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Case Details (Sorted by Vaccination Date)

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VAERS ID:301260 (history)  Vaccinated:2007-12-28
Age:14.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Male  Submitted:2007-12-31, Days after onset: 3
Location:Florida  Entered:2007-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Mild Upper Respiratory Symptoms
Preexisting Conditions: Allergy to Sulfa PMH: recent URI symptoms.
Diagnostic Lab Data: CT Brain unremarkable LABS: repeat CT scan of head revealed small right inferior frontal contusion w/small amt parenchymal hemorrhage but no significant mass effect; no skull fx; right parieto-occipital, subgaleal hematoma.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2385BA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Brain contusion, Cerebral haematoma, Computerised tomogram abnormal, Computerised tomogram normal, Concussion, Contusion, Convulsion, Dyskinesia, Fall, Headache, Lethargy, Loss of consciousness, Nausea, Post-traumatic epilepsy, Posturing, Scan brain, Syncope, Syncope vasovagal, Traumatic brain injury, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Syncope/Collapse; Observed posturing; transfer to Port Orange Emergency Room for evaluation seizure activity and rule out vasovagal response to vaccine. 1/18/08 Reviewed hospital medical records which reveal patient experienced syncopal episode while at pcp office after vaccine. Struck head when fell & had LOC, jerking of arms. Exam in ER on 12/28/07 revealed HA, nausea & occipital contusion. Improved w/meds & d/c to home. FINAL ER DX: vasovagal syncopal episode; concussion; fall. Patient had several episodes of vomiting, HA & lethargy. Returned & admitted for observation 12/29/2007-1/1/2008. Neuro consult done. FINAL DX: post-concussive syndrome s/p syncopal episode; CHI w/fontal contusion; possible post traumatic seizure; subgaleal hematoma.

VAERS ID:301412 (history)  Vaccinated:2007-12-28
Age:61.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Male  Submitted:2008-01-02, Days after onset: 5
Location:Tennessee  Entered:2008-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor 10 mg daily, ASA 81mg every other day, Niacin 150mg BID, Ambien CR 10mg hs prn
Current Illness: none
Preexisting Conditions: NKDA, BPH (no medical tx at this time)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1175F0SCRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ09220IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Soreness/pain in right arm at site of Pneumovax 23 injection shortly after administration. Pt had erythema and induration at site that night that progressed to shoulder and mid forearm within the next 3-4 days, chills and felt feverish x 3-4 days. Pt took ibuprofen q 4-6 hrs and used warm compresses. Pt called ID fellow on 12/31 to report adverse reaction. Pt states he is improving but has not totally recovered as of report today.

VAERS ID:301639 (history)  Vaccinated:2007-12-28
Age:50.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New Hampshire  Entered:2008-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Musculoskeletal pain, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling, pain (L) shoulder.

VAERS ID:301641 (history)  Vaccinated:2007-12-28
Age:15.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2007-12-28, Days after onset: 0
Location:New York  Entered:2008-01-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Asthma, chronic IM-$g PE tubes
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hyperhidrosis, Injection site pain, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pt received Gardasil injection-then-<1 minute collapsed onto floor. Patient did c/o pain during and after injection. Pt''s legs were raised and she was observed for 20 min and given juice. Small amt of diaphoresis to forehead noted after collapse

VAERS ID:301955 (history)  Vaccinated:2007-12-28
Age:15.0  Onset:2007-12-29, Days after vaccination: 1
Gender:Female  Submitted:2008-01-08, Days after onset: 10
Location:Colorado  Entered:2008-01-08
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U1IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Gait disturbance, Musculoskeletal stiffness, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Patient & parent state when she woke on 12/29/07 arms & legs felt "stiff" & "hurt". Difficulty walking lasted through the day. Resolved spontaneously by evening. Not seen by physician.

VAERS ID:302667 (history)  Vaccinated:2007-12-28
Age:1.3  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2008-01-11, Days after onset: 14
Location:Massachusetts  Entered:2008-01-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MVZ Fl
Current Illness: Ear infection 2 weeks prior
Preexisting Conditions: None
Diagnostic Lab Data: Blood work, BC, urine culture, CXR all week.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2291B23IM 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB141AA0IM 
HIBV: HIB (ACTHIB)SANOFI PASTEURUF291AC3IM 
Administered by: Private     Purchased by: Public
Symptoms: Blood test, Chest X-ray, Culture urine, Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Febrile seizure - fever 103

VAERS ID:303062 (history)  Vaccinated:2007-12-28
Age:61.0  Onset:2008-01-02, Days after vaccination: 5
Gender:Female  Submitted:2008-01-21, Days after onset: 19
Location:California  Entered:2008-01-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HTN, Hyperlipidemia
Diagnostic Lab Data: Zoster culture positive 1/07/2008
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Herpes simplex serology positive, Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine administered 12/28/2007. Seen in Urgent Care clinic 1/05/2008 with facial rash, viral culture obtained verifying Herpes Zoster infection.

VAERS ID:303294 (history)  Vaccinated:2007-12-28
Age:0.3  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2008-01-22, Days after onset: 25
Location:Maryland  Entered:2008-01-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: barium enema X-ray 01/03/08 intussusception resolved; physical examination 01/14/07 normal. Labs and Diagnsotics: UC (-). LP with CSF with (+) RBCs. CSF protein 47. otherwise WNL. CBC with Hct 30.8, Hgb 10.4, WBCs 13.1. Labs and Diagnos
CDC Split Type: WAES0801USA03165
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURCZ607AA1 LL
HIBV: HIB (ACTHIB)SANOFI PASTEURME852AA1 RL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0170-21 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH808666D1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0971U1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Barium enema, CSF protein normal, Culture urine negative, Enema administration, Full blood count, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lethargy, Listless, Lumbar puncture normal, Oral intake reduced, Physical examination normal, Red blood cells CSF positive, Screaming, Ultrasound abdomen abnormal, Vomiting, White blood cell count
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 17 week old female with no pertinent medical history or drug allergies who on 02-NOV-2007 and 28-DEC-2007 was vaccinated PO with her first and second doses of RotaTeq (lot# 657459/0509U, 656387/0971U). There was no concomitant medication. On 28-DEC-2007 the patient experienced intussusception and was hospitalized on 03-JAN-2008. The intussusception was resolved with a barium enema. The patient did not require surgical interventions. On approximately 06-JAN-2008 2-3 days after hospitalization, the patient was discharged home and was noted to be recovered. On 14-JAN-2008 the patient was seen for a follow-up visit with the physician and her exam was normal. On that same day after the exam, therapy with RotaTeq was discontinued by the physician. There was no product quality complaint. Additional information has been requested. 01/25/2008 Vax record received and data entered. 01/29/2008 MR received for ER visit 1/3/08. Infant to ER with screaming, vomiting, and listlessness. No po intake that day. Impression: Viral syndrome. Vomiting. Child transfered to another facility for further care. 03/27/2008 MR received for DOS 01/4-6/2008 with D/C DX: Intussusception. Infant presented to local hospital with lethargy, decreased po intake and vomiting. Pt later had a bloody stool. IS noted on Abd US. Air contrast enema successful in reducing IS. Pt began taking PO well and became more alert and was d/c home.

VAERS ID:304622 (history)  Vaccinated:2007-12-28
Age:27.0  Onset:2007-12-29, Days after vaccination: 1
Gender:Female  Submitted:2008-02-11, Days after onset: 44
Location:Unknown  Entered:2008-02-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NKDA/NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1731SCLA
Administered by: Military     Purchased by: Military
Symptoms: Neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: LEFT DISTAL ULNAR NEUROPATHY.

VAERS ID:305178 (history)  Vaccinated:2007-12-28
Age:39.0  Onset:2008-01-01, Days after vaccination: 4
Gender:Female  Submitted:2008-02-19, Days after onset: 49
Location:Virgin Islands  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy: NSAIDS
Diagnostic Lab Data: Normal x-ray to wrist.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526U SCRA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, X-ray
SMQs:, Arthritis (broad)
Write-up: Joint pain right wrist.

VAERS ID:305281 (history)  Vaccinated:2007-12-28
Age:21.0  Onset:2007-12-28, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 48
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; ADVAIR
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00100
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received concerning a 21 year old female who on 04-JUN-2004 was vaccinated with her first dose of Gardasil (lot 657617/0384U) and her second dose of Gardasil (lot 658222/0927U) on 23-AUG-2007 without any ill effects. Concomitant therapy included ADVAIR and albuterol. On 28-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot 659437/1266U) and experienced a full body rash. She was sent to her primary health care provider. Additional information has been requested.

VAERS ID:305694 (history)  Vaccinated:2007-12-28
Age:0.3  Onset:2008-01-11, Days after vaccination: 14
Gender:Female  Submitted:2008-02-20, Days after onset: 40
Location:Illinois  Entered:2008-02-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Rapid Strep neg; 1/11/08, CBC- RBC 17.3, HgB 11.9, HCT 39, platelets 272; 1/11/08, blood, urine, CSF neg; 1/17/08, CBC-RBC 17.7, HgB 10, HCT 30, platelets 445; ESR 67; CRP 6; echo, 1/18/08, diffuse dilation R CA, L CA, L AD CA between 2.5-4 mm, no aneurysms 4/11/08-records received-Cardiac echo negative, however echo on 1/18/08-abnormal with diffuse dilation of right coronary artery, left main and left anterior descending coronary arteries. WBC 17,000, 56 segs. platelets 272,000. Normal liver functions. Potassium high at 5.3. Triglycerides high at 204. Neutrophil % 39.7.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA1IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0222U1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01691IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH653981A1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0903U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Blood culture negative, Blood potassium increased, Blood triglycerides increased, Body temperature increased, C-reactive protein increased, CSF culture negative, Coronary artery dilatation, Culture urine negative, Echocardiogram abnormal, Erythema, Full blood count, Haematocrit decreased, Haemoglobin normal, Irritability, Kawasaki's disease, Liver function test normal, Neutrophil percentage increased, Platelet count normal, Pyrexia, Rash, Red blood cell sedimentation rate increased, Scleral hyperaemia, Streptococcus identification test negative, Tongue disorder, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Vasculitis (narrow), Lipodystrophy (broad), Scleral disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: 4 1/2 m/o female dx with Kawasaki Disease. Symptoms began 1/4/08 - fever x5d, rash, scleral injection change in mucous membrane. Labs consistent with Kawasaki disease. Increased ESR-67, increased plat 445, negative blood, urine, CSF cultures, rapid Strep, echo with diffuse dilation of coronary arteries. Hospitalized 1/11-1/15 then another hospital 1/18-1/19. Received IVIG, aspirin. Cardiology consult. 4/11/08-records received -admitting DX Incomplete Kawasaki. Presented to PCP 7 days prior to admission with C/O red rash on extremities, torso and temperature of 103. Admitted for 5 days. LP, blood and urine culture negative. Injected sclerae. Beefy red tongue and lips. Irritable. Seen in follow-up 1/18/08- irritable. Exam normal except for fissuring of lips and puffiness of feet. No fever.

VAERS ID:323117 (history)  Vaccinated:2007-12-28
Age:65.0  Onset:2008-03-15, Days after vaccination: 78
Gender:Female  Submitted:2008-07-23, Days after onset: 130
Location:Florida  Entered:2008-08-22, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol 50mgm/daily; Diovan HCT 12.5 mgm/daily
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: May 8 - B12 lab done: Result very low 250; Treatment B-12 injections
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Acne, Neuralgia, Nuclear magnetic resonance imaging, Vitamin B12 deficiency
SMQs:, Peripheral neuropathy (narrow)
Write-up: 5/8 Sought neurologists treatment for persistent "nerve pain" rotating from back of head across right mastoid region extending to top of head. MRI done to check on known Cervical Rupt. Discs. (No change) (Never relayed information to Dr. of "pimples" on scalp in lower hair line at back of head). Pain has diminished but not disappeared.

VAERS ID:339941 (history)  Vaccinated:2007-12-28
Age:19.0  Onset:2008-01-02, Days after vaccination: 5
Gender:Female  Submitted:2009-01-22, Days after onset: 386
Location:Pennsylvania  Entered:2009-02-18, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: At time- None
Current Illness: None- Healthy
Preexisting Conditions: None PMH: Family hx: juvenile idiopathic polyarthritis.
Diagnostic Lab Data: 2/18/08 Anachoice screen; Ferritin; Rheumatoid Factor; Creactive protein; CBC; PIT; Differential; Chest x-ray. LABS: WBC 13.9(H). Herpes simplex virus (-). MRI of right knee done 12/2006 abnormal. Noted to have CRP increase & R
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.14482IMUN
Administered by: Private     Purchased by: Other
Symptoms: Abasia, Antinuclear antibody, Arthralgia, Arthritis, Aspiration joint, C-reactive protein increased, Chest X-ray, Differential white blood cell count, Full blood count, Genital herpes, Herpes simplex serology negative, Impetigo, Joint effusion, Joint swelling, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Oral herpes, Polyarthritis, Rheumatoid arthritis, Rheumatoid factor increased, Serum ferritin, Synovitis, Tendon pain, Tendonitis, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed Rheumatoid Arthritis-- Pain began within 5 days of last dose of GARDASIL vaccination. Severe joint pain--unable to walk. 2/26/09 Received PCP vaccine records & medical records of 1/2-8/29/2008. FINAL DX: Rheumatoid arthritis Records reveal patient had known right knee, left hip & low back pain. By 2/08 had diffuse joint swelling while at college & seen in student health where CRP & RA factor both (+). Referred to Rheum. Tx w/steroids, plaquenil, methotrexate & humira. Right knee synovial fluid drained 6/08. RTC 7/08 w/right heel pain x 1 mo. Dx w/right Achilles tendonitis. Referred to ortho but did not go. RTC 8/08 w/probably genital herpes & oral cold sores. Tx w/antivirals. Symptoms did not resolve, seen in student health & dx w/impetigo. 3/4/09 Received Rheum medical records of 2/08-12/08. FINAL DX: intensely inflammatory additive symmetrical polyarthritis w/flagrant synovitis while on steroids Records reveal patient experienced joint pain, swelling & stiffness beginning 12/07. Exam revealed multiple sites of synovitis, right knee warmth & effusion. Tx w/additional meds of hydroxychloroquine & methotrexate. Humira added later as s/s persisted.

VAERS ID:301895 (history)  Vaccinated:2007-12-29
Age:46.0  Onset:2007-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-01-02, Days after onset: 4
Location:Ohio  Entered:2008-01-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA319BA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Pruritus
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient became lightheaded and remained in chair for 20-30 minutes. She requested water. She kept her head lowered to help with lightheadedness. She reported itching especially on her head. We gave 50 mg PO Benadryl and symptoms improved in 30-40 min. Her husband took her home. We made a follow up call to patient early afternoon next day and she said she was fine.

VAERS ID:301899 (history)  Vaccinated:2007-12-29
Age:57.0  Onset:2007-12-30, Days after vaccination: 1
Gender:Male  Submitted:2008-01-02, Days after onset: 3
Location:Michigan  Entered:2008-01-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA319BA0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Eye pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed itchy eyes and neck rash 24 to 48 hours after receiving the vaccine. Patient instructed to take OTC Benadryl.

VAERS ID:301974 (history)  Vaccinated:2007-12-29
Age:0.5  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2008-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH85398182IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0024U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Local reaction, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vomiting and local injection site induration.

VAERS ID:307086 (history)  Vaccinated:2007-12-29
Age:0.2  Onset:2007-12-29, Days after vaccination: 0
Gender:Male  Submitted:2008-03-14, Days after onset: 75
Location:California  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Caffeine; Phenobarbital; NaCl; FESO4
Current Illness: 24 wk preemie
Preexisting Conditions: S/P PDA, Ligation. prematurity, Lung disease, Sz disorder with IVH - now resolved-full feeds PMH: 23 wk preemie, birth wt 466 grams, d/c weight 700 grams. Mom w/premature lable, vaginal bleeding & PROM. C-section. PMH: adrenal insuficiency, airway obstruction, apnea of prematurity, GERD, hyperbilirubinemia, IVH, osteopenis, PDA, poor feeder, TPN, pulmonary insufficienty & int
Diagnostic Lab Data: CRP 2.6 - 4+; WBC with 3 b 20 S LD LABS: CRP on 12/31/07 2.6. CRP 0.94 on 1/2/08. CRP on 1/4/08 0.23.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1243F0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351740UNRL
Administered by: Private     Purchased by: Unknown
Symptoms: Apnoea, Basophil count increased, Blood culture negative, C-reactive protein increased, Caffeine consumption, Continuous positive airway pressure, Culture urine negative, Lymphocyte percentage decreased, Reflux oesophagitis, Sepsis neonatal, Transfusion, White blood cell count
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific dysfunction (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Increasing apneas requiring septic work-up/antibiotics. Symptom started about25 hours after DTaP/IPV. Blood//urine cultures negative. 4/4/08 Reviewed hospital medical records of 11/8-12/04/2007. Patient transferred to outlying birth hospital on 12/4/07 w/interim d/c summary dated 3/14/08. FINAL DX: cardiac arrest 11/8; extreme prematurity; RDS; chronic lung disease; PDA; pulmonary interstitial emphysema; seizures; IVH; ROP; anemia; thrombocytopenia, adrenal insufficiency; hypotension,hyperbilirubinemia, electrolyte instability, coagulopathy, metabolic acidosis, all resolved; coag-neg staph bacteremia, resolving. Records reveal patient had been transferred from outlying birth hospital at 10 days of age for PDA ligation on 11/9. Patient experienced multiple problems associated w/extreme prematurity. Transfused w/multiple blood products. Stabilized & returned to birth hospital on 12/4/2007. Records from birth hospital that accompanied VAERS report reveal patient experienced hyponatremia at time of vaccination on 12/28 & 12/29. Dx w/newborn sepsis on 12/30. 4/18/08 Reviewed hospital medical records for 12/4/07-03/19/2008. FINAL DX: 23 wk preemie, anemia of prematurity, ROP, SGA, at risk RSV. 4/29/08 Reviewed hospital records for 12/28/2007-1/5/2008 including vax record for 12/28 & 12/29/2007. Records reveal patient continued on CPAP & caffiene for apnea since 11/22, last apnea noted 12/27, mostly self resolved. Was on Pb for seizures, last seizure noted 11/26. Had increased apneas overnight 12/29-30. Caffiene & high flow nasal cannula increased. Started IV antibiotics on 12/31 for increased CRP of 2.6 & presumed sepsis. Transfused 12/31. CRP 0.94 on 1/2/08. 6 apnea spells 1/3-1/4/2008 w/probable reflux. CRP 1/4 0.23.

VAERS ID:340969 (history)  Vaccinated:2007-12-29
Age:26.0  Onset:2008-01-24, Days after vaccination: 26
Gender:Female  Submitted:2009-03-02, Days after onset: 403
Location:Oregon  Entered:2009-03-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA04384
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
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, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first and second 0.5mL doses of GARDASIL on 29-JUN-2007 and 29-SEP-2007. The physician reported that they believed the patient was pregnant on 10-DEC-2007. On 29-DEC-2007, the patient was vaccinated with the dose of GARDASIL. On 24-JAN-2008 the patient experienced miscarriage. Lab test performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review miscarriage has been considered an other important medical event. Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage (WAES #0902USA04455). Additional information has been requested.

VAERS ID:340970 (history)  Vaccinated:2007-12-29
Age:26.0  Onset:2008-06-01, Days after vaccination: 155
Gender:Female  Submitted:2009-03-02, Days after onset: 274
Location:Oregon  Entered:2009-03-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Miscarriage
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA04455
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
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, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female who was vaccinated with first, second and third 0.5mL dose of GARDASIL on 29-JUN-2007, 29-SEP-2007 and 29-DEC-2007. On 24-JAN-2008, the patient had a miscarriage (MSD WAES # 0902USA04384). Subsequently in June 2008 the patient became pregnant again and on August 2008 the patient had another miscarriage. Lab tests performed included unspecified pregnancy test. This is one of two reports concerning the same patient. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:322819 (history)  Vaccinated:2007-12-29
Age:25.0  Onset:2007-12-29, Days after vaccination: 0
Gender:Female  Submitted:2008-08-20, Days after onset: 234
Location:Foreign  Entered:2008-08-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808AUS00131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0582U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotension, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information 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 on 29-DEC-2007 was vaccinated with GARDASIL (Lot No. 657874/0582U, Batch No. J2299, Expiry date 26-FEB-2010). On 29-DEC-2007, 10 to 15 minutes after vaccination, the patient experienced syncope, hypotension, loss of consciousness and pallor. It was described that the patient collapsed and was unconscious. The patient was treated in Accident/Emergency Department and was hospitalised. The patient was given adrenaline, oxygen and IV steroids. The patient was informed by the emergency department physician that the reaction was not anaphylaxis. The patient recovered from syncope, hypotension, loss of consciousness and pallor later that day. The agency considered that syncope, hypotension, loss of consciousness and pallor were possibly related to therapy with GARDASIL. The original reporting source was not provided. Additional information is not expected.

VAERS ID:393914 (history)  Vaccinated:2007-12-29
Age:0.2  Onset:2009-07-23, Days after vaccination: 572
Gender:Male  Submitted:2010-07-29, Days after onset: 371
Location:Foreign  Entered:2010-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test, 27Jul2009, positive
CDC Split Type: B0586519A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA269CA1IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA379A1PO 
Administered by: Other     Purchased by: Other
Symptoms: Gastroenteritis rotavirus, Rotavirus test positive
SMQs:
Write-up: This case was reported by a physician and described the occurrence of rotavirus gastroenteritis breakthrough in 21-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and /or concurrent vaccination included INFANRIX HEXA; GlaxoSmithKline; intramuscular; given on 24 November 2007 and 29 December 2007. On 24 November 2007 and 29 December 2007, the subject received 1st dose and 2nd dose of ROTARIX (oral). On 23 July 2009, 19 months after vaccination with 2nd dose of ROTARIX, the subject experienced rotavirus gastroenteritis breakthrough. The subject was treated with PARACETAMOL. On 25 July 2007, the subject was hospitalised for 3 days. The stool test performed on 27 July 2009 was positive for rotavirus. On 27 July 2007, the subject was discharged from hospital. On 29 July 2009, the events were resolved. After several attempts, no further information has been received. This case has therefore been closed.

VAERS ID:301725 (history)  Vaccinated:2007-12-30
Age:14.0  Onset:2007-12-30, Days after vaccination: 0
Gender:Female  Submitted:2008-01-04, Days after onset: 5
Location:Iowa  Entered:2008-01-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Sulfa
Diagnostic Lab Data: ER VISIT--no labs or x-rays
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHB437AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2548AA0IDRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA5IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immunizations given in our office at 11:30 a.m. Patient left office and was in town shopping when she began to experience itching and rash on neck, face and upper extremities. Symptoms began around 1 p.m. and patient presented to local ER around 1:30 p.m. She was given IM Benadryl 50 mg and IM SoluMedrol 125 mg in the ER.

VAERS ID:301377 (history)  Vaccinated:2007-12-31
Age:35.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-02, Days after onset: 2
Location:Minnesota  Entered:2008-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro, Protonix, Singulair, Nasocort, Azmacort, verapamil, meclizine, Proair, Ceravent.
Current Illness: None
Preexisting Conditions: Codeine, morphine, Septra, Zithromax
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2842AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Chest discomfort, Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: 1:30pm -1:45pm estimated time of injection Patient left clinic with no concerns post injection. Then called clinic at 2:15pm estimated with on set of slight dyspnea and patient advised fast heart rate with chest tightness. 3:00-3:15pm seen in clinic for above complaint. 3:30pm IV started, IV Solu Medrol given. No local reaction noted at site of injection. Patient vitals stable running 110 systolic 70''s diastolic during event. Resp rate 18-20. Pulse 70''s Not obviuos SOB noted in clinic. 4:00pm Patient stable & sent home.

VAERS ID:301411 (history)  Vaccinated:2007-12-31
Age:9.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Male  Submitted:2008-01-02, Days after onset: 1
Location:Washington  Entered:2008-01-02
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: Extreme prematurity. Chart with extensive medical history not in our office.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS809563IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1509U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site mass, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt had lump at injection site that evening. Redness and swelling began on 1/1/2008.

VAERS ID:301453 (history)  Vaccinated:2007-12-31
Age:4.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Male  Submitted:2008-01-02, Days after onset: 2
Location:Kentucky  Entered:2008-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bacterial conjunctivitis
Preexisting Conditions: Latex allergies, asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2431AA4 LL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2508AA1 LL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02733 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412U1 RL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1577U1  
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythematous and edematous area 6 3/4in by 5 3/4in on right thigh. No breaks in skin. Even this has become erythematous, has increased today.

VAERS ID:301628 (history)  Vaccinated:2007-12-31
Age:20.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-03, Days after onset: 3
Location:Michigan  Entered:2008-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Estrostep Fe
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IM 
Administered by: Private     Purchased by: Private
Symptoms: Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncopal episode while getting off exam table after Gardasil injection. Hit forehead (on left side) presumably on floor or wall. Ice pack to forehead. Evaluation at Oakwood Healthcare Center.

VAERS ID:301755 (history)  Vaccinated:2007-12-31
Age:50.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Male  Submitted:2008-01-04, Days after onset: 3
Location:Texas  Entered:2008-01-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COZAAR, DOXYCYCLINE, FLONASE, ASA
Current Illness: N/A
Preexisting Conditions: UNKNOWN
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA312BA2IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAO27321SCRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1132U0SCLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURAO39421IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PT. RETURNED TO CLINIC ON 1-2-08 AND REPORTED REDNESS AT SITE OF PNEUMOCOCCAL INJ. LEFT ARM. SITE HAD AREA OF REDNESS AND EDEMA PRESENT MEASURING 115MM X 115MM. PT. DID NOT REPORT ANY OTHER S/S.

VAERS ID:301771 (history)  Vaccinated:2007-12-31
Age:11.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Male  Submitted:2008-01-02, Days after onset: 1
Location:North Carolina  Entered:2008-01-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2446AA1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225BB0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1331U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized erythema and induration at site of injection of Varivax.

VAERS ID:301772 (history)  Vaccinated:2007-12-31
Age:11.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Male  Submitted:2008-01-02, Days after onset: 1
Location:North Carolina  Entered:2008-01-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2446AA7IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225BB0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1331U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized reaction at site of injection with erythema and induration secondary to Varivax.

VAERS ID:301774 (history)  Vaccinated:2007-12-31
Age:13.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Male  Submitted:2008-01-03, Days after onset: 3
Location:New York  Entered:2008-01-07, 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: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA02091UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Anaphylactic reaction, Diarrhoea, Rash generalised, Tachycardia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt presented with stomach pain and diarrhea 12 hours after vaccine administration and body rash, welts, and tachycardia about 26 hours after vaccine administration. Pt treated & diagnosed by Dr. at ambulatory care center. Dx was anaphylaxis from vaccine & Dr. advised hospitalization, family declined.

VAERS ID:301960 (history)  Vaccinated:2007-12-31
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-01
Location:New York  Entered:2008-01-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0869U2SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1580U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Accidental overdose, Asthenia, Hypokinesia, Immediate post-injection reaction, Inappropriate schedule of drug administration, Medication error, Pain
SMQs:, Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Medication errors (narrow)
Write-up: Immediate pain followed later by decreased strength and movement of arm. A third dose of MMR had been mistakenly administered.

VAERS ID:301970 (history)  Vaccinated:2007-12-31
Age:18.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Female  Submitted:2008-01-04, Days after onset: 3
Location:California  Entered:2008-01-08, 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: None, BCP''s
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Nausea, headache, dizziness - next day after vaccine administration.

VAERS ID:301973 (history)  Vaccinated:2007-12-31
Age:6.0  Onset:2008-01-02, Days after vaccination: 2
Gender:Male  Submitted:2008-01-03, Days after onset: 1
Location:Alabama  Entered:2008-01-08, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2487AA IMLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0494U IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1101U  LA
Administered by: Public     Purchased by: Other
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Light rash similar to varicella noted after VCV vaccine given.

VAERS ID:302117 (history)  Vaccinated:2007-12-31
Age:0.9  Onset:2008-01-03, Days after vaccination: 3
Gender:Female  Submitted:2008-01-09, Days after onset: 6
Location:Texas  Entered:2008-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Resolving otitis media and URI
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2797AA2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUE990AA2IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02982SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHBO8702142IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Bowel movement irregularity, Decreased appetite, Erythema multiforme, Joint swelling, Otitis media, Rash erythematous, Skin discolouration, Skin lesion
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient was diagnosed with otitis media on 12/27/07 and treated with amoxicillin after 2 days of temperature to 100 F, decreased appetite and slight increase in the number of bowel movements. She returned 4 days later for a regularly scheduled checkup for delayed immunizations and had been without fever since the prior visit and ears were improving. On 12/31/07, she received DTaP3, Hib3, IPV3, PCV3. In the evening on 1/3/08, she began developing a red, raised rash and possible swollen knee (L). She also reported eating shrimp near (but probably after) the rash appeared. The rash was seen by me on 1/4 and was red, raised, with target lesions and some with purple centers. There were no mouth lesions. CBC was unremarkable, ESR was elevated. The rash became worse and she was seen in the ER at Hospital on 1/4 and 1/5 as the swelling of the lower extremities and rash spread. It was felt to be erythema multiforme. Amoxicillin was stopped on 1/3/08 and patient''s rash resolved spontaneously by 1/7/08.

VAERS ID:302327 (history)  Vaccinated:2007-12-31
Age:45.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-03, Days after onset: 3
Location:Washington  Entered:2008-01-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: loratadine, Protonix, Singulair, Qvar, Sudafed, metoclopramide
Current Illness:
Preexisting Conditions: Allergies to Codeine, Ceftin. Dx: GERD, asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2509AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: L deltoid swelling, redness, pain. Onset 12/31/07. Tx: ice, muscle relaxer.

VAERS ID:302501 (history)  Vaccinated:2007-12-31
Age:6.0  Onset:2008-01-02, Days after vaccination: 2
Gender:Male  Submitted:2008-01-04, Days after onset: 2
Location:Tennessee  Entered:2008-01-11, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1663U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Rash papular
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fine red papular rash beginning at (R) elbow and generalizing to cover trunk and extremities.

VAERS ID:302631 (history)  Vaccinated:2007-12-31
Age:19.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-09, Days after onset: 9
Location:Nebraska  Entered:2008-01-14, 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: None
Current Illness: "Viral type" gastroenteritis. stomach upset in AM.
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient fainted in waiting room while checking out after receiving first guardasil vaccination. Treated with observation and remaining supine with monitoring of vital signs - was alert/oriented and vital signs stable - observed about 45 min to one hour as she was dizzy also up until about 45 minutes after the event. Mildly hypotensive.

VAERS ID:302642 (history)  Vaccinated:2007-12-31
Age:1.1  Onset:0000-00-00
Gender:Female  Submitted:2008-01-08
Location:Ohio  Entered:2008-01-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0282U0 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70145K3IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1328U0 RL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, red bump on thigh

VAERS ID:302647 (history)  Vaccinated:2007-12-31
Age:23.0  Onset:2008-01-03, Days after vaccination: 3
Gender:Male  Submitted:2008-01-09, Days after onset: 6
Location:Wisconsin  Entered:2008-01-14, 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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURLC2842AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on neck and upper back, started 1-3-08 after Tdap vaccination. Flat macules on upper chest/back. Rash not pruritic, no histaminic flushing of cheeks. Rash does not appear to be urticarial.

VAERS ID:302650 (history)  Vaccinated:2007-12-31
Age:63.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Missouri  Entered:2008-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: My right arm was sore I could Raised up to put my clothing on. I had put hot towels on it for three days, and take pain pills

VAERS ID:302654 (history)  Vaccinated:2007-12-31
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-04
Location:Wisconsin  Entered:2008-01-14, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU1856AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Tetanus injection site red, swollen, warm to touch, Donor went to her Doctor - Antibiotic prescribed

VAERS ID:302690 (history)  Vaccinated:2007-12-31
Age:72.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Female  Submitted:2008-01-15, Days after onset: 14
Location:South Carolina  Entered:2008-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allegra, Norvasc, Premarin, Crestor
Current Illness: None
Preexisting Conditions: Pt. states she has many allergies. Vaccine components were reviewed and pt denied allergies to any.
Diagnostic Lab Data: Several labs drawn per patient. Pt does not know which labs were drawn.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1414U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dry mouth, Dyskinesia, Laboratory test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Received vaccine at 1 PM. At 2:30 AM pt awakened with dry mouth, shaking, and "jerking". Was advised to go to ER wherein the physician drew lab work and stated her symptoms were related to her receiving the vaccine. Symptoms resolved spontaneously.

VAERS ID:302709 (history)  Vaccinated:2007-12-31
Age:15.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-14, Days after onset: 14
Location:Unknown  Entered:2008-01-15, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Liver transplant
Preexisting Conditions:
Diagnostic Lab Data: computed axial - head and neck - no results reported; X-ray - no results reported
CDC Split Type: WAES0801USA00501
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Head injury, Loss of consciousness, Syncope, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a mother concerning her 15 year old daughter who has had a liver transplant. There were multiple concomitant medications but none were specified. On 31-DEC-2007 the patient was vaccinated with her first dose of Gardasil. The mother reported that her daughter fainted within 10 minutes after receiving the vaccination. She passed out for about 1 minute after hitting her head. She was seen in the emergency room and required 7 staples in her head to close the wound she received. A CT of the head and neck was performed, as well as X-rays. No results were reported. Her head injury was considered to be immediately life-threatening and disabling. Additional information has been requested.

VAERS ID:302967 (history)  Vaccinated:2007-12-31
Age:9.0  Onset:2008-01-02, Days after vaccination: 2
Gender:Male  Submitted:2008-01-03, Days after onset: 1
Location:New Jersey  Entered:2008-01-17, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: yearly visit
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500489P IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1567U SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Reddened area raised measuring 8 cm by 5 cm on upper left arm

VAERS ID:303055 (history)  Vaccinated:2007-12-31
Age:17.0  Onset:2008-01-02, Days after vaccination: 2
Gender:Female  Submitted:2008-01-20, Days after onset: 18
Location:New York  Entered:2008-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Saw doctor. Symptoms were starting to improve at that point (a few days later).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Dysphagia, Mastication disorder, Musculoskeletal discomfort, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Over the course of several days, symptoms worsened. Started with tingling in extremities, then uncomfortable feeling in abdomen (like a balloon was pushing up), then difficulty chewing, swallowing, inability to eat, felt like "a grapefruit" was in her neck, wrapping around it from the back. All sensations were like nothing she had felt before.

VAERS ID:303209 (history)  Vaccinated:2007-12-31
Age:36.0  Onset:2008-01-10, Days after vaccination: 10
Gender:Female  Submitted:2008-01-22, Days after onset: 12
Location:Ohio  Entered:2008-01-22
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1309U IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Muscular weakness, Oral herpes, Pain in extremity, Trismus
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (narrow), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Approx 10 days after injection of MMR noticed an ache in base of R metacarpal joint. That week the ache and weakness spread through R hand and by 1/15 was in both hands/wrists. Also developed cold sores (first in a long time) at lower lip edge. Still c/o pain and weakness in both hands, unable to open a jar. No treatment.

VAERS ID:304104 (history)  Vaccinated:2007-12-31
Age:3.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Female  Submitted:2008-01-24, Days after onset: 23
Location:California  Entered:2008-02-01, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: U/A negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2525AA2UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB17VA1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Henoch-Schonlein purpura, Rash, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Henoch - Schonlein Purpura (HSP) Rash 24-48 hours after Hep A #2, Fluzone. No Treatment. No complications. Self resolved in < 1 wk.

VAERS ID:304664 (history)  Vaccinated:2007-12-31
Age:16.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-02-08, Days after onset: 39
Location:Tennessee  Entered:2008-02-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00845
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular accident, Paralysis, Walking aid user
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a physician concerning a 16 year old female who on approximately 31-DEC-2007 was vaccinated with the first dose of Gardasil and experienced a stroke. The patient was admitted to the hospital where she remained for 3 weeks. The patient experienced an unspecified partial paralysis. After 3 weeks, the patient was discharged and could walk with the assistance of a walker. As of 04-FEB-2008, the patient was recovering. The physician felt that the stroke and partial paralysis were disabling. No further information is available.

VAERS ID:305312 (history)  Vaccinated:2007-12-31
Age:24.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 45
Location:Michigan  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis allergic
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00543
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Influenza, Muscle spasms, Nausea, Pain in extremity, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a 24 year old female with no pertinent medical history and no known allergies who on 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM. Concomitant therapy included a tetanus shot in the opposite arm. On 31-DEC-2007 the patient felt nauseous and had a pain in her arm. On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in. Unspecified medical attention was sought. As of 04-JAN-2008, the patient''s arm was "kind of tingly and numb" and she reported she was recovering. Additional information has been requested. 04/07/2008 Information has been received from a 24 year old female (117 lbs.. 53 in.) with chronic perennial allergic rhinitis who on 31-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot #659055/1522U) 0.5 mL IM. Concomitant therapy included a tetanus shot in the opposite arm. On 31-DEC-2007 the patient felt nauseous and had a pain in her arm. On 01-JAN-2008, the patient felt like she had the flu and had muscle spasms in the arm she got the injection in. Unspecified medical attention was sought. As of 04-JAN-2008, the patient''s arm was "kind of tingly and numb" and she reported she was recovering. Follow-up information received from the physician reported that the patient reported arm pain, nausea, chills and sweats on 02-JAN-2008. The patient''s outcome was not reported. No further information is expected.

VAERS ID:305798 (history)  Vaccinated:2007-12-31
Age:20.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 45
Location:New Jersey  Entered:2008-02-19, 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: unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0801USA03233
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 20 year old female who in 2007 was vaccinated with the second dose of GARDASIL. On 31-DEC-2007 the patient experienced pain at the injection site, swelling at the injection site and redness at the injection site. The patient sought unspecified medical attention. No further information was available an no lot number was provided. Additional information has been requested.

VAERS ID:305711 (history)  Vaccinated:2007-12-31
Age:64.0  Onset:2008-01-01, Days after vaccination: 1
Gender:Unknown  Submitted:2008-02-15, Days after onset: 45
Location:North Carolina  Entered:2008-02-26, Days after submission: 11
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: Mediastinal cyst; allergic rhinitis; sleep apnea; chr pain; hyperprolactinemia
Diagnostic Lab Data: CT head pending for tremors
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1537U IMRA
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram head, Local reaction, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Localized reaction. Reports tremors to upper ext. Neurologist does not feel tremors r/t pneumo vaccine. Appt pending for evaluation.

VAERS ID:305859 (history)  Vaccinated:2007-12-31
Age:73.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-01-03, Days after onset: 3
Location:Idaho  Entered:2008-02-27, Days after submission: 55
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc 5mg daily a.m.; Coreg 6.25 mg daily a.m.; Lisinopril 20 mg twice daily a.m. & p.m.; Levoxyl 25 mcg daily a.m.; Premarin .625 mg 6 x per week; Flax oil softgels 2000 mg 6 x per week; Evening primrose 500 mg 6 x per week; Glucosamine/
Current Illness: Fibromyalgia
Preexisting Conditions: Flagel; Vicodin; Morphine; Demerol
Diagnostic Lab Data: Unknown
CDC Split Type: IDO8002
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Body temperature decreased, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Client called this nurse and reported that after receiving #1 Twinrix a couple hours later client noted her ankles hurting. Now client reports severe aching in all joints, a low grade fever 99-100. Nausea and shooting pain.

VAERS ID:306042 (history)  Vaccinated:2007-12-31
Age:49.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Male  Submitted:2008-02-21, Days after onset: 52
Location:Pennsylvania  Entered:2008-02-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Lisinopril 10mg qd; Synthroid 125mg qd.
Current Illness: None
Preexisting Conditions: Hypertension; Hyperlipidemia; Graves'' disease.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2469AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Left deltoid pain and in approximately 2 days pain to elbow approximately 2 days pain down to wrist. On approximately 1/15/08 developed discomfort in antecubital space. He still has discomfort in left deltoid and left antecubital space lasting approximately 2 minutes at a time several times per day.

VAERS ID:306558 (history)  Vaccinated:2007-12-31
Age:16.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-03-05, Days after onset: 65
Location:Wisconsin  Entered:2008-03-06, 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: WAES0802USA05684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1426F1IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 16 year old female student, who on 02-AUG-2007 was vaccinated with a first dose of Gardasil. No reaction was reported after the first dose. On 31-DEC-2007 the patient was vaccinated IM in the left deltoid with a second dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included Pneumovax 23, administered in the left deltoid. It was reported that "each injection site was spread apart from the other." On 01-JAN-2008 the patient experienced pain, swelling, and erythema in the left upper arm and was treated with unspecified antibiotics. On 02-JAN-2008 the patient was seen in the office. The patient recovered after a week and a half on approximately 14-JAN-2008. The physician considered the pain, swelling, and erythema of the left upper arm to be other important medical events. Additional information has been requested.

VAERS ID:306734 (history)  Vaccinated:2007-12-31
Age:12.0  Onset:2008-01-08, Days after vaccination: 8
Gender:Male  Submitted:2008-03-05, Days after onset: 57
Location:Idaho  Entered:2008-03-10, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2008-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: sibling w/VSD repair. PE tubes @3yo.
Diagnostic Lab Data: Globulin 2.3 1.8-3.5 g/dl; ALB/Glob ratio 1.4 1.0-2.7 ratio; Bilirubin, TOT 0.2 <2.0 mg/dl; ALT 21 5-50 u/L; ALK Phos 144 103-429 u/L; AST 30 14-40 u/L; CK, TOT 161 25-287 u/L; Myoglobin 147 (high) LT 65 ng/ml; Troponin-T <0.01 0.00-0.10 ng/ml. LABS: in ER, venous pH 6.94 (L), CO2 16 (L), serum myoglobin 147 (H), anion gap 23 (H), glucose 278 (H), total protein 5.7 (L), albumin 3.3 (L).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2382BA UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio normal, Anion gap increased, Arthralgia, Aspartate aminotransferase normal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin, Blood creatine phosphokinase normal, Blood glucose increased, Blood pH decreased, Carbon dioxide decreased, Cardiac arrest, Globulin, Hypertrophic cardiomyopathy, Inappropriate schedule of drug administration, Myoglobin blood increased, Protein total decreased, Sudden death, Troponin, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Medication errors (narrow)
Write-up: Sudden death on school playground. 3/11/08 Reviewed medical records that accompanied autopsy report which reveal patient who appeared large for his age was involved in after school snow ball fight w/friends then ran across street approx 50 yards to parent''s vehicle & collapsed over the car. Parent & other bystanders witnessed event & called 911. Parent told ER patient was gurgling, color drained from face & eyes glassed over. Transported to ER where resuscitation unsuccessful. 3/25/08 Reviewed pcp medical records of 12/31/07. Only complaint was of slight pain right knee s/p bike crash. Pt wt 148 lbs, ht 63.5 in, BMI 25.8. BP 100/60. Vax record supplies lot #. Family hx: parent w/HTN.

VAERS ID:309830 (history)  Vaccinated:2007-12-31
Age:  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 85
Location:Unknown  Entered:2008-04-16, Days after submission: 21
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: WAES0802USA05331
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache
SMQs:
Write-up: Information has been received from a 62 year old female consumer who reported that her mother developed a headache after receiving Zostavax (Oka/Merck) on 31 DEC 2007. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:310213 (history)  Vaccinated:2007-12-31
Age:62.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 85
Location:Unknown  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00541
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 62 year old female consumer with no medical history, drug reactions or allergies who on 31-DEC-2007 was vaccinated with 0.65 ml of ZOSTAVAX. There was no concomitant medication. On 31-DEC-2007 the patient developed redness and swelling at the injection site, and ran low grade fever after receiving the vaccine. There were no lab diagnostic studies performed. The caller also reported that her mother developed a headache after receiving ZOSTAVAX on 31-DEC-2007. The reporter declined to offer any additional information. Additional information has been requested.

VAERS ID:310411 (history)  Vaccinated:2007-12-31
Age:1.1  Onset:0000-00-00
Gender:Female  Submitted:2008-04-07
Location:Illinois  Entered:2008-04-21, Days after submission: 14
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: None Reported
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0499U3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184U0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB44013C3IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1360U0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Abscess
SMQs:
Write-up: Received call 4/3/08 from Dr inquiring about what vaccines were administered on 12/31/07. At City County Health Dept. stated child had developed an abscess on right thigh physician stated child previously treated for abscess on left thigh. Documentation at 12/31/07 visit Health Dept indicates mother reported "History of abscess left leg with 4 month old shots ? DTAP"

VAERS ID:311368 (history)  Vaccinated:2007-12-31
Age:45.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2488AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient returned to pharmacy 4/18/08 stating that her shoulder was hurting as a result of vaccination given 12/31/07. Vaccine provider was not present. Patient won''t return calls. No other information.

VAERS ID:319823 (history)  Vaccinated:2007-12-31
Age:13.0  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-07-18, Days after onset: 199
Location:Unknown  Entered:2008-07-21, Days after submission: 3
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: Concussion
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA01279
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Hypoaesthesia, Paralysis
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a sales representative who was told by health professionals of media reports concerning a 13 year old female, who on 31-DEC-2007 was vaccinated with a first dose of GARDASIL. On 31-DEC-2007 the patient experienced memory loss, numbness of body and paralysis. A pediatrician was told by a consumer that the consumer doubted the validity of the report. It was reported that the patient played soccer, and as a result has a history of concussions. The patient recovered on an unknown date. the event could not be confirmed. No product quality complaint was involved. The memory loss, numbness of body, and paralysis were considered to be disabling. Additional information is not available.

VAERS ID:333338 (history)  Vaccinated:2007-12-31
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-25
Location:Nebraska  Entered:2008-11-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 11/30/2007)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound
CDC Split Type: WAES0801USA00316
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Initial and follow-up information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 31-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 658560/1062U). There were no concomitant medications. Subsequently, the patient was pregnant. The patient had an office visit. An ultrasound was performed. The patient''s last menstrual period was 30-NOV-2007 and her estimated delivery date was 11-AUG-2008. No product quality complaint was involved. In January 2008 the patient had an elective termination. It was unknown if the fetus was normal and if the products of conception were examined. The patient had no previous pregnancies. Upon internal review the elective termination was considered to be an other important medical event. Additional information is not expected.

VAERS ID:336937 (history)  Vaccinated:2007-12-31
Age:17.0  Onset:2008-02-25, Days after vaccination: 56
Gender:Female  Submitted:2009-01-09, Days after onset: 319
Location:Massachusetts  Entered:2009-01-09
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: PMH: BCP since 10/07. Preemie w/NICU & intubation. ITP at 2-3 yo. Sibling w/intrauterine CVA, cerebral palsy & protein s def; aunt w/DVT; parent & grandparent w/protein s deficiency; parent w/no hx of thrombosis & not on coumadin; grandparent w/recurrent thrombosis.
Diagnostic Lab Data: LABS: EKG abnormal w/biatrial enlargement w/RV strain. Troponin 2.13(H). Chest CT scan c/w large bilateral PEs. Echocardiogram abnormal w/RV enlargement, tricuospid regurg, pulmonary HTN.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Computerised tomogram abnormal, Deep vein thrombosis, Dilatation atrial, Dilatation ventricular, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal, Electrocardiogram abnormal, Familial risk factor, Headache, Hypercoagulation, Intensive care, Orthostatic hypotension, Pulmonary embolism, Pulmonary hypertension, Pyrexia, Tachycardia, Tachypnoea, Tricuspid valve incompetence, Troponin increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received HPV vaccine on 10/23/07 and 12/31/07. On 2/25/08 patient presented with breathing difficulty and was diagnosed with pulmonary embolism. Sibling and mother subsequently diagnosed with Protein S deficiency and patient presumed to have this as well. Patient began OCPs 10/07. Pulmonary embolism likely related to underlying hypercoagualability and use of OCPs, but we are reporting just in case HPV could also have been a factor. 01/26/09 Reviewed hospital medical records of 2/25-3/4/2008. FINAL DX: bilateral pulmonary emboli w/left common iliac DVT. Records reveal patient experienced DOE x 3 weeks & acute SOB w/chest pressure on 2/25. Fever & dizziness 2 weeks prior. Frontal HA 1 week prior. Seen by PCP 2/25 & found to have tachycardia, tachypnea, orthostatic BP. Admitted to PICU. Cardio, vascular surgery, Heme, Pulm consults done. Tx w/anticoagulant meds. D/C to home on continued anticoagulant meds w/thrombotic w/u to continue as outpatient in Hematology clinic. 4/24/09 Received Heme clinic med recs of 3/4/08-1/13/09. FINAL DX: PE assoc w/OCP Records reveal coumadin d/c 7/14/08 & covered w/lovenox to permit protein s testing. Patient self d/c coumadin as of 1/13/09 & no further medical records available.

VAERS ID:349082 (history)  Vaccinated:2007-12-31
Age:18.0  Onset:2008-06-01, Days after vaccination: 153
Gender:Female  Submitted:2009-06-12, Days after onset: 376
Location:Texas  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: [Therapy unspecified]
Current Illness: Pregnancy NOS (LMP = Unknown); Depression
Preexisting Conditions: Attention deficit disorder
Diagnostic Lab Data: Urine beta-human, 05/31/08, negative; Urine beta-human, 06/03/08, positive
CDC Split Type: WAES0806USA00890
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), 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 physician for the Pregnancy Registry for GARDASIL regarding an 18 year old female with depression and a history of attention deficit disorder (1988) who on 31-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 657006/0188U; site not reported). On 31-DEC-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 658554/0928U; site not reported). On 31-MAY-2008 (also reported as 4 days ago), the patient took a home pregnancy test which was negative. On 03-JUN-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # reported as "0178U"; site not reported). Concomitant therapy included an unspecified antidepressant. On 03-JUN-2008, the patient took four home pregnancy tests which were all positive. The LMP date was not reported. The patient sought unspecified medical attention in the office. The patient outcome was not reported. No additional information was provided. All telephone attempts to contact the physician have been unsuccessful. Follow up information was received from the licensed practical nurse concerning the 18 year old patient who experienced miscarriage in approximately June 2008 which was about 2-3 weeks after the initial report was called in June 2008. The patient was doing fine. Upon internal review, miscarriage was determined to be an other important medical event. Additional information is not expected.

VAERS ID:309529 (history)  Vaccinated:2007-12-31
Age:0.3  Onset:2008-01-19, Days after vaccination: 19
Gender:Male  Submitted:2008-04-15, Days after onset: 86
Location:Foreign  Entered:2008-04-15
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 20Jan2008, Abnormalunit; Air contrast barium enema, 20Jan2008, Invaginationunit; Aspiration biopsy, 20Jan2008, Negativeunit; Band neutrophil percentage, 20Jan2008, 6%; Fecal occult blood, 20Jan2008, positiveunit; Lymphocyte
CDC Split Type: B0508483A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abnormal faeces, Aspiration biopsy, Band neutrophil percentage increased, Barium double contrast, Enema administration, Haematochezia, Hypertrophy, Intussusception, Lymphocyte percentage decreased, Neutrophil percentage increased, Occult blood positive, Peristalsis visible, Platelet count increased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP + IPV + Hib; manufacturer unspecified; intramuscular; given on 30 October 2007 and on 31 December 2007; Hep B; manufacturer unspecified; intramuscular; given on 2 September 2007 and on 30 October 2007; Rotarix; GlaxoSmithKline; oral given on 30 October 2007; tuberculosis vaccine; manufacturer unspecified; intradermal; given on 2 September 2007. On 31 December 2007, the subject received 2nd dose of Rotarix (oral), lot number not provided. On 19 January 2008, 19 days after vaccination with Rotarix, the subject experienced one bloody stool. On 20 January 2008, he experienced 3 times vomiting. The subject was brought to emergency ward. At examination, abdominal pain with normal peristalsis was found. He experienced current jelly stool and intussusception was suspected. The laboratory tests showed white blood cell 23800/mm3, neutrophils 71%, neutrophil band 6%, lymphocytes 18%, platelets 820000/mm3. The fecal occult blood test was positive whereas the fine needle aspiration biopsy was negative. Abdominal X-ray showed air fluid level with distal gas. The diagnosis of intussusception was confirmed by the barium air enema. The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention). On 20 January 2008, surgery was performed and ileocolic intussusception of 20 cm was found as well as Peyer plaques hypertrophy. The intussusception was reduced without complication. No resection was performed. On 23 January 2008, the events were resolved. The subject was discharged from hospital on 25 January 2008 in good clinical condition. The physician considered the events were possibly related to vaccination with Rotarix. Follow-up received on 9 April 2008: The events were resolved on 25 January 2008.

VAERS ID:343781 (history)  Vaccinated:2007-12-31
Age:  Onset:2007-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-04-08, Days after onset: 463
Location:Foreign  Entered:2009-04-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Appendicectomy; Breast cosmetic surgery
Diagnostic Lab Data: electrocardiogram, normal; echocardiography, normal; cardiac pharmacological stress test, normal; Holter monitoring, normal; Holter monitoring, arterial pressure Holter test: a sustainable hypotension was found; diagnostic laboratory test,
CDC Split Type: WAES0904USA00763
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Activities of daily living impaired, Anorexia, Anxiety, Arrhythmia supraventricular, Asthenia, Cardiac stress test normal, Dizziness, Echocardiogram normal, Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Eye pain, Headache, Hypotension, Nausea, Norepinephrine increased, Nuclear magnetic resonance imaging normal, Ocular hyperaemia, Sinus tachycardia, Syncope, Tachycardia paroxysmal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received on 30-MAR-2008 through a company representative from a health care professional concerning an adult female (exact age not reported) had no allergies or toxic habits and had an appendectomy and plastic surgery breast augmentation with implant, who was vaccinated with the first and second and the third dose of GARDASIL vaccine (batch number not reported) on 31-OCT-2007, 31-DEC-2007 and 29-APR-2008 respectively. According to the report sent by one of the doctors, a cardiologist, it was reported that a few months ago, exact date not reported, the patient visited the doctor due to paroxistic tachycardia, dizziness and syncope. The patient reported that these symptoms began months ago. The first syncope episode occurred on the 31-DEC-2008, the day she received the second dose of GARDASIL vaccine. From that day on, the patient presented a varied clinical picture with several symptoms including asthenia, adynamia, nausea, appetite loss, diffuse abdominal pain, hyperemia appeared in both eyes. Several times a fainting sensation and tachycardia had had preceded the hypotension episodes, these occurred while resting or during normal activity, they were not triggered by a stressful situation. She attended the emergency room several times , due to these events, and the patient would often be diagnosed with an anxiety attack, this fact had hidden and delayed the proper diagnosis. According to information sent by the reporter: Physical examination: baseline ECG, echocardiogram, stress test and Holter ECG were all normal. In the arterial pressure Holter test a sustainable hypotension was found. Several ECG were performed during tachycardia and hypotension crisis, sinus tachycardia and some episode of atrial rhythm was registered, atrial rhythm showed a similar frequency to the sinus. The patient was initially attended by ophthalmologist due to the ocular hyperemia and ocular pain. Initially it was thought to be a pheochromocytoma or a similar tumor vs carcinoid. Routine blood tests with hemogram an

VAERS ID:363686 (history)  Vaccinated:2007-12-31
Age:  Onset:2007-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-10-29, Days after onset: 667
Location:Foreign  Entered:2009-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 46 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0812285A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cerebrovascular accident, Fall, Feeling abnormal, Hemiplegia, Immunisation reaction, Impaired work ability, Malaise, Walking aid user
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: This case was reported by a consumer and described the occurrence of stroke in a male subject of unspecified age who was vaccinated with FLUVIRAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 31 December 2007 at 10:00 the subject received unspecified dose of FLUVIRAL (intramuscular, left arm). On 31 December 2007, less than one day after vaccination with FLUVIRAL, the subject experienced bad experienced (unspecified), not feeling well, fell to floor and stroke. The subject left the hospital at 10:30, where he had the vaccination, and on his way home he stopped for a drink because he was not feeling well and "started to become bad". The subject arrived home at 11:00 where he fell to the floor and experienced a stroke. He was found by his wife at 15:00 and rushed by ambulance to the hospital. Different tests were run and the results were normal. The subject was hospitalised for 46 days and was released on 14 February 2008. The subject was transferred to another hospital for rehabilitation from 14 February 2008 until May 2008. On an unspecified date in 2008 the subject started physiotherapy. On an unspecified date the patient experienced left-side paralysis (arm and leg, uses cane (assistive device) and inability to work. At the time of reporting the outcome of bad experienced (unspecified), not feeling well, fell to floor and stroke were unspecified). At the time of reporting the outcome of rehabilitation was resolved. At the time of reporting the outcome of left-sided paralysis, physiotherapy, uses cane and inability to work were unresolved. The subject was sure that the vaccine was the cause of the stroke because before he was very healthy and active. The subject also mentioned that the attending physician at the hospital stated that the stroke was caused by the vaccine.

VAERS ID:426374 (history)  Vaccinated:2007-12-31
Age:0.1  Onset:2008-01-06, Days after vaccination: 6
Gender:Male  Submitted:2011-06-29, Days after onset: 1269
Location:Foreign  Entered:2011-06-29
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: urinary pterins increased cellular immunity activation, antiHBs (+), antiHBc (+), antiHAV IgM (+), sepsis (Staphyl. aureus),
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUNREGISTERED1IJLG
Administered by: Public     Purchased by: Public
Symptoms: Anti-HBc antibody positive, Anti-HBs antibody positive, Azotaemia, Cardiac arrest, Disability, Disseminated intravascular coagulation, Hepatitis A antibody positive, Hypercalcaemia, Hypokalaemia, Hypoperfusion, Hypotonia, Psychomotor retardation, Resuscitation, Staphylococcal sepsis, Staphylococcus test positive, Thrombocytopenia, Urine analysis abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: born healthy, 2nd of 75 cases hepatitis B in first day of life, 100% acquired disability, retardatio psychomotorica, cardiac arrest, st. post reanimationem, post DIC (dissem. intravasc. coagulopathy), hypotonia, thrombocytopenia, hypokaliemia, hypercalcemia, azothermia, hypoperfusion,

VAERS ID:305639 (history)  Vaccinated:2008-01-01
Age:0.4  Onset:2008-01-15, Days after vaccination: 14
Gender:Female  Submitted:2008-02-14, Days after onset: 30
Location:New Jersey  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance, 01/15?/08, negative; electroencephalography, 01/15?/08, negative; diagnostic laboratory, 01/15?/08, negative
CDC Split Type: WAES0801USA03802
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 20 week old female with no known allergies or pertinent medical history who on approximately 01-JAN-2008 was vaccinated with a second dose of Rotateq. On 15-JAN-2008 the patient had a seizure. The patient was hospitalized. MRI of the brain was negative, EEG was negative and unspecified blood work was negative. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Additional information from the physician indicated that no further information is available. Additional information is not expected.

VAERS ID:305972 (history)  Vaccinated:2008-01-01
Age:14.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 44
Location:Illinois  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA04642
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Feeling cold, Feeling hot, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician and a healthcare professional concerning a 14 year old female who on approximately 01-JAN-2008 was vaccinated with a second dose of Gardasil (659439/1267U). On approximately 01-JAN-2008 following vaccination the patient experienced fainting. Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested. Initial and follow-up information has been received froma physician and a healthcare profesional concerning a 14 year old female who on 27-DEC-2007 was vaccinated with a third dose of HPV vaccine. (659439/1267U). At 12:15 on 27-DEC-2007 following vaccination the patient experienced fainting. In follow-up it was reported that she passed out as she was walking out the exam door. She was aware that she was fainting because she felt hot, cold, then fell to the floor. Post incident she was oriented x3 and stated "didn''t know why she fainted." Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:306024 (history)  Vaccinated:2008-01-01
Age:16.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 44
Location:New York  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vertigo
SMQs:, Vestibular disorders (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female who in January 2008, was vaccinated intramuscularly with her second dose of Gardasil. In January 2008, the patient experienced vertigo. The patient had gone to a neurologist, but it was not known if the patient went to the neurologist for this reason or another reason. The patient''s outcome was not reported. Additional information has been requested.

VAERS ID:326474 (history)  Vaccinated:2008-01-01
Age:  Onset:2008-01-01, Days after vaccination: 0
Gender:Unknown  Submitted:2008-08-14, Days after onset: 225
Location:Unknown  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA05737
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician''s assistant concerning a patient who in approximately January 2008, "7 months ago", was vaccinated with the first dose of GARDASIL vaccine (yeast). On the same day, "shortly after the first dose was given", the patient developed a "knot" at the injection site. The patient had since been given the next 2 doses and had not reported any adverse reactions. On an unspecified date the patient recovered from a "knot" at the injection site. The patient contacted the physician''s office and sought unspecified medical attention. Additional information has been requested.

VAERS ID:346716 (history)  Vaccinated:2008-01-01
Age:27.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2009-05-14, Days after onset: 498
Location:Unknown  Entered:2009-05-18, 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: Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0904USA00585
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a 27 year old female with sulfonamide allergy who "about a year ago", in approximately 2008 was vaccinated with the first dose of GARDASIL vaccine injection. Concomitant therapy included EFFEXOR and ADVAIR. "After getting the vaccine", the patient experienced a lump, itchiness and warmth at the injection site that lasted about 4 months when the patient was recovered. No further information is available.

VAERS ID:304786 (history)  Vaccinated:2008-01-01
Age:30.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-02-12, Days after onset: 42
Location:Foreign  Entered:2008-02-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: ADIPOSIS
Diagnostic Lab Data: Alanine aminotransferase, Jan2008, 160; alanine aminotransferase, 2008, 156; aspartate aminotransferase, 2008, 77; aspartate aminotransferase, Jan2008, 103; gamma GT, 2008, 52; gamma GT, Jan2008, 60
CDC Split Type: D0056076A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Metabolic syndrome, Type 2 diabetes mellitus
SMQs:, Liver related investigations, signs and symptoms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of increased hepatic enzymes in a 30-year-old female subject who was vaccinated with Twinrix adult (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included adiposis. In January 2008, approximately three weeks before the initial report, the subject received 1st dose of Twinrix adult (unknown route and application site). In January 2008, 3 days after vaccination with Twinrix adult, the subject a test showed increased aspartate aminotransferase, increased alanine aminotransferase and increased gamma GT. Additionally the patient was diagnosed for the first time with diabetes mellitus type 2 and metabolic syndrome. This case was assessed as medically serious by GSK. At the time of reporting the hepatic enzymes had decreased (improved). Follow-up information has been requested.

VAERS ID:306278 (history)  Vaccinated:2008-01-01
Age:24.0  Onset:2008-02-22, Days after vaccination: 52
Gender:Male  Submitted:2008-03-03, Days after onset: 10
Location:Foreign  Entered:2008-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0056263A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Epistaxis, Pancytopenia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a hospital pharmacist and described the occurrence of pancytopenia in a 24-year-old male subject who was vaccinated with Twinrix adult (GlaxoSmithKline). On an unknown date in 2008 the subject received an unspecified dose of Twinrix adult (1 ml, unknown). After an unknown period of time post vaccination with Twinrix adult, on 22 February 2008, the subject experienced uncontrolled epistaxis which did not stop. The subject was hospitalised for this event for an unknown period of time. In hospital, the subject was diagnosed with pancytopenia. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:306489 (history)  Vaccinated:2008-01-01
Age:2.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-03-04, Days after onset: 63
Location:Foreign  Entered:2008-03-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Growth retardation
Preexisting Conditions:
Diagnostic Lab Data: White blood cell count revealed leukopenia
CDC Split Type: TRWYEH02817108
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Leukopenia, Pyrexia, Vomiting, Weight decreased, White blood cell count abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevnear was received from a healthcare professional regarding a 2-year-old female patient who experienced vomiting, mild fever, diarrhea and loss of weight. The patient received the first dose in Jan-2008. The patient''s concurrent illness includes growth retardation. Concomitant medications were not reported. The patient experienced vomiting, mild fever, diarrhea, and loss of weight within one to two days after receiving the Prevenar vaccine. Recently (2008), the patient was hospitalized for the symptoms. Her condition has been reported to be recovering. The reporter considers the events not related to Prevenar. White blood cell count (results: revealed leukopenia) was done on an unspecified date. No additional information was available at the time of this report.

VAERS ID:309076 (history)  Vaccinated:2008-01-01
Age:24.0  Onset:2008-03-01, Days after vaccination: 60
Gender:Female  Submitted:2008-04-07, Days after onset: 36
Location:Foreign  Entered:2008-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance imaging Comment: without findings; diagnostic laboratory test Comment: "liquor" - without findings; serum ANA 1:1024
CDC Split Type: WAES0804USA00446
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody positive, Hypoaesthesia, Laboratory test normal, Nuclear magnetic resonance imaging normal
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (narrow), Guillain-Barre syndrome (broad)
Write-up: Information has been received from Health Authority agency (reference number PEI2008002877) concerning a 24 year old female with who on an unspecified day in November 2007 was vaccinated with her first dose of Gardasil (lot number, route and site of administration not reported) and tolerated it well. On an unspecified date in January 2008 the patient received her second dose of Gardasil (lot number, route and site of administration not reported). There was no concomitant medication. On an unspecified date in March 2008 the patient experienced a left-sided hypaesthesia. The patient was hospitalized on an unspecified date. Labs were performed on an unspecified date and a magnetic resonance imaging and "liquor" were without findings, and serum antinuclear antibodies test was 1:1024. At the time of reporting symptoms were slightly improving. Other business partner numbers include E200802771. Additional information is not expected.

VAERS ID:309237 (history)  Vaccinated:2008-01-01
Age:12.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 98
Location:Foreign  Entered:2008-04-10, 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 blood test-results were showing signs of improvement
CDC Split Type: WAES0804USA01491
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis reactive, Henoch-Schonlein purpura, Joint stiffness, Joint swelling, Laboratory test, Pharyngolaryngeal pain, Skin discolouration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a consumer concerning her 12 year old daughter, who in January 2008, was vaccinated with a first dose of Gardasil. The batch number was not reported. Four days post vaccination the patient became ill with a severe sore throat developing into stiff joints and swelling which were discolored. The patient was still under the review of a consultant pediatrician who thought the reactions the patient experienced were most likely post streptococcal reactive arthritis with Henoch-Schonlein purpura, however due to the proximity of the Gardasil vaccination and the fact that it is a relatively new vaccine, he did not rule the possibility out. The patient did not have her second Gardasil vaccination which was due in March because the patient was still suffering from new swellings and her blood results were only just beginning to show signs of improvement. The patient''s arthritis was almost better. The patient''s consultant was not 100% certain that it was not a reaction to the vaccination. The reactive arthritis, Henoch-Schonlein purpura, sore throat, stiff joint, and swelling were considered to be other important medical events. Other business partner numbers included: E2008-03100. Additional information is not available.

VAERS ID:311460 (history)  Vaccinated:2008-01-01
Age:13.0  Onset:2008-01-09, Days after vaccination: 8
Gender:Female  Submitted:2008-05-01, Days after onset: 112
Location:Foreign  Entered:2008-05-02, 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: No reaction on previous exposure to vaccine.
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA05691
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0483U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: Information has been received from a pediatrician concerning a 13 year old female, who in January 2008, was vaccinated with a second dose of GARDASIL (Lot# 0483U; Batch# NG20160). Nine days post vaccination the patient experienced a facial palsy. The patient recovered completely within three months. It was reported that the first vaccination with GARDASIL was well tolerated. Other business partner numbers included: E2008-03798. Additional information is not expected. The file is closed.

VAERS ID:315568 (history)  Vaccinated:2008-01-01
Age:35.0  Onset:2008-04-01, Days after vaccination: 91
Gender:Female  Submitted:2008-06-09, Days after onset: 69
Location:Foreign  Entered:2008-06-09
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: Leukocyte count NOS, Apr2008, 3.5
CDC Split Type: D0057462A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Leukopenia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of leukopenia in a 35-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) and PRIORIX. In January 2008 the subject received the second dose of TWINRIX adult together with a dose of PRIORIX. Three months after vaccination with PRIORIX and TWINRIX adult, in April 2008, the subject''s leukocytes were found at 3.5 (units not specified). At the time of reporting the outcome of the event was unspecified. This case was assessed as medically serious by GSK.

VAERS ID:316070 (history)  Vaccinated:2008-01-01
Age:20.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-11, Days after onset: 161
Location:Foreign  Entered:2008-06-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance imaging, ??May?08, suggests this patient has developed multiple sclerosis
CDC Split Type: WAES0806CAN00053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a physician concerning a 20 year old female who in June 2007, was vaccinated with the first dose of GARDASIL, lot #not available. In August 2007 the patient was vaccinated with the second dose of GARDASIL, lot # not available and in January 2008 the patient was vaccinated with the third dose of GARDASIL, lot # not available. In approximately May 2008, the patient experienced multiple sclerosis. In approximately May 2008, the MRI suggested that this patient had developed multiple sclerosis. Upon internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.

VAERS ID:317340 (history)  Vaccinated:2008-01-01
Age:14.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 174
Location:Foreign  Entered:2008-06-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance imaging, 05Jun08, without pathological findings; electromyography, 05Jun08, without pathological findings; electronystagmography, 05Jun08, without pathological findings
CDC Split Type: WAES0806USA03270
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electromyogram normal, Electronystagmogram normal, Hypokinesia, Immediate post-injection reaction, Injection site anaesthesia, Injection site pain, Nuclear magnetic resonance imaging normal, Pain in extremity
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a clinic pediatrician concerning a 14 year old female patient who was vaccinated with a second dose of GARDASIL (Batch # not reported) I.M. into the upper arm in January 2008 (exact vaccination date not reported). The patient developed numbness and pain of the arm (vaccination site) immediately p.v. The adverse events lasted for 2 to 3 days. Five months after this vaccination the patient developed suddenly pain in the extremities; she was unable to move her legs properly. The patient was hospitalized due to the adverse events on 05-JUN-2008. No pathological findings have been found. MRI (spinal + head), ENG and EMG were without pathological findings. The outcome of the events was not reported. Other business partner numbers included: E2008-05345. Additional information has been requested.

VAERS ID:317976 (history)  Vaccinated:2008-01-01
Age:17.0  Onset:2008-02-29, Days after vaccination: 59
Gender:Female  Submitted:2008-06-30, Days after onset: 121
Location:Foreign  Entered:2008-07-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness: Migraine
Preexisting Conditions:
Diagnostic Lab Data: Magnetic resonance imaging, 29Feb08, sinusitis; Electroencephalography, 17?Apr08, showed no pathologies; Visual evoked potential, 17?Apr08, showed no pathologies; Ophthalmological exam, +0.6, left and right eye. No indication of optic neur
CDC Split Type: WAES0806USA08203
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test normal, Diplopia, Electroencephalogram normal, Eye burns, Eye pruritus, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination normal, Sinusitis, Vision blurred, Visual disturbance, Visual evoked potentials normal, Visual field defect
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from an Health Authority concerning a 17 year old female with a history of migraine, who was vaccinated with the third dose of GARDASIL (lot # not provided), in January 2008. It was reported that the patient was hospitalized from 17-APR-2008 to 18-APR-2008. By hospital report it was reported that the patient developed visual disturbance, diplopia, visual field defect, eye itching, eye burning and blurred vision "6 to 9 weeks ago" (onset date not specified). Examinations by an outpatient ophthalmologist, neurologist and an ear, nose and throat (ENT) specialist were without pathological findings). A Magnetic Resonance Imaging (MRI) in the outpatient department showed sinusitis on 29-FEB-2008. The sinusitis was treated with penicillin for 12 days. The examinations as cerebrospinal fluid puncture, sleep electroencephalography (EEG), visual evoked potential (VEP) which were performed in hospital showed no pathologies. The ophthalmological examination showed abnormal visus (+0.6 left eye and +0.6 right eye). There was no indication of optic neuritis. It was intended to refer the patient to the psychologist. At the time of reporting the symptoms were ongoing. Concomitant therapy included hormonal contraceptives for systemic use. Other business partner numbers included: E2008-05653 and PEI2008007916. No further information is available.

VAERS ID:318404 (history)  Vaccinated:2008-01-01
Age:53.0  Onset:2008-01-15, Days after vaccination: 14
Gender:Female  Submitted:2008-07-07, Days after onset: 173
Location:Foreign  Entered:2008-07-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0736320A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Pneumonitis, Pulmonary vasculitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Vasculitis (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of pneumonitis in a 53-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). In mid January 2008 the subject received 3rd dose of TWINRIX (unknown). Approximately 2 weeks after vaccination with TWINRIX, the subject experienced pneumonitis and pulmonary vasculitis. This case was assessed as medically serious by GSK. The subject was treated with high dose immunosuppressive therapy that keeps the condition under control, however, when the dose of immunosuppressive therapy is decreased, the condition worsens. At the time of reporting the outcome of the events was unspecified.

VAERS ID:318494 (history)  Vaccinated:2008-01-01
Age:19.0  Onset:2008-06-17, Days after vaccination: 168
Gender:Female  Submitted:2008-07-07, Days after onset: 20
Location:Foreign  Entered:2008-07-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA09126
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a general practitioner (this case was poorly documented) concerning a 19 year old female who in January 2008, was vaccinated with a second dose of GARDASIL via intramuscular route in her deltoid. On 17-JUN-2008 the first symptoms of multiple sclerosis appeared. Previous unspecified vaccinations were well tolerated. Multiple sclerosis was considered to be an other important medical event. Other business partner numbers included E2008-05898. Additional information is expected.

VAERS ID:318631 (history)  Vaccinated:2008-01-01
Age:  Onset:2008-05-01, Days after vaccination: 121
Gender:Female  Submitted:2008-07-09, Days after onset: 69
Location:Foreign  Entered:2008-07-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA00975
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood product transfusion, Facial paresis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a medical student concerning a female patient who in January 2008 was vaccinated IM into the deltoid muscle with a 3rd dose of GARDASIL. The patient developed unilateral facial paresis for the first time in May 2008, additionally she developed paraesthesia and loss of energy. The events resolved under treatment with immunoglobulins (unspecified) in May 2008. The adverse events reoccurred end of June 2008 and were ongoing at the time of the reporting. The patient was hospitalized on an unspecified date and the following care was in the outpatient department. On an unspecified date, the patient was vaccinated with 1st and 2nd dose of GARDASIL. No adverse effect occurred. Other business partner numbers included E2008-06126.

VAERS ID:322083 (history)  Vaccinated:2008-01-01
Age:11.0  Onset:2008-02-01, Days after vaccination: 31
Gender:Female  Submitted:2008-08-13, Days after onset: 193
Location:Foreign  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: B. pertussis serology, Feb2008, positive; Anti-PT antibody was positive.
CDC Split Type: B0532694A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNGM
Administered by: Other     Purchased by: Other
Symptoms: Antibody test positive, Cough, Inappropriate schedule of drug administration, Pertussis identification test positive
SMQs:, Anaphylactic reaction (broad), Vasculitis (broad), Hypersensitivity (broad), Medication errors (narrow)
Write-up: This case was reported by a physician, via a GSK sales representative, and described the occurrence of possible Bordetella pertussis in a 11-year-old female subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). In January 2008, the subject received a booster dose of INFANRIXTETRA (batch number unknown). In February 2008, one month after vaccination with INFANRIXTETRA, the subject presented with possible Bordetella pertussis with persisted cough. Bordetella pertussis serology (anti-PT antibody) was positive. A possible vaccination failure was then reported. In March 2008, persisted cough resolved. This case was assessed as medically serious by GSK.

VAERS ID:322397 (history)  Vaccinated:2008-01-01
Age:18.0  Onset:2008-05-01, Days after vaccination: 121
Gender:Female  Submitted:2008-08-15, Days after onset: 106
Location:Foreign  Entered:2008-08-18, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: spinal tap, ??May08, CSF: normal; diagnostic laboratory test, 22Jul08, viral serologies: negative; diagnostic laboratory test, 22Jul08, assay for immunoglobulins: normal; diagnostic laboratory test, 22Jul08, rickettsiosis: negative; lymphoc
CDC Split Type: WAES0808USA01793
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody negative, C-reactive protein increased, CSF test normal, Haemoglobin normal, Headache, Immunoglobulins normal, Inflammation, Lumbar puncture, Lymphadenopathy, Lymphocyte count decreased, Lymphopenia, Neck pain, Platelet count normal, Pyrexia, Serology negative, Torticollis, Toxoplasma serology negative, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from the patient''s mother via a health authorities (reference number: MA20081362) concerning her 18 year old daughter who in January 2008, was vaccinated with the first dose of GARDASIL (batch number not reported), on an unspecified date received the second dose of GARDASIL and in July 2008 was vaccinated with the third dose GARDASIL IM. The patient''s mother explained that her daughter had received 3 injections of GARDASIL, the latest of which was very recent. Exact dates of vaccination were not specified. In late May 2008, the patient was hospitalized in internal medicine due to a febrile episode with cephalgia. Meningeal syndrome was ruled out by normal CSF and spontaneous resolution of fever and torticollis. The patient was rapidly discharged due to high school exams. No aetiology was found. On 18-JUL-2008, she was hospitalized again due to the same symptoms: fever, cephalgia and vomiting with an onset on 15-JUL-2008, and also left-side cervicalgia with palpable lymph nodes. The patient did not present with skin eruption, adenopathy except left cervical adenopathy - nor hepatosplenomegaly. Signs of inflammation were found, with increased CRP at 245 mg/L on 19-JUL-2008. The same day, the patient also had lymphopenia at 0.88 g/L. It is noteworthy that she had already had lymphopenia at 1.14 g/L during her first hospitalization on 30-MAY-2008- Levels of hemoglobin and platelets were normal. Cervicalgia and fever resolved very rapidly. CRP level decreased at on 22-JUL-2008 and lymphopenia resolved on 22-JUL-2008 with lymphocytes at 2.54 g/L. Paraclinic work-up enabled to rule out many aetiologies: toxoplasmosis, viral serologies and rickettsiosis were negative. Investigations for antinuclear antibodies were negative. Assay for immunoglobulins was normal. Grisel''s syndrome was ruled out. The patient was discharged from internal medicine unit after a six day hospitalization. At the time of reporting the patient had recovered. Health authorities considered that the ch

VAERS ID:325168 (history)  Vaccinated:2008-01-01
Age:31.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 251
Location:Foreign  Entered:2008-09-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Arthralgia
Preexisting Conditions: Infection
Diagnostic Lab Data: ophthalmological exam, ??Jan08, no pathologies; magnetic resonance imaging, 27Feb08, normal; serum B. burgdorferi Western blot IgM Ab, 06?Mar08, negative; cerebrospinal fluid culture, 06Mar08, normal
CDC Split Type: WAES0809USA00101
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, CSF culture negative, Diplopia, Dizziness, Hypoaesthesia, Immunology test, Inappropriate schedule of drug administration, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Paralysis, Vertigo, Visual disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow), Ocular motility disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a 31 year old female consumer who in January 2008, was vaccinated with a third dose of GARDASIL. One to two weeks post-vaccination, she developed dizziness, double vision, numbness and paralysis. On 06-MAR-2008 she was admitted to a neurological department of a hospital. An infection was excluded in hospital. Dizziness and double vision were ongoing at the time of reporting. The outcome of numbness and paralysis was not reported. The first dose of GARDASIL was administered in July 2007, and the second dose of GARDASIL was in October 2007 and were well tolerated. The family physician was contacted and confirmed the events of the patient. A doctor''s report was sent indicating that the patient was hospitalized from 06-MAR-2008 to 08-MAR-2008. At the end of January 2008 the patient developed continuous vestibular vertigo with abnormal vision (rotating colored circles). She was referred to the ophthalmologist and the examination showed no pathologies. Approximately 14 days prior to hospitalization the patient experienced blurred vision and a few days prior she complained of weakness of both hands with mild hypoaesthesia. A Cranial MRI from 27-FEB-2008 and cerebro spinal fluid on 06-MAR-2008 showed normal results and an infectious genesis of the symptoms was ruled out. There was no indication of a chronic inflammatory CNS disease. Borrelia IgM was negative. The abnormal vision resolved in an unspecified time. Vestibular vertigo and blurred vision were ongoing. The outcome of hypoaesthesia and weakness was not reported. The patient had had a history of borreliosis in 2006, and since then recurrent arthralgia. Other business partner numbers included E2008-08099. Additional information has been requested.

VAERS ID:327471 (history)  Vaccinated:2008-01-01
Age:22.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-07, Days after onset: 279
Location:Foreign  Entered:2008-10-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness: Allergy to metals; Penicillin allergy; Hay fever
Preexisting Conditions: Epstein-Barr virus infection; Immunisation
Diagnostic Lab Data: Diagnostic laboratory test, 13Feb08, 13/3, cell count; Computed axial tomography, 13Feb08, (CTT) Hypodense areas; Magnetic resonance imaging, 13Feb08, three foci with diffusion disorder, suspicion of ADEM; Neurological examination, 18Feb08,
CDC Split Type: WAES0810USA00331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy brain abnormal, C-reactive protein increased, CSF test abnormal, Chest X-ray normal, Computerised tomogram abnormal, Coordination abnormal, Disturbance in attention, Electrocardiogram normal, Electroencephalogram normal, Fatigue, HIV antibody negative, Headache, Hepatitis A antibody positive, Hepatitis B antibody negative, Hepatitis B antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Influenza, Leukoencephalomyelitis, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Somatosensory evoked potentials, Ultrasound scan normal, Vertigo, Visual disturbance, Visual evoked potentials abnormal, White blood cell count increased
SMQs:, Liver infections (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from the health authority (reference no. PEI2008014818) concerning a 22 year old female patient with allergy to metals (nickel), penicillin allergy and hay fever and a history of epstein-barr virus infection who on 16-NOV-2006 was vaccinated with TD-VIRELON (lot #015031A), toleration not reported. On 27-OCT-2007 the patient was vaccinated with a first dose of MUTAGRIP (lot #B0614-1) IM into the left upper arm. In January 2008, the patient was vaccinated with the third dose of RECOMBIVAX HB (manufacturer unknown) (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). End of December 2007 until beginning of January 2008 the patient had a severe flu (no serology). Afterwards she experienced fatigue, impaired coordination, headache, visual disturbance, impaired concentration and vertigo. On 13-FEB-2008 to 22-FEB-2008 she was hospitalized. Cerebrospinal fluid showed slight pleocytosis and positive oligoclonal bands. IgG and IgM intrathecal neg/borrelia ASI IgG & IgM neg. Magnetic resonance imaging revealed 3 lesions with diffusion disorder. In the hospital acute disseminated encephalomyelitis was diagnosed. The patient was treated with high-dose prednisolone and improved. Other relevant tests included: 13-FEB-2008 cell count: 13/3; leukocytes 10.02/nl (normal range: 4.3-10.8). "CCT" showed hypodense areas. On 15-FEB-2008 human immunodeficiency virus 1 and/or 2 antibody avidity index (Anti-HIV 1/2) was negative. Serum hepatitis C antibody test (Anti-HCV) was negative; serum hepatitis B surface antigen test (HBsAG) negative; serum hepatitis B surface antibody screen (anti-HBs) - positive; serum hepatitis B surface antibody screen (Anti HBs titer determination) - 1000 IE/1; serum hepatitis B core immunoglobulins G and M antibody test (anti-HBc (IgG + IgM) negative; serum hepatitis B(e) antigen test (HBe-antigen) negative; serum hepatitis A immunoglobulins G and M antibody test (anti-HAV (IgG + IgM) positive. Serum hepatitis A immunoglobulin

VAERS ID:336189 (history)  Vaccinated:2008-01-01
Age:0.2  Onset:2008-11-28, Days after vaccination: 332
Gender:Male  Submitted:2008-12-29, Days after onset: 31
Location:Foreign  Entered:2008-12-29
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: B0551651A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Barium enema, Enema administration, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: This case was reported by a physician via a GSK representative and described the occurrence of invagination of intestine in a 13 month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical condition was unspecified. First dose of ROTARIX was given in December 2007. In January 2008, the subject received a 2nd dose of ROTARIX (oral, batch not available). On 28 November 2008, 10 months after the second vaccination with ROTARIX, the subject developed invagination of intestine, confirmed by unspecified investigations. The subject was treated with barium salt and event resolved without sequelae. This case was assessed as medically serious by GSK. The physician considered the event was unrelated to vaccination with ROTARIX.

VAERS ID:337300 (history)  Vaccinated:2008-01-01
Age:18.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-13, Days after onset: 378
Location:Foreign  Entered:2009-01-14, 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: Unknown
Current Illness:
Preexisting Conditions: Smoker
Diagnostic Lab Data: ultrasound, normal
CDC Split Type: WAES0810USA04462
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Ultrasound scan normal
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 specialist concerning a female who on JAN-2008 was vaccinated with the first dose of GARDASIL (Lot and batch number not reported) while she was at 5 amenorrhea weeks. The patient ignored her pregnancy at time of vaccination. At time of reporting the patient had no adverse effect, echography during pregnancy was normal. The reporter did not see the patient yet she had just received a letter from the gynaecologist who followed her. The patient should give birth soon. This case was not enrolled in the Pregnancy Registry: patient''s age was unknown. Other business partner numbers included: E2008-09680. Additional information was received from a specialist who reported that a corrective version was created on 12-Dec-2008 to enroll the patient in the Pregnancy Registry. Follow-up information received through the outcome pregnancy questionnaire on 06-Jan-2009: Case upgraded to serious. The patient was 18 years old. There was no congenital anomaly, no genetic problem in the family, no consanguinity with the partner. The patient had medical risk factor with smoking (10 cigarettes/day). There was no complication during this pregnancy. Diagnostics performed during pregnancy were normal. There was no infection and no disease during pregnancy. Pregnancy seemed to be not followed by the reporter. On 17-Sep-2008 at 17 amenorrhea weeks the patient suffered from an idiopathic early foetal death in utero. Products of conception were analyzed: there was a normal but sanguinolentis foetus. Died baby boy''s weight was 0.3 kg, he was normal, without any post-natal complication and no congenital anomaly. The case was closed. No further information was expected.

VAERS ID:346256 (history)  Vaccinated:2008-01-01
Age:18.0  Onset:2008-02-01, Days after vaccination: 31
Gender:Female  Submitted:2009-05-12, Days after onset: 465
Location:Foreign  Entered:2009-05-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: CERAZETTE
Current Illness: Urinary tract infection
Preexisting Conditions:
Diagnostic Lab Data: biopsy, 20Nov08, a superficial necrotising dermatitis; diagnostic laboratory test, 20Nov08, bullous exanthema was detected by immunofluorescence; diagnostic laboratory test, 14Feb09, HSV antibodies: 1:24000 titer (normal up to 1:230); diagn
CDC Split Type: WAES0905USA00439
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy intestine normal, Biopsy skin abnormal, Blood immunoglobulin A, Blood immunoglobulin A decreased, Burning sensation, Condition aggravated, Dermatitis bullous, Drug eruption, Ear, nose and throat examination abnormal, Endometriosis, Erythema, General physical health deterioration, Helicobacter infection, Herpes simplex serology positive, Immunology test, Laboratory test abnormal, Menstrual disorder, Oral herpes, Pain in extremity, Pelvic pain, Pharyngitis, Rash, Serum ferritin decreased, Skin lesion, Skin necrosis, Streptococcus identification test positive, Urinary tract infection
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal infections (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: It was reported by an internist that an 18-year-old female patient was vaccinated IM with a first dose of GARDASIL (lot # not reported) into the deltoid muscle in January 2008. Concomitant suspect therapy included COTRIM FORTE and ibuprofen. Other concomitant therapy included CERAZETTE. The patient had a history of frequent urinary tract infection. In February 2008, she experienced herpes labialis and in May 2008, she was in a reduced general condition. Two doctor''s letter had been provided. On 21-MAY-2008 the patient was referred to the dermatologist. It was reported that on 20-MAY-2008, the patient (without a history of allergies) experienced pain and a burning sensation with a bullous rash at the right thigh. Therefore the patient had been treated with SOLU-DECORTIN by the family doctor. COTRIM FORTE was take for 4 days until one day before this consultation. The clinical examination showed reddened skin changes at the thigh. Due to the result of two previous performed histological biopsies a linear IgA dermatosis in childhood or herpiform dermatitis Duhring were suspected. Further special examinations as detection of endomysium antibodies as well as direct immunofluorescence (DIF) were intended to clarify the diagnosis. The patient was admitted to a day hospital on 20-NOV-2008: Since the last visit of dermatologist the skin lesions (bullous eruption) meanwhile spread to other parts of the body. A previous consultation in August 2008 in an out patient department of the university suspected a drug eruption caused by COTRIM FORTE. But a suspicion of a bullous autoimmune dermatose could not be confirmed by a skin biopsy. A control biopsy on 20-NOV-2008 showed superficial necrotising dermatitis. Bullous exanthema was detected by immunofluorescence. No indication for autoimmune disease of the skin. It was reported that the patient had administered usually COTRIM FORTE due to frequent urinary tract infection. The last time in June 2008. Further she suffered from frequent menstrual disorder and endometriosis was susp

VAERS ID:349808 (history)  Vaccinated:2008-01-01
Age:17.0  Onset:2009-01-01, Days after vaccination: 366
Gender:Female  Submitted:2009-06-22, Days after onset: 171
Location:Foreign  Entered:2009-06-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test, ??09, negative blood work-up; diagnostic laboratory test, ??09, Lactate/pyruvate dosage, with or without garrot, was abnormal; serum magnesium, ??09, deficiency in Erythrocytic magnesium; serum EPSTEIN-BARR virus
CDC Split Type: WAES0906USA03027
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood magnesium decreased, Blood test normal, Convulsion, Dyskinesia, Epstein-Barr virus antibody negative, Fatigue, Hyperventilation, Influenza like illness, Lactate pyruvate ratio abnormal, Muscle spasms, Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from Health Authorities concerning a 17 year old female who was vaccinated with the 1st dose of GARDASIL in January 2008, the 2nd dose in April or May 2008 and the 3rd in August 2008. In January 2009, the patient presented with influenza-like episode during 15 days, with no fever. During a cross-country running at school, the patient collapsed at the end of the kilometer. It took her several hours to recover. One week later, still in January 2009, she experienced tetany seizures at the least effort, associated with hyperventilation, very intense muscle cramps and abnormal movements. The patient also had chronic fatigue and muscle weakness in January 2009. Complementary examination showed a negative blood work-up, a deficiency in erythrocytic magnesium and a negative infectious mononucleosis test. In March 2009, the patient experienced again a very severe tetany seizure which led to her hospitalization in neurology. The following work-up were normal: EEG, electromyography at test, CT scanner, muscle biopsy. However, lactate/pyruvate dosage, with or without garrot, was abnormal. Investigations were carried on concerning an enzymatic deficiency (results not provided). At the time of report, the patient had recovered from tetany seizure but not from chronic fatigue and muscle weakness. The Health Authorities assessed the causal relationship between the reported reactions and vaccinations as doubtful according to the foreign method of assessment. Other business partner numbers included E2009-05004. Additional information is not expected.

VAERS ID:350337 (history)  Vaccinated:2008-01-01
Age:28.0  Onset:2008-07-01, Days after vaccination: 182
Gender:Female  Submitted:2009-06-26, Days after onset: 360
Location:Foreign  Entered:2009-06-29, 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: WAES0906PNL00016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
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: Information has been received from a physician concerning her 28 year old female sister with a history of 0 pregnancies and 0 live births who in January 2008 was vaccinated with third dose of GARDASIL. There were no concomitant medications. Subsequently, she became pregnant on April 2008. In approximately July 2008, the patient experienced miscarriage after 10 weeks. Relationship of the miscarriage to therapy with GARDASIL is unknown. The reporter also mentioned that the patient later on became pregnant with her second child and is due to deliver the baby any time soon. Upon internal medical review, miscarriage was considered an other important medical event. This is one of two reports from the same source. No further information is available.

VAERS ID:351749 (history)  Vaccinated:2008-01-01
Age:18.0  Onset:2008-09-01, Days after vaccination: 244
Gender:Female  Submitted:2009-07-17, Days after onset: 319
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: Hypermetropia
Preexisting Conditions: There was no medical history of neurological disorders in the subject''s family. The subject wore glasses since she was 3-years-old. 2 to 3 weeks before the events onset, there was a person died in the subject''s family.
Diagnostic Lab Data: Anti-HBs antibody, Jul2009, <0; Nuclear magnetic resonance ima, Sep2008, normal; Optical coherence tomography, Sep2008, normal; Scan, Sep2008, normal; Visual acuity test, Sep2008, 2/10; Visual acuity test, Sep2008, 6/10
CDC Split Type: B0583599A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody positive, Blindness, Corrective lens user, Diplopia, Nuclear magnetic resonance imaging normal, Optical coherence tomography, Scan, Visual acuity reduced, Visual acuity tests abnormal
SMQs:, Liver infections (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer and described the occurrence of unilateral vision loss in a 18-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hypermetropia for which the subject wore glasses since she was 3-year-old. There was no medical history of neurological disorders in the subject''s family. 2 to 3 weeks before the events onset, a person died in the subject''s family. In October 2007, on unspecified date, the subject received a first dose of ENGERIX B adult (20 mcg, injection site and batch unknown). In January 2008, the subject received a second dose of ENGERIX B adult (20 mcg, injection site and batch unknown). In September 2008, 8 months after vaccination with ENGERIX B adult, the subject experienced sudden left eye vision loss, with a visual acuity at 2/10 and diplopia. Right eye vision was normal. MRI, Scan, optical coherence tomography, neurological and optic nerves examinations were performed in September 2008: all results were normal. No etiology was found. 48 to 72 hours after the events occurrence, left eye vision improved with visual acuity at 6/10. This value was unchanged since that time. Since September 2008, the subject wore glasses with prism on left glass. In July 2009, the subject''s anti-HBs antibodies were negative. The neurologist of the subject did not recommend pursuing hepatitis B vaccination. This case was assessed as medically serious by agency. At the time of reporting the events were unresolved.

VAERS ID:365545 (history)  Vaccinated:2008-01-01
Age:22.0  Onset:2008-07-01, Days after vaccination: 182
Gender:Female  Submitted:2009-11-05, Days after onset: 492
Location:Foreign  Entered:2009-11-06, 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: Precancerous cells present; Cervicectomy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911CAN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Drug exposure during pregnancy, Foetal disorder, Premature labour, Stillbirth
SMQs:, 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: Information has been received from a 22 year old female with a history of precancerous cells present (caused by HPV) in 2004 and partial cervicectomy who in approximately January 2008, was vaccinated with the first dose of GARDASIL, lot # not available. In approximately March 2008, the patient was vaccinated with the second dose of GARDASIL, lot # not available. In July 2008 the patient found out she was pregnant. In September 2008 the patient was vaccinated with the third dose of GARDASIL, lot # not available (on the recommendation of her physician). In approximately January 2009 the patient went into premature labor (at 23 and a half weeks gestation) and her son was still born. Upon internal review, 23 and a half weeks gestation and stillbirth were considered to be other important medical events. No further information is available. This is one of several reports received from the same source.

VAERS ID:367645 (history)  Vaccinated:2008-01-01
Age:91.0  Onset:0000-00-00
Gender:Male  Submitted:2009-11-13
Location:Foreign  Entered:2009-11-16, Days after submission: 3
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: Unknown
Current Illness: Radiation exposure
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA01855
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Inappropriate schedule of drug administration, Myelodysplastic syndrome, Pallor, Platelet count decreased, Red blood cell count decreased, White blood cell count decreased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Blood premalignant disorders (narrow), Hypotonic-hyporesponsive episode (broad), Myelodysplastic syndrome (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial information has been received from the patient''s family concerning a 91 year old male patient, an atomic bomb survivor, who in December 2007 (dose and indication not reported) and January 2008 (indication not reported) was vaccinated with PNEUMOVAX 23. No information on concomitant therapy was provided. On an unspecified date, the patient developed complexion ill after the second inoculation of PNEUMOVAX 23. In the fall of 2008, the patient developed red blood cell count, white blood cell count and platelet count decreased. In February 2009, the patient developed myelodysplastic syndrome and died. At the time of this report, the outcome of complexion ill and red blood cell count, white blood cell count and platelet count decreased were unknown. The reporter (patient''s family) considered that the myelodysplastic syndrome was serious due to death. The reporter did not assess the seriousness of the complexion ill and the red blood cell count, white blood cell count and platelet count decreased. The reporter felt that the causal relationship of the complexion ill, the red blood cell count, white blood cell count and platelet count decreased and the myelodysplastic syndrome to PNEUMOVAX 23 was unknown. No further information is available. The comment of patient''s family: I didn''t know the cause of death but I became concerned due to inappropriate vaccination and telephoned.

VAERS ID:380868 (history)  Vaccinated:2008-01-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2010-02-18
Location:Foreign  Entered:2010-02-19, 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: Sickle cell anaemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002USA01758
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Pneumonia streptococcal
SMQs:
Write-up: Information has been received from a health care professional, via health care agency (90375). This case concerns a female patient of unknown age. The patient had a history of sickle cell anemia. The patient was due to have received PNEUMOVAX 23 (lot # and batch # not reported) in January 2008. The reporter stated that although the vaccination was scheduled the patient probably did not attend. It was also stated that the patient may have been vaccinated in 2003. On an unreported date the patient died. The post mortem results stated the cause of death as streptococcal pneumonia type B. Other business partner numbers include E2010-00927. No further information is available.

VAERS ID:429879 (history)  Vaccinated:2008-01-01
Age:24.0  Onset:0000-00-00
Gender:Female  Submitted:2011-08-15
Location:Foreign  Entered:2011-08-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1108ISR00024
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amputation
SMQs:
Write-up: Information has been received from a physician in an advisory call center who received the information from a 24 year old female who on approximately 01-JAN-2008 was vaccinated with GARDASIL first and second doses. Subsequently the patient experienced amputation (not reported but probably of cervix). There were no further available details. Upon internal review, amputation was considered to be an other important medical event. Additional information has been requested.

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