment if needed. HA had coded as non-serious: throat tightness, tingling, and urticaria. The outcome was coded as "recovered without sequealae" by HA on an unspecified date. There is no more information. Case is closed. Relevant test: Blood pressure: ok. Oxygen saturation: ok. Throat tightness, tingling, and urticaria were considered to be other important medical events. Other business partner numbers included E2010-01943.

VAERS ID:385593 (history)  Vaccinated:2009-04-01
Age:25.0  Onset:2009-04-01, Days after vaccination: 0
Gender:Female  Submitted:2010-04-20, Days after onset: 384
Location:Foreign  Entered:2010-04-21, 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: Pregnancy NOS (LMP = 14Mar09)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 03Dec09, normal
CDC 'Split Type': WAES0905USA00410
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0807X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Caesarean section, Drug exposure during pregnancy, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This is a case of pregnancy follow up. This case was initially reported by a health care professional on 23-APR-2009. 80679. This case concerns a 25 year old female patient. The patient had no previous pregnancies. The patient was not taking any concomitant medications. The patient received MMR II (lot# not reported) on 01-APR-2009. The patient was subsequently found to be pregnant. Her LMP was 14-MAR-2009 (estimated delivery date was 19-DEC-2009). No adverse effect was reported. Additional was received on 17-JUN-2009 from the nurse. The vaccine was confirmed to be MMR II (batch# NJ13610, lot# 660274/0807X, expiry date 30-JUN-2010). Follow up received from a healthcare professional on 22-MAR-2010: The patient was fit and well with no recreational drug use. The patient had one previous pregnancy with no problems. The patient did not receive any fertility treatment. The patient received dose one 0.5 ML MMR II on 01-APR-2009 at 2-3 weeks gestation. The patient had an ultrasound scan on 03-DEC-2009 which was normal. She had no complications during pregnancy. The patient delivered a male infant on 29-DEC-2009 at 40 weeks and 4 days gestation. The infant was delivered by caesarean section with no complications. The infant weighed 4.2 kg and had no malformations or anomalies diagnosed at birth. Upon internal review a corrective version was created on 12-APR-2010 to upgrade the case and code the event of caesarean section. Follow up received on 13-APR-2010 from the initial reporter: No further information is available regarding the indication for caesarean section. Caesarean section was considered to be an other important medical event. Other business partner numbers include: E2009-03693.

VAERS ID:386478 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2010-04-30
Location:Foreign  Entered:2010-05-03, 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: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1004USA03865
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a physician via a literature article. In one particular foreign country, reporting of adverse events following immunisation (AEFI) has been mandatory by law since 1988. The goal of the study was a detailed analysis of reporting AEFI received by a foreign Federal Office of Public Health between 1991 and 2001. Overall, 1013 AEFI were reported during the study period. This case is linked with 7 other cases issued from the literature (same article, different vaccines, different reactions): E2010-02610, E2010-02611, E2010-02612, E2010-02613, E2010-02614, E2010-02615 and E2010-02616. A 25 year old female patient experienced elective termination of pregnancy after receiving an injection of MMR II (batch number not reported, manufacturer unknown) on an unspecified date during the first trimester of pregnancy. The time to onset and patient''s outcome were not reported. The AEFI was assessed as very likely or certainly related to immunization. Termination of pregnancy -elective was considered to be an other important medical event. Other business partner numbers include: E2010-02610. No further information is available.

VAERS ID:387258 (history)  Vaccinated:2009-12-28
Age:25.0  Onset:2009-12-28, Days after vaccination: 0
Gender:Male  Submitted:2010-05-11, Days after onset: 133
Location:Foreign  Entered:2010-05-12, 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: No previous adverse reactions history to other drugs. No known clinical history.
Diagnostic Lab Data: Lab tests do not have relevant changes. Brain MRI and TC EC with no changes. Lumbar puncture with cerebrospinal fluid compatible with lymphocytic meningitis.
CDC 'Split Type': E201002986
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Computerised tomogram normal, Headache, Lumbar puncture abnormal, Meningitis, Nuclear magnetic resonance imaging brain normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow)
Write-up: Case received from Health Authorities in foreign country under the reference number L201002-987 on 03-May-2010 and transmitted by SPMSD. A 25-year-old male patient had received a first dose of STAMARIL (batch n. D55503, site and route of administration not reported) on 03-Dec-2009. The patient received concomitant vaccination with salmonella typhi Vi antigen (MFR UNK, batch number not reported) on 03-Dec-2009 and inactivated hepatitis A virus (MFR UNK, batch number not reported) on 28-Dec-2009. These vaccines were not considered as suspect by the HA. On 28-Dec-2009, ie 25 days p-v with STAMARIL, the patient experienced meningitis for 11 days. The patient was seen by the physician for headache and fever (no other events were reported at the time) after 1 day of evolution. Lab tests didn''t show any relevant abnormality. Brain MRI and cranium encephalic CT scan didn''t show any abnormality. Lumbar puncture with cerebrospinal fluid was compatible with lymphocytic meningitis. There was no isolation of any agent (suspected aetiology viral). The patient''s condition gradually improved with symptomatic therapy. A specific treatment of the AEs with paracetamol and ibuprofen was administered. It was specified that the patient had no previous adverse reaction history to other drugs and no known clinical history. At the time of reporting the patient was currently asymptomatic. Meningitis, fever and headache were coded by the HA. The patient had fully recovered.

VAERS ID:387512 (history)  Vaccinated:2009-12-28
Age:25.0  Onset:2009-12-28, Days after vaccination: 0
Gender:Male  Submitted:2010-05-13, Days after onset: 135
Location:Foreign  Entered:2010-05-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance imaging, 28?Dec09, brain with no changes; computed axial tomography, 28?Dec09, encephalic with no changes; spinal tap, 28?Dec09, compatible with lymphocytic meningitis
CDC 'Split Type': WAES1005USA01192
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Headache, Lumbar puncture abnormal, Meningitis, Nuclear magnetic resonance imaging brain normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow)
Write-up: Case received from foreign Health Authorities under the reference number L201002-987 and transmitted by foreign agency. A 25 year old male patient had received a first dose of STAMARIL (batch # D55503, site and route of administration not reported) on 03-DEC-2009. The patient received concomitant vaccination with Typhoid vaccine (manufacturer unknown, batch number not reported) on 03-DEC-2009 and Hep A (manufacturer unknown, batch number not reported) on 28-DEC-2009. These vaccines were not considered as suspect by the HA. On 28-DEC-2009, ie 25 days post vaccination with STAMARIL, the patient experienced meningitis for 11 days. The patient was seen by the physician for headaches and fever (no other events were reported at the time) after 1 days of evolution. Lab tests didn''t have any relevant changes. Brain MRI cranium encephalic CT scan didn''t show any abnormality. Lumbar puncture with cerebrospinal fluid was compatible with lymphocytic meningitis. There was no isolation of any agent (suspect aetiology viral). The patient''s condition gradually improved with symptomatic therapy. A specific treatment of the AEs with paracetamol and ibuprofen was administered. It was specified that the patient had no previous adverse reactions history to other drugs and no known clinical history. At the time of reporting the patient was currently asymptomatic. Meningitis, fever and headache were coded by HA. The patient had fully recovered. Other business partner numbers included: E2010-02986. Additional information has been requested.

VAERS ID:389497 (history)  Vaccinated:2010-01-13
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-27
Location:Foreign  Entered:2010-05-27
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': B0645799A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Blood test abnormal, Drug exposure before pregnancy
SMQs:, Haematopoietic erythropenia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This prospective pregnancy case was reported by a physician and described the occurrence of drug exposure during pregnancy in a 26-year-old female patient who received MALARONE tablet over for malaria. Concurrent medications included NICOTINE Patches. On 18 February 2010 the patient started MALARONE (oral) at 1 tablet daily and completed the course of treatment on 14 March 2010. The subject conceived one week after starting MALORONE and had therefore experienced drug exposure during pregnancy. The estimated date of delivery and date of last menstrual period were not provided. At the time of reporting, the subject was 5 weeks pregnant. A physician reported on 06/04/2010 that a 26 year old female was commenced MALARONE tablets for malaria at a dose of 1 tablet daily around 18/02/2010 and subsequently conceived one week after. The patient was 5 weeks pregnant at the time of reporting. The MALARONE course was completed on 14/03/2010 as a completed course. No other adverse events were reported. No further information, in particular batch details, was available at the time of reporting. Follow up information received on 19-May 2010: The date of last menstrual period was provided as 26 February 2010. On 13 January 2010, the patient received an unspecified dose of Hepatitis A (manufacturer unknown) and an unspecified dose of Tetanus vaccine (manufacturer unknown). On 29 January 2010 the subject also received an unspecified dose of ''swine flu'' vaccine (manufacturer unknown). The patient had therefore experienced vaccine exposure before pregnancy after receiving the three vaccines. On 27 April 2010, it was reported that the patient''s ''booking bloods'' were ''ok bar mild anaemia noted''. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event of mild anemia was unspecified.

VAERS ID:389728 (history)  Vaccinated:2010-04-06
Age:25.0  Onset:2010-04-15, Days after vaccination: 9
Gender:Female  Submitted:2010-05-27, Days after onset: 42
Location:Foreign  Entered:2010-06-01, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2010023429
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Convulsion, Fatigue, Malaise, Pneumonia, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Report received from the foreign Regulator on 20-MAY-2010. A female patient received one dose of FLUVAX on 06-APR-2010. Medical history and concomitant medications were unknown. On an unknown date, the patient was unwell with general fatigue after vaccination. The events worsened and on 15-APR-2010, the patient was diagnosed with pneumonia. She also experienced convulsions, severe fever and rigors. The patient was treated with antibiotics, painkillers and sedatives for shakiness. The patient''s outcome was recovered on an unknown date. The reporter considered the events possible to the suspect drug, FLUVAX. This case was considered serious due to medical significance. The company considered the event of pneumonia possibly related to the suspect drug, FLUVAX. The company considered the other events unassessable due to lack of information regarding time to onset. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:390785 (history)  Vaccinated:2010-03-26
Age:25.0  Onset:2010-03-26, Days after vaccination: 0
Gender:Female  Submitted:2010-06-16, Days after onset: 82
Location:Foreign  Entered:2010-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Birth twin; Cervical vertebra injury; discordant twin; family history of multiple sclerosis
Preexisting Conditions: Triplet pregnancy, delivered
Diagnostic Lab Data: Examination: Computed tomogram of cranium on 27 April 2010: normal; Cranial magnetic resonance tomogram on 28 April 2010: no hint for inflammatory lesions: Magnetic resonance tomogram of cervical spine on 30 April 2010: mildly reduced fluid signal of intervertebral disk cervical vertebral body 4 to like degenerative changes, most likely an older inflammatory lesion, liquor signal uneventful; Lumbar puncture on 28 April 2010: pleocytosis of 9 cells, local immunoglobuline synthesis IgG 67%, positive for oligoclonal bands; Laboratory examination of serum: negative for Borrelia; Electrophysiological examination 28 April 2010: normal motor evoked potential, normal visual evoked potential, normal somatosensory evoked potential; Erythrocyte sedim
CDC 'Split Type': D0067855A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA020CC2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Borrelia test negative, CSF immunoglobulin increased, CSF oligoclonal band present, Computerised tomogram head, Computerised tomogram normal, Hypoaesthesia, Lactose intolerance, Lumbar puncture abnormal, Nerve stimulation test normal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging normal, Paraesthesia, Pleocytosis, Polymerase chain reaction, Post lumbar puncture syndrome, Red blood cell sedimentation rate normal, Sensory disturbance, Somatosensory evoked potentials, Visual evoked potentials normal
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a neurologist and described the occurrence of numb sensation in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). According to the consumer''s report, she developed approximately 2 weeks after 3rd vaccination with CERVARIX numb sensation and sensory disturbances from slightly to moderate at right leg. On 27 April 2010, these sensations spread out in whole right half of body inclusive of right half of face and forehead. Therefore, the subject was hospitalised at neurological unit. Symptoms resolved without any treatment. According to the physician''s report, the subject was triplet (triplet pregnancy and delivered) and had one monovular (birth twin) and one biovular sister (discordant twin). The triovular triplet (as reporter) developed multiple sclerosis. Medical history did not include paresthesia, hypesthesia, visual disturbance and paresis. Magnetic resonance tomogram of cervical spine showed older cervical vertebra injury. On 26 March 2010, 12 November 2009 and 10 September 2009 the subject received 3rd dose, 2nd dose and 1st dose of CERVARIX (unknown route and application site) from her gynaecologist. On 27 April 2010, the subject was hospitalised in emergency admission due to numb sensation of right leg, which persisted already 1 week. In further course, symptoms spread out to hemihypesthesia at upper extremities and right side of face. She developed paresthesia including tingling in right leg. She did not develop headache. After several examinations, no hint for autoimmune vasculitis was found. Hemihypesthesia improved in further course. The physician diagnosed possible chronic central nervous system inflammation, hemihypesthesia of right side of the body, pleocytosis in cerebrospinal fluid, oligoclonal bands present in cerebrospinal fluid, post lumbar puncture syndrome and lactose intolerance. Polymerase chain reaction (PCR) to search for Varicella zoster and Herpes simplex was performed, but results were outstanding. In summary, the physician suspected inflammatory genesis of hemihypesthesia most likely, which was provoked by vaccination with CERVARIX. The physician did not surely base the diagnosis of chronic inflammatory central nervous system process due to normal results of magnetic resonance tomogram of cranium and cervical spine. When the subject was discharged from hospital on 03 May 2010, focal neurological deficit was resolved. The subject was hospitalised for 7 days and the physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the other events was unspecified. Follow-up information has been requested.

VAERS ID:391712 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:2010-06-16
Gender:Female  Submitted:2010-06-29, Days after onset: 13
Location:Foreign  Entered:2010-06-29
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: UNK
CDC 'Split Type': B0661218A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 25-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 injection site, lot number not provided). On 16 June 2010, at an unspecified time after vaccination with CERVARIX, the subject experienced loss of consciousness. The physician considered the event was clinically significant (or requiring intervention). On 16 June 2010, the event was resolved. The physician considered the event was related to vaccination with CERVARIX.

VAERS ID:391950 (history)  Vaccinated:2009-12-16
Age:25.0  Onset:2010-05-16, Days after vaccination: 151
Gender:Male  Submitted:2010-07-01, Days after onset: 46
Location:Foreign  Entered:2010-07-02, 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:
Diagnostic Lab Data:
CDC 'Split Type': 2010024147
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)CSL LIMITED90204001 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Influenza A virus test positive, Myalgia, Pyrexia, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Report received from a regulator on 26-MAY-2010. A 25 year old male patient received H1N1 influenza vaccine (brand unspecified) on an unknown date. The patient had no medical history of note. Concomitant medications were unknown. On 16-MAY-2010, the patient developed a fever 40.1, cough and myalgia. The patient was treated empirically with KLACID and ibuprofen. The event outcome was recovered. The company considered events unassessable due to lack of information regarding time to onset. Information derived from this AE report does not change the current safety profile of the product. Follow up information received from the Regulator on 22-JUN-2010. The events occurred 151 days post vaccination. Vaccination date was 16-DEC-2009 by military. The batch number was 90204001. Follow-up information received on 24-JUN-2010. On 18-MAY-2010, a polymerase chain reaction (PCR) test on throat swab confirmed influenza A subtyping H1N1v2009. Event ''vaccine failure'' was added to the case. The case was upgraded to serious due to medical significance. The company considered events certain / highly probably in relation to the suspect drug, PANVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:391995 (history)  Vaccinated:2010-03-13
Age:25.0  Onset:2010-03-13, Days after vaccination: 0
Gender:Female  Submitted:2010-07-02, Days after onset: 110
Location:Foreign  Entered:2010-07-02
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:
Diagnostic Lab Data: Blood pressure, 13Mar2010, 60mmHg
CDC 'Split Type': B0643135A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Loss of consciousness, Malaise, Pallor, Petit mal epilepsy, Shock, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of absence attacks in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 March 2010 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, lot number not provided). On 13 March 2010, less than one day after vaccination with CERVARIX, the subject experienced syncopal attack. The physician considered the event was clinically significant (or requiring intervention). The subject was treated with corticosteroid (Intravenous steroids). On 13 March 2010, the event was resolved. The physician considered the event was related to vaccination with CERVARIX. Follow up information received on 23 June 2010. On 13 March 2010 the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, deltoid of the left upper arm, lot number not provided). On 13 March 2010, immediately after vaccination with CERVARIX, the subject experienced absence attacks and shock; she presented facial pallor saying that she was feeling sick, and then she lost consciousness. One minute later, the consciousness was recovered. The blood pressure was 60mm Hg. Instantly she received concomitant intravenous injection of LACTEC 500 ml and 2 ampoules of SAXIZON 100. On 13 March 2010, the events were resolved. Physician''s comment: Absence attacks and painful shock were related to CERVARIX. It was considered that the event was painful shock attributed to intramuscular injection.

VAERS ID:393088 (history)  Vaccinated:2010-07-08
Age:25.0  Onset:2010-07-08, Days after vaccination: 0
Gender:Female  Submitted:2010-07-16, Days after onset: 8
Location:Foreign  Entered:2010-07-19, Days after submission: 3
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': WAES1007USA01073
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Lethargy, Local reaction, Malaise, Nausea, Pyrexia, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a physician via CSL as part of a business agreement (manufacturer control # 20100708VN1) concerning a 25 year old female who on 08-JUL-2010 was vaccinated IM with her third 10 microgram dose of RECOMBIVAX HB. On 08-JUL-2010, at 21:30, the patient experienced nausea, vomiting, fever overnight (afebrile when examined), lethargy, dizziness, tachycardia, malaise and minimal local reaction (left deltoid region) after receiving her third dose of RECOMBIVAX HB requiring medical intervention. Her condition had been reviewed by a medical practitioner, who prescribed the following medications for her treatment: paracetamol, metodopramide and an antihistamine. At the time of the report, the patient had not recovered. Causality assessment was reported as unknown. Nausea, vomiting, fever, lethargy, dizziness, tachycardia, malaise and minimal local reaction (left deltoid region) were considered to be disabling and other important medical events by the reporter. Additional information has been requested.

VAERS ID:396443 (history)  Vaccinated:2010-07-29
Age:25.0  Onset:2010-07-29, Days after vaccination: 0
Gender:Female  Submitted:2010-08-24, Days after onset: 26
Location:Foreign  Entered:2010-08-25, 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: Asthma
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1008USA02891
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphagia, Dysphonia, Eye swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (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 (broad), Hypersensitivity (narrow)
Write-up: This case was received from the agency on 16-AUG-2010 (reference # ADR 20679011). This case was medically confirmed. A 25 year old female patient with a history of asthma who was receiving concomitant MICROCYNON as oral contraception, received a dose of MMR II intramuscularly on 29-JUL-2010 (manufacturer and batch number not reported). Fifteen minutes post vaccination, the patient returned with moderate swelling to her face and eyes, her voice sounded restricted and swallowing was restricted. The doctor on site escorted the patient to hospital for observation. The patient required medical intervention (unspecified) to prevent occlusion of the airway. The patient was recovering at the time of reporting but the final patient outcome was not reported. The agency coded the events of angioedema, distorted voice and swallowing impaired. The case was considered serious for hospitalization and other medically significant reasons. Other business partner numbers include E2010-04908.

VAERS ID:396923 (history)  Vaccinated:2010-08-01
Age:25.0  Onset:2010-08-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-30, Days after onset: 29
Location:Foreign  Entered:2010-08-30
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:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0670887A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
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)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In August 2010, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site, lot number not provided). In August 2010, at an unspecified time after vaccination with CERVARIX, the subject experienced syncope and convulsion. The physician considered the events were clinically significant (or requiring intervention). On 1 August 2010, the events were resolved.

VAERS ID:397334 (history)  Vaccinated:2010-05-04
Age:25.0  Onset:2010-05-04, Days after vaccination: 0
Gender:Female  Submitted:2010-09-02, Days after onset: 121
Location:Foreign  Entered:2010-09-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cerebral paralysis
Diagnostic Lab Data: Unknown
CDC 'Split Type': 201004667
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH004AA UNUN
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)
Write-up: Case received through sanofi pasteur on 25 August 2010 under the local reference number BR2010-268. A 25-year-old female patient, with a medical history of cerebral paralysis had received a dose of Influenza A/H1N1 vaccine; batch number UH004AA, route and anatomical site of administration unknown, on 04 May 2010. The patient had an unknown family medical history, an unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies. On 04 May 2010, 6 hours after immunization, the patient had a seizure. It was unclear if the patient was hospitalized or not (date of admission was reported as of 23 April 2010, clarification requested) Corrective treatment was unknown. The patient outcome was unknown. This case was assessed serious as a significant medical condition. Documents held by sender: none.

VAERS ID:397630 (history)  Vaccinated:2010-08-25
Age:25.0  Onset:2010-08-25, Days after vaccination: 0
Gender:Female  Submitted:2010-09-07, Days after onset: 13
Location:Foreign  Entered:2010-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: DRUG ALLERGY
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 25Aug2010, 60/40mmHg; Electrocardiogram, 25Aug2010, Normal
CDC 'Split Type': B0672377A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactoid reaction, Asthenia, Cyanosis, Dizziness, Dyspnoea, Electrocardiogram normal, Loss of consciousness, Nausea, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer and described the occurrence of anaphylactoid reaction in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concomitant medical conditions included allergy: Procaine, solution of Sodium hydrocarbonate + Sodium chloride +Potassium chloride. On 25 August 2010, the subject received 1st dose of CERVARIX (route and injection site unknown, batch number not provided). On 25 August 2010, less than one day after vaccination with CERVARIX, the subject experienced cyanosis of face, loss of consciousness, tremor, weakness, dyspnea, blood pressure of 60/40 mmHg. The subject was treated with Epinephrine, prednisolone and clemastine (all intramuscular). In the emergency room, relevant test was performed and showed normal ECG. The subject was treated with dexamethasone (intramuscular). The subject refused from hospitalisation. A treatment with Antihistamine was recommended for 2 weeks. On 26 August 2010, 1 days after vaccination with CERVARIX, the subject developed nausea, cyanosis of face and dizziness. At the time of reporting, anaphylactoid reaction, nausea, cyanosis of face and dizziness were resolved, but the outcome of other events was unspecified.

VAERS ID:403466 (history)  Vaccinated:2010-09-21
Age:25.0  Onset:2010-09-21, Days after vaccination: 0
Gender:Female  Submitted:2010-10-14, Days after onset: 23
Location:Foreign  Entered:2010-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Asthma; No known drug allergies
Diagnostic Lab Data: UNK
CDC 'Split Type': B0678436A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Dermatitis, Increased tendency to bruise, Malaise, Rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory authority (GB-MHRA-ADR 20713897) and described the occurrence of widespread rash in a 25-year-old female subject who was vaccinated with FLUARIX. The subject''s medical history included asthma, the subject had no known allergies. Concurrent medications included MICROGYNON. On 21 September 2010 the subject received unspecified dose of FLUARIX (.5 ml, intramuscular). On 21 September 2010, on that same day after vaccination with FLUARIX, the subject experienced widespread rash from neck to toes, felt generally unwell, skin inflammation, exanthema with easy bruising and contusion. The regulatory authority reported that the subject was taking hydroxyzine and tetracycline. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Widespread rash from neck to toes & exanthema with easy bruising. Taking hydroxyzine and tetracycline. Medically significant: widespread inflamed rash and patient feels generally unwell.

VAERS ID:404069 (history)  Vaccinated:2010-04-19
Age:25.0  Onset:2010-04-19, Days after vaccination: 0
Gender:Male  Submitted:2010-10-18, Days after onset: 182
Location:Foreign  Entered:2010-10-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data:
CDC 'Split Type': 201005232
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH004AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Erythema, Eyelid oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur affiliate, from the Ministry of Health through foreign Institute (local case reference number BR2010-430). A 25-year-old male patient, whose medical history and concomitant therapies were not reported, received a dose of H1N1 vaccine (manufactured by sanofi pasteur, batch number UH004AA, route and anatomical site of administration not reported), on 19 April 2010. On the same day, the patient developed edema of both eyelids and face erythema. The patient self-medicated with "histamine" which provided improvement. The patient''s outcome was unknown. According to the report, the status of the case has been confirmed. No other information was provided. The case was classified as "moderate". This case was assessed as serious due to the mention of anaphylaxis. Documents held by sender: None.

VAERS ID:404242 (history)  Vaccinated:2010-04-08
Age:25.0  Onset:2010-04-08, Days after vaccination: 0
Gender:Female  Submitted:2010-10-18, Days after onset: 193
Location:Foreign  Entered:2010-10-19, 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: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201005178
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURERUF966AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the ministry of health through foreign institute (local case reference number BR2010-486). A 25-year-old female patient with no reported medical history had received a dose of H1N1 vaccine (manufacturer unknown, batch number UF966AA, route and anatomical site of administration unknown), on 08 April 2010. On 08 April 2010, i.e. on the vaccination day, the patient presented with rash, fever and pruritus which evolved to cure without sequelae. Despite the case was classified as "Moderate" by the reporter, there was a mention of "Anaphylaxis". The case was considered as serious i.e. a significant medical condition. The patient''s outcome was recovered. List of Documents held by Sender: none.

VAERS ID:407564 (history)  Vaccinated:2010-04-05
Age:25.0  Onset:2010-04-05, Days after vaccination: 0
Gender:Male  Submitted:2010-10-19, Days after onset: 197
Location:Foreign  Entered:2010-10-20, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Epilepsy that was treated with medication; however the patient had stopped his medication on an unknown date.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201005351
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURERUH001AH UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Convulsion, Dizziness, Musculoskeletal chest pain, Nausea, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the "Ministry of Health" through foreign institute (local case reference number BR2010-655). A 25-year-old male patient, who has medical history of epilepsy and who had stopped taking his medication (date not reported), had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH001AH corresponding to lot number 1003060 which was allocated at packaging by institute, route and anatomical site of administration not reported) on 05 April 2010 and 4 hours after vaccination the patient presented with dizziness, nausea and vomiting. He also complained of intense pain in the intercostal left side that was radiating to the epigastrium. On 23 April 2010, the patient received medical assistance, presenting with seizures. The patient was hospitalized (dates not reported). The case was classified as "Severe". Outcome was reported as unexpected sudden death. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to the Seizures and unexpected sudden death. Documents held by sender: None.

VAERS ID:405328 (history)  Vaccinated:2010-09-05
Age:25.0  Onset:2010-09-13, Days after vaccination: 8
Gender:Female  Submitted:2010-10-25, Days after onset: 42
Location:Foreign  Entered:2010-10-25
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:
CDC 'Split Type': PHHY2010AT69221
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphoma, Musculoskeletal pain, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Malignant tumours (narrow), Malignant lymphomas (narrow)
Write-up: Initial report received from Health Authorities (reference number: 34893) on 14 Oct 2010: This patient with unknown medical history was vaccinated with RABIPUR (batch number unknown) on 05 Sep 2010 and on 12 Sep 2010. After the vaccination, the patient experienced mild pain and a swelling at left shoulder on 13 Sep 2010. The patient also presented with a lymphoma "as large as a fist" located in left axilla from 15 Sep 2010 to 16 Sep 2010. On 17 Sep 2010, the swelling had disappeared. The final outcome of the events was reported as completely recovered. The reporter assessed the events as serious (other medically important condition).

VAERS ID:405366 (history)  Vaccinated:2008-11-01
Age:25.0  Onset:2010-04-01, Days after vaccination: 516
Gender:Female  Submitted:2010-10-25, Days after onset: 207
Location:Foreign  Entered:2010-10-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1010USA01816
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anogenital warts, Electrocauterisation
SMQs:
Write-up: Information has been received from a physician concerning a 25 year old female patient with no previous exposure to this or related drug who in November 2008, was vaccinated with her third dose of GARDASIL (lot number unknown. The physician reported that in April 2010, external genital warts (condyloma acuminata) appeared. On 18-JUL-2010 the patient recovered from genital warts. Genital warts were considered to be an other important medical event due to cauterization in October 2010 by the physician. No further information is available.

VAERS ID:407586 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2010-10-28
Location:Foreign  Entered:2010-10-28
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: UNK
CDC 'Split Type': B0680210A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure abnormal, Movement disorder, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neck pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported by a physician and described the occurrence of inability move head in a 25-year-old female subject who was vaccinated with ALPHARIX (GlaxoSmithKline). In 2009, in the morning, the subject received unspecified dose of ALPHARIX (unknown route and injection site), lot number not provided. The same day in the afternoon, the subject experienced blood pressure problems and vomiting. At an unspecified date, the events were resolved. On 19 October 2010, the subject received another dose of ALPHARIX (unknown route and injection site), lot number not provided. Half an hour after vaccination, everything was fine. Approximately 4 hours after vaccination with ALPHARIX, the subject experienced stiff neck with inability to move head and right-sided neck and shoulder muscle pain. The subject didn''t make a wrong or sudden movement with her head or neck that could explain the adverse events. No fever or headache was experienced. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:410017 (history)  Vaccinated:2010-03-25
Age:25.0  Onset:2010-04-05, Days after vaccination: 11
Gender:Female  Submitted:2010-11-23, Days after onset: 232
Location:Foreign  Entered:2010-11-24, 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: no reported medical history
Diagnostic Lab Data: not reported
CDC 'Split Type': 201006563
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER100035 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Hemiparesis, Lip disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case report is part of a batch of several hundred reports associated with H1N1 vaccine, that was received by sanofi pasteur affiliate under local case reference number BR2010-707 from foreign Institute who received these reports on 08 November 2010 from the "Ministry of Health". A 25-year-old female patient, with no reported medical history, was diagnosed with severe hemiparesis with lip commissure deviation on 05 April 2010, i.e. 11 days after she had received a dose of pandemic H1N1 vaccine, batch number "100035" on 25 March 2010 (manufacturer name, route and administration site not reported). 11 days after vaccination, the patient started presenting headache, syncope when attempting to ambulate, left hemiparesis and lip commissure deviation of intermittent character. Under neurological monitoring, she had good outcome. The reporter stated that the status of the case was "confirmed" ( i.e. the event was related to the vaccine). The case was reported as serious without seriousness criteria. Upon internal review, the seriousness criteria was selected as "other : medically significant events".

VAERS ID:411432 (history)  Vaccinated:2010-07-27
Age:25.0  Onset:2010-08-01, Days after vaccination: 5
Gender:Female  Submitted:2010-12-03, Days after onset: 124
Location:Foreign  Entered:2010-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: LEG NUMBNESS
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0672145A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Benign neoplasm of spinal cord, Fall, Nervous system disorder, Surgery
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of benign spinal tumor in a 25-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline). On 27 July 2010, the subject received 1st dose of CERVARIX (unknown route of administration, lot number not provided). Mid August 2010, within weeks of vaccination with CERVARIX, the subject fell down and she went to consult orthopedic doctor. The doctor performed some test on the subject and neurological signs showed the subject had high brain problem which may have lead to impair body balance. The reporter refused us to contact the doctor and refused to complete the AE follow-up form. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 31 August 2010. The subject''s body balance was impaired and so she fell down easily. The physician had diagnosed that the subject might have some problem in an unknown part of the brain. The subject will have MRI scan to find out the problem. Follow-up information received on 22 November 2010: Medical conditions included numbness in legs since March 2010. In August 2010, 1 month after vaccination with CERVARIX, while the subject planned the 2nd dose, a benign tumor in spine was diagnosed. The subject was hospitalised. The subject underwent an operation and was pending for the 2nd and 3rd dose of CERVARIX. GSK case number B0685586A is a duplicate of this case. All future correspondence will be submitted to this case.

VAERS ID:413021 (history)  Vaccinated:2010-12-07
Age:25.0  Onset:2010-12-07, Days after vaccination: 0
Gender:Female  Submitted:2010-12-17, Days after onset: 10
Location:Foreign  Entered:2010-12-17
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': B0688278A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA100AA UNAR
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Loss of consciousness, Musculoskeletal stiffness
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), 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)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 7 December 2010, the subject received unspecified dose of CERVARIX (.5 mg, intramuscular, unknown injection site). On 7 December 2010, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness, decreased blood pressure and muscle stiffness. The physician considered the events were clinically significant (or requiring intervention). On 7 December 2010, the events were resolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:413884 (history)  Vaccinated:2010-09-21
Age:25.0  Onset:2010-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-01-03, Days after onset: 104
Location:Foreign  Entered:2011-01-03
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: No relevant medical history
Diagnostic Lab Data: Blood test, normal
CDC 'Split Type': B0679268A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA526AI IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Dry skin, Eczema, Erythema, Immediate post-injection reaction, Rash generalised, Rash pruritic, Skin test, Urticaria, Wound secretion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a practice nurse and described the occurrence of generalized rash in a 25-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Oral contraceptive (Oral contraceptive pill). On 21 September 2010 the subject received unspecified dose of FLUARIX (1 injection, intramuscular, unknown). That same day, on 21 September 2010, immediately after vaccination with FLUARIX, the subject experienced generalized rash which then became dry, itchy and eczema like. The subject was prescribed some steroid cream (type unknown) for the rash. The rash improved after the use of the steroid cream however her skin became ''red, raw all over and it was seeping, which looked like it she had been in a fire''. The subject had several blood tests for a differential diagnosis but results were normal. The subject also had a rash test with unknown results. The subject had previously been vaccinated with flu vaccines but no reaction was reported. At the time of reporting the outcome of the events were was unspecified. A practice nurse reported on 13/10/2010 that a 25 year old female patient was administered a single dose of FLUARIX vaccine on 21/09/2010 via intramuscular injection. The patient noted that ''straight away'' after vaccination, she developed a ''generalised rash which became dry, itchy and eczema like''. She consulted her doctor who had referred her to the accident and emergency department whereby she was prescribed some steroid cream (type unknown) for the rash. Her rash improved after the use of the steroid cream however her skin became ''red, raw all over and it was seeping, which looked like it she had been in a fire''. The patient had several blood tests for a differential diagnosis but results were normal. She had also had a rash test with unknown results. The patient had previously been vaccinated with flu vaccines but no reaction was reported. The patient''s drug history included the oral contraceptive pill. Follow-up information received on 20 December 2010: Concurrent medications included MICROGYNON 30. That same day 21 September 2010 at an unknown time after vaccination with FLUARIX, the subject experienced dry rash, itchy rash, eczematous like rash, skin red, wound weeping, raw skin and viral looking rash (possible reaction to FLUARIX). The reporter stated that ''reported less severe recurrence of urticarial rash - minor''. The reporter considered that the events were serious. Towards the end of November 2010, rash appears to have been resolved and skin red, wound weeping and raw skin improved.

VAERS ID:414738 (history)  Vaccinated:2010-12-09
Age:25.0  Onset:2010-12-18, Days after vaccination: 9
Gender:Female  Submitted:2011-01-14, Days after onset: 27
Location:Foreign  Entered:2011-01-14
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: High vaginal smear, 18Dec2010, Group B streptoc; Neutrophils, 18Dec2010, 14.43; Ultrasound scan, 17Dec2010, foetal detail -; White blood cell count, 18Dec2010, 19.2
CDC 'Split Type': B0693164A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Cytomegalovirus test negative, Drug exposure during pregnancy, Neutrophil count increased, Rubella antibody negative, Smear cervix, Streptococcal infection, Streptococcus test positive, Toxoplasma serology negative, Ultrasound foetal, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This retrospective pregnancy case was reported by a physician via the foreign regulatory authority (GB-MHRA-EYC 00055729) and described the occurrence of miscarriage in a pregnant 25-year-old female subject who was vaccinated with influenza virus vaccine. Concurrent medications included SALBUTAMOL and Beclomethasone diplopionate. On 9 December 2010 the pregnant subject received an unspecified dose of Influenza virus vaccine (.5 ml, intramuscular) 9 days after vaccination with Influenza virus vaccine on18 December 2010, the subject experienced spontaneous miscarriage at 20 weeks, increased white blood cell count (19.2), increased neutrophil count (14.43) and high vaginal smear confirmed group B streptococcal infection. The regulatory authority reported that the events were clinically significant (or requiring intervention). Ultrasound for foetal detail was normal the day before spontaneous miscarriage. At the time of reporting, outcome of the events was unknown. Ultrasound for foetal detail was normal the day before spontaneous miscarriage. White Cell Count 19.2, neutrophils 14.43. High vaginal smear - Group B streptococci. No evidence of toxoplasma; Cytomegalovirus or rubella IgM. Given seasonal flu jab 9 days previously. Miscarriage at 20 weeks.

VAERS ID:417729 (history)  Vaccinated:2010-09-21
Age:25.0  Onset:2010-09-21, Days after vaccination: 0
Gender:Female  Submitted:2011-02-28, Days after onset: 160
Location:Foreign  Entered:2011-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Asthma; Not allergic to eggs. Not known to have allergies to excipients in FLUARIX or to proteins in FLUARIX.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0701449A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Pruritus, Purpura, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 20926622) and described the occurrence of an allergic reaction in a 25-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included asthma. On 21 September 2010 the subject received an unspecified dose of FLUARIX. On 21 September 2010, 4 hours after vaccination with FLUARIX, the subject experienced an allergic reaction, generalized rash, itching, urticaria and purpura. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was given unknown treatment. The events lasted 2 or 3 weeks and then were resolved. Four hours after FLUARIX vaccine, the patient experienced an allergic reaction - generalised rash, purpuric, urticarial. Lasted two to three weeks - needed treatment. Resolved. Patient went to Accident and Emergency Department - not admitted to hospital.

VAERS ID:419426 (history)  Vaccinated:2010-10-22
Age:25.0  Onset:2010-10-31, Days after vaccination: 9
Gender:Female  Submitted:2011-03-24, Days after onset: 144
Location:Foreign  Entered:2011-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: RENITIS
Diagnostic Lab Data: ALLERGY TESTS SHOWED THAT PATIENT REACTED TO THIS VACCINE, NO OTHER RELEVANT ALLERGIES.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAMPVA090AE0IJRA
Administered by: Other     Purchased by: Private
Symptoms: Allergy test positive, Urticaria, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: URTICARIA IN LEGS, HANDS, EARS, ARMS, BIG, IN TRATMENT WITH CORTICOIDS, AND ANTIHISTAMINICS SINCE THAT DATE UNTIL MARCH 2011 WITHOUT GETTING BETTER, VACCINE: HUMAN PAPILOME.

VAERS ID:419653 (history)  Vaccinated:2010-04-15
Age:25.0  Onset:2010-04-15, Days after vaccination: 0
Gender:Female  Submitted:2011-03-25, Days after onset: 344
Location:Foreign  Entered:2011-03-28, 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: No reported medical history.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101579
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER04AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-069). A 25-year-old female patient, whose medical history was not reported, had received her dose of H1N1 during a national campaign (manufacturer unknown, batch number "04AA", route and anatomical site of administration not reported) on 15 April 2010. No other vaccines were concomitantly administered. On 15 April 2010, i.e. the day of immunization, the patient experienced cough, dyspnea and "other serious and/or unusual adverse events". The patient was hospitalized. The patient recovered without sequelae on an unspecified date. No further information was provided. 6 hours is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine) and under investigation. The action taken was also mentioned: "no action taken". Documents held by sender: none.

VAERS ID:419669 (history)  Vaccinated:2010-04-24
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2011-03-25
Location:Foreign  Entered:2011-03-28, 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: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101649
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH040AD0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Convulsion, Gait disturbance, Headache
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-363). A male patient, whose medical history and concomitant therapies were not reported, had received his 1st primary dose of H1N1 manufactured by sanofi pasteur, batch number UH040AD (also reported "VH040AD"), route and anatomical site of administration not reported) on 24 April 2010. On an unspecified date, the patient experienced afebrile seizure, headache, "difficulty in deambulation" and "other serious and/or unusual adverse events". 24 hours is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The patient was not hospitalized. The patient recovered without sequelae on an unspecified date. No further information was provided. The case was assessed as serious by the Ministry of Health due to other medical important condition. The case status was discarded (the Ministry of Health assessed the adverse events are unrelated to the vaccine). The action taken was also mentioned: "the scheme was maintained". Documents held by sender: none.

VAERS ID:419675 (history)  Vaccinated:2010-04-27
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2011-03-25
Location:Foreign  Entered:2011-03-28, 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: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101655
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH039AH0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Erythema, Headache, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-240). A female patient, whose medical history and concomitant therapies were not reported, had received her 1st primary dose of H1N1 (manufactured by sanofi pasteur, batch number UH039AH, route and anatomical site of administration not reported) on 27 April 2010. On an unspecified date post-vaccination, the patient experienced "pain, readness and heat", headache and "other serious and/or unusual adverse events". 4 hours is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The patient was not hospitalized. The patient recovered without sequelae on an unspecified date. No further information was provided. The case was assessed as serious by the Ministry of Health due to other medical important condition. The case status was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). The action taken was also mentioned: "the scheme was maintained". Documents held by sender: none.

VAERS ID:419678 (history)  Vaccinated:2010-04-10
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2011-03-25
Location:Foreign  Entered:2011-03-28, 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: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101658
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH002AH0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event
SMQs:
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-259). A male patient, whose medical history and concomitant therapies were not reported, had received his 1st primary dose of H1N1 (manufactured by Sanofi Pasteur, batch number UH002AH, route and anatomical site of administration not reported) on 10 April 2010. On an unspecified date, the patient experienced other serious and/or unusual adverse events. 20 minutes is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The patient''s outcome was unknown. No further information was provided. The case status was not defined (the Ministry of Health did not evaluate the causal relationship). The action taken was also mentioned: "ignored". Documents held by sender: none.

VAERS ID:419695 (history)  Vaccinated:2010-04-07
Age:25.0  Onset:2010-04-08, Days after vaccination: 1
Gender:Female  Submitted:2011-03-25, Days after onset: 351
Location:Foreign  Entered:2011-03-28, 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: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101591
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURERA80CA179A0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Induration, Local reaction, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-380). A 25-year-old female patient, whose medical history and concomitant therapies were not reported, had received her 1st primary dose of H1N1 (manufacturer unknown, batch number A80CA179A, route and anatomical site of administration not reported) on 07 April 2010. On 08 April 2010, the patient experienced local reaction, enduration, pain, redness, heat and headache. The patient was hospitalized. The patient recovered without sequelae on an unspecified date. No further information was provided. 24 hours is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of health classified the adverse events on category 4 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). The action taken was also mentioned: "the scheme was maintained". Documents held by sender: none.

VAERS ID:420483 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-07
Location:Foreign  Entered:2011-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0711333A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This case was reported by a health care professional and described the occurrence of spontaneous abortion in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included CERVARIX (GlaxoSmithKline) 1st dose given on an unspecified date. On an unspecified date, the subject received 2nd dose of CERVARIX (intramuscular, left deltoid). Lot number not provided. At unspecified time, the subject was found to be pregnant. No details about the pregnancy were provided. At an unspecified time after vaccination with 2nd dose of CERVARIX, the subject experienced spontaneous abortion. At the time of reporting the events were resolved. This case is one of 3 subjects who experienced the same event before the 3rd dose of CERVARIX during a vaccine campaign. The 3 subjects completed the schedule and were in good condition. No further information was available.

VAERS ID:420566 (history)  Vaccinated:2010-04-17
Age:25.0  Onset:2010-04-19, Days after vaccination: 2
Gender:Male  Submitted:2011-04-07, Days after onset: 353
Location:Foreign  Entered:2011-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101863
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEUR002A4 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-613). A 25-year-old male patient, whose medical history and concomitant therapies were not reported, had received his dose of H1N1 (manufactured by sanofi pasteur, batch number 002A4, route and anatomical site of administration not reported) on 17 April 2010. The patient had no "simultaneous" vaccine. On 19 April 2010, the patient experienced severe pain on the body, muscle pain, high fever at 40 degrees C, intense headache, prostration and pain in the shoulder where the vaccine was applied. The patient was hospitalized on unspecified dates. Symptom classification was reported as "light/mild". The outcome was not reported. No further information was provided. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of Health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:420574 (history)  Vaccinated:2010-04-13
Age:25.0  Onset:2010-04-13, Days after vaccination: 0
Gender:Female  Submitted:2011-04-07, Days after onset: 359
Location:Foreign  Entered:2011-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101790
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH001AE UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dyspnoea, Headache, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-439). A 25-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 (manufactured by sanofi pasteur, batch number UH001AE, route and anatomical site of administration not reported) on 13 April 2010. The patient had no "simultaneous" vaccine. On 13 April 2010, the patient experienced "light/mild" dyspnea six hours post vaccination. Dyspnea persisted and also presented nausea, vomiting, body shivers and light headache. The patient was hospitalized on unspecified dates. The outcome was not reported. No further information was provided. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:420591 (history)  Vaccinated:2010-04-19
Age:25.0  Onset:2010-04-21, Days after vaccination: 2
Gender:Female  Submitted:2011-04-07, Days after onset: 351
Location:Foreign  Entered:2011-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101812
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUH040AD UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Drug exposure during pregnancy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-470. A 25-year-old pregnant female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 (manufactured by sanofi pasteur, batch number UH040AD, route and anatomical site of administration not reported) on 19 April 2010. The patient had no "simultaneous" vaccine. On 21 April 2010, the patient experienced "light/mild" fever (38C) and diarrhea. The patient was hospitalized on unspecified dates in order to receive medical care. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of Health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:420750 (history)  Vaccinated:2010-07-14
Age:25.0  Onset:2010-07-14, Days after vaccination: 0
Gender:Female  Submitted:2011-04-08, Days after onset: 268
Location:Foreign  Entered:2011-04-11, 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: Not reported; "Simultaneous" vaccine : pneumococcal polysaccharide 23-valent (unspecified date)
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201101915
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER1003092 UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Hypotonic-hyporesponsive episode
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-544). A 25-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 (from unknown manufacturer, batch number 1003092, route and anatomical site of administration not reported) on 14 July 2010. The patient had "simultaneous" vaccine with pneumococcal polysaccharide 23-valent vaccine (unspecified date). On 14 July 2010, the patient experienced "serious" hypotonic hyporesponsive episode and afebrile seizure. It was unknown if the patient was hospitalized or not. The outcome was not reported. No further information was provided. The case was assessed as serious by the Ministry of Health due to "other serious or unexpected events". The Ministry of Health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:421865 (history)  Vaccinated:2010-11-06
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-28
Location:Foreign  Entered:2011-04-28
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: Heart rate, Nov2010, 100bpm
CDC 'Split Type': B0713990A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Hypoaesthesia, Hypoaesthesia facial, Injection site anaesthesia, Laboratory test, Pain, Tachycardia, Vision blurred, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician via a sales representative and by a consumer and described the occurrence of visual impairment in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination included 1st dose of CERVARIX without observed any adverse events. On 6 November 2010, the subject received 2nd dose of CERVARIX (.5 ml, route and injection site unknown). In November 2010, 12 hours after vaccination with CERVARIX, the subject woke up with intense stomach pain, intense tachycardia (100 beats per minute) and pain in the trunk. Then the subject visited the outpatient unit of a hospital where she underwent a series of tests (reporter was unaware of which tests were performed or which were the results). The events resolved without treatment and left the hospital without admission. In April 2011, 5 months after vaccination with CERVARIX, the subject presented with sudden partial face, neck and upper left arm numbness and transient vision impairment (haze). This case was assessed as medically serious by GSK. The subject intended to perform neurological tests and she stated that she did not intend to perform the 3rd dose of CERVARIX. At the time of reporting, the outcome of these last events was unspecified.

VAERS ID:422298 (history)  Vaccinated:2010-10-20
Age:25.0  Onset:2010-10-20, Days after vaccination: 0
Gender:Female  Submitted:2011-05-05, Days after onset: 197
Location:Foreign  Entered:2011-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cervical dysplasia; Smoker
Preexisting Conditions: Cervical conisation
Diagnostic Lab Data: UNK
CDC 'Split Type': B0714658A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site movement impairment
SMQs:
Write-up: This case was reported by a pharmacist and described the occurrence of injection site movement impairment in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included cervical conisation because the subject experienced a severe cervical dysplasia. The subject was a smoker since the age of 15 (20 cigarettes/day) and could not quit. On 15 September 2010, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown injection site). No adverse event were reported. On 20 October 2010, the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, left upper deltoid). On 20 October 2010, less than one day after vaccination with CERVARIX, the subject experienced injection site movement impairment (difficulty when left shoulder was elevated). The subject experienced this event periodically (approximately once every 2 weeks). A third injection of CERVARIX was planned but was postponed due to the above mentioned event. At the time of reporting the event was unresolved. Follow-up received on 26 April 2011 by a physician: The physician considered the event was clinically significant (or requiring intervention). The symptoms on the left shoulder were periodic and could be due by another disease. She was referred to an orthopaedic specialist. When she visited the specialist, the subject did not have the event and it seemed not to be a causal relationship to CERVARIX.

VAERS ID:423012 (history)  Vaccinated:2011-05-06
Age:25.0  Onset:2011-05-07, Days after vaccination: 1
Gender:Female  Submitted:2011-05-16, Days after onset: 9
Location:Foreign  Entered:2011-05-17, 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:
Preexisting Conditions: No personal family medical history; No history of adverse event to a vaccine or a drug; Unknown family medical history; No concomitant therapy.
Diagnostic Lab Data: Complete blood count (CBC) performed on 07 May 2011 was normal. Complete blood count (CBC), glucose, thyroid-stimulating hormone (TSH) and urine tests were performed on 09 May 2011 as well as electrocardiogram: results pending.
CDC 'Split Type': 201102718
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose, Blood thyroid stimulating hormone, Dyspnoea, Electrocardiogram, Full blood count normal, Tachycardia, Urine analysis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Case received from a Healthcare Professional in a foreign country on 09 May 2011 under the reference number BR2011-201. A 25-year-old female patient, with no personal medical history and no concomitant therapy, had received her booster dose of influenza vaccine (manufacturer and batch number unknown) by intramuscular route in the left arm on 06 May 2011. The patient had no history of adverse event to a vaccine or a drug and did not make chronic medications use. On 07 May 2011, the patient experienced dyspnea and tachycardia. She sought medical help and a complete blood count (CBC) was performed which was normal. The patient was treated with serum therapy and propranolol 1 dose on 07 May 2011. She improved temporarily. Symptoms persisted and the patient was admitted to hospital for observation on 09 May 2011. Complete blood count (CBC), glucose, thyroid-stimulating hormone (TSH) and urine tests were performed on 09 May 2011 as well as electrocardiogram. The patient had not recovered at the time of reporting.

VAERS ID:425388 (history)  Vaccinated:2011-05-10
Age:25.0  Onset:2011-05-10, Days after vaccination: 0
Gender:Female  Submitted:2011-06-14, Days after onset: 35
Location:Foreign  Entered:2011-06-14
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: No previous reaction when initial course given
Diagnostic Lab Data: UNK
CDC 'Split Type': B0724651A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHBV988AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Dysgeusia, Hypotension, Presyncope, Procedural nausea, Rash macular, Vaccination complication, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory agency (# GB-MHRA-EYC 00065083) and described the occurrence of near fainting in a 25-year-old female subject who was vaccinated with Hepatitis B surface antigen. Previous vaccinations included Hepatitis B. "No previous reaction when initial course given." On 10 May 2011 the subject received unspecified dose of Hepatitis B surface antigen (intramuscular). On 10 May 2011, 0 days after vaccination with Hepatitis B surface antigen, the subject experienced near fainting, post procedural nausea, vomiting, hypotension, blotchy rash, metallic taste and chest tightness. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 10 May 2011, the events were resolved. It was reported that the subject was later diagnosed as having had a "reaction to Hepatitis B vaccine." Verbatim Text: Later diagnosed as reaction to Hepatitis B vaccine.

VAERS ID:425921 (history)  Vaccinated:2007-02-05
Age:25.0  Onset:2010-05-04, Days after vaccination: 1184
Gender:Female  Submitted:2011-06-22, Days after onset: 414
Location:Foreign  Entered:2011-06-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic to penicillin
Preexisting Conditions:
Diagnostic Lab Data: Pertussis serology positive, 19May2010, positive
CDC 'Split Type': B0668925A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B006BB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bordetella test positive, Pertussis, Vaccine breakthrough infection
SMQs:
Write-up: This case was reported by a pharmacist via a representative and described the occurrence of pertussis breakthrough in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In 2008 the subject received unspecified dose of BOOSTRIX. In March 2010, 18 months after vaccination with BOOSTRIX, the subject experienced pertussis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Follow up received on 24 September 2010: Subject''s medical conditions included penicillin allergy and occasional alcohol use. It was confirmed that on 05 February 2007 the subject was vaccinated with a booster dose of BOOSTRIX. On 04 May 2010 the subject developed pertussis. Relevant test around 19 May 2010 included positive pertussis blood test. On 02 June 2010 the event was resolved. The pharmacist considered the event was probably related to vaccination with BOOSTRIX.

VAERS ID:426181 (history)  Vaccinated:2011-05-24
Age:25.0  Onset:2011-05-24, Days after vaccination: 0
Gender:Male  Submitted:2011-06-23, Days after onset: 30
Location:Foreign  Entered:2011-06-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Allergic reaction to antibiotics; Environmental allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1106USA02853
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURERG0239 IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0218Z SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Malaise, Presyncope, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Case received from Health Authority (case n. 142516) through an agency (local case n. IT275/11). Initial report received on 10-JUN-2011. Case medically confirmed. A 25 year old male patient was vaccinated on 24-MAY-2011 with one dose of DIFTAVAX ADULT (batch n. G0239-4) IM and concomitantly with one dose of MMR II (lot number 667058/02118Z; batch n. NP07550) SC. On the same day, right after vaccination, the patient presented with malaise and lipothymia (no loss of consciousness) and onset of diffuse itchy cutaneous rash. The patient was treated with SOLUMEDROL 500 in IV solution 100cc and TRIMETON 1 vial in IV solution 250 cc. The outcome was recovered on 24-MAY-2011. Upon medical review the Company judged relevant to code the adverse event "malaise" which was mentioned in the narrative but not coded by Health Authority. Upon medical review the company considered the symptoms medically significant and upgraded the case to serious. Other business partner numbers included E2011-03599. The case is closed. No further information is available.

VAERS ID:428572 (history)  Vaccinated:2009-06-01
Age:25.0  Onset:2009-07-01, Days after vaccination: 30
Gender:Female  Submitted:2011-08-02, Days after onset: 762
Location:Foreign  Entered:2011-08-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Caffeine consumption
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound fetal, 01Jul2009, no abnormalities
CDC 'Split Type': B0736275A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gastroenteritis, Intra-uterine death, Maternal exposure during pregnancy, Ultrasound foetal, Ultrasound scan normal, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a regulatory authority (# NL-LRB-125572) and described the occurrence of intra-uterine death in a 25-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Subject''s mother medical history included multiple episodes of intra-uterine death. Concurrent medical conditions included consumption of high caffeine level beverage: 10 cans of red-bull a week. Otherwise, the subject was healthy. Concurrent medications included Paracetamol during 1st trimester of pregnancy. In June 2009, the subject received booster dose of Hepatitis B vaccine (intramuscular, unknown injection site and batch number) due to a new job in health care which began approximately at the conception time. Her last menstrual period and estimated date of delivery were not provided. The subject was vaccinated during 1st trimester of gestation. On 01 July 2009, after 12-13 weeks of gestation, a fetal ultrasound was performed and the foetus was healthy. By the end of July 2009, 1 month after vaccination with Hepatitis B vaccine, the subject experienced gastro-enteritis and one episode of vomiting. The outcome of gastro-enteritis was unspecified. On 10 August 2009, at 4 months of gestation, the subject experienced intra-uterine death. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 10 August 2009, a placental examination and foetal autopsy revealed no abnormalities. The regulatory authority reported that foetal death was unlikely to be related to vaccination with Hepatitis B vaccine due to lack of support from medical literature and relatively high background of incidence and family history. 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:429607 (history)  Vaccinated:2011-05-25
Age:25.0  Onset:2011-05-26, Days after vaccination: 1
Gender:Male  Submitted:2011-08-12, Days after onset: 78
Location:Foreign  Entered:2011-08-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': PHHY2011DE70121
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURERE1250 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test, Borrelia test, CSF test, Electroneurography, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow)
Write-up: Case number PHHY2011DE70121 is an initial report from the foreign health authority (ref: PEI2011024783) received on 02 Aug 2011. This report refers to a 25-year-old male patient. His past medical history was not provided. His previous vaccination included RABIPUR on 19 Mar 2008. He was vaccinated with MENVEO (batch number X1010) via subcutaneous route on 19 May 2011. He was concomitantly vaccinated with REPEVAX (batch number: E1250-3) intramuscularly on 25 May 2011. He presented with Guillain-Barre-Syndrome (GBS) and hypoesthesia of the acra (in context with GBS) on 26 May 2011. He also experienced both sided facial paresis (also seen in context with GBS) on 14 Jun 2011. He was hospitalized on unspecified date. CSF examination, electroneurography (ENG), autoimmune diagnostic and antibodies against B burgdorferi in CSF and serum were performed. However, results were not provided. Facial paresis on both sides resolved on 20 Jun 2011. The outcome of the other events was not reported.

VAERS ID:431087 (history)  Vaccinated:2011-05-03
Age:25.0  Onset:2011-05-30, Days after vaccination: 27
Gender:Female  Submitted:2011-08-24, Days after onset: 86
Location:Foreign  Entered:2011-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: DYSMENORRHEA
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0941907A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA048AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Condition aggravated, Dysmenorrhoea, Endometriosis, Laboratory test abnormal, Laparoscopic surgery, Menorrhagia, Oophorectomy, Ovarian mass, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Ovarian tumours of unspecified malignancy (broad)
Write-up: This female subject was enrolled in a cross-over study. On 06 August 2010, 03 May 2011 and 01 July 2011, the subject received the 1st, 2nd and 3rd dose of CERVARIX in the left deltoid, after negative urine pregnancy tests. This 26-year-old subject''s past medical history included dysmenorrhea since she was 16-years-old. Her history also included participation in the clinical trial for which she was vaccinated with HAVRIX in the left deltoid with the first dose on 13 October 2004, second dose on 16 November 2004 and third dose on 07 March 2005, after negative urine pregnancy tests. She was closed out of the CVT protocol on 01 December 2009. On 30 May 2011, 27 days after the 2nd dose of CERVARIX, this 25-year-old subject developed probable bilateral endometrioma. The subject was hospitalised. The subject was treated with DANAZOL, oral contraceptive and surgery. The event resolved on 11 August 2011. The investigator reported the probable bilateral endometrioma as possibly related to CERVARIX due to the time that elapsed between the application of the vaccine and the start of the symptoms. Investigator comments: During visit on 18 August 2011 subject reported that on 30 May 2011 she consulted to a private doctor due to dysmenorrhea and menorrhagia. A sonogram showed a mass in the left ovary. She was prescribed with oral contraceptives for 2 months and had blood tests (she does not know details). In a medical follow-up appointment she was informed that the lab tests were abnormal (she does not know details) and laparoscopy was scheduled. She was hospitalized on 27 July 2011 and the same day she underwent the laparoscopy. During the procedure she had a left total oophorectomy and a right partial oophorectomy performed. She was discharged 29 July 2011 with recommendations and with indication of oral treatment with DANAZOL for unlimited period. She referred she felt fully recovered approximately on 11 August 2011. She is taking the treatment. She has a follow-up appointment on 30 August 2011. Recommendations were given. The medical chart will be reviewed as soon as possible. Diagnosis: probable bilateral endometrioma.

VAERS ID:433048 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:2011-08-12
Gender:Female  Submitted:2011-09-02, Days after onset: 21
Location:Foreign  Entered:2011-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Tonsillectomy
Diagnostic Lab Data: Alanine aminotransferase, 17Aug2011, 234U/L; Alkaline phosphatase, 17Aug2011, 51U/L; Aspartate aminotransferase, 17Aug2011, 204U/L; Gamma GT, 17Aug2011, 21U/L; White cells, 17Aug2011, 4.310^3/mm3
CDC 'Split Type': B0741813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood test abnormal, Gamma-glutamyltransferase normal, Gastroenteritis, Headache, Hepatitis A, Nausea, Vaccination failure, Vomiting, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a consumer and described the occurrence of hepatitis A in a 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included tonsillectomy (2 years ago). On unspecified dates, the subject received complete scheme of vaccination with TWINRIX (intramuscular, unknown site of injection, batch number not provided). First dose was probably given in November, second dose in December and last dose 4 or 6 months afterwards (the subject didn''t remember exactly). On 12 August 2011, at an unspecified time after vaccination with complete scheme with TWINRIX, the subject experienced abdominal pain, headache, nausea and vomiting. The physician requested laboratory tests and gave diagnosis of gastroenteritis. The subject was treated with antibiotics but the symptoms continued during several days. Other blood analysis was made and according to the physician, the subject experienced Hepatitis A. The subject thought that it was due to a vaccination failure. This case was assessed as medically serious by GSK. Relevant test results included 234 U/L for Alanine aminotransferase, 51 U/L for Alkaline phosphatase, 204 U/L for Aspartate aminotransferase, 21 U/L for Gamma GT and 4.3 10^3/mm3 for white cells. These results dated from 17 August 2011. No serologic test for Hepatitis A was provided. At the time of reporting, the events were unresolved.

VAERS ID:435053 (history)  Vaccinated:2011-09-05
Age:25.0  Onset:2011-09-05, Days after vaccination: 0
Gender:Male  Submitted:2011-09-20, Days after onset: 15
Location:Foreign  Entered:2011-09-21, 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: Past medical history was not provided. A dose of IPV MERIEUX, (lot-no. not reported) was previously given at an unspecified date - toleration was not reported.
Diagnostic Lab Data:
CDC 'Split Type': E201105446
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE0481 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Grand mal convulsion, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was received from the Health Authorities on 13-Sep-2011 (reference number PEI2011029388). Case is medically confirmed. A 25-year-old male patient received a booster of IPV MERIEUX (lot-no. E0481-6) IM into the right upper arm on 05-Sep-2011. Immediately after the vaccination the patient experienced a tonic-clonic seizure lasting for about 20 seconds. The patient was not hospitalised, however further neurological check-up was scheduled. At the time of the report the patient had recovered. The HA assessed the seriousness criteria for seizure to be medically significant. Reportedly, the patient previously received a dose of IPV MERIEUX (lot-no. not reported) at an unspecified date - toleration was not reported.

VAERS ID:435372 (history)  Vaccinated:2011-05-11
Age:25.0  Onset:2011-05-11, Days after vaccination: 0
Gender:Female  Submitted:2011-09-22, Days after onset: 134
Location:Foreign  Entered:2011-09-23, 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: The patient had a medical history of chronic disease. The patient had received a dose of influenza H1N1 in 2010, without reaction.
Diagnostic Lab Data:
CDC 'Split Type': 201108798
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3960AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Bronchospasm, Cough, Dyspnoea, Laryngeal oedema, Oropharyngeal pain, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3787). A 25-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 11 May 2011. The patient had a medical history of chronic disease (not specified). The patient had received a dose of influenza H1N1 vaccine in 2010, without reaction. On 11 May 2011, 3 hours post-vaccination, the patient experienced severe anaphylaxis level 1. She experienced dry cough, sore throat, bronchospasm, breathing difficulty and closing throat sensation. She received medical care and was diagnosed with glottis oedema. The patient was treated with injectable DECADRON and adrenaline. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:441529 (history)  Vaccinated:2011-10-12
Age:25.0  Onset:2011-10-12, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 23
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:
Current Illness:
Preexisting Conditions: No information reported.
Diagnostic Lab Data:
CDC 'Split Type': E201106647
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEUR  IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Glossodynia, Musculoskeletal discomfort, Swollen tongue
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Case received from Health Authorities on 27-Oct-2011 under the reference number N201110-1623 via the local site Sanofi Pasteur. Case reported by a nurse to the HAs. Case medically confirmed. A 25-year-old female patient had received a dose of TYPHIM VI (batch n. and site of administration not reported), a dose of STAMARIL (batch n. and site of administration not reported), a dose of IMOVAX POLIO (batch n. and site of administration not reported) and a dose of meningococcal polysaccharide vaccine (MFR, batch n. and site of administration not reported) via intramuscular route on 12-Oct-2011. The same day as vaccination, 10 minutes later, the patient presented with burning tongue, swollen tongue and neck discomfort. An assessment of vital functions was done (blood pressure 139/93 mmHg at 01.20 pm and 126/84 mmHg at 01.45 pm) and at 02.15 pm she left the primary care center where the vaccines were administered. At 05.00 pm in the same day, by telephone contact, the patient referred that the symptoms persist without recovery and she was advised by the primary care center to visit the emergency room. Outcome: Unknown.

VAERS ID:441741 (history)  Vaccinated:2011-07-14
Age:25.0  Onset:2011-07-14, Days after vaccination: 0
Gender:Female  Submitted:2011-11-07, Days after onset: 116
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:
Current Illness: Pregnancy NOS (LMP = 10Aug11)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1111USA00458
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0935Y0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Maternal exposure before pregnancy, Medication error
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Case of pregnancy follow-up and misuse received from Health Authorities on 28-OCT-2011 under the reference number L201110-1205 via the local site Sanofi Pasteur MSD. Case medically confirmed. Initial source was a nurse. A 25-year-old female patient had received by medication error, 1 month before became pregnant (estimated date +/- 10-AUG-2011) the first dose of MMR II (lot number: 665597/0935Y, batch number: NN43900, site of administration not reported) via intramuscular route on 14-JUL-2011. No known clinical history. There was no suspicion of interaction between medicines. The same drug was not reintroduced. There were no known previous reactions to other drugs. There was no specific treatment. Patient without taking any concomitant medication. Outcome: unknown. The events were considered as other important medical events by the agency. Other business partner number included: E2011-06652. No further information is available.

VAERS ID:442370 (history)  Vaccinated:2008-09-29
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-10
Location:Foreign  Entered:2011-11-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201110793
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER07081651UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event
SMQs:
Write-up: This case report is part of a batch of several hundred reports associated with Rabies Vaccine, that was received on 27 October 2011 by sanofi pasteur affiliate, from the "Foreign Ministry of Health" (local case reference number BR-BT-2011-4288). A female patient, whose medical history and concomitant therapies were not reported, had received her 2nd dose of Rabies Vaccine (manufacturer not reported, batch number "0708165", route and anatomical site of administration not reported) on 29 September 2008. The suspect vaccine was reported as "RV", i.e. Rabies Vaccine/Vero. On an unspecified timeframe post-vaccination, the patient experienced other serious or unexpected adverse events. The patient''s symptoms lasted for 1 hour. She recovered without sequelae. The case was assessed as serious by the Ministry of Health due to other important medical condition. The patient was not hospitalized. The status of this case was "confirmed" (the Ministry of Health assessed the adverse events as related to the vaccine). The recommended "conduct" was "schedule maintained". Documents held by sender: none.

VAERS ID:443158 (history)  Vaccinated:2011-10-26
Age:25.0  Onset:2011-10-26, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 23
Location:Foreign  Entered:2011-11-21, 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: diagnostic laboratory test, rheumatological check up were all negative; diagnostic laboratory test, search for infectious causes (unspecified) were normal
CDC 'Split Type': WAES1111USA01614
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Cast application, Laboratory test normal, Oedema peripheral, Pain in extremity, Polyarthritis, Rheumatoid factor negative, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: This case was received from a physician on 27-OCT-2011. The case is medically confirmed. A 25 year old female patient received Dose 1 of GARDASIL (lot # not reported) IM into the upper arm in the morning of 26-OCT-2011 (side was unknown, reporter is not the vaccinating physician). The same day at about 3 PM the patient presented with arthritis of the wrist with swollen lower arm and pain at the contralateral arm. The patient was referred to an outpatient clinic where a plaster cast was fitted. At the time of the report the symptoms were persisting. The reporter stated that she rather does not see a causal relation to the vaccination. Previous unspecified vaccinations were tolerated well. Follow up information was received on 10-NOV-2011: the reporter was contacted by phone. Meanwhile the patient''s condition had worsened and she was hospitalized (case upgraded to serious). Arthritis had changed from arm to knee and ankle joint (polyarthritis). Additionally for short time the patient''s abdominal wall was swollen. Diagnostics including rheumatological check up and search for infectious causes (not specified) were all negative or normal respectively. Crohns disease was ruled out. No diagnosis was established. The hospital physicians did not see a causal relation to the vaccination, they assumed an unspecified viral infection. Therapy was carried out with ibuprofen. At the time of this report the patient was free of complaints. Other business partner number included E2011-06542.

VAERS ID:443949 (history)  Vaccinated:2011-11-06
Age:25.0  Onset:2011-11-07, Days after vaccination: 1
Gender:Female  Submitted:2011-11-23, Days after onset: 16
Location:Foreign  Entered:2011-11-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 07Nov2011, 37.6deg.C
CDC 'Split Type': B0763330A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Appendicitis, Pyrexia, Surgery
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of appendicitis in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history or concurrent medical conditions were not provided. On 6 November 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site, lot number not provided). On 7 November 2011, 1 day after vaccination with CERVARIX, the subject experienced febricula at 37.6 deg.C, abdominal pain and abdominal discomfort. She didn''t present with other systemic or other local symptoms. The subject was treated with antipyretic. No tests were performed. On 7 November 2011, febricula was resolved and abdominal discomfort was unresolved. The outcome of abdominal pain was unspecified. Incorrect initial entry was found on follow-up, it was not mentioned that the subject was hospitalised and therefore the case was considered as serious. Follow-up information received on 21 November 2011: On 7 November 2011, 1 day after vaccination with CERVARIX, the subject experienced appendicitis. She was operated and recovered. She was discharged in a good health status.

VAERS ID:444128 (history)  Vaccinated:2011-09-26
Age:25.0  Onset:2011-09-26, Days after vaccination: 0
Gender:Unknown  Submitted:2011-11-30, Days after onset: 65
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:
Diagnostic Lab Data: Blood glucose, 26Sep2011, 99mg%; blood pressure, 26Sep2011, 90/60mmHg
CDC 'Split Type': B0764553A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB239AG0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose normal, Convulsion, Hypotension, Loss of consciousness, Syncope
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician via a regulatory authority (PL-URPL-OCR-20111102009) and described the occurrence of fainting in a 25-year-old subject of unspecified gender who was vaccinated with TWINRIX adult (GlaxoSmithKline). The subject had no adverse reaction during previous vaccinations. On 26 September 2011, the subject received 1st dose of TWINRIX adult (intramuscular, injection site unknown). On 26 September 2011, within minutes of vaccination with TWINRIX adult, the subject experienced fainting, fleeting loss of consciousness, convulsion and hypotension. There was no miction or defecation during this episode. The regulatory authority reported that the events were clinically significant (or requiring intervention). Blood pressure was 90/60 mmHg and glycemia was 99 mg%. At the hospital, diagnostic tests (unspecified) were done and then the subject was directed home. The subject was treated with hydrocortisone sodium succinate (100mg, IV) and sodium chloride (NaCl, 500 ml 0.9%). 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:444283 (history)  Vaccinated:2011-07-01
Age:25.0  Onset:2011-11-11, Days after vaccination: 133
Gender:Female  Submitted:2011-12-02, Days after onset: 21
Location:Foreign  Entered:2011-12-02
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: UNK
CDC 'Split Type': A0949205A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA102AB2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion missed, Maternal exposure before pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen abnormal, Uterine contractions during pregnancy, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This female subject was enrolled in a study. On 21 January 2011, 11 February 2011, and 01 July 2011, the subject received the 1st, 2nd and 3rd dose of CERVARIX after negative urine pregnancy tests. The subject''s past medical history included no previous pregnancies. She did not use a birth control method prior to the pregnancy. She attended prenatal care at the local clinic. This was her first pregnancy within the study. Pregnancy diagnosis was by urine test. On 14 October 2011, 3 months after the 3rd dose of CERVARIX vaccine, this 26-year-old subject was reported to be pregnant. Her last menstrual period occurred on 09 July 2011. The subject was exposed to the vaccine before conception. The estimated delivery date was 10 April 2012. On 11 November 2011, four months after the 3rd dose of CERVARIX, this 26-year-old subject experienced missed miscarriage. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with dilation and curettage. The event resolved on 13 November 2011. The investigator reported the missed miscarriage and vaccine exposure before pregnancy as possibly related to CERVARIX due to the time elapsed between the application of the vaccine and the LMP. Investigator comments: On 23 November 2011, the subject reported by telephone that she started with mild vaginal bleeding on 11 November 2011 for which she consulted to the local clinic where they told her that they were normal contractions, suppositories were applied (she did not know the name) and she was discharged. On 12 November 2011, she continued with vaginal bleeding and she consulted to the local clinic, lab tests were performed and she was transferred to the local hospital where a sonogram was performed at the emergency room that same day (12 November 2011) and they told her that she presented a missed miscarriage, therefore, she was admitted. She underwent dilation and curettage on 13 November 2011 without complications and she was discharged in the afternoon of that same day in good general conditions. The subject reported that she felt totally recovered on 13 November 2011. The medical chart will be reviewed as soon as possible. Diagnosis: missed miscarriage.

VAERS ID:446625 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-27
Location:Foreign  Entered:2012-01-03, Days after submission: 7
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: Diagnostic laboratory test, ??08, Confirmed an autoimmune reaction; Magnetic resonance imaging, ??08, some demyelination in patient''s brain
CDC 'Split Type': WAES1112USA02119
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Arthropathy, Asthenia, Autoimmune disorder, Balance disorder, Demyelination, Dizziness, Fatigue, General physical health deterioration, Laboratory test abnormal, Nausea, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad), Arthritis (broad)
Write-up: Information has been received from a blog on the internet concerning a healthy 25 year old female patient reporting on herself who on an unspecified date, was vaccinated with a first dose of GARDASIL (lot number, dose and route not reported). It was reported that prior to GARDASIL, the patient was a happy, healthy 25 year old completing her bachelors degree while working full-time in administration. She was about to embark on a Post Graduate Degree in Journalism. Despite being kept busy by work and study, she found the time to go out with friends and dance at their favorite club almost every weekend. During 2008 and 2009, the patient''s health mysteriously began to deteriorate into a myriad of inexplicable symptoms including dizziness, nausea, joint pain, a collapsing knee, loss of balance, chronic fatigue and weakness. Even though she visited a multitude of health professionals, including both general practitioners and specialists, who performed a broad range of tests; no one was able to say what was wrong with her. Tests confirmed an autoimmune reaction and an MRI showed some demyelination in patient''s brain similar to that experienced by multiple sclerosis (MS) patients. However, nothing was definitive. She was given pain killers and steroids, but no real explanation. Just prior to Christmas in 2009, the patient by chance read an article in the newspaper about a possible link between GARDASIL and multiple sclerosis. The patient collected her medical file and created a timeline. It showed that her symptoms had begun within weeks of receiving her first vaccination. The onset of the worst symptoms coincided with the receipt of her last vaccination. Immediately, she began to research on the internet. What she discovered was a plethora of other girls with stories just like hers. Fourteen months after her last vaccination, the patient was still on steroids. The patient was forced to discontinue her post graduate studies, was unable to work full time and sometimes unable to work at all. The patient still experienced daily symptoms including chronic fatigue and some neurological difficulties. Despite maintaining a brave face throughout the GARDASIL ordeal, the patient felt like a shadow of who she once was or, could have been. Upon internal review the adverse events were considered to be disabling. Addition information is not expected.

VAERS ID:447136 (history)  Vaccinated:2011-12-12
Age:25.0  Onset:2011-12-13, Days after vaccination: 1
Gender:Female  Submitted:2012-01-10, Days after onset: 28
Location:Foreign  Entered:2012-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0772727A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Hypersensitivity, Musculoskeletal stiffness, Photophobia, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a physician, via the regulatory authority, and described the occurrence of an allergic reaction in a 25-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unknown). On 12 December 2011 the subject received an unspecified dose of influenza virus vaccine (1 IU Axa, intramuscular, batch details unknown). On 13 December 2011, approximately 1 day after vaccination with influenza virus vaccine, the subject experienced a ''primary'' allergic reaction, fever, headache, urticaria, stiff neck and photophobia. The subject was hospitalised. At the time of reporting the events were improved. Primary allergic reaction, pyrexia, headache, localised urticaria, neck stiffness, photophobia.

VAERS ID:447814 (history)  Vaccinated:2012-01-04
Age:25.0  Onset:2012-01-05, Days after vaccination: 1
Gender:Unknown  Submitted:2012-01-23, Days after onset: 18
Location:Foreign  Entered:2012-01-23
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': D0074027A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB874CB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Appendicitis, Decreased appetite, Gastrointestinal disorder, Surgery
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of gastrointestinal problems in a 25-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 January 2012 the subject received unspecified dose of ENGERIX B (unknown). On 5 January 2012, 1 day after vaccination with ENGERIX B, the subject experienced upper and lower gastrointestinal problems (intervallic) and complained of loss of appetite. At the time of reporting the outcome of the events was unspecified. Follow-up information received 17 January 2012: A physician confirmed that on 4 January 2012, the subject received the 2nd dose of ENGERIX B (intramuscular, left arm). The subject also confirmed that the symptoms were attributed to an acute appendicitis. The subject was hospitalised and underwent surgery. On 9 January 2012, the event upper and lower gastrointestinal problems were resolved. The physician considered the events were unrelated to vaccination with ENGERIX B. No further information will be available.

VAERS ID:448350 (history)  Vaccinated:2011-04-27
Age:25.0  Onset:2011-05-15, Days after vaccination: 18
Gender:Female  Submitted:2012-01-30, Days after onset: 260
Location:Foreign  Entered:2012-01-30
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: Abortion Spontaneous Incomplete; C-section Delivery; Miscarriage; Pre-Eclampsia
Diagnostic Lab Data: UNK
CDC 'Split Type': A0963175A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hashitoxicosis, Hyperthyroidism, Laboratory test abnormal, Mood altered, Palpatory finding abnormal, Thyroid disorder, Weight decreased, Wrong drug administered
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This female subject was enrolled in a cross-over study sponsored by National Cancer Institute (NCI). On 13 April 2010, the subject was vaccinated in the left deltoid with the 1st dose of CERVARIX, after negative urine pregnancy test. On 20 May 2010, by mistake, the subject received the 1st dose of TWINRIX and on 27 April 2011, the subject received the 2nd dose of CERVARIX, after negative urine pregnancy test. The subject''s past medical history included 3 pregnancies with one resulting in a c-section delivery following pre-eclampsia (see case A0863575A for further details), one pregnancy resulting abortion spontaneous incomplete (see case B0467399A for further details) and the other resulting in a miscarriage. Concomitant medication included Depo-provera as a birth control method. On 15 May 2011, 18 days after the 2nd dose of CERVARIX, 12 months after the 1st dose of TWINRIX, this 25-year-old subject developed hashitoxicosis. The event was clinically significant (or requiring intervention) and was assessed an autoimmune disease. The subject was treated with propylthiouracil, propranolol hydrochloride and lithium carbonate. The event improved on an unspecified date and the subject was following up with a specialist. The investigator reported the hashitoxicosis as not related to TWINRIX and assessed the event as possibly related to CERVARIX due to the short time elapsed between the last dose of vaccine and the onset of symptoms. Investigator comments: On 24 January 2012 the subject reported during visit that approximately on 15 May 2011 she noted an important weight loss as well as changes in her mood and she also palpated "small buds" in her neck for which she consulted to the primary care center where she had lab tests performed and she was told that she presented an abnormality in her thyroid gland for which she was referred to hospital. In the medical center she was diagnosed with hyperthyroidism of autoimmune etiology (hashitoxicosis) and she was prescribed treatment medications. She referred that with his treatment she felt better. Currently she continues to take th indicated treatment and attending follow-up with the specialist in the hospital. Note: In reference to the specialist brought by the subject documented as possible: hashitoxicosis (primary hyperthyroidism). The medical chart will be reviewed as soon as possible. Diagnosis: Hashitoxicosis.

VAERS ID:448484 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2012-01-31
Location:Foreign  Entered:2012-01-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to lactose; Neurodermatitis
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, up to 40degC
CDC 'Split Type': D0073409C
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA509AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bedridden, Headache, Pain in extremity, Pyrexia, Rash, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer, via a physician, via a pharmacist, and described the occurrence of fever in a 25-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included allergy to lactose and neurodermatitis. Concurrent medications included Birth control (Contraceptive (unspecified)). After previous vaccinations with INFLUSPLIT SSW, the subject experienced fever, rash, limb pain, headache and bedridden. In 2010 the subject received unspecified dose of INFLUSPLIT SSW (unknown route and application site). At an unspecified time after vaccination with INFLUSPLIT SSW, the subject experienced fever (up to 40 degC), rash, limp pain, severe headache and bedridden for 2-3 weeks. The GSK physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. After the next vaccination with INFLUVAC (Abbott) the events recurred. Please see main case D0073409A for additional report regarding the same subject or the same reporter.

VAERS ID:449462 (history)  Vaccinated:2008-07-28
Age:25.0  Onset:2008-08-01, Days after vaccination: 4
Gender:Female  Submitted:2012-02-10, Days after onset: 1288
Location:Foreign  Entered:2012-02-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Endometriosis
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1201USA04126
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Hypoaesthesia, Multiple sclerosis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a a health care professional (local reference # AUS/12/0157) concerning a 25 year old female patient with a history of endometriosis at 19 years (2006), who on 28-JUL-2008 was vaccinated with the third dose of GARDASIL (Lot # not reported). Concomitant therapy included YASMIN. The health professional reported that in August 2008, she experienced numbness from head to toes about three weeks after the third dose of GARDASIL. The patient was in emergency department for 5-6 hours following the experience. Another episode of numbness/tingling and chronic fatigue was in December 2008. In December 2008, the patient was diagnosed with multiple sclerosis in December 2008. At the time of the report, the patient''s outcome was unknown. Multiple sclerosis was considered to be disabling and other medical event by the reporter. Additional information is not expected.

VAERS ID:449769 (history)  Vaccinated:0000-00-00
Age:25.0  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:
Preexisting Conditions: The patient had a medical history of asthma; Unknown concomitant therapy
Diagnostic Lab Data: results pending
CDC 'Split Type': 201201672
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza, Influenza A virus test
SMQs:
Write-up: Case received from a consumer (lay media) in a foreign country on 07 February 2012 under the reference number BR-BT2012-0351. This case is linked with case 2012-01673. A 25-year-old male patient, with a medical history of asthma and unknown concomitant therapy, had received a dose of H1N1 (manufacturer, batch number, route and site of administration unknown) on an unspecified date. On an unspecified date post-vaccination, the patient presented symptoms of influenza A H1N1. The patient was hospitalized. H1N1 virus infection was suspected. The patient was treated with TAMIFLU. A sample of his blood was sent to laboratory to confirm the diagnosis, but the results were pending. The patient was recovering at the time of reporting.

VAERS ID:451128 (history)  Vaccinated:2012-02-01
Age:25.0  Onset:2012-02-26, Days after vaccination: 25
Gender:Female  Submitted:2012-03-05, Days after onset: 8
Location:Foreign  Entered:2012-03-05
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: Alanine aminotransferase incre, Feb2012, above 2000U/l; Aspartate aminotransferase inc, Feb2012, above 2000U/l; Lactate dehydrogenase increase, Feb2012, 918U/l; Quick''s value decreased, Feb2012, 38%
CDC 'Split Type': D0074664A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, Nausea, Prothrombin time shortened, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a hospital physician and described the occurrence of severe increase of alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) in a 25-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On an unknown date early in February 2012 the subject received the third dose of TWINRIX adult (1 ml, unknown). Approximately two weeks post vaccination with TWINRIX adult, on 26 February 2012, the subject experienced nausea and vomiting. On 27 February 2011 the subject was hospitalised for an unknown period of time. Laboratory examinations, performed on an unknown date in February 2012, showed severely increased alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) to more than 2000 U/l both, increased lactate dehydrogenase (LDH) to 918 U/l and decreased Quick''s value to 38%. No cause for these events has been found up to 01 March 2012. At the time of reporting, on 01 March 2012, the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:451220 (history)  Vaccinated:2007-09-17
Age:25.0  Onset:2012-01-10, Days after vaccination: 1576
Gender:Female  Submitted:2012-03-06, Days after onset: 56
Location:Foreign  Entered:2012-03-07, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Cervical smear, ??Aug10, Showed PAP I; Cervical smear, 10Jan12, PAP IVa; Diagnostic pathological examination, 06Feb12, Hystology of the portio showed a small area of squamous epithelial carcinoma; Deoxyribonucleic acid analysis, 13Jan12, Cytometry: Severe cervical lesion of prospective malign potency; Cervix HPV DNA assay, 20Jan12, Positive for type 16
CDC 'Split Type': WAES1203USA00162
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0233U0IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical conisation, Cervix carcinoma stage 0, Cervix disorder, Flow cytometry, Histology abnormal, Human papilloma virus test positive, Papilloma viral infection, Pathology test, Smear cervix abnormal
SMQs:, Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow)
Write-up: This case was received from a Health Care Professional (nurse, mother of the patient) on 24-FEB-2012. The case was medically confirmed. A 25 year old female patient received dose 3 of GARDASIL (batch number: NF58540, lot number: 0253U) IM into the upper arm on 20-MAR-2008. In August 2010, the last smear test showed PAP I. Several reports on findings were made available. On 10-JAN-2012, a portio and cervical smear test showed suspicion of severe cervical lesion with cervical crypt involvement. The result was classified as PAP IVa. On 13-JAN-2012, a DNA cytometry showed severe cervical lesion of prospective malign potency with DNA-polyploidy (assessed as being possibly caused by HPV-infection) and formation of a DNA-aneuploid stem line. A conisation was recommended. On 20-JAN-2012, a hybridisation of the smear test was positive for "high risk" HPV-types, a molecular biological test showed positive HPV-type 16. On 06-FEB-2012, the patient underwent conisation and histology of the portio showed a small area of squamous epithelial carcinoma in situ with no infiltrative growth. The lesion was removed within healthy tissue. The patient had received dose 1 of GARDASIL (batch number: NF46740; lot number: 0233U) IM into the upper arm on 17-SEP-2007 and dose 2 (batch number: NG01520; lot number: 1536F) IM into the upper arm on 21-NOV-2007 - toleration was not reported. The patient had first sexual contact with intercourse in 2001. File closed. Carcinoma in situ of cervix and Papanicolaou smear abnormal, class IV A were considered as other important medical events by the reporter. Other business partner number included: E2012-01370. No further information is available.

VAERS ID:452748 (history)  Vaccinated:2012-03-14
Age:25.0  Onset:2012-03-16, Days after vaccination: 2
Gender:Female  Submitted:2012-03-30, Days after onset: 14
Location:Foreign  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0791222A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of dyspnea in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline) (unknown route and injection site) given on 20 February 2012. On 14 March 2012, the subject received 2nd dose of CERVARIX (unknown route and injection site, batch number not provided). On 16 March 2012, 24 hours after vaccination with CERVARIX, the subject experienced allergic reaction (rash) first in the face and then on the entire body. The same day, the subject looked for medical advice at a local clinic. Severe urticaria was diagnosed by an allergologist. On 19 March 2012, 6 days after vaccination with CERVARIX, the subject experienced dyspnea. The rash didn''t resolve. The subject was hospitalised. On 21 March 2012, the rash didn''t disappear and the subject remained hospitalized. On 23 February 2012, the treating physician was contacted. He confirmed that the rash resolved and that the subject was discharged from the hospital. At the time of reporting, all the events were resolved.

VAERS ID:452973 (history)  Vaccinated:2012-01-31
Age:25.0  Onset:2012-02-01, Days after vaccination: 1
Gender:Female  Submitted:2012-04-03, Days after onset: 61
Location:Foreign  Entered:2012-04-04, 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: Polyneuritis; Polyarthritis
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1203USA03700
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1165Z UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contraindication to vaccination, Mumps, Rubella
SMQs:, Oropharyngeal infections (narrow)
Write-up: This case of misuse (contraindication to vaccination due to immunosuppressive therapy) (E2012-01855) was received from a healthcare professional in a foreign country on 19-MAR-2012 with additional information (completed reporting form) received on 22-MAR-2012. The case is medically confirmed. A 25-year-old female patient with a medical history of polyneuritis and polyarthritis for which she concomitantly takes methotrexat, received a dose of MMR II (lot-no. G006571) on 31-JAN-2012, route and site of administration were not reported. After an unspecified latency the patient developed a severe mumps and rubella infection in February 2012. At the time of the report the outcome was not reported. The seriousness was assessed by the reporter as having involved persistent and/or significant disability or incapacity. The drug event relationship between the events and the vaccination was assessed as definite. Additional information is not expected.

VAERS ID:453318 (history)  Vaccinated:2012-03-14
Age:25.0  Onset:2012-03-15, Days after vaccination: 1
Gender:Female  Submitted:2012-04-10, Days after onset: 26
Location:Foreign  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pollinosis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0793837A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB921BF IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Blood pressure decreased, Heart rate decreased, Nausea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# 2012-01041) and described the occurrence of anaphylactic shock in a 25-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Medical condition included pollinosis. On 14 March 2012, the subject received unspecified dose of ENGERIX B adult (1 ml, intramuscular, unknown injection site). On 15 March 2012, 27 hours after vaccination with ENGERIX B adult, the subject experienced anaphylactic shock: she had urticaria on torso and on arms, nausea and depression of blood pressure and pulse. The subject was treated with Adrenalin and SOLU-MEDROL. Under this treatment, she was cardiovascular stable and was brought to the hospital where she was hospitalised. At the time of reporting, the events were resolved rapidly and without damage. She was already discharge on the next morning. The regulatory authority reported that the events were possibly related to vaccination with ENGERIX B 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. Therefore the case has been closed.

VAERS ID:454120 (history)  Vaccinated:2011-10-05
Age:25.0  Onset:2011-10-09, Days after vaccination: 4
Gender:Female  Submitted:2012-04-19, Days after onset: 193
Location:Foreign  Entered:2012-04-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1204USA01847
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Pain in extremity, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was received from the Local Health Authorities on 10-APR-2012 (ref # PEI 2012010554). This case was medically confirmed. A 25-year-old female patient with no underlying diseases (weight 75 kg) received a dose of GARDASIL, I.M, on 05-OCT-2011, (lot # and site of administration were not reported). Four days later, on 09-OCT-2011, the patient presented with an allergic urticaria, dyspnea and pain in limbs. She received treatment with oral prednisolone 10 mg. At the time of the report to the Health Authority on 17-OCT-2011, the outcome was not reported. The Health Authority considered the events to be medically significant. Case was closed. Other business partner numbers included: E2012-02322. No further information is available.

VAERS ID:454192 (history)  Vaccinated:2011-05-27
Age:25.0  Onset:2011-05-31, Days after vaccination: 4
Gender:Female  Submitted:2012-04-23, Days after onset: 328
Location:Foreign  Entered:2012-04-23
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: CBC, 31May2011, leukocytosis; Urine analysis, 31May2011, normal
CDC 'Split Type': A0974643A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA102AB2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain lower, Appendicitis, Colposcopy, Flank pain, Full blood count abnormal, Laboratory test abnormal, Leukocytosis, Nausea, Surgery, Urine analysis normal, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This female subject was enrolled in the HPV study sponsored by agency. On 22 October 2010, 24 November 2010, and 27 May 2011 the subject received the 1st, 2nd and 3rd dose of CERVARIX. Concomitant medications included YASMIN for birth control. On 31 May 2011, four days after the 3rd dose of CERVARIX, this 25-year-old subject developed acute appendicitis. The subject was hospitalised. The subject was treated with tramadol hydrochloride, dipyrone, cephalothin sodium and paracetamol. The event resolved on 30 June 2011. The investigator reported the acute appendicitis as possibly related to CERVARIX due to the short time elapsed between the last dose application of the vaccine and the start date of the symptoms. Investigator comments: On 11 November 2011, the subject reported during her colposcopy visit that on 30 June 2011 she started with pain in right flank for which she consulted to the local clinic on 31 June 2011 from where she was transferred to the local hospital. She had lab tests performed and she was diagnosed with acute appendicitis. That same day, she underwent surgery without complications. She felt completely recovered on 30 July 2011. On follow-up of serious adverse event with diagnosis of acute appendicitis, on 19 April 2012, the subject''s medical chart was reviewed at the local hospital where the following information was found: 31 May 2011: She was referred from the local health area to emergency room. She reported pain in right lower quadrant since today when she got up, nausea, no vomiting. Physical exam: antalgic position deambulation, soft/depressible abdomen, very painful in right flank and fossa. Diagnostic impression: abdominal pain, discard acute appendicitis. At the emergency room: Physical exam: soft/depressible painful in right iliac fossa abdomen, rebound sign (+). Plan: nothing by mouth, complete blood count, surgeon evaluation. Later, physical exam: afebrile, painful in right iliac fossa abdomen, McBurney (+), rebound sign (+). Plan: admit her, transfer without complications. Pre surgery diagnosis: acute appendicitis, post surgery diagnosis: grade II acute appendicitis. Plan: post surgical protocol, treatment. 31 May 2011: afebrile, healed wound, soft/depressible abdomen. Plan: discharge, treatment. Discharge diagnosis: acute appendicitis. This report was elaborated with information contained in two adverse event forms, corresponding to the initial serious adverse report dated 11 November 2011 and to the current serious adverse event follow-up when it was reclassified as possibly related to vaccine CERVARIX. Diagnosis: acute appendicitis.

VAERS ID:454562 (history)  Vaccinated:2012-02-24
Age:25.0  Onset:2012-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-04-27, Days after onset: 62
Location:Foreign  Entered:2012-04-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0075371A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB235AE2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2012012539) and described the occurrence of loss of consciousness in a 25-year-old male subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). Past medical history was not provided. Previous vaccinations with not further specified vaccines, including vaccinations with the first two doses of TWINRIX ADULT (GlaxoSmithKline), have been well tolerated. On 24 February 2012 the subject received the third dose of TWINRIX ADULT (1 ml, intramuscular, unknown). Less than one day post vaccination with TWINRIX ADULT, on 24 February 2012, the subject experienced acute dyspnea and loss of consciousness for about one minute. The regulatory authority reported considered that the events were clinically significant (or requiring intervention). At the time of reporting, on 27 February 2012, the events were resolved. No further information will be available.

VAERS ID:454753 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-30
Location:Foreign  Entered:2012-05-01, 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: Pap test, high risk HPV positive, subtype HPV 16
CDC 'Split Type': WAES1204USA04267
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical conisation, Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: This case was received from a healthcare professional on 20-APR-2012. The case was medically confirmed. A 25-year-old female patient was diagnosed with "at least" CIN III approximately five years after she had received the complete vaccination series with three doses of GARDASIL (lot number, batch number, dates/routes/site of administration were not reported). It was stated that changes were already seen macroscopically. A smear tests showed High risk HPV positive, subtype HPV 16. A conisation was performed, the result was pending. At the time of the report the outcome was not reported. To be noted that the patient had sexual intercourse before vaccination series. Upon medical review the company considered the case to be serious due to other medically important condition. Other business partner numbers included E2012-02638. Additional information has been requested.

VAERS ID:454933 (history)  Vaccinated:2011-01-04
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-03
Location:Foreign  Entered:2012-05-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Intermittent Febrile Episodes; Weak Immune System
Preexisting Conditions: EBV Infection
Diagnostic Lab Data: UNK
CDC 'Split Type': D0075365A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Hypersensitivity, Intestinal haemorrhage, Leukopenia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2012011987) and described the occurrence of intestinal hemorrhage in a 25-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). The subject''s medical history included EBV infection (serology test showed expired EBV infection). Concurrent medical conditions included intermittent febrile episodes (for periods of 3 days) since childhood. On 4 January 2011 the subject received 1st dose of TWINRIX ADULT (unknown route injection site). In January 2011, within one month after vaccination with TWINRIX ADULT, the subject experienced intestinal hemorrhage, leukopenia, difficult allergies, myalgia and complete loss of strength among other events. Infections and carcinomas were excluded. The subject was hospitalised for an unspecified period of time. Psychiatrist letter from 06 September 2011: Prior to visit of psychiatrist the subject consulted several medical ambulances, several hospitals, non-medical practitioners and psychotherapists. Psychosomatic findings were inconspicuously, there were no affective disorder, no fear symptoms and no delusional symptoms. The subject looked fragile, with dark rings around the eyes, but intelligent and open-minded. The psychiatrist suspected a rare aftereffect of vaccination with TWINRIX ADULT. According to psychiatrist the subject had possibly a weak immune system prior to vaccination. There was no evidence for psychosomatic or psychiatric illness. At the time of reporting, on 03 April 2012, the events were unresolved. No further information will be available.

VAERS ID:455898 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2012-05-18
Location:Foreign  Entered:2012-05-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1205USA02551
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AG  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Confusional state, Endotracheal intubation, Intensive care, Psychotic behaviour
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: This case was received from a health care professional on 08-MAY-2012, under the reference number Pivotal 4865. This case was medically confirmed. A 25 year old male patient with an unreported medical history and concomitant medication received a dose of a Hep B (manufacturer, batch number and lot number not reported), route and site not reported, on an unreported date. The patient also received a dose of IXIARO (batch number and lot number not reported), route and site not reported, on the same day. On an unreported date, within 24 hours of receiving the vaccinations, the patient experienced acute psychotic behavior leading to hospitalization. The patient became confused and extremely agitated and had to be admitted to the intensive care unit where the patient was anaesthetized and intubated. At the time of reporting the patient was in the intensive care ward at the hospital. At the time of reporting the patient had not yet recovered. Other business partner numbers include E2012-03005. No further information is available.

VAERS ID:456606 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2012-05-31
Location:Foreign  Entered:2012-05-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No information reported
Diagnostic Lab Data: UNK
CDC 'Split Type': B0803602A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AG  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Agitation, Confusional state, Endotracheal intubation, Intensive care, Psychotic behaviour
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: This case was reported by a healthcare professional, via a foreign regulatory authority and described the occurrence of psychotic behavior in a 25-year-old male subject who was vaccinated with Hepatitis B vaccine (unknown manufacturer). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown route site, and batch details also unknown) and an unspecified dose of IXIARO (unknown route site, and batch details also unknown). At an unspecified time "within 24 hours" after vaccination with Hepatitis B vaccine and IXIARO, the subject experienced acute psychotic behaviour, confusion and agitation. The subject was hospitalised and had to be admitted to the intensive care unit where he was anaesthetised and intubated. At the time of reporting the events were unresolved. MHRA Verbatim Text: This case was received from a health care professional in a foreign country on 08-May-12 under the reference number 4865. This case is medically confirmed. A 25 year old male patient with an unreported medical history and concomitant medication received a dose of hepatitis B vaccine (manufacturer, batch number not reported), route and site not reported, on an unreported date. The patient also received a dose of IXIARO (batch number not reported), route and site not reported, on the same day. On an unreported date, within 24 hours of receiving the vaccinations, the patient experienced acute psychotic behaviour leading to hospitalisation. The patient became confused and extremely agitated and had to be admitted to the intensive care unit where the patient was anaesthetised and intubated. At the time of reporting the patient was in the intensive care ward at the hospital. At the time of reporting the patient had not yet recovered.

VAERS ID:456665 (history)  Vaccinated:2012-05-25
Age:25.0  Onset:2012-05-25, Days after vaccination: 0
Gender:Female  Submitted:2012-06-01, Days after onset: 7
Location:Foreign  Entered:2012-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperventilation; Syncopal Attack
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 25May2012, 150/90
CDC 'Split Type': B0804308A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA102AB0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Hyperventilation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of hyperventilation in a 25-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included hyperventilation and syncopal attack. On 25 May 2012, the subject received 1st dose of CERVARIX (intramuscular, left arm). On 25 May 2012, 45 minutes after vaccination with CERVARIX, the subject experienced hyperventilation and syncopal attack. This case was assessed as medically serious by GSK. The subject was treated with hydrocortisone, PHENERGAN and diazepam. She was observed during 6 hours and was discharged. On 25 May 2012, the events were resolved. The physician considered the events were unrelated to vaccination with CERVARIX.

VAERS ID:460021 (history)  Vaccinated:2012-07-10
Age:25.0  Onset:2012-07-10, Days after vaccination: 0
Gender:Female  Submitted:2012-07-20, Days after onset: 10
Location:Foreign  Entered:2012-07-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anti factor VIII antibody positive; Anti factor VII antibody positive
Preexisting Conditions: Convulsion; Hormonal contraceptives, Convulsion
Diagnostic Lab Data: 07/10/2012, Blood test, Normal
CDC 'Split Type': WAES1207ISR006820
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Condition aggravated, 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)
Write-up: This spontaneous report as received from a consumer (Local reference # ISR/12/152) regarding his 25 years old daughter with a history of seizures immediately after taking contraceptive pills in 2006/2007. After the event the patient was diagnosed with antibodies to clotting factors 6 or 7 or 8 (reporter did not recall the exact clotting factor). Therefore therapy with oral contraceptives was discontinued. On 10-JUL-2012 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, in her arm (route and lot number not reported). No other co-suspects were reported. No concomitant therapy included. At the moment the needle was pulled out from the arm - within 10-15 seconds - the patient lost consciousness for quite a while and experienced seizure. The patient referred to emergency room. Blood tests and other tests were normal. The patient was discharged from the emergency room after 10-15 hours. The patient recovered from lost consciousness and seizures. Further investigation was made by the patients'' physicians. The relatedness for loss of consciousness and seizures is unknown for GARDASIL. Upon internal review seizures and lost of consciousness were considered to be medically significant event. Additional information has been requested.

VAERS ID:461062 (history)  Vaccinated:1995-05-16
Age:25.0  Onset:1995-09-01, Days after vaccination: 108
Gender:Female  Submitted:2012-08-03, Days after onset: 6181
Location:Foreign  Entered:2012-08-03
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: CSF test, May1996, See text; Neurological examination, Feb1997, See text; Nuclear magnetic resonance ima, Mar1997, See text; May 1996: CSF test: oligoclonal distribution of gammaglobulins in the CSF which lead to the diagnosis of multiple sclerosis; February 1997: Neurological examination: sharp deep tendon reflexes; March 1997: Brain MRI: a few hypersignals in white matter with an ovalary lesion slightly edematogenic situated in the middle part of the right oval center. The aspect was suggestive of a multiocular fibrosis-like demyelinating inflammatory impairment
CDC 'Split Type': B0818650A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1734A62SYRUN
Administered by: Other     Purchased by: Other
Symptoms: CSF oligoclonal band absent, Central nervous system lesion, Eye pain, Hyperreflexia, Hypoaesthesia, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Paraesthesia, Sensory disturbance, Visual evoked potentials normal, Visual field tests normal, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad)
Write-up: This case was reported by the foreign Regulatory Authority (reference LL20120739) and described the occurrence of multiple sclerosis in a 25-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject belongs to an association. This case was reported to the association by the subject herself. The subject''s medical history and concomitant medications, if any, were not specified. On 04 October 1994, 10 November 1994 and on 16 May 1995, the subject received a full course of hepatitis B vaccination with three primary doses of ENGERIX B (dosing, injection site and route unknown) with the corresponding batch numbers; 15 18BG (1st dose), 15 61 C6B (2nd dose) and 17 34 A6 (3rd dose). In September 1995, i.e. approximately four months after vaccination with ENGERIX B, the subject had optic neuritis in left eye. In May 1996, optic neuritis was also observed in right eye. Optic neuritis abated in both eyes after treatment with corticoids. CSF analysis showed no oligoclonal distribution of gammaglobulins which lead to the diagnosis of multiple sclerosis. In July 1996, the subject experienced subjective sensory disorders with tingling and numbness in left lower limb. The events abated within a couple of weeks with corticotherapy per os received over a period of eight days. In 1997, the diagnosis of multiple sclerosis was made. Beginning in January 1997, visual disorders appeared again (date of onset not specified). The subject presented with darkened vision in right eye associated with pain, and with no major changes in visual field or visual evoked potentials. The subject was treated with corticoids per os at 50 mg daily. In February 1997, there were no clinical changes of previously observed visual disorders. Neurological examination showed sharp deep tendon reflexes with no pyramidal irritation. The rest of the examination did not show any functional complaint and was similar to the previous one (negative). In March 1997, brain MRI confirmed the presence of a few hypersignals in white matter with an ovalary lesion slightly edematogenic situated in the middle part of the right oval center. The aspect was suggestive of a multiocular fibrosis-like demyelinating inflammatory impairment. The regulatory authority report that the events were clinically significant (or requiring intervention). At the time of reporting, multiple sclerosis was unresolved. According to the regulatory authority, based on the foreign method of assessment, multiple sclerosis as dubiously related to the vaccination with ENGERIX B.

VAERS ID:464833 (history)  Vaccinated:2012-05-24
Age:25.0  Onset:2012-08-28, Days after vaccination: 96
Gender:Female  Submitted:2012-09-12, Days after onset: 15
Location:Foreign  Entered:2012-09-12
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: Delivery of baby
Diagnostic Lab Data: Pregnancy test, positive; Sonogram, 29Aug2012, results: the fet
CDC 'Split Type': A0992936A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blighted ovum, Maternal exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen abnormal, Uterine dilation and curettage, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This female subject was enrolled in a study. On 24 August 2011 and 24 May 2012, the subject was vaccinated in the left deltoid with the 1st and 2nd dose of ENGERIX B. The subject did not receive the 3rd dose. The subject''s past medical history included one previous pregnancy resulting in a delivery of baby (see case B0403903A for further details); this is her second pregnancy within the study which was not reported. She did not use a birth control method before the pregnancy. Her last menstrual period (LMP) occurred on 20 May 2012. She attended prenatal care. Concomitant medications included Iron and Folic acid during the pregnancy. On 28 August 2012, 96 days after the 2nd dose of ENGERIX B, this 25-year-old subject developed a blighted ovum. The subject was hospitalised. The subject was treated with curettage and vaginal gel. The event resolved on 07 September 2012. The investigator reported the blighted ovum was possibly related to ENGERIX B due to the time elapsed between the last dose of vaccine and the last menstrual period (LMP). Investigator comments: On 10 September 2012 the subject reported spontaneously the following information: She reported that she started with moderate transvaginal bleeding on 28 August 2012 for which she consulted to the emergency room (ER) of the local clinic from where she was transferred to the local hospital. She was admitted the same day and on 29 August 2012 a sonogram was performed and they told her that "the fetus has not developed". She had vaginal gel applied for 3 days. On 04 September 2012 she underwent uterine dilation and curettage. She was discharged the same day in good general condition without treatment and with medical reference to the local clinic. She felt fully recovered on 07 September 2012, approximately. The medical chart will be reviewed when possible. Diagnosis: Blighted ovum.

VAERS ID:465228 (history)  Vaccinated:2012-09-04
Age:25.0  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 13
Location:Foreign  Entered:2012-09-17
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1209DNK006078
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN43360 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case received from a Health Care Professional via the Health Authorities in a foreign country on 10-Sep-2012 under the reference numbers DK-DKMA-ADR-21835604 and EFO3213. Case medically confirmed. A 25-years-old female patient (weight 60 kg, height 170 cm) had received injection of GARDASIL (batch number G009615; lot number NN43360, intramuscular, dose 1) on 04-Sep-2012 and 5 minutes post vaccination she developed anaphylaxis, difficult to breathe and dizziness. At the time of reporting the outcome was recovering for anaphylaxis and unknown for difficult to breathe and dizziness. The patient did not receive any other medication. No causality assessment was provided. No further information expected.

VAERS ID:466956 (history)  Vaccinated:2011-09-29
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-28
Location:Foreign  Entered:2012-09-28
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: Electroencephalogram showed diffuse brain suffering despite a normal magnetic resonance imaging. Lumbar puncture showed a lymphocytic meningitis with hyperproteinorachia. PCR for human simplex virus (HSV), enteroviruses, measles and T. whipplei antibodies were negative in the cerebrospinal fluid. No antineuronal antibodies were found. Serology for Lyme disease, chlamydia, mycoplasma, enteroviruses, HSV, varicella zoster virus, arboviruses antibodies were negative. Anti-measles IgG, anti-rubella IgG and anti-mumps IgG were detected.
CDC 'Split Type': WAES1209FRA011822
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, Ataxia, Bacterial test negative, Borrelia test negative, CSF test normal, Chlamydia test negative, Electroencephalogram abnormal, Enterovirus test negative, Eye movement disorder, Immunoglobulin therapy, Lumbar puncture abnormal, Measles antibody positive, Meningitis aseptic, Mumps antibody test positive, Mycoplasma test, Nervous system disorder, Opsoclonus myoclonus, Polymerase chain reaction, Rubella antibody positive, Urinary retention, Varicella virus test negative, Viral test negative
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Ocular motility disorders (narrow)
Write-up: Case retrieved from the literature on 24-Sep-2012. Case medically confirmed. A 25-year-old male patient developed opsoclonus myoclonus syndrome after receiving a dose of MMRVAXPRO (batch number not reported) on 29-Sep-2011. Eleven days post vaccination he was admitted to hospital for urinary retention, ataxia and involuntary eye movements. Electroencephalogram showed diffuse brain suffering despite a normal magnetic resonance imaging. Lumbar puncture revealed lymphocytic meningitis with hyperproteinorachia. PCRs for human simplex virus (HSV), enteroviruses, measles and T. whipplei antibodies were negative in the cerebrospinal fluid. NO antineuronal antibodies were found. Serologies for Lyme disease, chlamydia, mycoplasma, enteroviruses, HSV, varicella zoster virus, arboviruses antibodies were negative. Anti-measles IgG, anti-rubella IgG and anti-mumps IgG were detected. The patient was given corrective treatment with intravenous immunoglobulin. Symptoms regressed in a few days. On 25-Nov-2011 the patient had still not completely recovered.

VAERS ID:470750 (history)  Vaccinated:2012-10-02
Age:25.0  Onset:2012-10-02, Days after vaccination: 0
Gender:Female  Submitted:2012-10-19, Days after onset: 17
Location:Foreign  Entered:2012-10-22, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic urticaria; Anaphylactic reaction to ibuprofen
Diagnostic Lab Data:
CDC 'Split Type': 2012033644
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED23849421A IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Cough, Dyspnoea, Generalised erythema, Nausea, Pruritus, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: This health authority report (initial receipt 13-Oct-2012) concerns a 25-year-old female patient, who had a previous anaphylactic reaction to ibuprofen several months ago and since developed chronic urticaria. She had several flu vaccinations in the past / previous years with no ill effects. On 02-Oct-2012 at 14:15, the patient received ENZIRA (batch number: 23849421A) at a dose of 0.5 mL intramuscularly in deltoid muscle. Fifteen minutes later, the patient felt itchy and nauseous, but she did not tell immunising staff and carried on working. At 14:50 the immunising staff called the patient. The patient reported intense itching and redness to limbs, body and face. She experienced sudden intense cough with her stating they could not breathe and felt like throat was tightening. She also had nausea ++ and was anxious. She tried to use EPIPEN which she carried as she had a previous anaphylactic reaction to ibuprofen. Adrenaline was administered at 14:55 and the patient was transferred to Accident and Emergency at 15:01 for further assessment and treatment. The patient was fit well with none of these symptoms prior to vaccination. The outcome for ''anaphylactic reaction to vaccine'' was recovered on 02-Oct-2012. The outcome for ''dry cough'' was unknown. Reporter''s comment: The health authority considered the events as serious as the events were considered life-threatening and ENZIRA as a suspect drug. The health authority considered events as anaphylactic reaction to vaccine.

VAERS ID:471808 (history)  Vaccinated:2007-05-18
Age:25.0  Onset:2007-05-18, Days after vaccination: 0
Gender:Female  Submitted:2012-10-26, Days after onset: 1988
Location:Foreign  Entered:2012-10-26
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy
Preexisting Conditions: Fever post vaccination
Diagnostic Lab Data: UNK
CDC 'Split Type': D0077206A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB069AC0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Condition aggravated, Cystitis, Hypersensitivity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a health professional, via regulatory authority (DE-PEI-PEI2012046533) and described the occurrence of worsening of allergy into bronchial asthma in a 25-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Concurrent medical conditions included allergy. The subject experienced mild fever after the bacillus calmette-guerin vaccination (other manufacturer; unknown route and application site) given in 1982 and after the tick-borne encephalitis vaccination (non-GSK manufacturer; unknown route, unspecified upper arm) given on 13 May 2008. On 18 May 2007 the subject received 1st dose of TWINRIX adult (unknown route, unspecified upper arm). On the day of vaccination, on 18 May 2007 the subject experienced mild fever. After the next vaccination with TWINRIX adult the fever recurred. On 24 July 2007 the subject received 2nd dose of TWINRIX adult (unknown route, unspecified arm). On 25 July 2007, 1 day after vaccination with TWINRIX adult, the subject experienced high persistent fever and cystitis. Following both vaccinations, an allergy aggravated into bronchial asthma. The physician considered the events were maybe disabling. At the time of reporting the events fever and cystitis were resolved and the bronchial asthma was unresolved.

VAERS ID:472527 (history)  Vaccinated:2012-09-12
Age:25.0  Onset:2012-10-08, Days after vaccination: 26
Gender:Female  Submitted:2012-11-01, Days after onset: 24
Location:Foreign  Entered:2012-11-01
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: Pregnancy
Diagnostic Lab Data:
CDC 'Split Type': WAES1210GBR014459
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blighted ovum, Exposure during pregnancy, Haemorrhage, Pain, Ultrasound antenatal screen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This pregnancy case was received from the Health Protection Agency in a foreign country on 25-Oct-2012. HPA REF 564. This case is medically confirmed. A 25-year-old female patient received a second dose of MMR II (manufacturer and batch number not reported), route and site not reported, on 12-Sep-2012. The patient was pregnant at the time of vaccination. Her LMP was 26-Aug-2012 and her EDD was 02-Jun-2013. The patient did not experience any adverse effect following vaccination. The patient received the first dose of MMR II (manufacturer and batch number not reported) on 01-Jan-1990. The patient''s vaccination history stated that she was suspectible to MMR II for vaccination as the patient was a health care professional. The patient was taking concomitant folic acid 400mcg for the pregnancy. The patient had no previous pregnancy. On 08-Oct-2012, 26 days post vaccination, the patient had an ultrasound scan due to slight pain and bleeding which showed intrauterine pregnancy uncertain viability. The ultrasound was to be repeated after 10 days. The patient outcome was not reported. Upon internal review the events were considered to be medically significant.

VAERS ID:474335 (history)  Vaccinated:2012-10-09
Age:25.0  Onset:2012-10-09, Days after vaccination: 0
Gender:Female  Submitted:2012-11-06, Days after onset: 28
Location:Foreign  Entered:2012-11-06
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': B0840646A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPATYP: HEP A + TYP (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Erythema, Headache, Nasal congestion, Pain
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a consumer via the foreign regulatory authority and described the occurrence of headache in a 25-year-old female subject who was vaccinated with Hepatitis A + Typhoid Vaccine (GlaxoSmithKline), dtpa-ipv (non-gsk). On 9 October 2012, the subject received an unspecified dose of Hepatitis A + Typhoid Vaccine (unknown), and an unspecified dose of DTPa-IPV (Non-GSK). On the same day later, on 9 October 2012, at an unspecified time after vaccination with DTPa-IPV (Non-GSK) and Hepatitis A + Typhoid Vaccine, the subject experienced ache, congestion nasal, and headache. On 10 October 2012, the subject experienced redness. On the same day, the event of headache resolved. On 11 October 2012, nasal congestion resolved. On 12 October 2012, the patient experienced bruising of arm. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events of ache, redness and bruising of arm, had improved. Agency Verbatim Text: Experienced ache, bruising of arm, congestion nasal, headache and redness.

VAERS ID:474548 (history)  Vaccinated:2012-10-17
Age:25.0  Onset:2012-10-22, Days after vaccination: 5
Gender:Female  Submitted:2012-11-15, Days after onset: 24
Location:Foreign  Entered:2012-11-15
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: UNK
CDC 'Split Type': B0844259A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Hypoaesthesia, Laryngeal oedema, Pharyngeal oedema, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of allergic reaction in a 25-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). On 17 October 2012, the subject received an unspecified dose of TWINRIX ADULT (administration site and route unknown). On 22 October 2012, 5 days after vaccination with TWINRIX ADULT, the subject experienced allergic reaction with laryngeal edema, and throat edema. This case was assessed as medically serious by GSK. The subject was treated with CORTICOID and XYZALL. On 29 October 2012, 12 days after vaccination with TWINRIX ADULT, the subject experienced chest congestion nos and numbness of the left breast area. At the time of reporting, the events were resolved. The physician considered the events were possibly related to vaccination with TWINRIX ADULT.

VAERS ID:475417 (history)  Vaccinated:2012-09-10
Age:25.0  Onset:2012-10-18, Days after vaccination: 38
Gender:Female  Submitted:2012-11-27, Days after onset: 40
Location:Foreign  Entered:2012-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211DNK010451
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Aborted pregnancy, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Case received from a physician via the Health Authorities on 20-Nov-2012 under the reference number DK-DKMA-ADR 21920538 and DK-DKMA-EFO3662. Case medically confirmed and assessed as serious. A 25-year-old female patient (height and weight not reported) with no relevant medical history reported, had received the first injection of GARDASIL (batch number H003811) via intramuscular route and not reported site of administration on 10-Sep-2012 during unacknowledged pregnancy. On 18-Oct-2012, during week 6 of pregnancy, the patient experienced "aborted pregnancy". No concomitant medication was reported. No other vaccines or medications were administered. At the time of reporting, the patient had not recovered from aborted pregnancy. A causality assessment was not provided. No further information expected.

VAERS ID:477681 (history)  Vaccinated:2012-08-13
Age:25.0  Onset:2012-11-02, Days after vaccination: 81
Gender:Female  Submitted:2012-12-11, Days after onset: 39
Location:Foreign  Entered:2012-12-11
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: Delivery of baby
Diagnostic Lab Data: Sonogram, 02Nov2012, fine; Sonogram, 04Nov2012, fine; Transvaginal ultrasound scan, 05Nov2012, see text; Vaginal sonogram on 05 November 2012 revealed a missed miscarriage.
CDC 'Split Type': A1004435A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion missed, Haemorrhage, Maternal exposure before pregnancy, Surgery, Ultrasound scan normal, Ultrasound scan vagina abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This female subject was enrolled in a study. On 15 February 2012, 16 April 2012 and 13 August 2012, the subject received the 1st, 2nd and 3rd dose of CERVARIX after negative urine pregnancy tests. On 15 February 2012, 16 April 2012 and 13 August 2012, the subject received the 1st, 2nd and 3rd dose of ENGERIX B after negative urine pregnancy tests. The subject''s past medical history included two previous pregnancies resulting in two deliveries of a baby (see case B0433827A for more details on one delivery during the study). She did not use any birth control method before becoming pregnant. Her last menstrual period (LMP) occurred on 02 September 2012. The subject was exposed to vaccine before conception. She attended prenatal care. Concomitant medications during pregnancy included iron and folic acid. On 02 November 2012, 81 days after the 3rd dose of CERVARIX and the 3rd dose of ENGERIX B, this 25-year-old subject experienced missed miscarriage. The subject was hospitalised and the event was clinically significant (or requiring intervention). The subject was treated with contraception. The event resolved on 14 November 2012. The investigator reported the missed miscarriage as possibly related to CERVARIX and ENGERIX B due to the time elapsed between the LMP and the last vaccination. Investigator comments: On 05 December 2012, the subject reported by phone that approximately on 02 November 2012 she started with brown bleeding for which she consulted to the emergency room of the local hospital. She refers that she had a sonogram performed, she indicated that all was fine and she was admitted this same day. On 04 November 2012 she had a pelvic exam performed and she had scant bleeding, she had a sonogram performed and continued fine. On 05 November 2012 she had a vaginal sonogram performed and she was diagnosed with a missed miscarriage. She was taken to the operating room on 06 November 2012. She denies complications during or after the surgery. She was discharged on 07 November 2012 with contraceptive treatment and without followup appointment. She felt fully recovered on 14 November 2012. The medical chart will be reviewed as soon as possible. Diagnosis: Missed miscarriage.

VAERS ID:479074 (history)  Vaccinated:2012-11-29
Age:25.0  Onset:2012-11-29, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 22
Location:Foreign  Entered:2012-12-21
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:
CDC 'Split Type': PHHY2012DE118064
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11058 IMLA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERATYPB098BA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Flank pain, Laboratory test normal, Ultrasound abdomen normal
SMQs:, Retroperitoneal fibrosis (broad)
Write-up: Case number PHHY2012DE118064 is an initial spontaneous report received from the foreign Health Authority (reference number: DE-PEI-PEI2012064753) on 20 Dec 2012. This report refers to a 25-year-old female patient. Past medical history and concomitant medication were not provided. On 29 Nov 2012, the patient was vaccinated with MENVEO (batch number: A11058) intramuscularly into the left upper arm and with TYPHERIX (batch number: ATYPB098BA, other manufacturer) intramuscularly into the right upper arm. On 29 Nov 2012, the patient presented with flank pain and back pain lasting for one day. The patient was hospitalized due to these events. Lab test and ultrasound abdomen were performed without pathological result. The final outcome was reported as completely recovered. The causality was not reported. No other information was available.

VAERS ID:483928 (history)  Vaccinated:2012-05-09
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-07
Location:Foreign  Entered:2013-02-08, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201301842
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER1171153 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the foreign Ministry of Health. An adult female patient (age reported as "25 years 7 months and 21 days old"), whose medical history and concomitant therapies were not reported, had received a dose of Influenza vaccine (manufacturer unknown) during a campaign, lot number "1171153", (route and anatomical site of administration not reported) on 09 May 2012. On an unspecified date post-vaccination the patient experienced myalgia. The patient''s outcome was recovered with no sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. Documents held by sender: None.

VAERS ID:486379 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2013-03-06
Location:Foreign  Entered:2013-03-07, 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:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Malaria test was negative. Result of Human immunodeficiency virus (HIV) test was not available. No other etiologies were evaluated. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) negative (no detectable anti-YFV antibodies or genome). Results of IgM and IgG level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF and urine were not available and were negative in serum, blood or plasma (no detectable anti-YFV antibodies or genome). Results of reciprocal neutralization titer
CDC 'Split Type': 201303445
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood immunoglobulin E increased, Blood immunoglobulin G, Blood immunoglobulin M, CSF test, Dizziness, HIV test, Hypersensitivity, Malaria antibody test negative, Muscular weakness, Polymerase chain reaction, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "Background serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. Method: From 2007 to 2010, eight countries implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. Results: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. Conclusions: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventative mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventative YF vaccination campaigns. All countries were included in the analysis except one due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described the 25-year-old male patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Two days post-vaccination, the patient had his first clinical evaluation. The diagnosis hypersensitivity and severe allergic reaction. Brighton anaphylaxis case definition was not fulfilled. Malaria test was negative. Result of Human immunodeficiency virus (HIV) test was not available. No other etiologies were evaluated. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) negative (no detectable anti-YFV antibodies or genome). Results of IgM and IgG level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF and urine were not available and were negative in serum, blood or plasma (no detectable anti-YFV antibodies or genome). Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was $g500IE/ml. The time between vaccination and sample collection for the analyses conducted at the Institute was 3 days. The patient recovered on an unspecified date. Upon internal review, the case was considered as serious due to other important medical condition.

VAERS ID:486437 (history)  Vaccinated:0000-00-00
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-05
Location:Foreign  Entered:2013-03-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Human immunodeficiency virus (HIV) test was negative. Results of malaria test were not available. No further tests to evaluate other etiologies were done. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) positive (positive detection of anti-YFV antibodies or genome) and IgG (1:100) strongly positive (strongly positive detection of anti-YFV antibodies ($g1:500)). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available. Recip
CDC 'Split Type': 201303429
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood immunoglobulin E, Blood immunoglobulin G, Blood immunoglobulin M, CSF test, HIV test negative, Malaria antibody test, Polymerase chain reaction, VIIth nerve paralysis, Yellow fever vaccine-associated neurotropic disease
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, FY vaccine-associated neurologic disease (YEL-AND) and YF-vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFI''s that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated FY vaccine during preventive mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventive YF vaccination campaigns. All countries were included in the analysis due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 25-year-old female patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Less than 1 day post-vaccination, the patient developed facial paralysis as primary symptoms. Eight days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated neurotropic disease (YEL-AND) with neurologic reaction; Brighton case definition was not applicable. Human immunodeficiency virus (HIV) test was negative. Results of malaria test were not available. No further tests to evaluate other etiologies were done. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) positive (positive detection of anti-YFV antibodies or genome) and IgG (1:100) strongly positive (strongly positive detection of anti-YFV antibodies ($g1:500)). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available. Reciprocal neutralization titer (1:x) was measured at 22. Results of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Inst

VAERS ID:487114 (history)  Vaccinated:2013-02-22
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-15
Location:Foreign  Entered:2013-03-15
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amitriptyline
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0872843A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHBVC164BD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Rash, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (Foreign-Medicines and Healthcare products Regulatory Agency # GB-MHRA-EYC 00097904) and described the occurrence of rash in a 25-year-old