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Case Details (Sorted by Vaccination Date)

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VAERS ID:289377 (history)  Vaccinated:2007-08-27
Age:11.0  Onset:2007-08-28, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 2
Location:Wisconsin  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0454U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Induration, Pyrexia, Skin warm, Tenderness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: cellulitis 3x3 inch induration, warm to touch, fever, tender. Doubled in size in 24 hours. Treated with Omnicef

VAERS ID:289737 (history)  Vaccinated:2007-08-27
Age:38.0  Onset:2007-08-28, Days after vaccination: 1
Gender:Female  Submitted:2007-08-31, Days after onset: 3
Location:Kentucky  Entered:2007-09-04, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No meds
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS419011A1IMRA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Headache, Night sweats
SMQs:
Write-up: Donor received 2nd/5 rabies vaccinations on 8/27/07. She did not report any problems with 1st/5 on 8/24/07. After 2nd vaccination, on 8/23/07 while sleeping donor began to c/o night sweats, chills and headache symptoms "come and go", but have not completely resolved as of 8/31/07. Donor stable when presenting to center, no additional complaints. Donor removed from program. No further vaccinations given.

VAERS ID:289835 (history)  Vaccinated:2007-08-27
Age:4.0  Onset:2007-08-28, Days after vaccination: 1
Gender:Male  Submitted:2007-08-28, Days after onset: 0
Location:North Carolina  Entered:2007-09-05, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: NC07090
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1985CA4IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0651U1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (R) thigh tenderness onset same day as vaccine. Morning after, parent noted significant swelling to right upper thigh. Seen in office and noted to have generalized swelling of right thigh from groin extending to and involving the right knee. No erythema or measured sign of reaction at injection site. Leg is warm to touch with uniform swelling to anterior and posterior thigh. Given Motrin and Benadryl, cold compress PRN.

VAERS ID:290722 (history)  Vaccinated:2007-08-27
Age:1.0  Onset:2007-08-29, Days after vaccination: 2
Gender:Male  Submitted:2007-09-07, Days after onset: 9
Location:Wisconsin  Entered:2007-09-17, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Peeling fingers
Preexisting Conditions: Eczema 9-06/GERD 10-06
Diagnostic Lab Data: Negative strep
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB162AB0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1275F2IMUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0791U0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Skin exfoliation, Streptococcus identification test negative
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Periungual desquamation.

VAERS ID:290458 (history)  Vaccinated:2007-08-27
Age:0.2  Onset:2007-08-27, Days after vaccination: 0
Gender:Male  Submitted:2007-09-12, Days after onset: 16
Location:Foreign  Entered:2007-09-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: head circumference (result: 41 cm); body temperature (results: 36.2 deg. C.); heart rate (results; 148 bpm); blood electrolytes (results: within normal range); blood gases (results: pCO2 33.8 mmHg; pH 7.41; HCO3 22.3 mmol/L; BE-2.4 mmol/L); blood glucose (results: 120 mg/dL); blood lactic acid (results: 2.0 mmol/L); and oxygen saturation (results: 99-100%)
CDC Split Type: DEWYE257204SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21C294A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH259110IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Base excess negative, Blood bicarbonate normal, Blood electrolytes normal, Blood gases abnormal, Blood glucose increased, Blood lactic acid decreased, Blood pH normal, Body temperature increased, Head circumference normal, Heart rate increased, Hyperhidrosis, Hypersensitivity, Oxygen saturation normal, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority (PEI) regarding a 2-month-old male patient who experienced vasovagal reaction, differential diagnosis acute allergic reaction. The patient received the first dose on 27-Aug-2007. After vaccination with Prevenar and Infanrix hexa the patient was carried on his mother''s arm and became very quiet, pale and sweaty. The patient was diagnosed with vasovagal reaction, differential diagnosis acute allergic reaction on 27-Aug-2007. He did not experience any efflorescences, his blood pressure was stable and the oxygen saturation 99%. An intravenous entry was put and the patient was hospitalised by an emergency doctor. The patient arrived in hospital in good general condition, he was rosy and his fontanelle was within normal level. His breathing did not show any signs for obstruction or ronchus and his heart action was clear and rhythmic. During hospitalisation the patient was monitored closely and a blood gas analysis was done. The patient recovered and was discharged from hospital the next day on 28-Aug-2007. On 27-Aug-2007 test results were: head circumference (results: 41 cm); body temperature (results: 36.2 deg. C.); heart rate (results: 148 bpm); blood electrolytes (results: within normal range); blood gases (results: PC02 33.8 mmHg; pH 7.41; HC03 22.3 mmol/L; BE-2.4 mmol/L); blood glucose (results: 120 mg/dL); blood lactic acid (results: 2.0 mmol/L); and oxygen saturation (results: 99-100%).

VAERS ID:291041 (history)  Vaccinated:2007-08-27
Age:  Onset:2007-08-29, Days after vaccination: 2
Gender:Male  Submitted:2007-09-20, Days after onset: 22
Location:Foreign  Entered:2007-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Atacand plus; Aspirin
Current Illness: Unknown
Preexisting Conditions: HYPERTENSION ARTERIAL, TICK BITE
Diagnostic Lab Data: Examinations: Throat-nose-ear examination: Tympanum grey with outlines, Weber''s test without lateralisation of sound, Rinne''s test positive at both sides, mirror test without pathologic findings. Laboratory tests: Blood count, clinical chem
CDC Split Type: D0054487A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB088CA IMLL
Administered by: Other     Purchased by: Other
Symptoms: Audiogram abnormal, Balance disorder, Blood count normal, Borrelia burgdorferi serology negative, Coagulation test normal, Ear, nose and throat examination normal, Laboratory test normal, Nausea, Nystagmus, Ultrasound Doppler abnormal, Vertigo, Vestibular disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Ocular motility disorders (narrow)
Write-up: This case was reported by a physician and described the occurrence of vestibular dysfunction in a male subject of unspecified age who was vaccinated with Twinrix adult, GlaxoSmithKline for prophylaxis. The subject''s medical history included tick bite four weeks before, without erythema. Concurrent medical conditions included arterial hypertension. Concurrent medications included Atacand plus and Aspirin protect. On 27 August 2007 the subject received 2nd dose of Twinrix adult (intramuscular, unknown deltoid). On 29 August 2007, 2 days after vaccination with Twinrix adult, the subject experienced sudden vertigo in the morning, with balance disorder, nausea and vomiting. There was no headache or subjective hearing loss. The subject was hospitalised for 9 days and diagnosed with vestibular dysfunction. On admission tympanum was normal and hearing test without findings (Weber, Rinne and mirror test). Blood test and infection serology for Borreliosis, Herpes simplex virus (HSV), varicella zoster virus (VZV), influenza and parainfluenza were without pathologic findings. Doppler sonogram of head showed no sign for haemdynamically effective stenoses. Magnetic resonance tomogram (MRT) of head showed no sign for neurinoma of acousticus, but a small arachnoidal cyst, which was not considered relevant. Audiogram revealed medicochlear sound perception disorder up to 20 dB right-sided and 25 dB left-sided. Vestibulogram showed spontaneous, provoked and postural nystagmus to the left with thermic loss at the right. The subject was treated with Vomex, Trental, Haes 6% and 500.0 (infusion). On discharge the symptoms had subjectively improved. Spontaneous nystagmus was resolved. The vaccination course with Twinrix adult was discontinued. No further information will be available.

VAERS ID:291379 (history)  Vaccinated:2007-08-27
Age:0.4  Onset:2007-08-29, Days after vaccination: 2
Gender:Male  Submitted:2007-09-25, Days after onset: 27
Location:Foreign  Entered:2007-09-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Somnolence; Asthenia
Preexisting Conditions:
Diagnostic Lab Data: white blood cell count (results: 13.7 cells/uL); blood bilirubin (results: 5.02 mg); haemoglobin (results: 4.1 mg/dL); red blood cell count (results: 5.4 cells/uL); reticulocyte percentage (results: 2.5%); mean cell volume (results: 146 (low: 77/high: 105)); platelet count (results: 460 (low: 180/high: 400)); and coombs direct test (results: positive). Additionally, coombs indirect test (results: positive) was done on an unspecified date
CDC Split Type: ITWYE345120SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia haemolytic autoimmune, Blood bilirubin normal, Coombs direct test positive, Coombs indirect test positive, Faeces pale, Haemoglobin decreased, Mean cell volume increased, Pallor, Platelet count increased, Red blood cell count normal, Reticulocyte count normal, Urine analysis abnormal, White blood cell count normal
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Biliary system related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 5-month-old male patient who experienced autoimmune hemolytic anemia. The patient received the second dose on 27-Aug-2007. The patient experienced autoimmune hemolytic anemia on 29-Aug-2007 showing orange-coloured stools, hyperchromic urine and skin pallor. The event involved or prolonged inpatient hospitalization. The patient was treated with cortisone and transfusions. The event was reported as recovering. On 29-Aug-2007 test results were: white blood cell count (results: 13.7 cells/uL); blood bilirubin (results: 5.02 mg); haemoglobin (results: 4.1 mg/dL); red blood cell count (results: 5.4 cells/uL); reticulocyte percentage (results: 2.5%); mean cell volume (results: 146 (low: 77/high: 105); platelet count (results: 460 (low: 180/high: 400)); and coombs direct test (results: positive). Additionally, coombs indirect test (results: positive) was done on an unspecified date. No additional information was available at the time of this report.

VAERS ID:291832 (history)  Vaccinated:2007-08-27
Age:42.0  Onset:2007-08-29, Days after vaccination: 2
Gender:Male  Submitted:2007-10-01, Days after onset: 33
Location:Foreign  Entered:2007-10-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0054678A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB088CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Acute vestibular syndrome, Balance disorder
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow)
Write-up: This case was reported by a regulatory authority (vaccines, biologicals) # DE-PEI-PEI2007008988 and described the occurrence of acute vestibular syndrome in a 42-year-old male subject who was vaccinated with Twinrix adult, GlaxoSmithKline. The regulatory authority has received this case via a agency by an unknown physician. The reporting physician was also the consumer. The physician was self-vaccinating. On 27 August 2007 the subject received an unspecified dose of Twinrix adult (1 ml, intramuscular, unknown application site). There was no complaint concerning the pharmaceutical quality of Twinrix adult. Approximately two days post vaccination with Twinrix adult, on 29 August 2007, the subject experienced acute vestibular syndrome with complete loss of equillibrium .This case was assessed as medically serious by a GSK physician. At the time of reporting the outcome of the events were unspecified. No further information will be available.

VAERS ID:291933 (history)  Vaccinated:2007-08-27
Age:15.0  Onset:2007-08-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-02, Days after onset: 36
Location:Foreign  Entered:2007-10-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified)
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electrocardiogram 27AUg07 Comment: slightly elongated QT duration; WBC count 27Aug07 7.4; hemoglobin 27Aug07 12.9 g/dl; serum C-reactive protein 27Aug07 2.1 mg/dl
CDC Split Type: WAES0709USA04086
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein normal, Electrocardiogram QT prolonged, Haemoglobin normal, Hypersensitivity, Syncope, White blood cell count normal
SMQs:, Torsade de pointes/QT prolongation (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority, concerning a 15 year old female patient, who on 27-AUG-2007 was vaccinated with the first dose of Gardasil (lot# not provided). Concomitant therapy included hormonal contraceptives (unspecified). On 27-AUG-2007, a "short time" after the vaccination and while leaving the physician''s office, she experienced an episode of syncope, and a second episode "while on the way back." She was hospitalized for monitoring and evaluation. Treatment included Ringer''s solution, penciclovir (FENISTIL), prednisolon (SOLU-MEDROL) and antihistamine (CIMEBEXAL), for suspicion of an allergic reaction. The only pathological finding was en elongated QT duration on the electrocardiogram (ECG). The patient left the hospital after a few hours, against the physician''s advice, though she was considered to be recovered. The hospital physician recommended a Schellong-Test and continued ECG evaluation. 27-Aug-2007 electrocardiogram, slightly elongated QT duration 27-Aug-2007 white blood cell count, 7.4 27-Aug-2007 blood hemoglobin test, 12.9 g/dl 27-Aug-2007 serum C-reactive protein test, 2.1 mg/dl The file is closed. Other business partner numbers include: E2007-06236 and PEI2007008833.

VAERS ID:293085 (history)  Vaccinated:2007-08-27
Age:20.0  Onset:2007-09-20, Days after vaccination: 24
Gender:Female  Submitted:2007-10-12, Days after onset: 22
Location:Foreign  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: magnetic resonance imaging Comment: hypersignals in the white matter; spinal tap Comment: normal
CDC Split Type: WAES0710USA02244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaesthesia, Lumbar puncture, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a physician concerning a 20 year old female with no relevant medical history who on 27-AUG-2007 was vaccinated intramuscularly into the left deltoid with a first dose of Gardasil. There was no concomitant medications. On 20-SEP-2007 twenty-four days after vaccination, the patient developed anesthesia, then saddle paresthesia and paresthesia of the lower limbs. The patient was hospitalized for work-up. Magnetic resonance imaging (MRI) showed hypersignals in the white matter. Lumbar puncture was normal. The diagnosis of confirmed multiple sclerosis (MS) was found in the hospitalization report. At the time of the report the patient had not recovered. The reporting physician did not believe that MS was related to vaccination with Gardasil. The reporting physician considered MS to be serious due to disability and hospitalization. No further information is available. Other business partner numbers included E2007-06744.

VAERS ID:295004 (history)  Vaccinated:2007-08-27
Age:0.3  Onset:2007-08-27, Days after vaccination: 0
Gender:Male  Submitted:2007-10-29, Days after onset: 63
Location:Foreign  Entered:2007-10-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had similar ADR after previous vaccinations.
Diagnostic Lab Data: not reported
CDC Split Type: 200703498
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURERB01921IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB01271IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Cyanosis, Dyspnoea, Incorrect route of drug administration, Injection site erythema, Injection site oedema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities on 17 October 2007. A 03-month old male patient with no reported medical history, had received a second intramuscular dose of Imovax Polio, batch number B0127 and a second intramuscular dose of Diftetkok (MFR UNK), batch number B0192, on 27 August 2007. According to the reporter, Diftetkok was injected incorrectly since it should be administered intradermally. A few hours post-vaccination, the patient experienced high temperature injection site redness and oedema. He also cried more than 3 hours. On 27 August 2007, the patient also experienced dyspnea and cyanosis. He had similar ADR after previous vaccinations. The patient was hospitalized on unspecified dates. He recovered. this case was assessed as clinically significant.

VAERS ID:295848 (history)  Vaccinated:2007-08-27
Age:0.2  Onset:2007-08-28, Days after vaccination: 1
Gender:Male  Submitted:2007-11-05, Days after onset: 69
Location:Foreign  Entered:2007-11-07, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No concurrent illnesses.
Preexisting Conditions: No known allergies, no pre-existing medical history. He had received the 1st intramuscular dose of Hepatitis B vaccine on 27 June 2007, BCG vaccine on 28 June 2007, and the 2nd dose of Hepatitis B on 30 July 2007. The patient had not experienced any adverse events following prior vaccinations.
Diagnostic Lab Data: Lab test revealed: WBC 17.36*10^9/L on blood routine test; B Ultrasonograph showed obvious abdominal distension.
CDC Split Type: 200703591
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR10930IMGM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER200606010PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, CSF test normal, Cerebral haemorrhage, Convulsion, Demyelination, Foaming at mouth, Gaze palsy, Hyperreflexia, Hypokinesia, Hypotonia, Immunodeficiency, Immunoglobulins decreased, Muscle twitching, Nervous system disorder, Nuchal rigidity, Pupil fixed, Pyrexia, Reye's syndrome, Ultrasound abdomen abnormal, White blood cell count increased
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Report received from a healthcare professional on 25 October 2007 via our company representative. A 02-month-old male patient, with no relevant medical history, had received in the morning of 27 August 2007 the 1st dose of Act-Hib, lot reported as "?1093-2" intra-muscularly in the buttock associated with OPV. In the afternoon of 28 August 2007, he experienced fever at 38.5C. After treatment as an outpatient in local healthcare unit, the temperature dropped to normal. On 01 September 2007, the patient presented with eyes fixation, left extremities twitch, right extremities movement decreased and foaming at the mouth. Then the patient was admitted to hospital for further treatment and diagnosis. On 01 September 2007, the physical examination showed: T= 37C, R= 40, P= 120, vomit-milk, extremities muscle power normal, left extremities decreased muscular tone, neck rigidity, knee jerk hyperreflexia, Babinski sign positive. Lab test revealed: WBC 17.36*10^9/L on blood routine test; B Ultrasonograph showed obvious abdominal distension. Preliminary Diagnosis were : 1. central nervous system infection; 2. Intracranial hemorrhage, 3 Convulsion due to brain develop defects, 4 blood poisoning, 5 Reye syndrome. Then the patient received treatment for central nervous system purulent infection on 02 September 2007, but on 03 September 2007, the result of cerebrospinal fluid was normal, and purulent meningitis was excluded. Total immunoglobulin was less than 4g/L, suggesting the possibility of immunodeficiency. On 04 September 2007, he had neck rigidity. Muscle power 3 degree in right lower extremity, left and right upper extremities muscle power was normal. On 05 September 2007, it was noted muscle power 2 degree in the right lower extremity. On 07 September 2007, he presented with muscle power 3 degree in right lower extremity, right knee jerk hyporeflexia. On 08 September 2007, he had muscle power 4 degree in right lower extremity, right knee jerk hyporeflexia. Doctor considered whether there was demyelination following immun

VAERS ID:296539 (history)  Vaccinated:2007-08-27
Age:14.0  Onset:2007-08-27, Days after vaccination: 0
Gender:Female  Submitted:2007-11-12, Days after onset: 77
Location:Foreign  Entered:2007-11-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0711USA01511
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fall, Head injury, Immediate post-injection reaction, Muscle twitching, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 14 year old female who on 27-AUG-2007 was vaccinated with a first dose of Gardasil (lot # unknown) IM in the deltoid muscle. There was no concomitant medication. On 27-AUG-2007, immediately post-vaccination the patient fainted and "twitched" with arms and legs for about 30 seconds. She fell down and injured her head. Due to this she was admitted to the hospital. The patient recovered and was discharged after about one week. Additional information is not expected. Other business partners included are: E2007-07626.

VAERS ID:298467 (history)  Vaccinated:2007-08-27
Age:0.2  Onset:2007-08-27, Days after vaccination: 0
Gender:Male  Submitted:2007-11-29, Days after onset: 94
Location:Foreign  Entered:2007-12-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: On 21 September 2007, lab tests showed WBC 7.8 X 10^9/L, neut 3.7%, RBC 3.68 X 10^12/L, Hgb 104 g/L, hct 30.0%, MCH 28.3 pg, plt 281 X 10^9/L. On 21 September 2007, stool examination revealed yellow loose stools. On 24 September 2007, lab t
CDC Split Type: 200703913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURA02180UNUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Crying, Culture stool positive, Diarrhoea, Faeces discoloured, Granulocyte count increased, Haematocrit decreased, Haemoglobin decreased, Injection site erythema, Injection site induration, Injection site swelling, Lymphocyte count increased, Mean cell haemoglobin concentration, Mean cell haemoglobin normal, Mucous stools, Neutrophil count increased, Neutrophil count normal, Platelet count normal, Pyrexia, Red blood cell count normal, Stool analysis abnormal, White blood cell count
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received on 19 November 2007. A 02-month-old male patient, with no reported medical history, had received his 1st dose of Act-Hib, batch number A0218-1 and his 1st dose of OPV (MFR UNK, batch number not reported) on 27 August 2007. On 27 August 2007, in the night, the patient experienced fever at 37.9-38.1 C for 1 week, injection site redness, injection site swelling and injection site induration (3 X 3 cm). The patient was treated in the clinical department as an out-patient for anorexia (1 week), loose stools with little mucus on 21 September 2007. On 21 September 2007, lab tests showed WBC 7.8 X 10^9/L, neut 3.7%, RBC 3.68 X 10^12/L, Hgb 104 g/L, hct 30.0%, MCH 28.3 pg, plt 281 X 10^9/L. On 21 September 2007, stool examination revealed yellow loose stools. On 24 September 2007, lab tests showed WBC 8.2 X 10^9/L, neut 9.5%, RBC 3.98 X 10^12/L, Hgb 112 g/L, hct 32.7%, MCG 28.1 pg, plt 296 X 10^9. On 08 October 2007, lab tests showed WBC 6.9 X 10^9/L, neut 9.0%, AC 1.0%, RBC 4.19 X 10^12/L, Hgb 114 g/L, hct 33.7%, MCH 27.2 pg, plt 274 X10^9/L. On 22 October 2007 (in another hospital), lab tests showed WBC 5.4 X 10^9/L, gran 0.8 X 10^9/L, gran-R 0.15%, Lymph 4.1 X10^9/L, Lymph-R 0.75%, RBC 4.09 X 10^12/L, Hgb 124 g/L, hct 0.329%, MCH 30.3 pg, MCHC 377 g/L, plt 263 X 10^9/L, PDW 12.5. On 24 October 2007 (in another hospital), lab tests showed WBC 7.3 X 10^9/L, neut 8.3%, RBC 4.31 X 10^12/L, Hgb 114 g/L, hct 33.9%, MCG 26.9 pg, MCV 78.7 pg, plt 274 X 10^9/L. The patient also experienced anorexia and crying on an unspecified date. The patient received unknown agents from 27 August 2007 as an out-patient. The outcome was not reported. Upon internal review, this case was upgraded to serious.

VAERS ID:304281 (history)  Vaccinated:2007-08-27
Age:0.3  Onset:2007-08-27, Days after vaccination: 0
Gender:Male  Submitted:2008-02-04, Days after onset: 161
Location:Foreign  Entered:2008-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 27Aug2007 38.2Deg C
CDC Split Type: B0505662A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS    
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA320B IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Febrile convulsion, Muscle spasms, Musculoskeletal stiffness, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of febrile convulsion in a 3-month-old male subject who was vaccinated with combined Infanrix-polio-HIB for prophylaxis. On 27 August 2007, the subject received unspecified dose of Infanrix-polio-HIB (intramuscular, unknown injection site). On 27 August 2007, 6 hours after vaccination with Infanrix-polio-HIB, the subject experienced febrile convulsion (38.2 Deg C) with pallor and stiffness without shaking. The mother assessed the events as cramps. The elevated temperature persisted during the night and the following day. The subject was hospitalised. At the time of reporting the events were resolved. The regulatory authority reported that the events were probably related to vaccination with Infanrix-polio-HIB.

VAERS ID:308872 (history)  Vaccinated:2007-08-27
Age:17.0  Onset:2007-10-16, Days after vaccination: 50
Gender:Female  Submitted:2008-04-03, Days after onset: 170
Location:Foreign  Entered:2008-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: electroencephalography ??Oct07 Comment: without pathologies; sleep study ??Oct07 Comment: without pathologies
CDC Split Type: WAES0804USA00532
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537F0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electroencephalogram normal, Myoclonus, Sleep study normal
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad)
Write-up: Information has been received from a health authority concerning a 17 year old female patient who on 27-AUG-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 1537F; Batch# NP37110). On 16-OCT-2007 and on 18-OCT-2007 the patient experienced rhythmic myoclonias lasting for about three hours. The patient was successfully treated with RIVOTRIL. The patient was hospitalized for check up on 18-OCT-2007. Electroencephalography and sleep deprivation electroencephalography were without pathologies. Subsequently, the patient recovered. It was reported that the patient received the second (and probably also the third) dose of Gardasil, no adverse effect was observed. The patient had well tolerated previous vaccinations in infancy and childhood. Other business partner numbers include: E200802619 and PEI2008002767. Additional information is not expected. This case is closed.

VAERS ID:324902 (history)  Vaccinated:2007-08-27
Age:15.0  Onset:2007-09-14, Days after vaccination: 18
Gender:Female  Submitted:2008-07-03, Days after onset: 293
Location:Foreign  Entered:2008-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: ultrasound, 13May08, joint sonography: no signs for arthritis in examined joints; electrocardiogram, 13May08, no pathological findings; transthoracic echocardiography, 13May08, slight mitral insufficiency; magnetic resonance imaging, 14May0
CDC Split Type: WAES0806USA03499
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Aphthous stomatitis, Appendicectomy, Appendicitis, Arthralgia, Arthritis, Arthropathy, Back pain, Blood immunoglobulin A increased, Blood iron decreased, Bone pain, C-reactive protein increased, Culture stool negative, Echocardiogram, Echocardiogram abnormal, Electrocardiogram normal, Enthesopathy, Fibrin D dimer increased, HLA marker study, Iron deficiency, Juvenile arthritis, Lymphadenopathy, Mastication disorder, Meningism, Microcytic anaemia, Mobility decreased, Night sweats, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Transferrin saturation decreased, Ultrasound scan normal
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a general practitioner concerning a 15 year old female who in springtime 2008 was vaccinated with a dose of GARDASIL. Subsequently the patient experienced meningism from which she recovered within a not reported time. Afterwards the patient developed rheumatic disease (not otherwise specified) and was hospitalised (exact date not yet reported). At the time of reporting the patient was not recovered. Follow up information has been received. On 11-APR-2008, the patient was vaccinated with a 3rd dose of GARDASIL. She underwent an appendectomy due to appendicitis starting on 12-APR-2008. She also complained about pain in mandibular joint and difficulty in mastication. In the course swelling of feet and she was unable to walk. Concomitantly the patient complained about enlarged axillary lymph nodes, oral aphthae and night sweat. The patient was hospitalised from 13-MAY-2008 to 15-MAY-2008 due to suspicion of juvenile rheumatic disease. Symptoms had started about 1 year ago with relapsing pain in cervical spine and pain in knee. Due to increased ESR and IgA values (see lab date) differential diagnoses of a chronic gastrointestinal inflammation with extraintestinal manifestation and a reactive arthritis couldn''t be definitely ruled out. Under treatment with VOLTAREN symptoms improved notedly. A check up in the rheumatological outpatient department was arranged in six weeks. The patient was told to continue the medication with VOLTAREN and physiotherapy. Upon medical letter dated 05-JUN-2008 the following diagnoses were established: multiple joint disorders (symptoms included arthritis, mobility decreased, juvenile rheumatoid arthritis, pain in joint, mastication disorder, unable to walk, swelling of feet); microcyteic anaemia, iron deficiency, enthesopathy and mandibular joint arthritis. No further information is available. The case was closed. Other business partner numbers included E2008-05437.

VAERS ID:321008 (history)  Vaccinated:2007-08-27
Age:16.0  Onset:2008-02-20, Days after vaccination: 177
Gender:Female  Submitted:2008-07-31, Days after onset: 161
Location:Foreign  Entered:2008-08-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Paraesthesia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00277
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0734U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Central nervous system lesion, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form concerning a 16 year old female with a history of vague episode of paraesthesia (2004) who on 27-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot No. 655743/0313U, Batch No. J1022, Expiry date, 08-AUG-2009). On 25-OCT-2007, she was vaccinated with the second dose of GARDASIL (Lot No. 657874/0582U, Batch No. J2299, Expiry date 26-FEB-2010). On approximately 18-FEB-2008, she was vaccinated with the third dose of GARDASIL (Lot No. 658214/0734U, Batch No. J2895, Expiry date 13-MAR-2010). On 20-FEB-2008 the patient experienced headache, central nervous system lesion and paraesthesia. It was described that approximately 2 days post vaccination with the third dose of the vaccine, the patient developed headache then 2 days later developed spinal sensory syndrome and paraesthesia. The patient was referred to a neurologist who identified particularly aggressive multiple lesions. On 20-JUN-2008, the patient''s outcome was unknown. The agency considered that headache, central nervous system lesion and paraesthesia were possibly related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the events to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:452418 (history)  Vaccinated:2007-08-27
Age:0.0  Onset:0000-00-00
Gender:Male  Submitted:2012-03-23
Location:Foreign  Entered:2012-03-26, 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: WAES1203USA01477B1
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Foetal disorder, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received from a consumer (local reference number MHKG-12-0025, DPOC number HK-12-000150), for GARDASIL, a Pregnancy Registry product, concerning her 0 day old son, whose mother on 27-AUG-2007, was vaccinated with the first dose of GARDASIL (lot number, dose and route not reported) and on 23-OCT-2007, was vaccinated with the second dose of GARDASIL (lot number, dose and route not reported). The mother reported that she discovered she was pregnant in January 2008. On an unspecified date, the mother was examined on 4th month of pregnancy and it was discovered that the fetus had deletion at chromosome 21. The baby boy birth pre-term at 36 weeks gestation ( 9 months), on an unspecified date. The baby encountered harelip and cleft palate at birth. It was noted that at the time of the report the boy was 3.5 years old and had developmental delay. The consumer stated that both her and her husband did not have "such chromosome defect". At the time of the report the baby boy''s events persisted. The events of deletion at chromosome 21, birth pre-term at 36 weeks gestation, harelip, cleft palate and developmental delay were considered to be congenital anomalies by the baby''s mother. The reporter felt that deletion at chromosome 21, birth pre-term at 36 weeks gestation , harelip, cleft palate and developmental delay were possibly related to GARDASIL. The mother''s experience has been captured in WAES 1203USA01477. Additional information is not expected.

VAERS ID:551244 (history)  Vaccinated:2007-08-27
Age:52.0  Onset:2007-10-01, Days after vaccination: 35
Gender:Female  Submitted:2014-10-20, Days after onset: 2576
Location:Foreign  Entered:2014-10-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 08/11/2003, STAMARIL; 08/11/2003, REVAXIS; 02/1995, Arthralgia; 02/1995, Polyarthritis; 11/22/1993, GENHEVAC B, 1st dose; GENHEVAC B, 2nd dose; GENHEVAC B, 3rd dose; 11/14/1994, GENHEVAC B, 4th dose; 11/17/1999; GENHEVAC B, booster dose
Diagnostic Lab Data: 09/2008, Biopsy, Macrophagic myofasciitis
CDC Split Type: FR2014GSK005471
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB147AA0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Biopsy site unspecified abnormal, Fatigue, General physical health deterioration, Myalgia, Myofascitis, Pain, Polyarthritis, Rheumatoid arthritis
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of macrophagic myofasciitis in a 52-year-old female patient who received HAVRIX (batch number AHAVB147AA, expiry date unknown). The patient''s past medical history included joint pain and inflammatory polyarthritis. Previously administered products included GENHEVAC B (1st dose), GENHEVAC B (2nd dose), GENHEVAC B (3rd dose), GENHEVAC B (4th dose), GENHEVAC B (booster dose), STAMARIL and REVAXIS. On 27th August 2007, the patient received the first dose of HAVRX (intramuscular). In October 2007, 61 days after receiving HAVRIX, the patient experienced rheumatoid polyarthritis (serious criteria GSK medically significant), chronic pain, chronic fatigue, joint pain and muscle pain. On an unknown date, the patient experienced macrophagic myofasciitis (serious criteria disability). On an unknown date, the outcome of the macrophagic myofasciitis, rheumatoid polyarthritis, chronic pain, chronic fatigue, joint pain and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the macrophagic myofasciitis, rheumatoid polyarthritis, chronic pain, chronic fatigue, joint pain and muscle pain to be related to HAVRIX. Additional information provided was: From 1993 to 1994 (national vaccination campaign against hepatitis B), the patient received requisite doses. The patient was vaccinated with GENHEVAC B (1st dose) on 22 November 1993, GENHEVAC B (2nd dose and 3rd dose) on unspecified date. In February 1995, the patient suddenly experienced very severe joint pain. After months of wandering, general practitioner sent patient to a rheumatologist at hospital. After examination, an inflammatory polyarthritis was diagnosed. In addition, the patient continued to receive doses of GENHEVAC B (4th dose) on 14 November 1999, GENHEVAC B (booster dose) on 17 November 1999, STAMARIL and REVAXIS on 11 August 2003. On 27th August 2007, the patient received the 1st dose of HAVRIX (intramuscular). In October 2007, the patient experienced very severe muscular and joint pains associated with a severe general fatigue. Physician thought it was a recurrence, stronger than the previous ones of polyarthritis. The patient consulted rheumatologist as there was no improvement in the symptoms. After investigations, the rheumatologist disadvised to receive the 2nd dose of hepatitis A vaccine. In September 2008, biopsy showed a macrophagic myofasciitis. There was no curative treatment and patient''s problems were ongoing. The patient''s general health state was going from bad to worse. Pains and fatigue persist leading to numerous sick leaves and recognition of disabled worker status. The patient did not receive more vaccination containing aluminum. The patient was significant handicap in daily and professional activities. The patient had difficulties to move, had severe chronic pains and bad general health state with very severe fatigue.

VAERS ID:289241 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-08-28, Days after onset: 0
Location:Minnesota  Entered:2007-08-28
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: anaphylaxis to gummy bears, unknown substance.Caniosynostosis.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2606AA4IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA0IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURZ10093IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0787U3062U0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Eye swelling, Lip swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient was given DTAP, MMR/Varicella (combined vaccine), IPV and Hepatitis A. Approximately 15min after injections developed swelling of eyes and lips. He developed hives and diffuse erythema. No skin changes at the local sites of injections.

VAERS ID:289243 (history)  Vaccinated:2007-08-28
Age:15.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-28, Days after onset: 0
Location:California  Entered:2007-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.MSD 0012U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematoma, Muscle twitching, Syncope, Tooth injury
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: 3 to 5 second Syncopal episode after HPV vaccine given. Twitching of right arm noted, recovered alertness quickly after postictel. Hematoma left brow/temple and chipped left lower incisor. NV intact. Observed patient for 1 hour. Had not had a meal in 15 hours(skipped breakfast).

VAERS ID:289274 (history)  Vaccinated:2007-08-28
Age:11.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-28, Days after onset: 0
Location:Pennsylvania  Entered:2007-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hashimoto''s Disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB179AA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2157BA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B009BA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0833111UNLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Syncope after immunization administration.

VAERS ID:289319 (history)  Vaccinated:2007-08-28
Age:14.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-29, Days after onset: 0
Location:Tennessee  Entered:2007-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depakote 125 mg; Allegra 30mg PO BID; Nasacort and Albuterol MDI''s
Current Illness: None
Preexisting Conditions: Allergies, Seizures, ADD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2223AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0517U1SCLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2cm x 4cm area that is red and swollen. Parent just noticed today and brought her straight in at 3:30 PM (8/29/07). Pt denied any other symptoms. Vital signs normal. Keflex was given, pt''s parent instructed to watch and if gets any worse call Dr. or go to ER.

VAERS ID:289337 (history)  Vaccinated:2007-08-28
Age:25.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-29, Days after onset: 1
Location:Virginia  Entered:2007-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER000000000000 UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER000000000000 UNUN
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: Patient was given Anthrax, PPD and TDAP without her HCG results. Patient is pregnant.

VAERS ID:289347 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-29, Days after onset: 1
Location:Texas  Entered:2007-08-29
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Milk and egg allergies, extreme sensitivity. Cold induced Asthma. PMH: prior allergic reaction, anaphylaxis, asthma Allergies: dairy, egg, septra, omnicef, Pcn.
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2657AA4IDLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB181AA1IDRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURZ10O91IDRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1006U1IDLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Chest pain, Cough, Hypersensitivity, Increased upper airway secretion, Pharyngeal oedema, Pyrexia, Urticaria, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Anaphylaxis, throat swelling causing coughing, wheezing, chest pain, mucous drainage within 10 minutes of the shots given. Patient recieved Epi jr., albuterol through a spacer and two tablets of benadryl. Then she had xeponex through a nebulizer. She stabilzed. Enroute to ER to be observed, Anaphlaxis occured again, with body hives, wheezing, coughing and she also had a high fever. She recieved another breathing treatment with ALbuterol and an Epi Jr once again. Oxygen was then given and she was admitted to ER. She was then give IV steroids and Motrin for fever. She was evaluated 6 hours and released. She is still running high fever and is on antihistimines. 8/31/07 Received vax record from pcp which corrected vax info. VAERS database updated w/same. 10/26/07 Received hospital medical records which reveal patient experienced coughing, vomited, wheezing , & increased phlegm. Seen in ER 8/27/07 from pcp office. Had already received repeat epi pen prior to arrival along with orapred, nebs, O2 & benadryl. Tx w/additional IV steroids & benadryl. Improved & d/c to home from ER. FINAL DX: acute allergic reaction.

VAERS ID:289382 (history)  Vaccinated:2007-08-28
Age:11.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 1
Location:Michigan  Entered:2007-08-30
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: ALLERGIES: AMOXICILLIN, ZINC
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2491AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0089U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: PT NOTICED LOCALIZED EDEMA AND ERYTHEMIA ONE DAY AFTER INOCULATION (PT VISIT WAS 2 DAYS AFTER INOCULATION). NO PAIN OR TENDERNESS TO AREA. PT WAS AFEBRILE. INPECTION REVEALED LOCAL AREA TO BE 14.5 CM. NO ASSOCIATED SXS. PT WAS TREATED WITH CEPHALEXIN 500MG, TID, F10D. WILL RETURN TO CLINIC IS SXS ARE DO NOT RESOLVE.

VAERS ID:289399 (history)  Vaccinated:2007-08-28
Age:15.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-30, Days after onset: 2
Location:New York  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2370AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0605U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness and swelling left arm for 2 days.

VAERS ID:289419 (history)  Vaccinated:2007-08-28
Age:42.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Male  Submitted:2007-08-30, Days after onset: 0
Location:North Carolina  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1104UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large redness and swelling size of arm. Warm to touch.

VAERS ID:289421 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Female  Submitted:2007-08-30, Days after onset: 0
Location:Georgia  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2744BA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10693UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0424U1UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1028U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, swollen spot on left arm.

VAERS ID:289433 (history)  Vaccinated:2007-08-28
Age:12.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 1
Location:Washington  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0800U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2359AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1023U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient''s right arm became swollen and warm to the touch on 8/29/07. Patient also c/o "itchy" feeling.

VAERS ID:289434 (history)  Vaccinated:2007-08-28
Age:10.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-08-30, Days after onset: 2
Location:Washington  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: VIRAL URI WITH FEVER
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1023U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient''s left arm became swollen and warm to the touch the evening the vaccine was administered.

VAERS ID:289436 (history)  Vaccinated:2007-08-28
Age:0.2  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 1
Location:California  Entered:2007-08-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac sice 1 month of age.
Current Illness: None
Preexisting Conditions: GERD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.97143010PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying, Diarrhoea, Proctalgia, Rash erythematous, Screaming
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: About 30 hours after our daughter recieved the Rota Teq oral vaccine, she got diarrhea accompanied by a bright red rash around her anus. The rash is extremely painful when touched or when she has a bowel movement, which leads to her screaming and crying for about 30 min each time. There was previously absolutely no rash in the affected area. There were no other changes in diet or routine except Rota Teq oral vaccine.

VAERS ID:289593 (history)  Vaccinated:2007-08-28
Age:13.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-01, Days after onset: 3
Location:New York  Entered:2007-08-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: hirsutism
Preexisting Conditions: Atopic dermatitis; Ninsulism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056CA5IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURH2276BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC288AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Hirsutism, Oedema peripheral, Wrong drug administered
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)
Write-up: Right arm mildly swollen. Seen yesterday measure 33cm diameter. Left arm 32 cm Menactra given and in the same arm DTaP. aware d/emor stole let know.

VAERS ID:289595 (history)  Vaccinated:2007-08-28
Age:11.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-31, Days after onset: 2
Location:Minnesota  Entered:2007-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: WBC
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1029U1UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Headache, Myalgia, Pyrexia, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had fever, cephalgia and myalgias 24 hrs after vaccines.

VAERS ID:289597 (history)  Vaccinated:2007-08-28
Age:25.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-31, Days after onset: 3
Location:Virginia  Entered:2007-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Alesse OCP''s
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U1 LA
Administered by: Public     Purchased by: Private
Symptoms: Burning sensation, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Left deltoid region began burning (by patient history I did not witness) and hurting went to ED by car at 11:55 PM.

VAERS ID:289600 (history)  Vaccinated:2007-08-28
Age:13.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Male  Submitted:2007-08-30, Days after onset: 0
Location:Illinois  Entered:2007-08-31, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2688AA  RA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1014U1 RA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right arm red swollen slightly tender and small area and induration. Erythema 6" x 4"

VAERS ID:289601 (history)  Vaccinated:2007-08-28
Age:0.2  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-31, Days after onset: 2
Location:North Carolina  Entered:2007-08-31
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: Labs on 8/31/07 normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B110AB0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0065U0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB55845F0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0968U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Agitation, Diarrhoea, Irritability, Laboratory test normal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)
Write-up: Developed vomiting and fussiness. Later developed diarrhea (not bloody). Went to ED on 8/30 not dehydrated.

VAERS ID:289609 (history)  Vaccinated:2007-08-28
Age:4.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-08-30, Days after onset: 1
Location:North Carolina  Entered:2007-08-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2289AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08723SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0806F1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0336U1SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythematous swelling at site of injection.

VAERS ID:289610 (history)  Vaccinated:2007-08-28
Age:78.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 1
Location:Massachusetts  Entered:2007-08-31, 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: VERAPAMIL, CEFUROXIME, LISINOPRIL, HCT, FESO4
Current Illness: Pneumonia
Preexisting Conditions: HTN, S/P Breast cancer, cataracts, dyslipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1229F1IM 
Administered by: Private     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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling and redness upper arm

VAERS ID:289726 (history)  Vaccinated:2007-08-28
Age:14.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-08-30, Days after onset: 2
Location:California  Entered:2007-09-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Kepra
Current Illness: None
Preexisting Conditions: Epilepsy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: pain at injection site 2 days later. No s/s of infection or erythema. No treatment needed

VAERS ID:289736 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-08-28, Days after onset: 0
Location:Oregon  Entered:2007-09-04, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2059AA3IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ030623IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0911U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Cough, Eye irritation, Eye swelling, Ocular hyperaemia, Sneezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Glaucoma (broad), Corneal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 6:30 pm coughing, sneezing-p 88 res no redness swelling warmth 6:45 pm P 88R, Reg unlabored breathing. No change 25 mg po Benadryl po given 7:10 pm 82/58, 90R, unlabored resp-started sneezing, rubbing eyes, eyes puffy and blood shot. 2.5 ml Epinephrine SC (L) arm. Improvement with redness in minutes. Paramedics arrived no further meds given at health department

VAERS ID:289860 (history)  Vaccinated:2007-08-28
Age:81.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Female  Submitted:2007-09-05, Days after onset: 6
Location:Florida  Entered:2007-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.97334011IMLA
Administered by: Public     Purchased by: Public
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Area of injection red and swollen, sore to touch.

VAERS ID:289869 (history)  Vaccinated:2007-08-28
Age:8.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-05, Days after onset: 7
Location:New Mexico  Entered:2007-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1024U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient brought in to Clinic on 8/29/2007. Noted 3x3 cm induration with redness and itching to posterior aspect of right arm at injection site. Per parent had gradually gotten worse over 24 hours. Patient evaluated by Dr. and treated with Benadryl po and Keflex. Upon follow up after 24 hours treatment, parents stated patient doing better. Follow up after 5 days, completely resolved.

VAERS ID:290029 (history)  Vaccinated:2007-08-28
Age:1.3  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-09-06, Days after onset: 8
Location:Tennessee  Entered:2007-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB175AA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1436F3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845B3IMRL
Administered by: Public     Purchased by: Public
Symptoms: Abnormal faeces, Pyrexia, Rash, Roseola
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever of 102-103 on 8/30/07. mon states child had foul bm''s & fine rash in groin area on 9/3/07. continued with fever 9/5/05. afebrile at this time but woke with fine rash over entire body and along the hairline. Pediatrician feels that the DX is roseola.

VAERS ID:290041 (history)  Vaccinated:2007-08-28
Age:1.3  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-08-30, Days after onset: 1
Location:West Virginia  Entered:2007-09-06, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF111AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0427F0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47442C3IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0722U0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red and swollen bilat. thigh worse on right. Diagnosed with cellulitis; treated with Cephalexin 125mg.

VAERS ID:290045 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Female  Submitted:2007-08-30, Days after onset: 0
Location:New York  Entered:2007-09-06, 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:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B033AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR0425F3SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.Z03241IMRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: erythema, increased warmth, sl. tender at injection site: left upper lat. arm/deltoid injected 2 days ago; tx: antibiotics NSAID, ice prn

VAERS ID:290049 (history)  Vaccinated:2007-08-28
Age:4.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Female  Submitted:2007-08-30, Days after onset: 0
Location:Washington  Entered:2007-09-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSC265AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0441N SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Condition aggravated, Eczema, Injection site erythema, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received DTaP in LA thigh 8/28/07 she comes in today with erythema at the site, an area of 4 x 4 cm. Rash on chest since this AM act eczema on hands-Benadryl 12.5 mg PO given

VAERS ID:290052 (history)  Vaccinated:2007-08-28
Age:6.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-08-29, Days after onset: 1
Location:Oklahoma  Entered:2007-09-06, 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: Singulair 4 mg
Current Illness: None
Preexisting Conditions: NKDA, Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0125U1IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Given Varivax at medical center. Left office and returned with emesis approx 10 min after shot Emesis -$g urticaria-$g 25 mg Benadryl given. VSS throughout. D/C with rash. Completely resolved by A.M.

VAERS ID:290055 (history)  Vaccinated:2007-08-28
Age:0.4  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-08-30, Days after onset: 1
Location:Massachusetts  Entered:2007-09-06, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B110AB1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUE958AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08679K1UNLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (R) thigh 0.5 cm in diameter red raised nodule (L) thigh 0.25 cm in diameter red raised nodule

VAERS ID:290063 (history)  Vaccinated:2007-08-28
Age:6.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-08-29, Days after onset: 1
Location:Missouri  Entered:2007-09-06, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10693IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0417U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1111R0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Eye swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Within 5-10 of receiving vaccinations client c/o itching feet and eyes, eyes became puffy after 5 mins-client given 25mg diphenhydramine SQ-itching subsided within 20 mins

VAERS ID:290086 (history)  Vaccinated:2007-08-28
Age:0.4  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-09-05, Days after onset: 8
Location:Illinois  Entered:2007-09-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC218132BA1IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1127F1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300C1IMRL
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp 102.5 w/i 24 hours of vaccine.

VAERS ID:290087 (history)  Vaccinated:2007-08-28
Age:1.5  Onset:2007-08-30, Days after vaccination: 2
Gender:Male  Submitted:2007-09-05, Days after onset: 6
Location:Illinois  Entered:2007-09-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056RA3IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1127F2IMRL
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Injection site erythema
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Possible allergic rx 5-6 cm erythema at DTaP site.

VAERS ID:290088 (history)  Vaccinated:2007-08-28
Age:0.4  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-09-05, Days after onset: 7
Location:Illinois  Entered:2007-09-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132BA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1127F1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300C1IMRL
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp 102.8 24 hours post immunization.

VAERS ID:290094 (history)  Vaccinated:2007-08-28
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2007-09-06
Location:Unknown  Entered:2007-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1280F0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Hepatitis A given at 2 months old by mistake. Needed Hepatitis B #2.

VAERS ID:290095 (history)  Vaccinated:2007-08-28
Age:6.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-09-06, Days after onset: 8
Location:Minnesota  Entered:2007-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Swelling and fever~DTaP (no brand name)~5~5~In Patient
Other Medications: Claritin 10mg Reditabs; Benefiber
Current Illness:
Preexisting Conditions: Cold induced urticaria Hx of peanut allergy - outgrown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1015U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccine given in left arm 8/28/07. Fever of 103 within 24 hours, swelling 14x14cm area with erythema on the left arm. Interventions Benadryl and Tylenol - swelling g x 5 days.

VAERS ID:290126 (history)  Vaccinated:2007-08-28
Age:1.4  Onset:2007-09-07, Days after vaccination: 10
Gender:Female  Submitted:2007-09-08, Days after onset: 1
Location:Pennsylvania  Entered:2007-09-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.098440UNLA
Administered by: Private     Purchased by: Private
Symptoms: Pallor, Rash, Rash maculo-papular, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Macular/papular rash - started face, neck, chest, arms, abdomen - progressing and + blanching, + clear nasal discharge.

VAERS ID:290223 (history)  Vaccinated:2007-08-28
Age:1.3  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-09-06, Days after onset: 9
Location:California  Entered:2007-09-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056DA3IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB346AB2IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.067U2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH47442F3IMRL
Administered by: Private     Purchased by: Other
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever to 104 and febrile seizure < 24 hours after vaccine administration. Seizure duration was about 15 minutes. Paramedics transferred patient to ER. Seizure resolved after PR versed administered.

VAERS ID:290254 (history)  Vaccinated:2007-08-28
Age:21.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-09-10, Days after onset: 13
Location:California  Entered:2007-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Patient seen at Hospital emergency department and diagnosed with syncopal episode, dehydration, and short PR interval.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2689AA5IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dehydration, Electrocardiogram PR shortened, Loss of consciousness, Muscle contractions involuntary, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Patient had large tonic muscular contraction throughout his body immediately following administration of Tdap which lasted approximately 1 minute. The patient was then unconscious for another minute. Patient then regained consciousness on his own. Transported to ER by ambulance.

VAERS ID:290288 (history)  Vaccinated:2007-08-28
Age:58.0  Onset:2007-09-10, Days after vaccination: 13
Gender:Female  Submitted:2007-09-11, Days after onset: 1
Location:Maine  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Local reaction only~Tetanus Toxoid (no brand name)~1~55~In Patient
Other Medications: Synthroid, Zocor, Attenolol
Current Illness: None
Preexisting Conditions: PCN- Hives, Had local reaction to Tetanus given in 2004. Unknown manufacturer.
Diagnostic Lab Data: Rubella titer Negative done on 8/9/2007 before vaccination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1028F SCLA
Administered by: Public     Purchased by: Private
Symptoms: Rash, Rubella antibody negative
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash over entire back

VAERS ID:290339 (history)  Vaccinated:2007-08-28
Age:7.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-30, Days after onset: 1
Location:New York  Entered:2007-09-12, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0651U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB0869080IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin nodule, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling, redness, tenderness 3x3ccm 7x5 cm (R) upper arm. 1.5 x 1.5cm lump over (R) upper arm.

VAERS ID:290351 (history)  Vaccinated:2007-08-28
Age:1.0  Onset:2007-08-31, Days after vaccination: 3
Gender:Male  Submitted:2007-09-12, Days after onset: 12
Location:New York  Entered:2007-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Platelet count = 15,000 on 9/4/07; 5,000 on 9/5/07; 71,000 on 9/6/07 following WinRho.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0495U0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184U0SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Petechiae, Platelet count decreased, Rash generalised
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed petechial rash over entire body on 8/31/2007, 3-4 days after immunization with MMR and Hep A vaccines. Otherwise asymptomatic, with no site of active bleeding. Seen by my in office on 9/4/07 and sent to ER at Hospital. Discharged home and seen by pediatric hematology at Hospital on 9/5/07 with rpeat platelet count = 5,000. Treated with WinRho but developed reaction - was admitted overnight for observation. Repeat platelet count 9/6/07 = 71,000. Discharged with follow-up 9/11/07.

VAERS ID:290673 (history)  Vaccinated:2007-08-28
Age:0.3  Onset:0000-00-00
Gender:Male  Submitted:2007-09-07
Location:Missouri  Entered:2007-09-17, Days after submission: 10
Life Threatening? No
Died? Yes
   Date died: 2007-09-02
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None PMH: Nasal congestion. Birth Hx: c-section. Mother smoker & diabetic.
Diagnostic Lab Data: Autopsy report pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2657AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF169AA1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10091SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB26510K1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0972U1PO 
Administered by: Private     Purchased by: Private
Symptoms: Autopsy, Pulse absent, Respiratory arrest, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: Sudden infant death. Family visiting relatives found baby unresponsive in crib. 6/13/08 Autopsy report states COD as SIDS. Report states patient traveled with family out of state over holiday w/e. Placed in portable crib for nap. Found unresponsive & cool approx 3 hrs later. CPR started & EMS called but no pulse or respirations.

VAERS ID:290687 (history)  Vaccinated:2007-08-28
Age:19.0  Onset:2007-09-05, Days after vaccination: 8
Gender:Female  Submitted:2007-09-16, Days after onset: 11
Location:Ohio  Entered:2007-09-17, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 19 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No significant illnesses
Diagnostic Lab Data: Gastroenteritis - abd pain - arm pain - surgical emergency 11/5/07-records received-Humeral X-ray confirm air subcutaneous and in muscle confirming diagnosis of necrotizing fascitis. Wound cultures positive for clostridium septicum.Colonscopy and endoscopy negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2394BA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Amputation, Clostridium difficile sepsis, Colonoscopy, Culture positive, Culture wound positive, Endoscopy normal, Gastroenteritis, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Necrotising fasciitis, Pain in extremity, Pyrexia, Surgery, Wound debridement, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Menactra given 8/28/07. 9/6/07 Necrotizing fascitis opposite arm from injection - organism Clostridium Septra resulting in amputation (R) arm, (R) scapula. 11/5/07-records received for DOS 9/7-9/26/07- DC DX: Right upper extremity necrotizing soft tissue infection. Seen in ED with 13 hours increasing pain, swelling redness and bruising RUE, inflammation began in posterior lateral arm prox to distal humerus and down to mid radius. Immediate surgical debridement included four quarter amputation and debridement and irrigation of chest wall musculature with clavicle excision. Post op day 1 repeat debridement of necrotic tissue and amputation. Per 60 day follow up: This young lady had Clostridium perfringens sepsis causing a necrotizing fascitis 1 wk after pneumococcal vaccination warranting R upper extremity amputation.

VAERS ID:290708 (history)  Vaccinated:2007-08-28
Age:0.1  Onset:2007-09-02, Days after vaccination: 5
Gender:Female  Submitted:2007-09-10, Days after onset: 8
Location:Florida  Entered:2007-09-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B124BA0UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.007540UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB4M300C0UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0972U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Abnormal behaviour, Crying
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Behavioral changes, inconsolable on day 6 after vaccines.

VAERS ID:290817 (history)  Vaccinated:2007-08-28
Age:24.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-09-18, Days after onset: 21
Location:Tennessee  Entered:2007-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Allergic reaction~DTaP (no brand name)~UN~1~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None noted at time -- patient later found out she had had allergy to DTAP as child.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2688AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Arthralgia, Musculoskeletal stiffness, Pyrexia, Similar reaction on previous exposure to drug
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The subject was vaccinated as a part of a clinical trial examining post-exposure antibiotic prophylaxis for pertussis. As a aprt of the study all persons, if eligible, receive the licensed Tdap vaccine. The subject was vaccinated by a member of the study team at 09:13 in the right deltoid on August 28, 2007. She had not experienced any adverse effects when evaluated at 09:18. Later that day she developed fever up to 102.5F, arthralgias, and a stiff neck, prompting her to present to the Emergency Department. She stated she was treated with intravenous fluids, analgesics, and antihistamines. She was discharged home from the Emergency Department. Her symptoms resolved within approximately 36 hours. Subject was screened for contraindications to vaccination at the time of enrollment. During screening, she reported no history of an allergic or adverse reaction to diphtheria, tetanus, or pertussis vaccines. Subsequent to the adverse event, the subject learned from her mother she had previously experienced a severe reaction to a tetanus, diphtheria, and pertussis vaccine as a child.

VAERS ID:290846 (history)  Vaccinated:2007-08-28
Age:9.0  Onset:2007-09-05, Days after vaccination: 8
Gender:Male  Submitted:2007-09-13, Days after onset: 8
Location:Maine  Entered:2007-09-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrocortisone 2.5% cream
Current Illness:
Preexisting Conditions: Obesity, anxiety, behavioral problems, Asperger disorder, eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1028U1 LA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pyrexia, Rash pruritic, Scab
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient has itchy red bumps on trunk, approximately 25-30. Started a few days ago (around 9-5-07) now a few are scabbed over, fever comes and goes.

VAERS ID:290865 (history)  Vaccinated:2007-08-28
Age:4.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Female  Submitted:2007-09-11, Days after onset: 12
Location:Florida  Entered:2007-09-18, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC606AA4 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0426U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Right thigh - proximal anterior 9 x 10cm - Erythema, tender. Aventis Lot# C60699 Exp 3-15-09

VAERS ID:290877 (history)  Vaccinated:2007-08-28
Age:0.5  Onset:2007-09-10, Days after vaccination: 13
Gender:Female  Submitted:2007-09-18, Days after onset: 8
Location:Colorado  Entered:2007-09-19, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: stool rotavirus antigen 09/10/07 - positive for rotavirus
CDC Split Type: WAES0709USA01497
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0507U2PO 
Administered by: Other     Purchased by: Other
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a medical assistant concerning a 6 month old female with no pertinent medical history or drug allergies, who on 16-APR-2007, 26-JUN-2007, and 28-AUG-2007 was vaccinated with the first (lot# 656192/0022U), second (lot# 656185/1234F) and third (lot# 657359/0507U) oral doses of Rotateq. There was no concomitant medication. On 10-SEP-2007 the patient developed rotavirus characterized by vomiting, diarrhea, and dehydration and was hospitalized. The patient sought medical attention via the physician''s office because of vomiting and diarrhea. The patient was treated with intravenous fluids to correct dehydration. The patient''s stool tested positive for Rotavirus. No other symptoms or treatment were reported. Subsequently the patient was recovering. There was no product quality complaint. Rotavirus was considered to be immediately life-threatening by the reporter. Additional information has been requested.

VAERS ID:290893 (history)  Vaccinated:2007-08-28
Age:24.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-08-31, Days after onset: 2
Location:Illinois  Entered:2007-09-19, 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: Yasmin daily
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ01220IMRA
Administered by: Private     Purchased by: Private
Symptoms: Headache, Influenza like illness, Injection site pain, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt reports soreness (L) deltoid at injection site. Then developed flu-like symptoms, headache, nausea and multiple emesis. The night of the injection 8/28-8/29 that continued following day. Instructed to take Tylenol. On 8/30/07 pt reports feels better, eating/drinking well.

VAERS ID:290910 (history)  Vaccinated:2007-08-28
Age:48.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-19, Days after onset: 21
Location:Georgia  Entered:2007-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt taking Darvocet, Cipro, Phenergan, Tizanidine, and Protonix.
Current Illness: None reported.
Preexisting Conditions: None reported
Diagnostic Lab Data: Pt states she has had blood counts performed at private MD office and Emergency Room.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0711U0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Blood count, Decreased appetite, Diarrhoea, Fatigue, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pt called today with c/o headache, generalized achiness and fatigue, decreased appetite, stomach aches, nausea and diarrhea.

VAERS ID:290965 (history)  Vaccinated:2007-08-28
Age:11.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-09-14, Days after onset: 17
Location:Illinois  Entered:2007-09-20, 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: N/A
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1213F0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2183AA0UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tues. night 8/28/07 c/o headache. Child woke up 8/29/07 at 6am with headache, fever 100.9 and dizziness. Advil given x 2 during the day. Child missed 1 day of school. Mom stated fine on 8/30/07. Mom called physician when symptoms occurred.

VAERS ID:290969 (history)  Vaccinated:2007-08-28
Age:59.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-20, Days after onset: 22
Location:South Carolina  Entered:2007-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness: NONE
Preexisting Conditions: Allergic to penicillin 10/22/07-records received- HX: rheumatoid arthritis complicated by Sjogren''s syndrome and Raynaud''s phenomenon. Hypertension and hyperlipidemia. Allergies to Penicillin and Cipro.
Diagnostic Lab Data: NONE records received 10/22/07-Potassium 3.4.
CDC Split Type: SC0715
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB139AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA02213IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood potassium decreased, Dehydration, Diarrhoea, Similar reaction on previous exposure to drug, Vomiting, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Received Tdap, Hep A, and Typhoid Vi on 8/28/07. Patient began vomitting at 9:30 AM on 8/29/07 and also experienced diarrhea. Patient became very dehydrated and was admitted to Hospital on 8/29/07. On 8/30th - patient much improved. Discharged on 8/30, stable and tolerating fluids well. 10/22/07-records received for DOS 8/29/07 and 9/6-9/7/07-DC DX: Dehydration, resolved. Vomiting and nausea, resolved. Diarrhea, resolved. Rheumatic disease. Side effect from Imuran. Second admission in month for vomiting and diarrhea and dehydration and both times it happened after she took her Prednisone and Imuran. Started with projectile vomiting. Previous episode this same month she blamed on Hepatitis A immunization.

VAERS ID:293703 (history)  Vaccinated:2007-08-28
Age:23.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-17, Days after onset: 19
Location:Florida  Entered:2007-09-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory - negative
CDC Split Type: WAES0709USA00048
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Gait disturbance, Impaired work ability, Laboratory test normal, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 23 year old female with a sulfonamide and penicillin allergy and no other pertinent medical history who on an unspecified date received her second dose of Gardasil. Subsequently, she had joint pain. She was seen by a rheumatologist, but unspecified tests came back negative. Subsequently, she recovered. on 28-AUG-2007 the patient was vaccinated with her third dose of Gardasil, 0.5 mL (Lot # 658556/1060U). Concomitant therapy included lamotrigine (LAMICTAL) and varenicline tartrate (CHANTIX). On 29-AUG-2007 after receiving her third dose of Gardasil, the patient complained of generalized joint and muscle pain. The pain was so strong that she could not walk. She had to stay in bed and was not able to go to work. The physician noted the patient had no problems with the first dose of Gardasil and only had joint pain after second dose and after the third dose, pain reappeared all over her body. The patient called the physician and sought medical attention. Patient Quality Complaints (PQC) were not involved. The physician considered generalized joint and muscle pain to be disabling because the patient could not walk. Additional information has been requested. In follow-up it was reported by the physician, that the patient a 23 year old, female with a sulfonamide and penicillin allergy and no pertinent medical history and no illness at the time of vaccination who on 28-AUG-2007 was vaccinated intramuscularly into the left arm with the third dose of GARDASIL, (Lot # 658556/1060U). It was reported that on 29-AUG-2007, the patient at first had joint pain in both hands and then generalized muscle pain and joint pain throughout the whole body. It was reported that the patient felt better and recovered on 31-AUG-2007. Additional information has been requested.

VAERS ID:291313 (history)  Vaccinated:2007-08-28
Age:4.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-09-18, Days after onset: 20
Location:Michigan  Entered:2007-09-25, 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: Recurrent UTI
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B062AA4IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01703SCUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0916U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt received 4 yo immunization in bilateral legs. Seen again 3 d later after developed redness, bruising, itching and warmth to area. No fever. Pt treated with Benadryl for reaction and Cephalexin 350/5 2 tsp PO 7d for possible cellulitis.

VAERS ID:291683 (history)  Vaccinated:2007-08-28
Age:1.1  Onset:2007-09-04, Days after vaccination: 7
Gender:Female  Submitted:2007-09-28, Days after onset: 24
Location:Illinois  Entered:2007-10-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: chest X-ray 09/04?/07
CDC Split Type: WAES0709USA04383
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF024AB3IMUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0612U0SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB53981A3IMUN
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Chest X-ray, Convulsion, Pneumonia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 13 month old female, with no medical history and no allergies, who on 28-AUG-2007 was vaccinated with a first subcutaneous dose of ProQuad (Oka/Merck upgrade process) (Lot# 657782/0612U). Concomitant vaccines, administered on the same day, included a fourth intramuscular dose of Prevnar (Lot# B53981A) and a fourth intramuscular dose of ActHib (Lot# UF024AB). There was no illness at the time of vaccination and no adverse events following prior vaccinations. On 04-SEP-2007, at 6:00 a.m., the patient experienced a seizure, as stated by the patient''s mother, and a high temp of 103.2, measured rectally. The patient was diagnosed with pneumonia of the lower right lung and was hospitalized for three days. Subsequently, the patient recovered. Additional information has been requested.

VAERS ID:291735 (history)  Vaccinated:2007-08-28
Age:5.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-09-25, Days after onset: 28
Location:West Virginia  Entered:2007-10-01, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B090BA0IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.029160SCRL
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Parent had requested Immunization records from pediatrician, and HD had sent record request/ on 8-28-07. Mother called Dr''s office, told her child had never rec''d vaccinations there when she came to the health dept. we called and was told the same thing. We started her immunizations as though she had never had any and gave her Pediarix for her 1st DTaP, IPV, Hep B. On 9-24-07 She sent the attached form from the PCP. The Pediarix was given as a "booster", but unintentionally and through no fault of the health dept

VAERS ID:291875 (history)  Vaccinated:2007-08-28
Age:0.5  Onset:2007-08-29, Days after vaccination: 1
Gender:Male  Submitted:2007-09-26, Days after onset: 28
Location:Pennsylvania  Entered:2007-10-02, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B074AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08672K0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1239F1PO 
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Temp 103.6 x 24 hrs. Responded to Tylenol and Motrin.

VAERS ID:298851 (history)  Vaccinated:2007-08-28
Age:13.0  Onset:2007-09-01, Days after vaccination: 4
Gender:Female  Submitted:2007-10-12, Days after onset: 41
Location:New York  Entered:2007-10-15, 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: Unknown
Current Illness:
Preexisting Conditions: influenza immunisation
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA00231
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Headache, Hypoaesthesia facial, Malaise
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Information has been received from a registered nurse concerning a 13 year old female with no drug allergies and with a history of influenza immunisation on 22-SEP-2007 who on 28-AUG-2007 was vaccinated intramuscularly with a first 0.5 mL dose of Gardasil (Lot # 658556/1060U). "A few days after vaccination", the patient developed joint pain, headache, numbness in face and malaise. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complain was involved. Additional information has been requested.

VAERS ID:293438 (history)  Vaccinated:2007-08-28
Age:13.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-10-04, Days after onset: 37
Location:California  Entered:2007-10-17, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.106140IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2370BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Pt fainted. Per mom - seizure-like movement for a few seconds. Then became alert and awake. I saw pt immediately after the fainting episode - no post-ictal. No follow-up required.

VAERS ID:293873 (history)  Vaccinated:2007-08-28
Age:19.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-10-22, Days after onset: 55
Location:Indiana  Entered:2007-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair, Seasonale
Current Illness: Nursing school required a "booster" because she had the 3 shot series more than 10 years ago in 1993-94
Preexisting Conditions: exercise induced asthma, allergic to penicillan, sulfa, macrobid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 3IDLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Anxiety, Chest discomfort, Dysphonia, Dyspnoea, Fatigue, Feeling hot
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)
Write-up: within 1 1/2 hours she began having trouble breathing, tightness, bad stomach pain, felt very hot, very tired - wanted to go to sleep right then, became hoarse, very anxious, felt like she could cry - she used an inhaler to help with her breathing, she has exercise induced asthma

VAERS ID:294430 (history)  Vaccinated:2007-08-28
Age:10.0  Onset:2007-08-29, Days after vaccination: 1
Gender:Female  Submitted:2007-10-25, Days after onset: 57
Location:Pennsylvania  Entered:2007-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ciprodex for LOE dx 8/28/07 Ibuprofen prn pain
Current Illness: Psoriasis referrel to dermatology Left Otitis External
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0340U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pain,swelling, and redness at injection site. Also developed a fever low-grade 99.1. Diagnosed with cellulitis and treated with keflex 500mg tid X7days.

VAERS ID:299009 (history)  Vaccinated:2007-08-28
Age:52.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-10-31, Days after onset: 64
Location:Florida  Entered:2007-11-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject has previously received flu shots with no reactions.
Diagnostic Lab Data: UNK
CDC Split Type: A0678487A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS2F6010110UNRA
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of a medication error in a 52-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline). On 28 August 2007 at 15:00 the subject received 1st dose of Flulaval at 0.5 ml in the right arm. On 28 August 2007, immediately following vaccination with Flulaval, it was noted that the vaccine given was from the past flu season (2006-2007). This was considered to be a medication error. The subject also developed injection site redness and swelling on 28 August 2007. At the time of reporting the medication error was unresolved. In the reporter''s opinion, the events were probably related to treatment with Flulaval.

VAERS ID:295743 (history)  Vaccinated:2007-08-28
Age:12.0  Onset:2007-09-01, Days after vaccination: 4
Gender:Female  Submitted:2007-10-23, Days after onset: 52
Location:Michigan  Entered:2007-11-06, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: None
Diagnostic Lab Data: + mono 9/6/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0018U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2359AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Face oedema, Infectious mononucleosis, Lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Facial edema became 9/1/07 with weakness and generalized lymphadenopathy. Diagnosed with mono 9/6/07. Facial edema 9/1/07 - 9/10/07.

VAERS ID:299943 (history)  Vaccinated:2007-08-28
Age:13.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 78
Location:Unknown  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Hypoaesthesia facial, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a Physician Assistant (P.A.) that a consumer''s mother reported concerning her 13 year old daughter who on 28-AUG-2007 was vaccinated IM with a first dose of Gardasil. The reporter indicated that on 28-AUG-2007 the patient experienced headache, fainting, legs and hands pain and numbness on half of her face after getting Gardasil. No further information was provided. The patient had not recovered. Additional information has been requested.

VAERS ID:297024 (history)  Vaccinated:2007-08-28
Age:66.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2007-11-16, Days after onset: 80
Location:California  Entered:2007-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Subacute cholecystitis. RT sided submandibular nodule.
Preexisting Conditions: Colon CA. GERD
Diagnostic Lab Data: Doppler ultrasound to rule out dvt on 8/29
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.UNKNOWN0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Ultrasound Doppler
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Per nursing notes (8/28 at 1830): Patient c/o pain to R upper arm at site where pna shot was given on 8/28 site red, swollen red area approx 10x4 inches. site marked. MD paged. Vanco ordered and apply hot packs. Patient has remained afebrile. Received vanco 1g x 1 on 9/29 at 2300. 11/20/2007 MR receved for DOS 8/28-30/2007 with Discharge DX: Right neck nodule. Local allergic reactions to Pneumovax RUE. Pt initially admitted for abdominal pain received Pneumovax prior to D/C. Subsequently developed an area of erythema at injection site. Afebrile. D/C delayed x 1 day for tx with abx.

VAERS ID:302757 (history)  Vaccinated:2007-08-28
Age:79.0  Onset:2007-12-28, Days after vaccination: 122
Gender:Male  Submitted:2008-01-15, Days after onset: 18
Location:California  Entered:2008-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: nkda. PMH: Atrial Fibrillation on Coumadin, TIA with R eye amaurosis fugax, L eye blindness, Bladder CA s/p resection, DVT, PE. Recent URI with ear pain. NKDA.
Diagnostic Lab Data: MRI of brain and face that showed no CVA but facial nerve enhancement seen. Labs and Diagnostics: CBC, Chem 7, lytes, LFTs, UA, cardiac markers, and lipase all WNL. PTT 43.6. INR 2.5. CXR showed bibasilar atelectasis. Head CT showed no acute changes. Brain MRI showed no acute changes. MRI of the face and brain 1/9/08 (+) for facial nerve enhancement c/w Bell''s Palsy.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0761U SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time prolonged, Areflexia, Blood electrolytes normal, Cardiac enzymes normal, Chest X-ray abnormal, Computerised tomogram, Drooling, Dysarthria, Facial pain, Facial palsy, Facial paresis, Full blood count normal, Headache, International normalised ratio, Laboratory test normal, Lipase normal, Neck pain, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Pitting oedema, Sensory loss, Urine analysis normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Patient with Bells Palsy 4 months after Zostavax vaccine. 02/12/2008 MR received for DOS 12/28-29-/2007 with D/C DX: Lower motor neuron pattern R facial weakness most likely 2'' to ischemic infarct. Paroxysmal Atrial Fibrillation. Transient Iscemic attack-amaurosis fugax. L eye blindness since childhood infection. Prior to admit pt noted drooling of H2O on drinking, H/A, and R facial droop with dysarthria. PE (+) for R upper motor neuron pattern facial droop, mild dysarthria, decreased vibration sensation of lower extremities, 1+ pitting edema, Ankle DTRs 0. Idiopathic Bell''s Palsy was included in the differential dx however given hx of A-fib, pt was treated as such. 2/20/08 spoke with reporter who states DX is Bell''s Palsy confirmed by later facial MRI. Facial weakness was not due to an infarct, and the hospital reports were incorrect per reporter. 02/22/2008 Additional records received from reporter including records from above admission. F/u appts confirm DX: Bell''s Palsy. MRI of the face and brain 1/9/08 (+) for facial nerve enhancement c/w Bell''s Palsy. PE (+) severe R 7th cranial nerve palsy. Pt reports onset of headache since DX of Bell''s Palsy with R sided neck and facial pain. F/U 2/5 with BP somewhat improved. Per 60 day follow up: Residual facial weakness.

VAERS ID:308211 (history)  Vaccinated:2007-08-28
Age:0.2  Onset:2008-03-19, Days after vaccination: 204
Gender:Female  Submitted:2008-03-25, Days after onset: 6
Location:Texas  Entered:2008-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown. PMH: none. NKDA.
Diagnostic Lab Data: Barium enema X-ray 03/20/08. Labs and Diagnostics: Abd US (+) for ileocolic intussusception. KUB (+) for a paucityof gas in RUQ suspicious for IS. Air contrast barium enema
CDC Split Type: WAES0803USA03574
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B097AB0UNLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.UF113AA0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845E0UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0242U0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Barium double contrast, Enema administration, Intussusception, Middle ear effusion, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow)
Write-up: Information has been received from a physician concerning a 9-month-old female who on 28-AUG-2007 was vaccinated with an oral 2 ml dose of ROTATEQ. Concomitant vaccination included PEDVAXHIB (OMPC) (manufacturer unknown), PEDIARIX and PREVNAR. On 19-MAR-2008 the patient experienced abdominal pain after receiving ROTATEQ. The patient was taken to the emergency room and was diagnosed with intussusception and was hospitalized. A barium enema was given and the patient was released on 20-Mar-2008. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested. 4/30/2008 MR reeived for DOS 3/19-20/2008 with Final DX: Intussusception s/p reduction by air enema. Pt presented to ER with 4 day hx of abdominal pain and NBNB emesis. PE (+) for slight abd distention. Successfully reduced by Air Enema. No further vomiting or fever. Left purulent ear effusion noted prior to d/c. Sent home with azithromycin if pt develops ear pain.

VAERS ID:312045 (history)  Vaccinated:2007-08-28
Age:29.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2007-10-17, Days after onset: 50
Location:Maine  Entered:2008-05-01, Days after submission: 197
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~1~0~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: He had a bat bit in April. He received the following previous vaccines: IMOVAX - dose 1 and IMOGAN - dose 1 on 14 August 2007; IMOVAX - dose 2 - intramuscularly on 17 August 2007; IMOVAX - dose 3 - intramuscularly on 21 August 2007. There were no adverse reactions reported after the vaccinations.
Diagnostic Lab Data:
CDC Split Type: 200702994
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA02083IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lymphadenopathy, Nasal congestion, Pharyngolaryngeal pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from a patient on 29 August 2007. A 29 year old, male patient (with no medical history) developed a stuffy nose, sore throat and swollen glands in the neck, a few hours after receiving his fourth dose of IMOVAX (lot number A0208-2) intramuscularly in the right arm on 28 August 2007. He had a bat bit in April. He received the following previous vaccines: IMOVAX - dose 1 and IMOGAN - dose 1 on 14 August 2007; IMOVAX - dose 2 - intramuscularly on 17 August 2007; IMOVAX - dose 3 - intramuscularly on 21 August 2007. There were no adverse reactions reported after the vaccinations. At the time of the report, the symptoms were resolving. Follow-up information received on 12 October 2007 from a health care professional. The case was reviewed, and there was no additional information.

VAERS ID:311968 (history)  Vaccinated:2007-08-28
Age:14.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 244
Location:West Virginia  Entered:2008-05-09, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Obesity; Acne; dysmenorrhea; Scoliosis; Chest pain;
Diagnostic Lab Data: BMP, Ca+ (fortified), Folate, B12, Magnesium. All within normal limits. diagnostic laboratory, normal
CDC Split Type: WAES0804USA0663
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U2IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2395BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Blood calcium normal, Blood folate normal, Blood magnesium normal, Blood test normal, Chest pain, Cough, Diarrhoea, Fatigue, Headache, Heart rate decreased, Nausea, Neuropathy peripheral, Pain, Palpitations, Paraesthesia, Sinusitis, Vitamin B12 normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Tingling of hands, legs and feet. Occasional headache. Had these symptoms after receiving each Gardasil injection , worse right after injection, improved with time, but not completely resolved. 5/29/2008 MR received from PCP In for 14yr WCC on 8/28/07. Recently seen in ER for chest pain/heart racing and slowing. EKG reportedly normal. Menactra and Gardasil given. Seen again 9/17/07 with N, V & D, body aches and pains and tingling everywhere. C/O h/a, fatigue and cough. DX: Headache, Sinusitis, Arthralgias. Gardasil # 3 given 3/11/08. Pt seen 4/16/08 with c/o tingling of hands and feet and headaches which began after Gardasil vax. DX: Peripheral neuropathy. Pt referred to neurology but did not go as symptoms were resolving somewhat although not completely gone as off 8/8/08. This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a physician, concerning a 14 year old female patient, who on an unknown date was vaccinated with the first dose of GARDASIL, and subsequently developed tingling and numbness in her arm. Following the vaccination with the second dose (date not specified), the patient again developed numbness and tingling in her arm, as well as peripheral neuropathy. Following the vaccination with the third dose (date not specified), she again developed peripheral neuropathy. The physician sent her to a neurologist (details not provided). At the time of this report, the patient had not recovered from peripheral neuropathy. Follow up information was received on 30-MAY-2008. The registered nurse reported that the patient was vaccinated with the first dose of GARDASIL lot 658556/1060U on 28-AUG-2007. She received the second dose of GARDASIL lot 658563/1063U on 30-OCT-2007. She received the third dose of GARDASIL lot 668387/1967U on 11-MAR-2008. The registered nurse reported that on 16-APR-2008 the patient was seen by the physician. The patient''s mother stated that after the first dose of GARDASIL lot 658556/1060U she had headaches sometimes and that she developed tingling and numbness in her arm. It was reported that after the patient received the second and third dose of GARDASIL lot 658563/1063U and lot 660387/1067U, the patient again developed tingling and numbness in her arm and peripheral neuropathy. The registered nurse stated that the patient''s "lab work" was normal. On 19-APR-2008, the patient was referred to a pediatric neurologist. The patient was scheduled to see the neurologist on 08-JUL-2008. The registered nurse did not know if the patient had recovered. Additional information has been requested. Follow-up information was received on 20-JUN-2008. The registered nurse reported that the patient also recovered on 28-AUG-2007 the first dose of menigococcal ACTW conj vaccine (dip toxoid) lot U2395BA via IM in the right arm (deltoid). Other concomitant vaccination included the third dose via IM in the right arm (deltoid) of FLUZONE lot U2451AA on 10-OCT-2007. It was also reported that the patient has a history of obesity, acne, dysmenorrhoea, scoliosis and chest pain. The patient also had laboratory work done including BMP, Ca+, folate, B12, magnesium, all within normal limits. The patient is being treated for face with "benzaclin CaCl topically." The patient''s outcome is unknown. Additional information has been requested.

VAERS ID:313745 (history)  Vaccinated:2007-08-28
Age:10.0  Onset:2007-08-30, Days after vaccination: 2
Gender:Male  Submitted:2008-05-16, Days after onset: 260
Location:Michigan  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: General symptom; Tracheo-oesophageal fistula; Multiple congenital abnormalities; Macrosomia; Hydrocephalus
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA06399
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB18ZAA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1012U1SCRA
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: Information has been received from a registered nurse concerning a 10-year-old male with a history of "NKAM", tracheo-oesophageal fistula, multiple congenital abnormalities, macrosomia and hydrocephalus who on 28-AUG-2007 was vaccinated subcutaneous in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658177/1012U). Concomitant vaccine administered on 28-AUG-2007 included a second intramuscular dose of Havrix (lot # AHAVB18ZAA) administered in the left arm. On 30-AUG-2007, the patient developed a red, swollen painful local at injection site (duration 24-48 hours) that was treat with a cool compress and ibuprofen (manufacturer unknown). On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:314207 (history)  Vaccinated:2007-08-28
Age:8.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 262
Location:Virginia  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp 08/29/07 101
CDC Split Type: WAES0709USA01970
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1018U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a certified nurse practitioner concerning an 8 year old female who on 28-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (LOT# 658196/1018U) in left arm, subcutaneously. On 29-AUG-2007, the patient experienced a small raised area at the site of injection then redness spread. On 30-AUG-2007, the red area was spreading (8X8 cm), swelling with yellow drainage, and fever up to 101. She was diagnosed with cellulitis. The outcome of the patient''s events were not reported. Additional information has been requested.

VAERS ID:314230 (history)  Vaccinated:2007-08-28
Age:1.0  Onset:2007-09-18, Days after vaccination: 21
Gender:Male  Submitted:2008-05-16, Days after onset: 241
Location:Kentucky  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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA02452
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash, Roseola
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist concerning his 12 month old son with no pertinent medical history or drug allergies who on 28-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-SEP-2007 the patient developed a rash. Medical attention was sought via contact to the physician''s office. No lab diagnostic studies were performed. It was noted that the patient was not recovered. There was no product quality complaint. Follow-up information has been received from a pharmacist indicating that the rash that developed on approximately 18-SEP-2007 3 weeks after vaccination, was a reaction not associated with varicella virus vaccine live (Oka/Merck), but caused by another viral infection (ROSEOLA). No further information is available.

VAERS ID:314842 (history)  Vaccinated:2007-08-28
Age:12.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 262
Location:New York  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: cellulitis; Latex allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA05331
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1007U1SC 
Administered by: Private     Purchased by: Public
Symptoms: Hypersensitivity, Swelling face, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 12 year old 25 kg patient who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of Menactra. Subsequently, the patient developed an unspecified allergic reaction. The patient was treated with a one time dose of Orapred 45 mg. No further information was provided. There was no product quality complaint involved. Follow up information has been received from another health care professional concerning this 12 year old male with cellulitis and a latex allergy who was vaccinated SC in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658018/1007U) on 28-AUG-2007. Fifteen minutes after vaccination the patient had facial swelling and throat irritation. Unspecified medical attention was sought. On an unspecified date the patient recovered. There were no adverse events following prior vaccination. Additional information is not expected.

VAERS ID:314846 (history)  Vaccinated:2007-08-28
Age:6.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 262
Location:Unknown  Entered:2008-05-23, 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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA05413
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1025U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Rash, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 6 year old male with no pertinent medical history, drug reactions or allergies who on 28-AUG-2007 was vaccinated with a "booster shot" of varicella virus vaccine live (Oka/Merck) (Lot # 658413/1025U). There was no concomitant medication. On 28-AUG-2007, the patient experienced severe vomiting, developed a rash and swelling "immediately after he was given varicella virus vaccine live (Oka/Merck)". The patient was treated with Benadryl. There were no lab diagnostic studies performed. Additional information has been requested.

VAERS ID:317475 (history)  Vaccinated:2007-08-28
Age:22.0  Onset:2007-08-28, Days after vaccination: 0
Gender:Female  Submitted:2008-05-30, Days after onset: 276
Location:Arizona  Entered:2008-06-18, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Drug hypersensitivity; General physical condition
Preexisting Conditions: Immunisation; Rash
Diagnostic Lab Data: laboratory test - MMR titer negative
CDC Split Type: WAES0710USA02358
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site papule, Measles antibody negative, Mumps antibody test negative, Nausea, Rash, Rubella antibody negative
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician''s assistant concerning a 22 year old healthy female employee with an aspirin allergy and no other drug allergies and no pertinent medical history who on approximately 28-AUG-2007 was vaccinated with the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. Following vaccination on approximately 30-AUG-2007 the patient developed an immediate rash on the upper extremities, nausea, lightheadedness which lasted for 2 days, then resolved. On approximately 30-AUG-2007, there was also an injection site reaction that with a 20 mm in diameter circular red and raised lesion with central induration that was tender to the touch for 5 weeks. There was no wheezing or shortness of breath reported. On 04-OCT-2007, the patient returned for a second vaccination with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and was examined. The patient had a negative titer for M-M-R. No other labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information from the reporting physician assistant indicated that the 22 year old female phlebotomist had a history of rash following immunization with a dose of diphtheria toxoid (+) tetanus toxoid in 2006, "ROS negative" was vaccinated on approximately 28-AUG-2007 with the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Illness at the time of vaccination was denied. On 28-AUG-2007 following vaccination, the patient developed multiple rashes to the upper extremities and felt nauseous and was lightheaded for 2 days. The patient was seen at clinic on 04-OCT-2007. The patient did not return for a follow-up visit. Additional information has been requested.

VAERS ID:319135 (history)  Vaccinated:2007-08-28
Age:86.0  Onset:2007-09-17, Days after vaccination: 20
Gender:Female  Submitted:2008-06-24, Days after onset: 281
Location:Pennsylvania  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSAMAX; aspirin; LIPITOR; folic acid; CENTRUM SILVER
Current Illness: Rib fracture; Osteoporosis; lipids increased; Sulfonamide allergy; Allergic reaction to antibiotics
Preexisting Conditions: Motor vehicle accident; Cerebrovascular accident; RAYNAUDS; Diverticulosis
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA03472
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0882U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning an 86 year old female consumer with no pertinent medical history who on an unspecified date was vaccinated with 1 dose of zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD) and VALTREX. Subsequently, on 17-SEP-2007 the patient developed a rash on "her lower buttocks." Medical attention was sought in the emergency room. On an unspecified date the patient recovered. There was no product quality complaint involved. Follow-up information has been received from a health professional concerning this 86 year old female with osteoporosis, increased lipids, sulfonamide and CIPRO allergies and a history of a motor vehicle accident, cerebrovascular accident, RAYNAUDS and diverticulosis who on 28-AUG-2007 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658085/0882U). The patient was recovering from a rib fracture due to a motor vehicle accident at the time of vaccination. Additional concomitant therapy included minerals (unspecified) (+) CENTRUM SILVER, LIPITOR, aspirin and folic acid. Subsequently, on 17-SEP-2007 at 2:45 PM the patient had a painful rash on her left buttocks and leg. The patient was diagnosed with shingles. The patient was given VALTREX 1 gm three times a day X 1 week and VICODIN as needed for pain. On 26-Sep-2007, the patient had an office visit and was improved (recovered). Additional information is not expected.

VAERS ID:321852 (history)  Vaccinated:2007-08-28
Age:69.0  Onset:2007-08-31, Days after vaccination: 3
Gender:Male  Submitted:2008-07-30, Days after onset: 334
Location:California  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: Unknown
Current Illness: Hyperlipidaemia; Hypertension
Preexisting Conditions: Prostate cancer
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA00254
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0961U UNLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health professional concerning a 69 year old male with hyperlipidaemia, hypertension, a history of prostate cancer, and no drug allergies, who on 28-AUG-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658074/0961U). On 31-AUG-2007 the patient developed an injection site reaction with left arm swelling, redness from the left elbow to the shoulder, and fatigue. The patient called the physician and was instructed to apply ice to the injection site reactions and to take TYLENOL or ADVIL for discomfort. No laboratory diagnostics were performed. At the time of the report, the patient''s outcome was unknown. No product quality complaint was involved. This report is 1 of 3 reports from the same source. Additional information has been requested.

VAERS ID:336895 (history)  Vaccinated:2007-08-28
Age:22.0  Onset:2007-09-04, Days after vaccination: 7
Gender:Female  Submitted:2008-12-12, Days after onset: 465
Location:California  Entered:2008-12-15, 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: None
Current Illness: Pregnancy NOS (LMP = 7/4/2007)
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 10/30/07, confirmation of pregnancy; Ultrasound, 12/14/07, within normal limits; Beta-human chorionic, positive; Serum alpha-fetoprotein, positive; Hemoglobin, 10.9
CDC Split Type: WAES0712USA03771
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein, Anaemia, Drug exposure during pregnancy, Foetal disorder, Haemoglobin decreased, Postpartum depression, Pregnancy test positive, Ultrasound scan normal
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received through Pregnancy Registry for a 22 year old female consumer with 2 previous full term deliveries who on 28-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot # 656050/0245U). There was no concomitant medication. On approximately 04-Sep-2007, the patient had a pregnancy test which was positive (LMP approximately 04-JUL-2007). The patient reported having an ultrasound; however, no additional information was provided. The patient sought unspecified medical attention. On 30-OCT-2007, the patient had a positive pregnancy test. The estimated conception date is 27-JUL-2007. The estimated date of delivery is 09-APR-2008. In further follow up, a nurse practitioner reported that the patient delivered a female baby on 23-MAY-2008. The baby weighed 10 pounds 2 ounces, was 20 inches, and the APGAR score was unknown. The infant was macrosomic and had no other abnormalities or complications. During pregnancy, the patient experienced anemia (HgE 10.9). The patient experienced failure to progress because of the large baby during the labor/delivery. On 14-DEC-2007, the patient had an ultrasound which was within normal limits. On an unspecified date, the patient had a positive alpha-fetoprotein test. There were no infections or illnesses during pregnancy. Follow-up information was received from a nursing supervisor who stated that the patient went to their offices on 11-JUN-2008 suffering post-partum depression and was referred to "psych". Additional information has been requested.

VAERS ID:426979 (history)  Vaccinated:2007-08-28
Age:0.2  Onset:2007-09-16, Days after vaccination: 19
Gender:Male  Submitted:2011-07-07, Days after onset: 1390
Location:Foreign  Entered:2011-07-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA04220
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyelonephritis
SMQs:
Write-up: Information has been received from an investigator concerning a 10 week old male who entered a study. On 28-AUG-2007, 08-OCT-2007 and 07-NOV-2007, respectively, the patient was vaccinated with 3 doses of ROTATEQ. On 16-SEP-2007 the patient experienced pyelonephritis. On 19-SEP-2007, the patient recovered from pyelonephritis. The reporting investigator felt that pyelonephritis was possibly related to study therapy. Pyelonephritis was considered to be an other important medical event by investigator. Other business partner numbers include 200800082. Additional information has been requested.

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