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Case Details (Sorted by Vaccination Date)

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VAERS ID:309088 (history)  Vaccinated:2008-04-08
Age:11.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-08, Days after onset: 0
Location:Michigan  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U3IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache
SMQs:
Write-up: FRONTAL HEADACHE AFTER 15 MINUTES. FELT BETTER WITH SUPINE.

VAERS ID:309218 (history)  Vaccinated:2008-04-08
Age:1.1  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Maryland  Entered:2008-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Urticaria on abdomen, both legs and both arms with onset approximately 24 hours after vaccine administration. Treated with Benadryl and prednisolone in emergency department.

VAERS ID:309223 (history)  Vaccinated:2008-04-08
Age:11.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:North Carolina  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: None
Current Illness: None
Preexisting Conditions: Trees: Pecan trees
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2559AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC2888AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1805U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Feeling hot, Induration, Oedema peripheral
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received vaccines 4/8/08. On 4/9/08 patient noted to have developed large, red, swollen area to left upper arm overnight. Warm to touch. Area of induration 3 1/2 x 3 1/2 inches.

VAERS ID:309225 (history)  Vaccinated:2008-04-08
Age:24.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 1
Location:California  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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Pt received a Gardasil shot #1 in (Lt) delt on 4-8-08 at 3:00 pm-she got a "vasovagal reaction." She recovered within a few minutes.

VAERS ID:309267 (history)  Vaccinated:2008-04-08
Age:16.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-10, Days after onset: 1
Location:Pennsylvania  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2862AA6UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Headache, Nausea, Pyrexia, Wrong drug administered
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Beginning the morning after shots, and lasting for about 24 hours, she had fever of about 101, nausea (no vomiting) and headache. She could not get out of bed. She felt fine when she awoke the following day.

VAERS ID:309268 (history)  Vaccinated:2008-04-08
Age:46.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-10
Location:Minnesota  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper Resp Infection 4-8-08, sore throat and cough
Preexisting Conditions: hyperlipidemia, depression, and GERD
Diagnostic Lab Data: Neg Strep throat culture 4-8-08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1539U3IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture throat negative, 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: Patient received a pneumo-ps injection to his left Deltoid on 4-8-08, He had called and said that it started swelling and got red 1 day after injection, and worsened on 4-10-08.

VAERS ID:309269 (history)  Vaccinated:2008-04-08
Age:4.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-10, Days after onset: 1
Location:New York  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B069AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983IMLA
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC)MERCK & CO. INC.018261SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom called office this morning and said, patient''s right arm was swollen, red and hot to the touch. Also has a fever. These symptoms started the day that the vaccines were given. I requested for her to bring patient into the office for Dr. to see him. Area of redness was measured 10cm.X12cm. by Dr.

VAERS ID:309271 (history)  Vaccinated:2008-04-08
Age:19.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Georgia  Entered:2008-04-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0552U2IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1274U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Neck pain, Pain, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient reports having a small area after recieving the vaccine. States noticed her arm had more redness yesterday evening with some pain radiating up the arm to her neck, also c/o headache. Area appears to be around 3 inches diameter, raised, and red. Advised patient to take Benadryl as directed until reaction subsides. Also to alternate warm and cold compress as needed. Advised patient if area worsens to seek medical care.

VAERS ID:309294 (history)  Vaccinated:2008-04-08
Age:11.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-08, Days after onset: 0
Location:New York  Entered:2008-04-10, 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: Xopenex;Sihallais; Nasonex
Current Illness: None
Preexisting Conditions: Allergies - Environmental. Mother denied allergy to medi/vacc prior to administration.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2419AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA5UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1788U1UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Rhinorrhoea, Swelling, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: About 15 minutes after administration of vaccines, mother stated that he started getting runny nose, itching in back of throat/nose. No difficulty breathing, no stridor. Patient was sent to ER for anti-histamine/further treatment. Mother then stated that this had happened before at another clinic. Patient had redness and swelling to right deltoid region only 24 hours later.

VAERS ID:309707 (history)  Vaccinated:2008-04-08
Age:19.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Indiana  Entered:2008-04-16, 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: Microgestin, Tylenol
Current Illness: Sore throat
Preexisting Conditions: None
Diagnostic Lab Data: Strep test (rapid), neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Chills, Fatigue, Headache, Hyperhidrosis, Laboratory test normal, Pyrexia, Streptococcus identification test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Fever-current 99.3-has had chills/sweats today. Sore throat-predated immunization. Fatigue-all day today. Skipped class. Headache-all day today.

VAERS ID:309711 (history)  Vaccinated:2008-04-08
Age:62.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-10, Days after onset: 2
Location:Minnesota  Entered:2008-04-16, 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: None
Preexisting Conditions: Hyperlipidemia; Coronary Artherosclerosis
Diagnostic Lab Data: WBC 7900
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1419U UNLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Injection site reaction, Injection site swelling, Malaise, Pyrexia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Weakness, chills, fever, malaise. Reaction at site- 5 cc swelling

VAERS ID:309717 (history)  Vaccinated:2008-04-08
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2008-04-08
Location:D.C.  Entered:2008-04-16, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B069AA2IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF329AA2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499232IMUN
Administered by: Public     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: Vaccine omitted, check wasn''t clear.

VAERS ID:309731 (history)  Vaccinated:2008-04-08
Age:8.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-09, Days after onset: 0
Location:Iowa  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: Singulair
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1360U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus, 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: Patient has a swollen area the size of an egg on the (L) arm. It is red, swollen, and itching. Came home from school.

VAERS ID:309858 (history)  Vaccinated:2008-04-08
Age:13.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-10, Days after onset: 2
Location:Maine  Entered:2008-04-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018CA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: rash at site within 6 hrs -extreme redness and swelling picture available on request

VAERS ID:309871 (history)  Vaccinated:2008-04-08
Age:1.5  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-10, Days after onset: 1
Location:Ohio  Entered:2008-04-17, 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: Resolved strep pharyngitis =$g strep dx 3/27/08
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2950AA3UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Skin warm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: DTaP given 4/8/08 in Lt thigh. Afternoon/eve of 4/9/08 - L thigh red & swollen. Swollen & red from diaper line to knee. Warm, fever 102 degrees 4/10/08. 4/12/08 - swelling subsided. Still on 4/14/08 looks bruised & greyish, still tender. Used dry heat to area & Tylenol.

VAERS ID:310051 (history)  Vaccinated:2008-04-08
Age:88.0  Onset:2008-04-10, Days after vaccination: 2
Gender:Female  Submitted:2008-04-18, Days after onset: 8
Location:Maryland  Entered:2008-04-18
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: At the time of the patient''s initial visit, the question regarding medications was checked "no" to any current medication. However, on 4-18-08, her son-in-law says she does take medications for blood pressure and diabetes.
Current Illness:
Preexisting Conditions: High Blood Pressure and Diabetes PMH: NIDDM, hyperlipidemia, hypothyroidism, breast cancer w/left mastectomy
Diagnostic Lab Data: LABS: CT scan revealed acute cholecystitis. CXR showed RLL consolidation. EKG WNL. Echocardiogram WNL. WBC max 24.3 (H), alk phos 333(H), ALT 70(H), AST 102(H)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF175AA SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Alanine aminotransferase increased, Anaemia, Aspartate aminotransferase increased, Atrial fibrillation, Blood alkaline phosphatase increased, Chest X-ray abnormal, Cholecystitis, Cholecystitis infective, Cholelithiasis, Computerised tomogram abnormal, Dehydration, Diarrhoea, Echocardiogram normal, Electrocardiogram normal, Haemorrhage, Hypertension, Hypothyroidism, Laparoscopy, Lung consolidation, Nausea, Purulence, Renal failure, Surgery, Type 2 diabetes mellitus, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Infectious biliary disorders (narrow), Biliary system related investigations, signs and symptoms (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypothyroidism (narrow), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient''s family called our office on 4-11-08 stating she was c/o nausea and diarrhea on 4-10-08, but feeling some better on 4-11-08. The nurse advised the family to seek medical attention if symptoms continued or got worse. On 4-18-08 the patients son-in-law contacted our office. He informed us patient had seen her physician who was admitting her to the hospital with a concern of renal failure. 6/13/08 Reviewed hospital medical records of 4/18-4/24/2008. FINAL DX: acute cholecystitis w/cholelithiasis w/gangrenous & purulent gallbladder; anemia secondary to blood loss; atrial fibrillation w/rapid ventricular response, resolved; HTN; NIDDM; hypothyroidism. Records reveal patient experienced abdominal pain, nausea, vomiting, diarrhea, dehydration x 7 days prior to admit. Surgery of lap cholecystectomy. Developed atrial fib post operatively & had very slow recovery overall. D/C to home w/PICC line for continued IV antibiotics.

VAERS ID:310499 (history)  Vaccinated:2008-04-08
Age:14.0  Onset:2008-04-10, Days after vaccination: 2
Gender:Female  Submitted:2008-04-16, Days after onset: 6
Location:New Hampshire  Entered:2008-04-22, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1806U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L arm, red, edematous, itchy at site of Varivax inj. Rx''d with Augmentin 875mg 1 BID x10 days.

VAERS ID:310543 (history)  Vaccinated:2008-04-08
Age:4.0  Onset:2008-04-11, Days after vaccination: 3
Gender:Male  Submitted:2008-04-11, Days after onset: 0
Location:California  Entered:2008-04-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1796U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 10 x 11cm area erythema

VAERS ID:310544 (history)  Vaccinated:2008-04-08
Age:4.0  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-11, Days after onset: 2
Location:California  Entered:2008-04-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 4/8/8
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B062AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01263UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1313U1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Rash + swelling at L upper arm.

VAERS ID:310562 (history)  Vaccinated:2008-04-08
Age:1.5  Onset:2008-04-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-22, Days after onset: 13
Location:Florida  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT, Complete blood work up, Spinal tap, UA, and several reflex tests 4/29/08-records received-Rapid strep on 4/11 in ED negative. CSF glucose 62, protein 18, culture no growth, blood culture staphylococcus species aggultination negative. urinalysis WNL. CT head WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2355BA3IMUN
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Ataxia, Blood culture positive, Body temperature increased, CSF culture negative, CSF glucose normal, CSF pressure normal, Computerised tomogram normal, Encephalitis, Fall, Fatigue, Feeding disorder, Pyrexia, Rash erythematous, Screaming, Staphylococcal infection, Staring, Streptococcus identification test, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Within 24 hours of administration of DTaP and Hep A patient began temperatures exceeding 101. Extreme fatigue, Prolonged screaming, grabbing head, unable to walk or feed self. Rash developed by day 4 and staring of into space events were noted. 4/29/08-DC Summary received for DOS 4/15-4/16/08-DX: Cerebellitis. Presented with fever to 101, beginning on 4/8/08. Developed ataxia and fevers persisted. Erythematous rash developed on torso and extremities. Two days prior to admission noted to have difficulty walking and fell. Twin sisiter also became ill with high fevers and rash. 1/26/2010 Follow up: Still has problems with fine motor skills and coordination.

VAERS ID:310576 (history)  Vaccinated:2008-04-08
Age:1.0  Onset:2008-04-15, Days after vaccination: 7
Gender:Male  Submitted:2008-04-22, Days after onset: 7
Location:New York  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PROHIBIT)SANOFI PASTEUR210AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1308U0IMRL
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1590243IMLL
VARCEL: VARICELLA (VARILRIX)GLAXOSMITHKLINE BIOLOGICALS1509U0IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Rash generalised, Rash papular, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient had MMR vaccine on 04/08/2008. Had vomiting, diarrhea on 04/15/2008. Developed a generalized rash (papular). No fever.

VAERS ID:310727 (history)  Vaccinated:2008-04-08
Age:72.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-10, Days after onset: 2
Location:Texas  Entered:2008-04-23, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1419U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site warmth, Pyrexia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large reddened area - warm to touch at site of injection, swelling, tenderness, fever.

VAERS ID:310744 (history)  Vaccinated:2008-04-08
Age:1.0  Onset:2008-04-17, Days after vaccination: 9
Gender:Male  Submitted:2008-04-23, Days after onset: 6
Location:Michigan  Entered:2008-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illness
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp. 102 degrees started April 17th in the pm. Fever went to 103.7 on April 18th in pm. Used Tylenol to help reduce fever, also used ice pack on groin area and under arms. Had a few red dots on body and progressively got more as the days went on. Fever lasted until April 21st, which was a low grade 99.7.

VAERS ID:310747 (history)  Vaccinated:2008-04-08
Age:0.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-23, Days after onset: 15
Location:Pennsylvania  Entered:2008-04-23
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: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: The subject has no relevant medical history or history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0724194A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Hepatitis B surface antigen positive
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of elevated direct bilirubin in a 1-day-old male subject who was vaccinated with Engerix B (GlaxoSmithKline). There were no concurrent medications. On 8 April 2008 the subject received 1st dose of Engerix B at 0.5 ml in an unknown thigh. On 8 April 2008, less than one day after vaccination with Engerix B, the subject experienced elevated direct bilirubin. On 14 April 2008, 6 days after administration of Engerix B, the subject tested positive for hepatitis B surface antigen. The baby was to be hospitalized on 22 April 2008 for further evaluation. At the time of reporting the events were unresolved.

VAERS ID:310754 (history)  Vaccinated:2008-04-08
Age:0.2  Onset:2008-04-09, Days after vaccination: 1
Gender:Male  Submitted:2008-04-18, Days after onset: 9
Location:Texas  Entered:2008-04-23, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Stool culture pending, Hemoccult
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B133BA UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF274AA UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC49917 UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1636U PO 
Administered by: Private     Purchased by: Private
Symptoms: Culture stool, Haematochezia, Irritability, Mucous stools, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad)
Write-up: Irritability for 2-3 days - Grossly bloody stool x 48 hrs; guaiac pos, mucous visible in stool

VAERS ID:310756 (history)  Vaccinated:2008-04-08
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-24
Location:North Carolina  Entered:2008-04-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2290AA5UNLA
Administered by: Private     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: None. Patient should have gotten TDAP instead but DTAP can be used as booster for Tetanus.

VAERS ID:313107 (history)  Vaccinated:2008-04-08
Age:10.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 36
Location:Texas  Entered:2008-05-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Concurrent Conditions: Syncope
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02598
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 10 year old female with a history of fainting when receiving shots, who on 08-APR-2008 was vaccinated with the first dose of Gardasil vaccine. After receiving the vaccination the patient fainted. Also, the patient had a history of disliking shots and she had fainted before and after receiving vaccinations, unknown medical attention was sought. The patient was recovered. Additional information is not expected.

VAERS ID:316344 (history)  Vaccinated:2008-04-08
Age:31.0  Onset:2008-04-11, Days after vaccination: 3
Gender:Male  Submitted:2008-06-16, Days after onset: 66
Location:Guam  Entered:2008-06-16
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
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW040030A0OTLA
Administered by: Military     Purchased by: Military
Symptoms: Cellulitis, Pain
SMQs:
Write-up: Cellulitis 3 days post vaccination. TX at local Emergency Room Clyndamycin IV and Tyl 325mg PO PRN for Pain

VAERS ID:319397 (history)  Vaccinated:2008-04-08
Age:0.2  Onset:2008-05-24, Days after vaccination: 46
Gender:Male  Submitted:2008-07-15, Days after onset: 52
Location:New York  Entered:2008-07-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC; ultrasound, positive for intussusception 7/17/08-records received- WBC 13.7. Ultrasound positive for intussusception. Air contrast enema partiall successful with repeat attempt folllowing day successful reduction.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B074AA0UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEUR356AB0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08050UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458870UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0015X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Barium double contrast, Constipation, Decreased appetite, Full blood count, Intussusception, Irritability, Lethargy, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad)
Write-up: Blood per his rectum, fussy, lethargic. 7/17/08-records received with report for DOS 5/24-5/26/08-DC DX: Intussusception. Presented to Ed with history of bloood per rectum. Fussy. Appetitie decreased. Constipated. One hard stool day before and vomtiting once.

VAERS ID:334350 (history)  Vaccinated:2008-04-08
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2008-11-20
Location:Michigan  Entered:2008-12-09, Days after submission: 19
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
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU2070BA1IMRL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER208721IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1243U1PO 
Administered by: Military     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: TRIHIBIT combo given before 15 months of age. No side effects reported.

VAERS ID:334449 (history)  Vaccinated:2008-04-08
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2008-11-20
Location:Michigan  Entered:2008-12-09, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB1IDRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08721IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1390U1PO 
Administered by: Other     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Dtap-HIB combo given before 15 months of age. No side effects reported.

VAERS ID:342596 (history)  Vaccinated:2008-04-08
Age:13.0  Onset:2008-04-08, Days after vaccination: 0
Gender:Female  Submitted:2009-03-24, Days after onset: 350
Location:Arizona  Entered:2009-03-25, 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: Calcium (unspecified); Iron (unspecified); Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 12/28/2007)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04651
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Large for dates baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)
Write-up: Information has been received from a consumer, who was the guardian of the patient, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no pertinent medical history or drug reactions or allergies who on 08-APR-2008 was vaccinated with a 0.5 ml dose of GARDASIL. On the same day, the patient was also vaccinated with VARIVAX (Merck), tetanus toxoid vaccine, diphtheria toxoid vaccine, meningococcal conj vaccine (unspecified), hepatitis A virus vaccine (unspecified) (manufacturer unknown) and "ACHD". Concomitant therapy included calcium (unspecified), iron (unspecified) and prenatal vitamins. It was reported that the patient would be delivering next week. There were no lab tests performed. It was reported that the patient had no ill effects from this. The patient sought unspecified medical attention via the physician. Follow-up information was received from a staff member in the physician''s office via phone call. It was reported that the patient delivered a healthy and normal baby boy on 05-OCT-2008 via C-section. The C-section was performed because the baby was "like 12 lbs". The reporter did not have any additional information to provide. Upon internal review, the baby was "like 12 lbs" that required C-section was considered to be other important medical event. Additional information is not expected.

VAERS ID:349753 (history)  Vaccinated:2008-04-08
Age:0.1  Onset:2008-04-08, Days after vaccination: 0
Gender:Unknown  Submitted:2009-05-28, Days after onset: 415
Location:Maryland  Entered:2009-06-17, Days after submission: 20
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: WAES0804USA02211
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a medical assistant (MA) concerning a 41-day-old patient who on 08-Apr-2008 was inadvertently vaccinated with a 0.5ml dose of Hepatitis A virus vaccine inactivated instead of hepatitis B virus vaccine (MSD). It was unknown if medical attention was sought and no problems were reported. It was noted that this was not a case of product confusion. Additional information has been requested.

VAERS ID:393114 (history)  Vaccinated:2008-04-08
Age:0.4  Onset:2008-04-12, Days after vaccination: 4
Gender:Male  Submitted:2010-07-19, Days after onset: 828
Location:New Jersey  Entered:2010-07-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seizure Disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1IJLG
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 1IJLG
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 1IJLG
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 1IJLG
Administered by: Other     Purchased by: Other
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Infant had grand mal seizures on 4/12/2008 and 4/18/2008.

VAERS ID:430051 (history)  Vaccinated:2008-04-08
Age:85.0  Onset:2009-03-26, Days after vaccination: 352
Gender:Male  Submitted:2011-07-19, Days after onset: 845
Location:New York  Entered:2011-08-03, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1104USA00560
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a physician concerning an 85 year old male who on 08-APR-2008 was subcutaneously vaccinated with ZOSTAVAX (Merck) (dose and lot# not reported). On 26-MAR-2009 and on 21-DEC-2010 the patient experienced shingles two times within four years of receiving ZOSTAVAX (Merck). It was unspecified if the patient sought medical attention. The patient was treated with VALTREX. At the time of reporting, the outcomes were unknown. Additional information has been requested.

VAERS ID:309209 (history)  Vaccinated:2008-04-09
Age:4.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Florida  Entered:2008-04-09
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 PASTEURC2800AA IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA0298 IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1307W SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1786W SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Sneezing, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: CHILD STARTED TO SNEEZE, RUB NOSE, WHEEZE & COUGH. DR ADMINISTERED .15 MG WITHIN 5 MINUTES OF RETURNING TO THE EXAM ROOM, THE REACTION WAS ALMOST IMMEDIATELY. EMS WAS CALLED AT 1137, ARR. 1143. 110/70, P 170''S, O2 SAT INITIALLY WAS 83 - AFTER NEB TX 2.5MG/3ML SAT INCREASED TO 96 PERCENT. SENT VIA EMS. APPEARED TO BE SOMEWHAT RECOVERED.

VAERS ID:309212 (history)  Vaccinated:2008-04-09
Age:2.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-09
Location:Ohio  Entered:2008-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC759AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: I was to give pt dtap, I gave the child dtap but it was the adult dose(Adacel).

VAERS ID:309229 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Massachusetts  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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1567U1SCRL
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Skin warm, Syncope
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: About 5 minutes after vaccine given Lg. reddened area, hot to touch, faint rash noted on chest- Benadryl .25mm/5ml-2tsp PO

VAERS ID:309360 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-11, Days after onset: 2
Location:Missouri  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNKOWN
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B060AB4IMLA
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURERA04243IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.I669U1SCLA
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lethargy, Pallor, Throat irritation, Vomiting
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: PT BECAME PALE, LETHARGIC. VOMITED. PT STATED THROAT FEELS FUNNY. EPI PEN JR.

VAERS ID:309386 (history)  Vaccinated:2008-04-09
Age:58.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-11, Days after onset: 0
Location:Virginia  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins; Fish oil
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB108AA0UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04900UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1383U0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937BA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA04460IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Size of half dollar - redness and heat at injection site.

VAERS ID:309388 (history)  Vaccinated:2008-04-09
Age:73.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-11, Days after onset: 0
Location:Vermont  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Darvon; Demerol; Amoxicillin; Levaquin; Doxycycline; Tricor; Gemfibrosil; Lipitor
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1835U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt called 9 AM on 4/11/08 c/o at 4" circular red, raised, itching vaccine site. Recommended Benadryl and Ibuprofen.

VAERS ID:309392 (history)  Vaccinated:2008-04-09
Age:67.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-12, Days after onset: 3
Location:Pennsylvania  Entered:2008-04-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1873U0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt called 4/12/08 approximately 11:30 AM. On Thursday AM, 11/10/08 she noticed a rash at site of injection. By 4/10/08 PM, the rash extended from site of injection to elbow. Rash is red, warm, itchy and painful. Rash stayed same through 4/12/08. On 4/13/08 AM, pt reported rash improving and not painful. 09/24/2008 Information has been received from a physician concerning a 67 year old female with no illness at the time of vaccination, allergies to penicillin and sulfonamides who on 09-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) SC in the left arm (Lot #659759/1873U) at 1:30 PM. On 09-APR-2008 at 8:00 PM, the patient noticed a rash at the site of injection. By 10-Apr-2008 PM, the rash extended from the site of the injection to the elbow. The rash was red, warm, itchy, and painful. The rash remained the same through 12-Apr-2008. On 13-Apr-2008, the patient reported that the rash was improving and not painful. Follow up information was received from the physician with no additional information. No further information is available.

VAERS ID:309393 (history)  Vaccinated:2008-04-09
Age:11.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-11, Days after onset: 2
Location:Massachusetts  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2542AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Pallor
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Local blanching redness at deltoid site of injection.

VAERS ID:309396 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-11, Days after onset: 1
Location:Tennessee  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1069 UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.17840 UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain, Oedema peripheral, Pruritus
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received vaccine son Wednesday. Thurs. his parent reported that he had (L) arm swelling, itching, and pain at injection site. No N&V, no fever, no constitutional sxs.

VAERS ID:309397 (history)  Vaccinated:2008-04-09
Age:4.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Male  Submitted:2008-04-11, Days after onset: 0
Location:Tennessee  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03423SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1314U1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1361U1SCRL
Administered by: Private     Purchased by: Unknown
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, red, swollen area in (Rt) upper thigh approx 8cm x 8cm, very warm to touch.

VAERS ID:309429 (history)  Vaccinated:2008-04-09
Age:9.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-11, Days after onset: 1
Location:New York  Entered:2008-04-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Admission in hospital LABS: WBC 8.8, eos 8% (H). Blood c/s neg. Nasal swab for MRSA neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1568U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Cellulitis, Eosinophil percentage increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Methicillin-resistant Staphylococcus aureus test negative
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling and pain Rt upper arm. 4/15/08 Reviewed hospital medical records for 4/11-4/12/2008. FINAL DX: no d/c available; admit dx acute cellulitis Records indicate patient experiencedswelling, redness & pain RUE since vaccination on 4/8/08. Seen by PCP & tx w/antibiotics. Returned to PCP with markedly increased swelling, tenderness & induration; no fever. Sent to hospital for admission.

VAERS ID:309448 (history)  Vaccinated:2008-04-09
Age:77.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-14, Days after onset: 3
Location:California  Entered:2008-04-14
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: Allergies: Catapres Patch
Diagnostic Lab Data: Dr prescribed Diphenhydramine capsule 25mg T1 capsule q4h Prn for itching.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1079U0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt called on 4/11/2008 @ 0930 pt immunizations site has redness, swelling and itchiness denies any SOB, chest pain, or tightness on the chest. Instruct pt to call Primary care Provider for fu. Pt called Primary Care Provider (see attached note).

VAERS ID:309460 (history)  Vaccinated:2008-04-09
Age:34.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-14, Days after onset: 4
Location:North Dakota  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Codeine, Lanolin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Pain
SMQs:, Arthritis (broad)
Write-up: Joint pain (ankles, knee, pelvis, neck); muscle pain (calves, thighs, shoulder, neck); Pain stated 24 hours after shot, and lasted for 24 hours.

VAERS ID:309486 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-14, Days after onset: 3
Location:Kansas  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Season allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2606AA0UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0868U1UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0783U1UNUN
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Skin discolouration, Skin papilloma, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 07/11/2006 MILD Other LOCAL RED ELEVATION WARMTH WITH WHITE RING AROUND

VAERS ID:309635 (history)  Vaccinated:2008-04-09
Age:14.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-11, Days after onset: 1
Location:Massachusetts  Entered:2008-04-16, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0570U1IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02980SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U1SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1567U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local mild redness/tenderness, warmth, on the R site of arm. Fever.

VAERS ID:309684 (history)  Vaccinated:2008-04-09
Age:10.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 0
Location:Florida  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: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1918U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Anxiety, Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Pt does not handle getting shots very well. Pt "worked herself up", and caused her to feel dizzy and light-headed, which lead to her "passing out".

VAERS ID:309875 (history)  Vaccinated:2008-04-09
Age:8.0  Onset:2008-04-17, Days after vaccination: 8
Gender:Female  Submitted:2008-04-17, Days after onset: 0
Location:Virginia  Entered:2008-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1560U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pruritus, Injection site vesicles, Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Eight days after vaccine patient developed 2-3 pruritic varicella blister lesions at site of injection.

VAERS ID:310067 (history)  Vaccinated:2008-04-09
Age:14.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-14, Days after onset: 4
Location:Oklahoma  Entered:2008-04-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ROM was found after
Preexisting Conditions: Asthma-Ear, Nose and Throat Dr-rec. the Pneumovax shots
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU256AA0IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH0866F0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Injection site discolouration, Injection site pain, Injection site swelling, Otitis media, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt was awakened at midnight with pain in left deltoid. By noon on 041008 had HA; 101 fever and severe pain in deltoid. Arm was swollen at injection site. Friday-104 fever, taking Advil & Tylenol every 4 hours for pain. Swelling moving down arm to elbow. Injection site dull in color. Went to Dr. Px with ROM and given antibiotic. Told to go to HD to report immunization reaction. Mother had been in contact with HO during this time. Client and mother

VAERS ID:310154 (history)  Vaccinated:2008-04-09
Age:4.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Male  Submitted:2008-04-18, Days after onset: 9
Location:Texas  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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA030123SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1798U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Mydriasis, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)
Write-up: Parent called on-call physician with complaint of child sleeping most of the afternoon and very sedate; call came at 7:07 pm - child was awake and alert at that time with eyes described as very dilated but reactive

VAERS ID:310167 (history)  Vaccinated:2008-04-09
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-11
Location:Michigan  Entered:2008-04-18, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Varicella (no brand name)~2~11~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.191761SCUN
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 3/4 x 2 3/4 red area hard (warm) right arm

VAERS ID:310380 (history)  Vaccinated:2008-04-09
Age:26.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-15, Days after onset: 4
Location:North Carolina  Entered:2008-04-21, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4/09/08 left deltoid sore after shot given later in day. 4/11/08 nurse noted after lunch around 2:00 pm area where small pox given 20 years ago red, hot to touch and swollen touchy. Had used ice pack 4/10/08 with only wash cloth. Advise use cool wash cloth only 4x daily and Ibuprofen as on package. Saw NP later 4/11/08, better 4/14/08. Saw NP 4/14/08 and has appointment 4/18/08 to see again - looks much better today 4/15/08. Redness gone, less swelling and soreness using cool compresses and Ibuprofen.

VAERS ID:310429 (history)  Vaccinated:2008-04-09
Age:1.7  Onset:2008-04-16, Days after vaccination: 7
Gender:Male  Submitted:2008-04-21, Days after onset: 5
Location:Florida  Entered:2008-04-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Flovent, Xopenex
Current Illness: No
Preexisting Conditions: mild persistent asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.08194 UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.16554 UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site vesicles, Scab
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left thigh where Varivax immunization was placed developed a 1 1/2 x 1" indurated area with vesicles on skin. ~4 vesicles which crusted.

VAERS ID:310503 (history)  Vaccinated:2008-04-09
Age:17.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-11, Days after onset: 1
Location:Kansas  Entered:2008-04-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Exam unremarkable
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2567AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Headache
SMQs:
Write-up: Headache, onset day after Menactra.

VAERS ID:310541 (history)  Vaccinated:2008-04-09
Age:1.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Male  Submitted:2008-04-17, Days after onset: 8
Location:Arizona  Entered:2008-04-22, 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: Vit with Fe, Captopril HCl, sperondlictal, Atazepam, Dig, Lasex, Caroedrol
Current Illness: cough, coarse lung sound
Preexisting Conditions: Dilated CM, s/p cardiac arrest, hypoxic ischemia, encephalopathy, spcotic quadriparesis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B142AB2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF241AC2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1672U0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1791U0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Within seconds of receiving vaccines, noticed skin mottled and then bright red on back, face spreading to extremities. Benadryl and Tylenol given per J tube per order. Pt observed and D/c to home per Dr. order.

VAERS ID:310566 (history)  Vaccinated:2008-04-09
Age:63.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-22, Days after onset: 13
Location:Maryland  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Hypertension, Hypothyroidism, Hyperlipidemia, Sigmoid Diverticulosis, Diabetes
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red immediately after immunization, hard to touch, itchy. Patient applied rubbing alcohol. Now still red, slightly indurated 5.5 x 10 cm. Patient prescribed Claritin 10 mg QD and Westcort Cream to be applied TID.

VAERS ID:310577 (history)  Vaccinated:2008-04-09
Age:2.0  Onset:2008-04-19, Days after vaccination: 10
Gender:Male  Submitted:2008-04-22, Days after onset: 3
Location:Ohio  Entered:2008-04-22
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: none
Diagnostic Lab Data: XRay
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN3IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gait disturbance, Injection site swelling, X-ray
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)
Write-up: Patient had received 3 prior DTaP shots, but was not caught up on them at 2 years, so a DTaP shot was given 3 days after DTaP shot, leg was greatly swollen, about twice the size of normal thigh. Was not hard, but still fleshy feeling and did not have fever. More noteworthy, 10 days afer shot, he started limping in the opposite leg that shot was administered. 14 days after he is still limping, intermittenly, but has gotten worse. Xrays came out normal. Are still proceeding with diagnosis.

VAERS ID:310721 (history)  Vaccinated:2008-04-09
Age:11.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-04-17, Days after onset: 6
Location:Wisconsin  Entered:2008-04-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2842AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed large violaceous induration surrounding injection site. Fever 102.

VAERS ID:310886 (history)  Vaccinated:2008-04-09
Age:1.3  Onset:2008-04-20, Days after vaccination: 11
Gender:Male  Submitted:2008-04-21, Days after onset: 1
Location:Ohio  Entered:2008-04-25, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: mom had febrile seizures in childhood.
Diagnostic Lab Data: EKG, EEG, Cat Scan, Blood work x 3, and Pulse O2 monitor LABS: HCT 31.2 (L), plts 488 (H). CXR WNL. CT of head WNL. CRP 2.3 (H). Creatinine 0.5 (L). UA WNL. Blood, throat & urine c/s neg. EEG WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0428U0UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0674U0UNLL
Administered by: Public     Purchased by: Public
Symptoms: Abnormal behaviour, Blood creatinine decreased, Blood culture negative, Blood test, C-reactive protein increased, Chest X-ray normal, Computerised tomogram, Computerised tomogram normal, Convulsion, Culture throat negative, Culture urine negative, Electrocardiogram, Electroencephalogram, Electroencephalogram normal, Febrile convulsion, Haematocrit decreased, Otitis media, Oxygen saturation, Platelet count increased, Purulent discharge, Pyrexia, Rash generalised, Rash maculo-papular, Rhinorrhoea, Skin discolouration, Tremor, Upper respiratory tract infection, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Child had fever increased to 104. On and off for few days. Had went to 102. 9th day after vaccines were given had seizure at 11:30-Sat-AM. Went to "hospital" where test were run for 2 days. Nothing was seen by that test 1st phys. thought no relation to vaccines; #2 Dr. felt it was. 5/2/08 Received hospital medical records for 4/19-4/21/2008. FINAL DX: febrile seizure, possibly viral in etiology & slight otitis media Records reveal patient experienced shaking movements of extremities, discoloration of face & mouth lasting approx 45 secs while in highchair in restaurant followed by period of being ''out of it''. Had intermittent fever since immunizations & developed maculopapular rash all over. Had been seen by PCP 1 or 2 days after immunizations for otitis media & placed on antibiotics but intermittent fever continued. Admit exam revealed URI symptoms w/purulent nasal discharge. No further seizure activity noted & d/c to home on continued oral antibiotics.

VAERS ID:310917 (history)  Vaccinated:2008-04-09
Age:20.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-23, Days after onset: 14
Location:Unknown  Entered:2008-04-25, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: computed axial - no results reported
CDC Split Type: WAES0804USA02772
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Computerised tomogram, Convulsion, Head injury, Headache, Hypertension, Injection site pain, Nausea, Suture insertion, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from an office manager at a physician''s office concerning a 20 year old female who was vaccinated with a first dose of GARDASIL (lot number, route and site not reported) on an unspecified date. The patient received a second dose of GARDASIL (lot number not reported) intramuscularly on an unspecified date. The office manager reported that the patient fainted and hit her head on a railing while making an appointment for her third dose at the receptionist desk. The patient also became hypertensive, began seizing, and throwing up. The patient was admitted to the hospital where she received 7 stitches. A computed axial tomography was performed (results not reported). The patient was admitted on 09-APR-2008 and released on 10-APR-2008. After being released the patient is still experiencing pain at the injection site, headaches, nausea and back pain. At the time of reporting the patient had not recovered. Additional information has been requested.

VAERS ID:311037 (history)  Vaccinated:2008-04-09
Age:22.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-04-21, Days after onset: 11
Location:Washington  Entered:2008-04-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Broken nose
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1740UNUN
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN234A0UNUN
RAB: RABIES (IMOVAX)SANOFI PASTEURA02570UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0 LA
Administered by: Military     Purchased by: Unknown
Symptoms: Malaise, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received several vaccines to include smallpox 9 APR 08. Presented with 1 day old overall rash, mild malaise, Temp 100.4. Rash mildly pruritic. Had Clindamycin 1 week for nasal fracture. No Hx of allergy to Clindamycin.

VAERS ID:311208 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-29, Days after onset: 19
Location:Virginia  Entered:2008-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1794U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, swollen 8x8cm erythema left upper arm, hot to touch, no fever.

VAERS ID:311418 (history)  Vaccinated:2008-04-09
Age:55.0  Onset:2008-04-29, Days after vaccination: 20
Gender:Female  Submitted:2008-05-01, Days after onset: 2
Location:Arizona  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: arthritic reaction~Measles + Mumps + Rubella (no brand name)~1~50~In Patient
Other Medications:
Current Illness: none
Preexisting Conditions: rafampine, sulfa, ct scan dye, macrodantin
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA2IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia, Dizziness, Malaise, Myalgia, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: about 12 days after injection I had episodic dizzy spells, then on 4/29 I just wasn''t feeling well. on 4/30 I had severe migrating muscle pain w/ occ. pain in knee and hip joints. nex day I ache all aver w/ most severe pain in lt lateral thigh, ? fever, malaise.

VAERS ID:311422 (history)  Vaccinated:2008-04-09
Age:45.0  Onset:2008-04-13, Days after vaccination: 4
Gender:Male  Submitted:2008-05-01, Days after onset: 18
Location:California  Entered:2008-05-01
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hep C
Preexisting Conditions: Hep c with hepatic insufficiency, depression, alcoholism, macrocytic anemia PMH: alcoholic cirrhosis, quit ETOH 8 mos prior, anemia. Family hx: DM & HTN
Diagnostic Lab Data: LABS: WBC 12.6(H), H/H 9.6/28.1(L), plts 187, neutros 85%(H), lymphs 9%(L), eos 15.5%(H). Sodium 128(L), BUN/creat 29/2.0(H), total bili 2.4(H), ALT 15(L). CXR atelectasis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.141DU1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase decreased, Blister, Blood bilirubin increased, Blood creatinine increased, Blood sodium decreased, Blood urea increased, Cellulitis, Chest X-ray abnormal, Drug administered at inappropriate site, Eosinophil percentage increased, Erythema multiforme, Haematocrit decreased, Haemoglobin decreased, Hypersensitivity, Lymphocyte percentage decreased, Mouth ulceration, Neutrophil percentage increased, Oedema peripheral, Oral intake reduced, Platelet count normal, Rash generalised, Skin ulcer, Stevens-Johnson syndrome, Tinea pedis, Urticaria, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient admitted to hospital after developed rash suspicious for Steven Johnson syndrome, this rash began 4 days after he received the Hepatitis B shot, his second dose of the series. 06/27/08 Reviewed hospital medical records of 4/16-4/18/2008 FINAL DX: no d/c summary available. H&P states Stevens-JOhnson syndrome secondary to hepatitis B vaccine. records reveal patient experienced a worsening urticarial rash since day after vaccination. Had been seen in ER on 4/13 & dx w/allergic reaction to hepatitis vaccine, cellulitis & tinea pedis. Sent home on antibiotics & antifungal meds. Bilateral LE & hands swollen. Seen by dermatologist, dx w/erythema multiforme & received steroid injection. Condition worsened. Developed oral lesions 2 days prior to admission & had decreased oral intake. Seen by PCP, sent to ER & admitted. Skin lesions were now clear blisters & more violaceous involving entire body w/ulcers on feet that had ruptured. Tx w/IV steroids & IVF.

VAERS ID:311457 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 22
Location:Texas  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: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: total serum human, did not show patient was pregnant
CDC Split Type: WAES0804USA05085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a medical assistant concerning a 19 year old female, who on 09-APR-2008 was vaccinated with a 0.5mL first dose of Gardasil. Subsequently, the patient was pregnant. It was reported that the office did not conduct a pregnancy test prior to the vaccination. The patient called the office to report that she experienced a miscarriage on 21-APR-2008. The patient went to see the physician. A total serum human chorionic gonadotropin test was performed and did not show that the patient was pregnant. On 09-APR-2008 the patient experienced received first dose while pregnant. At the time of the report, the outcome of the patient was unknown. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:311520 (history)  Vaccinated:2008-04-09
Age:23.0  Onset:2008-04-29, Days after vaccination: 20
Gender:Male  Submitted:2008-05-03, Days after onset: 4
Location:Unknown  Entered:2008-05-03
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: Non at this time currently the Ship is in the middle of the Ocean. Patient is being monitore daily by Independent Duty Corpsman. Patient condition improved. Still has pitting edema, erythema, mild TTP and rash to his lower right leg. No fever, no palpitation normal BP.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW04-003-A0OTLA
Administered by: Military     Purchased by: Military
Symptoms: Blood pressure normal, Dehydration, Erythema, Pain, Palpitations, Pitting oedema, Pyrexia, Rash, Tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash, erythema, pitting edema of the lower right leg, and pain with palpation, Fever of 101F tachycardia, dehydration, heart palpitation (skipping heart). Condition occurs after 20 days of SPV inoculation.

VAERS ID:311706 (history)  Vaccinated:2008-04-09
Age:19.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 21
Location:North Carolina  Entered:2008-05-06, 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: Depo Provera 104mg SQ
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2720AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt reported a pruritic rash over abdomen and back that started soon after 04/09/08 clinic visit and lasted a few days.

VAERS ID:312248 (history)  Vaccinated:2008-04-09
Age:44.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-05-13, Days after onset: 34
Location:Florida  Entered:2008-05-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient
Other Medications: Avalide 300/12.5 mg daily
Current Illness: Denies
Preexisting Conditions: HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB443BA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Asthenia, Blood pressure, Dizziness, Heart rate normal, Immediate post-injection reaction
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Received first dose of Engerix-B 1 mL IM, Lt deltoid. Immediately became weak and lightheaded. No LOC. Placed head between knees, BP 110/69. Placed in supine position, 86/55 P 60 bpm, 90/50, 109/62. Entire episode lasted approx 10 minutes. No further side effects. Contributed to having not eaten that day.

VAERS ID:312286 (history)  Vaccinated:2008-04-09
Age:4.0  Onset:2008-04-12, Days after vaccination: 3
Gender:Male  Submitted:2008-04-28, Days after onset: 16
Location:Arizona  Entered:2008-05-13, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02733SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1485U1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1497U1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) deltoid redness, swelling, warmth

VAERS ID:312883 (history)  Vaccinated:2008-04-09
Age:24.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 35
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA02224
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Erythema, Immediate post-injection reaction, Local reaction, Sensation of heaviness, Skin warm
SMQs:, Anaphylactic reaction (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse concerning a 24 year old female who on 09-APR-2008 was vaccinated IM in the right arm with the first 0.5 ml dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included vitamins (unspecified). On 09-APR-2008 the patient experienced immediate local reaction to the right arm (injection site arm), developed redness up to inches in diameter, increased warmth, pain down arm into chest, heaviness in the right arm and heaviness in chest. The office has been observing the patient and the redness has begun to lessen. Patient outcome is unknown. Medical attention was sought in the office. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/4/2008. The redness, warmth, and pain down arm and into chest lasted approximately 30 minutes before the symptoms abated. The patient had no respiratory distress. Unknown medical attention was sought in the office. No product quality complaint was involved. Additional information has been requested.

VAERS ID:313171 (history)  Vaccinated:2008-04-09
Age:15.0  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-05-14, Days after onset: 33
Location:Ohio  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: Ureteric reimplantation
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA04633
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse concerning a 15 year old white female student who on 09-APR-2008 at 10 am was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659964/1978U). Concomitant therapy included TRINESSA. The patient''s mother called office indicating that on 11-APR-2008 the patient experienced generalized itching, site not reddened and no rash. The patient recovered on 14-APR-2008. No product quality complaint was involved. Additional information has been requested. This is a follow-up to report (s) previously submitted on 5/14/2008- Initial and followup information has been received from a nurse concerning a 15 year old female student who was vaccinated with the first dose of GARDASIL on 07-JAN-2008. On 09-APR-2008 at 10 am the patient was vaccinated in the right deltoid with the second dose of GARDASIL (Lot # 659960/1987U). Concomitant therapy included TRINESSA. The patient''s mother called office indicating that on 11-APR-2008 the patient experienced generalised itching, site not reddened, looks fine, and no rash. The patient was given ZYRTEC and had some relief. The office recommended BENADRYL and to go in the ER if the reaction worsens. The office called to check on 14-APR-2009 with no response from the patient. The patient recovered on 14-APR-2008. Additional information has been requested.

VAERS ID:312709 (history)  Vaccinated:2008-04-09
Age:15.0  Onset:2008-04-30, Days after vaccination: 21
Gender:Male  Submitted:2008-05-06, Days after onset: 6
Location:Michigan  Entered:2008-05-20, Days after submission: 14
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: MRI of head with contrast ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2560AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA5IMLA
Administered by: Public     Purchased by: Private
Symptoms: Aphasia, Headache, Nuclear magnetic resonance imaging, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Onset of rt hand parakensia "fell asleep" while typing on computer. Sx''s progressed to entire arm and to rt foot and leg. Pt also experienced expressive aphasia. Sx''s lasted 30 minutes and severe headache followed, lasted 8-12 hours then resolved. No recurrance. No Hx of similar Sx.

VAERS ID:313821 (history)  Vaccinated:2008-04-09
Age:42.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Male  Submitted:2008-05-28, Days after onset: 48
Location:D.C.  Entered:2008-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, Vitamin C
Current Illness: None
Preexisting Conditions: NKDA, History of borderline cholesterol, managed by diet; History of elevated blood pressure on occasion, but not diagnosed with hypertension
Diagnostic Lab Data: NL ECG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)ACAMBIS, INC.VV04003A IDLA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Developed atypical chest pain 1 day following receipt of SPV. Chest pain waxed and waned over next couple of days and patient was seen in ER on 11 April with normal exam. No associated symptoms or radiation. CP described as "little tightness in my chest...not really painful, but more bothersome". Noted burning quality that felt like heartburn, but different from heartburn in duration compared to previous heartburn episodes. No improvement of pain after receipt of IM TORADOL and po MYLANTA in ER. Chest pain did not change with changes in position or with deep breaths. (Patient sought evaluation on at least 2 other occasions for continued chest pain over next several weeks.)

VAERS ID:315586 (history)  Vaccinated:2008-04-09
Age:4.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2008-06-02, Days after onset: 53
Location:Utah  Entered:2008-06-09, 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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA6UNRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB2001UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08735UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0201U1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1778U1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling on both arms, at vaccine site no fever, no breathing difficulty.

VAERS ID:316995 (history)  Vaccinated:2008-04-09
Age:17.0  Onset:2008-04-30, Days after vaccination: 21
Gender:Female  Submitted:2008-06-13, Days after onset: 44
Location:Michigan  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: Unknown
Diagnostic Lab Data: Vaginal culture, negative
CDC Split Type: WAES0805USA04541
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Culture negative, Genital pain, Genital tract inflammation, Vulvovaginal discomfort
SMQs:
Write-up: Information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported). Concomitant therapy included ALESSE. On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia. The patient sought unspecified medical attention with an office visit. At the time of this report, the patient was recovering from redness, soreness and swelling of the labia. No additional information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported). Concomitant therapy included ALESSE. On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia, later reported as pain and burning in the vaginal area. Patient''s vaginal culture was negative. The patient sought unspecified medical attention with an office visit. At the time of this report, the patient was recovering from redness, soreness and swelling of the labia. No additional information was provided. Additional information has been requested.

VAERS ID:316705 (history)  Vaccinated:2008-04-09
Age:0.2  Onset:2008-04-09, Days after vaccination: 0
Gender:Male  Submitted:2008-06-06, Days after onset: 58
Location:California  Entered:2008-06-20, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B136CA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF237AD0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015K0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1701U0PO 
Administered by: Private     Purchased by: Public
Symptoms: Depressed level of consciousness, Gaze palsy, Hypersomnia, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Fell asleep shortly after vaccine, difficult to awaken, ashy/pale color, eyes rolled back in sleep, finally awakened 8 hrs. after shots.

VAERS ID:317243 (history)  Vaccinated:2008-04-09
Age:71.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-16
Location:Texas  Entered:2008-06-24, Days after submission: 69
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: SHINGLES~Zoster (Zostavax)~1~71~In Patient
Other Medications: UNKNOWN
Current Illness: CLIENT UNSURE WHEN RASH STARTED.
Preexisting Conditions:
Diagnostic Lab Data: NONE ACCORDING TO CLIENT. HAD FLU W/DR ON 4/21.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1079U0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Pain of skin, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: RECEIVED SHINGLES SHOT ON 4/9/08. HAD A RASH TO (LT) HIP/THIGH. CLIENT CAN''T REMEMBER IF SHE DEVELOPED RASH BEFORE OR W SHOT. REALLY NOTICED IT TO BE PAINFUL ON 4/12/08. WENT TO ER ON 4/14 - NO DIAGNOSTIC TEST DONE.

VAERS ID:318568 (history)  Vaccinated:2008-04-09
Age:55.0  Onset:2008-07-07, Days after vaccination: 89
Gender:Female  Submitted:2008-07-08, Days after onset: 1
Location:Minnesota  Entered:2008-07-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Bactrim
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937AA1IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Nurse administered ADACEL injection to pt 7-7-08 and pt already had ADACEL injection on 4-9-08.

VAERS ID:318956 (history)  Vaccinated:2008-04-09
Age:25.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 90
Location:Connecticut  Entered:2008-07-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA04740
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X2UNUN
Administered by: Private     Purchased by: Private
Symptoms: Device malfunction, Underdose
SMQs:, Medication errors (broad)
Write-up: This is in follow-up to report(s) previously submitted on 7/8/2008. Information has been received from a health professional concerning a 25 year old, 130 pound female with no illnesses at time of vaccination, and no pre-existing allergies; birth defects or medical conditions, who on 09-APR-2008 was vaccinated with a partial dose of GARDASIL (lot # 655604/0052X) due to a malfunction of the pre-filled syringe. The syringe malfunctioned before the complete dose could be administered. The patient was subsequently administered a complete dose of GARDASIL at the same office visit. No problems were reported. Patient outcome was not reported. Additional information has been requested. The SR # is 1-3040431198. No additional information is expected.

VAERS ID:319217 (history)  Vaccinated:2008-04-09
Age:5.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 76
Location:Maryland  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02348
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a physician concerning a patient who on 09-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that the zoster vaccine live (Oka/Merck) was inadvertently stored in the varicella virus vaccine live (Oka/Merck) (MSD) storage area of the vaccine refrigerator. There were no adverse symptoms. The event occurred as a result of human error. The bottle was "not seen properly" as stated by the physician. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician had no suggestions with regards to changing labeling, storage conditions, etc. The physician felt it was simply a case of human error. At the time of the report the patient''s status was unknown. There was no product quality complaint involved. Follow up confirmed that there was one female 5 year old patient. No additional information is expected.

VAERS ID:319456 (history)  Vaccinated:2008-04-09
Age:77.0  Onset:2008-04-15, Days after vaccination: 6
Gender:Male  Submitted:2008-06-24, Days after onset: 70
Location:Florida  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; CARDIZEM CD; ZETIA; folic acid; SYNTHROID; niacin; PAXIL; RISPERDAL; saw palmetto; ZOCOR; FLOMAX
Current Illness: Cholesterol high
Preexisting Conditions: Atrial flutter; Cardiac ablation
Diagnostic Lab Data: diagnostic procedure 04/22/08 shingles - Test=culture
CDC Split Type: WAES0804USA05975
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1874U0SC 
Administered by: Other     Purchased by: Other
Symptoms: Culture positive, Herpes zoster, Tenderness
SMQs:
Write-up: Information has been received from a nurse concerning an approximately 74 year old male consumer with no known allergies, high cholesterol and a history of "arterial flutter corrected with ablation" who on 09-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 659762/1874U). Concomitant therapy included CARDIZEM CD, ezetimibe (MSD), FLOMAX, saw palmetto, aspirin, niacin, SYNTHROID, simvastatin (MSD), PAXIL, folic acid and RISPERDAL. Subsequently, the patient developed a tender area on his scalp. On 22-APR-2008 or 23-APR-2008 the patient was seen by a dermatologist and a culture of the area was performed. The results can back as shingles. At the time of the report this patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. Follow-up information from the registered nurse indicated no new information. Additional information is not expected.

VAERS ID:319675 (history)  Vaccinated:2008-04-09
Age:0.6  Onset:2008-06-03, Days after vaccination: 55
Gender:Unknown  Submitted:0000-00-00
Location:Louisiana  Entered:2008-07-17
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: None
Diagnostic Lab Data: stool rotavirus PNA, 06/04/08, positive; Stool for fecal, 06/04/08, none seen; stool gross blood, 06/04/08, negative
CDC Split Type: WAES0806USA00856
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0616X2PO 
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rotavirus infection, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow)
Write-up: Information has been received from a nurse concerning an 8 month old patient who was vaccinated po on 04-DEC-2007, 25-JAN-2008 and 09-APR-2008 with the first, second, and third doses of ROTATEQ (first dose lot # 657606/1391U and third dose lot # 660550/0616X). The nurse reported that the patient developed rotavirus, confirmed by the office lab technician. It was reported that the patient sought medical attention, unspecified. The outcome was not reported. Follow-up information was received from a nurse concerning a 9 month old (previously reported as an 8 month old) patient. On 03-JUN-2008 the patient experienced vomiting for 3 to 4 days and diarrhea for 2 to 3 days. On 04-JUN-2008 a stool test was done which was positive for Rotozyme, negative hematest and no fecal white blood cells seen. The patient was seen for a doctor visit. It was reported that the patient recovered. This is one of several reports from the same source. Additional information has been requested. No further information is expected.

VAERS ID:320685 (history)  Vaccinated:2008-04-09
Age:16.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2008-07-28, Days after onset: 110
Location:California  Entered:2008-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 3/19/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA05684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 16 year old female with no medical history, and no drug reactions/allergies, who on 09-APR-2008 was vaccinated intramuscularly with her first 0.5ml dose of GARDASIL (lot# 659964/1978U) while pregnant. It was reported that the patient was "9 weeks pregnant on 22-May-2008" (estimated LMP = 19-Mar-2008). The patient has no symptoms. Unspecified medical attention was sought by calling the office. No further information available. In follow-up information it was reported that date of last menstrual period was 19-MAR-2008 and the estimated delivery date was 24-DEC-2008. On 16-JUN-2008 the patient had an elective termination of pregnancy. It was reported that LMP was 19-MAR-2008, so the patient was approximately 13 weeks. It was unknown if the products of conception were examined and it was unknown if the fetus is normal. Upon internal review elective termination was determined to be an other important medical event. Additional information is not expected.

VAERS ID:321025 (history)  Vaccinated:2008-04-09
Age:44.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2008-07-28, Days after onset: 109
Location:Virginia  Entered:2008-08-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Depakote; Zocor; Wellbutrin; Topamax; Vivel.
Current Illness:
Preexisting Conditions: Elevated cholesterol, migraines, and allergy to penicillin. Past history of "increased reaction to PPD testing". Also reported a history of "gyn problems", and noted a "bad year with respiratory infections".
Diagnostic Lab Data: 22/Apr/2008: WBC low, platelets 88; decreased to 20 over next 36 hours.
CDC Split Type: 200802436
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Arthralgia, Biopsy bone marrow, Chills, Epstein-Barr virus test, Fatigue, Gingival bleeding, Haemoptysis, Haemorrhage, Headache, Injection site pain, Insomnia, Intermittent claudication, Petechiae, Platelet count decreased, Platelet transfusion, Purpura, Pyrexia, Serum sickness, Vaginal haemorrhage, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gingival disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This case was received from a physician on 23 July 2008. The physician was also the patient. A 44-year-old female patient received an injection of ADACEL on 09 April 2008 (lot number, route, and site were not reported). Medical history included migraines, elevated cholesterol, penicillin allergy, "gyn problems", and a history of recurrent respiratory infections. One day after vaccination, the patient began experiencing a severe headache; two days after vaccination, she reported a sleepless night. On 12 April 2008, three days after vaccination, she developed a macular rash over her entire body, and reported feeling exhausted. She took a five-hour nap during the day, and by evening had developed a fever of 104.2 degrees Fahrenheit, with shivering. She also noted that the injection site was extremely sore. On 13 April 2008, four days after vaccination, the patient developed arthralgia, described as rolling, symmetric pain in the joints including the knees, wrists, metacarpals, and shoulders. No swelling or redness was noted. The maculopapular rash resolved, but the severe headache continued. On 15 April 2008, six days after vaccination, the patient developed right upper quadrant pain which lasted four days, and claudication in the calves. She subsequently developed a purpuric rash behind the knees, petechia on the lower legs, and hemoptysis (exact start dates unknown). The petechia faded after a few days, but reappeared on 22 April 2008. At that time she also developed subcutaneous bleeding, vaginal bleeding, and bleeding from the gums. Additionally, a sore on her body would not stop bleeding. Laboratory values at that time showed low white blood cells, and a platelet count of 88. Within 36 hours the platelet count had dropped to 20, and she was admitted to the hospital. Inpatient testing including a bone marrow aspiration and Epstein Barr Virus testing; results were not provided. She received a platelet transfusion, and bleeding continued for 36 hours. She remained hospitalized for four days. Per the reporter, she

VAERS ID:324235 (history)  Vaccinated:2008-04-09
Age:1.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Male  Submitted:2008-07-30, Days after onset: 112
Location:Arizona  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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02760
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a Registered Nurse concerning a 14 month old male child who on 09-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine inadvertently instead of PREVNAR. This was reported as human error. No adverse event reported. The outcome was unknown. Additional information has been requested.

VAERS ID:326252 (history)  Vaccinated:2008-04-09
Age:20.0  Onset:2008-04-18, Days after vaccination: 9
Gender:Female  Submitted:2008-04-23, Days after onset: 5
Location:Oregon  Entered:2008-08-26, Days after submission: 125
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE
Current Illness: None
Preexisting Conditions: hypothyroidism
Diagnostic Lab Data:
CDC Split Type: 200801147
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224CA IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0342 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2936B IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Initial report received on 18 April 2008 from a nurse in the USA. A 20 year old female patient received on 09 April 2008 a left deltoid intramuscular injection of ADACEL (lot # C2936BA), a left deltoid intramuscular injection of IPOL (A0342-2) and a right deltoid intramuscular injection of a HEPATITIS A vaccine (GSK, lot # AHAVB224CA). The patient''s medical history included no known allergies and hypothyroidism and concomitant medication was LEVOTHYROXINE. The patient had no illness at the time of vaccination. On 18 April 2008, nine days post-vaccination, the patient developed a sore left arm. There were no signs and symptoms of infection and no decreased range of motion. The recommended treatment was "OTC" pain medication and warm packs. At the time of reporting, 18 April 2008, the patient had not recovered.

VAERS ID:323493 (history)  Vaccinated:2008-04-09
Age:75.0  Onset:2008-07-10, Days after vaccination: 92
Gender:Unknown  Submitted:2008-08-27, Days after onset: 48
Location:California  Entered:2008-08-27
Life Threatening? No
Died? Yes
   Date died: 2008-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood cholesterol increased, Death, Myocardial infarction
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Lipodystrophy (broad)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, died on 7/10/2008 in home due to myocardial infarction and high cholesterol. Vaccination took place on 4/9/07. According to the physician, the relationship to treatment is ''None". We would be happy to forward the Study''s SAE Report Form upon request.

VAERS ID:326963 (history)  Vaccinated:2008-04-09
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2008-09-29
Location:Michigan  Entered:2008-10-03, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR208721SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.139001PO 
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: DTaP - Hib combo given before 15 months of age. No side effects reported

VAERS ID:329246 (history)  Vaccinated:2008-04-09
Age:26.0  Onset:2008-04-18, Days after vaccination: 9
Gender:Female  Submitted:2008-10-20, Days after onset: 185
Location:Ohio  Entered:2008-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Got Tuberculosis test on 3-31-08. Read negative on 4-2-08
Current Illness: healthy
Preexisting Conditions: none known
Diagnostic Lab Data: Bloodwork: positive for Rheumatoid Arthritis. But have not had any other signs or symptoms since then, and it is now 6 months later.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERUN UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood test abnormal, Inappropriate schedule of drug administration, Injection site pain, Joint stiffness, Rheumatoid arthritis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)
Write-up: 4/9/08 Recieved TDAP: normal soreness at injection site 4/18/08 Knees felt stiff and took effort to get up and down 4/19/08 Joint paint in knees, elbows, wrist, shoulers, ankles when used to apply force; could not function normally: opening objects, brush hair, climb steps, put on seat belt (took advil and did not help joint pain. no other symptoms) 4/20/08 went to E.R. Examined by intern: wanted to do blood work but had to check with attending first. Examined by attending: told me to take motrin and sent me home. (I am VERY frustrated at this point because nothing is helping the pain, and the ammount of money I spent at the E.R. to get no answers) 4/21/08 Joint pain was now in virtually every joint in body progressing to jaw, fingers, toes etc. Called Med Center to make appointment with my dr and couldn''t get in until Wednesday 4/23/08 Joint pain was begining to go away...latest joint pain occurring was first to go away. Dr ordered blood work. 4/25/08 Joint pain was now localized where it originally started: knees and ankles. Blood work came back that my count for Rhematoid arthritis was over 40. It is now in October and I have not had any of the above signs or symptoms.

VAERS ID:336293 (history)  Vaccinated:2008-04-09
Age:  Onset:2008-04-11, Days after vaccination: 2
Gender:Female  Submitted:2008-12-30, Days after onset: 263
Location:Massachusetts  Entered:2008-12-30
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: Allergic to Penicillans
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1462U SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Swelling, Tenderness
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: Arm/elbow - swollen over distal portion of triceps down to elbow. Very slight erythema. Area of swelling approx 7 or 8 cm in diam. Mild tenderness in area of swelling.

VAERS ID:338645 (history)  Vaccinated:2008-04-09
Age:17.0  Onset:2008-04-09, Days after vaccination: 0
Gender:Female  Submitted:2009-01-16, Days after onset: 282
Location:Utah  Entered:2009-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Colposcopy, 12/03/08, results showed high risk HPV
CDC Split Type: WAES0812USA03738
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Papilloma viral infection
SMQs:
Write-up: Information has been received from a physician concerning an 18 year old female patient who on 6-DEC-2007 was vaccinated with the first dose of GARDASIL (lot # not provided). On 09-APR-2008 the patient received the second dose of GARDASIL (lot # not provided). A colposcopy done approximately on 3-DEC-2008, "2 weeks ago", showed the patient was high risk HPV. Possible exposure to HPV through her boyfriend. Patient went to the doctor''s office. At the time of the report the patient had not yet recovered. Additional information has been requested.

VAERS ID:348884 (history)  Vaccinated:2008-04-09
Age:26.0  Onset:0000-00-00
Gender:Male  Submitted:2009-02-11
Location:Michigan  Entered:2009-03-03, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR, Nasal Spray
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: 08AV00285SP
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2332SCRA
Administered by: Other     Purchased by: Private
Symptoms: Alopecia
SMQs:
Write-up: Received a haircut on 4/15/08. At that time, he noticed a dime-sized area of hair loss on scalp, back of head.

VAERS ID:343196 (history)  Vaccinated:2008-04-09
Age:0.0  Onset:2008-04-12, Days after vaccination: 3
Gender:Female  Submitted:2009-03-06, Days after onset: 328
Location:Arizona  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Jaundice
Diagnostic Lab Data: diagnostic laboratory 04/23/08 - endocrine disorders - normal; diagnostic laboratory 04/23/08 - hemoglobinopathies - normal; diagnostic laboratory 04/23/08 - biotinidase deficiency - normal; diagnostic laboratory 04/23/08 - galactosemia - n
CDC Split Type: WAES0809USA03006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Blood bilirubin unconjugated increased, Diarrhoea, Flatulence, Jaundice
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from certified physician assistant (PAC) concerning a 3 day old, 7 pounds, 5 ounce, 19.75 inch, female with a history of jaundice who on 09-APR-2008 was vaccinated with RECOMBIVAX HB (manufacturer unknown). There was no concomitant medication. On approximately 12-APR-2008 the patient was seen by the (PAC) for jaundice. There was no reported history of mom/baby incomparability per the parents. It was reported that the infant was a healthy appearing, alert, normally nourished, well hydrated child in no acute distress. The infant had skin symptoms of jaundice to the hips. Bilirubin levels were drawn and were as follows: neonatal bilirubin was high at 12.3; and indirect bilirubin was high at 12.0. The infant was seen in follow-up the following day 13-APR-2008. Neonatal bilirub was high at 13.3; and indirect bilirubin was high at 12.9. On 14-APR-2008 the mom reported that the child "looks less yellow today." The physician assistant reported the jaundice to be improved. On 23-APR-2008 at a follow-up visit, the baby was reported to be "doing well presently without any significant abnormalities identified on exam." On 12-MAY-2008 at a well exam, it was reported that the patient experienced gas and explosive stools with similac. The infants weight was noted to be 8 pounds and 12 ounces, and height was 22 inches. The patient was to continue with routine immunizations. Additional information has been requested.

VAERS ID:345014 (history)  Vaccinated:2008-04-09
Age:1.4  Onset:0000-00-00
Gender:Male  Submitted:2009-04-10
Location:Unknown  Entered:2009-04-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: The patient was not taking any concomitant medications.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: Laboratory test (results: bacterial pneumonia) was done in 2008.
CDC Split Type: USWYEH05814408
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Dyspnoea, Ear infection, Febrile convulsion, Laboratory test abnormal, Pneumonia bacterial, Pyrexia, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (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), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was considered medically important. Information regarding PREVNAR was received from consumer regarding a 15-month-old male patient who experienced asthma, bacterial pneumonia, ear infection, vomiting and febrile seizure. The patient received the third dose on 09-Apr-2008. Within 48 hours of being administered the PREVNAR vaccine, the patient experienced a fever, shortness of breath with wheezing, vomiting, and a febrile seizure after being administered the third dose of the PREVNAR in April-2008. He was also diagnosed with an ear infection, bacterial pneumonia and asthma in 2008. The patient was not hospitalized. The patient was treated with oral and injectable antibiotics. No additional information was available at the time of this report. No additional information was available at the time of this report.

VAERS ID:348025 (history)  Vaccinated:2008-04-09
Age:9.0  Onset:2008-04-10, Days after vaccination: 1
Gender:Female  Submitted:2009-05-15, Days after onset: 400
Location:Pennsylvania  Entered:2009-05-21, 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:
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA03185
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1654U1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site lymphadenopathy, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a registered nurse concerning a 9 year old patient with a history of premature puberty and asthma and a drug reaction/allergies that included an unknown reaction to flu vaccine, who on 09-APR-2008 was vaccinated IM with a dose of VARIVAX (Merck) (lot number: 659610/1654U). Suspect therapy included GARDASIL. On 10-APR-2008 the patient developed local swelling, redness and a lump under the skin at the injection site. Recommended treatment was ice and MOTRIN. There were no lab diagnostic studies performed. Unspecified medical attention was sought, via phone call to the office. The outcome was reported as recovering. There was no product quality complaint. Follow-up information from the reporting medical assistant (also reported as registered nurse) indicated that the 9 year old female who on 09-APR-2008 at 12:00 was vaccinated IM with her second dose of VARIVAX (Merck) (lot# 659610/1654U). After vaccination the patient developed redness and swelling. Additional information has been requested.

VAERS ID:460426 (history)  Vaccinated:2008-04-09
Age:1.0  Onset:2008-04-24, Days after vaccination: 15
Gender:Female  Submitted:2012-07-28, Days after onset: 1556
Location:Virginia  Entered:2012-07-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestion and cough.
Preexisting Conditions: Bronchiolitis
Diagnostic Lab Data: EEG completed to determine any permanent neurological damage. Test negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0809U0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1559U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Electroencephalogram normal, Gaze palsy, Petit mal epilepsy, Rash generalised, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on trunk, arms, neck, cheek and legs. Administered Benadryl for rash. Two weeks post-vaccination, episodes of petit mal seizures daily, eyes rolling back into head, for two weeks. Noted MMR vaccine reaction by LPN on 4/25/08.

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