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Case Details (Sorted by Vaccination Date)

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VAERS ID:453139 (history)  Vaccinated:2012-04-06
Age:18.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-06, Days after onset: 0
Location:Florida  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NKA
Current Illness: NKA
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1586AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1171AA IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4053AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080DA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1248AA SCLA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: 10 MINUTES POST VACCINIATION, PT.C/O NAUSEA, CHEST PAIN, TINGLING IN ARMS. NO LOSS OF CONSCIOUSNESS. VITALS TAKEN, ICE APPLIED TO NECK, RESCUE CALLED. PATIENT TO HOSPITAL BY AMBULANCE. ALERT AND RESPONSIVE, ORIENTED X 3.

VAERS ID:453142 (history)  Vaccinated:2012-04-06
Age:13.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:2012-04-06, Days after onset: 0
Location:Kansas  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1416AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1726AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Balance disorder, Cold sweat, Dizziness, Headache, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Felt light-headed after receiving 3 injections. Sat for about 5 min. with an ice pack and fan running. Was feeling worse and asked to lie down. Started to move him to next room to recliner, but he passed out. Skin clammy, color very pale. Let him lie on floor for another 20 minutes until he finally became completely conscious enough to know what was going on. At the time he left the office (40 minutes after shots were administered) his BP was 90/52, skin color pink, but still appeared a little unsteady and c/o headache.

VAERS ID:453149 (history)  Vaccinated:2012-04-06
Age:11.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-06, Days after onset: 0
Location:Washington  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: only over-the-counter multivitamin and vitamin D that she had been on for some time
Current Illness: no
Preexisting Conditions: asthma, eczema
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1291AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4024AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B065CB0IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Immediate post-injection reaction, Nervousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Fainted immediately. Caught by MA and aroused immediately. Was pale and nervous for several minutes. Was monitored with feet up in recumbent position until felt better. Was observed in clinic for 15 minutes until walked out comfortably.

VAERS ID:453151 (history)  Vaccinated:2012-04-06
Age:33.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-06, Days after onset: 0
Location:New Mexico  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: I was supposed to get a tetanus vaccine, but instead was accidentally given tuberculin (PPD) intramuscularly because my health practitioner was distracted. She did not even notice that she had given me the wrong product. I noticed the bottle and alerted her. I do not know if I will be having any effects because of this. All she could do was apologize. This is malpractice, and so I am reporting it. How can a health professional be injecting a patient without paying attention to what is being injected? I have not been able to get any information on possible effects of the tuberculin.

VAERS ID:453248 (history)  Vaccinated:2012-04-06
Age:29.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-09, Days after onset: 3
Location:Alaska  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: headache~Tetanus Diphtheria (no brand name)~~0.00~Patient
Other Medications: cetirizine, Astepro, Singulair, budesonide-fomoterol, proventil, papaya, vitamin D, prenatal vitamin
Current Illness: no
Preexisting Conditions: Asthma, allergic rhinitis, allergies to pitted fruits, almonds, cats, grass, pollen, mold, dust mites.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0025AE0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Hyperhidrosis, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Local pain, swelling, redness; fever, chills, sweats, fatigue, arthralgias x 3 days - starting to improve now.

VAERS ID:453512 (history)  Vaccinated:2012-04-06
Age:10.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:2012-04-09, Days after onset: 3
Location:Pennsylvania  Entered:2012-04-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1206AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Severe localized pain, swelling, erythema - tx w/po BENADRYL/steroids.

VAERS ID:453513 (history)  Vaccinated:2012-04-06
Age:51.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-09, Days after onset: 3
Location:Iowa  Entered:2012-04-12, 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:
Current Illness: None
Preexisting Conditions: hypertension
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3957CA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Headache, Hyperhidrosis, Palmar erythema, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Within 12 minutes of injection noted, dull HA/dizziness, feeling sweaty, palms both hands were slightly reddened. Within a couple more minutes throat feeling full - taken to Emergency Dpt at this point for evaluation/treatment.

VAERS ID:453536 (history)  Vaccinated:2012-04-06
Age:28.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 6
Location:Kentucky  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Methadone, Xanax, Prozac, prenatal vitamins, Percocet, and Motrin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1849AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Chills, Erythema, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling, fever, chills. Given Benadryl and a prescription for Bactrim.

VAERS ID:453545 (history)  Vaccinated:2012-04-06
Age:21.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 6
Location:Mississippi  Entered:2012-04-12
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: None
Diagnostic Lab Data:
CDC Split Type: MS12003
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB223CA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE12880 RA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH110AA0 RA
Administered by: Public     Purchased by: Public
Symptoms: Feeling abnormal, Hyperhidrosis, Nausea, Pulse pressure decreased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient in to receive immunizations for international travel. About 10 minutes past receipt patient c/o nausea, sweating, feeling bad. Patient drank a little coke without relief of s/s. V/O 60/ weak radial pulse - ammonia under patient''s nose; started IV of N?S in right arm. 911 called. Patient more alert and walked to ambulance stretcher. Patient using phone; transported to Medical Center. Pateint d/c from ER on 4/6 when checked on him at 4:30 p.m. Spoke with patient 4/12/2012. States completely recovered. States ER gave him Rx for nausea (Phenergan) although he has not taken in a few days. Still plans to travel in June. Will visit private provider for f/u and Rx for Maleria medication.

VAERS ID:453756 (history)  Vaccinated:2012-04-06
Age:65.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Ohio  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1786AA SCUN
Administered by: Private     Purchased by: Other
Symptoms: Injection site cellulitis, Pyrexia, Red blood cell sedimentation rate increased, Sepsis syndrome, White blood cell count increased
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Cellulitis site of injection (SQ). Fever, sepsis syndrome. WBC 20 K sed rate 65.

VAERS ID:453866 (history)  Vaccinated:2012-04-06
Age:64.0  Onset:2012-04-12, Days after vaccination: 6
Gender:Male  Submitted:2012-04-17, Days after onset: 5
Location:California  Entered:2012-04-17
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; HTN; Test. def.; Peri-neuro-hyperlipid; Shingles 2009; CAD; Sleep apnea
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1600AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Blister, Genital rash, Skin haemorrhage
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (broad)
Write-up: Patient called 4-5 days post vaccine to complain of rash on shaft of penis this developed into blistery lesions which bleed, dried up and resolved by 4/16/12.

VAERS ID:453868 (history)  Vaccinated:2012-04-06
Age:31.0  Onset:2012-04-09, Days after vaccination: 3
Gender:Male  Submitted:2012-04-11, Days after onset: 2
Location:Georgia  Entered:2012-04-17, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG15411IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH285AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Received vaccines on 4/6/12. On 4/11/12 reported via phone conversation that on night of 4/9/12 he developed a rash with hives on lower legs and trunk. 4/13/12 Patient saw his PCP & reports rash/hives.

VAERS ID:454098 (history)  Vaccinated:2012-04-06
Age:3.0  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:2012-04-20, Days after onset: 14
Location:Florida  Entered:2012-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE. I do not know the manufacturer of the vacines. I never asked the doctor. So I listed unknown but in fact there may be a name brand to them.
Current Illness: NO.
Preexisting Conditions: NONE.
Diagnostic Lab Data: Went to the emergency room in hospital today. Doctor could not help because there was no neurologist in & they did not see any immediate danger. His doctor did routine bloodwork which came back good & emergency room ran some urine tests in which I do not have results the yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 3  
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 3  
Administered by: Unknown     Purchased by: Other
Symptoms: Abnormal faeces, Asthenia, Blood test normal, Dark circles under eyes, Decreased appetite, Hypersomnia, Nervousness, Pyrexia, Tic, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad)
Write-up: Mild fever (between 98 & 99) for 2 weeks now. Sleeps through his nap into the next day for 2 weeks now (Sleeps about 18 hours a day). Loss of appetite. Soft smelly stool. Loss of energy. Black & red circles under eyes even after sleeping 18 hours a day. Nervous tick (on & off again). This happened in the past when hes received vaccines. Only that in the past these symptoms were only 1 week long. Now its extending 2 weeks long. I always take him back to the doctor to tell him whats going on & his answer is always the same.............these symptoms are not caused by the vaccines, its just a bug he has!

VAERS ID:455181 (history)  Vaccinated:2012-04-06
Age:21.0  Onset:2012-04-08, Days after vaccination: 2
Gender:Female  Submitted:2012-04-26, Days after onset: 18
Location:South Carolina  Entered:2012-05-08, Days after submission: 12
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: ADHD
Diagnostic Lab Data: See above
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB532AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4308BA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Arthralgia, C-reactive protein increased, Full blood count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative
SMQs:, Arthritis (broad)
Write-up: Polyarthralgias (shoulders, elbows, knees, hands) following administration of vaccines below. Elevated ESR and CRP, normal CBC & Rheumatoid factor. NSAID treatment resulted in symptom resolution.

VAERS ID:455400 (history)  Vaccinated:2012-04-06
Age:1.2  Onset:2012-04-07, Days after vaccination: 1
Gender:Male  Submitted:2012-05-11, Days after onset: 34
Location:Michigan  Entered:2012-05-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: Dermatitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB550AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH400AA3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0512AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172453IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1066AA0IMLL
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Weight bearing difficulty
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Unable to bear weight on right leg. Swollen and tender to touch.

VAERS ID:458392 (history)  Vaccinated:2012-04-06
Age:0.3  Onset:2012-04-11, Days after vaccination: 5
Gender:Female  Submitted:2012-06-21, Days after onset: 71
Location:Florida  Entered:2012-06-28, 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:
Current Illness: None
Preexisting Conditions: Heart M
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC415AA1IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1481AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH912931IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0040AA1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Diarrhoea, Restlessness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 5 days after vaccines pt had diarrhea and restlessness.

VAERS ID:458413 (history)  Vaccinated:2012-04-06
Age:0.3  Onset:2012-04-07, Days after vaccination: 1
Gender:Female  Submitted:2012-06-28, Days after onset: 82
Location:Ohio  Entered:2012-06-28
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315DA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH431AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9169741IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB210A1PO 
Administered by: Private     Purchased by: Other
Symptoms: Fontanelle bulging, Lumbar puncture normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal disorders (narrow)
Write-up: Brought to office 1 day after receiving PEDIARIX with bulging fontanel & low grade fever 99.7 (ax) sent to ER for spinal tap, which was negative.

VAERS ID:462400 (history)  Vaccinated:2012-04-06
Age:0.4  Onset:2012-04-06, Days after vaccination: 0
Gender:Male  Submitted:2012-06-08, Days after onset: 63
Location:California  Entered:2012-08-20, Days after submission: 73
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Atrial septal defect; Pulmonic stenosis (hemodynamically stable, scheduled for f/u in 1 year
Diagnostic Lab Data: EEG - normal (awake and asleep); EKG - mild left axis deviation, normal sinus rhythm
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4074AA1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF309211UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1394AA1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Culture negative, Depressed level of consciousness, Electrocardiogram abnormal, Electroencephalogram normal, Gaze palsy, Hypotonia, Laboratory test normal, Lumbar puncture normal, QRS axis abnormal, Somnolence, Toxicologic test normal
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: The patient received routine immunizations at his well baby visit on 4/6/12; a few hours later he was noted to be sleeping longer than his usual nap. Mom found him difficult to arouse, limp and with his eyes "rolled back". He transported to ER then hosp. for 2 days and was normal by exam and monitoring. His LP, septic w/o cultures. Chemistry panel and toxic screen were normal. An out-pt. EEG was normal. Mild pulmonic stenosis. Hemodynamically stable, no arrythmia, atrial septal defect.

VAERS ID:480999 (history)  Vaccinated:2012-04-06
Age:0.3  Onset:2012-04-07, Days after vaccination: 1
Gender:Female  Submitted:2012-11-30, Days after onset: 237
Location:Ohio  Entered:2013-01-10, Days after submission: 41
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: No concomitant medications or relevant medical history. No adverse events were reported following receipt of prior immunizations.
Diagnostic Lab Data: Spinal tap, negative
CDC Split Type: A0982041A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315DA1UNLL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERUH412AA IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH916974 IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB210A PO 
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Fontanelle bulging, Lumbar puncture normal
SMQs:, Neuroleptic malignant syndrome (broad), Neonatal disorders (narrow)
Write-up: This case was reported by a physician and described the occurrence of bulging anterior fontanel in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-GSK) ; non-GSK manufacturer; unknown; unknown given on 6 April 2012; live ROTARIX ; GlaxoSmithKline; unknown given on 6 April 2012; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 6 April 2012. There were no concurrent medications. On 6 April 2012 the subject received 2nd dose of PEDIARIX (unknown, left thigh); lot number was reported as "ACZ21B315DA". On 7 April 2012, 1 day after vaccination with PEDIARIX, the subject experienced bulging anterior fontanel and fever. The physician reported the subject was administered the standard dose of PEDIARIX on 06 April 2012. One day after the injection the mother brought the subject to the office, it was noted that the subject had a bulging anterior fontanel. The subject''s axillary temperature was 99.7 degrees [fever]. The subject was sent to the emergency department. A spinal tap was done and showed nothing. It was negative. The subject was sent home. The physician noted the events resolved and when the subject had her six month physical, all events resolved. No other events were noted. The immunization series was delayed. At the time of reporting the bulging anterior fontanel and fever were resolved. The physician considered the events were possibly related to vaccination with PEDIARIX. Follow up information received from the physician on 03 July 2012. The physician reported that the subject was brought to the office on 07 April 2012, one day after receiving PEDIARIX with bulging fontanel and low grade fever. The subject was sent to the emergency room for spinal tap which was negative. The physician noted that the PREVNAR was given intramuscularly (IM), the ROTARIX was given orally and the haemophilus influenzae type b vaccine was given IM. Only the PEDIARIX was listed as a suspect product.

VAERS ID:508685 (history)  Vaccinated:2012-04-06
Age:5.0  Onset:2013-09-19, Days after vaccination: 531
Gender:Female  Submitted:2013-10-21, Days after onset: 32
Location:Maryland  Entered:2013-10-21
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1321AA1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Papule, Rash pustular, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Wide spread papules, pustules and vesicular eruption concentrated on upper trunk, ear, neck, and upper arms.

VAERS ID:453195 (history)  Vaccinated:2012-04-07
Age:75.0  Onset:2012-04-08, Days after vaccination: 1
Gender:Male  Submitted:2012-04-09, Days after onset: 1
Location:Indiana  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Telnase, lisinopril
Current Illness:
Preexisting Conditions: seasonal allergy, hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Soreness, redness.

VAERS ID:453314 (history)  Vaccinated:2012-04-07
Age:55.0  Onset:2012-04-07, Days after vaccination: 0
Gender:Female  Submitted:2012-04-10, Days after onset: 3
Location:Ohio  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA0SCRA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Headache, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient reports itching and swollen at injection site shortly after administration. Works with a physician, so Monday was started on Keflex. Had chills, and headache, has become more swollen and raised, it is hot and sore.

VAERS ID:453825 (history)  Vaccinated:2012-04-07
Age:0.3  Onset:2012-04-07, Days after vaccination: 0
Gender:Female  Submitted:2012-04-13, Days after onset: 6
Location:Virginia  Entered:2012-04-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Scales~Influenza (Seasonal) (no brand name)~1~0.00~Patient|Scales~Influenza (Seasonal) (no brand name)~2~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201203807
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIE-VAX)SANOFI PASTEUR 2SYRUN
Administered by: Private     Purchased by: Other
Symptoms: Hypotonia, Injection site dryness, Injection site exfoliation
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial report was received from a consumer, who was also the patient''s parent, on 09 April 2012. A two-month-old patient had received an injection of IMOVAX Rabies, sanofi pasteur SA (lot number, route and site unknown) on 31 March 2012, 03 April 2012 and 07 April 2012 and an injection of Immunoglobulin human antirabies (manufacturer, lot number, route and site unknown) on 31 March 2012. After the third dose of IMOVAX on 07 April 2012, the patient "went limp and was like a rag doll for 10 minutes." The patient also had "scaly dry areas at every injection site for IMOVAX and Immunoglobulin." The patient had no illness at the time of vaccination. Past medical history and concomitant medications were not reported. The patient''s outcome was not reported. Documents held by sender: None.

VAERS ID:453893 (history)  Vaccinated:2012-04-07
Age:11.0  Onset:2012-04-07, Days after vaccination: 0
Gender:Male  Submitted:2012-04-09, Days after onset: 2
Location:Illinois  Entered:2012-04-17, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB539CA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0963AA1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Feeling cold, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Brief fainting spell 15 minutes after administration, cold & sweaty, dizziness & lightheaded. Patient recovered after 40 minutes.

VAERS ID:454001 (history)  Vaccinated:2012-04-07
Age:20.0  Onset:2012-04-07, Days after vaccination: 0
Gender:Female  Submitted:2012-04-10, Days after onset: 3
Location:South Carolina  Entered:2012-04-19, Days after submission: 9
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
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Headache, nausea, dizziness.

VAERS ID:460990 (history)  Vaccinated:2012-04-07
Age:  Onset:2012-04-07, Days after vaccination: 0
Gender:Female  Submitted:2012-07-27, Days after onset: 111
Location:Unknown  Entered:2012-07-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1204USA02879
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: Information has been received concerning a female who on 07-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Upon investigation of an allergic reaction, it was determined that the customer was given an influenza virus vaccine (unspecified, manufacturer unknown) by a pharmacist. The influenza vaccine was administered correctly and according to protocol. The customer stated that she had an allergic reaction to the vaccine (not specified to which vaccine the reaction occurred). She did seek medical treatment (unspecified). The outcome of the allergic reaction was not provided. Information was received from a telephone call. On 03-MAY-2012, it was verified that the patient was vaccinated with ZOSTAVAX (Merck), not the flu vaccine. Additional information is not expected.

VAERS ID:454258 (history)  Vaccinated:2012-04-07
Age:0.2  Onset:2012-04-07, Days after vaccination: 0
Gender:Male  Submitted:2012-04-20, Days after onset: 13
Location:Foreign  Entered:2012-04-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Personal and family history, ongoing illness, and risk factors reported as "none".
Diagnostic Lab Data: Not reported
CDC Split Type: 201203866
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH00610IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Case received from a physician via the local affiliate in a foreign country on 12 April 2012 under the local reference number CN2012043. A two-month-old male patient had received a primary first dose intramuscular right thigh injection of IMOVAX POLIO (lot number H0061-1) and a primary first dose intramuscular 0.5 ml right deltoid injection of Hib vaccine (manufacturer GSK, lot number not reported) on 07 February 2012, and on the evening of vaccination, he developed a severe fever; body temperature was up to 39.3 degrees Celsius. Corrective treatment consisted of antipyretics (details not reported). Complementary investigations were not reported. Personal and family history, ongoing illness, and risk factors were reported as "none". History of adverse events to vaccine or drug and complimentary investigations were not reported. The patient had not been hospitalized. At the time of the report, fever had not been relieved and the event remained ongoing. Outcome was not recovered. Seriousness for this case has been assessed as Other - Medically Significant (specify: long duration of fever). Documents held by sender: None.

VAERS ID:458067 (history)  Vaccinated:2012-04-07
Age:0.2  Onset:2012-04-07, Days after vaccination: 0
Gender:Male  Submitted:2012-06-25, Days after onset: 79
Location:Foreign  Entered:2012-06-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Premature baby 26 to 32 weeks, 30 weeks of amenorrhea and 1 day of disharmonious delayed growth rate with a weight of 1.11 kg
Diagnostic Lab Data: heart rate (07Apr2012): bradycardia at 43
CDC Split Type: 2012145771
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Pain, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad)
Write-up: This is a spontaneous report from the regulatory authority, number: LY20120775. A 2-month-old male infant received 0.5 ml single dose of PREVENAR 13 via intramuscular route on 07Apr2012 and one dosage form single dose of INFANRIX HEXA via intramuscular route on 07Apr2012. Batch numbers not stated. Relevant medical history included premature birth at 30 weeks of amenorrhea and 1 day with disharmonious delayed growth. On 01Feb2012 birth weight was 1.11 kg. The newborn was included in a observational study assessing the risk of drug-related adverse events associated with off-label prescription in newborns at the neonatal department and the neonatal resuscitation unit. Concomitant medication included FUMAFER via oral route 10 mg/kg once daily from 26Mar2012 and still ongoing, GAVISCON NOURRISSONS via oral route 0.9 mL seven times a day from 18Mar2012 and still ongoing, UVESTEROL VITAMINES A, D, E and C via oral route 1 mL once daily from 02Mar2012 and still ongoing and INEXIUM 2 mg/kg once daily from 26Mar2012 and still ongoing (route of administration not stated). Indication was not stated for all of these drugs. On 07Apr2012, the infant weight was of 2.68 kg. After the injections (time not specified), on 07Apr2012 the patient experienced bradycardia, pain and fever which were considered as medically significant. He experienced bradycardia at 43 requiring stimulation. Seven hours after the vaccines administration, he developed a behavior indicating pain and requiring the injection of one dose of paracetamol (trade name unknown); and 11 hours after, he developed fever and tachycardia. The outcome was favorable. At the time of the report, the patient had recovered without sequelae. Based on the Official Method of Causality Assessment, both suspected products were rated by the agency as doubtful. No FU attempts needed. No further information expected.

VAERS ID:465349 (history)  Vaccinated:2012-04-07
Age:0.7  Onset:2012-04-23, Days after vaccination: 16
Gender:Female  Submitted:2012-09-14, Days after onset: 144
Location:Foreign  Entered:2012-09-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 07-APR-2012, Body temperature, 36.0 Centigrade; Platelet count (unknown date): was under 10000 uL
CDC Split Type: 2012222031
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURERF39C SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG14610SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH11H01A0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Platelet count decreased, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad)
Write-up: This is a spontaneous report received from the agency through a contactable pediatrician. The regulatory authority report number was PREVENAR 584. An 8-month-old female patient received the first dose of PREVENAR (Lot Number: 11H01A) subcutaneously, the first dose of ACTHIB (Lot Number: G1461) subcutaneously, and DTP (Lot Number: F39c) subcutaneously all at 2:18 p.m. on 07Apr2012. The patients medical history and concomitant medications were not reported. The patient''s body temperature before the administration on 07Apr2012 was 36.0 degrees Celsius. At 4:00 p.m. on 23Apr2012, the patient''s mother noted thrombocytopenic purpura developed on both the patient''s hands and lower legs and then brought her to the reporter''s hospital. A diagnosis of vaccine-induced thrombocytopenia was made at the pediatrics department of another hospital. The patient was treated with gamma globulin and unspecified steroids and responded well to treatment. The patient was discharged from the hospital on 01May2012. The outcome of the event, thrombocytopenic purpura, was recovered on 08May2012. The reporting pediatrician classified the event as serious and assessed it as related to PREVENAR.

VAERS ID:465854 (history)  Vaccinated:2012-04-07
Age:0.7  Onset:2012-04-23, Days after vaccination: 16
Gender:Female  Submitted:2012-09-20, Days after onset: 150
Location:Foreign  Entered:2012-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history not reported. Concomitant medication not reported.
Diagnostic Lab Data: On 23 April 2012, peripheral blood test showed decreased platelet count: 10000/uL.
CDC Split Type: 201208470
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLA
HIBV: HIB (ACTHIB)SANOFI PASTEURG14610SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ecchymosis, Immunoglobulin therapy, Petechiae, Platelet count decreased, Thrombocytopenic purpura, Vaccination complication
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad)
Write-up: Initial case received from Health Authorities, under reference number HIB-420, through the local affiliate on 10 September 2012 under the local number A201200249. An 08-month-old female patient, with no relevant medical history and no concomitant medications, had received her 1stsubcutaneous dose of ACT-HIB (batch number G1461) in the right upper arm, concomitantly with a subcutaneous dose of DPT (manufacturer unknown, batch number not reported) in the left upper arm and her 1st subcutaneous dose of PREVENAR (other manufacturer, batch number reported) in the left upper arm on 07 April 2012. Her weight at birth was at 2.984 kg. Body temperature before the vaccination was 36.0 degrees C. On 23 April 2012, the patient presented with petechiae and ecchymosis on both hands and both lower limbs. The patient was seen by a physician; peripheral blood test showed decreased platelet count: 10000/uL. The patient was hospitalized on 23 April 2012; She was diagnosed with vaccine-associated thrombocytopenia purpura. Gamma globulin and steroids were administered with good response; the patient improved steadily. The patient was discharged on 01 May 2012. The patient recovered on 08 May 2012. Physician''s comment: There was no likely cause of the event other than the vaccine. Documents held by sender: none.

VAERS ID:453648 (history)  Vaccinated:2012-04-08
Age:76.0  Onset:2012-04-08, Days after vaccination: 0
Gender:Female  Submitted:2012-04-13, Days after onset: 5
Location:Colorado  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: minocycline, olmesartan, gabapentin, omeprazole, conjugated estrogens, DHEA, progesterone, testosterone, armour thyroid, risendronate, various OTC multivitamins, various OTC supplements, fish oil, lotemax and restasis eyedrops, probiotics
Current Illness: Small bowel obstruction
Preexisting Conditions: NKDA, hypertension, hypothyroidism, degenerative joint disease, osteoporosis
Diagnostic Lab Data: afebrile, WBC 6.7
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cellulitis, Injection site swelling, White blood cell count normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Pneumovax in left deltoid later that day pt had swelling at injection site with 2.5X1 inch area. It appeared as cellulitis. Pt was treated with Benadryl, ice, heat, antibiotics, and observation. Pt discharged the next day on oral antibiotics with following up wound care appt with PCP as an outpatient.

VAERS ID:454118 (history)  Vaccinated:2012-04-08
Age:81.0  Onset:2012-04-16, Days after vaccination: 8
Gender:Female  Submitted:2012-04-20, Days after onset: 4
Location:Pennsylvania  Entered:2012-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See list provided
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1266AA1SCUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red, itchy area at injection site, size of a softball - used BENADRYL cream on area. 4 day later says size has decreased & no longer itchy.

VAERS ID:459644 (history)  Vaccinated:2012-04-08
Age:11.0  Onset:2012-04-20, Days after vaccination: 12
Gender:Female  Submitted:2012-07-18, Days after onset: 89
Location:Texas  Entered:2012-07-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Abdominal pain
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: CT, MRI all normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1291AA UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4072BA UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4103BA UNRA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Computerised tomogram normal, Nuclear magnetic resonance imaging normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient has been having abdominal pain x 3 months. Mom thinks it might be the HPV vaccine.

VAERS ID:453201 (history)  Vaccinated:2012-04-09
Age:30.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-09, Days after onset: 0
Location:Texas  Entered:2012-04-09
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 noted
Preexisting Conditions: none noted
Diagnostic Lab Data: Patient has had no side effects as of this time.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B073AC2IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG112411IMLA
Administered by: Military     Purchased by: Military
Symptoms: Incorrect dose administered
SMQs:
Write-up: Patient received the Tdap and Typhoid immunization on 04/05/2012 and then again on 04/09/2012.

VAERS ID:453274 (history)  Vaccinated:2012-04-09
Age:16.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-09, Days after onset: 0
Location:Pennsylvania  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVONORGEST; LORATADINE; LUVOX CR
Current Illness: None
Preexisting Conditions: Bee venom; Hypothyroidism
Diagnostic Lab Data: BP and HR checked in sitting and supine position; BENADRYL given 50 mg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1860AA1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Muscle tightness, Nausea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Felt nauseated and had tightness in her neck/throat.

VAERS ID:453281 (history)  Vaccinated:2012-04-09
Age:0.4  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-10, Days after onset: 0
Location:Massachusetts  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Vomiting~Rotavirus (Rotateq)~1~0.20~Patient
Other Medications: TRIVISOL (vitamin supplement)
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3867AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF241411IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0328AA1PO 
Administered by: Private     Purchased by: Public
Symptoms: Vaccine positive rechallenge, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 2/16/12 received PCV13, PENTACEL (DTaP, Hib, IPV), ROTATEQ and vomited right away-large amounts. 4/9/12 received PCV13, PENTACEL, ROTATEQ and vomited within 24 hours of immunes.

VAERS ID:453284 (history)  Vaccinated:2012-04-09
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2012-04-10
Location:Texas  Entered:2012-04-10
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315DA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1531AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF803831IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB244A1PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying, Injection site erythema, Injection site induration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad)
Write-up: Crying a lot, fever 102.3, on thighs where shots were given area of redness and induration. F/u 1 week use warm soaks & massage.

VAERS ID:453312 (history)  Vaccinated:2012-04-09
Age:1.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-10, Days after onset: 1
Location:New York  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRRA
Administered by: Private     Purchased by: Private
Symptoms: Depressed mood, Eating disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: Prior to event he was not too willing to eat and looking kind of sad. After dinner he vomited and continued to throughout the night.

VAERS ID:453425 (history)  Vaccinated:2012-04-09
Age:25.0  Onset:2012-04-11, Days after vaccination: 2
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:Arizona  Entered:2012-04-11
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: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4104CA UNLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Induration, Local reaction
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pt. return to clinic - localized reaction. Induration size of 25 cents, redness 2 1/2 in x 2 1/2 in. Advised to use cool compress, TYLENOL or BENADRYL.

VAERS ID:453427 (history)  Vaccinated:2012-04-09
Age:4.0  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-11, Days after onset: 1
Location:Mississippi  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0512AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1249AA1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: On Lt thigh (KINRIX given). 4in x 3in redness, warm to touch - 4/11/12 at 9:10am appeared 4/10/12. Tiredness. Rash on Lt cheek (Monday) almost gone now. Mother given BENADRYL, Ibuprofen, cool compresses. No SOB.

VAERS ID:453424 (history)  Vaccinated:2012-04-09
Age:1.3  Onset:2012-04-11, Days after vaccination: 2
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Arizona  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, Advil.
Current Illness: Mild cold.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Pain, Rash macular, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Red Blotch 3 inches in diameter. Swelling of entire thigh. Hot to the touch and painful.

VAERS ID:453428 (history)  Vaccinated:2012-04-09
Age:67.0  Onset:2012-04-11, Days after vaccination: 2
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Pennsylvania  Entered:2012-04-12
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: NKA; HTN; DM; CAD; Gout
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1743AA1IMAR
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt experienced redness, pain & swelling medial lower bicep after injection. Treated with antibiotic for cellulitis & BENADRYL seen in office 4/12.

VAERS ID:453473 (history)  Vaccinated:2012-04-09
Age:46.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-09, Days after onset: 0
Location:Nebraska  Entered:2012-04-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB211BA0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3846AA0IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE04420IMUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH140AA0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Rash papular
SMQs:
Write-up: Within 5 minutes of injection, a few red papules developed on both arms. They were not pruritic. Following diphenhydramine 50 mg IM, no further lesions occurred. The patient was sitting comfortably.

VAERS ID:453546 (history)  Vaccinated:2012-04-09
Age:41.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 3
Location:North Carolina  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1123AA SCRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Headache, Insomnia, Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Headache, fever/chills, unable to sleep, stiffness shoulders and neck that has not resolved.

VAERS ID:453578 (history)  Vaccinated:2012-04-09
Age:28.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 3
Location:Texas  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vyvanse
Current Illness: no
Preexisting Conditions: - allergic to penicillin, Septra, Ceclor - asthma
Diagnostic Lab Data: 98.1 F (afebrile)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA0IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH110AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Pain, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Started itching at extremities, no visible rash; felt feverish and achy the following night.

VAERS ID:453581 (history)  Vaccinated:2012-04-09
Age:0.3  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 2
Location:Maryland  Entered:2012-04-13, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4156AB1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172431IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41B215A1PO 
Administered by: Public     Purchased by: Public
Symptoms: Injection site papule, Injection site reaction, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Small papular reaction bilateral thighs near injection sites "itchy" bumps.

VAERS ID:453666 (history)  Vaccinated:2012-04-09
Age:25.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-13, Days after onset: 4
Location:Rhode Island  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NORDETTE-28; BCP
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Had rash 10 days after Meningococcal vaccine.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Rash, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Patient received 3rd GARDASIL 10:10 AM 4/9/12. At noon felt nausea. Returned to Health Services 2 PM with foreign body sensation in throat. Given Epi/BENADRYL and sent to ER. Given Prednisone at ER and discharged. Service 4 AM 4/10/12 with foreign body sensation - not as intense. Treated with Prednisone, ZYRTEC in our office 4/10/12 11:30. Better next 24 hours.

VAERS ID:453712 (history)  Vaccinated:2012-04-09
Age:34.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-13, Days after onset: 4
Location:Washington  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen over the counter as directed. No other medications disclosed during patient encounter.
Current Illness: No, patient declared no flu like illness at time of vaccination. Patient was afebrile. Past medical History listed below.
Preexisting Conditions: Declared no previous vaccination reactions. Allergies: No known medical allergies, reports allergy to shellfish. Past medical history: memory loss (prior military service in operation iraqi freedom, xerosis cutis.
Diagnostic Lab Data: Patient blood pressure 120/80 immediately after event and recovered in 2-3 minutes.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS49011A0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Patient became lightheadness and nausea after receiving Human Rabies Immunoglobulin (HRIG) HyperRAB lot#26NJR01 exp 12 Jun 2013. Patient received 13 mL (milliliters) dosed by weight of 215 pounds. Patient received dose intramuscularly with 23 gauge needle given by nurse. Medication dispersed in right deltoid, right and left anterolateral thigh. Patient also received rabies vaccine, 1 milliliter IM, RabAvert Lot#49011A exp June 2015 to L deltoid. After event, I physician immediately at bedside and blood pressure 120/80. Symptoms resolved within 2-3 minutes. Patient received Rabies VIS (Vaccine Administration Sheet) and verbal informed consent was obtained prior to vaccine administration. Patient instructed to report immediately to Emergency Department for difficulty breathing, wheezing, itching at back of the throat, hives, worsening of symptoms, change in level of consciousness.

VAERS ID:453714 (history)  Vaccinated:2012-04-09
Age:60.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-14, Days after onset: 5
Location:California  Entered:2012-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Actonel, Levoxyl, Aciphex, Calcium+D
Current Illness: none
Preexisting Conditions: osteopenia, hypo-thyroidism, GERD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  SYR 
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site swelling, Tic
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Within a few short minutes of getting vaccination my face perspired profusely and I felt very faint. I had to lay down for 20 minutes before it passed. On the third day after the injection (04/12) I noted a slightly raised red skin coloring at the injection site about 1" X 2". This had not appeared by the morning of 4/10 and was not checked again until 4/12. Throughout the day on 4/12, I had a persistent intermittent tic under my left eye, which I have not had before. It has now subsided.

VAERS ID:453740 (history)  Vaccinated:2012-04-09
Age:17.0  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 6
Location:West Virginia  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi Vitamin
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: Full blood work ordered after 12 hour fasting - All result were normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA10059 UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076AA UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Body temperature increased, Dizziness, Full blood count normal, Headache, Oropharyngeal pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 3:00 AM Sore throat, headache. 8:00 AM headache, dizzy. 9:30 AM Fainted, Temp 99.8 BP 100/60 Pulse 116/122.

VAERS ID:453780 (history)  Vaccinated:2012-04-09
Age:38.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-16, Days after onset: 7
Location:Ohio  Entered:2012-04-16
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Naprosyn, Fluticasone
Current Illness: None Known
Preexisting Conditions: Codeine, Contrast Dye, Morphine
Diagnostic Lab Data: None done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1002AA SCLA
Administered by: Unknown     Purchased by: Military
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Hypotension, Pruritus generalised, Swelling face, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Swelling of face, thoat tightness, SOB. Generalized itching, hives, dizziness. Hypotension within 10 minutes of the allergic reaction.

VAERS ID:453848 (history)  Vaccinated:2012-04-09
Age:13.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-10, Days after onset: 1
Location:Massachusetts  Entered:2012-04-17, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101320IMLA
Administered by: Private     Purchased by: Public
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: 4 1/2 hrs post vaccine felt throat discomfort and tightness chest with some difficulty breathing. Resolved within a few minutes. Felt tired afterwards.

VAERS ID:453895 (history)  Vaccinated:2012-04-09
Age:0.4  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-16, Days after onset: 7
Location:Massachusetts  Entered:2012-04-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4059AA1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH917241IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1240AA1PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Body temperature increased, Irritability
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Mom called, T. 100.5, somewhat fussy. Advised TYLENOL q 6 hours. Call if symptoms worse.

VAERS ID:453932 (history)  Vaccinated:2012-04-09
Age:1.0  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 6
Location:Florida  Entered:2012-04-18, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: H/O wheezing x 1 in Aug 2011 along with an ear infection 8/11
Diagnostic Lab Data: Not available to me - done at hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH52AA3IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0597AA0SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF171553IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0864AA0SCUN
Administered by: Private     Purchased by: Public
Symptoms: Cyanosis, Staring
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Staring spells, cyanosis on 4/10/12 -$g admitted to hospital. Started on KEPPRA.

VAERS ID:453935 (history)  Vaccinated:2012-04-09
Age:0.5  Onset:2012-04-11, Days after vaccination: 2
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Florida  Entered:2012-04-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: RAD
Diagnostic Lab Data: Ultrasound on 4/11/12 in hospital - c/w intussusception
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4128221IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF803831IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.170922 UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Intussusception, Surgery, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow)
Write-up: Pt developed intussusception and had surgery on 4/11/12. Pt still hospitalized currently.

VAERS ID:454173 (history)  Vaccinated:2012-04-09
Age:10.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-23, Days after onset: 14
Location:Missouri  Entered:2012-04-23
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
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101320IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B078BA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: Gave MENVEO, afterwards discovered child only 10 yrs old. CDC hotline called.

VAERS ID:454191 (history)  Vaccinated:2012-04-09
Age:2.0  Onset:2012-04-23, Days after vaccination: 14
Gender:Female  Submitted:2012-04-23, Days after onset: 0
Location:California  Entered:2012-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Chicken Pox vaccine. Large red bump appeared at injection site 15 days after vaccination. Tiny red bumps in the middle of back. Complaining that her back was "itchy."

VAERS ID:454275 (history)  Vaccinated:2012-04-09
Age:75.0  Onset:2012-04-21, Days after vaccination: 12
Gender:Female  Submitted:2012-04-24, Days after onset: 3
Location:Washington  Entered:2012-04-24
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 PASTEURU3487CA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt''s left arm - swollen & itching 10 days after the vaccination & got better after couple of days.

VAERS ID:454292 (history)  Vaccinated:2012-04-09
Age:1.1  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-24, Days after onset: 15
Location:California  Entered:2012-04-24
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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0255AA SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143AA SCLL
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever and blotchy rash over trunk. patient was treated with Benadry.

VAERS ID:454359 (history)  Vaccinated:2012-04-09
Age:66.0  Onset:2012-04-10, Days after vaccination: 1
Gender:Unknown  Submitted:2012-04-25, Days after onset: 15
Location:Alabama  Entered:2012-04-25
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: HTN; DM
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA1IMRA
Administered by: Private     Purchased by: Private
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: Erythema, swelling, pain near injection site right arm.

VAERS ID:454385 (history)  Vaccinated:2012-04-09
Age:1.1  Onset:2012-04-12, Days after vaccination: 3
Gender:Male  Submitted:2012-04-16, Days after onset: 4
Location:Hawaii  Entered:2012-04-25, Days after submission: 9
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1120AA0UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1408AA0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Lip swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: (1) Started having hives on the third day & spread all over the body in 2 days & waxes & wanes. (2) Lips swollen on the 7th day.

VAERS ID:454386 (history)  Vaccinated:2012-04-09
Age:11.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 3
Location:Oklahoma  Entered:2012-04-25, Days after submission: 13
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: Asthma; Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4072AA UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074AA UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1250AA1UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient presents local reactions with swelling and redness in his upper arms. For treatment BENADRYL and Ice.

VAERS ID:454393 (history)  Vaccinated:2012-04-09
Age:33.0  Onset:2012-04-11, Days after vaccination: 2
Gender:Female  Submitted:2012-04-18, Days after onset: 7
Location:Nevada  Entered:2012-04-25, 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:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC008AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pruritus, Rash, Skin irritation
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Client noticed a rash on both shins and both forearms the AM of 04/11/12. By PM, rash had spread above knees. Rash did not spread above forearms but became more noticeable. Appeared dry, red, raised, irritated with small red bumps. Slight itching but mainly irritated feeling. It "seemed like a razor burn but I hadn''t shaved or used any new soap." Client remembered she had gotten a rash with dose #1. Rash confined to upper back, arms, not legs. Rash more diffuse, "almost like little pimples but didn''t have a head on them". Denies use of new soap, lotion or wearing new clothing. As of 04/18, client still has rash on lower shins. She has not seen primary care doctor due to lack of insurance at this time. Client received dose #1 Hep B, ENGERIX B, same lot number on 02/15/12. Received dose #1 Tdap, BOOSTRIX, at same time. Lot #AC52B066AA.

VAERS ID:454469 (history)  Vaccinated:2012-04-09
Age:0.4  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-26, Days after onset: 16
Location:Unknown  Entered:2012-04-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Dry spots which turned into eczema after following dose~DTaP + HepB + IPV (no brand name)~1~0.17~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1 RL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 1 LL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 1 LL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eczema, Food allergy, Inflammation, Milk allergy, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Noticed colorless bumps after her 4 month dtap shot a week prior to adverse event. Then following week she got hib and polio on 4/9/12. The next morning on 4/10/11 he woke up with hives and inflamed eczema where her colorless bumps were. She got hives after breast feeding. She now has a milk protein allergy. She was getting hives after I would eat cheese. This only started happening after the immunizations. She never had allergys before. I would eat cheese and drink milk all the time.

VAERS ID:454472 (history)  Vaccinated:2012-04-09
Age:0.3  Onset:2012-04-17, Days after vaccination: 8
Gender:Male  Submitted:2012-04-26, Days after onset: 9
Location:California  Entered:2012-04-26
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: Stool Cx (-); C diff (-); Giardia (-); Fecal WBL (-)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4182AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF803821IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1544AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Clostridium test, Culture stool negative, Diarrhoea, Faeces discoloured, Mucous stools, Parasite blood test, White blood cells stool negative
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea started 4-17-12. Green, watery stools with mucus. No fever, no vomiting. Has 4-5 stools per day. Labs neg. Referred to GI clinic for evaluation.

VAERS ID:454588 (history)  Vaccinated:2012-04-09
Age:1.6  Onset:2012-04-24, Days after vaccination: 15
Gender:Female  Submitted:2012-04-28, Days after onset: 4
Location:New Jersey  Entered:2012-04-28
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0601AA0SCLL
Administered by: Private     Purchased by: Other
Symptoms: Rash generalised, Rash morbilliform, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Diffuse morbilliforme rash involving entire body coalescencing. Facial puffiness.

VAERS ID:454614 (history)  Vaccinated:2012-04-09
Age:13.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-11, Days after onset: 2
Location:Pennsylvania  Entered:2012-04-30, Days after submission: 19
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: Pertussis vaccine allergy; Diagnoses: ADHD, Epilepsy, Convulsive disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM110320IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Firmness, redness and swelling.

VAERS ID:454618 (history)  Vaccinated:2012-04-09
Age:66.0  Onset:2012-04-14, Days after vaccination: 5
Gender:Unknown  Submitted:0000-00-00
Location:New York  Entered:2012-04-30
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1198AA UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Zoster-like rash on left thigh.

VAERS ID:454628 (history)  Vaccinated:2012-04-09
Age:54.0  Onset:2012-04-18, Days after vaccination: 9
Gender:Female  Submitted:2012-04-30, Days after onset: 12
Location:Kentucky  Entered:2012-04-30
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: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1449AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Headache, Hyperhidrosis, Oropharyngeal pain, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: 04/18 Woke up w/ terrible body aches. Episode of sweats. No fever. Took Tylenol. 04/20 Continued body aches, developed rash on face, ears, scalp and arms. Later upper chest and thighs. 04/23 Sore throat, mild headache.

VAERS ID:454677 (history)  Vaccinated:2012-04-09
Age:31.0  Onset:2012-04-22, Days after vaccination: 13
Gender:Female  Submitted:2012-04-30, Days after onset: 8
Location:Michigan  Entered:2012-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? Yes
Previous Vaccinations: Guillain-Barre syndrome~ ()~~5.00~Patient
Other Medications: vitamin C, one a day women''s vitamin, desogen birth control
Current Illness: None
Preexisting Conditions: Depression
Diagnostic Lab Data: MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4051AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Guillain-Barre syndrome, Monoplegia, Nuclear magnetic resonance imaging
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Admitted on the 22nd for back pain and ascending paraalysis in right arm. No respiratory difficulties. Still inpatient physical therapy.

VAERS ID:454737 (history)  Vaccinated:2012-04-09
Age:54.0  Onset:2012-04-12, Days after vaccination: 3
Gender:Female  Submitted:2012-05-01, Days after onset: 19
Location:Wisconsin  Entered:2012-05-01
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: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt c/o swollen lymph nodes in neck/collar bone area with redness, pain, and swelling at injection site. Evaluated by Dr. and treated with ice pack therapy, Ibuprofen 400-600mg TID, and Keflex 500 mg TID.

VAERS ID:454825 (history)  Vaccinated:2012-04-09
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-12
Location:Georgia  Entered:2012-05-02, Days after submission: 20
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA0SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Burning, itching, redness, swelling at around injection site. Ended up calling MD, who sent pt to urgent care. Pt received DECADRON shot & Z-PAK for allergic reaction. No other symptoms.

VAERS ID:455026 (history)  Vaccinated:2012-04-09
Age:61.0  Onset:2012-04-13, Days after vaccination: 4
Gender:Female  Submitted:2012-05-05, Days after onset: 22
Location:Minnesota  Entered:2012-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: "Hole in heart" reported by patient
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1161AA SCLA
Administered by: Other     Purchased by: Private
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)
Write-up: Ischemic stroke.

VAERS ID:455364 (history)  Vaccinated:2012-04-09
Age:13.0  Onset:2012-04-19, Days after vaccination: 10
Gender:Female  Submitted:2012-05-11, Days after onset: 22
Location:Kansas  Entered:2012-05-11
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586BA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1359AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Fall, 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)
Write-up: Patient was sitting on the exam table, RN who administered HPV and Hep A vaccines had her back to the pt. talking with mother of pt. 1-2 minutes after vaccine administered pt. fainted and fell face first off the exam table. Loss of consciousness for 5-10 seconds, Dr. was summoned to the room immediately and pt. was moved to the exam table and examined by Dr.

VAERS ID:455622 (history)  Vaccinated:2012-04-09
Age:1.6  Onset:2012-04-11, Days after vaccination: 2
Gender:Female  Submitted:2012-05-15, Days after onset: 34
Location:California  Entered:2012-05-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lump/mass in left breast
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227202IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1212AA0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Blister, Erythema, Exposure to communicable disease, Pain, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mom stated pt began having a rash with blistery type lesions to left lower extremity and buttocks. Pt did not have fever - blisters became red and then popped. Pt complained they hurt but did not itch. Mom stated pt did not act sick & played with other children and ate as usual. Lesions have improved at time of visit - per Mom. Mom denies problem at injection site. Pt had been exposed to caregiver with history of MRSA.

VAERS ID:458932 (history)  Vaccinated:2012-04-09
Age:1.7  Onset:2012-04-24, Days after vaccination: 15
Gender:Female  Submitted:2012-07-10, Days after onset: 77
Location:New Jersey  Entered:2012-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1204USA03861
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1062AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Decreased activity, Decreased appetite, Rash generalised, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 20 month old patient with no drug reaction, no allergies, and no pertinent medical history who on 09-APR-2012 was vaccinated subcutaneously with a 5.0ml dose of VARIVAX (Merck) (LOT# 671126/1062AA, exp. date 05-Jul-2013). There was no concomitant medication. The physician mentioned on 21-APR-2012 the patient developed chicken pox. The child had 10 lesions and no fever. The patient had visited office to sought medical attention. At the time of this report, the patient had not recovered. Follow up information has been received from a physician who reported that the 20 month child female patient with no illness at the time of vaccination, no pre-existing allergies, birth defects and medical conditions was vaccinated with a first dose of VARIVAX (Merck) (671126/1062AA), IM, (previously reported as SQ) at 18:00. The physician described that on 24-APR-2012 at 18:00 (previously reported as 21-APR-2012) the patient experienced chickenpox, rash that had grown from leg to "over all body", decreased appetite and activity. There were no labs performed. At the time of reporting, the patient''s outcome from rash that had grown from leg to "over all body", decreased appetite and activity was unknown. Additional information has been requested.

VAERS ID:461094 (history)  Vaccinated:2012-04-09
Age:75.0  Onset:2012-05-19, Days after vaccination: 40
Gender:Female  Submitted:2012-07-28, Days after onset: 70
Location:Georgia  Entered:2012-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1205USA04148
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1266AA SCLA
Administered by: Other     Purchased by: Other
Symptoms: Joint swelling, Musculoskeletal pain, Neck pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a pharmacist concerning a 75 year old female with allergy to penicillin, sulfa, PRILOSC, OTC) and LEVAQUIN and none pertinent medical history who on 09-APR-2012 was vaccinated with one 0.65 ml dose of ZOSTAVAX (Merck) (lot #: 671140/1266AA, expiration date unknown) subcutaneously in left arm. On 19-MAY-2012 the patient experienced in the left arm pain that was radiating up and down the arm that went up to the shoulder and neck. This was a sharp constant pain and very painful. There was no redness or swelling at the injection site. The patient''s left wrist felt mildly swollen. Patient made a phone call to seek medical attention. "Hydrocodone (manufacturer unknown) for pain but it did not relieve the pain". No lab test performed. At the time of this report, patient had not recovered. Additional information is not expected.

VAERS ID:491519 (history)  Vaccinated:2012-04-09
Age:0.0  Onset:2012-04-19, Days after vaccination: 10
Gender:Male  Submitted:2013-05-13, Days after onset: 389
Location:Pennsylvania  Entered:2013-05-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tamiflu; Amox
Current Illness: RESOLVED FLU-LAST FEVER 4 DAYS PRIOR; BOM- slow improvment
Preexisting Conditions: None
Diagnostic Lab Data: CBC/CXR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB677AB0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0130420SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0146270SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Chest X-ray, Cyanosis, Dyspnoea, Fatigue, Full blood count, Mydriasis, Pyrexia, Respiratory rate increased, Staring, Tension, Tremor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fever began 4/19. was 104 at ED, no temp take at home. Was at bd party. Was staring, large pupils, not responding ?lips turned blue. Breathing harder and faster. "Was tense and shaking" lasted 1 min total. Very tired for 1hr after. Taken to ER. Given rocephin/omnicef.

VAERS ID:520946 (history)  Vaccinated:2012-04-09
Age:  Onset:2012-04-09, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-28, Days after onset: 659
Location:Unknown  Entered:2014-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009199
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.00869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:520963 (history)  Vaccinated:2012-04-09
Age:  Onset:2012-04-09, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-28, Days after onset: 659
Location:Unknown  Entered:2014-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009200
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:453958 (history)  Vaccinated:2012-04-09
Age:14.0  Onset:2012-04-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-18, Days after onset: 9
Location:Foreign  Entered:2012-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0795446A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Fall, Loss of consciousness, Presyncope, Syncope, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s body temperature before the vaccination was 36.6 degrees Centigrade. On 9 April 2012, at 15:20, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left upper arm). The subject received the vaccination in a sitting positive on a sofa. On 9 April 2012, at 15:21, 1 minute after vaccination with CERVARIX, the subject experienced syncope, afebrile convulsion, vasovagal reaction, loss of consciousness and loss of posture. When she received the vaccination, the subject remembered that she was told that it would be completed soon, but she had no memory after that. After the vaccination was completed, she lay as if she fell sideways. Convulsion-like movement was noted once in each upper extremity. She regained consciousness immediately and was placed under observation while taking a rest with the lower extremities raised for 30 minutes. Thirty minutes later, she was able to walk by herself and left for home. The physician considered the events were clinically significant (or requiring intervention). On 9 April 2012, the events were resolved after 30 minutes. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:454121 (history)  Vaccinated:2012-04-09
Age:59.0  Onset:0000-00-00
Gender:Male  Submitted:2012-04-19
Location:Foreign  Entered:2012-04-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Amyotrophic lateral sclerosis; Paralysis; Mechanical ventilation; Gastric fistula
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure measurement, 09Apr12, Slightly decreased; chest X-ray, 10Apr12, Negative; chest computed axial tomography, 10Apr12, Negative; body temp, 10Apr12, 38 degrees C; serum C-reactive protein, 10Apr12, 5 mg/dL, Also reported as 5.0-5.9; serum procalcitonin, 10Apr12, Strong positive
CDC Split Type: WAES1204USA01346
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Blood culture, Blood pressure decreased, C-reactive protein increased, Chest X-ray normal, Computerised tomogram normal, Procalcitonin increased, Pyrexia, Sepsis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a physician and a pharmacist concerning a 59 year old male patient with amyotrophic lateral sclerosis (ALS), asthma, nerve paralysis, ventilation user and gastric fistula who on 09-APR-2012 was vaccinated with a dose of PNEUMOVAX 23 injection, parenteral, 0.5 ml once a day (lot number not reported). Information of concomitant medication was unknown. On 09-APR-2012, the patient received pneumococcal vaccine (as stated above), after coming back home, fever began to appear. Blood pressure slightly decreased. In April 2012, the patient developed sepsis. On 10-APR-2012, the patient visited the hospital. The patient had fever of 38 degrees C and bacterial infection was suspected. CRP was positive in the 5''s (5.0-5.9). Procalcitonin was +++, showing strong positive. Chest X-ray and CT showed negative. At the time of this report, the patient had not recovered from sepsis. The patient was under observation with ZOSYN via drip infusion. The reporting physician considered that the sepsis was serious due to other important medical event. The reporting physician felt that sepsis was definitely related to pneumococcal vaccine. Reporter''s comment: This patient had been treated at home for neurological intractable disease called ALS and he was a ventilator user. He had nerve paralysis and had difficulty in swallowing medications, so medications had been administered via gastric fistula. Because of this type of patient, there was a concern that aspiration pneumonia and pneumonia might repeatedly occur because of ill condition of respiratory function, and therefore pneumococcal vaccine was injected. There was probably some kind of bacterial infection. Since pneumococcal vaccine was injection yesterday, it was also speculated that there might be relation with this too. Blood culture was examined but the result has not come out yet. Additional information has been requested.

VAERS ID:455141 (history)  Vaccinated:2012-04-09
Age:1.5  Onset:2012-04-12, Days after vaccination: 3
Gender:Female  Submitted:2012-05-07, Days after onset: 25
Location:Foreign  Entered:2012-05-08, 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:
Current Illness:
Preexisting Conditions: No medical history (including allergy); No concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201204539
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG14542UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: General physical health deterioration, Kawasaki's disease, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow)
Write-up: Case received from the Health Authorities through the local foreign affiliate on 26 April 2012 under the reference number HIB-363 (local reference number A201200122). An 01-year and 06-month-old female patient, with no medical history (including allergy) and no concomitant therapies, had received her 3rd subcutaneous dose of ACT-HIB, batch number G1454, on 09 April 2012. On 12 April 2012 (ay "00:00am"), i.e. 3 days post-vaccination, the patient experienced pyrexia over 38.5 C. Her general condition was bad. She was hospitalized from 13 to 21 April 2011. The diagnosis was Kawasaki''s disease. Unspecified treatment was given. The outcome was "recovering" on 17 April 2012. The causality of the case was not assessable. Documents held by sender: none.

VAERS ID:455290 (history)  Vaccinated:2012-04-09
Age:79.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-10
Location:Foreign  Entered:2012-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease; Spinal cord disorder
Preexisting Conditions: Cardiac pacemaker insertion
Diagnostic Lab Data:
CDC Split Type: PHHY2012AR031393
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS113621 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Bone pain, Dizziness, Dyspnoea, Feeling abnormal, Gait disturbance, Sensation of heaviness, Tremor
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad)
Write-up: Case number PHHY2012AR031393 is an initial spontaneous report received from a consumer on 12 Apr 2012 with a follow up information received on 18 Apr 2012 with the follow-up received on 03 May 2012: This refers to a 79-year-old female patient. Her medical history included chronic problems in the spinal column, chronic obstructive pulmonary disease (COPD) and pacemaker placement. Concomitant medications included calcium every mornings and Simethicone 250mg sometimes. Her vaccination history included administration of AGRIPPAL S1 in 2011, without any problem. She was vaccinated with AGRIPPAL (batch number: 113621 and expiry date: Aug 2012) on 09 Apr 2012. On 11 Apr 2012 she experienced walking instability, dizziness, bony pain and tremors. She consulted the rheumatologist, who indicated DIOXAFLEX as a treatment measure (medication that she was receiving). At the moment of this report she did not have tremors but she felt worse. In the follow up information, it was reported that she had heaviness in lower limb which was described as a certain kind of walking instability. She did not have fever and had appetite. She said that, she was consulted her treating cardiologist due to dyspnea (onset date was not informed) and cardiologist answered pacemaker was a little accelerated. Physician reported that, she was not evaluated for the events previously. The event outcome of heaviness in lower limb and walking instability was reported as condition unchanged and that of tremors was reported as complete recovery and the rest of the events were not reported. Follow up received on 18 Apr 2012: Medical history updated, Heaviness in lower limb coded as an event, outcome of the events updated. Follow-up received on 03 May 2012: Updated concomitant medications (calcium and simethicone), adverse event (dyspnea) and physician comments.

VAERS ID:464673 (history)  Vaccinated:2012-04-09
Age:59.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-11
Location:Foreign  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0992415A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Breast cancer
SMQs:, Malignant tumours (narrow), Breast malignant tumours (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of breast cancer in a 59-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on 22 December 2011. On 9 April 2012 the subject received 2nd dose of ENGERIX B (unknown). Recently, less than one year after vaccination with ENGERIX B, the subject experienced breast cancer. The pharmacist inquired if it was best to administer the 3rd dose of ENGERIX B before or after the subject''s scheduled lumpectomy. No side effects were reported with the 1st and 2nd dose of ENGERIX B but the subject is due for her 3rd dose of ENGERIX B but has to undergo a lumpectomy due to recent diagnosis of breast cancer. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the breast cancer was unspecified.

VAERS ID:478793 (history)  Vaccinated:2012-04-09
Age:13.0  Onset:2012-04-10, Days after vaccination: 1
Gender:Female  Submitted:2012-12-19, Days after onset: 253
Location:Foreign  Entered:2012-12-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood sugar test also carried out at Accident and Emergency department.
CDC Split Type: B0853408A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose, Electrocardiogram, Nervousness, Panic attack, Psychiatric symptom, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a foreign regulatory authority (GB-MHRA-EYC 00085798) and described the occurrence of panic attack in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic medications included 2 doses of CERVARIX. On 9 April 2012 the subject received the 3rd dose of CERVARIX. On 10 April 2012, 1 day after vaccination with CERVARIX, the subject experienced vomiting. On 11 April 2012, the patient experienced a panic attack. The patient was taken to Accident and Emergency where they carried out an electrocardiogram (ECG) and blood sugar tests (results not specified). On an unknown date the patient also experienced nervousness. The regulatory authority reported that the events were disabling. Relevant test results included [laboratory results/hospital investigations]. At the time of reporting the outcome of the events was unspecified. MHRA Verbatim Text: My daughter had the 3rd part of the course on the Monday, on Tuesday sent home from school after vomiting. On Wednesday she experienced the first panic attack. She was taken to Accident and Emergency (A and E). Doctor there carried out electrocardiogram (ECG), blood sugar and after researching on the internet suggested a connection with the immunisation. Now three weeks later these attacks are occurring regularly. My GP has told her they will subside eventually. But in the meantime a normal healthy girl has been turned into a nervous, unconfident person.

VAERS ID:453316 (history)  Vaccinated:2012-04-10
Age:0.2  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-04-10, Days after onset: 0
Location:Massachusetts  Entered:2012-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4144AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0894AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHE796650IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0378AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 4 hours after receiving PENTACEL in (L) thigh, area became red, swollen, warm, hard intradermal mass, severe irritability.

VAERS ID:453346 (history)  Vaccinated:2012-04-10
Age:0.3  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 1
Location:Virginia  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: congestion x 5 days
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4117AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF561771IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1474AA1PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad)
Write-up: Mom noticed redness on leg surrounding injection site after patient woke up from nap @ 3:30 PM today. No fever, acting slightly more fussy, no cough or breathing changes. Upon arriving at office, CPNP describes reaction as mild erythema on right thigh 2" x 2.5" in diameter surrounding the injection site, no fluctuance, no pain on palpation. She stated the redness seemed to "come and go" while she was in the room. Mom and dad stated the redness was "much less" when in office than it was earlier.

VAERS ID:453352 (history)  Vaccinated:2012-04-10
Age:54.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:Florida  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYR 
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Chills, Headache, Musculoskeletal stiffness
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: 54 yr old F pt was given Zostavax injection 4/10 at 1000 hr. Pt called the facility at 4/11 0045 hr. Pt c/o stiff neck and shivering. Pt denied fever. Follow up call 4/11 at 1013 hr. Pt was enroute to hospital. Pt c/o severe stabbing h/a and max temp of 103.0 f. Case was reviewed with Toxicologist and plan to f/u with pt & hospital.

VAERS ID:453368 (history)  Vaccinated:2012-04-10
Age:24.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:New York  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline Hyclate 100mg 7Feb2012 Prenatal Vitamins 30Aug2011
Current Illness: none
Preexisting Conditions: none stated by patient
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3071IMLA
Administered by: Military     Purchased by: Military
Symptoms: Human chorionic gonadotropin negative, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: On 04/10/2012 in the clinic the said patient came into the clinic and did a urine HCG test with negative results at 0830. At this time she requested a serum HCG to be performed and this test was ordered and drawn. At this time she was asked if there was any reason why she would think that this test would show different results then the negative urine HCG had and she said no. She had not even missed a menses at this time. She then came back at 1513 and received her 2nd Anthrax dose. At 0730 on 04/11/2012 we received the report from the lab that the serum HCG came back positive. She came into the clinic and received her counseling from the PA and the nursing staff. The chief of Preventive Medicine has been informed and the unit has been informed that the said patient cannot deploy.

VAERS ID:453383 (history)  Vaccinated:2012-04-10
Age:4.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-04-11, Days after onset: 1
Location:Texas  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NO MEDS
Current Illness: URI and Conjunctivitis
Preexisting Conditions: Presumed Peanut Allergy; History of severe Eczema up to age 3
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4002BA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG150014SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1296AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1437AA1SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pruritic urticaria of face, chest, arms and shoulders. No respiratory or cardiac issues. IM Epinephrine and po Benadryl given. Transported to Emergency Room via ambulance for further observation and treatment.

VAERS ID:453399 (history)  Vaccinated:2012-04-10
Age:70.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:New Hampshire  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA 81 mg po daily Atenolol 100mg po BID Coumadin 5mg po daily Hydrochlorothiazide 50 mg po daily Lipitor 40mg po daily Vitamin E 100 units po daily
Current Illness:
Preexisting Conditions: Proxismal Atrial Fib-on anticoagulation, HTN, Hyperlipidemia, S/P left shoulder fx, CHF; allergies: Tylenol, Codiene
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA0IMRA
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, redness, tenderness, warmth. Ice packs and elevation.

VAERS ID:453406 (history)  Vaccinated:2012-04-10
Age:12.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 1
Location:California  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None; NKA
Diagnostic Lab Data: Blood pressure 98/50; Heart rate 72; Resp. rate 20; Post seizure blood pressure 108/83; Blood glucose 87
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0477AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood glucose normal, Convulsion, Dyskinesia, Gaze palsy, Presyncope, Protrusion tongue, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Post-Syncope Seizure, 30 seconds after receiving GARDASIL 0.5 ml left deltoid patient had vasovagal reaction - fainted eyes rolled back. Tongue protruded, full body jerking for 15 seconds, patient unresponsive during seizure activity, EMS notified.

VAERS ID:453420 (history)  Vaccinated:2012-04-10
Age:56.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:Montana  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: soft palate defect at birth, reconstructed
Diagnostic Lab Data: CBC pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1759AA SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Full blood count, Lymphadenopathy, Pain, Palatal disorder, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Achy, feverish, swelling of soft palate and lymph nodes.

VAERS ID:453426 (history)  Vaccinated:2012-04-10
Age:41.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 1
Location:North Carolina  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congenital bronchiectasis
Preexisting Conditions: Allergy SEPTRA; Congenital bronchiectasis; Renal agenesis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Feeling hot, Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Local erythema, edema, tenderness, warmth within 12 hrs treated with antihistamines & cool compress.

VAERS ID:453429 (history)  Vaccinated:2012-04-10
Age:3.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:Michigan  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Adverse event.~Pneumo (Prevnar13)~UN~0.00~Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergy to Penicillin and Codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181724UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had a large amount of redness. Swelling, and itching at site of immunization. Pt did not have any trouble with breathing. Parents gave BENADRYL and brought pt in. They were instructed to continue BENADRYL.

VAERS ID:453448 (history)  Vaccinated:2012-04-10
Age:5.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:North Carolina  Entered:2012-04-12
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: None
Diagnostic Lab Data: Clinical observation
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0870AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0827AA1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: (L) thigh with blanching redness & warmth, swelling noted, painful - all symptoms were noted the day after vaccine given.

VAERS ID:453555 (history)  Vaccinated:2012-04-10
Age:11.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:California  Entered:2012-04-12
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
TDAP: TDAP (ADACEL)SANOFI PASTEURU4304BA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1402AA1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Left arm swollen at inj. site & red yesterday. Slightly improved today, achy & vomiting today. Arm was painful yesterday, but improved today. Rx given for ZOFRAN & return if worse.

VAERS ID:453572 (history)  Vaccinated:2012-04-10
Age:0.6  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Virginia  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Just weaned off phenobarbital 3 weeks ago
Current Illness: None
Preexisting Conditions: Pt followed since 3wks old for myoclonic seizures and on phenobarbital. Just weaned off med in last 3 weeks after neurology said EEG''s were normal.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC14B121BB2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4231BB0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1189AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181732IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0887AA2PO 
Administered by: Military     Purchased by: Military
Symptoms: Abnormal behaviour, Body temperature increased, Chest X-ray normal, Crying, Injection site erythema, Laboratory test normal, Staring, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Infant began with inconsolable crying when at ER found to have temperature 103.8. CXR, Lab, and UA were reported as normal by mother. Given Motrin and discharge home. Returned to another ER at 4PM with behavior changes, staring and local erythema to right thigh was noted. 4/12/12 Erythema now 10mm X35 mm on lateral thigh. Temp 98.8 and infant happy and smiling.

VAERS ID:453574 (history)  Vaccinated:2012-04-10
Age:28.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Hawaii  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Minor Redness~Anthrax (Biothrax)~UN~24.00~Patient
Other Medications: Nexium
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV30711IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient received 0.5 ml Anthrax IM in left deltoid on 10APR2012 at 0915. On 11APR2012, patient began to notice swelling and itchiness at 12 noon. The left deltoid increased in redness, swelling, itchiness, and tenderness throughout the day. Patient reported on 12APR2012 at 0845 with the prior listed signs and symptoms. Medical staff notified. Patient given heat pack, ACE Bandage, and 25 mg Benadryl PO. Patient will continue to be monitored by hospital personnel for any signs of resolution.

VAERS ID:453576 (history)  Vaccinated:2012-04-10
Age:4.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:North Carolina  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC IBUPROFEN
Current Illness: N/A
Preexisting Conditions: HISTORY OF AUGMENTIN ALLERGY (RASH ON 05/29/09)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193BA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1570AA2SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880445IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1433AA2SCLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Erythema, Feeling hot, Injection site erythema, Injection site induration, Pain, Tenderness
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: ONSET SLOWLY PROGRESSIVE REDNESS AND LOCAL HEAT STARTED 04/11/12; FEW VESICLES NOTED BUT NOW RESOLVED, SOME SUBJECTIVE COMPLAINTS OF SORENESS/TENDERNESS - ON EXAM 6.5CM X 5CM AREA OF MILD INDURATION AND ERYTHEMA LEFT ARM BELOW DELTOID.

VAERS ID:453586 (history)  Vaccinated:2012-04-10
Age:12.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:Texas  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1359AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA101270IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B073CA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Disturbance in attention, Fatigue, Injection site erythema, Injection site swelling, Pain in extremity
SMQs:, Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad)
Write-up: (L) upper arm - redness around entire upper arm - swollen - pt. is tired, unable to concentrate and leg pain bilaterally.

VAERS ID:453640 (history)  Vaccinated:2012-04-10
Age:68.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 2
Location:Washington  Entered:2012-04-12
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0693AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Feeling abnormal, Headache, Herpes zoster, Injection site erythema, Injection site swelling, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt got severe swelling at the site of injection. Very Red, about 3 inches in diameter. No pain or drainage at site. In addition, she feels tingly in her hands and feet and has a headache in the back of her head. She states ''she just doesn''t feel right'' after the injection. I advised her to check with her doctor due to the side effects from the vaccine. She is getting better now, as the redness has gone down to about 1" or so. Still feels the tingle but not as bad as before. We think she may have a small case of shingles from the vaccine.

VAERS ID:453641 (history)  Vaccinated:2012-04-10
Age:19.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 2
Location:Wisconsin  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: Cough
Preexisting Conditions: Allergic to Bees
Diagnostic Lab Data: CBC, BMP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dehydration, Erythema, Full blood count, Headache, Metabolic function test, Nausea, Oedema peripheral, Pyrexia, Skin warm, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Warm, red, swollen right arm. Facial redness, frontal headache, nausea, vomiting, fever, dehydration.

VAERS ID:453626 (history)  Vaccinated:2012-04-10
Age:11.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Male  Submitted:2012-04-13, Days after onset: 1
Location:Kentucky  Entered:2012-04-13
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURV3906AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR20296855UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Tender, swollen, erythema (L) upper arm mildly firm, but no induration. Min splotchy erythema (12-16 cm width x 15 cm length) & itching.

VAERS ID:453651 (history)  Vaccinated:2012-04-10
Age:46.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-04-13, Days after onset: 3
Location:Michigan  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothizide, Tylenol.
Current Illness: Denied
Preexisting Conditions: NKA
Diagnostic Lab Data: As of this date, patient has responded to Solu Medrol 125mg IM, Benadryl 50mg po x3 doses so far. Is 50% better today from when I saw him on afternoon shift yesterday.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4034AA IM 
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Dizziness, Erythema, Malaise, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: General aches and malaise developed systemic pinkened skin progressed to reddened. Developed dizziness, malaise worse, low grade temp of 100.00.

VAERS ID:453656 (history)  Vaccinated:2012-04-10
Age:17.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Male  Submitted:2012-04-12, Days after onset: 0
Location:Texas  Entered:2012-04-13, 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: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4104AA5IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1207AA1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness about 2 inches in diameter at injection site (R) arm from varicella vaccination. Pt c/o pain & itching at inj site. Monitor injection site & report any changes.

VAERS ID:453702 (history)  Vaccinated:2012-04-10
Age:4.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 2
Location:Arizona  Entered:2012-04-13, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1024AA1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1377AA1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Local reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized reaction - swelling, erythema & pain.

VAERS ID:453704 (history)  Vaccinated:2012-04-10
Age:48.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-13
Location:Florida  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: laceration
Preexisting Conditions: Mood disorder
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU4173AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Neck pain, Pain in extremity, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Swollen & indurated, red & pt states that it is warm, fever, neck pain, lt arm pain.

VAERS ID:453729 (history)  Vaccinated:2012-04-10
Age:54.0  Onset:2012-04-13, Days after vaccination: 3
Gender:Male  Submitted:2012-04-13, Days after onset: 0
Location:Texas  Entered:2012-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI
Preexisting Conditions: Diabetes
Diagnostic Lab Data: CBC - WBC elevated 13.7 with a mild left shift
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Full blood count, Injection site cellulitis, Shift to the left, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Cellulitis at the injection site. Treated with oral antibiotic. Follow-up scheduled in 3 days.

VAERS ID:453731 (history)  Vaccinated:2012-04-10
Age:77.0  Onset:2012-04-13, Days after vaccination: 3
Gender:Female  Submitted:2012-04-14, Days after onset: 1
Location:Iowa  Entered:2012-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa - allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Eye pruritus, Eyelid oedema, Pruritus, Skin exfoliation, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Redness, itching, warmth on face, palms of hands, chest & legs started 4-13-2012 (3 days post immunization) itchy eyes - swelling rim of eyelids. No difficulty breathing or swelling of tongue. 4/15 Face is peeling eyes still itching. 4/16 - Redness gone still face peeling no eyes itching.

VAERS ID:453777 (history)  Vaccinated:2012-04-10
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-16
Location:Illinois  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0747AA SCLL
Administered by: Unknown     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: CHILD HAS NOT HAD ANY ADVERSE REACTION.

VAERS ID:453792 (history)  Vaccinated:2012-04-10
Age:25.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Female  Submitted:2012-04-16, Days after onset: 4
Location:Michigan  Entered:2012-04-16
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: Allergies: Penicillin, Seasonal
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1524AA1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Burning sensation, Insomnia, Muscular weakness, Musculoskeletal stiffness, Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Client c/o pain and weakness in right arm and hand. Hand stiff and swollen. Unable to lift a glass of milk. C/o tingling and burning in elbow and shoulder. Has had fever on and off. Arm is constantly throbbing. Pain wakes her up at night. Instructed to be seen by primary care physician on 4/16/2012.

VAERS ID:453803 (history)  Vaccinated:2012-04-10
Age:74.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 2
Location:Indiana  Entered:2012-04-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; thyroid; cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Pain, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt stated noticed redness / splotching and felt expanded next AM. No itchy but yes pain. Today better but saw MD and MD said just use hydrocortisone cream. Is better now.

VAERS ID:453805 (history)  Vaccinated:2012-04-10
Age:20.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 2
Location:Tennessee  Entered:2012-04-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No c/o illness
Preexisting Conditions: NKA; NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC039AA1IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.0963AA1IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0342AA0SCUN
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and 1/2 dollar sized blistering at varicella administration site surrounding area of erythema and heat. CDC contacted. Tx = cold compress, analgesia, & BENADRYL. Patient instructed to go to ER if area worsens.

VAERS ID:453807 (history)  Vaccinated:2012-04-10
Age:61.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-13, Days after onset: 2
Location:Pennsylvania  Entered:2012-04-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High cholesterol; IBS; osteopenia; migraine; anxiety; B12 & Vit D deficiency
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1197AA0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 4cm x 7cm shaped rash began 1 day after injection at site of injection. Tender, warm, itchy.

VAERS ID:453864 (history)  Vaccinated:2012-04-10
Age:43.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Female  Submitted:2012-04-12, Days after onset: 0
Location:Maryland  Entered:2012-04-17, 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: SYNTHROID; CHANTIX; generic PRILOSEC; MVI; CA++
Current Illness: None
Preexisting Conditions: Sinus problems; Thyroid disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB231AA1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: 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: Day after receiving 2 vaccines, pt. had a rapid heart-rate that lasted approx. 1 min. also c/o "hard to get my breath." States she''s never noticed this happening before.

VAERS ID:453888 (history)  Vaccinated:2012-04-10
Age:70.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-17, Days after onset: 6
Location:California  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Vivelle dot (estrogen patch), losartin, Zoloft, panto__erole (GERD), multi-vitamin, Vit''s D, C, E; mag-ox, fish oil, calcium citrate
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1199AA0SYRLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Headache, Immediate post-injection reaction, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Pruritus, Pyrexia, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Redness, Itching & Swelling started immediately. Then 24 hours after injection Chills, Fever, Headache, Flu-like feeling, increased Muscle Soreness. Injection site raised, hot & red. This started fairly soon after shot was received. The area around the injection site was 1/2 of a golf ball in size, with the redness area expanding from the back of my upper arm to my elbow in length and 4"-5" in width. Muscle soreness continued for 1 week. Benadryl helped itchiness.

VAERS ID:453898 (history)  Vaccinated:2012-04-10
Age:65.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-17, Days after onset: 6
Location:Wisconsin  Entered:2012-04-17
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: PCN; Iodine; Rubber; gas
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1743AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left deltoid has a 50mm round, pink, warm, raised area that is itchy over 7 days. Medical staff states to use warm compresses several times per day & return to clinic if not getting better.

VAERS ID:453918 (history)  Vaccinated:2012-04-10
Age:38.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-10, Days after onset: 0
Location:Washington  Entered:2012-04-17, 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:
Current Illness: Swelling; redness and hot; painful
Preexisting Conditions: IMITREX
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB493BA1IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE05760IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Once I pulled the needle out I noticed immediate swelling and redness. Patient also complaint of pain, cool compress applied, 600 mg ibuprofen given PO within 10 min swelling & redness decreased. Topical anesthetic applied to site per MD orders (mc cream).

VAERS ID:453936 (history)  Vaccinated:2012-04-10
Age:10.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-04-13, Days after onset: 2
Location:Virginia  Entered:2012-04-18, 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: METHYLIN; BACTROBAN; Amoxicillin; Clonidine HCl
Current Illness: None
Preexisting Conditions: Symptom, insomnia NOS; Sinusitis, acute NEC; Diarrhea; Disorder, attention deficit w/o hyperactivity; Cleft palate, unspecified; Infantile cerebral palsy, unspecified; Anxiety state NOS; Unspecified delay in development; Pierre robin syndrome; Other extrapyramidal diseases and abnormal movement disorders; Hypotony of eye, unspecified; Conditions due to anomaly of unspecified chromosome;
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0UNLL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4030AA0UNRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071BB0UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0979AA1UNLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness/swelling and warm to the touch 1 day after vaccine.

VAERS ID:454088 (history)  Vaccinated:2012-04-10
Age:16.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 1
Location:New Jersey  Entered:2012-04-20, Days after submission: 9
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0565Z0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Headache, Lethargy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Mother reports pt. c/o fever, headache onset 7 PM 4/10/12. Treated with ADVIL 4 tsp. 4.11.12 AM continues to c/o lethargy, nausea, fever 100.2 - to take ADVIL 4 tsp at 1330. 4/11/12 430 PM - spoke to pt. - reports improv. of symptoms.

VAERS ID:454089 (history)  Vaccinated:2012-04-10
Age:1.2  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-20, Days after onset: 9
Location:Pennsylvania  Entered:2012-04-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Daughter had cut finger on soup can. Hence we got her a TDAP for the tetanus vaccination.
Preexisting Conditions: None
Diagnostic Lab Data: Hospital diagnosed patient as having Bronchiolitis. She received albuterol treatment, later followed by prednisone.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140BA0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Bronchiolitis, Cough, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Eosinophilic pneumonia (broad)
Write-up: Daughter had cough and sounded very congested respiratory wise. Around 7pm taken to the ER where they administered a breathing treatment. Given an albuterol inhaler. She was nominally better and worsened the following day. She was taken for a second treatment and given Prednisone which seemed to have a strong positive affect.

VAERS ID:454266 (history)  Vaccinated:2012-04-10
Age:61.0  Onset:2012-04-14, Days after vaccination: 4
Gender:Female  Submitted:2012-04-23, Days after onset: 9
Location:Oregon  Entered:2012-04-24, Days after submission: 1
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: HTN; Colitis; Allergic rhinitis; Osteoarthritis; IBS
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1600AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Increased swelling in joints, most pronounced in DIP joints of fifth fingers bilaterally.

VAERS ID:454320 (history)  Vaccinated:2012-04-10
Age:78.0  Onset:2012-04-11, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 5
Location:Ohio  Entered:2012-04-25, Days after submission: 9
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1197AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: (R) elbow to little finger numbness.

VAERS ID:454387 (history)  Vaccinated:2012-04-10
Age:50.0  Onset:2012-04-14, Days after vaccination: 4
Gender:Female  Submitted:2012-04-25, Days after onset: 11
Location:Ohio  Entered:2012-04-25
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB524AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3541AA0UNRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE04420UNRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pruritus, Skin lesion, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Rec''d HepA #1, Tdap & Typhoid on 4-10-12. Broke out with red, raised hive described as a "cherry tomato" - progressively got larger - also has 4 smaller lesions. Initial break-out 1 week later and smaller lesions 11 days following vaccines. Mild itching.

VAERS ID:454394 (history)  Vaccinated:2012-04-10
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-10
Location:Michigan  Entered:2012-04-25, Days after submission: 15
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: NKA; Otitis media; Allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0870AA1UNRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1256AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Local reaction, Wrong drug administered
SMQs:
Write-up: Pt was mistakenly administered ZOSTAVAX instead of varicella. She experienced a minimal localized reaction at the injection site, which was relieved by childrens pain relief and topical BENADRYL.

VAERS ID:454555 (history)  Vaccinated:2012-04-10
Age:59.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-24, Days after onset: 14
Location:Massachusetts  Entered:2012-04-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis
Preexisting Conditions: Hypothyroidism; Endocervical polyp; chondromalacia patella
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient spoke with PCP on 4/20/12. She reported that she had a febrile reaction to Tdap along with chills and myalgias that lasted a few days. Pt has had boosters in the past without problems. ? relation to Pertussis component?

VAERS ID:454578 (history)  Vaccinated:2012-04-10
Age:23.0  Onset:2012-04-26, Days after vaccination: 16
Gender:Male  Submitted:2012-04-29, Days after onset: 3
Location:Unknown  Entered:2012-04-29
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 to strawberries, Ceclor
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Other     Purchased by: Military
Symptoms: Rash, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 16 days post vaccination, diffused raised rash, started on hands, progressed to trunk and lower and upper extremities. Does not itch, but blisters are tender. Senior Medical Officer awaiting response from Infectious Disease for plan of care.

VAERS ID:454681 (history)  Vaccinated:2012-04-10
Age:29.0  Onset:2012-04-13, Days after vaccination: 3
Gender:Female  Submitted:2012-04-30, Days after onset: 17
Location:Wisconsin  Entered:2012-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mononessa (birth control)
Current Illness: none
Preexisting Conditions: Allergy - Penicillin
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4304AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt calls to state she has a hard 50 cent sized red area that is warm to the touch at injection site. She also complains of soreness in the arm. She was instructed to apply ice, take ibuprofen, and call if symptoms persist.

VAERS ID:455525 (history)  Vaccinated:2012-04-10
Age:40.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Virginia  Entered:2012-05-14
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455568 (history)  Vaccinated:2012-04-10
Age:23.0  Onset:0000-00-00
Gender:Male  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455570 (history)  Vaccinated:2012-04-10
Age:21.0  Onset:0000-00-00
Gender:Male  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455571 (history)  Vaccinated:2012-04-10
Age:47.0  Onset:0000-00-00
Gender:Male  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455572 (history)  Vaccinated:2012-04-10
Age:29.0  Onset:0000-00-00
Gender:Male  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455580 (history)  Vaccinated:2012-04-10
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:455581 (history)  Vaccinated:2012-04-10
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2012-04-27
Location:Virginia  Entered:2012-05-14, Days after submission: 17
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: Expired Smallpox given with positive reaction, no clinical adverse effect noted.

VAERS ID:456396 (history)  Vaccinated:2012-04-10
Age:48.0  Onset:2012-04-20, Days after vaccination: 10
Gender:Female  Submitted:2012-05-20, Days after onset: 30
Location:California  Entered:2012-05-29, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Headaches
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Public     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash all over arms, legs, feet, stomach lasting about 2 1/2-3weeks started on 4-20-12 went to urgent care.

VAERS ID:456593 (history)  Vaccinated:2012-04-10
Age:23.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Female  Submitted:2012-05-23, Days after onset: 41
Location:Illinois  Entered:2012-05-31, Days after submission: 8
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: Obesity
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4137AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Lymph node pain, Nodule, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Tdap on 4/10/12. She presented to our triage RN on 4/12 complaining of a "knot" on her shoulder. She was seen by me on 4/13/12. She had pain & redness at injection site. Erythema was 4-5 cm in diameter. She also had a < 1 cm (L) supraclavicular lumph node that was tender. She was seen by another doctor on 5/11/12 & lymph node was resolving. (Some fullness in area - but not LAD).

VAERS ID:457027 (history)  Vaccinated:2012-04-10
Age:  Onset:2012-04-30, Days after vaccination: 20
Gender:Female  Submitted:2012-06-07, Days after onset: 38
Location:Florida  Entered:2012-06-08, Days after submission: 1
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: None
Diagnostic Lab Data: Diagnostic laboratory, Came up as what the physician believes as a false positive for lupus.
CDC Split Type: WAES1206USA00221
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, False positive investigation result, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a female patient with no pertinent medical history, who on an unknown date was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). The reporter stated that 1-2 months after the 2nd dose of GARDASIL the patient experienced weakness, tiredness, fatigue and muscle aches. The physician did unspecified lab work that came up as what the physician believes as a false positive for lupus. The patient went to an unspecified Rheumatologist who ran another set of unspecified lab work (results unspecified) and the Rheumatologist did not believe the symptoms the patient was experiencing was related to lupus. The physician thought the patient''s symptoms were related to the patient being a teenager and not related to GARDASIL. The patient did not have a problem after receiving the 1st dose of GARDASIL. No treatment was given for an AE. At the time of the report the patient''s status was not recovered. The patient sought medical attention - office visit. Upon internal review unspecified diagnostic laboratory tests performed: the physician believed as a false positive for lupus were considered to be an other important medical event. Additional information has been requested.

VAERS ID:457679 (history)  Vaccinated:2012-04-10
Age:9.0  Onset:0000-00-00
Gender:Female  Submitted:2012-06-19
Location:New York  Entered:2012-06-19
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:
Diagnostic Lab Data: None
CDC Split Type: NYC1200008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1229AA0UNUN
Administered by: Public     Purchased by: Public
Symptoms: Alopecia
SMQs:
Write-up: Alopecia following HPV vaccine #1. Of notice, mother has long standing hx of alopecia but she had never sought medical attention. Referral to derm clinic.

VAERS ID:458136 (history)  Vaccinated:2012-04-10
Age:0.6  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-06-26, Days after onset: 77
Location:Florida  Entered:2012-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cold, ear infection
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 2  
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2IM 
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 2IM 
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 2IM 
Administered by: Private     Purchased by: Other
Symptoms: Injection site mass, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Fever for three days, lumps under vaccine site.

VAERS ID:458454 (history)  Vaccinated:2012-04-10
Age:0.5  Onset:2012-05-20, Days after vaccination: 40
Gender:Female  Submitted:2012-06-27, Days after onset: 38
Location:Wisconsin  Entered:2012-06-29, Days after submission: 2
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: The subject''s medical history was not reported. The subject''s vaccination history included 2 doses of PENTACEL; received on 05 December 2011 and 06 February 2012 (lot numbers not reported).
Diagnostic Lab Data:
CDC Split Type: 201206234
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a seven-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 05 December 2011, 06 February 2012 and 10 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 20 May 2012, approximately 40 days after the last dose and a paroxysmal cough on 26 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.

VAERS ID:458475 (history)  Vaccinated:2012-04-10
Age:0.5  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-06-29, Days after onset: 79
Location:Texas  Entered:2012-06-29
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: Microcephaly with delay
Diagnostic Lab Data: Microcephaly with delay
CDC Split Type: TX120024PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4061AA2IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB842AA2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169772IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0041AE2PO 
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever 103-104 with seizure. Occurred 12 hours after immunizations given. Seizure lasted 3-5 minutes.

VAERS ID:462569 (history)  Vaccinated:2012-04-10
Age:29.0  Onset:2012-04-23, Days after vaccination: 13
Gender:Male  Submitted:2012-08-17, Days after onset: 116
Location:Virginia  Entered:2012-08-21, Days after submission: 4
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: The subject had a past medical history of high blood pressure and asthma.
Diagnostic Lab Data:
CDC Split Type: 201207539
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Military     Purchased by: Military
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I increased
SMQs:, Myocardial infarction (narrow)
Write-up: This study case was received from the investigator on 13 August 2012. A 29-year-old male subject received the following vaccinations on 10 April 2012: an injection of ACAM2000 (lot number not reported), an injection of Anthrax Vaccine (manufacturer and lot number not reported) and an injection of Tdap (manufacturer and lot number not reported). On 22 April 2012, Troponin I was abnormal at 00.19. On 23 April 2012, the subject had a normal ECG. On 23 April 2012, the subject was diagnosed with unspecified disease of the pericardium. The subject had a normal echocardiogram on 07 May 2012. The subject had past medical history of high blood pressure. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.

VAERS ID:474692 (history)  Vaccinated:2012-04-10
Age:81.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-21
Location:Oregon  Entered:2012-10-17, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0973926A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080DA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Dyspepsia, Fatigue, Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of feeling unwell in a 81-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Trazodone, Gabapentin and Omeprazole. On 10 April 2012 (noonish to 14:00) the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. In April 2012, less than one week after vaccination with BOOSTRIX (on or before 12 April 2012), the subject experienced feeling unwell, nausea, heartburn, vomiting (x1) and tiredness. At the time of reporting the events were improved, but not resolved. It was reported that the subject was attempting to make an appointment with her physician regarding these symptoms. Follow-up information was received on 08 May 2012 via pharmacist. The subject was seen by a physician, who felt the reaction was no due to immunization. The subject was reported to have improved, no more nausea. At the time of the report no other details were provided.

VAERS ID:476201 (history)  Vaccinated:2012-04-10
Age:1.0  Onset:2012-10-05, Days after vaccination: 178
Gender:Male  Submitted:2012-10-29, Days after onset: 24
Location:Missouri  Entered:2012-11-06, Days after submission: 8
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: Hydrocele congenital
Diagnostic Lab Data: Varicella zoster CX
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1697AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0402AA0SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181723IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1272AA0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Culture, Herpes zoster
SMQs:
Write-up: Dx with shingles, area face, course about 10d tx - acyclovir and KEFLEX.

VAERS ID:482851 (history)  Vaccinated:2012-04-10
Age:16.0  Onset:2012-04-28, Days after vaccination: 18
Gender:Female  Submitted:2013-01-24, Days after onset: 271
Location:West Virginia  Entered:2013-01-29, Days after submission: 5
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 44 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: MRI; MRV; Neuro. work up; spinal tap x 4; EMG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM100610UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075AA5UNUN
Administered by: Public     Purchased by: Public
Symptoms: Anti-ganglioside antibody, Asthenia, Benign intracranial hypertension, Blood immunoglobulin G, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Immunology test, Lumbar puncture, Neurological examination, Nuclear magnetic resonance imaging, Paraesthesia, Venogram
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: 2 wks after vaccine tingling in feet & sides of hands. To local hospital - 3 tx of IVIG & sent home on steroids (5/10/12) - 6/12 Progressive weakness - to hospital Guillain Barre Syndrome. In & out of hospital almost monthly since (19 admissions). 7/12 dx with CIDP. 11/2/12 had G01B IGG Antibody, EIA serum. Now dx with pseudotumor of brain from steroids.

VAERS ID:489005 (history)  Vaccinated:2012-04-10
Age:3.0  Onset:2013-04-10, Days after vaccination: 365
Gender:Male  Submitted:2013-04-11, Days after onset: 1
Location:New Jersey  Entered:2013-04-11
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: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH751AA1IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC052AA2IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H0157861IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF736530IMLL
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mother called at 1:10 PM & describe red blotches all over child''s face. The child told mother it was itchy. Dr''s office was notified. Spoke with Dr. in same practice, who said mother should give 2 tsps of Children''s Benadryl. Mother was called & instructed.

VAERS ID:502216 (history)  Vaccinated:2012-04-10
Age:0.1  Onset:2012-10-29, Days after vaccination: 202
Gender:Male  Submitted:2013-07-31, Days after onset: 275
Location:Texas  Entered:2013-09-11, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: At the time of reporting, there were no concomitant medications or relevant medical history. There had been no reported adverse events following previous vaccinations.
Diagnostic Lab Data: Stool culture, positive A rotavirus; A stool culture (Rotaviral AG) was done in the hospital and the report was positive A rotavirus gastroenteritis.
CDC Split Type: A1000032A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB213A0PO 
Administered by: Private     Purchased by: Public
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of rotavirus in a 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012; hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on 28 June 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 28 June 2012. On 10 April 2012 and 28 June 2012 the subject received 1st dose and 2nd dose of ROTARIX (oral "regular dose"). On 29 October 2012, 4 months after vaccination with the 2nd dose of ROTARIX and 7 months after vaccination with the first dose of ROTARIX, the subject experienced rotavirus and vaccination failure. The subject had received 2 doses of ROTARIX and was diagnosed with rotavirus in the hospital on 29 October 2012. The subject was hospitalized for 48 hours and then released to outpatient care. Relevant test results included a stool culture obtained in the hospital and the result was positive for A rotavirus. At the time of reporting the events were unresolved. The healthcare professional (nurse) considered the events were unrelated to vaccination with ROTARIX. The nurse did not feel that the vaccine caused the infection. Follow up information received from nurse on 29 January 2013. A stool culture (rotaviral AG) was done in the hospital and the report was positive A rotavirus gastroenteritis. The nurse documented that there were no other causes of gastroenteritis present and there was no past medical history.

VAERS ID:512531 (history)  Vaccinated:2012-04-10
Age:2.0  Onset:2012-04-19, Days after vaccination: 9
Gender:Male  Submitted:2013-11-12, Days after onset: 572
Location:North Carolina  Entered:2013-11-12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1542AA  RL
Administered by: Private     Purchased by: Private
Symptoms: Autism, Autoimmune disorder, Irritability, Measles post vaccine, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Measles rash on face, stomach and back; extreme fussiness; developed hives 8 days after measles rash began; diagnosed with autism 9 months after hives began; 1.5 years after vaccine, still has chronic autoimmune hives.

VAERS ID:520183 (history)  Vaccinated:2012-04-10
Age:  Onset:2012-04-10, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-22, Days after onset: 652
Location:Unknown  Entered:2014-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA008587
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 10-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:592501 (history)  Vaccinated:2012-04-10
Age:1.3  Onset:2012-04-12, Days after vaccination: 2
Gender:Male  Submitted:2015-09-02, Days after onset: 1238
Location:California  Entered:2015-09-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MD noted on 3/7/2014 IgG to measles. Physician office told us to give Blue Tylenol and Ibuprofen.
Current Illness: Recently recovered from illness (high fever and vomit) a couple of weeks earlier after a trip.
Preexisting Conditions: Food, animal and environment allergies
Diagnostic Lab Data: Diagnosed with Language impairment then diagnosed with autism spectrum disorder
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1759AA0UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1213AA0UNUN
Administered by: Unknown     Purchased by: Other
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Developmental delay, Diarrhoea, Language disorder, Pyrexia, Rash generalised, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Rash that developed all over the body which worsened each day for about 10 days. Along with very high fever (104), vomit, poop explosions. Then slowly over the course of a couple of months my son lost his babbling, eye contact and stopped developing.

VAERS ID:453954 (history)  Vaccinated:2012-04-10
Age:13.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-04-18, Days after onset: 8
Location:Foreign  Entered:2012-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0795165A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA135DB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure immeasurable, Dizziness, Hypotension, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), 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), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of syncope in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 10 April 2012, the subject received the unspecified dose of CERVARIX (administration site and route unknown). On 10 April 2012, 5 minutes after vaccination with CERVARIX, the subject experienced tremor, dizziness and hypotension. The blood pressure was so low that it was not measurable. The subject was put down to horizontal position and the symptoms improved. After 5 minutes, she seemed to be recovered but symptoms quickly came back and she had a syncope. The subject was hospitalised for 2 days for observation, from 10 to 11 April 2012. The subject was treated with ADRENALIN and diazepam. On 10 April 2012, the events were resolved. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:455299 (history)  Vaccinated:2012-04-10
Age:36.0  Onset:2012-04-14, Days after vaccination: 4
Gender:Male  Submitted:2012-05-09, Days after onset: 25
Location:Foreign  Entered:2012-05-10, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic asthma; Neurodermatitis; Smoker
Preexisting Conditions:
Diagnostic Lab Data: platelet count, 20Apr12, 109/nl; WBC count, 24Apr12, 13.6 ul; WBC count, 24Apr12, 12.7 ul; platelet count, 24Apr12, 33 and 36/nl; WBC count, 25Apr12, 11.5 ul; platelet count, 25Apr12, between 12 and 17/nl; platelet count, 26Apr12, 12/nl; platelet count, 27Apr12, 19/nl; platelet count, 28Apr12, 15/nl; platelet count, 29Apr12, 24/nl; WBC count, 30Apr12, 13.9 ul; platelet count, 30Apr12, 25/nl
CDC Split Type: WAES1205USA00780
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0790AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Haematoma, Influenza like illness, Platelet count decreased, Thrombocytopenia, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a healthcare professional on 27-APR-2012 with additional information received on 02-MAY-2012. The case was medically confirmed. A 36-year-old male patient with a medical history of allergic asthma, nicotine abuse and neurodermatitis received a first dose of MMR II (lot# 671544/0790AA and batch# G015673) intramuscularly into the left deltoid muscle on 10-APR-2012. Approximately four days later, on 14-APR-2012, the patient presented with flu-like symptoms and breathing difficulties. The patient received treatment with amoxicillin, a dose of SOLU-DECORTIN 100 mg intravenously, to be continued orally with DECORTIN H 70 m, and BRONCHOSPASMIN. On 19/20-APR-2012 small haematoma were noted on the left forearm. On 20-APR-2012 blood tests showed thrombocyte count of 109/nl. On 24-APR-2012 platelet count decreased further between 33 and 36/nl with white blood cell count = 12.7ul and 13.6ul later on the same day. Subsequently the patient was hospitalized and during hospitalisation with prednisolone was continued, treatment with PANTOZOL was started. On 25-APR-2012 white blood cell count was 11.5ul with platelet count ranging between 12 and 17/nl. On 26-APR-2012 platelet count was 12/nl. The patient received the first platelet concentrate and platelet count decreased to 19,000/nl on 27-APR-2012. On 28-APR-2012 platelet count was 15/nl. The patient received a second platelet concentrate and platelet count = 24/nl on 29-APR-2012. On 30-APR-2012 white blood cell count 13.9 ul and platelet count = 25/nl. At the time of the report the patient was still hospitalized and the thrombocytopenia was ongoing. The outcome of the flu-like symptoms and breathing difficulties were not reported. The reporter assessed the events to be life-threatening and the drug event relationship was assessed as probably related to the vaccination. Other business partner numbers included: E2012-02803. A Lot check was initiated. No further information is available.

VAERS ID:455356 (history)  Vaccinated:2012-04-10
Age:0.3  Onset:2012-04-11, Days after vaccination: 1
Gender:Male  Submitted:2012-05-10, Days after onset: 29
Location:Foreign  Entered:2012-05-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0800195A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA387BB PO 
Administered by: Other     Purchased by: Other
Symptoms: Dehydration, Gastroenteritis, Hypovolaemic shock
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypovolaemic shock conditions (narrow), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a physician via a regulatory authority (PT-INFARMED-N201205-56) and described the occurrence of acute gastroenteritis in a 3-month-old male subject whow as vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (manufacturer unspecified) given on 9 January 2012 and on 14 March 2012. There was no previous known reactions to any other drug. The subject was fed with artificial milk (S26 Gold). On 10 April 2012, the subject received 1st dose of ROTARIX (oral). On 11 April 2012, 1 day after vaccination with ROTARIX, the subject experienced acute gastroenteritis, severe dehydration and hypovolemic shock. The subject was hospitalised for 12 days and the regulatory authority reported that the events were life threatening. The subject was treated with intensive fluid therapy (unspecified). At the time of discharge, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with ROTARIX. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. Therefore the case has been closed.

VAERS ID:455559 (history)  Vaccinated:2012-04-10
Age:11.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-05-14, Days after onset: 34
Location:Foreign  Entered:2012-05-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Diagnostic Lab Data:
CDC Split Type: E201202915
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURH0317 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Convulsions local, Gaze palsy, Livedo reticularis, Loss of consciousness, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case received from the Health Authorities in a foreign country on 02-May-2012 under the reference number NY20120316. Case medically confirmed. A 11-year-old male patient presented with malaise with loss of consciousness of about 10 seconds, upper limbs convulsions, eye rolling and lips mottling after he had received a dose of TYPHIM (batch number H0317-1) via intramuscular route in the left arm on 10-Apr-2012. Subsequently the patient experienced asthenia which persisted for about one hour and then resolved. At the time of reporting the patient had totally recovered without any sequelae. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful according to the Foreign method of assessment. Upon medical review the company judged relevant to code the following adverse event: "mottled skin" (MedDRA LLT) which was mentioned by the CA in the narrative but not coded.

VAERS ID:455663 (history)  Vaccinated:2012-04-10
Age:14.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-05-16, Days after onset: 36
Location:Foreign  Entered:2012-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 10Apr2012, 95/54mmHg; Oxygen saturation, 10Apr2012, 95%; Pulse rate, 10Apr2012, 60bpm
CDC Split Type: B0801187A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Bed rest, Feeling abnormal, Pain, Pallor, Presyncope
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of vasovagal reaction in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 10 April 2012, at 17:55, the subject received the 3rd dose of CERVARIX (0.5 ml, intramuscular, left upper arm). The body temperature before the vaccination: 36.3 degrees Centigrade. On 10 April 2012, at 18:00, 5 minutes after vaccination with CERVARIX, the subject presented with poorly feeling and facial pallor after the vaccination. Blood pressure, SpO2 and pulse rate were 95/54 mmHg, 95% and 60 bpm, respectively. She was placed under bed rest, and recovered from the events in 10 minutes. On an unspecified time after vaccination, the subject experienced pain. The physician considered the events were clinically significant. The events vasovagal reaction, poor feeling and facial pallor resolved on 10 April 2012. At the time of reporting the outcome of the event pain was unspecified.

VAERS ID:456840 (history)  Vaccinated:2012-04-10
Age:0.7  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-06-05, Days after onset: 56
Location:Foreign  Entered:2012-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0800132A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA711G IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA11005 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Diarrhoea, Hypotonia, Hypotonic-hyporesponsive episode, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician via regulatory authority (# PL-URPL-OCR-20120420006) and described the occurrence of hypotonia nos in a 7-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline) and Hep B vaccine (non-gsk). On 10 April 2012, the subject received an unspecified dose of INFANRIX-POLIO-HIB (intramuscular, administration site unknown) and an unspecified dose of Hep B vaccine (Non-GSK) (intramuscular, unknown). On 10 April 2012, 1 day after vaccination with Hep B vaccine (Non-GSK) and INFANRIX-POLIO-HIB, the subject experienced hypotonia nos, vomiting, diarrhea, and hypotonic-hyporesponsive episode. The subject was hospitalised. At the time of reporting, the events were resolved. Follow-up information received on 28 May 2012: On 11 April 2012, at about 1 pm, the subject was taken by an ambulance due to weakness, paleness of skin and hypotonia. From the early morning, he vomited 3 times (bilious vomiting) with one loose stool. No fever. During hospitalisation, the subject was like a "rag doll" but was conscious all the time. The subject was treated with hydration and his condition improved fast. On the next day, he was discharged on mother''s demand. The physical examination showed no abnormalities, except slight irritation. At the time of reporting, the events were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK.

VAERS ID:457022 (history)  Vaccinated:2012-04-10
Age:55.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-06-07, Days after onset: 58
Location:Foreign  Entered:2012-06-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA00066
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1170Z IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling hot, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information was obtained on a request by the Company from the agency (local reference # AUS/12/1072) via a Public Case Detail (case # OPR299054) concerning a 55 year old female who on 10-APR-2012 was vaccinated intramuscularly with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669581/1170Z, batch # S0725). On 10-APR-2012 the patient''s left arm was incredibly painful to move the shoulder about 4 hours after PNEUMOVAX 23-sudden onset OE- warmth over deltoid, range of motion shoulder severely restricted with pain. Treatment included CELEBREX 1 od or 1 bd. Observed SA in a week should be settled. The agency felt that the adverse events were possibly related to therapy with PNEUMOVAX 23. The adverse events were considered to be disabling. At the time of the report, outcome of the patient was unknown. The original reporting source was not provided. Additional information is not expected.

VAERS ID:457126 (history)  Vaccinated:2012-04-10
Age:70.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2012-06-08, Days after onset: 59
Location:Foreign  Entered:2012-06-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA00066
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.S45620SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (local reference # AUS/12/1074, OPR # 298855), concerning a 70 year old female who on 10-APR-2012 was vaccinated SC with the first dose of PNEUMOVAX 23 (batch# reported as "S4562). On 10-APR-2012, 6 hours post vaccination, the patient''s left arm became hot and painful with swelling. Overnight swelling became more extensive from shoulder to elbow and painful to touch. The patient had self administered paracetamol and applied ice packs, and presented to GP and had commenced on KEFLEX. Later, the patient admitted to hospital for IV antibiotics. 20 hours post administration, the patient presented to GP and complained of arm painful, with extensive arm swelling from shoulder to elbow, red and hot. On 12-APR-2012, SV add it; swelling circumferential, shoulder to elbow, very red and painful, hot to touch. At the time of reporting, the patient had not yet recovered from these events. The agency considered that these events certainly related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.

VAERS ID:457481 (history)  Vaccinated:2012-04-10
Age:1.4  Onset:2012-05-23, Days after vaccination: 43
Gender:Female  Submitted:2012-06-14, Days after onset: 22
Location:Foreign  Entered:2012-06-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Computed axial tomography, normal; WBC count, 8000 /ul, negative; Cytomegalovirus antigen, negative; Serum mumps AB, positive; Serum Epstein-Barr virus antibody test, negative; Herpes simplex virus antigen test, negative
CDC Split Type: WAES1206USA01926
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Eyelid function disorder, Herpes simplex serology negative, Mumps antibody test positive, VIIth nerve paralysis, White blood cell count normal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Case received from a physician on 08-JUN-2012 via the contractual partner VIANEX under the reference number 2015. Case medically confirmed. A 17-month-old female patient without medical history had received a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (batch number not reported) via intramuscular route (administration site not reported) on 10-APR-2012. Later, on 23-MAY-2012, 6 weeks post-vaccination, the patient developed facial drooping of the right half of the face, including the forehead. The upper and the lower portions of the right half of the face were paretic, the corner of the mouth dropped unilaterally and the patient was unable to close the right eye. The patient was hospitalized for 3 days up to 25-MAY-2012. Laboratory examination was performed: white blood cell was 8000/ul, serology for mumps was positive; serology for EBV, CMV, herpes simplex were negative and CT scan of the head was unremarkable. The diagnosis of the reporting physician was a peripheral facial nerve paralysis, possibly related to the vaccination. No treatment was administered except an eye lubricant. The symptoms gradually remitted during the following two weeks. Other business partner numbers included E2012-03732. No further information is available.

VAERS ID:457838 (history)  Vaccinated:2012-04-10
Age:0.3  Onset:2012-05-11, Days after vaccination: 31
Gender:Female  Submitted:2012-06-21, Days after onset: 41
Location:Foreign  Entered:2012-06-21
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Adenovirus test, 11May2012, NEGATIVE; Alanine aminotransferase, 11May2012, 26IU/L; Alanine aminotransferase, 12May2012, 23IU/L; Albumin, 11May2012, 4.7g/dL; Albumin, 12May2012, 4.1g/dL; Albumin globulin ratio, 11May2012, 2.4; Albumin globulin ratio, 12May2012, 2.3; Alkaline phosphatase, 11May2012, 539IU/L; Alkaline phosphatase, 12May2012, 538IU/L; Amylase, 11May2012, 51U/L; Amylase, 12May2012, 72U/L; Aspartate aminotransferase, 11May2012, 28IU/L; Aspartate aminotransferase, 12May2012, 28IU/L; Band neutrophil count, 11May2012, 0%; Band neutrophil count, 12May2012, 0%; Basophils, 11May2012, 0.5%; Basophils, 12May2012, 0.5%; Bicarbonate, 11May2012, 19.5mmol/L; Bilirubin total, 11May2012, 0.3mg/dL; Bilirubin total, 12May2012, 0.2mg/dL; Blood gl
CDC Split Type: B0804208A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Adenovirus test, Alanine aminotransferase normal, Albumin globulin ratio, Amylase normal, Aspartate aminotransferase normal, Band neutrophil count decreased, Basophil percentage, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood bilirubin decreased, Blood calcium normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine decreased, Blood glucose normal, Blood ketone body increased, Blood lactate dehydrogenase normal, Blood pH decreased, Blood phosphorus normal, Blood potassium decreased, Blood sodium normal, Blood urea decreased, Blood uric acid increased, C-reactive protein increased, Carbon dioxide normal, Culture stool negative, Enema administration, Eosinophil percentage increased, Gamma-glutamyltransferase normal, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Laboratory test normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume normal, Mean platelet volume decreased, Monocyte percentage, Neutrophil percentage decreased, Oxygen saturation decreased, PO2 decreased, Platelet count increased, Protein total decreased, Red blood cell count, Red cell distribution width normal, Rotavirus test negative, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Respiratory failure (broad)
Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 17-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP, given on 10 April 2012, Hib (non-gsk), given on 12 March 2012, SYNFLORIX, given on 12 March 2012 and the 1st dose of ROTARIX, given on 12 March 2012. On 10 April 2012, the subject received the 2nd dose of ROTARIX (1.5 ml, oral, batch number not provided). On 11 May 2012, 31 days after vaccination with ROTARIX, the subject began to have invagination of intestine and was admitted to the hospital. On an unspecified date, the subject recovered from the event and was discharged. The subject was hospitalised. The reporting physician considered unlikely that ROTARIX was the cause of the event, because the invagination of intestine developed 1 month after the second vaccination of the drug, and in addition, invagination of intestine could occasionally develop in infants who received no vaccination. Additional information received on 01 June 2012: On 10 May 2012, at 9:00, the subject experienced vomiting frequently. On 10 May 2012, at 15:00, the subject had bloody stools. On 11 May 2012, at 11:00, after the consultation with the previous physician, the subject was referred to the reporting hospital. The subject was suspected of having invagination of intestine and manipulation was performed after abdominal ultrasound. The intestinal intussusception reduction was done promptly. On 11 May 2011, test for stool rotavirus antigen, adenovirus, and Norovirus were all negative and stool cultures was negative. On 12 May 2012, at 13:00, the subject was discharged from the hospital without recurrence. On 15 May 2012, at 11:00, the subject visited the hospital after the discharge. It was confirmed that the subject had no problems at home either and thus the follow-up was completed. Findings with enema of air or contrast medium confirmed intussusception. There was no family history of intussusception or intestinal abnormality, past laparoscopic surgery, congenital intestinal malformation, or intussusception. Abnormality disappeared with enema of contrast media/fluid pressure/air. The causal relationship to ROTARIX was unknown, since the invagination of intestine itself was not rare for the subject''s age. However, it could not be ruled out completely. Additional information received on 12 June 2011: On 10 April 2012, the subject received the 2nd dose of ROTARIX (batch number was provided). on 11 May 2012, laboratory results showed CRP increased (2.4 mg/dL), albumin globulin ratio abnormal (2.4), creatine phosphokinase decreased (42 U/L), alkaline phosphatase increased (539 U/L), creatinine low (0.17 mg/dL), high potassium (5.0), high calcium (10.6), blood ketone body increased, white blood cell count high (10100/mcL), low haemoglobin (10.2 g/dL), low haematocrit (33%), mean cell volume low (81.3 fL), mean cell haemoglobin low (27.7 pg), increased platelet count (50.4 x10^4/mcL), mean platelet volume decreased, pH decreased (7.338), decreased PO2, carbon dioxide total decreased (27.1 mmHg), decreased oxygen saturation, total protein decreased (5.9 g/dl). On 12 May 2012, laboratory results showed blood urea nitrogen decreased (3 mg/dL) and decreased uric acid (3.1 mg/dL). On 11 May 2012, the events bloody stools and vomiting resolved. On 12 May 2012, the event invagination of intestine had resolved. No further information is available for this case. This case is closed.

VAERS ID:464048 (history)  Vaccinated:2012-04-10
Age:1.0  Onset:2012-05-15, Days after vaccination: 35
Gender:Female  Submitted:2012-09-04, Days after onset: 112
Location:Foreign  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209GB000844
Vaccination
Manufacturer
Lot
Dose
Route
Site
MENHIB: MENINGICOCCAL CONJUGATE + HIB (UNKNOWN)UNKNOWN MANUFACTURER  SYRUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Dysstasia, Emotional distress, Insomnia, Intervertebral discitis, Posture abnormal, Skin disorder, Weight gain poor
SMQs:, Dystonia (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: This case was received from the health authority on 29-Aug-2012. GB-MHRA-ADR 21814475. The original reporter was a consumer. This case is not medically confirmed. A 12 month old female patient received an injection of MMR (manufacturer and batch number not reported), route and site not reported, and MENITORIX (batch number not reported), route and site not reported, and PREVENAR 13 (batch number not reported), route and site not reported, on 10-Apr-2012. On 16-Apr-2012, six days post vaccination, the patient was taken to A&E with severe bad possible eczema. The patient was referred to a dermatologist and whilst waiting for the appointment the patient got worse each day. She had no appetite at all, was refusing to stand, refusing to sit upright, not sleeping and very distressed. The patient was weighed approximately one month post vaccination and had not gained weight for five months. The patient had the dermatology appointment about one month post vaccination and was bandaged up arms, legs and body. The patient was taken back to A&E twice over the weekend as the parent knew something was not right. Approximately six days after the appointment, on 15-May-2012, 35 days post vaccination, she was diagnosed with discitis (described as an infection around the disc of the spine). She was admitted to hospital and was on antibiotic drip for ten days and then on oral antibiotics for eight weeks. The reporter stated that this discitis was a month old which came around the same time as the vaccinations. The reporter stated that now all the infection has gone so has the possible eczema. The reporter believes that this is not just a coincidence as their health care professional keeps telling them. The patient recovered from the discitis and the skin disorder on 25-May-2012. The outcome of the other events was unknown. The events were considered to be serious by the reporter due to hospitalisation.

VAERS ID:464247 (history)  Vaccinated:2012-04-10
Age:1.0  Onset:2012-04-16, Days after vaccination: 6
Gender:Female  Submitted:2012-09-05, Days after onset: 142
Location:Foreign  Entered:2012-09-06, Days after submission: 1
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: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012212382
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Eczema, Emotional distress, Insomnia, Intervertebral discitis, Weight gain poor
SMQs:, Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This is a spontaneous report from a contactable consumer via the contactable Regulatory Authority. Regulatory Authority Number ADR 21814475. A 12-months-old female patient received a dose of PREVENAR 13, MENITORIX at unknown dose parenteral and MMR vaccine of unknown dose parenteral, all on 10Apr2012. The patient medical history and concomitant medications were not reported. The consumer reported that her daughter received her immunizations. Approximately 6 days after vaccines, she took her to Accident and Emergency with severe bad eczema for which she was referred to the dermatology with awaiting appointment. Waiting for this appointment her daughter got worse each day-no appetite at all, refusing to stand, refusing to sit upright, not sleeping, very distressed. The reporter had her weighed approximately a month after the vaccines and she had not gained weight for 5 months. Approximately a month after the vaccines she had an appointment in dermatology; she was bandaged up arms legs and body. The reporter took her back to Accident & Emergency twice, as reported, that weekend as they, as reported, knew something was not right. Approximately 6 days after the appointment the patient was diagnosed with discitis. She was admitted on an antibiotic drip for 10 days and was on oral antibiotics for 8 weeks. This discitis was a month old which came around the same time she had all the immunisation. The reporter stated that now all this infection was gone and all the eczema has gone too. The reporter believed that this was not just a coincidence as the health professional kept telling her (as reported). The patient recovered from invertebral discitis and eczema severe on 25May2012. At the time of this report the outcome of appetite lost, sleep difficult, emotional distress and weight gain poor was unknown. The reporter considered the events to be serious as they caused or prolonged hospitalisation. No follow-up attempts possible. No further information is expected.

VAERS ID:466592 (history)  Vaccinated:2012-04-10
Age:70.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-09-26, Days after onset: 169
Location:Foreign  Entered:2012-09-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVAPRO; LASIX; Metformin; LIPITOR; MINIPRESS; NOTEN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012033410
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  IMAR
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Fatigue, Injection site reaction, Oedema peripheral, Pain, 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)
Write-up: This health authority report (initial receipt 17-Sep-2012) concerns a 70 year old male patient. Concomitant medications included irbesartan, furosemide, metformin, prazosin and atenolol. On 10-Apr-2012, the patient received FLUVAX (batch unknown) via intramuscular injection at a dose of 0.5 ml. On the same day, he received in the same arm PNEUMOVAX 23 (batch unknown) via intramuscular injection at a dose of 0.5 ml. The patient had previously had the FLUVAX brand many times without any apparent reaction. The PNEUMOVAX 23 was his first dose. On 10-Apr-2012, the patient had a large site reaction - a red sore swollen arm on the day of the injection. He felt tired, with aches, pains (body). He told his GP (general practitioner) the next day and the GP told him to take celecoxib 200 mg/day and loratadine 10 mg/day for 3 days. The event outcome was recovered within 5 days. Reporter''s comments: The reporter considered event serious due to incapacity/disability and possible in relation to the suspect drugs.

VAERS ID:475672 (history)  Vaccinated:2012-04-10
Age:51.0  Onset:2012-05-01, Days after vaccination: 21
Gender:Female  Submitted:2012-11-29, Days after onset: 212
Location:Foreign  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Non-GSK Propranolol hcl
Current Illness: Essential tremor; Psoriasis
Preexisting Conditions: Back pain
Diagnostic Lab Data: UNK
CDC Split Type: D0076634A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB235AE0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Impaired work ability, Mononeuritis, Monoplegia, Neurological symptom, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer and described the occurrence of paralysis leg in a 51-year-old female subject (herself) who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included back pain and "banal diseases". Concurrent medical conditions included essential tremor and psoriasis. Concurrent medications included Non-GSK DOCITON. Previous vaccinations with REPEVAX and PEVAXIS were well tolerated. On 10 April 2012 the subject received 1st dose of TWINRIX adult (unknown route, left arm). Approximately 3 weeks after vaccination with TWINRIX adult, the subject experienced pain over right leg, down to the foot. On 10 May 2012 the subject received 2nd dose of TWINRIX adult (unknown route, left arm). Again, the subject experienced severe pain over right leg, numbness-right foot and plexus neuritis (mononeuritis of leg). On 15 June 2012, the subject experienced impaired work ability. Follow-up was received from the consumer on 19 September 2012, including the same questionnaire. At the time of reporting, the events were improved. Oral follow-up information was received from the consumer on 27 November 2012. She reported that "on June 2012 she developed neurological symptoms after vaccination with TWINRIX, after the 2nd dose of TWINRIX she even experienced symptoms of paralysis (paralysis leg) and was unable to work for a long time".

VAERS ID:477871 (history)  Vaccinated:2012-04-10
Age:0.2  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2012-12-13, Days after onset: 247
Location:Foreign  Entered:2012-12-13
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: No other medications
Current Illness: Prophylaxis; Wolff-Parkinson-White syndrome
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUS004114
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Intensive care, Supraventricular tachycardia
SMQs:, Supraventricular tachyarrhythmias (narrow)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 8 weeks old male patient with wolf parkinson white syndrome. The patient was vaccinated with dose 1, 1 DF ROTATEQ (route and lot number not reported) on 10-APR-2012. Other suspect therapies included INFANRIX HEXA and PREVENAR dose 1, 1 DF on 10-APR-2012 No concomitant medications were reported. On 10-APR-2012 the patient experienced supraventricular tachycardia 4-5 hours post 2/12 immunisations. Patient was hospitalized in the neonatal intensive care unit (NICU) at the time at time and treated with intravenous medication. Patient was referred to clinic (25-JUN-2012) and admitted to hospital for 4/12 and 6/12 vaccinations. The outcome of supraventricular tachycardia was unknown. Supraventricular tachycardia was reported to be possibly related to all 3 suspect products. Additional information is not expected. The original reporting source was not provided.

VAERS ID:500866 (history)  Vaccinated:2012-04-10
Age:56.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Male  Submitted:2013-08-28, Days after onset: 505
Location:Foreign  Entered:2013-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone; Ciclosporin
Current Illness: Hepatocellular carcinoma, Due to hepatitis C virus
Preexisting Conditions: 12/27/2008, Liver transplant
Diagnostic Lab Data:
CDC Split Type: PHHY2013FR091902
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2013FR091902, is an initial spontaneous report received from the foreign Health Authority (reference number: PC20130491) on 22 Aug 2013. This report refers to a 56 years old male patient. His medical history included liver transplantation on 27 Dec 2008 and current condition included hepatocellular carcinoma due to hepatitis C virus. Co-suspect medication included oral prednisone (unknown manufacturer) from 15 Dec 2010 (indication and dose not reported). He was vaccinated with MENVEO (batch number: not reported), subcutaneously on 28 Mar 2012 and 10 Apr 2012. He also started treatment with oral ciclosporin (unknown manufacturer) at an unknown dose from 27 Dec 2012 for unspecified indication. Serotypes were performed before and after the vaccination for serogroups A, C, Y, and W-135. The patient had not yet presented immunity against serogroups A, Y and W135. There was non seroconversion after the two injections of MENVEO. The outcome was reported as condition unchanged. Only drug ineffective was coded as adverse event by the foreign HA. The event was assessed as medically significant. The foreign HA assessed the causal relationship between the adverse event and MENVEO as probable and possible interaction between ciclosporin and prednisone.

VAERS ID:518225 (history)  Vaccinated:2012-04-10
Age:15.0  Onset:2012-04-12, Days after vaccination: 2
Gender:Female  Submitted:2013-12-31, Days after onset: 628
Location:Foreign  Entered:2013-12-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic Rhinitis
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 10Apr2012, 36.5 C
CDC Split Type: B0955996A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Anxiety, Depression, Diarrhoea, Fear, Irritability, Irritable bowel syndrome, Nausea, Neurosis, School refusal, Stress, Suicide attempt
SMQs:, Acute pancreatitis (broad), Suicide/self-injury (narrow), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# V13001039) and described the occurrence of neurosis in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included allergic rhinitis. Historic vaccination included 1st and 2nd dose of CERVARIX (GlaxoSmithKline; intramuscular and unknown site of injection) given on 10 July 2011 and 13 August 2011 respectively. On 10 April 2012, the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, left deltoid). On 12 April 2012, 2 days after vaccination of CERVAVIX, the subject experienced digestive symptoms such as queasy, gastralgia, and diarrhoea. Although the subject visited the department of internal medicine in a nearby hospital and a general hospital, the symptoms did not improve easily. On an unknown date, a diagnosis of irritable bowel syndrome was made, for which DOGMATYL, MIYA BM, COLONEL, NAUZELIN, and ACINON were prescribed. In April 2012, (late in this month), the irritable bowel syndrome tended to improve. The subject experienced a class change in April 2012 and had been under intense stress. Around this time, the subject began to have a more anxious feeling when thinking of going to school. On 7 May 2012, the subject presented to the department of psychosomatic medicine of a local hospital. WYPAX, MEILAX, and DOGMATYL were prescribed. On 31 May 2012, as the symptoms did not improve and ZOLOFT was additionally prescribed. In June 2012, the subject experienced increased anxious and irritated feeling, and began to have school refusal. On 5 June 2012, the subject presented to the department of mental health of hospital. Subsequently, the symptoms improved and deteriorated repeatedly, and the subject became unable to go to not only school but also a dental clinic. On an unknown date, the subject presented with a suicide attempt, based on which a diagnosis of depression was made. In December 2013, remission from the depression was achieved. However, the subject could not go to school and occasionally experienced flashbacks of fear, for which treatments such as counseling were continued. The subject was under oral treatment with ABILIFY, DOGMATYL, and WYPAX. Treatment such as eye movement desensitization reprocessing (EMDR) was performed. No pain in sites such as limbs was noted over the course. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, queasy, diarrhoea and stomach pain were resolved and neurosis, depression, attempt to suicide and irritable bowel syndrome were improved. The outcome of the other events was unknown.

VAERS ID:537893 (history)  Vaccinated:2012-04-10
Age:2.0  Onset:2012-04-10, Days after vaccination: 0
Gender:Female  Submitted:2014-07-25, Days after onset: 836
Location:Foreign  Entered:2014-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 04/10/2012, Body temperature, 39 degrees C, also reported as ($g38.6), Fever; 04/10/2012, Body temperature, 38 degrees C, also reported as ($g38.6), Fever
CDC Split Type: WAES1407CHN011204
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0950Z0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Cough, Pneumonia mycoplasmal, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This spontaneous report as received from Agency (Agency # 1876115) refers to a 2 year old female patient. On 10-APR-2012 the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose 0.5 units not provided, vaccine batch R3046, lot number 0950Z, expiration date not reported) intramuscular in the deltoid. There was no concomitant medication reported. On 10-APR-2012, the patient experienced fever of 38 degrees C (also reported as $g38.6 degrees C) at 6 pm, which aggravated to 39 degrees C with cough. The patient visited clinic on 16-APR-2012. There was no localized swelling nor localized induration. The diagnosis was Mycoplasma pneumonia. The event caused hospitalization on an unspecified date. The outcome of the event was reported as recovered on an unknown date. The event of Mycoplasma pneumonia was considered by reporter as a coincidental event. Adverse Event primary category was undetermined (other). The event was not cluster AEFI (Adverse Event Following Immunization) nor serious AEFI. According to local regulation serious AEFI definition, this case was not assessed as serious by agency, although it resulted in hospitalization. Additional information is not expected due to no patient''s and physician''s contact information was available.

VAERS ID:626748 (history)  Vaccinated:2012-04-10
Age:  Onset:0000-00-00
Gender:Male  Submitted:2016-03-11
Location:Foreign  Entered:2016-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: DKSA2016SA045284
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER0130A1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG95641UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF362351UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Blood heavy metal abnormal, Decreased immune responsiveness, Ear infection, Granuloma, Injection site pruritus, Pneumonia, Pyrexia, Reaction to drug excipients, Skin depigmentation, Skin test positive, Vaccination site haemorrhage, Viral infection, Vitiligo
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Initial unsolicited case received from SPMSD under the reference number: Case received from Patient Insurance Company (PIC) via HA and other company SSI on 29-Feb-2016 with reference numbers DK-DKMA-ADR 23372406 and DKSSI0111128. This case is medically confirmed as PIC has based the case on confirmation from physician and medical records. The company noted that the Act-Hib component does not contain aluminium. A 5-month-old male infant patient received haemophilus type b polysaccharide vaccine (Act-Hib, batch number G9564, Dose 1) on 07-Feb-2012, haemophilus type b polysaccharide vaccine (Act-Hib, batch number G9564, Dose 2) on 10-Apr-2012, haemophilus type b polysaccharide vaccine (Act-Hib, batch number H8078, Dose 3) on 21-Jan-2013. Other suspect products included: -diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (Ditekipol, batch number 0130A, Dose 1) on 07-Feb-2012 -diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (Ditekipol, batch number 0130A, Dose 2) on 10-Apr-2012 -diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (Ditekipol, batch number 0136A, Dose 3) on 21-Jan-2013 -pneumococcal vaccine (Prevenar 13, batch number F50733, Dose 1) on 07-Feb-2012 -pneumococcal vaccine (Prevenar 13, batch number F36235, Dose 2) on 10-Apr-2012 -pneumococcal vaccine (Prevenar 13, batch number F89200, Dose 3) on 21-Jan-2013. The patient experienced Aluminum allergy on an unknown date, Reaction to drug excipient on an unknown date, Vaccination triggered granuloma on an unknown date, Decreased immune system/often gets sick/frequent illness on an unknown date, Pneumonia on an unknown date, Otitis on an unknown date, Fever on 12-APR-2012, Vitiligo (white pigmentation changes) on left back thigh on an 6-Aug-2013, Itching at the vaccination site on an unknown date and Itches often until it bleeds on an unknown date. The patient''s outcome was reported as Unknown. Other relevant information: Decision: the patient''s injury aluminium allergy and the events as a result are covered by the law. The case: the parent of the patient has sought compensation on behalf the patient, because he after vaccination with the child immunization program developed aluminium allergy and granuloma on both thighs. According to the parent, the patient has due to aluminium allergy often been sick with pneumonia, otitis and fever, since the allergy probably has caused decreased immune system. In addition, the white pigmentation changes is believed to be due to the vaccination. On 12-Apr-2012, two days post vaccination the patient hospitalized due to high fever. He was discharged on 14-Apr-2012. On 17-Apr-2012, he was hospitalized again due to asthmatic bronchitis. Treated with inhalations of Ventoline with good effect and was discharged on 08-Apr-2012, the patient was several times at his own physician with pneumonia, otitis and fever. On 06-Aug-2013, according to physician''s medical record, the patient had vitiligo (white pigmentation changes on left back thigh). On 27-Feb-2015, the patient was at own physician with itching at the vaccination site. Locoid ointment was prescribed. The patient was seen by a dermatologist on 19-Jun-2015 after referral from own physician. Dermovat cream and Duoderm patch was recommended. Dermatologist performed skin patch test and nickel on 24-Aug-2015. On 27-Aug-2015 the test results showed aluminium allergy. Nickel test was negative. The reporter has informed, that the patient has granulomas on both thighs which varies in size. He has severe itching and often scratches until it bleeds. The itching can disturb him a lot during play and becomes worse during a virus attack. In addition it has been reported that the patient often gets sick and has pigment changes on the left back thigh. Reasoning: The PIC has set 10-Apr-2012 as the day of injury and that this injury occurred after vaccination on 10-Apr-2012. PIC has evaluated that the aluminium allergy and the adverse event which ha

VAERS ID:453421 (history)  Vaccinated:2012-04-11
Age:0.2  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-11, Days after onset: 0
Location:Florida  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 0 LG
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.   LG
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Private     Purchased by: Private
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Thigh swollen, red, & warm. Fussiness, uncontrolled crying.

VAERS ID:453434 (history)  Vaccinated:2012-04-11
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Alabama  Entered:2012-04-12
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC525074CA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:453503 (history)  Vaccinated:2012-04-11
Age:65.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Male  Submitted:2012-04-11, Days after onset: 0
Location:New York  Entered:2012-04-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA1IMRA
Administered by: Private     Purchased by: Private
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: Right upper arm - reddened, warm to the touch, area swollen - advised, ibuprofen, ice to area and rest arm. Patient stated symptoms started 2 hrs. after vaccination.

VAERS ID:453553 (history)  Vaccinated:2012-04-11
Age:1.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:Florida  Entered:2012-04-12
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1007AA0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0976AA0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mother called at 4pm & said baby had red dots all over her that she noted 1/2 hr ago. Denied itching.

VAERS ID:453573 (history)  Vaccinated:2012-04-11
Age:65.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 0
Location:South Carolina  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prometrium 100mg once daily. Oxybutynin 5mg twice daily.
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.126AA SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red, itchy, warm spot at injection site, local and generalized. No rash reported, nor shortness of breath, nor rapid heart rate. No systemic side effects reported. Advised to monitor and seek physician advice or hospital if condition worsens or other symptoms present. Benadryl suggested for itch.

VAERS ID:453577 (history)  Vaccinated:2012-04-11
Age:1.3  Onset:2012-04-11, Days after vaccination: 0
Gender:Male  Submitted:2012-04-12, Days after onset: 1
Location:Indiana  Entered:2012-04-12
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4130AA0IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4217AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1455AA1IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB513AA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0512AA0SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227221IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1095Z0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Patient''s mother noticed rash within 5 minutes of vaccination. RN noted red rash to abdomen and left thigh. Mother states patient did not have rash prior to vaccination. Patient remained in clinic for 25 minutes after vaccination with no further events noted. Call to mother placed 4/12/12 at 2:40 pm. Mother reports rash better and patient had low grade fever.

VAERS ID:453644 (history)  Vaccinated:2012-04-11
Age:34.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-12, Days after onset: 0
Location:Florida  Entered:2012-04-12
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: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Influenza, Lethargy, Myalgia, Nasopharyngitis, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Shaky, sore muscles, dizzy, light headed, lethargic. The feeling of the onset of a cold or flu.

VAERS ID:453649 (history)  Vaccinated:2012-04-11
Age:19.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-13, Days after onset: 2
Location:North Carolina  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS 1SYRRA
Administered by: Public     Purchased by: Private
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: The shoulder where the shot was given became slightly sore and progressed to an extreme sore later in the evening about 8:00 PM. It has been 2 full days and my shoulder is still very sore.

VAERS ID:453654 (history)  Vaccinated:2012-04-11
Age:45.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-13, Days after onset: 1
Location:North Carolina  Entered:2012-04-13
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: Allergic Rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4046AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, body aches about 24 hours after shot. Fever continued 4/13/12 at 10am - temp 100.2.

VAERS ID:453699 (history)  Vaccinated:2012-04-11
Age:65.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-13, Days after onset: 2
Location:Oregon  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis
Preexisting Conditions: Sulfa; Lovastatin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA SYRUN
Administered by: Public     Purchased by: Public
Symptoms: Drug eruption, Erythema, Local reaction, Pruritus, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Drug eruption - Localized reaction to Pneumococcal injection 2 days ago. Redness 6cmx7cm eruption, with swelling, redness, & mild itching. Pt given Hydrocortisone cream 1%, 250mg SOLU-MEDROL 250mg injection, BENADRYL 50mg injection, & BENADRYL 25mg PO q 6hrs.

VAERS ID:453708 (history)  Vaccinated:2012-04-11
Age:73.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-13, Days after onset: 1
Location:California  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: No illness
Preexisting Conditions: No allergies etc
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0659AA1SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Dollar size wheal at injection site.

VAERS ID:453709 (history)  Vaccinated:2012-04-11
Age:3.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-13, Days after onset: 1
Location:Wyoming  Entered:2012-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Has a nebulizer at home for PRN use. Had been given a treatment the day before shots and had a treatment the day of the rash appearing. Mom not sure what the medication is, apparently a Proventil-type asthma medication.
Current Illness: Runny nose
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB441AA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9169213IMLL
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Lacrimation increased, Rash, Rash pruritic, Rash vesicular, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow)
Write-up: The child developed a rash "on both feet" per mom. Called back about 2:15 PM and she stated that the rash was on his neck and spreading up his face. She also stated that he had a temp. of 99.4. PHN saw the child at 4:00 PM when she brought all her children in to Public Health. He did have a rash on his abdomen, chest, and neck at this time. The rash was "itchy" and looked a bit like early chickenpox papules. PHN suggested several times that the child be taken to a pediatrician. She stated that she did not trust doctors, and that she might take him to the emergency room. The child was afebrile at 4:00 PM, eating and playing. Continued to have a runny nose and watery eyes.

VAERS ID:453696 (history)  Vaccinated:2012-04-11
Age:68.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-14, Days after onset: 2
Location:Washington  Entered:2012-04-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1265AA0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pruritus, Rash, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Large red knot at injection site & 2nd knot at elbow - tenderness & redness (4 in wide) between knots covered in red prickly rash on neck, back, chest & arms - even arm not injected. No fever. Rash area warm to the touch - itching - can still sleep well.

VAERS ID:453720 (history)  Vaccinated:2012-04-11
Age:62.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-15, Days after onset: 3
Location:Texas  Entered:2012-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ventolin rescue inhaler PRN, Advair inhaler one puff 2x pre day, Metformin 850mg 2x daily, Diovan 240mg daily, Lipitor 40mg daily, Glimepirede 1mg with breakfast, Escitalopram 20mg daily. Prevacid 30mg at bedtime. Lasix 20mg in am. Klor-c
Current Illness: none
Preexisting Conditions: History of asthma since birth, mild at the time of vaccine given. No wheezing or other problems of shortness of breath at time of vaccine given.
Diagnostic Lab Data: Dr. visit on 04/13/2012 to verify rash and condition. Given prescription for Atarax for itching and continued use of Ventolin inhaler and Advair inhaler as prescribed.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Eye swelling, Pruritus, Rash, Swelling face, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Raised fine rash on face, neck, and chest. Swelling of face and eyes, some wheezing occurred.

VAERS ID:453728 (history)  Vaccinated:2012-04-11
Age:4.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 4
Location:Louisiana  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: BOM
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B178CB4IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0961Z1IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1207AA1IMRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3 cm diameter of erythema around injection site.

VAERS ID:453741 (history)  Vaccinated:2012-04-11
Age:13.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 4
Location:West Virginia  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BYNABRILL, FLOVENT
Current Illness: NO
Preexisting Conditions: ASTHMA
Diagnostic Lab Data: WAS CHECKED FOR MONO AND STREP CAME BACK NEG.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Dyspnoea, Lymphadenopathy, Mononucleosis heterophile test negative, Pharyngeal erythema, Pharyngeal oedema, Streptococcus test negative, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: SWOLLEN GLANDS IN NECK, TONGUE SWELLED, RED SWELLED THROAT, TROUBLE BREATHING.

VAERS ID:453743 (history)  Vaccinated:2012-04-11
Age:66.0  Onset:2012-04-13, Days after vaccination: 2
Gender:Female  Submitted:2012-04-16, Days after onset: 3
Location:Tennessee  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benazepril-hctz 10-12.5 one a day Levothyroxine 100 mcg one a day Fluticasone nasal spray once a day Tramadol hcl 50 mg one to three a day
Current Illness: No
Preexisting Conditions: History of Herpes of the eye
Diagnostic Lab Data: None at this time
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.RX85250SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Herpes ophthalmic, Injection site erythema, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Ocular infections (narrow)
Write-up: Redness at corner of left eye indicating an onset of a break out of herpes of the eye. I usually take Valtrex when I have an onset but decided to wait because of taking the shingles shot. I called Pharmacy where I got the shot and they said that I''m not suppose to take an antiviral medicine for 14 days after the shot so I waited until Sunday the 15th of April by that time my eye had gotten alot worse and my left arm was really red where I had the shot so I deceided to start my Valtrex.

VAERS ID:453782 (history)  Vaccinated:2012-04-11
Age:5.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-16, Days after onset: 4
Location:Minnesota  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193DA IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1542AA SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1436AA SC 
Administered by: Private     Purchased by: Private
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: Swelling, pain and redness at site of injection, persited for 48 hours, no specific treatment.

VAERS ID:453796 (history)  Vaccinated:2012-04-11
Age:21.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-16, Days after onset: 5
Location:Unknown  Entered:2012-04-16
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: Pt knew she was pregnant but did not disclose this fact; her friend told the tech after the shot was given.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV307 IMLA
Administered by: Military     Purchased by: Military
Symptoms: Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: No event; reporting because govt does not recommend pregnant females to receive anthrax; pt knew she was pregnant but did not disclose this to the tech; after the shot her friend returned and told the tech about the pregnancy.

VAERS ID:453811 (history)  Vaccinated:2012-04-11
Age:16.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-16, Days after onset: 4
Location:California  Entered:2012-04-16
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Haematemesis, Nausea, Retching
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. received HPV vaccine approx. 5 PM 4/11/12. Awoke early morning hours of 4/12/12 with nausea/dry-heaving followed by spitting up scant amount of blood x 1. Temp approx 100-101 degrees. Pt. given aspirin x 1 by father. Decreased energy and appetite as of 9:15 AM 4/12/12.

VAERS ID:453876 (history)  Vaccinated:2012-04-11
Age:11.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:New York  Entered:2012-04-17, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1317AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4080AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythema, edema and warmth at site of injection proximal upper (L) arm.

VAERS ID:453884 (history)  Vaccinated:2012-04-11
Age:5.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-12, Days after onset: 0
Location:Texas  Entered:2012-04-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541CA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0853AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1145AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness, red red area approx. 2" x 1 1/2" no SOB, fever.

VAERS ID:453910 (history)  Vaccinated:2012-04-11
Age:12.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-13, Days after onset: 1
Location:Ohio  Entered:2012-04-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1697AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1359AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3960AB0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4030AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1065AA1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient received TDAP, HPV, and MCV-4 in (R) arm on 4-11-12. On afternoon of 4-12-12 noticed pain, swelling and redness of (R) arm. On 4-13-12 reports decreased pain. At O.V. on 4-13-12 area of warmth, red and induration 7" horizontal, 4" vertical lateral arm. 5" posterior arm in mid-upper arm (R). Increased redness from 4-12-12. Tx with KEFLEX 500mg TID x 7 days.

VAERS ID:453933 (history)  Vaccinated:2012-04-11
Age:57.0  Onset:2012-04-14, Days after vaccination: 3
Gender:Female  Submitted:2012-04-18, Days after onset: 4
Location:Kentucky  Entered:2012-04-18
Life Threatening? Yes
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: None
Preexisting Conditions: Allergic rhinitis; Cervical disc degeneration; Nicotine dependence
Diagnostic Lab Data: Elevated Troponin
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Angiogram normal, Catheterisation cardiac, Catheterisation cardiac normal, Chest pain, Computerised tomogram normal, Headache, Nuclear magnetic resonance imaging normal, Troponin increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Pt was admitted to the hospital with chest pains, had heart cath (-), c/o headache, had CT, MRA, MRI that were normal.

VAERS ID:453968 (history)  Vaccinated:2012-04-11
Age:1.5  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-18, Days after onset: 6
Location:Texas  Entered:2012-04-18
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B149BA3UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586CA UNLL
Administered by: Unknown     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: The day after the DTaP shot was given my daughter''s left upper thigh, around the area of the shot, was swollen, red, and hot to touch. The swelling and redness was 4 inches by 3 inches. Then on 4/13/2012 her entire left thigh was swollen.

VAERS ID:453969 (history)  Vaccinated:2012-04-11
Age:24.0  Onset:2012-04-13, Days after vaccination: 2
Gender:Male  Submitted:2012-04-18, Days after onset: 5
Location:Washington  Entered:2012-04-18
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: none
Diagnostic Lab Data: x-ray, labs and referral to cardiology.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3070IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B076DA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11240IMLA
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Laboratory test, X-ray
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Noticed chest pain couple days after during the day randomly feels chest pain since then. Patient came to clinic for follow up on 04/18/2012 and was evaluated by Dr.

VAERS ID:454034 (history)  Vaccinated:2012-04-11
Age:30.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Female  Submitted:2012-04-19, Days after onset: 7
Location:Washington  Entered:2012-04-19
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009CA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Injection site erythema, Injection site induration, Lymphadenopathy, Pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Abnormal soreness of upper extremity, chills, body aches. T 37.7, erythema 10cm x 6.5 cm with induration 5 cm x 6 cm at injection site. Right anterior cervical lymph nodes full with supraclavicular lymphadenopathy. Treated with Bactrim DS 1 by mouth twice a day for ten days.

VAERS ID:454038 (history)  Vaccinated:2012-04-11
Age:4.0  Onset:2012-04-11, Days after vaccination: 0
Gender:Male  Submitted:2012-04-11, Days after onset: 0
Location:Illinois  Entered:2012-04-19, 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: Allergic rhinitis; Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0953AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0978AA1SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2 hours after vaccination with KINRIX, swelling and redness at deltoid. Treated with BENADRYL.

VAERS ID:454081 (history)  Vaccinated:2012-04-11
Age:1.4  Onset:2012-04-11, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 1
Location:Iowa  Entered:2012-04-20, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B146AA IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0437AA IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF227224IMRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mom called in stating that she had called local physician, explained area to L. leg (HIB) site and he stated it was a local reaction. She described site as a pimple type raised area or bug bite, red no other s/s.

VAERS ID:454114 (history)  Vaccinated:2012-04-11
Age:53.0  Onset:2012-04-17, Days after vaccination: 6
Gender:Male  Submitted:2012-04-20, Days after onset: 3
Location:Missouri  Entered:2012-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness: None
Preexisting Conditions: NKMA; Hypercholesterolemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB524AA1IMRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU3815BA IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH276AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Pyrexia, Rhinorrhoea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 04/17/12 Onset of achiness, runny nose, fever, and some nausea. Described as "flu-like feeling". C/O "feeling tired" et fatigue. States took OTC BENADRYL. Contacted clinic 04/18/12 d/t cont. c/o. VS stable, temp 97.9 temporal artery. Cont. OTC meds for symptoms.

VAERS ID:454206 (history)  Vaccinated:2012-04-11
Age:17.0  Onset:2012-04-12, Days after vaccination: 1
Gender:Male  Submitted:2012-04-23, Days after onset: 11
Location:Florida  Entered:2012-04-23
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1561AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4707AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0972AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Eyelid function disorder, VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Child received TDAP, Varicella #2 and GARDASIL #1 on 4/11/12 at the Pediatric office - tolerated vaccines well, child went home, slept fine overnight. The following morning child awoke and child told his parents "my face feels slower on the lf. side, especially around my lf. eye". Child has Htx of eye twitching in the past - Dad feels that child has experienced this (eye twitching) in the past when child has been fatigued. Dad and pt. state that child lf. side of face appeared "somewhat slack and droopy" 2 days following his vaccine administration - child noted having difficulty closing his lf. eyelid and smiling on the lf. side of his face. These symptoms became progressively worse on 4/12/12. Dad recognized child''s symptoms as being "Bell''s Palsy" (Dad experienced Bell''s Palsy in 2007 - rt. side of Dad''s face, unknown cause). Dad feels that child lf. side of face is less slack in nature today - child is able to somewhat close his lf. eye on his own but is unable to smile using the lf. side of his mouth. Child does have feeling (sensation to touch and pain) on the lf. side of his face. Normal facial pigmentation. No htx of chest pain. No htx of SOB. No htx of smoking/drinking or drug usage. Normal taste sensation on his tongue. No htx of LOC. No word slurring noted. Child has been able to carry on daily activities appropriately. No htx of fever. Sleeping well. No rashes report. No joint pain or joint swelling. No head trauma. No rapid heart rate/no palpitations noted.

VAERS ID:454225 (history)  Vaccinated:2012-04-11
Age:1.0  Onset:2012-04-22, Days after vaccination: 11
Gender:Female  Submitted:2012-04-23, Days after onset: 1
Location:New York  Entered:2012-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma; Eczema; Ex preemie
Diagnostic Lab Data: None
CDC Split Type: NYC1200006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 3UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 3UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Public     Purchased by: Other
Symptoms: Pyrexia, Rash generalised, Rash papular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant