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Case Details (Sorted by Vaccination Date)

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VAERS ID:308516 (history)  Vaccinated:2008-03-28
Age:1.3  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 0
Location:California  Entered:2008-03-28
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1779U0SCLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PATIENT DEVELOPED ERYTHEMA AT INJECTION SITE POST VACCINATION. LEFT ANTEROLATERAL THIGH APPROX 6 CM IN DIAMETER. PREVIOUS VAERS WEB SUBMISSION INCORRECT DOCUMENTATION OF SITE. PLEASE USE THIS VAERS WEB SUBMISSION.

VAERS ID:308537 (history)  Vaccinated:2008-03-28
Age:2.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 3
Location:Indiana  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE- MOTHER REPORTS NO PRIOR REACTIONS TO VACCINATION
Preexisting Conditions: NONE
Diagnostic Lab Data: EVALUATION INCLUDED CXR, FLU SWAB, URINALYSIS, CHEMISTRY AND CBC - ALL RESULTS WITHIN NORMAL LIMITS.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU18087C3IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray normal, Full blood count, Gaze palsy, Pyrexia, Tremor, Urine analysis, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: CHILD RECEIVED TRIHIBIT VACCINATION AT 2:15 PM ON 3/28/08. MOTHER REPORTS AT 6 PM CHILD DEVELOPED A FEVER. SHE CALLED PHYSICIAN, INSTRUCTING HER TO CONTINUE TYLENOL/ADVIL COMBINATION. AT 9 PM THE CHILD''S FEVER INCREASED TO 104.5, WITH SHAKING, EYES ROLLING TO BACK OF HEAD, LIFELESS BEHAVIOR. CHILD TAKEN TO E.D. LAB AND X-RAY COMPLETED, DIAGNOSIS FEBRILE ILLNESS. CONTINUE TYLENOL/ADVIL COMBINATION. TO SEE PEDIATRICIAN ON 3/29/08, TEMP 100.3 TO SEE PEDIATRICIAN ON 3/30/08, TEMP 99.6. PEDIATRICIAN DIAGNOSIS TRIHIBIT REACTION. 3/31/08: MOTHER REPORTS CHILD BEHAVIOR NORMAL, AFEBRILE.

VAERS ID:308591 (history)  Vaccinated:2008-03-28
Age:11.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 0
Location:Virginia  Entered:2008-03-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1259U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2558AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2824AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1180U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: After receiving MENACTRA and VARIVAX in right arm, patient complained of right hand feeling tingly. Happened for 10 minutes. Applied ice pack and patient stated it felt better.

VAERS ID:308633 (history)  Vaccinated:2008-03-28
Age:79.0  Onset:2008-03-31, Days after vaccination: 3
Gender:Female  Submitted:2008-03-31, Days after onset: 0
Location:Tennessee  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: community acquired pneumonia, hematocrit 25% - iron deficiency anemia, chest pain
Preexisting Conditions: History myelodysplastic syndrome, history breast cancer s/p mastectomy. 4/14/08-records received-PMH: myelodysplastic syndrome, breast carcinoma.
Diagnostic Lab Data: 4/14/08-records received-HCT 25%, Blood culture no growth. CT chest negative for pulmonary embolus. CXR basilar pneumonia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0048X0IMRA
Administered by: Military     Purchased by: Private
Symptoms: Cellulitis, Chest X-ray abnormal, Computerised tomogram normal, Cough, Dyspnoea, Erythema, Febrile infection, Haematocrit decreased, Iron deficiency anaemia, Non-cardiac chest pain, Pleural effusion, Pneumonia
SMQs:, Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 3/31: erythema of right upper extremity periantecubital 20x10cm roughly - got Pneumovax deltoid 3 days ago; hold discharge (from hospital). 4/14/08-records received-Admitted 3/27/08- with C/O febrile illness, dyspnea, cough and chest pain. Seen in ED. DX Community acquired pneumonia. Iron deficiency anemia. 4/14/08-records received-Admitted 3/27/08- with C/O febrile illness, dyspnea, cough and chest pain. Seen in ED. DX Community acquired pneumonia. carcinoma. 4/22/08-DC Summary received for DOS 3/27-4/2/08-DC DX: Pneumonia. Chest pain, non-cardiac. Cellulitis. Pleural effusion. anemia.

VAERS ID:308656 (history)  Vaccinated:2008-03-28
Age:10.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-03-31, Days after onset: 2
Location:Pennsylvania  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enalapril; Claritin
Current Illness: None
Preexisting Conditions: Aortic stenosis; bicuspid aortic valve; mild intermittent asthma.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1781U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Local reaction, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large local reaction, fever for 24 hours, nausea, headache.

VAERS ID:308659 (history)  Vaccinated:2008-03-28
Age:78.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-03-31, Days after onset: 3
Location:Washington  Entered:2008-03-31
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0804U IMUN
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERU1992EA0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness/swelling of right upper extremity 3-4 hours after vaccine (PNEUMOVAX).

VAERS ID:308696 (history)  Vaccinated:2008-03-28
Age:34.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 3
Location:Maryland  Entered:2008-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1743IDRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2543AA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 34 Y/O MALE C/O HAVING MODERATED ANTHRAX SENSITIVITY TO RIGHT UPPER DELTOID MUSCLE, PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: PRURITIS, REDNESS, SORENESS, NUMBNESS, INITIAL ONSET WAS 03/29/08 ONE DAY POST IMMUNIZATION UNCHANGED UNTIL PRESENTATION IN CLINIC FOR EVALUATION TODAY. PT SEEN BY RN, NP. PRESCRIBED A TOPICAL ANTIPRURITIC, HEALTH TAUGHT CONTINUED SX/SX''S OF MEDICATION SENSITIVITY. PATIENT TO FOLLOW UP WITH PCM OR EMERGENCY ROOM IF SX''S PERSIST OR WORSEN.

VAERS ID:308697 (history)  Vaccinated:2008-03-28
Age:32.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 3
Location:New Jersey  Entered:2008-04-01
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: KNEE PROBLEMS
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB100AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 3/29/08-site of Tdap immunization red, hot to touch and swollen---3/30/08-developed fever (temp unknown), chills, headache, joint pain---3/31/08-developed rash around site of immunization, PMD advised ER visit, where client was given Benadryl and an antibiotic---4/1/08-systemic symptoms resolved, site still red and warm to touch but swelling has decreased

VAERS ID:308701 (history)  Vaccinated:2008-03-28
Age:1.3  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 3
Location:California  Entered:2008-04-01
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: Blood tests and xrays were done.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Dysstasia, Gait disturbance, Pyrexia, X-ray
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Within 24 hours, baby beame unable to stand, crawl or walk and had pain in legs, especially on left side. Had fever.

VAERS ID:308711 (history)  Vaccinated:2008-03-28
Age:0.5  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-04-01, Days after onset: 4
Location:New Jersey  Entered:2008-04-01
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: possible food allergies
Diagnostic Lab Data: Chest xray- clear. Flu test done, not the flu.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERNOT KNOWN2IMLL
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURERNOT KNOWN2PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Crying, Diarrhoea, Dyspnoea, Influenza serology negative, Lethargy, Rhinorrhoea, Swollen tongue, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Vaccine given at 11:30 am. Vomiting- began 2 hours after vaccination, continued for 48 hours. Diarrhea for 48 hours. Baby woke up with trouble breathing (12:00am). Tongue looked swollen. Coughing Began around this time. Went to ER. Chest Xray taken. Thick, clear mucous drip began for next 24 hrs. Lethargic, crying.

VAERS ID:308720 (history)  Vaccinated:2008-03-28
Age:23.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-01, Days after onset: 4
Location:Pennsylvania  Entered:2008-04-01
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Syncopal episode x 2, red hand/forearm same side as injection. Seen in ER, diagnosed varovagal reaction, no evidence allergic reaction.

VAERS ID:308724 (history)  Vaccinated:2008-03-28
Age:14.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 3
Location:Alabama  Entered:2008-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Febrile seizure~Measles + Mumps + Rubella (no brand name)~1~1~In Sibling
Other Medications: Adderall 20 mg
Current Illness: None
Preexisting Conditions: ADHD
Diagnostic Lab Data: UA - Blood, protein in urine, CBC WNL, CMP pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU566AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blood urine present, Full blood count normal, Laboratory test, Oedema peripheral, Pruritus, Pyrexia, Rash, Urine analysis abnormal, Urine protein, quantitative
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had fever, swelling of both arms and feet, with itching. Some rash on lower (L) arm. Benadryl PO at home. Medrol dose pak given.

VAERS ID:308728 (history)  Vaccinated:2008-03-28
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-28
Location:Maine  Entered:2008-04-01, 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: Ortho Tri-Cyclen; Differin; Levoxyl; Bactrim
Current Illness: None
Preexisting Conditions: hypothyroidism, mild mental retardation, acne, seizure d/o
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA IMUN
Administered by: Private     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: No adverse events happened. Dtap was given instead of a Tdap.

VAERS ID:308764 (history)  Vaccinated:2008-03-28
Age:14.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-04-02, Days after onset: 5
Location:Wisconsin  Entered:2008-04-02
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1908AA IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Outdated med. Dating 08Mar07 interpreted as March 7, 2008.

VAERS ID:308766 (history)  Vaccinated:2008-03-28
Age:64.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-02, Days after onset: 5
Location:Wisconsin  Entered:2008-04-02
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 (MENACTRA)SANOFI PASTEURU1908AA IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Outdated med 08Mar07 interpreted as March 7, 2008.

VAERS ID:308811 (history)  Vaccinated:2008-03-28
Age:67.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-02, Days after onset: 4
Location:Iowa  Entered:2008-04-03, 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: No change
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.1835U0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right ARM got red and puffy, according to Pt. on the next day. Started out "quarter-size". Progressed to "Golf ball-size" on 3rd day. Warm. No other symptoms, however. She took Only 1 Benadryl and didn''t work immediately, so called Ask a RN and went to E.R.-was told to take acetaminophen by RN, and Dr. at E.R. had told her to get on Benadryl course before leaving our pharmacy, upon vaccination.

VAERS ID:308923 (history)  Vaccinated:2008-03-28
Age:31.0  Onset:2008-03-30, Days after vaccination: 2
Gender:Female  Submitted:2008-03-31, Days after onset: 1
Location:Missouri  Entered:2008-04-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt not sure of any~ ()~~0~In Patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient described red, warm, tender swollen area at injection site with numbness in fingers. Went to urgent care and area without redness or warmth with minimal tenderness and intermittent numbness in finger. Swelling mild.

VAERS ID:308931 (history)  Vaccinated:2008-03-28
Age:0.2  Onset:2008-03-30, Days after vaccination: 2
Gender:Female  Submitted:2008-04-02, Days after onset: 3
Location:Tennessee  Entered:2008-04-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None
Preexisting Conditions: Prematurity; LBW; Positive drug screen at birth - THC.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA0IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04900IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458920IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0020X0PO 
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Crying, Diet refusal
SMQs:, Neuroleptic malignant syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Infant began inconsolable crying 48 hours after receiving vaccine. Crying accompanied by temperature 100-101 F. Refusal to eat. Crying evaluated in clinic 04-02-08. No site illness. Reaction determined to be from vaccines.

VAERS ID:308965 (history)  Vaccinated:2008-03-28
Age:53.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-04, Days after onset: 7
Location:Vermont  Entered:2008-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: RA; depression; hypothyroid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Baseball sized, red, raised area at site of injection with several red, warm to touch areas down arm. Achy with fever for 3-4 days, tremors, high level of discomfort in arm.

VAERS ID:308991 (history)  Vaccinated:2008-03-28
Age:9.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-03-31, Days after onset: 2
Location:Pennsylvania  Entered:2008-04-04, 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: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1512U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large area upper left arm, raised, warm, central reddened - clear d/c - no nodes.

VAERS ID:308954 (history)  Vaccinated:2008-03-28
Age:1.3  Onset:2008-04-01, Days after vaccination: 4
Gender:Female  Submitted:2008-04-06, Days after onset: 5
Location:New York  Entered:2008-04-06
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: Patient is on added iron.
Diagnostic Lab Data: blood, urine, heart & chest x-ray & other culture/lab
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER1745U0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Anorexia, Blood culture, Chest X-ray, Convulsion, Crying, Culture, Culture urine, Cyanosis, Dehydration, Discomfort, Irritability, Laboratory test, Staring, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Received MMR shot on 3/28/08, perfectly healthy with no problems prior to that date. On 3/31/08 patient stopped eating, drinking & was fussy. Morning of 4/1 she awoke with a high temp we were treating with ibuprofen. She was very uncomfortable & cried most of the day - still not eating or drinking, although she would reach for food. She was sitting on my lap crying (reaching for food then pushing it away) right before 7 pm when she made a gurgling noise, then slumped over and began seizing. Her eyes went blank, her body shaking, gurgling noises, saliva bubbles from her mouth, she turned blue and was unresponsive for just under 5 minutes. She was taken by ambulance to Medical Center where they ran some tests & treated her for febrile seizure & dehydration.

VAERS ID:309021 (history)  Vaccinated:2008-03-28
Age:23.0  Onset:2008-04-07, Days after vaccination: 10
Gender:Male  Submitted:2008-04-07, Days after onset: 0
Location:California  Entered:2008-04-07
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
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV040030OTRA
Administered by: Military     Purchased by: Military
Symptoms: Blister, Injection site bruising, Injection site erythema, Injection site induration, Pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt recieved smallpox vaccination on 3/38/08. On 4/4/08, pt returned for his 7 day follow up with a regular reaction: white vesicle 5mm, local itching, and local redness. On day 4/6/08, pt presented with a large erythemic smallpox site of 40x40mm induration. Site has purplish bruising of 40x40mm, local rash, and 5mm white vesicle. Pt reported adverse reaction to medical 4/7/0804.

VAERS ID:309125 (history)  Vaccinated:2008-03-28
Age:0.6  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-02, Days after onset: 4
Location:Georgia  Entered:2008-04-08, Days after submission: 6
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:
Diagnostic Lab Data: WBC 7,900; urine was negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B073AA2UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499172UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1692U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Pyrexia, Urine analysis normal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient having pronounced fever, currently 5 days with increase 103 degrees every night. Patient also having vomiting and diarrhea x2 days now. Fever started the day after vaccinations.

VAERS ID:309139 (history)  Vaccinated:2008-03-28
Age:13.0  Onset:2008-03-30, Days after vaccination: 2
Gender:Female  Submitted:2008-04-08, Days after onset: 9
Location:Wisconsin  Entered:2008-04-08
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Pruritus, Pyrexia, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Allergic reaction - itchy, swelling all over body, fever, rash lasting longer than 1 week. Treatment - Benadryl every 6 hours, steroids in ER.

VAERS ID:309151 (history)  Vaccinated:2008-03-28
Age:4.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Male  Submitted:2008-04-02, Days after onset: 4
Location:Maine  Entered:2008-04-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Skin warm, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Induration a vaccine site approximately 5 in x 6 in at upper arm. Warm to touch, tender.

VAERS ID:309160 (history)  Vaccinated:2008-03-28
Age:16.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 3
Location:Alabama  Entered:2008-04-08, 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: PCN, Sulfa, Keflex, Ceclor, ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Local reaction at immunization site - 6cm diameter area of erythema, induration, tenderness, & heat.

VAERS ID:309198 (history)  Vaccinated:2008-03-28
Age:2.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-03-31, Days after onset: 3
Location:New York  Entered:2008-04-09, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: similar sx~DTaP (no brand name)~3~1~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR208733UNRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Reaction to previous exposure to any vaccine
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling, redness, induration and soreness to whole upper arm now resolving. Started day of shot. Currently ~6 cm diameter patch remains 3 days after shot. Mom mentions today had similar after last DTaP on leg.

VAERS ID:309214 (history)  Vaccinated:2008-03-28
Age:43.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 12
Location:Minnesota  Entered:2008-04-09
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neck pain, Pain in extremity, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient states extreme pain in arm, warmth and swelling stated the night she received the vaccination. Her whole arm and into her neck were extremely painful. Patient states the Advil helped.

VAERS ID:309224 (history)  Vaccinated:2008-03-28
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-09
Location:Florida  Entered:2008-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz
Current Illness:
Preexisting Conditions: Biciilin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1806U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large red indurated local reaction to (R) arm at Varivax site (SQ) painful, warm.

VAERS ID:309402 (history)  Vaccinated:2008-03-28
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-07
Location:North Carolina  Entered:2008-04-11, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355BA UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1747U UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling. Tx - Tylenol/Motrin for pain. Presc for Keflex if worse.

VAERS ID:309490 (history)  Vaccinated:2008-03-28
Age:9.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-03-30, Days after onset: 1
Location:Ohio  Entered:2008-04-14, Days after submission: 15
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB200BA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site discolouration, Injection site papule, Local reaction, Rash pruritic, Scratch
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pale pink papules, a few scratched at site of immunization; itchy rash (local).

VAERS ID:309513 (history)  Vaccinated:2008-03-28
Age:  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 0
Location:Wisconsin  Entered:2008-04-15, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills
Current Illness:
Preexisting Conditions: Allergic to pyriolivin - numbness
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: 3/28/08 3:30pm received call from patient. States nausea, dizziness and weakness developed 1/2 hour after HPV injection. Symptoms have persisted. Appt offered to evaluate, patient declined. Per MD push fluids, Tylenol. Monitor.

VAERS ID:309553 (history)  Vaccinated:2008-03-28
Age:0.5  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-15, Days after onset: 17
Location:New York  Entered:2008-04-15
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: Sublingual cyst since birth, heart murmur
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF241AC1UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499211UNRL
Administered by: Private     Purchased by: Public
Symptoms: Face oedema, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling to face; Vomiting

VAERS ID:309620 (history)  Vaccinated:2008-03-28
Age:33.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-04-04, Days after onset: 7
Location:Utah  Entered:2008-04-16, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling|none~ ()~~0~In Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: stated he gets hives when he eats chicken, no hx of hives when eats eggs
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA1IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF197AA0SCLA
Administered by: Public     Purchased by: Private
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Palpitations, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: "Heart racing, thighs burning/itching, chest felt constricted, hives over entire body, difficulty breathing." ER at 1:00 PM. Benadryl, steroid (did not know name of steroid). Pepcid given IV. Sent home at 4:30 PM with Epi Pen. Rx for Benadryl, dose pack of steroid, Pepcid x7 days.

VAERS ID:309690 (history)  Vaccinated:2008-03-28
Age:33.0  Onset:2008-04-02, Days after vaccination: 5
Gender:Female  Submitted:2008-04-01, Days after onset: 1
Location:Idaho  Entered:2008-04-16, 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: cefprozil, finished antibiotic after 2/22/08
Current Illness: Sinus infection 2/22/08
Preexisting Conditions: Eczema
Diagnostic Lab Data:
CDC Split Type: ID08017
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSB096AA1IMUN
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30012911PO 
Administered by: Public     Purchased by: Private
Symptoms: Eczema, Rash papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed dot-like rash to the R side of belly button after 3rd dose of oral typhoid. "I have eczema". Began typhoid 3/28, finished the doses on 4/4. Saw the rash on 4/3/08. Rash now size of 2 quarters blended together.

VAERS ID:311148 (history)  Vaccinated:2008-03-28
Age:13.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 17
Location:Michigan  Entered:2008-04-16, Days after submission: 2
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
Diagnostic Lab Data:
CDC Split Type: WAES0804USA00177
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2546AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1798U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal, Urinary incontinence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated with the first dose of Gardasil (lot# not reported). Concomitant suspect therapy included Varivax (Oka/Merck) (MSD) (lot# not reported). Other concomitant therapy included Tdap (lot # not reported) and Hep A (unspecified) (lot# not reported). On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of Gardasil. Subsequently, the patient recovered from having urinated on herself and being dazed. The patient sought unspecified medical attention in the physician''s office. No other information is available at this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 04/14/2008. Information has been received from a physician concerning a 13 year old female with a history of asthma who on 28-MAR-2008 was vaccinated IM in the left arm with the first dose of GARDASIL (658182/1757U). Concomitant suspect therapy included SC vaccination in the left arm with VARIVAX (lot# 659940/1798U). Other concomitant therapy included IM vaccination in the left arm with ADACEL (Sanofi Pasteur) (C2904AA), IM vaccination in the right arm with HAVRIX (GSK)(AHAVB223AA) and IM vaccination in the right arm with MENACTRA (Sanofi Pasteur) (U2546AA). On 28-MAR-2008 the patient urinated on herself and was dazed for about 10 minutes after receiving the first dose of GARDASIL. Subsequently, the patient recovered from having urinated on herself and being dazed. The patient sought unspecified medical attention in the physician''s office. No other information is available at this time. Additional information received from B-form (18-APR-2008). The patient became light-headed and was incontinent of a large volume of urine. The patient remained listless for 3-4 minutes and responded within another 2 minutes. Additional information is not expected.

VAERS ID:309902 (history)  Vaccinated:2008-03-28
Age:36.0  Onset:2008-04-05, Days after vaccination: 8
Gender:Female  Submitted:2008-04-17, Days after onset: 12
Location:Massachusetts  Entered:2008-04-17
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: NKA etc. (per pt. 4/16/08)
Diagnostic Lab Data: Had RA X-ray (pet pt.) on 4-11-08 at hosp. (neg. findings per same).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC276AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Diarrhoea, Injection site mass, Oedema peripheral, Rash, Vomiting, X-ray normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. called me 4-16-08 & stated she had no redness or any symptoms until one wk. after the injection when she started with a lump at the injection site. She was seen at hosp. on 4-8-08 & cephalexin was prescribed. Stated she started with vomiting that same day & contributed it to the med. (she D/C''d med). On 4-11-08 vomiting was accompanied by diarrhea. Went back to hosp. on 4-11-08. Had I.V. infusion Toradol (for arm discomfort) & R.A. X-ray which was neg. Pt. was unhappy when physician Dx her with viral condition & hadn''t done labs/X-rays (which is why he most likely did an X-ray of her arm). The physician told her to continue the cephalexin & did not give her an IV antibiotic. The pt. D/C''d the cephalexin again on 4-11-08. She states that on Sun. April 13th, her entire arm became edematous & was accompanied by a rash so she decided to start the cephalexin again & increased her food intake with same. She called her PCP on Monday 4-14-08 (although she felt better in regard to n/v & arm) but the physician was not available. She received a return call from PCP''s answering service ??? today (4-16-08) & has an appointment scheduled for tomorrow 4-17-08. I asked her why she didn''t just see her PCP''s coverage & she stated she doesn''t like that physician. I''ve asked this patient to call me with any questions. I feel this situation had to have started with a minor local reaction which was not addressed & later when it progressed to a cellulitis, was not properly tended to (just my opinion from the history obtained).

VAERS ID:309907 (history)  Vaccinated:2008-03-28
Age:1.7  Onset:2008-04-04, Days after vaccination: 7
Gender:Male  Submitted:0000-00-00
Location:Tennessee  Entered:2008-04-17
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC279AA3IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0865U0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4-4-08 rash appeared, no fever, no runny nose per mother. 4-8-08 child seen in office, rash on face, trunk, back, and external genitalia-taking Benadryl. 4-9-08 child seen in office-rash is more pronounced all over including eyelids and ears-taking Benadryl and Orapred.

VAERS ID:310075 (history)  Vaccinated:2008-03-28
Age:32.0  Onset:2008-04-12, Days after vaccination: 15
Gender:Female  Submitted:2008-04-18, Days after onset: 6
Location:North Carolina  Entered:2008-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No diagnostic testing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Rash pruritic, Skin irritation
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Receiving vaccine due to non-immune status and with 3 month old infant. On 4/12 had initial "bump" on face with progression of large number of "bumps" on scalp, neck, chest, back, and arms. Bumps not fluid-filled, but quite itchy per client. Injection site edematous, hot to touch and painful - "feels very irritated" per client.

VAERS ID:310169 (history)  Vaccinated:2008-03-28
Age:0.7  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2008-04-18
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1485U0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1793U0SCLL
Administered by: Private     Purchased by: Private
Symptoms: No adverse event
SMQs:
Write-up: None - no adverse event. Vaccines given early.

VAERS ID:310427 (history)  Vaccinated:2008-03-28
Age:5.0  Onset:2008-03-30, Days after vaccination: 2
Gender:Female  Submitted:2008-04-18, Days after onset: 19
Location:Washington  Entered:2008-04-21, 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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U1UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site reaction, Local reaction
SMQs:
Write-up: Local skin rxn vs cellulitis at injection site 1-2 days post vaccine. Placed on Keflex x10 days.

VAERS ID:310514 (history)  Vaccinated:2008-03-28
Age:58.0  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-01, Days after onset: 3
Location:Wisconsin  Entered:2008-04-22, Days after submission: 21
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 PASTEURC2825AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine administered on 3/28/08. Significant pain and swelling began on 3/29/08. Swelling extended to under the arm and below the elbow. Treatment: ice, heat, Tylenol, Benadryl.

VAERS ID:310831 (history)  Vaccinated:2008-03-28
Age:0.3  Onset:2008-03-29, Days after vaccination: 1
Gender:Female  Submitted:2008-04-24, Days after onset: 26
Location:Connecticut  Entered:2008-04-24
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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Had possible concurrent afebrile UTI; MRI, EEG per above. LABS: Urine c/s (+) E. coli. EEG WNL. MRI WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF354AA1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04741IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458871IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1887U1PO 
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Culture urine positive, Electroencephalogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Postictal state, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: New onset seizure disorder within 24 hours. Still having seizure - MRI (borderline) and EEG (abnormal). 5/2/08 Reviewed hospital medical records of 4/3-4/5/2008. FINAL DX: new onset seizures Records reveal patient experienced witnessed seizure while home. Seen by PCP & had another witnessed seizure while in office w/generalized tonic-clonic activity w/postictal phase lasting approx 2 min. Parent reported that patient had been dazed upon awakening for approx 5 days but otherwise acting normal. Vomited night before admission. Admitted for observation. Peds neuro consult done & tx w/antiseizure meds. Had a few more episodes while hospitalized. Stabilized & d/c to home w/peds neuro clinic f/u.

VAERS ID:311051 (history)  Vaccinated:2008-03-28
Age:15.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 31
Location:West Virginia  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1478U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: ON FOLLOW UP VISIT PATIENT STATES ARM IS STILL SORE AT INJECTION SITE 1 MONTH LATER. NO KNOT OR REDNESS NOTED.

VAERS ID:311456 (history)  Vaccinated:2008-03-28
Age:18.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 34
Location:Ohio  Entered:2008-05-02, 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: Bactrim
Current Illness: Urinary tract infection
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA00974
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Lip swelling, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial and follow-up information has been received from a physician concerning an 18 year old female with a urinary tract infection at the time of vaccination and no allergies or drug reactions who on 28-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659182/1757U) injection in the left arm at 10:00 AM. Concomitant therapy included BACTRIM for the urinary tract infection. After receiving the vaccine in the office and on the way home the patient developed diffuse rash. On 29-MAR-2008 the patient was seen by the physician and saw the patient at that time had markedly swollen lips and she had a diffuse maculopapular rash all over. Subsequently, on an unspecified date the patient recovered from the rash and swollen lips. No further information was provided. The reporter felt that maculopapular rash and swollen lips were considered to be an other medical event. Additional information has been requested.

VAERS ID:311870 (history)  Vaccinated:2008-03-28
Age:20.0  Onset:2008-04-01, Days after vaccination: 4
Gender:Female  Submitted:0000-00-00
Location:Indiana  Entered:2008-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: seasonal inhalant allergies
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF175AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: On 4/2/08 pt came back to health center to have her arm checked. There was a 2 inch red raised wheal on arm at site of YF vaccine given 3-28-08. She states bump started on 4-1-08 around noon & was very itchy. On 4-2-08 she states the bump is the same size as 4-1-08 & less itchy. Denies itchiness elsewhere on body, difficulty breathing, swollen throat or other allergy sx.

VAERS ID:312171 (history)  Vaccinated:2008-03-28
Age:61.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-11, Days after onset: 14
Location:Illinois  Entered:2008-05-13, Days after submission: 32
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: Lupus in remission, DM, HTN, High Chol, artificial heart valve.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye pain, Pain
SMQs:, Glaucoma (broad)
Write-up: Pt rec''d Zostavax, that night pt developed pain under her skin all over her body, began in chest and upper bod and spread. Eye sockets hurt a lot as if she had a high fever. Vision was normal. Ached all over when touched any part of body. No rash, no fever, no GI symptoms; lasted one week then gradually subsided.

VAERS ID:312386 (history)  Vaccinated:2008-03-28
Age:6.0  Onset:2008-05-11, Days after vaccination: 44
Gender:Male  Submitted:2008-05-15, Days after onset: 4
Location:Colorado  Entered:2008-05-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: allergy to Ibuprofen Hx of ulcerative colitis
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU1958 IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.O157X0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Rash papular, Rash vesicular, Wrong drug administered
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Varicella form lesion approximately 6 cm in diameter left upper back at the T3 distribution. Some mild papular & vesicular lesions are noted in the center. Some blistering is noted that is unilateral.

VAERS ID:312801 (history)  Vaccinated:2008-03-28
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Florida  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA01521
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a nurse concerning a 12 year old female who on 24-JAN-2008 was vaccinated IM with the first dose of GARDASIL. On 28-MAR-2008, the patient was vaccinated IM with the second dose of GARDASIL. The patient reported pain in the arm at the injection site for 3 days after the vaccination was given. The pain in the arm included not being able to lift the arm. The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients. Unknown medical attention was sought through contact with the nurse. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES # 0804USA05546 and 0805USA01522). Additional information has been requested.

VAERS ID:312879 (history)  Vaccinated:2008-03-28
Age:25.0  Onset:2008-04-06, Days after vaccination: 9
Gender:Female  Submitted:2008-05-14, Days after onset: 38
Location:Massachusetts  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02194
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMUN
Administered by: Private     Purchased by: Other
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 25 year old female who on 28-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). On 07-APR-2008 the patient experienced hives all over her body, mildly itchy. She called the nurse on 08-APR-2008 to report the hives. The patient has no medication or food allergies, but mild lactose intolerance. She has not been exposed to any new things. She was taking antihistamines and the hives were improving; no trouble breathing or swallowing. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2008. GARDASIL Vaccine (lot # 659435/1265U). On 06-APR-2008 the patient experienced hives all over her body, midly itchy. She called the nurse on 08-APR-2008 to report the hives. She was taking antihistamines and the hives improved on 10-APR-2008; no problem breathing or swallowing. The decision was made to not continue with the series. No additionla information is expected.

VAERS ID:313073 (history)  Vaccinated:2008-03-28
Age:17.0  Onset:2008-04-01, Days after vaccination: 4
Gender:Female  Submitted:2008-05-14, Days after onset: 43
Location:California  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data: Neisseria gonorrhoeae, 03/31/08, not dected specimen tested (-) in the gen-probo aptima-2 screening assay using nucleic acid ampli; Chlamydia trachomatio, 03/31/08, not detected specimen tested (-) in the gen-probo aptima-2 screening assay using nucleic acid ampil; Cervix HPC DNA assay, 03/31/08, (+) hybrid capture 2 tests for high risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68
CDC Split Type: WAES0804USA03277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bacterial DNA test, Chlamydia identification test negative, Human papilloma virus test positive
SMQs:
Write-up: This is in follow-up to report(s) previously submitted on 5/14/2008: 7/8/2008. Information has been received from a mother concerning her 17 year old daughter with depression and no known drug allergies, who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified), LEXAPRO and ABILIFY. The patient also received MENACTRA on the same day she received GARDASIL. Four days after receiving her first dose of GARDASIL the patient tested HPV positive. Medical attention was sought via telephone. The patient had not recovered. No product quality complaint was involved. Follow up information received from the physician indicated that the patient received her GARDASIL in another physician''s office. Follow up information was received on 01-JUL-2008. A health care professional reaported that the patient received the dose of GARDASIL at another office. She also reported that the patient was seen at their office on 31-MAR-2008 for an annual pap smear which came back with positivefor HPV. The laboratory results were as follow: Cervical HPV came back positive: hybrid capture 2 tests for high risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/66. Chlamydia PCR and gonorrhoeae were not detected. Additional information is not expected. This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information received from the physician indicated that the patient received her GARDASIL in another physician''s office. Additional information has been requested.

VAERS ID:312743 (history)  Vaccinated:2008-03-28
Age:1.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-20, Days after onset: 53
Location:Georgia  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling
Other Medications: SINGULAIR 4mg chew, ZANTAC
Current Illness: none
Preexisting Conditions: History of GER -$g as of 3/28/08 resolved.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B145AA0UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF355AA0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016U3UNUN
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: During sleep on Friday (3/28/08) night, child woke up screaming for one hour and fever of 103. Child continued with fever 102-103 and "fits of fussiness and screaming" through 3/29/08-3/31/08.

VAERS ID:315970 (history)  Vaccinated:2008-03-28
Age:8.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-07, Days after onset: 40
Location:Wyoming  Entered:2008-05-29, Days after submission: 22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No relevant medical history and no concurrent medications. Reporter mentioned that the subject developed bumps following a previous vaccine but the father said it was a rash. Name of vaccine was unknown.
Diagnostic Lab Data: Unknown
CDC Split Type: A0721668A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER1441U UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1169F UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1475U UNUN
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, Limb discomfort, Medication error
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of vaccination error in a 8-year-old male subject who was vaccinated with BOOSTRIX, GlaxoSmithKline. Previous history of rash with unknown vaccine. Previous and/or concurrent vaccination included HEP A given on 28 March 2008; POLIO VIRUS given on 28 March 2008; MMR II (strain not specified) given on 28 March 2008; VARIVAX given on 28 March 2008. On 28 March 2008 at 08:45 the subject received BOOSTRIX (.5 ml, unknown, left arm) and experienced vaccination error. At the time of the report, no adverse event had been reported. Follow-up received on 01 April 2008 via the nurse. The nurse reported that the subject complained that his arm was sore. The outcome was unknown at the time of reporting. No further information was reported.

VAERS ID:317026 (history)  Vaccinated:2008-03-28
Age:11.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 77
Location:Indiana  Entered:2008-06-16, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA05619
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history who on 28-MAR-2008 was vaccinated with a first dose GARDASIL (Lot # 658556/1060U). There were no concomitant medications. On 28-MAr-2008, several hours after vaccination she developed a rash. The rash covered her body except her face and neck. The patient required an office visit and was treated with BEABDRYL. The rash resolved in 3 to 4 days. Additional information has been requested.

VAERS ID:318637 (history)  Vaccinated:2008-03-28
Age:25.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-07-09, Days after onset: 103
Location:Tennessee  Entered:2008-07-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 3/6/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 05/05/08, reason-viability no defectable fetal parts or cardiac activity within sac; ultrasound, 05/20/08, no fetal pole or yolk sac seen; suggested blighted ovum; beta-human chorionic, positive
CDC Split Type: WAES0804USA06374
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blighted ovum, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received for the Pregnancy Registry for GARDASIL from a 25 year old female consumer who on 28-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# not reported). Concomitant therapy included prenatal vitamins (unspecified) once daily. On 06-APR-2008 the patient found out she was 4 weeks pregnant. The patient had a positive home pregnancy test. Subsequently the patient experienced no adverse events and sought unspecified medical attention. The patient''s estimated conception date was approximately 19-MAR-2008, her last menstrual period was 06-MAR-2008 and her estimated delivery date was 10-DEC-2008. On 05-MAY-2008 an ultrasound was performed for viability, the results showed no defectable fetal parts or cardiac activity within the sac. On 20-MAY-2008 an ultrasound was performed and showed no fetal pole or yolk sac, which suggested a blighted ovum. The patient did not provide any information on the first and second dose. At the time of the report, the outcome of the patient was unknown. Upon internal review the blighted ovum was considered to be an other important medical event. Additional information has been requested.

VAERS ID:319347 (history)  Vaccinated:2008-03-28
Age:63.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 88
Location:Georgia  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA00417
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1429U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Medication errors (narrow)
Write-up: Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who on "last Friday" (28-MAR-2008) was vaccinated with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U) "in her lower arm between her wrist and elbow." There was no concomitant medication. Subsequently, right after receiving the vaccination she developed a red and inflamed injection site. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the patient indicated that the vaccination was ordered by her regular physician and administered by a physician friend after she picked it up from the pharmacy. It was noted that the vaccination was administered into her lower forearm. At the time of the report the patient''s status was unknown. The patient also reported that she had no adverse reaction. Additional information is not expected.

VAERS ID:318865 (history)  Vaccinated:2008-03-28
Age:0.5  Onset:2008-03-30, Days after vaccination: 2
Gender:Male  Submitted:2008-07-14, Days after onset: 106
Location:Michigan  Entered:2008-07-14
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: Keflex 250/5 4cc BID x 10 days.Altabax topical
Current Illness: Left thumb with erythematous papular vesicle, no discharge.
Preexisting Conditions:
Diagnostic Lab Data: Mg 2.7, ionized calcium 5.30, eosinophils 0.6. Ct head w/o contrast done 4-8-2008 and normal. EEG done 4-8-2008 was"normal awake and sleep EEG...when patient was awake the cerebral activity could not be well read because of the excessive m
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF240AB2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499192IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1692U2PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood calcium increased, Blood magnesium increased, Calcium ionised normal, Computerised tomogram normal, Electroencephalogram normal, Eosinophil count increased, Full blood count normal, Infantile spasms, Laboratory test normal, Musculoskeletal stiffness, Oral fungal infection, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: On 3-28-2008 patient received Dtap, Hib, Prevnar (PCV7) and Rotateq. Mom called office on 4-1-2008, stated on 3-30-2008 and 3-31-2008 noticed he had a spasm -neck, arms, legs got stiff all of a sudden, for few seconds, no fever, suggested appointment. Patient seen 4-2-2008 by Dr. Doctor ordered labs (CBC w/dif, Mg, ionized Ca and CMP) and EEG (awake and asleep, if possible, within 1 week). Also diagnosed oral fungal infection, nystatin suspension ordered and topical yogart to mouth. On 4-2-2008 EEG set up for 4-8-08. Mom called on 4-7-08 requesting referral to Pediatric Neurology. Dr reviewed labs and agreed to refer to Peds Neurology, labs slightly increase Mg, Calcium, slightly increased eosinophils. Dr request patient be rechecked tonight at office ASAP or ER if mom thought patient having repeated seizures. Also request repeat electrolytes. Patient seen 4-7-2008 by Dr. Dr diagnosed Status Epileptic, requested Vaers be done and admitted to Medical Center. 8/6/08-records received for DOS 4/7-4/8/08-DC DX: Motor overflow/benign infantile spasms. Presented with spasms of upper extremities over past 8 days.

VAERS ID:320845 (history)  Vaccinated:2008-03-28
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-25
Location:Tennessee  Entered:2008-07-30, 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: None
Preexisting Conditions: NKA/none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Patient given Hepatitis A #2 and HPV #3 on 3-28-08. Patient had positive pregnancy test 4-7-08.

VAERS ID:324221 (history)  Vaccinated:2008-03-28
Age:71.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 124
Location:North Carolina  Entered:2008-08-06, 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: Chronic cough; Asthma; Gastrooesophageal reflux; Bronchospasm; Osteoarthritis; Breath shortness; Postnasal drip
Preexisting Conditions: Unknown Endometriosis; Discectomy; Back surgery; Appendicectomy; Colonoscopy; Knee arthroplasty; Total abdominal hysterectomy
Diagnostic Lab Data: Unknown blood pressure, 03/28/08, 124/7 mmHg; peak expiratory flow, 03/28/08, 350; peak expiratory flow, 03/28/08, 390; physical examination, 03/28/08, see narrative; peak expiratory flow, 03/28/08, 370; total heartbeat count, 03/28/08, 74 b/min; respiratory rate, 03/28/08, 18 r/min; pulse oximetry, 03/28/08, 98%; temperature measurement, 03/28/08, 98.5 F
CDC Split Type: WAES0804USA00146
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1381U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure increased, Chest discomfort, Condition aggravated, Cough, Dyspnoea, Heart rate normal, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Obesity, Oxygen saturation, Respiratory rate decreased, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow)
Write-up: Information has been received from a nurse concerning a 71 year old female who on 28-Mar-2008 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 659147/1381U). On 28-MAR-2008, the patient experienced redness, swelling, pain, warmth and induration at the injection site several hours post vaccination. Unknown medical attention was sought by calling physician''s office. The patient''s symptoms continued. At the time of reporting the patient had not recovered. It was also reported that the patient might have had an injection site rash after a pneumococcal 23v polysaccharide vaccine (lot# not provided) given in the 1990''s. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2008. Information has been received from a nurse concerning a 71 year old female with asthma (since 1970), persistent cough, postnasal drip, gastrooesophageal reflux, breath shortness, bronchospasm and osteoarthritis and a history of endometriosis, discectomy, back surgery, colonoscopy, total abdominal hysterectomy and knee arthroplasty, maternal history of breast neoplasm, family history of diabetes mellitus and paternal grandmother with uterine cancer, who on 28-Mar-2008 at 9:10 AM was vaccinated intramuscularly into the left deltoid with a second 0.5 ml dose of PNEUMOVAX (lot# 659147/1381U). Concomitant therapy included AMITRIPTYLIN, LEVOXYL, pravastatin Na, PROTONIX, NEXIUM and albuterol. On 28-MAR-2008 the patient was evaluated in the office for a persistent cough. Her asthma was under good control without the need for maintenance medications. She did not even need to use albuterol in February 2008 she developed a respiratory infection after which she had been complaining of a pertinent cough associated with shortness of breath and tightness sensation in her chest. She has noticed occasional wheezing. She does not have hemoptysis. There is no fever or chills. There is no angina. The tightness is the chest does not radiate to her neck or left arm. The patient stated that she had a cardiac work up in the past including a stress test that was negative. She has a known history of gastric reflux disease with hiatal hernia for which is on NEXIUM. She also has a post nasal drip, but does not have chronic allergic rhinitis or sinus congestion. There are no other significant complaints. She has known osteoarthritis. Physical exam revealed that she was not observed to be obese. She was an alert, well developed, well nourished patient, in no acute distress. Pharynx was moist with no exudate. No adenopathy. Wheezing was hard. Heart rate and rhythm normal, no murmurs or jugular venous distention. Assessment revealed shortness of breath, cough, asthma, bronchospasm and esophageal reflux. The patient was given prescriptions for alprazolam, tamoxifen citrate, and TUSSIONEX PENNKINETIC ER for cough. On 28-MAR-2008 at 16:08, she called the office about her PNEUMOVAX injection site. She stated that the site was sore, hot to touch and has an area below the site that is reddened. She estimates the size to be 4x3. She stated that she received the pneumonia vaccine over ten years ago and had developed a red rash over half her arm. She had soreness at the site as well. She did not have any other adverse side effects at that time. She denies fever or trouble breathing. She was advised that the soreness and some swelling was normal and if the rash continued to increase in size or she developed a temperature $g101.5, difficulty breathing she should call us back or go to the emergency room. The patient was advised to take BENADRYL 50 mgs, TYLENOL and ADVIL as needed throughout the weekend. The patient acknowledged understanding of the instructions provided. On 31-Mar-2008 the patient''s symptoms continued and the patient had an office appointment for follow up of the adverse reaction to the pneumonia vaccine. The patient stated it was slightly tender and felt warm. She did not have fever or chills. S

VAERS ID:321718 (history)  Vaccinated:2008-03-28
Age:1.5  Onset:2008-03-28, Days after vaccination: 0
Gender:Male  Submitted:2008-08-08, Days after onset: 133
Location:Texas  Entered:2008-08-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF063AA3IMRL
Administered by: Private     Purchased by: Private
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Lacy non raised rash on body/extremities 4-5 hrs. after receiving HAV & HiB vaccine. Rash resolved after few hours. Mom just now informing us of rash.

VAERS ID:325697 (history)  Vaccinated:2008-03-28
Age:23.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 139
Location:Massachusetts  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA05360
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a registered nurse considering a 23 year old female with no known drug allergies and no previous medical history who on 28-JAN-2008 was vaccinated IM in the deltoid with her first dose of GARDASIL vaccine (yeast) (lot#659657/1487U) 0.5 ml. There was no concomitant medication. The patient received her second dose of GARDASIL vaccine (yeast) (lot# 659182/1757U, site not reported) on 28-MAR-2008. Subsequently she "passed out" and felt nauseous after the second dose. The patient did not seek treatment for her symptoms and recovered on an unspecified date. No further information was available Additional information has been requested.

VAERS ID:323090 (history)  Vaccinated:2008-03-28
Age:40.0  Onset:0000-00-00
Gender:Male  Submitted:2008-08-22
Location:Unknown  Entered:2008-08-22
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: SEPTRA: UNKNOWN REACTION
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA03944IMLA
Administered by: Military     Purchased by: Public
Symptoms: Mobility decreased, Muscle spasms
SMQs:, Dystonia (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: spasm in the left hand to the point he cannot bend his third left finger for 3-6months, every time he gets a shot.

VAERS ID:336145 (history)  Vaccinated:2008-03-28
Age:24.0  Onset:2008-06-09, Days after vaccination: 73
Gender:Female  Submitted:2008-12-22, Days after onset: 196
Location:Unknown  Entered:2008-12-29, 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:
Preexisting Conditions: No known drug allergy.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.3446U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperaesthesia, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received her second GARDASIL vaccine in June on her left arm. Patient states that her arm is stills swollen and feel very tender. She is sensitive to touch.

VAERS ID:338383 (history)  Vaccinated:2008-03-28
Age:1.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2008-12-18, Days after onset: 265
Location:Georgia  Entered:2009-01-16, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Montelukast sodium; Ranitidine hydrochloride
Current Illness: Allergic Rhinitis
Preexisting Conditions: Gastroesophageal reflux. A0723471A was one of three cases reported by the same physician. The physician stated that she had administered 20 doses of PEDIARIX during March of 2008, and three of the infant subjects between the ages of 2 and 4 months old (genders unspecified) developed screaming reactions within an hour of receiving PEDIARIX vaccinations. The reactions were describ
Diagnostic Lab Data: Body temperature, 28Mar2008, 102-103degrees F; Body temperature, 29Mar2008, 102-103degrees F; Body temperature, 30Mar2008, 102-103degrees F; Body temperature, 31Mar2008, 102-103degrees F; The subject had a fever ranging from 102 to 103 degr
CDC Split Type: A0723471A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B145AA1UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNLL
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Pyrexia, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, via a GSK sales representative, that described the occurrence of excessive screaming in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX, GlaxoSmithKline. In March 2008, the subject received the 2nd dose of PEDIARIX (.5 ml, unknown, right thigh). Within one hour after vaccination with PEDIARIX, the subject experienced a screaming reaction, described as "unconsolable non-stop screaming", which lasted for a period of several hours. At the time of reporting the event was resolved. The reporting physician considered the event was probably related to vaccination with PEDIARIX. Follow-up information was received on 23 May 2008 via a registered nurse, who indicated that this case was reported to a Regulatory Agency (VAERS ID # was not reported). The nurse reported that the subject was a 12-month-old female who was vaccinated with PEDIARIX on 28 March 2008. The subject''s medical history included gastroesophageal reflux. Concurrent medical conditions included allergic rhinitis. Concurrent vaccinations given on 28 March 2008 included ACTHIB, manufacturer unspecified; unknown; left thigh; and PREVNAR, manufacturer unspecified; unknown; left thigh. Concurrent medications included Singulair and Zantac. In addition to the previously reported excessive screaming, on 28 March 2008, at an unspecified time after vaccination with PEDIARIX, the subject experienced a fever and fussiness. The subject''s fever was reported to range from 102 to 103 degrees Fahrenheit for a period of four days, before resolving on 31 March 2008. The fussiness and excessive screaming were also reported to last for a period of four days, before resolving on 31 March 2008. As of 01 April 2008, all of the symptoms were reported to be resolved. The immunization series with PEDIARIX was discontinued. The reporting nurse considered the events to be related to vaccination with PEDIARIX.

VAERS ID:350753 (history)  Vaccinated:2008-03-28
Age:16.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2009-07-02, Days after onset: 461
Location:Rhode Island  Entered:2009-07-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 3/28/2008)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA07772
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female patient who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL. On 22-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient was pregnant. The patient has not experienced any know symptoms. The patient sought medical attention seen by the physician. Follow-up information was received from a health professional. The patient delivered on 05-DEC-2008 via C-section due to breech presentation. The baby was 6 lb 5 oz and completely normal and healthy with no congenital anomalies. Upon internal review, C-section due to breech presentation were determined to be an other important medical event. Additional information has been requested.

VAERS ID:418685 (history)  Vaccinated:2008-03-28
Age:42.0  Onset:0000-00-00
Gender:Male  Submitted:2011-03-07
Location:Unknown  Entered:2011-03-11, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: serum hepatitis B Ab, negative
CDC Split Type: WAES1004USA04344
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1609U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody negative
SMQs:
Write-up: Information has been received from a Registered Nurse (R.N.) concerning a now 44 year old male patient with no medical history or drug allergies who on 26-NOV-2007, 03-JAN-2008 and 28-MAR-2008 was vaccinated IM with the first (lot# 656680/0010U), second (lot# 656680/0010U) and third (lot# 659265/1609U) 1 ml dose of RECOMBIVAX HB, respectively. There was no concomitant medication. Subsequently the patient found to have negative antibody titers. Hepatitis B antibody test was performed. The patient contacted nurse by phone. The patient''s negative antibody titers persisted. This is one of several reports from the same source. This is an amended report. AE term now was mapped to anti-HBs antibody negative instead of negative antibody titers. Additional information has been requested.

VAERS ID:420051 (history)  Vaccinated:2008-03-28
Age:52.0  Onset:2011-03-29, Days after vaccination: 1096
Gender:Male  Submitted:2011-03-31, Days after onset: 2
Location:North Carolina  Entered:2011-03-31
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: BPH HTN Back pain Sleep disorder
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3727AA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Lymphadenopathy, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling under the arm - Lymphadenopathy Seen in office 3 days after Tdap given

VAERS ID:423653 (history)  Vaccinated:2008-03-28
Age:3.0  Onset:2010-09-17, Days after vaccination: 903
Gender:Male  Submitted:2011-05-12, Days after onset: 237
Location:Massachusetts  Entered:2011-05-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES1009USA04024
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1255U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a licensed practical nurse (L.P.N.) concerning a 3 year old male patient with no pertinent medical history and no drugs reactions or allegies who on 28-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot #658525/1255U; expiration date: 07-AUG-2009). There was no concomitant medication. The nurse reported that on 17-SEP-2010 the patient developed possibly shingles on his leg down to his foot and on the right side of his back. "The lesions were in small clusters but the patient had no pain or itchy". No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering from possibly shingles. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:343302 (history)  Vaccinated:2008-03-28
Age:1.1  Onset:2009-01-08, Days after vaccination: 286
Gender:Male  Submitted:2009-04-01, Days after onset: 82
Location:Foreign  Entered:2009-04-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA05340
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1699U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gastroenteritis rotavirus
SMQs:
Write-up: Initial information received on the 26-MAR-2009 from the Health Authority (reference number ES-AGEMED-218671344) concerning a 13 month old male who was administered on the 11-JUL-2008 the third dose of an oral ROTATEQ (lot #: 659684/0201X). First dose of ROTATEQ (lot #: 657990/1699U) was administered on the 28-MAR-2008. The second dose of ROTATEQ (lot #: 659684/0201X) was administered on an unspecified date. It had not been reported whether the patient presented any adverse event after the first and second doses or not. It was reported on 08-JAN-2009 the patient had rotavirus gastroenteritis. The patient was hospital admitted. Outcome was unknown. No further information was given. Other business partner numbers include E2009-02691.

VAERS ID:426988 (history)  Vaccinated:2008-03-28
Age:0.2  Onset:2008-04-20, Days after vaccination: 23
Gender:Female  Submitted:2011-07-07, Days after onset: 1173
Location:Foreign  Entered:2011-07-08, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA04150
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dehydration, Gastroenteritis, Laboratory test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a study sponsored by a public organization via an agency (case # 200800079). A 2.5 months old female patient with no specified medical history, had been treated with ROTATEQ, 1 dose form once a total for vaccination on 28-MAR-2008, 29-APR-2008 and 03-JUN-2008 respectively. On 20-APR-2008, the patient experienced gastroenteritis. The patient was hospitalized on 20-APR-2008. Etiological investigations were performed: IV rehydration with domperidone and alginates treatment was instaured. Outcome: The patient was recovering from gastroenteritis. Assessment: Gastroenteritis is expected. The investigator considered that there was a reasonable possibility that the event gastroenteritis was related to the study drug.

VAERS ID:308528 (history)  Vaccinated:2008-03-29
Age:14.0  Onset:2008-03-29, Days after vaccination: 0
Gender:Female  Submitted:2008-03-29, Days after onset: 0
Location:Illinois  Entered:2008-03-29
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: None
Diagnostic Lab Data: She has been sent for an EEG.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2409AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Dizziness, Dyskinesia, Electroencephalogram, Fall, Gaze palsy, Headache, Immediate post-injection reaction, Loss of consciousness, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: The Patient was sitting on a chair when Vaccine Gardasil was Administered. Then immediately her eyes rolled back, she lost consciousness and her body fell forward. After which the patients upper body started to shake and her arms were jerking. This lasted for 45 seconds- 1 min and then she regained consciousness. She complained of a headache, weakness and dizziness. I checked her pulse which was 76 bpm. We had her lay down for 30 min and drink some water after which she felt better.

VAERS ID:308535 (history)  Vaccinated:2008-03-29
Age:5.0  Onset:2008-03-30, Days after vaccination: 1
Gender:Male  Submitted:2008-03-31, Days after onset: 1
Location:Indiana  Entered:2008-03-31
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021BA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1776U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Hyperaesthesia, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Father states Left arm reddened, swollen. Denies fever. Further states slightly tender to touch. Moving arm without difficulty.

VAERS ID:308536 (history)  Vaccinated:2008-03-29
Age:5.0  Onset:2008-03-30, Days after vaccination: 1
Gender:Female  Submitted:2008-03-31, Days after onset: 1
Location:Indiana  Entered:2008-03-31
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B061AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA017023SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1747U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1776U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Hyperaesthesia, Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother states Left arm with redness and edema "the size of 2 fists". Area tender to touch, though child moves arm without difficulty. States she has used cold compresses without success. Denies fever. Recommended warm compresses and either Tylenol of Ibuprofen for symptomatic relief. To call physician on 4/1/08 if no improvement.

VAERS ID:309037 (history)  Vaccinated:2008-03-29
Age:14.0  Onset:2008-03-29, Days after vaccination: 0
Gender:Male  Submitted:2008-04-07, Days after onset: 9
Location:Michigan  Entered:2008-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERV06.51UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4 hours after the tetanus shot was given he had extreme aching and vomiting for 48 hours, temperature was 101.

VAERS ID:309117 (history)  Vaccinated:2008-03-29
Age:12.0  Onset:2008-03-30, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 2
Location:California  Entered:2008-04-08, 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: None
Current Illness: None
Preexisting Conditions: Aggressive behavior & overweight
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2425AA0IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1944AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness on mid-section of R arm pt. c/o pain.

VAERS ID:309216 (history)  Vaccinated:2008-03-29
Age:0.2  Onset:2008-03-29, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 11
Location:Pennsylvania  Entered:2008-04-09
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSHC21B0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF329AA IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC57542 IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0975U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Nearly inconsolable crying for most of a six hour period that began about an hour after receiving DTaP.

VAERS ID:309406 (history)  Vaccinated:2008-03-29
Age:27.0  Onset:2008-04-01, Days after vaccination: 3
Gender:Female  Submitted:2008-04-11, Days after onset: 10
Location:Nebraska  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS438011C0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Contusion, Injection site ulcer
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Donor has approx 4 inch bruise and small decubitus ulcer at injection site.

VAERS ID:309535 (history)  Vaccinated:2008-03-29
Age:0.4  Onset:2008-04-08, Days after vaccination: 10
Gender:Male  Submitted:2008-04-15, Days after onset: 7
Location:New Jersey  Entered:2008-04-15
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: Seborrheic Dermatitis, Eczema
Diagnostic Lab Data: None Yet
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2749AA1IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0378U1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF225AA1IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mom first called for swelling at Rt thigh on 04-08-2008. It was non tender, non erythmatous swelling without any fever or irritability. On 04-14-2008 Mom reported that swelling is getting red and tender without any fever. On examination local infection with possibility of developing abscess. With parents agreement patient is placed in Augmentin 600 mg/5 ml, 3 ml po bid. Will follow in 48 hr / earlier if patient gets worse. Today patient is still afebrile. Parents were explained about possible need for hospital admission and drainage if get worse and report if any fever or patient getting worse. This batch number is very close that of recalled batch of Comvax 0376 and 0387U. Was there is any contamination of this batch with same bacteria?

VAERS ID:309605 (history)  Vaccinated:2008-03-29
Age:10.0  Onset:2008-04-02, Days after vaccination: 4
Gender:Female  Submitted:2008-04-09, Days after onset: 7
Location:Indiana  Entered:2008-04-16, 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
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Public     Purchased by: Other
Symptoms: Rash generalised, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had rash-all over body started on stomach-had her soak in oatmeal. Vomited-just gave her water. Shot on Saturday-symptoms on Wednesday.

VAERS ID:310374 (history)  Vaccinated:2008-03-29
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-16
Location:Rhode Island  Entered:2008-04-21, 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:
Preexisting Conditions: NKDA; HTN; DJD; CVA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site ulcer
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 1 - 2 ulceration right deltoid region.

VAERS ID:316833 (history)  Vaccinated:2008-03-29
Age:25.0  Onset:2008-04-01, Days after vaccination: 3
Gender:Female  Submitted:2008-06-13, Days after onset: 73
Location:Unknown  Entered:2008-06-16, Days after submission: 3
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: None
CDC Split Type: WAES0805USA02053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acne
SMQs:
Write-up: Information has been received from a 25 year old female consumer who on 29-MAR-2008 was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. In "early April 2008", the patient experienced a severe acne breakout on her cheeks and forehead. The patient sought medical treatment in the office. She was initially treated with one month supply of doxycycline (unspecified), but the acne did not improve. On 09-MAY-2008, the patient was switched to prednisone (not further specified). At the time of this reporting the severe acne breakout has persisted. No further information is available.

VAERS ID:319229 (history)  Vaccinated:2008-03-29
Age:68.0  Onset:2008-03-29, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 87
Location:Pennsylvania  Entered:2008-07-11, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01823
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial and follow up information has been received from a pharmacist concerning a 68 year old female consumer who on 29-MAR-2008 at 10:00 was vaccinated SQ in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659763/1875U). Subsequently, on 29-MAR-2008 the patient developed redness, soreness and swelling at the injection site. (Previously reported as a general reaction at the injection site). The patient was treated with cold compresses and BENADRYL. The redness, soreness and swelling at the injection site had resolved as of 04-APR-2008 and the patient recovered. There was no product quality complaint involved. Additional information is not expected.

VAERS ID:324220 (history)  Vaccinated:2008-03-29
Age:51.0  Onset:2008-03-31, Days after vaccination: 2
Gender:Female  Submitted:2008-07-30, Days after onset: 121
Location:Colorado  Entered:2008-08-06, 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: Unknown
Current Illness:
Preexisting Conditions: Sinus disorder; Sulfonamide allergy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA00103
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0804U SCRA
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenitis
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist concerning a 51 year old female with sinus disorder and sulfonamide allergy who on 29-MAR-2008 was vaccinated SQ into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658200/0804U). On 31-MAR-2008, the patient developed lymphadenitis. Unknown medical attention was sought via telephone. The patient''s lymphadenitis persisted. No product quality complaint was involved. In follow up, the healthcare worker asked for information to identify the patient in the adverse reaction. No further information reported. Additional information has been requested.

VAERS ID:337277 (history)  Vaccinated:2008-03-29
Age:70.0  Onset:2008-04-08, Days after vaccination: 10
Gender:Male  Submitted:2008-12-23, Days after onset: 259
Location:New Jersey  Entered:2008-12-29, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02182
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCUN
Administered by: Public     Purchased by: Other
Symptoms: Herpes zoster, Insomnia, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 70 plus years old female with medical history unspecified who on 29-MAR-2008 was vaccinated with ZOSTER vaccine (Lot # was not provided), SC in his left arm at 11:00 AM. Concomitant therapy was unspecified. After receiving the ZOSTER vaccine, the patient experienced shingles. The patient was seen by a physician. At the time of reporting, the patient was recovering. Follow-up information was received from this registered nurse. On 08-APR-2008, after receiving the vaccine, the patient experienced rash and pain on the inside of his left thigh. He went to a "walk in clinic" and was treated with an antiviral drug for 7 days. The reporter also stated that the patient experienced great difficulty sleeping for 2 months (since approximately September 2008). The patient was treated by a physician. He went to a chiropractor and took a Tai Chi Chik Class for 8 weeks. The patient was seen by the physician. Lab and diagnostic test was unspecified. The patient recovered in July 2008. No further information is available.

VAERS ID:343373 (history)  Vaccinated:2008-03-29
Age:0.4  Onset:2008-03-29, Days after vaccination: 0
Gender:Male  Submitted:2009-04-02, Days after onset: 369
Location:Foreign  Entered:2009-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0554846A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPHEP: DTP + HEP B (TRITANRIX)GLAXOSMITHKLINE BIOLOGICALSAT15B432BB2UNLL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAHIBB676CB2UNLL
Administered by: Other     Purchased by: Other
Symptoms: Crying, Injection site pain, Injection site reaction, Movement disorder, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of injection site reaction in a 5-month-old male subject who was vaccinated with TRITANRIX-HB (GlaxoSmithKline), HIBERIX. On 29 March 2008, the subject received unspecified dose of TRITANRIX-HB (unknown route of administration, left thigh), unspecified dose of HIBERIX (unknown route of administration, left thigh). On unspecified date, at unspecified time after vaccination with TRITANRIX-HB and HIBERIX, the subject experienced injection site reaction and injection site tenderness. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified. Follow up information received on 14 March 2009: On 29 March 2008, the subject received 3rd dose of TRITANRIX-HB (unknown route of administration, left thigh) 3rd dose of HIBERIX (unknown route of administration, left thigh). On 29 March 2008, less than one day after vaccination with HIBERIX and TRITANRIX-HB, the subject experienced injection site reaction. The subject experienced high grade fever and crying due to pain and was unable to move. The subject was hospitalised. The subject was treated with PARACETAMOL. At the time of reporting the events were improved.

VAERS ID:308727 (history)  Vaccinated:2008-03-30
Age:40.0  Onset:2008-03-31, Days after vaccination: 1
Gender:Male  Submitted:2008-04-01, Days after onset: 1
Location:Nebraska  Entered:2008-04-01
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
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS438011C0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Injection on 03-30-08 - Donor called in to center on 03-31-08 to report stomach cramps after receiving Rabies vaccination. No pain at injection site. Denies rash, swelling or SOB.

VAERS ID:308787 (history)  Vaccinated:2008-03-30
Age:57.0  Onset:2008-04-01, Days after vaccination: 2
Gender:Female  Submitted:2008-04-02, Days after onset: 1
Location:North Carolina  Entered:2008-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I was bitten by a cat and it got infected.
Preexisting Conditions: I have severe allergies, mostly chemical, cats and dogs, red cedar and several antibiotics.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Diarrhoea, Erythema, Neck pain, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: I experienced severe stomach cramps, diarrhea, vomiting, turned bright red and had severe hives for about an hour all over my body, including my feet. Itching so bad I rubbed the skin off the back of my hand trying to get relief with a cold wet washcloth. I took my usual allergy pills, Sudafed, Singulair and doxepin, as well as two Benadryl. It took an hour for the itching to stop. The next day I had pain in the back of my neck and lower back and stomach cramps after eating. I took Naproxen for that. I didn''t have anymore vomiting or hives though.

VAERS ID:309140 (history)  Vaccinated:2008-03-30
Age:43.0  Onset:2008-03-28, Days after vaccination: -2
Gender:Male  Submitted:2008-03-30, Days after onset: 2
Location:Texas  Entered:2008-04-08, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HRIG, Talecris Biotherapeutics Inc., RUOQ x2/LUOQ x2
Current Illness: Reflux
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS417011C UNLA
Administered by: Private     Purchased by: Other
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: L hand numbness started 3-28-08. In ER 3-30-08; vaccine given.

VAERS ID:310056 (history)  Vaccinated:2008-03-30
Age:20.0  Onset:2008-04-10, Days after vaccination: 11
Gender:Male  Submitted:2008-04-10, Days after onset: 0
Location:California  Entered:2008-04-18, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1634SCUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV040031OTUN
Administered by: Military     Purchased by: Military
Symptoms: Chest pain, Dyspnoea, Headache, Injection site erythema, Musculoskeletal stiffness, Nausea, Pyrexia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headaches; fever 101.4; nausea; swelling; erythema at site; tenderness; neck stiffness; SOB; chest pain.

VAERS ID:319555 (history)  Vaccinated:2008-03-30
Age:37.0  Onset:2008-03-30, Days after vaccination: 0
Gender:Female  Submitted:2008-07-17, Days after onset: 109
Location:Foreign  Entered:2008-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0528947A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alcohol use, Blood pressure decreased, Decreased appetite, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (foreign Pharmacovigilance Centre # LRB-79000) and described the occurrence of syncope in a 37-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), DTP (A or W not known). The subject had her period during vaccination. On 30 March 2008 the subject received unspecified dose of HAVRIX (intramuscular), unspecified dose of DTP (A or W not known) (intramuscular). On 30 March 2008, less than one day after vaccination with DTP (A or W not known) and HAVRIX, the subject did not eat well and drank alcohol. The day after the subject presented syncope and decreased blood pressure. The subject was hospitalised. At the time of reporting the events were resolved.

VAERS ID:343172 (history)  Vaccinated:2008-03-30
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-31
Location:Foreign  Entered:2009-04-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903NZL00008
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0597F IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site abscess
SMQs:
Write-up: Information has been received from an agency, via CSL, as part of a business agreement, concerning a 15 year old female who on 30-MAR-2008 was vaccinated with GARDASIL (Lot # 655423/0597F, Batch # NE43240, Expiry date 26-MAY-2009). Subsequently, after vaccination, the patient experienced injection site abscess which required intervention. The severity of injection site abscess was reported as severe. At the time of reporting to the agency in June 2008, the outcome of injection site abscess was unknown. The agency considered that injection site abscess was probably related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the event of injection site abscess to be medically significant. Additional information is not expected.

VAERS ID:502051 (history)  Vaccinated:2008-03-30
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-11
Location:Foreign  Entered:2013-09-11
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: No other medications
Current Illness: Immunisation
Preexisting Conditions: Acne; 09/20/2008, GARDASIL, no adverse event; 07/23/2008, GARDASIL, no adverse event
Diagnostic Lab Data:
CDC Split Type: WAES1309FRA003886
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acute vestibular syndrome, Multiple sclerosis, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (narrow)
Write-up: Case received from a physician on 03-Sep-2013 and medically confirmed. A 18-year-old female patient with a history of acne had received the three doses of GARDASIL (batch number not reported) on 23-Jul-2008, GARDASIL on 20-Sep-2008 and 30-Mar-2008. The two first doses had been uneventful. In the end of 2010 she developed a vestibular syndrome associated with vertigo and vomiting. She was hospitalized from 25 to 28 January 2001 in neurological service for a check up. Multiple sclerosis was diagnosed. At the time of reporting, the patient was treated with a cure of TYSABRI with a good efficiency. To be noted that there was no familial history of autoimmune disease.

VAERS ID:308970 (history)  Vaccinated:2008-03-31
Age:81.0  Onset:2008-04-01, Days after vaccination: 1
Gender:Female  Submitted:2008-04-04, Days after onset: 3
Location:Minnesota  Entered:2008-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hyperlipidemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0048X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Type III immune complex mediated reaction
SMQs:, Hypersensitivity (narrow)
Write-up: Arthus reaction arm at injection. Tylenol and hot packs.

VAERS ID:319422 (history)  Vaccinated:2008-03-31
Age:62.0  Onset:2008-04-30, Days after vaccination: 30
Gender:Female  Submitted:2008-06-24, Days after onset: 55
Location:Unknown  Entered:2008-07-11, Days after submission: 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA04453
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dermatitis contact, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 62 year old female who "3 weeks ago" on approximately 31-MAR-2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. "Three days after" she was given the zoster vaccine live (Oka/Merck), on approximately 03-APR-2008, the patient had a rash on both collar bones and spoke to a nurse for medical attention. "Two weeks later''" on approximately 17-APR-2008, she had a rash on her thighs. The patient reported she put a band-aid on the rash and had a reaction to the band-aid she always used. She stated she never had rashes from the band-aid and never had rashes in general before. Subsequently, the patient recovered from the rash on both collar bones and rash on her thighs. Additional information has been requested. 09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the patient. She reported that the physician "did not see the rash", she only reported it over the phone. Additional information is not expected.

VAERS ID:343194 (history)  Vaccinated:2008-03-31
Age:0.1  Onset:2008-05-01, Days after vaccination: 31
Gender:Female  Submitted:2009-03-06, Days after onset: 309
Location:Texas  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mongolian spot; Torticollis
Preexisting Conditions: Jaundice neonatal
Diagnostic Lab Data: ultrasound 07/12/07 - pregnancy; diagnostic laboratory 03/13/08 - newborn screen - negative; venipuncture 03/13/08 -
CDC Split Type: WAES0809USA04315
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Acne infantile, Ear infection, Ear pain, Laboratory test, Otitis media, Postnasal drip, Rhinorrhoea, Tonsillar inflammation, Ultrasound scan, Venipuncture
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Neonatal disorders (narrow)
Write-up: Initial information has been received from the physician''s office via medical records concerning a baby girl with a history of neonatal jaundice, mongolian spots and torticollis after maternal exposure to GARDASIL (MSD WAES # 0708USA00006) who on 28-FEB-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown). On 13-MAR-2008 the baby came in for a well child visit at 15 days old. There were no complaint or concerns at this time. The baby recovered from neonatal jaundice. The following lab results for the baby was negative: newborn screen amino acid D/O, Fatty Acis D/O, Organic Acid D/O, Galactosemia, Biotinidase deficiency, Endocrine D/O and Hemoglobinopathy. A venipuncture was also performed. Follow-up was scheduled for 2 weeks. On 31-MAR-2008 the baby came in for a well child visit at one month and 3 days old. The baby had a rash on her shoulder and back (acne neonatorum). The baby was also administered DAPTACEL (Lot # C2951BA) IM 0.5 cc in the left thigh, ACTHIB (Lot # UF253AD) 0.5 cc on the right thigh, IPOL (Lot # A0490-2) IM 0.5 cc administered on the left thigh, ROTATEQ (lot # 660291/1829U) 2 mL administered orally and PREVNAR (lot # C45153) 0.5 cc administered on the right thigh. Follow-up was scheduled for 2 months. On 16-JUL-2008 the baby came in for a well child visit at 4 months and 18 days. The baby holds her neck to the right side and still had craddle cap. The baby was also administered DAPTACEL (C2934AA) IM 0.5 cc in the right thigh, ACTHIB (UF260AB) 0.5 cc on the left thigh, IPOL (Lot # A0492-2) IM 0.5 cc administered on the right thigh, ROTATEQ (Lot # 660600/0281X) 2 mL administered orally and PREVNAR (C65928) 0.5 cc administered on the left thigh. Follow-up was scheduled for 2 months. On 31-JUL-2008 the baby was 5 months 3 days and complained of a possible ear infection. The baby was pulling at the left ear, dry on ear lobe- not sure if it was drainage. Denies fever. ENT/respiratory examination revealed throat moist membranes, post nasal drip seen, tonsils

VAERS ID:454682 (history)  Vaccinated:2008-03-31
Age:1.3  Onset:2012-04-23, Days after vaccination: 1484
Gender:Female  Submitted:2012-04-30, Days after onset: 7
Location:Texas  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:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA3IDRL
Administered by: Private     Purchased by: Other
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Bumpy, itchy rash.

VAERS ID:312502 (history)  Vaccinated:2008-03-31
Age:55.0  Onset:2008-03-31, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 46
Location:Foreign  Entered:2008-05-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lorazepam; Fluvoxamine; Perphenazine; Amitriptyline HCl
Current Illness: PENICILLIN ALLERGY
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0519192A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Blister, Chills, Face oedema, Injection site erythema, Injection site oedema, Injection site pain, Lymphadenopathy, Pyrexia, Tremor
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (foreign regulatory authority # C200804-329) and described the occurrence of face edema in a 55-year-old female subject who was vaccinated with Ditanrix (GlaxoSmithKline). Previous reactions to the same vaccine: not known. Concurrent medical condition included allergic reaction to penicillin with widespread hives. Concurrent medications included Lorazepam, Fluvoxamine, Perphenazine and Amitriptyline hydrochloride. On 31 March 2008, the subject received the 1st dose of Ditanrix (intramuscular, unknown, lot number not provided). On 31 March 2008, less than one day after vaccination with Ditanrix, the subject experienced injection site pain, injection site redness, injection site edema, fever, tremor, shivering, axillary lymphadenopathy, blister, arthralgia and face edema. The adverse reaction has remained for more than 4 days. The patient was complaining referring to restrictions on their ability to perform the daily activities. The regulatory authority reported that the events were disabling. The subject was treated with paracetamol, ibuprofen and application of ice on the spot. At the time of reporting the events were resolved.

VAERS ID:321251 (history)  Vaccinated:2008-03-31
Age:36.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-04
Location:Foreign  Entered:2008-08-04
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO 7/7/7; Esomeprazole; Silymarin; Tylenol cold medication; Paracetamol; Calcium salt; Vitamin D
Current Illness: Unknown
Preexisting Conditions: The subjects past history is unremarkable apart from wisdom tooth extractions years ago and two children delivered by c-section. She is a non-smoker. The subject reported feeling very well prior to her trip on 17 April 2008. The subject did report, however, getting violently ill with vomiting and feeling extremely unwell for about 12 hours following the 2nd dose of TWINRIX. She add
Diagnostic Lab Data: Alanine aminotransferase, 26May2008, 1276; Alkaline phosphatase, 26May2008, 186; Aspartate aminotransferase, 26May2008, 848; Bilirubin, 26May2008, 107; GGT, 26May2008, 136; Hemoglobin, 26May2008, 129; Hepatitis B surface antibody, 26May2008
CDC Split Type: A0740957A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB097AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Antineutrophil cytoplasmic antibody positive, Antinuclear antibody negative, Anxiety, Aspartate aminotransferase increased, Biopsy liver abnormal, Blood alkaline phosphatase increased, Blood bilirubin increased, Cholestasis, Chromaturia, Chronic hepatitis, Diarrhoea, Fatigue, Fibrosis, Full blood count normal, Gamma-glutamyltransferase increased, Haemoglobin increased, Hepatitis A antibody, Hepatitis A antibody positive, Hepatitis B antibody, Hepatitis B antibody positive, Hepatitis B surface antigen negative, Hepatosplenomegaly, International normalised ratio decreased, Jaundice, Lymphadenopathy, Mononucleosis heterophile test negative, Nausea, Paraesthesia oral, Platelet count normal, Pruritus, Ultrasound abdomen abnormal, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of jaundice in a 36-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous vaccination included 1st dose of TWINRIX (GlaxoSmithKline) given on 10 March 2008 and a 2nd dose given on an unspecified date. Following the second dose of TWINRIX, the subject became violently ill with vomiting and feeling extremely unwell for about 12 hours following the 2nd dose of TWINRIX. She additionally reported that this episode was following a steak dinner with her family. The subject recovered completely and remained well until she went on her trip. Concurrent medications included ORTHO 7/7/7, NEXIUM, SILYMARIN, TYLENOL cold medication, TYLENOL, CALCIUM and Vitamin D. On 31 March 2008, the subject received 3rd dose of TWINRIX (unknown). An unspecified amount of time later, the subject traveled to another country. While there, and on the beach, the subject developed significant pruritis of her hands and the soles of her feet which gradually increased to be generalized. She returned home, and approximately two weeks prior to 04 June 2008, the subject reported feeling rather fatigued. Ten days prior to 04 June 2008, the subject woke up and noted jaundice. At that time, she also reported dark urine and a tingling on the tip of her tongue and noted a bit of nausea with some vomiting and diarrhea. The subject attributed the nausea, vomiting and diarrhea to anxiety. She was noted to have elevated liver function tests. Blood work on 26 May 2008 showed an ALT of 1,276, AST of 848, GGT of 136, alkaline phosphatase of 186 and a bilirubin of 107. Also at that time a CBC showed a white count of 4.4, hemoglobin of 129 and platelets of 290. Hepatitis B surface antigen was negative, hepatitis B surface antibody was positive and no anti-HBC was performed. Hepatitis A antibody IgM was negative on 27 May 2008. An abdominal ultrasound showed hepatosplenomegaly and peripancreatic adenopathy consistent with the history of hepatitis. Further blood work perfo

VAERS ID:328395 (history)  Vaccinated:2008-03-31
Age:0.5  Onset:2008-03-31, Days after vaccination: 0
Gender:Male  Submitted:2008-10-13, Days after onset: 196
Location:Foreign  Entered:2008-10-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data: Electroencephalogram, specific alterations
CDC Split Type: ITWYEG02334208
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA342A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA342A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA342A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA342A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH292381IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold sweat, Crying, Electroencephalogram abnormal, Epilepsy, Hypotonia, Pallor, Sopor
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 5-month-old male patient who experienced epilepsy. The patient received the second dose on 31-Mar-2008. The patient previously experienced no adverse event while taking PREVENAR and no adverse event while taking INFANRIX HEXA. Additional suspect medication included INFANRIX HEXA. Concomitant medications were not reported. The patient experienced epilepsy on 31-Mar-2008, after 5-6 hours from vaccination. The patient showed pallor, cold sweating, crying, hypotonia, sopor and doubtful loss of consciousness. The event involved or prolonged inpatient hospitalization. The patient definitely recovered on 31-Mar-2008. Electroencephalogram (results: specific alterations) was done on an unspecified date. No additional information was available at the time of this report.

VAERS ID:449969 (history)  Vaccinated:2008-03-31
Age:3.0  Onset:2011-01-16, Days after vaccination: 1021
Gender:Male  Submitted:2012-02-20, Days after onset: 400
Location:Foreign  Entered:2012-02-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: biopsy, 01Mar11, small intestine: positive for celiac disease; laboratory test, 01Mar11, anti-transglutaminase antibody test: positive
CDC Split Type: WAES1202USA02374
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Anti-transglutaminase antibody increased, Biopsy small intestine abnormal, Coeliac disease, Depressed mood, Growth retardation, Intussusception, Personality change
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Information has been received from the Health Authority under the reference number BR20110410 on 13-FEB-2012. Case medically confirmed. Case received on 17-NOV-2011 and received by an agency from another agency on 13-FEB-2012. A 3-year-old male patient, with no relevant medical history, received orally a dose of ROTATEQ (batch and lot numbers not reported) on 28-APR-2008. In 2009 to 2010, a growth retardation was noticed as well as a character change (isolation, sadness...). He also suffered from abdominal pain. On 16-JAN-2011 the patient was hospitalized due to an acute intestinal invagination. On 01-MAR-2011, anti-transglutaminase antibody test positive and small intestine biopsy led to diagnose coeliac disease. To be noted that no medical history of coeliac disease was found in the family. The patient had received orally a dose of ROTATEQ (batch number not reported) on 31-MAR-2008. At the time of reporting, the patient had recovered with sequelae. Upon medical review the company judged relevant to code the following adverse events: "Growth retardation", "Character change" and "Abdominal pain" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the method of assessment. Other business partner numbers include E2012-01025. No further information is available.

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