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Case Details (Sorted by Vaccination Date)

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VAERS ID:306679 (history)  Vaccinated:2008-03-06
Age:0.2  Onset:2008-03-07, Days after vaccination: 1
Gender:Male  Submitted:2008-03-07, Days after onset: 0
Location:Oregon  Entered:2008-03-07
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: Prematurity, apnea of prematurity, retinopathy of prematurity
Diagnostic Lab Data: Coagulation studies pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coagulation test, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Indurated, erythematous area (possibly small hemorrhage) 1.5 cm in diameter noted on L thigh approx. 3 1/2 hours after DTaP administration.

VAERS ID:307295 (history)  Vaccinated:2008-03-06
Age:33.0  Onset:2008-03-16, Days after vaccination: 10
Gender:Male  Submitted:2008-03-18, Days after onset: 2
Location:Wisconsin  Entered:2008-03-18
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: Aspirin, Motrin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSUNK4SCRA
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETHUNK0IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA022122IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injection site induration, Injection site vesicles, Otitis media, Rash, Sinusitis, Skin lesion
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rash present to upper arms and chest starting on 3/16/08. Had smallpox vaccination on 6Mar08. Had missed take check that was scheduled for 3/15/08. MD evaluation noted Greater than 15 skin lesions noted on chest, upper arms and back. Single vesicle of 8cm induration noted on L deltoid d/t smallpox vaccination. Also diagnosed with sinusitis and Otitis Media to both ears.

VAERS ID:307573 (history)  Vaccinated:2008-03-06
Age:51.0  Onset:2008-03-18, Days after vaccination: 12
Gender:Female  Submitted:2008-03-20, Days after onset: 2
Location:Rhode Island  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fexofenadine; Vitamin D; Fish Oil; MVI
Current Illness:
Preexisting Conditions: Migraines; Degenerative disc disease; depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1217F0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR02844AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash papular
SMQs:
Write-up: Patient with rash, papule. Non specific rash over head, neck and trunk. Diagnosis: modified measles vs rubella.

VAERS ID:307719 (history)  Vaccinated:2008-03-06
Age:19.0  Onset:2008-03-07, Days after vaccination: 1
Gender:Male  Submitted:2008-03-11, Days after onset: 3
Location:Missouri  Entered:2008-03-21, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV163 UNUN
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH4020076  UN
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURERA0221 UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Rash pustular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Sur with 16-20 Erythema pustule on left arm around recent tattoo. Symptoms can decrease with time.

VAERS ID:317613 (history)  Vaccinated:2008-03-06
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-12
Location:North Carolina  Entered:2008-06-26, Days after submission: 106
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: History of fever blisters since toddlerhood.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Blister, Lymph node pain, Lymphadenopathy, Oral herpes
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal infections (narrow), Hypersensitivity (broad)
Write-up: Developed a fever blister within 24 hours after receipt of the GARDASIL vaccine and about 48 hours after start of fever blister, developed painful submental lymph node. Lesions, vesicle start: 03/06/2008, comment: cold sore on chin, right below lower lip; Lymphadenopathy, posterior cervical chain start: 03/08/2008; Lymphadenopathy, submaxillary/submental start: 03/08/2008.

VAERS ID:388122 (history)  Vaccinated:2008-03-06
Age:70.0  Onset:2008-03-06, Days after vaccination: 0
Gender:Male  Submitted:2010-05-14, Days after onset: 798
Location:Arkansas  Entered:2010-05-17, 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: WAES0904USA02854
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1660U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Wrong drug administered
SMQs:
Write-up: Information has been received from a physician concerning an unknown number of older adult patients who on an unspecified date were vaccinated with VARIVAX (Merck) (dose and lot number not provided). The patients experienced local injection site reactions. Follow up call information was received from a physician and a registered medical assistant concerning a 70 year old male patient who on 06-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659724/1660U). The patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). This event was not a case of product confusion, but a result of human error. No further information is available. This is one of two reports from the same source.

VAERS ID:307357 (history)  Vaccinated:2008-03-07
Age:65.0  Onset:0000-00-00
Gender:Unknown  Submitted:2008-03-07
Location:Massachusetts  Entered:2008-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IMUN
Administered by: Public     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: No adverse events

VAERS ID:306683 (history)  Vaccinated:2008-03-07
Age:18.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-08, Days after onset: 1
Location:Tennessee  Entered:2008-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: iodine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS438011C0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow)
Write-up: Donor c/o itching and had a rash the approximate size of a 50 cent piece on lt side of lower back also c/o lower back pain.

VAERS ID:306685 (history)  Vaccinated:2008-03-07
Age:27.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Male  Submitted:2008-03-08, Days after onset: 0
Location:Georgia  Entered:2008-03-08
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1763SCLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Injection site induration, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Induration at injection site. Erythema and warm to touch. Painful, affecting RoM of left arm. Pt marked to monitor growth, put quarters 24h.

VAERS ID:306758 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-10, Days after onset: 2
Location:New Jersey  Entered:2008-03-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NOE
Preexisting Conditions: NONE
Diagnostic Lab Data: CSF - normal study, no growth at 2 days. Blood and Urine cultures - no growth at 2 days. 3/27/08-records received-RSV negative. Blood, urine and CSF culture negative. WBC 23,800. EEG normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B0638A1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1126F1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700C1IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, CSF culture negative, CSF test normal, Culture urine negative, Electroencephalogram normal, Febrile convulsion, Foaming at mouth, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Complex febrile seizures 12 hours after vaccine administration. Patient had full septic work up done and treated with antibiotics for 2 days prior to discharge. No focal neurology on discharge. 3/27/08-records received for DOS 3/8-3/10/08-DC DX Complex febrile seizure. Vaccine related febrile illness. Admitted with C/O febrile illness, new onset seizure times 2 in last 24 hours with frothing from mouth. Fever 104. No focal neuralgia, no signs of meningitis.

VAERS ID:306783 (history)  Vaccinated:2008-03-07
Age:5.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-10, Days after onset: 2
Location:North Carolina  Entered:2008-03-10
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: Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2355CA4UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U1UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1587U1UNRL
Administered by: Private     Purchased by: Unknown
Symptoms: Contusion, Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (broad)
Write-up: Child received DTaP and Varicella 3-7-08 in right thigh. Child seen in office 3-10-08 due to 2-3 inch erythema to right thigh. Bruising and itching noted to site.

VAERS ID:306864 (history)  Vaccinated:2008-03-07
Age:4.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 3
Location:Georgia  Entered:2008-03-11
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: Solumedrol 60mg IM, Benadryl 12.5/5 every 6 hours as needed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217BA0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA017023IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0291U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Severe/moderate itching, redness over entire thigh area, fever to touch.

VAERS ID:306867 (history)  Vaccinated:2008-03-07
Age:31.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 3
Location:New York  Entered:2008-03-11
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: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSHBVB521AN1IDRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184U1IDRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR02524AA1IDRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient had 2 shots on the arm on Friday morning and, in the evening felt itchy, sore, bump as well as hot red on the vaccinated right arm. No lymph glands and he got better on Monday 3/10/2008.

VAERS ID:306883 (history)  Vaccinated:2008-03-07
Age:19.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 3
Location:Indiana  Entered:2008-03-11
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: No Known Allergies
Diagnostic Lab Data: Blood draw from that day is not back as yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Blood test, Chills, Crying, Feeling abnormal, Hypoaesthesia, Hypoxia, Opisthotonus, Paralysis, Peripheral coldness, Speech disorder, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received HPV vaccination. She then went into blood drawing area to have blood checked for anemia. This was 45 min after vaccination. All was going well and then she felt odd, hands went numb, became temporarily paralyzed, could not move arms and difficult time speaking all the time alert to what was going on. She became ice cold, blood would no longer flow, she was eased to the floor, and then became very distraught with her inability to move arms, arched back, shivered. She did not lose bladder control, did not become diaphoretic as I would expect with a vasovagal response, she did lose partial memory for some of the event but was able to relay my phone number to the phlebotomist who called me, her father and a physician. Ambulance was already called and arrived just as I arrived, because she was not responding to regular supportive measures. After one hour of stable vitals she was able to sit up, and after 90 mins she was no longer orthostatic and she was able to leave the clinic. I was called to the blood draw clinic at 12:48 PM. It took 90 mins for patient to be able to stand and get food, fluids etc. Phlebotomist did complete her draw with no vagal reaction to this second attempt. We left the clinic, got light lunch, fluids, and after 2.5 hours she was safe to drive home. She followed me. She slept for two hours that afternoon and seems to have no more adverse affects. I suspected a vagal response and she insisted she had blood drawn before and this has never happened, and the paralysis of her hands and arms she found spooky, and terrifying. She had numbness of her hands but no peri-oral numbness until she began to come around and then became weepy. She responded to attention, but her extremities were quite cold, hypoxic appearing, yet she was not seen to hyperventilate or hypoventilate. The ambulance took a biox, I do not have that report, the ambulance also took vitals and I was told they were stable. I am a physiatrist and I was most concerned about learning if she had fallen and hit her head. I was assured she had not. I am also an acupuncturist and needled GV 27 a point used in acute syncope, and HT 7, used for anxiety, my presumptive dx at the time was still vasovagal reaction. She responded became more alert and less anxious. Her color improved but as I said it took 90 minutes before she could hold her head up without being symptomatic. Although I suspected a vagal response she insisted it was not, and my wife, not a physician, read the patient education literature from the physician''s office and proposed to me, this evening, that this may have been an adverse reaction. I decided to read the material myself and I am inclined to agree with her. At the very least we do not intend to give her the second dose of HPV. The paralysis was the feature most disturbing to my daughter and not what I would expect with either hyperventilation or vasovagal reaction. I see both in clinic with some frequency and this episode just did not fit, yet I led myself to believe this was all that had taken place. My daughters insistence that she knows what it is like to faint and this was very different, leads me to believe this was an adverse reaction. She has returned to college and has no complaints now.

VAERS ID:306957 (history)  Vaccinated:2008-03-07
Age:50.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-10, Days after onset: 1
Location:Minnesota  Entered:2008-03-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor; Fasomax
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: "No adverse event"

VAERS ID:307033 (history)  Vaccinated:2008-03-07
Age:13.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 5
Location:Washington  Entered:2008-03-13, 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: ADD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2538AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1503U SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 5 cm diameter area of swelling and erythema just inferior to Varivax injection site- O.U to eval 3/10/08. No Rx-thought to be local reaction.

VAERS ID:307040 (history)  Vaccinated:2008-03-07
Age:4.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Unknown  Submitted:2008-03-11, Days after onset: 2
Location:Texas  Entered:2008-03-13, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rash
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2157AA3UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01263UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0287U1UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1184U1UNRL
Administered by: Private     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash on left leg.

VAERS ID:307041 (history)  Vaccinated:2008-03-07
Age:69.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-10, Days after onset: 2
Location:South Carolina  Entered:2008-03-13, 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: None
Preexisting Conditions: Allergies: Cox II Inhib; Crestor; Sulfa. Dx: DJD; Chronic back pain; OA; hyperlipid
Diagnostic Lab Data: CPK and CMET checked on 3/10/2008.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURERA002B IMLA
Administered by: Private     Purchased by: Other
Symptoms: Blood creatine phosphokinase, Cardiac stress test, Erythema, Induration, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Severe erythema to left arm and induration about 14cm in diameter. Lower extremities with pain on palpation of muscles. Starting 3/7/08. Treatment Solumedrol 125mg IM; Medrol dose pack; Xyzal Rx; Zantac and Benadryl starting 3/10/2008.

VAERS ID:307078 (history)  Vaccinated:2008-03-07
Age:30.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-07, Days after onset: 0
Location:Virginia  Entered:2008-03-14, 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: Rocephin 2 grams IM
Current Illness: Cellulitis
Preexisting Conditions: None
Diagnostic Lab Data: Cellulitis right hand; Tdap and Rocephen given.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient BF was given IM Tdap at 1750, then Rocephin 2 grams IM at 1825. At approximately 1850 patient reported having itching/redness/hives. Patient was given 0.3cc EPL 1:1000 SC/Benadryl 50mg IM/Solu-Medrol 250 IV mixed with 500cc NS (IV). 4L 02 via nasal cannula and transported to ER.

VAERS ID:307099 (history)  Vaccinated:2008-03-07
Age:2.0  Onset:2008-03-14, Days after vaccination: 7
Gender:Male  Submitted:2008-03-14, Days after onset: 0
Location:Idaho  Entered:2008-03-14
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 BIOLOGICALSAC14B062AA1IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0642R1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR0A1691IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458920IMRL
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen area approximately 1.5cm in diameter, multiple areas on left and right legs. Patient''s mom called in adverse reaction 7 days after vaccines were administered. Cold compresses and use Tylenol and Benadryl were instructed for treatment.

VAERS ID:307136 (history)  Vaccinated:2008-03-07
Age:44.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 6
Location:Virginia  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: no allergies, diabetes
Diagnostic Lab Data:
CDC Split Type: VA005
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Lip swelling, Pruritus, Rash, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Client states around 9:30 that evening she had an outbreak of rash, itching starting on her hands & then all over body. Stated had swollen lips & had a hard time breathing when lying down. Used inhaler & Benadryl. Had swollen chin this am. Also states she ate shrimp last night.

VAERS ID:307139 (history)  Vaccinated:2008-03-07
Age:25.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-14, Days after onset: 5
Location:New Hampshire  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: 2 weeks post mono-like illness
Preexisting Conditions: PMH: possible cystic ovaries; anxiety; depressions; hyperlipidemia; resected prolactinoma 6/07; hypothyroidism.
Diagnostic Lab Data: MRI showed myofascitis. WBC 25 with bands. LABS: WBC 28,000. MRI of right arm revealed myofasciitis. Blood c/s neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1344U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Cellulitis, Chills, Differential white blood cell count abnormal, Headache, Injection site erythema, Injection site pain, Myofascitis, Nausea, Night sweats, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal, Oral intake reduced, Pain in extremity, Pharyngolaryngeal pain, Pyrexia, Tonsillar disorder, Vaccination complication, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Myelodysplastic syndrome (broad)
Write-up: Onset redness, exquisite pain over site of vaccination. Fever, chills, WBC 25 with bandemia. 5/1/08 Reviewed hospital medical records for 3/11-3/12/2008. FINAL DX: cellulitis right deltoid s/p immunization Records indicate patient experienced fever, nausea, chills, soaking night sweats, reduced oral intake, rigors, pounding HA & arm pain after multiple vaccinations in preparation for foreign travel. No reaction to prior vaccinations. Had sore throat x 1 week prior to vaccinations w/tonsillar exudate. Seen in ID clinic on day of admission. Improved & d/c to home on continued oral antibiotics.

VAERS ID:307141 (history)  Vaccinated:2008-03-07
Age:5.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-14, Days after onset: 6
Location:Washington  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: allergic rhinitis and right otitis media
Preexisting Conditions: allergic rhinitis
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA034223IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1312U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt was given a DTaP vaccination in his right deltoid. When the patient arrived home his right upper arm was hot, hard, red and swollen. On 3/8/08 his mother took him the ER (because it was a Saturday) to be checked because the swelling and redness was not subsiding. ER provided no treatment on their visit stating it was a normal reaction to a vaccine. I phoned the mother on 3/10/08 to follow up and was told that his arm was still swollen and uncomfortable. We recommended hot packs to the arm to help encourage absorption of fluid in his arm. He was seen today 3/14/08 in our office. His arm is still somewhat red and warm. Pt complains of itchiness and slight tenderness. There were no systemic reactions reported.

VAERS ID:307203 (history)  Vaccinated:2008-03-07
Age:59.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-11, Days after onset: 2
Location:California  Entered:2008-03-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pt consent specifies positive PPD in the past.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1823U0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had swelling, redness and itchiness at injection site. Injection site located left rear arm SQ. Pt noticed redness and mild pain on scale 3 on 3/8/08 Redness and swelling mild to moderate from site to elbow.

VAERS ID:307320 (history)  Vaccinated:2008-03-07
Age:1.1  Onset:0000-00-00
Gender:Female  Submitted:2008-03-15
Location:California  Entered:2008-03-18, 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: 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 BIOLOGICALSAHAVB216A0UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF215AB3UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458933UNLL
Administered by: Other     Purchased by: Other
Symptoms: Induration, Skin nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Lt thigh 1 cm firm, mobile, NT lump; no redness, FROM on hip and knee; pt walks alone.

VAERS ID:307323 (history)  Vaccinated:2008-03-07
Age:11.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-10, Days after onset: 2
Location:Texas  Entered:2008-03-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cefzil
Current Illness: Sinusitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0963U0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Fatigue, Induration, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Fever to 103, extreme fatigue. Significant pain in posterior upper arm. Swelling, redness, induration of most of upper posterior arm.

VAERS ID:307332 (history)  Vaccinated:2008-03-07
Age:10.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-10, Days after onset: 1
Location:North Carolina  Entered:2008-03-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Swelling and redness~DTaP (no brand name)~5~4~In Patient
Other Medications:
Current Illness: right otitis externa
Preexisting Conditions: Eczema-not active now
Diagnostic Lab Data:
CDC Split Type: NC08033
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB215AA0IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1587U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Blister, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 4x3 inch reaction of redness with 1inch of vesicles. Follow up with progress and recheck if not improving.

VAERS ID:307363 (history)  Vaccinated:2008-03-07
Age:18.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-12, Days after onset: 4
Location:Ohio  Entered:2008-03-19, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lo Ovral; Prozac; Nortriptyline; HC1
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0042U0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Confusional state, Dizziness, Erythema, Feeling abnormal, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: At 4:30PM on 3/7/08, patient experienced dizziness, slight confusion and "fogginess". At 7:00PM on 3/7/08 patient related "itching and redness all over". She took a dose of oral Benadryl that evening and was able to sleep. On 3/12/08 itching and generalized redness is still present, concentrating at the knee area.

VAERS ID:307514 (history)  Vaccinated:2008-03-07
Age:0.1  Onset:0000-00-00
Gender:Female  Submitted:2008-03-19
Location:Alabama  Entered:2008-03-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit A: Inj. 5000u. Wed, Thurs, Fri; Multivitamin 0.5 ml q day
Current Illness: None
Preexisting Conditions: Pre-term infant
Diagnostic Lab Data: No test ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: No adverse effects; Examined by Dr.

VAERS ID:307521 (history)  Vaccinated:2008-03-07
Age:41.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-03-20, Days after onset: 11
Location:Indiana  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0218U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Malaise, Pruritus, Swelling face, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Teacher was given the vaccine on Friday 3/7/08 at 3:00pm by late Friday night to early Saturday morning teacher awoke not feeling well had a very itchy throat. By late Saturday early Sunday the right side of her face was red puffy and itchy. On Monday morning I saw the teacher she told be about the the symptoms/ reaction she had over the weekend. I observed a red splotch in my opinion a hive on her face under her right eye. She stated that the splotch itched. I spoke with her at the end of the day she stated that the swelling was getting better, but she was still very itchy. I advised her to take some Benadryl once she got home. I spoke with the teacher again on Tuesday she stated that the Benadryl had helped and the red spot was gone. I spoke with the health dept. about the possible reaction and they advised against future inoculation.

VAERS ID:307557 (history)  Vaccinated:2008-03-07
Age:13.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 12
Location:Alaska  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0187U2UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site swelling, Oedema peripheral, Pruritus, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Left arm looked normal until a couple of days after vaccination, became swollen, slight raised, red, goose bumps with white dots on left deltoid where shot was given. No shortness of breath, arm itching. Applied Benadryl cream to arm, it helped with the itching, used for three to four days. Raise bumps is still there according to Mother on 3/20/2007 Watch for shortness of breath, see MD is arm becomes worse or bump does not go away. Warm packs and Benadryl cream to left deltoid arm. PHN RN

VAERS ID:307629 (history)  Vaccinated:2008-03-07
Age:20.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-19, Days after onset: 11
Location:Unknown  Entered:2008-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN
Current Illness:
Preexisting Conditions: Syncope; Immunisation; Anaesthesia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01774
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness, Pallor
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Information has been received from a certified nurse midwife concerning a 20 year old female with a history of syncope after unspecified vaccinations and anaesthesia who on 07-MAR-2008 was vaccinated IM with a first dose of GARDASIL (lot # 659665/1486U). Concomitant therapy included ORTHO TRI-CYCLEN. On 07-MAR-2008, right after vaccination, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure." The nurse brought in smelling salt and the patient "came back." The nurse did not let the patient leave the office for 2 hours. Later that day, the patient''s mother took her to the emergency department to check for any neurological problems and everything came back normal. The patient was not admitted. At the time of the report, the patient had improved. Upon internal review, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure" was considered to be an other important medical event. Additional information has been requested.

VAERS ID:307706 (history)  Vaccinated:2008-03-07
Age:20.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-07, Days after onset: 0
Location:New York  Entered:2008-03-21, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vits
Current Illness: Pregnancy EDC 10/27/08
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2461CA0IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA0IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1956DA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Malaise, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Immediately after vaccines given pt c/o not feeling well and pale, non-responsive, placed on floor O2 via mask 10L administered and pulse ox 99, glucose 82, BP 130/80, P 92. Pt responsive. Epipen 0.3mg IM LT, Benadryl 50mg IM RT, BP 116/70. Ambulance transported and pt to respond for evaluation.

VAERS ID:307947 (history)  Vaccinated:2008-03-07
Age:1.6  Onset:2008-03-16, Days after vaccination: 9
Gender:Male  Submitted:2008-03-17, Days after onset: 1
Location:Maine  Entered:2008-03-24, 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: None
Current Illness: None
Preexisting Conditions: Tongue tied
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA3UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2437AA0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1325F0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1762U0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient received DTaP, MMR and VARIVAX flu on 03/07/08 and had a febrile seizure 3/16/08.

VAERS ID:307956 (history)  Vaccinated:2008-03-07
Age:13.0  Onset:2008-03-17, Days after vaccination: 10
Gender:Female  Submitted:2008-03-20, Days after onset: 3
Location:Michigan  Entered:2008-03-24, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: X-ray of shoulder and elbow; CRP; Sed rate; CBC with diffi; Urine analysis; ANA; RF; Anti-DNA and Antiribonucleo protein
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, DNA antibody, Full blood count, Musculoskeletal pain, Raynaud's phenomenon, Red blood cell sedimentation rate, Rheumatoid factor, Urine analysis, X-ray limb
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad)
Write-up: (1) Raynaud Phenomenon left hand on 3-17-08 (2) Pain (L) elbow- 3-15-08 on 3-16-08 (3) Pain (L) shoulder 3-20-08

VAERS ID:307958 (history)  Vaccinated:2008-03-07
Age:1.2  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-14, Days after onset: 6
Location:Michigan  Entered:2008-03-24, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Qvar
Current Illness: none
Preexisting Conditions: total anomalous pulmonary venous return
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499172IMLL
Administered by: Private     Purchased by: Private
Symptoms: Balance disorder, Dizziness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: On evening of immunization developed fever of 104.3, seemed, dizzy and off balance. Resolved by 3-10-08

VAERS ID:307975 (history)  Vaccinated:2008-03-07
Age:1.0  Onset:2008-03-16, Days after vaccination: 9
Gender:Female  Submitted:2008-03-24, Days after onset: 8
Location:Georgia  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None
Preexisting Conditions: Increased platelet count at 9 month and 12 month checkups
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB516BA3IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1565U0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient presented with 7cm x 7cm area of swelling and extreme tenderness to left lateral thigh with 3cm x 3cm area of centered erythema. Seen in pediatrician''s office for symptoms 10 days after injections. Patient given Ceftriaxone q day for 3 days and Clindamycin for 10 days.

VAERS ID:308686 (history)  Vaccinated:2008-03-07
Age:  Onset:2008-03-08, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:Unknown  Entered:2008-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Zoster (Zostavax)~~61~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 24 hours after vaccine, red patch 2" x 1". Next day it was about 2" x 6 or 7 inches - hot - itchy. Doctor gave me Domeboro to use twice a day along with Vanos 2 times a day.

VAERS ID:308859 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-03-14, Days after vaccination: 7
Gender:Female  Submitted:2008-04-03, Days after onset: 20
Location:Kentucky  Entered:2008-04-03
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: PMH: none. NKDA.
Diagnostic Lab Data: Reduction of intussusception by air contrast enema. Labs and Diagnostics: Abdominal X-ray with mild stool load and non-obstructive bowel pattern. CXR WNL. Air Contrast Barium enema (+) for ileocolic Intussusception. Head CT (+) for sinus disease. CBC, UA, Chemistry unremarkable except Alk Phos 308. urine drug screen (-). Urine, stool and nasal cx (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B141AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351721IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1195U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Barium double contrast, Blood alkaline phosphatase increased, Chest X-ray normal, Culture stool negative, Culture urine negative, Drug screen negative, Full blood count normal, Haematemesis, Haematochezia, Intussusception, Laboratory test abnormal, Lethargy, Mucous stools, Muscle spasticity, Scan brain, Somnolence, Tremor, Unresponsive to stimuli, Urine analysis normal, Vomiting
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad)
Write-up: 03/14/2008 ileocolic intussusception reduced by air contrast enema at Hospital. Admitted for observation and discharged home the following day. 4/23/2008 MR received for DOS 3/14-15/2008 with D/C DX: Intussusception. Infant presented to ER with somnolence/unresponsiveness following an episode of vomiting milk. Pt also had a spastic/shaking episode with bloody emesis and bloody/mucusy stool. PE (+) for lethargy and bloody stool in diaper. IS reduced by Air contrast Barium enema and d/c home next day.

VAERS ID:309106 (history)  Vaccinated:2008-03-07
Age:0.4  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-04-08, Days after onset: 30
Location:Utah  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF237AD1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575401IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye swelling, Lethargy, Listless, Rash generalised, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Red rash developed all over her body, minor swelling in the eyes and tongue, listlessness and lethargy. Patient was aken to the emergency room where she was given Benadryl and observed for several hours.

VAERS ID:309520 (history)  Vaccinated:2008-03-07
Age:0.6  Onset:0000-00-00
Gender:Female  Submitted:2008-03-13
Location:Utah  Entered:2008-04-15, Days after submission: 33
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~~0~In Patient|none~ ()~~0~In Sibling|none~ ()~~0~In Sibling
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB215AA0UNRL
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: None. Hep A given to 7 mo old by mistaken ID.

VAERS ID:309663 (history)  Vaccinated:2008-03-07
Age:0.2  Onset:2008-04-02, Days after vaccination: 26
Gender:Male  Submitted:2008-04-11, Days after onset: 9
Location:Colorado  Entered:2008-04-16, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 5/6/08-records received-PMH: fetal alcohol syndrome. cocaine affecting fetus or newborn via placenta.
Diagnostic Lab Data: Abscess drained in hospital 5/6/08-records received-Needle aspirated 1/2cc of yellowish pus gram positive cocci identified as staph aureus (MSSA). Blood culture no growth. WBC 26.77, CRP 1.7. MRI showed severe myositis primarily involving vastus intermedius but no distinct fluid collection.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B141AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF183AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631110IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Abscess drainage, Aspiration biopsy, C-reactive protein increased, Debridement, Exostosis, Injection site swelling, Myositis, Nuclear magnetic resonance imaging abnormal, Oral intake reduced, Staphylococcus identification test positive, Staphylococcal skin infection, Ultrasound scan abnormal, Urine output decreased, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad)
Write-up: Myositis (L) leg - (L) Lower thigh - + staph aureus. S to all but PCN. 5/6/08-reecords received for DOS 4/7-4/11/08-DC DX: Left thigh myositis abscess. Six days prior to admission unable to straighten left leg, swelling noted in left thigh. Decreased oral intake and decreased urinary output. 4/2/08 diagnosed with Caffey''s disease. Treated as outpatient. Admitted to another facility for ultrasound showed fluid collection. Surgical intervention debridement.

VAERS ID:309691 (history)  Vaccinated:2008-03-07
Age:3.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 3
Location:Idaho  Entered:2008-04-16, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bactroban
Current Illness:
Preexisting Conditions: Eczema; Alopecia Areata
Diagnostic Lab Data: None
CDC Split Type: ID08014
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225CA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351712IMRL
Administered by: Private     Purchased by: Public
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow)
Write-up: Erythema multiforme.

VAERS ID:310318 (history)  Vaccinated:2008-03-07
Age:0.5  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-04-14, Days after onset: 37
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01767
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0969U1PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Information has been received from a registered nurse concerning a 6 month old male who on 15-NOV-2007 and 07-MAR-2008 was vaccinated PO with his first and second doses or ROTATEQ. No adverse reactions were reported. There was no product quality complaint. Additional information has been requested.

VAERS ID:310431 (history)  Vaccinated:2008-03-07
Age:14.0  Onset:2008-03-09, Days after vaccination: 2
Gender:Female  Submitted:2008-04-14, Days after onset: 35
Location:Pennsylvania  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01405
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
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)
Write-up: Information has been received from a physician concerning a 14 year old female who on 07-MAR-2008 was vaccinated with GARADASIL (lot# not reported). On 09-MAR-2008 the patient fainted. The patient''s outcome was not reported. Additional information has been requested.

VAERS ID:310804 (history)  Vaccinated:2008-03-07
Age:24.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-18
Location:Texas  Entered:2008-04-24, 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: No
Preexisting Conditions: No PMH: smoker. flu like symptoms 2 wks prior. Alcohol daily.
Diagnostic Lab Data: cath, Holter monitor and echo LABS: CPK 900, CKMB 75, troponin 10 as reported from outlying ER. Cardiac cath WNL. EKG w/ST elevations & Q waves. Echocardiogram WNL. WBC 11.5 (H), H/H 13.6/33.8 (L), lymphs 16% (L). Chemistry WNL. CT of chest & CXR WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS 0UNUN
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0 UN
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Catheterisation cardiac normal, Chest X-ray normal, Chest discomfort, Chest pain, Computerised tomogram normal, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Electrocardiogram ambulatory, Haematocrit decreased, Haemoglobin decreased, Laboratory test normal, Lymphocyte percentage decreased, Myocarditis, Troponin increased, Vaccination complication, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Vaccinated with the Smallpox "1st week in March" chest pn started 2 weeks later. Pt hospitalized hospital 22 Mar 08. Dx Myocarditis. 4/25/08 Reviewed hospital medical records for 3/29-3/31/2008. FINAL DX: none provided, no d/c summary available. Cardiac consult states probable myocarditis secondary to smallpox vaccine. Records reveal patient experienced chest pain, EKG changes & troponin elevation at outlying ER. Patient had substernal chest pain & tightness x 4 days. Transferred here for cardiac cath.

VAERS ID:310918 (history)  Vaccinated:2008-03-07
Age:24.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-04-24, Days after onset: 47
Location:Florida  Entered:2008-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 2/15/2008); Drug hypersensitivity; Papilloma viral infection
Preexisting Conditions: Papanicolaou smear abnormal
Diagnostic Lab Data: cervical smear 02/28/08 - abnormal showed atypical cell; serum HPV 18 02/28/08 - positive high risk as per lab results
CDC Split Type: WAES0803USA02837
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy, Human papilloma virus test positive, Smear cervix abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Initial and follow up information has been received from a health professional for Merck Pregnancy Registry, concerning a 24 year old female patient who had an allergy to aspirin and had an abnormal cervical smear on 28-FEB-2008 which showed atypical cells. Patient was positive for human papilloma virus (exact stain was not known). On 07-MAR-2008 she was vaccinated IM with her first dose of GRADASIL (lot # 655504/0052X). It was reported that there was no concomitant medication. The home pregnancy test showed that the patient was pregnant. The medical assistant mentioned that the patient was going to have an office visit on 18-Mar-2008. In follow up information from the doctor''s office it was reported that her last menstrual period was 15-FEB-2008 and expected delivery date would be 21-NOV-2008. On 23-MAR-2008 patient had an elective abortion which was five weeks after the LMP. The outcome of the event was unknown. Upon internal review elective termination of pregnancy was determined to be an other important medical event. Additional information is not expected.

VAERS ID:311013 (history)  Vaccinated:2008-03-07
Age:1.3  Onset:2008-04-10, Days after vaccination: 34
Gender:Male  Submitted:2008-04-16, Days after onset: 6
Location:Illinois  Entered:2008-04-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Croup
Preexisting Conditions: None PMH: OM & URI 3/2007. NSVD w/o complications. Family hx: celiac disease
Diagnostic Lab Data: MRI''s of spine LABS: outpatient x-rays of hip, thoracic & lumbar spine WNL. Brain MRI WNL. Cervical spine MRI abnormal & c/w transverse myelitis. Thoracolumbar spine MRI WNL. CBC WNL. Plts 543 (H). BUN 22 (H), creat 0.3 (L), anion gap 15 (H). LDH 245 (H). Uric acid 3.0 (L). Visual evoked potentials WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0874U2IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1259U0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Anion gap increased, Areflexia, Asthenia, Blood creatinine decreased, Blood lactate dehydrogenase increased, Blood urea increased, Blood uric acid decreased, Computerised tomogram abnormal, Dysstasia, Full blood count normal, Haematochezia, Hypotonia, Lymphocyte percentage increased, Muscular weakness, Myelitis transverse, Neutrophil percentage decreased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Paraplegia, Platelet count increased, Sensory loss, Spinal X-ray, Spinal cord disorder, Spinal cord oedema, Visual evoked potentials normal, X-ray of pelvis and hip normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow)
Write-up: Loss of lower extremity strength, cervical spinal cord inflammation, possible myelitis. 5/16/08 Reviewed hospital medical records for 4/16-4/21/2008. FINAL DX: myelitis transverse Records reveal patient experienced bilateral leg weakness as noted from transferring hospital. Continued IV steroids & then tapering oral steroids. Improved & D/C to home f/neuro f/u & continued outpatient PT. 4/29/08 Reviewed hospital medical records for 4/14-4/16/2008. FINAL DX: lower paraplegia; lower cervical intramedullary swelling. Records reveal patient experienced falls w/o being able to get up x 4 days. Was able to crawl. Seen by PCP who suspected left knee injury. Referred to ortho who suspected hip injury. Was to f/u next week but no improvement & was unable to stand. Noted to have bloody stool & returned to PCP. Referred to neuro who admitted. On exam, good strength in UEs & flaccid LEs. Areflexic & sensation decreased. Anal sphincter tone & reflex weak. CT scan of spine revealed edema from C3 through T1. Tx w/high dose steroids. Transferred to higher level of care.

VAERS ID:311651 (history)  Vaccinated:2008-03-07
Age:15.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Minnesota  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: triamincinolone, naproxen
Current Illness: no
Preexisting Conditions: none known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Fever, chills nausea since two hours after receiving the Gardasil shot x3 days ago.

VAERS ID:311996 (history)  Vaccinated:2008-03-07
Age:61.0  Onset:2008-03-09, Days after vaccination: 2
Gender:Female  Submitted:2008-05-09, Days after onset: 60
Location:Pennsylvania  Entered:2008-05-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Active Problems Anserine Bursitis (726.61) Central Hearing Loss Mar 25 2004 12:00AM (389.14); CENTRAL HEARING LOSS Dyshidrosis (705.81) Esophageal Reflux Jun 22 2004 12:00AM (530.81); ESOPHAGEAL REFLUX Hypercholesterolemia Mar 25 2004 12:00AM (272.0); PURE HYPERCHOLESTEROLEM Hypothyroidism Aug 4 2003 12:00AM (244.9); HYPOTHYROIDISM NOS Iron Deficiency Aug 12 2004 12:00AM (280.9); IRON DEFIC ANEMIA NOS Menopause Aug 4 2003 12:00AM (627.2); SYMPT MENOP/FEMALE CLIMACTERIC STATES Migraine Headache (Ophthalmoplegic) (346.80) Need For Prophylactic Antibiotics (V07.8); * prior to dental visits dur to R TKR, 14 Jul 2007 Obesity Jun 19 2006 12:00AM (278.00); OBESITY NOS Osteoarthrosis Aug 9 2004 12:00AM (715.90); OSTEOARTHROS NOS * knees,hips,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1874U3SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt. received Zostavax 0.65 ml subcutaneously in left upper arm on 3/7/08. On 3/9/08 she presented to her LMD with the following HPI extracted from her chart, " Patient comes to the clinic today with possible cellulitis to her left upper arm. She received a Zostavax two days ago. She noticed redness and swelling yesterday. the area is warm and raised. She denies fever, chills, sweats, or SOB." Physician actions are as follows: "Assessment Cellulitis (682.9); left upper extremity, site of vaccine- Zostavax Orders Cephalexin 500 MG Capsule;TAKE 1 CAPSULE EVERY 12 HOURS DAILY; Qty14; R0; Rx. Plan 1. Monitor area for further signs of infection as discussed. Increased redness, swelling, pain, fever or yellow green discharge. 2. Follow up as scheduled. Coun/Edu Patient is encouraged to call with any questions or concerns.

VAERS ID:312753 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 67
Location:Pennsylvania  Entered:2008-05-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA02255
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician and a registered nurse concerning an active infant female who in March 2008, was vaccinated PO with a dose of ROTATEQ (no lot# available). In 2008, the patient experienced diarrhea. The physician added that the patient had non-bloody diarrhea, no vomiting and no fever. The patient sought unspecified medical attention. subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.

VAERS ID:313592 (history)  Vaccinated:2008-03-07
Age:10.0  Onset:2008-03-09, Days after vaccination: 2
Gender:Female  Submitted:2008-05-16, Days after onset: 67
Location:North Carolina  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01460
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1587U1UN 
Administered by: Other     Purchased by: Other
Symptoms: Blister, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 10 year old female with no medical history or allergies, who on 07-MAR-2008 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck) (lot# 659430/1587U). There was no concomitant medication. On 09-MAR-2008, the patient developed a large erythematous area approximately 4X4 inches that had a vesicle in the middle. It was reported that there were no other symptoms. It was also reported that the patient went to the office. No diagnostic laboratory studies were performed. The patient''s large erythematous area persisted. No product quality was involved. Additional information has been requested.

VAERS ID:314989 (history)  Vaccinated:2008-03-07
Age:0.2  Onset:2008-03-26, Days after vaccination: 19
Gender:Male  Submitted:2008-06-05, Days after onset: 71
Location:Florida  Entered:2008-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: CONGESTION
Preexisting Conditions: NONE
Diagnostic Lab Data: 03/26/08 ULTRASOUND DONE AND 03/27/08 GASTROGRAFIN ENEMA DONE WHICH REVEALED AN INTUSSUSEPTION THAT COULD NOT BE REDUCED 6/19/08-records received-WBC 537, HGB 9.7, HCT 28.6, segs 69.3, lymphs 22.4. Urine 1+ protein, ketone 1+ and WBC 7-10,
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSSKB AC21B133AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURPMC UF343AD0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHWY C351700IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.MSD 0975U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Blood culture positive, Enema administration, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Laparotomy, Lymphocyte count decreased, Neutrophil percentage increased, Occult blood positive, Pallor, Protein urine present, Pyrexia, Rectal haemorrhage, Ultrasound scan abnormal, Urine ketone body present, Vomiting, White blood cell count decreased, White blood cells urine positive, X-ray normal
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad)
Write-up: 03/26/08 PRESENTED TO HOSPITAL W/ VOMITING, PALE IN COLOR, AND BRIGHT RED BLOOD IN DIAPER. LAB WORK AND IV''S DONE PRIOR TO TRANSFER TO HOSPITAL. 6/19/08-records received for DOS 3/26/08-presented to ED with C/O blood in stool, low grade fever, vomiting. Assessment: abdominal pain, vomiting, rectal bleeding. Transferred. 6/24/08-records received for DOS 3/26-3/27/08- DX: Intussusception. Vomiting began day prior to admission. Surgery laparotomy reduction of intussusception.

VAERS ID:316835 (history)  Vaccinated:2008-03-07
Age:20.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 97
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0805USA02060
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypokinesia, Injected limb mobility decreased, Pain in extremity, Presyncope, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse practitioner concerning a 20 year old female who on 07-MAR-2008 was vaccinated IM with the first dose of GARDASIL (659964/1978U). Per the reporter, the patient experienced extreme pain in her arm after receiving the first dose of GARDASIL. The pain was experienced in the same arm that the vaccine was administered and the patient noted that the pain made it difficult for her to move her arm. It was also noted that the patient nearly fainted at the office on the day of administration and that the patient had experienced vomiting in the evening of the date of administration. The patient sought unspecified medical attention in the physician''s office. Subsequently, the patient recovered from her extreme pain, decreased mobility, near fainting and vomiting. No further information was provided. Additional information has been requested. Additional information received from B-form (03-JUN-2008). The nurse practitioner reports that the patient received the second dose of GARDASIL vaccine (lot # not reported) on 09-MAY-2008. No further information on patient''s present status was provided. Additional information is not expected.

VAERS ID:317573 (history)  Vaccinated:2008-03-07
Age:4.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-05-30, Days after onset: 83
Location:Ohio  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Sulfonamide allergy
Preexisting Conditions: Premature birth
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01281
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2765AA4UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA0UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ05483UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1310U1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1790U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Pain, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 4 year old male with asthma, no allergies, and a history of a twenty-seven week gestational birth, who on 07-MAR-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant suspect therapy included a dose of varicella virus vaccine live (MSD). Other concomitant therapies included a dose of HAVRIX, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified), a dose of poliovirus vaccine inactivated (unspecified) and montelukast sodium (MSD). On 07-MAR-2008, the patient developed hives, welts, and rashes on his back that were very painful. The patient sought unspecified medical attention. It was reported that the patient had four out these five vaccines in the past. The only vaccine the patient had not had before was HAVRIX. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. 05/29/09 This is in follow-up to report(s) previously submitted on 5/30/2008. Follow-up information received 13-MAY-2008: On 07-MAR-2008 at 14:00 hours the patient was vaccinated subcutaneous in the "L" with a second dose of MMR II (lot# 656949/1310U) and subcutaneous in the "R" with a second dose of VARIVAX (Oka/Merck) (MSD) (lot # 659932/1790U). The patient has an allergy to BACTRIM. On 07-MAR-2008 at 17:00 hours the patient developed a rash on the face, neck and arms for 7 days with an itch that was diagnosed as urticaria. The patient was treated with BENADRYL as needed. On 17-MAR-2008 the patient recovered from hives, welts and rashes on the back, face, neck and arms that itched. Additional information has been received from a physician concerning a 5 year old male with asthma and allergies, who on 07-MAR-2008, two to three hours after vaccinations, experienced rash on face, arms and neck, with itching and was diagnosed with urticaria. The patient recovered within one week. There was no illness at time of vaccination. Suspect therapy included the second dose of VARIVAX (MSD), the fifth dose of DAPTACEL (lot # C2765AA) in the left deltoid, the fourth dose of IPOL (lot # Z0548) in the right deltoid and the first dose of HAVRIX (lot # AHAVB253AA) in the left deltoid. Additional information is not expected.

VAERS ID:317403 (history)  Vaccinated:2008-03-07
Age:1.0  Onset:2008-03-18, Days after vaccination: 11
Gender:Male  Submitted:2008-03-19, Days after onset: 1
Location:Texas  Entered:2008-06-25, Days after submission: 98
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA3IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458943IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1655U0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: RED RESILD MIST RASH THAT STARTED ON FOREHEAD & EARS ON 3/18/08. AS OF 3/19/08 RASH NOW IS ON HEAD, NECK, FACE, TORSO, BACK GROIN, ARMS & LEGS.

VAERS ID:318761 (history)  Vaccinated:2008-03-07
Age:14.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-11, Days after onset: 125
Location:North Carolina  Entered:2008-07-11
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: childhood kidney condition
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.758U1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, Pain, Pyrexia, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: On 12-14-07 pt received 1st HPV dose and parent noted flu like s/s. On 3-7-08 pt recevied 2nd HPV dose and parent noted fever 101, nausea, body aches, dizziness, and h/a lasting for two days.

VAERS ID:318957 (history)  Vaccinated:2008-03-07
Age:20.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-08, Days after onset: 122
Location:Idaho  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: Midrin; Indocin (Indomethacin sodium)
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA04016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U2IMUN
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Initial information and follow up has been received from a nurse concerning a patient who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). The patient received the second dose of GARDASIL (lot# not reported) 7 months after the first dose. On 07-MAR-2008 the patient received the third dose of GARDASIL (lot# 659180/1758U) (9 1/2 months after the first dose). Concomitant therapy included MIDRIN and INDOCIN. The patient''s outcome was not reported. The patient has been notified of need to repeat dose #3. Additional information has been requested.

VAERS ID:319260 (history)  Vaccinated:2008-03-07
Age:  Onset:2008-03-10, Days after vaccination: 3
Gender:Female  Submitted:2008-06-24, Days after onset: 106
Location:Unknown  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: WAES0803USA02155
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes simplex
SMQs:
Write-up: Information has been received from a physician concerning his female nurse who on approximately 07-MAR-2008 or 08-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 10-MAR-2008 the patient experienced an outbreak of herpes simplex virus (HSV-1). At the time of the report the patient''s status was unknown. Additional information has been requested.

VAERS ID:319268 (history)  Vaccinated:2008-03-07
Age:63.0  Onset:2008-03-11, Days after vaccination: 4
Gender:Female  Submitted:2008-06-24, Days after onset: 105
Location:Missouri  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: FOSAMAX; aspirin; ZETIA; flaxseed; AVAPRO; PREVACID; metformin; TOPROL XL TABLETS; omega-3 marine triglycerides; ACTONEL; CRESTOR
Current Illness: Diabetes; Hyperlipidaemia; Hypertension; Gastrooesophageal reflux disease
Preexisting Conditions:
Diagnostic Lab Data: VZV strain 03/13/0/08 - VZV WILD TYPE STRAIN
CDC Split Type: WAES0803USA01905
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Rash, Viral DNA test positive
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician and a pharmacist concerning a 63 year old female consumer with no known drug allergies, diabetes, hypertension, Gastrooesophageal reflux disease and hyperlipidaemia who on 07-MAR-2008 was vaccinated SQ in the left deltoid with 0.65mL (also reported as 0.5mL) of zoster vaccine live (Oka/Merck) (lot # "01429U"). Concomitant therapy included PREVACID, AVAPRO, TOPROL XL TABLETS, ezetimibe (MSD), alendronate sodium (MSD), CRESTOR, ACTONEL, metformin, flaxseed, fish oil and aspirin. Subsequently, on 11-MAR-2008 the patient had shingles symptoms. She had a shingles-like rash with no vesicles. There are 3 patches which were red and raised on her left, mid-lower back near T-11. It was also reported as "the patient developed shingles." Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/MERCK vaccine strain. Follow-up information indicated that the patient developed 3 lesions along the T12 dermatome. The patient also developed pain (rated 3 on a scale of 0 to 10). It was also noted that there was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected and sent to the laboratory on 13-MAR-2008. The sample was taken from a lesion along the T12 dermatome location. The PCR results for the specimen taken from a lesion along the T12 dermatome location was an ADEQUATE SPECIMEN and identified the presence of WT VZV. Additional information has been requested.

VAERS ID:319271 (history)  Vaccinated:2008-03-07
Age:55.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 108
Location:Unknown  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:
Current Illness:
Preexisting Conditions: Cold sores
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01792
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Herpes simplex, Inappropriate schedule of drug administration
SMQs:
Write-up: Information has been received from a physician concerning his 55 year old wife with no known drug allergies and a history of cold sores who on 07-MAR-2008 or 08-MAR-2008 was vaccinated SQ with one dose of 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included hormone replacement therapy (unspecified manufacturer/brand). Subsequently, on 11-MAR-2008 the patient experienced an outbreak of herpes simplex virus (HSV-1). The physician does not think the vaccine is related to her symptoms. Medical attention was sought, the physician was called. There were no lab studies performed. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:320396 (history)  Vaccinated:2008-03-07
Age:15.0  Onset:2008-04-15, Days after vaccination: 39
Gender:Female  Submitted:2008-07-24, Days after onset: 100
Location:Pennsylvania  Entered:2008-07-24
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: CT scan. EEG, and others 8/15/08-records received-CT scan showed mild asymmetry of ventricles, left frontal lobe single punctate lesion in white-gray matter junction in front area. EEG abnormal tracing due to generalized epileptiform disch
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1657U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Convulsion, Electroencephalogram abnormal, Epilepsy, Eye rolling, Grand mal convulsion, Somnolence
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: 4/15/08 Seizure occured at bedtime. Taken to E.D., CT scan done. 5/15/08 Seizure occured at bedtime. Taken to another Hosp. EEG showed mildly abnormal brain activity. Possibly hormonal trigger. Prescribed seizure medication, Kepra. Continues to be followed medically. 8/15/08-records received-4/21/08-The EEG was performed after one episode of generalized tonic-clonic seizure on 4/8/08. Presented to ED on 5/17/08-after seizure at home, eyes rolled back, sleepy afterward. Similar episode last month during her period. 5/22/08-neurology consult exam essentially normal. Impression: generalized epilepsy.

VAERS ID:323536 (history)  Vaccinated:2008-03-07
Age:65.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 144
Location:Pennsylvania  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: None
Current Illness:
Preexisting Conditions: Injection site swelling; Injection site erythema; Injection site warmth; Injection site rash; Drug hypersensitivity
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA02124
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a certified medical assistant concerning a 65 year old female patient with drug allergies to EFFEXOR XR, simvastatin (MSD), LIPITOR and ezetimibe (MSD), who on 07-MAR-2008 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). There was no concomitant medication. On 07-MAR-2008, the patient developed an injection site rash. The rash was described as a large, round 4X4 area of redness, was swollen, with minimal warmth to touch at the injection site. The patient called the office three days after the vaccination to report the reaction. The patient stated she received the ADACEL vaccination on 07-NOV-2007 and had an identical reaction. No diagnostic laboratory studies were performed. At the time of this report the patient recovered from the redness and warmth. The outcome of the rash and swelling was unknown. It was reported that no previous vaccination with pneumococcal 23v polysaccharide vaccine was noted. No product quality complaint was involved. Additional information has been requested.

VAERS ID:324215 (history)  Vaccinated:2008-03-07
Age:30.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2008-07-30, Days after onset: 143
Location:Utah  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pneumonia; Penicillin allergy; Anxiety; Non-smoker; Frequent headaches
Preexisting Conditions: Hysterectomy
Diagnostic Lab Data: Blood pressure 03/15/08 116/8; diagnostic procedure 03/15/08 pulse 73, respirations 14, pulse ox 98% on room air; blood pressure 03/12/08 111/8; diagnostic procedure 3/12/08 pulse 74, respirations 18, pulse ox 92% pm room air; WBC count 03/
CDC Split Type: WAES0803USA04438
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Band neutrophil count, Body temperature increased, Cellulitis, Chest discomfort, Chills, Dyspnoea, Heart rate, Influenza serology negative, Injected limb mobility decreased, Injection site erythema, Injection site pain, Oxygen saturation, Pain, Pyrexia, Red blood cell count decreased, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)
Write-up: Initial and follow up information has been received from a physician and a health professional concerning a 30 year old white female patient with a penicillin allergy, anxiety and frequent headaches, a past surgical history of hysterectomy and a noncontributory family history, negative for heart disease, cancer, stroke and diabetes. She is a nonsmoker and non drinker, who on 07-MAR-2008 at 10:00, was vaccinated into the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included KEFLEX, MOTRIN, TYLENOL and Z-PAK. Illness at the time of vaccination was pneumonia. It was reported that the patient was a resident of the facility where she received the vaccine. On 08-MAR-2008 at 08:30, the patient developed left upper extremity cellulitis after receiving the vaccine. The patient stated "the site was painful, red and she could not raise up her arm or put any pressure on it. Cellulitis spread up my arm to the top of my shoulder, down to my elbow and around my entire arm." The patient was evaluated and treated with Z-PAK, for pneumonia, at the long term care facility. On 12-MAR-2008, the patient was seen in the emergency room with complaints of chills and shortness of breath with intermittent fever. The patient completed treatment with Z-PAK on 08-MAR-2008. She was concerned about some residual right middle lobe and right lower lobe pneumonia, treated with a dose of ROCEPHIN and placed on KEFLEX. She was okay until 07-MAR-2008, but now has started back with some chills, shortness of breath and intermittent fever. She has some body aches and chest tightness. She stated that she had the pneumococcal 23v polysaccharide vaccine on 07-MAR-2008 and has now developed erythema, redness and tenderness to the area of the injection in the left upper extremity and down to her elbow. She denies vomiting. Physical exam revealed a blood pressure of 111/80, pulse 74, respiration rate 18 and temperature 36.2 with pulse oxygen of 92% on room air. She rates her pain six to seven out of ten. Med

VAERS ID:324422 (history)  Vaccinated:2008-03-07
Age:  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 144
Location:Utah  Entered:2008-08-06, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04148
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Malaise
SMQs:
Write-up: Information has been received from a health professional concerning a female staff member who on 07-MAR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). Subsequently, she developed cellulitis after receiving the vaccine. She was evaluated in a medical setting, and then admitted to the hospital where she was treated with intravenous antibiotics. She complained of generally not feeling well, which may have started prior to receiving pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). On an unspecified date, she recovered. No product quality complaint involved. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:321804 (history)  Vaccinated:2008-03-07
Age:51.0  Onset:2008-04-14, Days after vaccination: 38
Gender:Female  Submitted:0000-00-00
Location:Massachusetts  Entered:2008-08-11
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 except allergic to ampicillin
Diagnostic Lab Data: MRI, lumbar puncture, X-ray, extensive bloodwork & EMG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Neuropathy peripheral, Nuclear magnetic resonance imaging, Paraesthesia, Temperature intolerance, X-ray
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: Bilateral neuropathy. Numbing & tingling in hands & feet. Started approximately weeks after vaccination. Sensitivity to cold & heat in both hands.

VAERS ID:323022 (history)  Vaccinated:2008-03-07
Age:1.8  Onset:2008-06-01, Days after vaccination: 86
Gender:Male  Submitted:2008-08-20, Days after onset: 80
Location:Unknown  Entered:2008-08-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history and concomitant medications were not reported.
Diagnostic Lab Data:
CDC Split Type: 200802511
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURA0393 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Autism, Feeling abnormal, Purging, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Initial report received on 18 July 2008 from a consumer, who is the patient''s father. A 22 month old male patient, with no reported medical history other than autism diagnosed in 2008, received on 07 March 2008 a dose of ACT-HIB (lot number A0393). The child''s previous vaccination history included PRIORIX (GSK, lot number not reported) which was administered in January 2008. On the day of vaccination, 07 March 2008, the child developed high fever and was seen by a physician the following day. The patient received unspecified medication, but his condition further deteriorated the following day. The patient vomited and purged continuously for about 3 to 4 days and was extremely weak and "lifeless" for about two weeks following this episode. The patient also had a loss of appetite for a prolonged period (unspecified). At the time of the report, the patient''s recovery status was not reported. Follow-up information received on 11 August 2008 from a healthcare professional. Contact information for the patient''s physician was received and the physician was contacted. The physician was of the opinion that the cause of the digestive disorders presented by the child after HIB vaccination were probably due to a coincidental infection and were not related to the vaccine since gastroenteritis is very common in the country. The physician was unable to provide information on the treatment given or laboratory tests. According to the physician, the autism was diagnosed in June or July 2008 and the father, following investigation on the internet, suspected that it was related to MMR and HIB immunization. In the physician''s opinion, there was no link between the autism and immunizations.

VAERS ID:327521 (history)  Vaccinated:2008-03-07
Age:5.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-09-29, Days after onset: 205
Location:Wisconsin  Entered:2008-10-08, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0803USA01254
Vaccination
Manufacturer
Lot
Dose
Route
Site
MU: MUMPS (MUMPSVAX II)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from a licensed practical nurse concerning a 5 year old male patient who on 07-MAR-2008 was inadvertently vaccinated with a dose of MUMPSVAX instead of a dose of MMR II. There was no product quality complaint. Additional information has been requested.

VAERS ID:328748 (history)  Vaccinated:2008-03-07
Age:23.0  Onset:2008-04-25, Days after vaccination: 49
Gender:Female  Submitted:2008-10-08, Days after onset: 166
Location:Florida  Entered:2008-10-15, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None LABS: UA WNL, c/s neg. CMP WNL. T-spine x-ray WNL. LS spine abnormal & revealed lumbar spasm. Renal US neg. MRI spine 2/4/09 revealed straightening of t-spine & desiccation of intervertebral disc L4-L5.
CDC Split Type: WAES0809USA00353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Back pain, Culture urine negative, Metabolic function test normal, Muscle spasms, Musculoskeletal discomfort, Nuclear magnetic resonance imaging abnormal, Spinal X-ray abnormal, Ultrasound kidney normal, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Arthritis (broad)
Write-up: Information has been received from a 24 year old female with no pertinent medical history and no allergies who on 02-FEB-2008 was vaccinated with the first dose of GARDASIL IM 0.5ml. On 07-MAR-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5ml. On 07-AUG-2008 (reported as 08/07/2007) the patient was vaccinated with the third dose of GARDASIL IM 0.5ml. There was no concomitant medication. On 25-APR-2008 the patient experienced severe joint pain after receiving her second dose. The patient''s severe joint pain persisted. The patient sought medical attention. Additional information has been requested. 2/20/09 Received PCP medical records of 10/1/08-12/29/08. FINAL DX: none provided Records reveal patient experienced back pain, left paraspinal muscle spasms & bilateral hip pain. Tx w/meds, PT & referred for MRI.

VAERS ID:334423 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:0000-00-00
Gender:Female  Submitted:2008-11-21
Location:Michigan  Entered:2008-12-09, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF105AB/ZO8721IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08721IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413351IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1243C11PO 
Administered by: Other     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: DTAP-HIB combo given before 15 months of age. No side effects reported.

VAERS ID:337883 (history)  Vaccinated:2008-03-07
Age:0.2  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-12-03, Days after onset: 271
Location:Maryland  Entered:2008-12-16, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACTHIB, PEDIARIX, PREVNAR
Current Illness: Diaper rash, Hypersensitivity, Plagiocephaly, Hyperbilirubinaemia
Preexisting Conditions: Cephalhaematoma, Hospitalization
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01659
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1838U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Eczema, Excoriation, Flatulence, Plagiocephaly
SMQs:, Congenital, familial and genetic disorders (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician via medical records, concerning a 2 months old male with diaper rash, allergies, plagiocephaly, hyperbilirubinaemia, and history of cephalohematoma and hospitalization, who on 07-MAR-2008, was vaccinated with ROTATEQ (657989/1838U). Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-comp vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) (Lot # AC21B1AB), (PREVNAR) (Lot # 808702E) and (ACTHIB) (Lot # UF341AC). On 07-MAR-2008, the patient experienced intestinal gas. On 09-MAY-2008, the baby experienced eczema in face and trunk with excoriations in face (cheeks and forehead), and it was noticed that he had a flat occipital, plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 4 months of age. The patient was treated with Vaseline + 1% Hydrocortisone. On examination on 10-JUL-2008, it was noted that the baby still had Plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 6 months of age. No additional information is expected. The patient was also reported in WAES: 0707USA00777.

VAERS ID:346694 (history)  Vaccinated:2008-03-07
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-19
Location:Unknown  Entered:2009-05-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: diphtheria toxoid (+); MENACTRA
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA01925
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Lupus-like syndrome
SMQs:, Systemic lupus erythematosus (narrow)
Write-up: Information has been received from a registered nurse concerning an approximately 14 year old female patient who on 22-AUG-2007, 19-OCT-2007 and 07-MAR-2008 was vaccinated with the series of GARDASIL (lot#: 658556/1060U) of all doses) at another office experienced lupus like symptoms with neurological issues. The patient did see a neurologist. The patient also received MENACTRA and DTAP on 15-AUG-2007 (confirmed different data than initial GARDASIL). Nurse did not wish to be contacted. No further information available at the time of reporting. Upon internal review, lupus like symptoms was determined to be an other important medical event. No further information is available.

VAERS ID:347077 (history)  Vaccinated:2008-03-07
Age:1.0  Onset:2008-03-17, Days after vaccination: 10
Gender:Female  Submitted:2009-05-15, Days after onset: 424
Location:Louisiana  Entered:2009-05-21, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA04131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF297AA2UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1786U0UNRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site papule, Injection site vesicles
SMQs:
Write-up: Information has been received from a nurse concerning a female patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, dose and route not provided). It was reported that the patient experienced blister like lesions around the injection site. It is unknown if the date of 17-MAR-2008 is the date of vaccination or the AE onset date. It was unspecified if the patient sought medical attention. The patient''s outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from a nurse concerning a 12 month old female who on 07-MAR-2008 was vaccinated with the right thigh with a first dose of VARIVAX (Oka/Merck) (Lot # 659527/1786U) at 9:45 am. On 07-MAR-2008 at 9:45 am the patient was vaccinated into the left thigh with a third dose of ACTHIB. (Sanofi Pasteur) (Lot #UF297AA). There was no illness at the time of vaccination. On 17-MAR-2008 the patient experienced papules on the right anterior thigh 10 days after VARIVAX (Oka/Merck) was administered in the same location. On an unspecified date the patient recovered. Additional information is not expected.

VAERS ID:347867 (history)  Vaccinated:2008-03-07
Age:15.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2009-05-15, Days after onset: 433
Location:New York  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 01/03/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 08/13/08, no problems; ultrasound, 09/17/08, no problems
CDC Split Type: WAES0808USA02606
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1518U1SCUN
Administered by: Public     Purchased by: Other
Symptoms: Anaemia, Drug exposure during pregnancy, Ultrasound scan normal
SMQs:, Haematopoietic erythropenia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow-up information has been received from a licensed practical nurse for the pregnancy registry for VARIVAX (Merck) concerning a 15 year old female with no pertinent medical history and no allergies who was vaccinated with the first dose of VARIVAX (Merck) as a child. On 07-MAR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 659355/1518U) 0.5 ml SC and then discovered that she was pregnant. There was no concomitant medication. The last menstrual period was 03-JAN-2008. The estimated due date is 09-OCT-2008. No adverse effects reported. The prenatal ultrasound showed no problems. The baby was breech at this time and a C-section was scheduled soon (dates not provided). The patient sought medical attention in the office visit. Follow-up information was received. On 13-AUG-2008 and 17-SEP-2008 ultrasounds were performed with no problems. Other medication use during pregnancy included FeSO4 325mg twice a day for anemia on 25-AUG-2008. The serum alpha fetoprotein test (MSAFP) was performed too late. The patient with a history of 0 pregnancies 0 and 0 pre-term births on 24-OCT-2008 delivered a male baby weighing 7 pounds 11 ounces at 41 weeks. There was no complication during pregnancy and labor/delivery. There was no feature of congenital varicella zoster syndrome. Additional information is not expected.

VAERS ID:365438 (history)  Vaccinated:2008-03-07
Age:2.0  Onset:2008-09-05, Days after vaccination: 182
Gender:Male  Submitted:2009-11-05, Days after onset: 426
Location:Florida  Entered:2009-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no perfectly healthy
Preexisting Conditions: none other than a Penicillin allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 2 LL
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2 LL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 2 RL
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER 2  
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 2 RL
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 2 RL
Administered by: Private     Purchased by: Private
Symptoms: Aphasia, Communication disorder, Decreased eye contact, Social avoidant behaviour
SMQs:, Dementia (broad), Psychosis and psychotic disorders (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: stopped talking and communicating, he started to shut down, no eye contact, very withdrawn

VAERS ID:396221 (history)  Vaccinated:2008-03-07
Age:1.0  Onset:2008-03-17, Days after vaccination: 10
Gender:Male  Submitted:2010-08-23, Days after onset: 889
Location:Texas  Entered:2010-08-23
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Yes, just been sick with RSV/Bronchiolitis, had just completed corticosteroid medication for breathing/lungs, was still congested at visit and diagnosed with Purulent Rhinitis, and given antibiotic, all at same visit.
Preexisting Conditions: None other than the Respiratory Illnesses
Diagnostic Lab Data: Yes, diagnosed with: Encephalopathy (348.3), Diarrhea Disorder (787.91), Immune System Disorder (279.9), Metabolism Disorder (277.9), and Nutritional Deficiency Disorder (269.9), all of which he did not have prior to reaction following vaccination.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1483U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC492713IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1563U0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Diet refusal, Encephalopathy, Hypersensitivity, Immune system disorder, Lethargy, Malnutrition, Metabolic disorder, Oral disorder, Pyrexia, Rash, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: March 17, 2008, broke out in rash on head, then moved down body, arms, and legs. Rash was accompanied by fevers ranging from 103.5-104, spots in mouth, he would not eat or drink, lethargic, diarrhea started that evening, visited ER next day as we were out town, and when Pediatricians office finally called back, they said not to worry, give Tylenol for fever and Benadryl for rash, but he was ok. They did not even document in his chart about the reaction. I have pictures of the reaction, phone call records, ER visit records, so I have proof of the reaction without their documentation in his chart. ER dr where we were said it was just an allergic reaction of some unknown origin, refused to do labs, and said it would go away. Said the rash, diarrhea, and spots in mouth were a reaction to some virus he was fighting off. Yes, it was the MEASLES virus!

VAERS ID:480112 (history)  Vaccinated:2008-03-07
Age:  Onset:2008-03-07, Days after vaccination: 0
Gender:Unknown  Submitted:2013-01-03, Days after onset: 1763
Location:Unknown  Entered:2013-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA010808
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 21-DEC-2006, with the second dose on 07-MAR-2008, with the third dose on 07-JUN-2012 and with the fourth dose on 28-AUG-2012, respectively (doses, routes, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.

VAERS ID:307546 (history)  Vaccinated:2008-03-07
Age:6.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 12
Location:Foreign  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0513103A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of induration at injection site in a 6-year-old female subject who was vaccinated with Infanrix, poliomyelitis vaccine (Vacuna Poliomielitica) for prophylaxis. On 7 March 2008, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site, lot number not provided), unspecified dose of Poliomyelitis vaccine (intramuscular, unknown injection site). On 7 March 2008, less than one day after vaccination with Infanrix and Poliomyelitis vaccine, the subject experienced erythema, induration and pain at the injection site. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Poliomyelitis vaccine.

VAERS ID:307548 (history)  Vaccinated:2008-03-07
Age:6.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 12
Location:Foreign  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0513101A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMD-006637242) and described the occurrence of injection site induration in a 6-year-old female subject who was vaccinated with Infanrix (GlaxoSmithKline), Vacuna Poliomielitica (Berna) for prophylaxis. On 7 March 2008, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site, lot number not provided), unspecified dose of Poliomyelitis vaccine (intramuscular, unknown injection site). On 7 March 2008, less than one day after vaccination with Infanrix and Poliomyelitis vaccine, the subject experienced erythema and induration at the injection site. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with Infanrix and Poliomyelitis vaccine.

VAERS ID:307887 (history)  Vaccinated:2008-03-07
Age:26.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-21, Days after onset: 13
Location:Foreign  Entered:2008-03-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Drospirenone (+) ethinyl estradiol
Current Illness: Contraception; Anxiety
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803AUS00108
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Disorientation, Grand mal convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 26 year old female with contraception who on 07-MAR-2008 was vaccinated with her second dose of Gardasil. Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN). The patient was extremely anxious prior to the vaccination. On 07-MAR-2008 the patient immediately experienced tonic clonic seizure lasting for about 10 seconds. Following the seizures, the patient was disoriented for a further 10 seconds and then recovered. No adverse symptoms were noted since then. Subsequently, the patient recovered from tonic clonic seizure and disorientation. Upon internal medical review, the tonic clonic seizure was considered an other important medical event. Additional information has been requested.

VAERS ID:308142 (history)  Vaccinated:2008-03-07
Age:6.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-25, Days after onset: 17
Location:Foreign  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0513096A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Headache, Induration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (#606643242) and described the occurrence of induration in a 6-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline), Polio vaccine. On 7 March 2008 the subject received unspecified dose of Infanrix (intramuscular) lot number not provided, unspecified dose of Polio vaccine (intramuscular). On 7 March 2008, less than one day after vaccination with Infanrix and Polio vaccine, the subject experienced erythema, induration, headache and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting erythema underatum and fever were improved and headache outcome was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Polio vaccine.

VAERS ID:308143 (history)  Vaccinated:2008-03-07
Age:6.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Male  Submitted:2008-03-25, Days after onset: 17
Location:Foreign  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0513095A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a foreign regulatory authority (Regulatory Authority #206639242; and described the occurrence of induration in a 6-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) and Polio vaccine. On 7 March 2008 the subject received unspecified dose of Infanrix (intramuscular) lot number not provided, unspecified dose of Polio vaccine (intramuscular). On 7 March 2008, less than one day after vaccination with Infanrix and Polio vaccine, the patient experienced injection site pain, erythema and induration. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Polio vaccine.

VAERS ID:308144 (history)  Vaccinated:2008-03-07
Age:6.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-25, Days after onset: 17
Location:Foreign  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0513077A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Injection site pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# 906645142) and described the occurrence of induration in a 6-year-old female subject who was vaccinated with Infanrix (GlaxoSmithKline), Polio vaccine. On 7 March 2008 the subject received unspecified dose of Infanrix (intramuscular), unspecified dose of Polio vaccine (intramuscular). On 7 March 2008, less than one day after vaccination with Infanrix and Polio vaccine, the subject experienced erythema, induration, injection site pain and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix and Polio vaccine.

VAERS ID:309642 (history)  Vaccinated:2008-03-07
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2008-04-16
Location:Foreign  Entered:2008-04-16
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0516573A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA435A0PO 
Administered by: Other     Purchased by: Other
Symptoms: Circulatory collapse, Dehydration, Diarrhoea, Gastroenteritis rotavirus
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of rotavirus gastroenteritis in a 5-6 month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline). On 7 March 2008 the subject received 1st dose of Rotarix (oral). At an unspecified time after vaccination with Rotarix, the subject experienced rotavirus gastroenteritis with severe diarrhea, circulatory collapse due to dehydration. The subject was severely ill. The subject received rehydration treatment. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The vaccination course with Rotarix was discontinued. The mother refused to give the second dose after what has happened to the baby. The healthcare professional considered the events were possibly related to vaccination with Rotarix.

VAERS ID:309804 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-03-19, Days after vaccination: 12
Gender:Male  Submitted:2008-04-16, Days after onset: 28
Location:Foreign  Entered:2008-04-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Toxoplasmosis
Diagnostic Lab Data: ultrasound, 20Mar2008, acute intussusception on the right side; barium enema X-ray, 20Mar08, digestive perforation; laparotomy, 20Mar08, acute ileocecal IT with terminal ileum, valve and caecum necrosis
CDC Split Type: WAES0804USA02793
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Barium enema abnormal, Gastrointestinal necrosis, Gastrointestinal perforation, Haematochezia, Intestinal anastomosis, Intestinal resection, Intussusception, Laparotomy, Ultrasound scan abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow)
Write-up: Information has been received from an investigator concerning a 15 male who was enrolled in the clinical study. This study is sponsored by the hospital. This 3-month-old male patient with a history of toxoplasmosis received the second dose of Rotateq, the second primary dose of PENTAVAC and a dose of PREVENAR on 07-MAR-2008. He experienced vomiting two times a day on 18-MAR-2008 and 19-MAR-2008, he was found to have blood in nappies four times between 19-MAR-2008 and 20-MAR-2008. On 19-MAR-2008 he developed intussusception and was hospitalized on 20-MAR-2008. He had received the first dose of Rotateq, a dose of INFANRIX HEXA and a dose of PREVENAR on 01-FEB-2008. Etiological investigations were performed. Therapeutic measures consisted first of VIATOL. The echography diagnosis was acute intussusception on the right side. Radiologic barium enema registered a digestive perforation. An acute ileocecal intussusception with terminal ileum, valve and caecum necrosis were displayed on laparotomy. Right colic and ileo-caecal valve resection and ileo-colic termnio-terminal anastomosis were performed on 20-MAR-2008. Post-operating follow-up was favorable. The patient recovered with sequelae because of consequence of surgical procedure from intussusception on 20-MAR-2008. The investigator and the sponsor considered that there was a reasonable possibility that the event intussusception was related to the study drug. They considered that intussusception was related to one of the concomitant drugs. A previous gastroenteritis was possible some days before. Other business partner numbers include E2008-03228.

VAERS ID:310483 (history)  Vaccinated:2008-03-07
Age:1.0  Onset:2008-03-25, Days after vaccination: 18
Gender:Male  Submitted:2008-04-21, Days after onset: 27
Location:Foreign  Entered:2008-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Electroencephalogram, 00-Mar-2008, 3 EEGs were performed and the results were normal; Lumbar puncture, 00-Mar-2008, normal; Nuclear magnetic resonance imaging, normal
CDC Split Type: CAWYEG01404508
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coma, Convulsion, Dermatitis contact, Ear pain, Electroencephalogram normal, Endotracheal intubation, Familial risk factor, Heart rate increased, Hypersensitivity, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was considered medically important. Information regarding Prevenar was received from a consumer regarding a 1-year-old male patient who experienced coma, earache and convulsions. The patient received a dose on 07-Mar-2008. Healthy child. History of epilepsy/seizures on the father side. Concomitant medications were not reported. The patient experienced coma and earache in 2008 and convulsions on 25-Mar-2008. It was reported that the patient received his Prevnar vaccine on 7-Mar-2008 along with 2 other vaccines (MMRII) and another unspecified one. The child started convulsions on the 25-Mar-2008 at 5:00 AM. He went to the ER then was transferred by helicopter to hospital where he still remains hospitalized. Dilantin was prescribed to treat his accelerated heartbeat, but the child developed a hypersensitivity and swelled up. The patient was intubated but had a reaction to the tape used to maintain the tube in place that caused his "skin to come off". The child was treated with phenobarbital for his convulsion, then Topomax and finally Keppra. It was mentioned that the patient went into a coma for about 10 days but recovered. The aunt stated that the child was a healthy little boy and presented no medical history of any kind except that between 7-Mar-2008 and 25-Mar-2008, the child seemed to have earache with no fever associated to it and he was treated with antibiotics. Family history of seizures/epilepsy has also been reported from his father side. The reporter was uncertain about the number of dose of Prevnar already administered or not but she did stated that the child was up-to-date with his immunization profile. The child is now out of his coma and he is treated with phenobarbital and Keppra with mild convulsions stills occurring. No further details were available at time of initial report. The outcome of the events is not resolved for the convulsions but it is resolved for the coma and it is unknown if the earache is persisting or not. Electroencephalogram (results: 3 EEGs were performed and the resu

VAERS ID:311338 (history)  Vaccinated:2008-03-07
Age:1.7  Onset:2008-03-08, Days after vaccination: 1
Gender:Unknown  Submitted:2008-04-30, Days after onset: 52
Location:Foreign  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 08Mar2008 38.5deg. C
CDC Split Type: B0517953A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA372D IMLL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA372D IMLL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA372D IMLL
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Injection site bruising, Injection site oedema, Injection site reaction, Injection site warmth, Lividity, Pyrexia
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)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site warmth in a 21-month-old subject of unspecified gender who was vaccinated with Infanrix-IPV/Hib (GlaxoSmithKline). On 7 March 2008, the subject received unspecified dose of Infanrix-IPV/Hib (intramuscular, left thigh). On 8 March 2008, 1 day after vaccination with Infanrix-IPV/Hib, the subject experienced pyrexia (38.5 deg. C), injection site edema, injection site warmth and injection site bruising. Injection site reaction had more than 10 cm diameter and persisted more than 3 days. On the next day injection site oedema expanded to the skin region knee joint and livedo skin in that region was observed. The subject was hospitalised. After treatment (not specified) injection site oedema was withdrawn. Mobility of extremities and skin temperature become normal. On 29 March 2008, the pyrexia resolved. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix-IPV/Hib.

VAERS ID:314024 (history)  Vaccinated:2008-03-07
Age:85.0  Onset:2008-03-13, Days after vaccination: 6
Gender:Female  Submitted:2008-05-28, Days after onset: 76
Location:Foreign  Entered:2008-05-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIN, Jan07 - 05Mar08; BLOPRESS, Jan07 - 05Mar08; LOCHOL, Jan07 - 05Mar08; NORVASC, 05Mar08 - Unk; omeprazole, Jan07 - 05Mar08
Current Illness: Hypertension; Hypercholesterolaemia; Hepatic function disorder; Hepatic cancer metastatic
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA04582
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alopecia
SMQs:
Write-up: Information has been received from a health professional and a physician concerning an 85 year old female with hypertension, hypercholesterolaemia, mild hepatic function disorder and metastatic liver tumor (December 2005), who on 07-MAR-2008 was vaccinated with PNEUMOVAX 23. Concomitant therapy included BLOPRESS, LOCHOL, OMEPRAZON, AMLODIN and NORVASC. On 13-MAR-2008 the patient developed alopecia. On an unspecified date, the patient presented to a dermatologist and was prescribed steroid lotion. As no efficacy was observed after one month of treatment, she has currently been prescribed HIRUDOID lotion. Since the cause is unknown, she presented to the reporting physician again. At the time of the report, alopecia was progressing. The reporting physician felt that alopecia was definitely related to therapy with PNEUMOVAX 23, and considered alopecia to be serious as an other important medical event. No further information is available.

VAERS ID:322073 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-03-13, Days after vaccination: 6
Gender:Male  Submitted:2008-08-13, Days after onset: 153
Location:Foreign  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 13Mar2008, abnormal
CDC Split Type: B0532220A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Barium double contrast, Conjunctivitis, Enema administration, Familial risk factor, Haematochezia, Intussusception, Irritability, Pyrexia, Rhinorrhoea, Surgery, X-ray abnormal
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had genetic antecedents of cardiopathy. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 7 March 2008; Hep B (manufacturer unspecified, intramuscular) given on 19 December 2007 and 7 March 2008; pneumococcal vaccine (manufacturer unspecified, intramuscular) given on 7 March 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 19 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 13 March 2008, 6 days after vaccination with ROTARIX, the subject was taken to ER with rhinorrhea, conjunctival secretions, fever, irritability and 2 bloody stools like black current jelly. Intussusception was suspected. The patient was hospitalized. On 14 March 2008, ileo-ileo-cecolic intussusception was diagnosed with resolved by taxis with appendectomy without resection and complication. The subject had good response and favorable evolution. The physician considered the events were clinically significant or requiring intervention). Abdominal X-ray was performed and showed fluid levels and dilated bowel loops. Air or Liquid contrast enema did not show visible intussusception or soft tissue mass, or invagination of intestine, or specific abnormalities. On 26 March 2008, the events were resolved by surgery and the patient was discharged. The physician considered the events were possibly related to vaccination with ROTARIX.

VAERS ID:322074 (history)  Vaccinated:2008-03-07
Age:0.2  Onset:2008-05-04, Days after vaccination: 58
Gender:Female  Submitted:2008-08-13, Days after onset: 101
Location:Foreign  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0532328A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Grand mal convulsion, Haematochezia, Intussusception, Melaena, Mucous stools, Pyrexia, Surgery, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of ileo-caeco-colic intussusception in an 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous vaccination included hepatitis B vaccine recombinant (manufacturer unspecified, intramuscular) ; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 29 December 2007. On 7 March 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided; On 4 May 2008, 58 days after vaccination with ROTARIX, the subject was taken to emergency room and started with abdominal pain, colic, 8 episodes of vomiting, 2 bloody stools like black currant jelly, fever and 1 tonic-clonic seizure. The initial diagnosis was gastroenteritis but the occurrence of bloody stools corroborated the diagnosis of intussusception which was confirmed by abdominal x-ray. The surgery was done on 4 May 2008. Ileo-caeco-colic intussusception was resolved by taxis without intestinal resection and complication. The patient had good response and favorable evolution. Abdominal radiography performed did not show abnormalities, visible intussusception or soft tissue mass, fluid levels and dilated bowel loops. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 7 May 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. Additional information has been requested.

VAERS ID:337029 (history)  Vaccinated:2008-03-07
Age:18.0  Onset:2008-03-07, Days after vaccination: 0
Gender:Female  Submitted:2009-01-09, Days after onset: 308
Location:Foreign  Entered:2009-01-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811AUS00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0784U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a health professional via CSL as part of a business agreement (manufacturer control # GARD 2008 10 30 002), with follow-up information received from the health professional, concerning an 18 year old female who on 07-MAR-2008 was vaccinated with the second dose of GARDASIL (Lot # 658275/0784U, Batch #J3206, Expiry date 22-MAR-2010). At the time of vaccination with her second dose, the patient was not aware that she was 10 weeks pregnant. On 17-SEP-2008 the patient delivered a normal, healthy female baby weighing 2.83 kilograms. The baby was reported to be healthy and no abnormalities were observed. Follow-up information was received from the reporting health professional, via CSL. The infant was born at 37 weeks gestation with APGAR scores of 9 and 10. The infant was admitted to hospital in the first few weeks of life due to sepsis. This was successfully treated with intravenous antibiotics. The reporter stated that it was uncertain whether the infant''s sepsis was related to exposure to GARDASIL. Additional information is not expected.

VAERS ID:356955 (history)  Vaccinated:2008-03-07
Age:35.0  Onset:2008-03-08, Days after vaccination: 1
Gender:Female  Submitted:2009-09-10, Days after onset: 550
Location:Foreign  Entered:2009-09-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Traffic accident
Diagnostic Lab Data: Echography, see text; Nuclear magnetic resonance ima, Aug2008, normal; X-ray, normal
CDC Split Type: B0516413A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Allodynia, Asthenia, Bursitis, Dizziness, Echography abnormal, Hyperaesthesia, Muscle swelling, Nausea, Neuralgia, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity, Reaction to previous exposure to any vaccine, Sensation of heaviness, Sensory disturbance, X-ray normal
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a regulatory authority (# NL-LRB-75775) and described the occurrence of neuropathic pain in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject experienced nausea and dizziness with all previous vaccinations she has ever received. On 7 March 2008, the subject received unspecified dose of TWINRIX (intramuscular, left deltoid, lot number unknown). On 8 March 2008, 1 day after vaccination with TWINRIX, the subject experienced dizziness, arm pain and nausea. There was neither redness nor swelling at injection site. There was no fever. The subject was treated with paracetamol and physical therapy (Physiotherapy). No concomitant medications were reported. At the time of reporting, the events were unresolved. As no additional information was received after follow up request, the case has been closed. Follow up received on 03 September 2009 and on 10 September 2009: this was upgraded to serious. The subject''s medical history included a traffic accident on 1995. It was unknown if the subject was taken a concomitant medication. Previous vaccinations included 1st and 2nd dose of TWINRIX received on 03 July 2007 and 07 September 2007 respectively. The subject visited a foreign country during unspecified period for mental development purposes and shortly after her return on 07 March 2008 the subject received the 3rd dose of TWINRIX (left deltoid). On 08 March 2009 she also had a loss of strength. Furthermore she had neuropathic pain in muscular left deltoid and suffered in the past year, 4 times a bursal inflammation in left shoulder. The pain was described as progressive stinging pain in left upper arm and shoulder and heavy feeling of arm. While moving neck the pain was radiating to shoulder and lower arm. Other associated symptoms included sensibility disorder in arm, hyperalgesia and allodynia. The subject was treated with subacromial infiltration with limited results. She refused LYRICA and amitryptiline and she started unspecified treatment. TENS (transcu

VAERS ID:456301 (history)  Vaccinated:2008-03-07
Age:0.3  Onset:2008-04-11, Days after vaccination: 35
Gender:Female  Submitted:2012-05-25, Days after onset: 1505
Location:Foreign  Entered:2012-05-25
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: Diarrhoea; Vomiting; Bronchitis; Nasopharyngitis; Acute gastroenteritis
Diagnostic Lab Data: stool analysis, 04/14/08, adenovirus negative and rotavirus positive
CDC Split Type: WAES1106USA03997
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Gastroenteritis
SMQs:, Noninfectious diarrhoea (broad)
Write-up: Case described in the intermediate clinical study report provided by the sponsor of the study on 23-Jun-2010 under the reference number 200800013. Case medically confirmed. A 3 months old female patient has a medical history of diarrhea, vomiting, bronchitis, nasopharyngitis. She has a history of acute gastroenteritis was noted in the medical history of the father on the 07-APR-2008. she had been treated with ROTATEQ, 1 dose form once a month on 07-MAR-2008, 06-MAY-2008 and 30-MAY-2008, PCV, 1 dose form once a month from 04-MAR-2008 to 02-MAY-2008, DTP-IPV-Hib, 1 dose form once a month from 04-MAR-2008 to unknown. On 11-APR-2008, the patient experienced gastroenteritis. The patient was hospitalized on 12-APR-2008. Etiological investigations were performed: On the 14-APR-2008, stools analysis found adenovirus negative and rotavirus positive. Outcome: The patient had recovered from disorder gastrointestinal on 15-APR-2008. Assessment: Gastroenteritis is expected. The investigator considered that gastroenteritis was unlikely related (unlikely related is handled as related). The sponsor considered that gastroenteritis was unlikely related. Follow-up information received through the final clinical study report provided by the sponsor of the study on 11-MAY-2012 under the reference number 200800013. According to the sponsor the gastroenteritis was not related. Other business number included E2011-04096.

VAERS ID:504950 (history)  Vaccinated:2008-03-07
Age:5.0  Onset:2013-01-26, Days after vaccination: 1786
Gender:Female  Submitted:2013-09-30, Days after onset: 246
Location:Foreign  Entered:2013-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1309PRT014245
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.NF51210 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Salivary gland enlargement, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Case of vaccination failure from the Health Authorities on 19-Sep-2013 under the reference number C201309-33 via the local site Sanofi Pasteur. The primary reporter was a physician. A 10-year-old female patient developed unilateral swelling of salivary glands on 26-Jan-2013 9 years after receiving a dose of MMRII (batch number HS76060 H), subcutaneously on 29-Aug-2003 and 4 years after receiving a previous dose of MMRVAXPRO (batch and lot number NF51210), subcutaneously on 07-Mar-2008. The patient received unspecified anti-inflammatory therapy as symptomatic treatment. She had no relevant medical history and no previous adverse event to other drugs. The adverse reaction lasted 13 days and resolved on 07-Feb-2013. The reporter stated that the adverse reaction may be due to a probable vaccine failure. The Health Authorities assessed the causal relationship between the reported reaction/vaccination failure and MMR vaccination as certain according to the global introspection.

VAERS ID:307011 (history)  Vaccinated:2008-03-08
Age:15.0  Onset:2008-03-08, Days after vaccination: 0
Gender:Female  Submitted:2008-03-13, Days after onset: 4
Location:Georgia  Entered:2008-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fainting~ ()~~0~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217BA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1508U1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Administered HPV (Gardasil) vaccine #1 in child''s left deltoid. Patient fainted. I put ammonia under her nose. She woke up but was very pale and complained of her legs hurting. She then put her head between her legs and she began to feel better.

VAERS ID:311150 (history)  Vaccinated:2008-03-08
Age:24.0  Onset:2008-03-09, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 35
Location:Virginia  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Hay fever; Allergic reaction to antibiotics
Diagnostic Lab Data:
CDC Split Type: WAES0804USA00178
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 24 year old female with a history of hay fever and allergy to MACRODANTIN who on 08-MAR-2008 was vaccinated with the first dose of GARDASIL (655604/0052X). On 09-MAR-2008 the patient experienced an "allergic reaction" characterized by "hives and wheezing". Subsequently, the patient recovered from hives and wheezing. The patient sought unspecified medical attention. No other information was provided. Additional information has been requested.

VAERS ID:312748 (history)  Vaccinated:2008-03-08
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:West Virginia  Entered:2008-05-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bottle feeding
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01418
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a registered nurse concerning a (bottle-fed) female who on approximately 08-MAR-2008 was vaccinated with a dose of ROTATEQ. In approximately March 2008, the patient experienced diarrhea for about one month. The patient''s parent contacted the physician''s office via phone call for medical attention. The diarrhea resulted in about 10 diapers per day. The patient''s diarrhea persisted. It was noted that the child was received NUTRAMIGEN. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporters registered nurse indicated that she had no more information as this was a random phone call for the event. The patient was referred to her pediatrician. No further information is available.

VAERS ID:322505 (history)  Vaccinated:2008-03-08
Age:1.1  Onset:2008-03-10, Days after vaccination: 2
Gender:Female  Submitted:2008-03-12, Days after onset: 2
Location:California  Entered:2008-08-18, Days after submission: 159
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin
Current Illness: Otitis media; conjunctivitis
Preexisting Conditions: No
Diagnostic Lab Data: N/A
CDC Split Type: CA080012
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSBAC14B054BA0UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1170F0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015C0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1464U0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had been seen 2/28/08 for otitis media. She was seen 3/8/08 for well-child exam, she was afebrile and ear exam normal despite not completing Augmentin. 1 y/o vaccines given. That evening she developed fever. On 3/10/08 she had a seizure lasting 6-7 minutes. She was taken to medical center and diagnosed with febrile seizure. No labs or imaging done.

VAERS ID:329911 (history)  Vaccinated:2008-03-08
Age:78.0  Onset:2008-09-28, Days after vaccination: 204
Gender:Female  Submitted:2008-10-21, Days after onset: 23
Location:North Carolina  Entered:2008-10-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; ZETIA; Insulin; LASIX; Potassium; ASTELIN
Current Illness: None
Preexisting Conditions: DM; HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.01634 UNUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Herpes zoster, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Approximately 6 1/2 months after receiving the ZOSTAVAX Shingles vaccine, diagnosed with bad case of Shingles - large, red painful rash radiating from middle of back, under (L) arm and breast. Treated with VALTREX, Lidocaine Gel, ATARAX; DARVOCET. Mod to mild pain after Shingles rash dried up. Still recovering.

VAERS ID:338447 (history)  Vaccinated:2008-03-08
Age:20.0  Onset:2008-03-08, Days after vaccination: 0
Gender:Female  Submitted:2009-01-27, Days after onset: 325
Location:Foreign  Entered:2009-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 17Apr08)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, ??Oct?08, threatened premature labour; ultrasound, ??Oct?08, intrauterine growth retardation; ultrasound, Dating ultrasound: estimated conception date 15-APR-2008. Normal
CDC Split Type: WAES0806USA08713
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNGM
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amenorrhoea, Drug exposure during pregnancy, Foetal growth retardation, Incorrect route of drug administration, Threatened labour, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Fertility disorders (broad)
Write-up: Information has been received from a gynecologist, concerning a 20 year old female patient who was considered as non-enrolled as the vaccination was administered more than 1 month before the pregnancy start date (to be clarified). This is a case of misuse, is vaccine administered at inappropriate site. The patient started a spontaneous pregnancy (estimate conception date 15-APR-2008) 5 weeks after receiving on 08-MAR-2008 the first dose of GARDASIL (Lot #, Batch # not reported) in the buttock. Three days after vaccination (on 11-MAR-2008), the patient experienced vaginal bleeding. The outcome was not reported. absence of menstruations was noticed on 26-MAR-2008. The patient had concomitant contraception with DIANE 35. Conception date was estimated through dating ultrasound. Follow-up information on 24-JUN-2008 received by telephone: The reporter specified that the patient was 21 year old and that the vaccine was administered for a limit period of 1 month before the beginning of the pregnancy. The 15-APR-2008 was the pregnancy start date estimated by the ultrasound scan. Follow-up information was received on 31-JUL-2008 which reported that the patient is considered as enrolled in pregnancy registry as the vaccine was administered 5 weeks before conception date. Initials of the patient were modified. Patient''s date of birth, height and weight were reported. On 15-APR-2008, the patient started a spontaneous pregnancy (estimated date by the ultrasound). The echography was normal. Estimated date of delivery on 15-JAN-2009. She had no previous pregnancy. Consent form was provided. Follow-up information was received on 20-JAN-2009 which reported that the patient had complications, abnormal diagnostic performed and infection or disease during her pregnancy: echography at 22 amenorrhea weeks revealed threatened premature labour, intrauterine growth retardation, and then there was a suspicion of pulmonary embolism (unspecified date). she gave birth to a normal baby girl on 12-DEC-2008 at 36 amenorrhea weeks. Baby''s birth weight was 1.880Kg. Apgar score was 10 at 5mn. This case was assessed as serious by the company physician. Other business partner numbers included: E2008-05847. No further information is available.

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