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Case Details (Sorted by Vaccination Date)

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VAERS ID:334330 (history)  Vaccinated:2008-12-03
Age:15.0  Onset:2008-12-03, Days after vaccination: 0
Gender:Female  Submitted:2008-12-03, Days after onset: 0
Location:Connecticut  Entered:2008-12-09, 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: Metformin
Current Illness: None
Preexisting Conditions: Type II Diabetes
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X3IMLA
Administered by: Private     Purchased by: Private
Symptoms: Gait disturbance, Immediate post-injection reaction, Nausea, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt received GARDASIL #3 and within a five minutes became pale, limp, nauseous. Pt vomited twice, after lying down for about 20 minutes, recovered fully.

VAERS ID:335369 (history)  Vaccinated:2008-12-03
Age:4.6  Onset:2008-12-06, Days after vaccination: 3
Gender:Male  Submitted:2008-12-12, Days after onset: 6
Location:New York  Entered:2008-12-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2803AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling from elbow to shoulder x 2 days.

VAERS ID:345662 (history)  Vaccinated:2008-12-03
Age:47.0  Onset:2008-12-03, Days after vaccination: 0
Gender:Male  Submitted:2009-03-27, Days after onset: 113
Location:Colorado  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0812USA01782
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1419X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, 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 46 year old male patient with history of drug hypersensitivity to penicillin and shellfish based medications such as finasteride (MSD) WAES # 0812USA02142) who on 3-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 663198/1419X) on the arm. There was no concomitant medication. On 4-DEC-2008 the patient experienced redness at injection site, swelling at injection site and bump under the skin at injection site. Patient stated that the bump is approximately the size of half a dollar and the redness is about 4 times the size of the bump. Patient sought medical attention going to see the pharmacists. At the time of the report the patient had not recovered. This is one of several reports from the same patient. Additional information has been requested.

VAERS ID:419596 (history)  Vaccinated:2008-12-03
Age:0.6  Onset:2010-03-29, Days after vaccination: 481
Gender:Female  Submitted:2011-03-21, Days after onset: 357
Location:Texas  Entered:2011-03-25, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: stool rotavirus antigen, 03/29?/10, positive
CDC 'Split Type': WAES1004USA00155
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0925X2PO 
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test positive
SMQs:
Write-up: Information has been received from a nurse concerning a 22 month old female patient who was vaccinated orally with three doses of ROTATEQ (lot#s follow as 660682/0574X, 660880/0923X, 662618/0925X) respectively on 04-AUG-2008, 06-OCT-2008 and 03-DEC-2008. On an unspecified date in the week of 29-MAR-2010, the patient was tested positive for rotavirus after being fully vaccinated with ROTATEQ. The patient was brought to the doctor''s office and was treated with diet and fluids. At the time of this report, the patient was recovering. This is one of several reports from the same source. This is a consolidation of two reports concerning the same patient. Additional information has been requested.

VAERS ID:335934 (history)  Vaccinated:2008-12-03
Age:6.0  Onset:2008-12-03, Days after vaccination: 0
Gender:Female  Submitted:2008-12-22, Days after onset: 19
Location:Foreign  Entered:2008-12-23, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA03474
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0148X1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oedema, Tonsillar disorder, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health authority concerning a 6 year old female, who on 03-DEC-2008, was vaccinated with the second dose of MMR II, lot #660269/0148X, batch #NH555460. Secondary suspect therapy given the same day included the booster dose of TETRAVAC (batch #B0288-1). On 03-DEC-2008, 5-10 minutes post-vaccination, the patient presented with tonsillar edema and slight urticaria. She was treated with ADRENALIN, IM, TRIMETON, oxygen therapy and monitoring and a peripheral venous access was found. The outcome was recovered on 04-DEC-2008. The events were considered to be life-threatening. A lot check has been requested. No further information is available. The case is closed. Other business partner numbers included E2008-11488 and IT510/08.

VAERS ID:336191 (history)  Vaccinated:2008-12-03
Age:5.0  Onset:2008-12-05, Days after vaccination: 2
Gender:Male  Submitted:2008-12-29, Days after onset: 24
Location:Foreign  Entered:2008-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0551671A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B094BB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation, Injection site reaction, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# 041279) and described the occurrence of injection site inflammation in a 5-year-old male subject who was vaccinated with INFANRIX-POLIO (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR (GlaxoSmithKline, unknown injection site) given on an unspecified date. On 3 December 2008, the subject received unspecified dose of INFANRIX-POLIO (intramuscular, unknown injection site). On 5 December 2008, 2 days after vaccination with INFANRIX-POLIO, the subject experienced injection site inflammation, injection site reaction, lethargy and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with erythromycin. At the time of reporting the events were resolved.

VAERS ID:337090 (history)  Vaccinated:2008-12-03
Age:1.1  Onset:2008-12-03, Days after vaccination: 0
Gender:Male  Submitted:2009-01-12, Days after onset: 40
Location:Foreign  Entered:2009-01-13, 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: REFLUX ESOPHAGITIS
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 03Dec2008, 40.3deg. C; Body temperature, 04Dec2008, 40.1deg. C; Body temperature, 05Dec2008, 39.7deg. C; Body temperature, 11Dec2008, Up to 39.0deg. C; C-reactive protein, 03Dec2008, Negative; C-reactive protein, 11De
CDC 'Split Type': B0552490A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA363A2UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA363A2UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA363A2UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, C-reactive protein normal, Febrile convulsion, Heart rate increased, Oxygen saturation normal, Pyrexia, Rash generalised, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a foreign regulatory authority # NO-NOMAADVRE-FHI-2008-6968 and describe the occurrence of febrile convulsion in a 12-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), PREVENAR. Concurrent medical conditions included reflux esophagitis. On 3 December 2008, the subject received 3rd dose of INFANRIX-POLIO-HIB (parenteral) and 3rd dose of PREVENAR (parenteral). On 3 December 2008, less than one day after vaccination with INFANRIX-POLIO-HIB and PREVENAR, the subject experienced fever, upper respiratory tract infection, rash al over which ended on 4 December 2008. He also experienced febrile convulsion (first episode in the evening lasting for 8 minutes and the second episode on 04 December 2008 in the morning). On 11 December 2008, he had a new fever episode (up to 39 degrees Celsius). The subject was hospitalised. Relevant test results included on 3 december 2008; body temperature variating from 38 to 40.3 degrees Celsius, O2 saturation: 97%, C-reactive protein: negative and pulse rate: 147 bpm. The subject was treated with IBUX, PARACET and STESOLID. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO-HIB and PREVENAR.

VAERS ID:338033 (history)  Vaccinated:2008-12-03
Age:3.0  Onset:2008-12-03, Days after vaccination: 0
Gender:Female  Submitted:2009-01-22, Days after onset: 50
Location:Foreign  Entered:2009-01-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illnesses include atrial septal defect and ventricular septal defect
Preexisting Conditions:
Diagnostic Lab Data: Body temperature (results: 38.3 deg. C. ) was done on 05-Dec-2008. Body temperature (results: normal) was done on 10-Dec-2008.
CDC 'Split Type': HUWYEH07711509
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH34475 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Injection site erythema, Injection site extravasation, Injection site papule, Injection site swelling, Medication error, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 3-year-old female patient who experienced vomiting, coughing, fever, 4x4 cm area of erythema and swelling at the injection site, 1x1 cm hyperemic central papule at the injection site and a minor subcutaneous infiltration at the injection site (1x1 cm). The patient received a dose on 03-Dec-2008. On the day of vaccination, the patient experienced vomiting, coughing, and fever of 38.3 deg. C. Two days after being administered the PREVENAR vaccine, 05-Dec-2008, the patient experienced a 4x4 cm area of erythema and swelling at the injection site, and 1x1 cm hyperemic central papule at the injection site. The vomiting and coughing stopped on 06-Dec-2008. Physicial examination on 10-DEC-2008, showed a normal body temperature and a good general condition. The patient was considered recovered from all events except a minor subcutaneous infiltration at the injection site (1x1 cm). It was noted the PREVENAR was stored at 10 degrees C. No additional information was available at the time of this report.

VAERS ID:338779 (history)  Vaccinated:2008-12-03
Age:0.4  Onset:2008-12-03, Days after vaccination: 0
Gender:Female  Submitted:2009-01-30, Days after onset: 58
Location:Foreign  Entered:2009-02-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Diagnostic Lab Data:
CDC 'Split Type': 200900299
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20907001B UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA9712 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Initial report received from the Health Authorities on 26 January 2009 Under the Authority Reference number: PL-URPL-OCR-20081223005. Seriousness criteria: Hospitalization. A 4-month-old female patient with no reported medical history received ACTHIB, lot no: A9712-1, IMOVAX POLIO, lot no: A9712-1 and DTP on 3 December 2008. On the same day, five hours after vaccination first symptoms of fever occurred. Mother came with the child because of the fever and convulsions, which occurred at home at around 14:00 on the following day. The patient was hospitalized at an unspecified time and she was recovered with in an unspecified time frame.

VAERS ID:338863 (history)  Vaccinated:2008-12-03
Age:0.1  Onset:2008-12-03, Days after vaccination: 0
Gender:Unknown  Submitted:2009-02-02, Days after onset: 61
Location:Foreign  Entered:2009-02-03, 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: Not reported.
Diagnostic Lab Data:
CDC 'Split Type': 200900300
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20907001A UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA08023 UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Mobility decreased, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Depression (excl suicide and self injury) (broad)
Write-up: Initial report received from the Foreign Health Authorities on 26 January 2009 under the Authority Reference Number: PL-URPL-OCR-0081224004. Seriousness criteria: Other medically important condition. A 1-month-old patient of unspecified gender with no reported medical history received ACTHIB, lot no: A9712-1, EUVAX-B and DTP on 3 December 2008. The patient had a fever at approximately 40 C degrees since the day of the vaccination for 4 days. The patient cried inconsolably on the same day. "On the second day, a consultation with a pediatric neurologist because of left arm decreased mobility". "The reason was a painful reaction, without neurological decrease". "The child has been prophylactically referred for rehabilitation of the upper left limb." "The health status of the child was good and the patient was recovering at the time of the report.

VAERS ID:338977 (history)  Vaccinated:2008-12-03
Age:0.1  Onset:2008-12-03, Days after vaccination: 0
Gender:Unknown  Submitted:2009-02-03, Days after onset: 62
Location:Foreign  Entered:2009-02-04, 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: not reported
Diagnostic Lab Data: not reported
CDC 'Split Type': 200900307
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURA9739 IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Injection site extravasation, Injection site haematoma, Restlessness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (narrow)
Write-up: Case received from the foreign Health Authorities on 27 January 2009 under the local reference number PL-URPL-OCR-20090113003. An 01-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of ACTHIB, batch number A9739-1, in the left thigh, on 03 December 2008. On 03 December 2008, in the injection site area, the patient developed infiltration (approx. 3 x 3 cm) and bruising. There was no redness. Approximately 2.5-3 hours post-vaccination, the patient was very restless for 2 hours. The patient was hospitalized the same day. After admission, the patient had increased body temperature at 37.8C. The patient recovered on an unspecified date.

VAERS ID:339416 (history)  Vaccinated:2008-12-03
Age:10.0  Onset:2008-12-04, Days after vaccination: 1
Gender:Female  Submitted:2009-02-10, Days after onset: 68
Location:Foreign  Entered:2009-02-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Ultrasound, results without finding; Serum creatine kinase, ??Jan09, 98, CK-NAC value decreased; Serum creatine kinase, 263, Heightened CK-NAC
CDC 'Split Type': WAES0902USA01023
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0467U0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Myalgia, Myositis, Rhabdomyolysis, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Information has been received initially on 29-JAN-2009 from a school physician concerning a 10 year old female patient who on 03-DEC-2008 was vaccinated into the arm with the first dose of GARDASIL (Batch # NG14300 Lot # 0467U) (route not reported). On 09-DEC-2008 the female patient came for examination due to persistent muscle pain in the area of both thighs, incipient 24 hours post vaccination. It was reported that the injection site was not inflammatory and the female patient reported about persistent pain in both thighs during going and running, and in the area of the left hip. At the area of both quadriceps musculature local pain without external abnormality. It was reported, that as the female patient was sportive and trained (wrestler) a blood test (CPK-Creatinphosphokinase, CRP-C reactive protein) on an unspecified date the family doctor was initiated to exclude an iatrogenic rhabdomyolysis. Results were only reported for CK-NAC. As well, the female patient was examined at the emergency department and the pediatric department to exclude a coxitis fugax. An ultrasound examination of the hip was performed, results without finding. The diagnosis of a reactive myositis of both quadriceps muscles was reported. The lab was inconspicuous, except for a heightened CK NAC (263), ranges not reported. A lab control in January 2009 was performed. The CK NAC value decreased to 98, as well as the other parameters, inconspicuous. The physician observed, that the CK heightening was due to the local injection or activated due to concomitant reaction of musculature. Therefore the physician decided not to vaccinate the female patient with the second dose of GARDASIL, as she could not exclude an iatrogenic activated rhabdomyolysis. A treatment with antiphlogistics was unknown. The female patient recovered after about 2 weeks. Upon internal review suspicion of rhabdomyolysis was considered a medically significant event. Other business partner numbers include E2009-00844. Additional information is not expected. The case is clos

VAERS ID:339561 (history)  Vaccinated:2008-12-03
Age:5.0  Onset:2008-12-05, Days after vaccination: 2
Gender:Unknown  Submitted:2009-02-12, Days after onset: 69
Location:Foreign  Entered:2009-02-13, 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: not reported
Diagnostic Lab Data: not reported
CDC 'Split Type': 200900482
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEUR02861AD IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case received from the Health Authorities on 10 February 2009 under the local reference number PL-URPL-OCR-20090130002. A 05-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number 02861AD, on 03 December 2008. On 05 December 2008, i.e. 2 days post-vaccination, the patient experienced an injection site reaction which exceeded over the nearest joints and lasted for more than 3 days. The patient''s reaction included the whole right arm, elbow joint, 1/3 upper forearm and was described as skin redness, skin swelling/oedema and warm skin. The patient also developed fever at 39.5-39.9 degrees C which lasted up to 72 hours. The patient was hospitalized from 05 December 2008 to 11 December 2008. The patient recovered on an unspecified date.

VAERS ID:358523 (history)  Vaccinated:2008-12-03
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-25
Location:Foreign  Entered:2009-09-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown) Smoker; Alcohol use
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0909USA03204
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1697U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a Practice Nurse (P.N) via CSL as part of a business agreement for the pregnancy registry for GARDASIL concerning an 18 year old female patient who was reported to be an smoker and alcohol user who on 03-DEC-2008 was vaccinated with a dose of GARDASIL (Lot # 1697U and Batch # NH48330). It was reported that she discovered she was pregnant around the beginning of December last year, in her first trimester of pregnancy. On an unspecified date an elective abortion was carried out. Upon internal review elective abortion was determined to be an other important medical event. Additional information has been requested.

VAERS ID:334069 (history)  Vaccinated:2008-12-04
Age:37.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-05, Days after onset: 1
Location:Washington  Entered:2008-12-05
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: To an unknown antibiotic
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3029BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Conjunctivitis, Discomfort, Injected limb mobility decreased, Injection site swelling, Insomnia, Neck pain
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Approx 2.5 hrs after vacc. into L deltoid, pt had increasing discomfort. She had increasing pain into the night with diff. sleeping. She had c/o L lateral neck pain, decreased L arm range of motion, some swelling over injection site, but no redness. Today, neck feeling better, but onset of some left conjunctivitis. She has not taken any medication today.

VAERS ID:334112 (history)  Vaccinated:2008-12-04
Age:15.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-04, Days after onset: 0
Location:Missouri  Entered:2008-12-05, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERU2840AA UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2666AA UNLA
Administered by: Other     Purchased by: Public
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Patient sat down next to father after vaccines were given in the triage area. Several staff saw patient put head down and shook her head for a few seconds. Vital signs were then obtained of 10 minutes for 30 minutes. Vital signs were stable. Patient was given cold water to drink and crackers.

VAERS ID:334197 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-06, Days after vaccination: 2
Gender:Male  Submitted:2008-12-08, Days after onset: 2
Location:Arizona  Entered:2008-12-08
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B103AC0IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2806AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1079X1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1188X1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Inflammation, Local reaction, Rash pruritic, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: LOCAL RED, WARM AND INFLAMMED REACTION ON LEFT ARM, SHOULDER AREA. ITCHY RASH ALSO ON SHOULDER AREA.

VAERS ID:334202 (history)  Vaccinated:2008-12-04
Age:8.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-08, Days after onset: 4
Location:North Carolina  Entered:2008-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAMOX, CLARITIN, RHINOCORT
Current Illness: NONE
Preexisting Conditions: ALMONDS, AUGMENTIN
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2839AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Rash macular
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: SPLOTCHES, COUGH DIFFICULTY BREATHING PATIENT WAS TREATED WITH 0.3cc OF EPINEPHRINE (LDIM), PER DR''S ORDER.

VAERS ID:334204 (history)  Vaccinated:2008-12-04
Age:1.5  Onset:2008-12-05, Days after vaccination: 1
Gender:Male  Submitted:2008-12-08, Days after onset: 3
Location:Texas  Entered:2008-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zithromax, Miralax, Xopenex
Current Illness: Sinusitis
Preexisting Conditions: Dandy Walker Malformation
Diagnostic Lab Data: EEG - positive for spikes.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015F0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Convulsion, Electroencephalogram abnormal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: New onset of seizures within 24 hours of vaccine administration. Child has never had seizures prior to this.

VAERS ID:334225 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Male  Submitted:2008-12-06, Days after onset: 1
Location:California  Entered:2008-12-08, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B103AC UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling on (R) upper extremity.

VAERS ID:334228 (history)  Vaccinated:2008-12-04
Age:5.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-08, Days after onset: 4
Location:Arizona  Entered:2008-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Was premature baby 38 wks. Has Asthma plus RSV. Previous pneumonia multiple times
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU25829AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0380U0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Rash, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Onset of fever, vomiting and swelling/rashes, pain (L) arm following vaccination of PNEUMOVAX. Patient vomited, lasted 24 hrs. Tx with MOTRIN. Arm swelling, pain (L) arm, lasted 4 hrs. Tx with warm soaks.

VAERS ID:334229 (history)  Vaccinated:2008-12-04
Age:7.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-08, Days after onset: 3
Location:Arizona  Entered:2008-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2829AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0380U0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fever 103, vomiting, pain and swelling at injection site 11 hrs post vaccination. Fever and vomiting for 26 hours. Treated with Motrin/Tylenol, fluids, warm wash cloth to site.

VAERS ID:334233 (history)  Vaccinated:2008-12-04
Age:0.1  Onset:0000-00-00
Gender:Female  Submitted:2008-12-08
Location:Michigan  Entered:2008-12-08
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
HIBV: HIB (ACTHIB)SANOFI PASTEURUF441AA0IMLL
Administered by: Private     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: HIB was given instead of HEP B. No symptoms at this time.

VAERS ID:334586 (history)  Vaccinated:2008-12-04
Age:41.0  Onset:2008-12-08, Days after vaccination: 4
Gender:Female  Submitted:2008-12-09, Days after onset: 1
Location:Virginia  Entered:2008-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Started on Zithromax on 12/4/08
Current Illness: none
Preexisting Conditions: unknown
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Tdap vaccine administered L deltoid 12/4/08 12/8/08 noticied indurated red area over injection site 12/9/08 red undurated hot area approx 6 cm over injection site also c/o achy headachy feeling and chills temp 98.8

VAERS ID:334589 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Male  Submitted:2008-12-09, Days after onset: 4
Location:North Carolina  Entered:2008-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B084AB IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1249X1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0996X1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Pain, Pruritus, Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: PT WOKE UP THE DAY AFTER THE SHOTS WERE GIVEN WITH A RASH HEAD TO TOE. SOME SPOTS LOOKED LIKE SM DOTS, OTHER AREAS LOOKED LIKE HIVES. EXTREMELY ITCHY. ALSO C/O FEELING ACHY. PARENTS GAVE BENADRYL AND MOTRIN WHICH DID NOT RELIEVE SX. ATARAX 10MG EVERY SIX HOURS CALLED IN FOR PT. THEY HAD TO GIVE IT EVERY SIX HOURS FOR RELIEF. PT EVEN WOKE UP THAT NIGHT AND GAVE ATARAX AT ABOUT MIDNIGHT. THE NEXT MORNING WOKE UP WITH NO RASH AND NO SYMPTOMS.

VAERS ID:334933 (history)  Vaccinated:2008-12-04
Age:5.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-06, Days after onset: 2
Location:Unknown  Entered:2008-12-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Otherwise healthy five-year-old child who had not been previously ill within the last eight months - last infection being otitis media. No hospitalization or major illness.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site oedema, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Child was given IM Flu vaccination in pediatrician office. Site of injection - right vastus lateralis. Within 12 hrs pt. presented at site of injection erythema, edema/inflammation, localized pain, and low-grade fever - 99. Within 36 hours - symptoms had diffused to about 70% of right thigh. Child was taken to an Urgent Care center - dx with cellulitis; given sulfamethoxazole and trimethoprim.

VAERS ID:334939 (history)  Vaccinated:2008-12-04
Age:15.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-08, Days after onset: 3
Location:North Carolina  Entered:2008-12-11, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Joint swelling, Pain in extremity
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Severe bilateral hand pain, swelling, right wrist, elbow, foot pain and swelling. Onset 20 hours after 2nd injection in Right elbow. Treated 2-6 hours with MOTRIN x 48 hours.

VAERS ID:334942 (history)  Vaccinated:2008-12-04
Age:0.6  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-04, Days after onset: 0
Location:Pennsylvania  Entered:2008-12-11, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B167AA UNUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2811AA0UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR4F520AA2UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC715712UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0898X2PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying, Pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: Seemed himself all day. Got home at 5:30 pm. Crying was different, shaking for probably 5 minutes. Seemed like he was in pain. Good eye contact. Fell asleep on car ride home, more snuggly tonight. Appetite good, no vomiting. Was given TYLENOL 0.8 ml at 1pm.

VAERS ID:334950 (history)  Vaccinated:2008-12-04
Age:7.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-05, Days after onset: 0
Location:Ohio  Entered:2008-12-11, 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: ZYRTEC; SINGULA
Current Illness:
Preexisting Conditions: Immune deficiency; allergy rhinitis; asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1384U0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Right deltoid area with extensive erythema, warmth from shoulder to just above elbow. Tender to palpitation. Pain with ROM (range of motion) of shoulder.

VAERS ID:335092 (history)  Vaccinated:2008-12-04
Age:63.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-09, Days after onset: 4
Location:Texas  Entered:2008-12-11, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89985 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.08678 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injected limb mobility decreased, Joint swelling, Pain in extremity
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Sore arm that patient claimed to be immobile the next day after receiving 2 shots. Shoulder was swollen.

VAERS ID:335096 (history)  Vaccinated:2008-12-04
Age:39.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-09, Days after onset: 4
Location:Arizona  Entered:2008-12-11, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0867X SCUN
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: hives came on a few hours after vaccine (that evening).

VAERS ID:335107 (history)  Vaccinated:2008-12-04
Age:10.0  Onset:2008-12-08, Days after vaccination: 4
Gender:Male  Submitted:2008-12-11, Days after onset: 3
Location:New York  Entered:2008-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2731AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1010X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red circle around injection site - advised to apply cool compress and Motrin prn.

VAERS ID:335220 (history)  Vaccinated:2008-12-04
Age:74.0  Onset:2008-12-11, Days after vaccination: 7
Gender:Female  Submitted:2008-12-12, Days after onset: 1
Location:Wisconsin  Entered:2008-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hyzaar
Current Illness: None noted
Preexisting Conditions: No known allergies per patient. Hypertension. No other conditions known.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2806AA IMRA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERU2017AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Immunisation reaction, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient came in to clinic with "a reaction to the tetanus shot." Received Td immunization at this clinic 12/04/08 and on 12/11, patient noted that site became red, swollen and hot. Writer Noted large area (approximately 5cm wide by 7cm long) of erythemic patch, slightly raised, on L deltoid. Very hot to touch with one small streak going from top of erythemic patch in cephalic direction. Erythemic patch did not blanche. No adenopathy of L axilla noted. Sent to urgent care for evaluation and further treatment not available at these clinics.

VAERS ID:335293 (history)  Vaccinated:2008-12-04
Age:16.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:Connecticut  Entered:2008-12-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500553P0IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB319AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X3IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: None

VAERS ID:335341 (history)  Vaccinated:2008-12-04
Age:33.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-15, Days after onset: 11
Location:California  Entered:2008-12-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA1IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: LARGE LUMP IN LEFT DELTOID 60MM WIDE: tdap, ADMINISTERED AT THIS SITE. NO PAIN, NO REDNESS OR BRUISIN. HAS HAD NO FEVER OR DISCOMFORT. APETITE GOOD RESTING WELL. PATIENT FIRST NOTICED LUMP ON 12-04-208, RECEIVED IMMUNIZATION ON 12-0-2008.

VAERS ID:335418 (history)  Vaccinated:2008-12-04
Age:0.2  Onset:2008-12-06, Days after vaccination: 2
Gender:Female  Submitted:2008-12-11, Days after onset: 5
Location:Minnesota  Entered:2008-12-16, Days after submission: 5
Life Threatening? No
Died? Yes
   Date died: 2008-12-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B173AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF400AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC719750IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0926X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Pneumonia, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Child seen in clinic 12-4-08 - well child visit with vaccines given. Child put to bed 12-6-08 on stomach. Unresponsive two hours later by parents at home.2/20/09-autopsy report received-Sudden unexplained infant death, prone sleeping position. Minute foci of pneumonia.

VAERS ID:335501 (history)  Vaccinated:2008-12-04
Age:3.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-07, Days after onset: 2
Location:New Jersey  Entered:2008-12-17, 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: ALLEGRA
Current Illness: None
Preexisting Conditions: Asthma, seasonal allergies. 12/19/08-records received-PMH:Asthma. 2/13/09-records received-PMH: asthma and seasonal allergies.
Diagnostic Lab Data: MRI, Lead level, CBC, CMP 12/19/08-records received-CT head normal. MRI brain normal. 2/13/09-records received-Labs normal, CRP normal, Elisa lyme normal. CT normal. MRI brain normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1363X0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Ataxia, Blood lead, Borrelia burgdorferi serology negative, C-reactive protein normal, Cerebellar syndrome, Computerised tomogram normal, Encephalitis, Full blood count, Gait disturbance, Metabolic function test, Nuclear magnetic resonance imaging brain normal, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Ataxia (truncal and gait) which developed several hours after receiving MMR vaccine on 12-4-08. 12/19/08-records received for 12/7/08-consultation for C/O tremulous shaking both arms and subsequently gait was noted to be unsteady on 12/4/08. Neuro exam shows bilateral and intentions tremor bordering on dysmetria on left, mild truncal ataxia and moderate gait ataxia. Romberg''s sign negative. Plantar responses are bilaterally downgoing. Signs of cerebellitis or acute cerebellar ataxis. 2/13/09-records received for DOS 12/5-12/12/08,DC DX:Unsteady gait, porbably cerebellitis. Presented with inability to stand, shaking of both arms and unsteady ataxic leg gait. PE:dysmetria, ataxia and diadochokinesia.

VAERS ID:335578 (history)  Vaccinated:2008-12-04
Age:1.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-15, Days after onset: 10
Location:Ohio  Entered:2008-12-18, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0454X0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC256553IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0394X0SCRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Rt. upper leg has a 1 cm red raised area with blister-like bumps around it. No fever. No increase warmth to area.

VAERS ID:335645 (history)  Vaccinated:2008-12-04
Age:60.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Male  Submitted:2008-12-17, Days after onset: 12
Location:North Carolina  Entered:2008-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2798DA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1076X0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Lightheaded, dizzy, palpitations, patient went to ER and was given fluids.

VAERS ID:335743 (history)  Vaccinated:2008-12-04
Age:35.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-08, Days after onset: 4
Location:Wisconsin  Entered:2008-12-19, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOVENT, ALBUTEROL
Current Illness:
Preexisting Conditions: Asthma - Allergies to PCN sulfa Red dye (Antihistamine)
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Erythema, Induration, Tenderness
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Reports dizziness, and local redness within 2-3 hours of immunization 12/4/08 no syncope. No fever - dizziness was objective - lasting over nite (12 hours) now resolved. 3.5 x 2.5 cm Lt arm tender red hardened area centered remious.

VAERS ID:335847 (history)  Vaccinated:2008-12-04
Age:12.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Connecticut  Entered:2008-12-22
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: CT Head - normal 12/29/08-records received- Head CT normal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB329BA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram normal, Dizziness, Ear pain, Fall, Head injury, Headache, Immediate post-injection reaction, Loss of consciousness, Pallor, Scan brain, Somnolence, 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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Pt had syncopal episode 5 mins after receiving vaccine pt hit head during episode; slow to recover Admitted to hospital for observation 12/29/08-records received for DOS 12/4-12/5/08-DC DX: Syncopal episode. C/O feeling warm and pale after receiving vaccine, felt dizzy, fell, losing consciousness. C/O headache and ears hurting, hit the right side of had on door frame. Remained drowsy and pale.

VAERS ID:335949 (history)  Vaccinated:2008-12-04
Age:59.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-17, Days after onset: 13
Location:Arizona  Entered:2008-12-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89620 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0551X IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site pain, Lymph node pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Per pt., e-mailed about 11 pm that night (L) side began to get sore - (L) lymph nodes very tender and pain went down through the (L) side of ribs to pelvis. The site was hot, red, inflamed, and tender, could barely move (L) side was so sore and painful. Stayed in bed entire day - Sat., site still red, hot and sore. Sunday, getting back to normal.

VAERS ID:336043 (history)  Vaccinated:2008-12-04
Age:35.0  Onset:2008-12-20, Days after vaccination: 16
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2008-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0534X0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Pruritus, Pyrexia, Rash, Rash pustular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 12/22/08 called to report rash on Abdomen , shoulders, c/o itching, pustule on shoulder. Fever 100 degrees to 101 degrees.

VAERS ID:336009 (history)  Vaccinated:2008-12-04
Age:7.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-05, Days after onset: 0
Location:Texas  Entered:2008-12-24, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Seen by MD. 12/15/08 @ 11:10am
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50057P IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Papular rash on bridge of nose and around upper lip. Entire chin is red in circular pattern. No swelling of lips, no symptoms related to mouth or airway. No swelling of tongue or throat.

VAERS ID:336107 (history)  Vaccinated:2008-12-04
Age:0.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-09, Days after onset: 5
Location:Louisiana  Entered:2008-12-26, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': LA081205
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2356CA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04923IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0481X1SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0426X1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Cough, Dyspnoea, Rash erythematous, Rash generalised, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Within minutes after immunization coughing, c/o difficulty breathing, audible wheezing, red rash over entire body, welts on entire body. Hospital ER IV-gave BENADRYL and steroids IVP-released after 1 1/2 hour

VAERS ID:336327 (history)  Vaccinated:2008-12-04
Age:20.0  Onset:2008-12-11, Days after vaccination: 7
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2008-12-31
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.06050X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt had onset of pain at (R) shoulder vaccination site @ 12/11 of PM -exam c/w localized reaction at lateral aspect of deltoid no sign of infection or isotonic reaction.

VAERS ID:336505 (history)  Vaccinated:2008-12-04
Age:60.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Female  Submitted:2008-12-30, Days after onset: 25
Location:Texas  Entered:2009-01-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURV2741AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Tenderness
SMQs:
Write-up: Patient left arm still sore. Hard to grasp or lift heavy objects. Vaccine given on 12-4-08. No treatment given at this time.

VAERS ID:336932 (history)  Vaccinated:2008-12-04
Age:3.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-22, Days after onset: 18
Location:Mississippi  Entered:2009-01-09, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Soft Tissue Infection/Cellulitis
CDC 'Split Type': MS132008
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHAC21B143AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Injection site cellulitis, Injection site swelling, Soft tissue infection
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mom noted swelling to left upper arm @ 7pm on 12/4/08 but did''t think much of it until swelling had increased the next morning. Child seen in health department by nurse practitioner then referred to hospital received dignosis soft tissue infection/cellulitis and started on antibiotic.

VAERS ID:337150 (history)  Vaccinated:2008-12-04
Age:49.0  Onset:2008-12-11, Days after vaccination: 7
Gender:Female  Submitted:2009-01-08, Days after onset: 28
Location:Massachusetts  Entered:2009-01-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: CT Contrast dye
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0062X0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Oedema, Rash generalised, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Generalized body rash with mild edema,"patches" and hives.

VAERS ID:337444 (history)  Vaccinated:2008-12-04
Age:0.2  Onset:2009-01-06, Days after vaccination: 33
Gender:Unknown  Submitted:2009-01-14, Days after onset: 8
Location:Unknown  Entered:2009-01-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown. PMH: none
Diagnostic Lab Data: Unknown. Labs and Diagnostics: Abd US (+) for IS. Barium enema (+) for IS
CDC 'Split Type': WAES0901USA00993
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3180AA0IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0726X0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHDL62790IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1268X0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal tenderness, Barium enema abnormal, Constipation, Enema administration, Explorative laparotomy, Intussusception, Irritability, Large intestinal obstruction reduction, Lethargy, Nausea, Surgery, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad)
Write-up: Information has been received from a physician''s assistant (P.A.) concerning a approximately 3 month old patient who was vaccinated with a dose of ROTATEQ (lot # not reported) at the age of 6 weeks, in approximately Nov 2008. It was reported that the patient experienced intussusception "at 3 months of age", in approximately Jan 2009. Unspecified medical attention was sought. The baby had surgery and was hospitalized on 07-JAN-2009. As of 08-JAN-2009, the patient''s outcome was unknown. Intussusception was considered to be an other important medical event by the reporter. Additional information has been requested. 2/17/09 MR received for DOS 1/7-10/2009 with D/C DX: Intussusception. Pt presented with 1 day hx of persistant nausea with bilious emesis, decreased UO, obstipation, lethargy and irritability. PE (+) for RLQ tenderness. IS noted on US. Reduction attempted with air contrast enema, but unsucessful. To OR for exploratory lap and reduction. Bowel fxn returned 24 hrs post-op and diet advanced. D/C home 1/10/09. .

VAERS ID:338527 (history)  Vaccinated:2008-12-04
Age:1.6  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-08, Days after onset: 4
Location:Kentucky  Entered:2009-01-16, Days after submission: 39
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': MEDI0007604
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500553P0 UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non-serious report "given FLUMIST to 19-month-old" was received from a doctor''s medical assistant involving a 19-month-old male. On 14-Dec-2008 the patient received FLUMIST. On the same day, the patient received hepatitis B, DTap, PCV, IPV/OPV vaccines. The patient had no relevant medical history. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FLUMIST.

VAERS ID:338468 (history)  Vaccinated:2008-12-04
Age:58.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2009-01-22, Days after onset: 49
Location:California  Entered:2009-01-28, Days after submission: 6
Life Threatening? Yes
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0870X IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Chest discomfort, Dysphagia, Dyspnoea, Pharyngeal oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: 58 yo M with ESRD on HD, HTN, and DM presents to ER from HD center via ambulance after receiving PNEUMOVAX and developing sudden SOB. Pt states he was feeling fine and he received the shot and about an hour after being vaccinated began feeling swelling in his throat and tightness in his chest. Pt received 0.5 of 1-1000 epi, 125mg SOLUMEDROL, 50 mg BENADRYL at HD center. Pt states he is now feeling better but still c/o SOB, throat fullness, and difficulty swallowing. Pt states he has never had symptoms like this before. Symptoms: Anaphylaxis. Treatment Drugs Used: 1 EPINEPHRINE, 2 METHYLPREDNISOLONE, 3 DIPHENHYDRAMINE.

VAERS ID:341049 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-03-02, Days after onset: 88
Location:Missouri  Entered:2009-03-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Syncope~Influenza (Fluzone)~~8~In Sibling|Syncope~Influenza (Fluzone)~~9~In Sibling
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no past medical history and had not been taking any concomitant medications. The patient has two brothers who each experienced a syncopal event following receipt of FLUZONE.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 200900669
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2809A2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Bradycardia, Hypotonia, Pallor, Respiratory rate decreased, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial report received 23 February 2009 from a health care professional. A 4-year-old female patient had received a third dose intramuscular left deltoid injection of FLUZONE 2008-2009, lot number U2809AA on 04 December 2008 at 12:15 hours, and within 10 minutes, the patient experienced a syncopal episode where she became pale, limp and unresponsive with bradycardia and a low respiratory rate. The patient remained unresponsive until EMS arrived at the physician''s office. The patient was stimulated with sternal rub and oxygen by mask and taken to the emergency room. She was admitted overnight for observation and released the next day. The patient had no past medical history and had not been taking any concomitant medications. The patient recovered from the event. This patient has two brothers who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00670. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00670. Documents held by sender: None

VAERS ID:341067 (history)  Vaccinated:2008-12-04
Age:50.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-04
Location:Illinois  Entered:2009-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
SMQs:
Write-up: no adverse reaction Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.

VAERS ID:342648 (history)  Vaccinated:2008-12-04
Age:11.0  Onset:2008-12-06, Days after vaccination: 2
Gender:Female  Submitted:2009-03-13, Days after onset: 96
Location:Pennsylvania  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0902USA00849
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Local reaction
SMQs:
Write-up: Information has been received from a nurse concerning a 11 year old female patient who on 04-DEC-2008 was vaccinated with GARDASIL (lot# 661530/0575X). Concomitant therapy included MENACTRA and ADACEL. She received the vaccines in the other arm the same day. On 06-DEC-2008 the patient had a slight local reaction as her arm was inflamed. The patient was given KEFLEX. No further information is available.

VAERS ID:341933 (history)  Vaccinated:2008-12-04
Age:62.0  Onset:2008-12-20, Days after vaccination: 16
Gender:Female  Submitted:2009-03-17, Days after onset: 86
Location:California  Entered:2009-03-17
Life Threatening? No
Died? Yes
   Date died: 2008-12-31
   Days after onset: 11
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: See clinical report; simvastatin; metformin; ASP; COZAAR
Current Illness: None Known
Preexisting Conditions: see medical records - If I recall she did have other medication allergies 4/27/09-records received-PMH:borderline DM and HTN with DVT. allergies to grass, animals, dust.
Diagnostic Lab Data: See autopsy report opinion and clinical records from clinic.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Autopsy, Chest discomfort, Death, Dyspnoea, Eosinophilic myocarditis, Hyperhidrosis, Hypersensitivity, Myocarditis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Hypersensitivity (narrow)
Write-up: She dies on 12/31/08 - clinicians list hypersensitivity myocarditis of unk etiology - I autopsy case 1-14-09 - confirmed an eosinophilic myocarditis, unk etiology but cannot exclude ZOSTAVAX vaccination given around 12-4-08 - unk where, clinician indicate possible delayed hypersensitivity reaction. (She presented --$g to ER 12-20-08 with diaphoresis, chest tightness, SOB). 4/27/09-records received-COD Eosinophilic myocarditis, etiology not established.

VAERS ID:342051 (history)  Vaccinated:2008-12-04
Age:1.3  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-03-18, Days after onset: 103
Location:Georga  Entered:2009-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no, healthy
Preexisting Conditions: NKA; HX, HSV infection, cutaneous only; HSV meningitis, as infant; normal development
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2471AA3IMRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB659AA2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0264X0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC873103IMLL
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Had Hep B # 3, DTaP # 4, PCV # 4 and MMR # 1 on 12/4/08. At 8pm that night, pt had seizure with 104.2 temp. Went to medical center ER. TX with TYLENOL/MOTRIN, sent home. At 6am 12/5/08 had another seizure at home mom took her to ER. DX with seizure, sent home, per mom.

VAERS ID:342655 (history)  Vaccinated:2008-12-04
Age:13.0  Onset:2008-12-07, Days after vaccination: 3
Gender:Female  Submitted:2009-03-25, Days after onset: 107
Location:Ohio  Entered:2009-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: No pre-existing diagnosed issues 3/26/09-records received-PMH: sprained thumb and mononucleosis 4/20/09-records received-PMH:Depression PVCs.
Diagnostic Lab Data: MRI (1/20/09)- pineal cyst - neurosurgeon validated this was not impacting any vessels which would cause headache. CATSCAN: normal / Sleep study: no sleep apnea. 46 awakenings. Blood tests: normal / Allergy tests (2/2/09) : no allergies
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERU2795AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Allergy test negative, Asthenia, Blood test normal, CSF pressure normal, Computerised tomogram normal, Electrocardiogram abnormal, Fatigue, Headache, Hypophagia, Insomnia, Lumbar puncture normal, Malaise, Nausea, Nuclear magnetic resonance imaging abnormal, Scan brain, Sleep disorder, Sleep study abnormal, Ventricular extrasystoles, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Approximately 4:00PM 12/7/08 Symptom: Headache This came on suddenly. Pain level was a 5. Described as aching pain on back (upper) head. Was seen in ER on 12/9/08 after pain had continued for 48+ hours with no abatement (increased to level 7 pain) and getting < 4hrs of sleep per night. ER treated with Toradol, Midrin and Phenegrin. Pain level reduced to 4 and discharged from ER. Pain continued and increased to Level 7. Again treated at ER with no long term benefits. This has continued since 12/7. Pain is continual 24 x7. 3 ER visits and 4 day hospital admittance on 2/23/09 for high dose steroids IV. This did not aleviate pain. Insomnia that has occurred since 12/7 has been treated with Ambien since 2/26/09 3/26/09-records received for ED visit 12/9/08-C/O gradual onset of headache began 3 days ago. Bilateral sharp pain 7 out of 10. Nausea. Assessment:Headache. 4/20/09-records received-for DOS 2/23-2/26/09-Presented with headaches since 12/7/08 constant and localized to occipital region throbbing in character. HA is made worse by activity and unable to attend school for past 2 months. As HA worsens C/O feeling nauseous and has had decreased PO intake with 15 pound weight loss. Insomnia. Malaise, weakness, fatigue. Abdominal pain.

VAERS ID:345370 (history)  Vaccinated:2008-12-04
Age:26.0  Onset:2009-01-15, Days after vaccination: 42
Gender:Female  Submitted:2009-04-14, Days after onset: 88
Location:Unknown  Entered:2009-04-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP= 1/15/2009)
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory, 2/23/09
CDC 'Split Type': WAES0903USA04528
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0947X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Gastrooesophageal reflux disease, Laboratory test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse practitioner for the pregnancy registry of GARDASIL, concerning a 26 year old female patient with no pertinent medical history and no known drug allergies who on 4-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # 0947X) 0.5ml intramuscularly. On 3-FEB-2009 patient received second dose of GARDASIL (lot # 1702X) 0.5 ml intramuscularly. Patient is now pregnant, last menstrual period: 15-JAN-2009; estimated delivery date: 22-OCT-2009; estimated conception date: 29-JAN-2009. Concomitant medications during this pregnancy include ZANTAC PRN for GERD. Patient has had two previous pregnancies, both which ended due to elective termination 6 to 7 weeks from LMP. Patient sought medical attention via an office visit. On 23-FEB-2008 patient had OB labs done. No adverse effect was reported. Additional information has been requested.

VAERS ID:351851 (history)  Vaccinated:2008-12-04
Age:60.0  Onset:0000-00-00
Gender:Male  Submitted:2008-12-23
Location:New Jersey  Entered:2009-07-14, Days after submission: 202
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported.
Diagnostic Lab Data:
CDC 'Split Type': 200803914
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2810A IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3005 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough
SMQs:, Anaphylactic reaction (broad)
Write-up: This non-serious case was received from a physician on 08 December 2008. A 60-year-old male patient, with no reported medical history, received an injection of ADACEL (lot number UF456CA / C3005) and FLUZONE SV 2008-2009 (lot number U2810AA) on 04 December 2008. Approximately five hours after vaccination, the patient developed a "dry, hacking cough". The physician was going to prescribe cough medicine (unspecified). Outcome was not reported. Follow-up information was received 22 December 2008 from a health care professional. ADACEL was administered intramuscularly in the right deltoid and FLUZONE SV was administered intramuscularly in the left deltoid. The reporter kept in touch with the patient by telephone and reported that the symptom off cough subsided five to six hours after onset. The reporter spoke with the patient "that evening and following - patient felt fine". The patient recovered from the event. No additional information was provided.

VAERS ID:354172 (history)  Vaccinated:2008-12-04
Age:50.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 237
Location:Georga  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OS-CAL, NEXIUM, SYNTHROID, PRAVACHOL
Current Illness: Hypercholesterolaemia; Hypothyroidism; Drug hypersensitivity; Food allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0812USA01791
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1163X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site pain, Rash macular
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a healthcare worker concerning a 50 year old female patient with hypercholesterolaemia, hypothyroidism, CODEIDING hypersensitivity and wheat allergy who on 04-DEC-2008 was vaccinated with first dose of PNEUMOVAX (Lot #....), 0.5ml, intramuscularly. Concomitant therapy included PRAVACHOL, NEXIUM, SYNTHROID and OS-CAL. On 04-DEC-2008 after the patient received PNEUMOVAX developed left arm pain in the injection and a round red blotch about the size of a half dollar on her left shoulder and the same size blotch on the left side of her neck. There were no Laboratory or Diagnostics studies performed. At the time of the report on 05-DEC-2008 the patient was recovering. The patient sought medical attention office visit. Additional information has been requested.

VAERS ID:354564 (history)  Vaccinated:2008-12-04
Age:32.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2009-07-30, Days after onset: 237
Location:California  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 102.9
CDC 'Split Type': WAES0902USA00017
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH0619X0SCUN
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Feeling hot, Injection site warmth, Oedema peripheral, Pain, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from an office manager concerning a 32 year old male who on 04-EC-2008 was vaccinated with a dose of PNEUMOVAX (lot #: 660685/0619X). On approximately 04-DEC-2008, within 2 days of giving the vaccine, the patient had fever and a "swollen, red and hot arm". The patient recovered on an unspecified date. The patient contacted office for medical attention. Follow-up information was received from a health professional concerning a 32 year old white male who in 04-DEC-2008 morning was vaccinated SC with the first dose of PNEUMOVAX (lot #: 660685/0619X) into the left arm. In the morning of 05-DEC-2008 the patient developed fever 102.9, swollen arm, body body arch and warm at the site of injection. The patient sought medical attention by doctor visit. This is one of several reports received from the same source. No further information is expected.

VAERS ID:355573 (history)  Vaccinated:2008-12-04
Age:12.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 125
Location:Iowa  Entered:2009-08-13, Days after submission: 126
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007593
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Public     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 12-year- old female. The patient''s medical history included sinus problems; the patient was not taking any concomitant medications. On 04-Dec-2008, a certified medical assistant (CMA) in a community health inadvertently administered expired FLUMIST; the product was expired by nine days. The patient came into the clinic for sinus problems and the physician recommended the vaccine. Per the reporter, the CMA who administered the vaccine did not foll0w their internal clinic procedures. No adverse events have been reported since the vaccine error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 19-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.

VAERS ID:355625 (history)  Vaccinated:2008-12-04
Age:29.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2009-04-09, Days after onset: 125
Location:Missouri  Entered:2009-08-13, Days after submission: 126
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: No medical history information collected. No allergies to FLUMIST preservatives
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007713
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500540P0IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious report of expired FLUMIST given was received from a registered nurse concerning a 29-year-old male. On 04-Dec-2008, the patient was administered expired FLUMIST (12-Nov-2008); the product was expired by 22 days. The reporter indicated the FLUMIST expired at the beginning of the flu season. There was no adverse event associated with this event; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.

VAERS ID:354611 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-28, Days after vaccination: 24
Gender:Female  Submitted:2009-07-21, Days after onset: 204
Location:California  Entered:2009-08-19, Days after submission: 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': MEDI0008742
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500585P IN 
Administered by: Other     Purchased by: Other
Symptoms: Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)
Write-up: A serious report of trauma has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Dec-2008, the subject received FLUMIST. The subject was admitted to the hospital for trauma on 28-Dec-2008. The length of stay was one day. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the events was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.

VAERS ID:368003 (history)  Vaccinated:2008-12-04
Age:17.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-11-16, Days after onset: 347
Location:West Virginia  Entered:2009-11-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 10/01/2008) Passive smoking
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 07/13/09, moderate right sided hydrocele; lymphocyte count, 07/13/09, 25.0%, low; segmented neutrophil, 07/13/09, 65.0%, high; band neutrophil count, 07/13/09, 4%, 10 - 18; anisocyte, 07/13/09, slight; poikilocyte, 07/13/09, sli
CDC 'Split Type': WAES0812USA01628
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a licensed practical nurse, for the pregnancy registry of GARDASIL concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergic reactions, who on 04-DEC-2008 was vaccinated with the first dose of GARDASIL (lot number not provided) 0.5ml intramuscularly. There was not concomitant medication. Nurse reported that the patient was pregnant. Patient sought unspecified medical attention. No adverse effects reported. Follow up information was received from an obstetrician concerning a female patient with no pertinent medical history and no known drug allergies/drug reactions who on 04-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # not provided). It was reported that there were no complications, infections or illnesses during pregnancy. On 11-JUL-2009 the patient delivered a normal male baby (ID # 40105, weight 6 pounds and 14 ounces, length 19.5"). The patient was 40 weeks from her last menstrual period. There were no congenital anomalies or other complications. abnormalities. Follow-up information has been received via pediatric medical records from a physician concerning the patient''s baby with passive smoke risk. It was reported that on 13-JUL-2009, at the age of 3 days, the baby underwent an ultrasound test in order to investigate a scrotal mass. On 13-Jul-2009 the following test results were obtained: blood lymphocyte count 25.0 %, blood segmented neutrophil count 65.0%; blood band neutrophil count 4%, slight anisocyte observation, slight poikilocyte observation, slight polychromatic erythrocyte observation, slight macrocyte observation. On 14-JUL-2009, the ultrasound revealed moderate right sided hydrocele. The baby''s testicles appear to be normal with the right testicle measuring 1cm and the left testicle 9mm. Arterial flow was noted in both testicles. On 20-JUL-2009, the patient had a newborn exam which showed that the child was a little underweight at that time. The baby''s weight was 5.13 lb and his height was 20 in

VAERS ID:374775 (history)  Vaccinated:2008-12-04
Age:0.0  Onset:2009-07-13, Days after vaccination: 221
Gender:Female  Submitted:2009-12-21, Days after onset: 161
Location:West Virginia  Entered:2009-12-22, 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: Passive smoking
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 07/13/09, see narrative; anisocyte, 07/13/09, slight; band neutrophil count, 07/13/09, 4 %; lymphocyte count, 07/13/09, 25 %, low; segmented neutrophil, 07/13/09, 65 %, high; macrocyte, 07/13/09, slight; poikilocyte, 07/13/09, slight; polychromatic, 07/13/09, slight
CDC 'Split Type': WAES0812USA01628B1
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)
Write-up: Information has been received via pediatric medical records from a physician concerning a newborn patient with passive smoke risk who''s mother was vaccinated IM on 04-Dec-2008 with a 0.5ml first dose of GARDASIL while pregnant (WAES#0812USA1628). It was reported that on 13-JUL-2009, at the age of 3 days, the baby underwent an ultrasound test in order to investigate a scrotal mass. The ultrasound revealed moderate right sided hydrocele. The baby''s testicles appeared to be normal with the right testicle measuring 1cm and the left testicle 9mm. Arterial flow was noted in both testicles. The epididmyides appear normal. On 13-JUL-2009 the following test results were obtained: blood lymphocyte count 25.0%, blood segmented neutrophil count 65.0%; blood band neutrophil count 4%, slight anisocyte observation, slight poikilocyte observation, slight polychromatic erythrocyte observation, slight macrocyte observation. Also performed on this day were congenital hypothyroidism, hemoglobinopathy, galactosemai, biotinidase deficiency, congenital adrenal hyperplasia, cystic fibrosis, amino acid profile, fatty acid profile and organic acid profile. All reported as normal. The baby was seen for multiple well visits where the genitalia was reported as normal. At the time of this event, the patient recovered from Hydrocele. No further information is available. All available medical records will be provided upon request.

VAERS ID:384584 (history)  Vaccinated:2008-12-04
Age:0.5  Onset:2008-12-06, Days after vaccination: 2
Gender:Female  Submitted:2010-04-02, Days after onset: 481
Location:New York  Entered:2010-04-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0904USA02154
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3082AA0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF597AA0IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1169X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 6 month old patient (weight 20 pounds 10 ounces) with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions who on 04-DEC-2008 was vaccinated with the first dose of ROTATEQ (lot # 662876/1169X) oral administration. Concomitant therapy included DAPTACEL (Lot # C3082AA) and ACTHIB (lot # UF579AA). On 06-DEC-2008 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. On 04-FEB-2009 the patient received her second dose of ROTATEQ (lot # 662953/1169X), and her second dose of DAPTACEL and ACTHIB. On 06-FEB-2009 the patient experienced severe diarrhea, 5 times a day. Subsequently, 24 hours after the patient recovered. Additional information is not expected.

VAERS ID:398124 (history)  Vaccinated:2008-12-04
Age:23.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 607
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 10/3/2008); Penicillin allergy; Obesity; Routine health maintenance
Preexisting Conditions: Postpartum depression
Diagnostic Lab Data: Ultrasound, 12/24/08, singleton intra uterine pregnancy (routine rest); ultrasound, 06/12/09, renal: mild hydronephrosis R kidney (possibly secondary to pregnancy); Apgar score, 07/17/09, 8 (1 minute); Apgar score, 07/17/09, 9 (5 minutes)
CDC 'Split Type': WAES0812USA02810
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Cystoscopy, Drug exposure during pregnancy, Foetal disorder, Haematuria, Hydronephrosis, Muscle spasms, Muscle strain, Obesity, Streptococcal infection, Ultrasound kidney abnormal, Ultrasound scan normal, Wrong drug administered
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (narrow), Dystonia (broad), Accidents and injuries (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Chronic kidney disease (broad)
Write-up: Information has been received from a registered pharmacist concerning a 23 year old female patient with penicillin allergy who on 04-DEC-2008 was vaccinated with the first dose of GARDASIL, lot # 661044/0548X. It was reported that the patient was 10 weeks pregnant when vaccinated with her first dose of HPV vaccine. It was reported that, "pregnancy is normal to date". EDD was 10-JUL-2009. The patient sought medical attention at the physician''s office. Routine prenatal labs and ultrasound were scheduled. Follow up information has been received from a pharmacist for the pregnancy registry for GARDASIL, concerning a 23 year old female with penicillin allergy and obesity with a history of 1 pregnancy and 1 full term live birth with no birth defects or infant complications in previous pregnancies and a history of postpartum depression after first pregnancy, who on 04-DEC-2008 was vaccinated with a dose of GARDASIL (dose and route not provided) (lot number 661044/0548X). Concomitant therapy included prenatal vitamins (unspecified) for supplement. Routine lab test performed on 24-DEC-2008 included ultrasound with a result of singleton intra uterine pregnancy. Date of last menstrual period was reported as 03-OCT-2008, estimated conception date was reported as approximately 04-OCT-2008 and estimated delivery date was reported as 10-JUL-2009. Follow up information was received from the pharmacist. It was reported that the patient gave birth to a normal male infant with no congenital anomalies, weighing 9 pounds and 13.9 ounces (length 22 inches; head circumference 36.3cm) on 17-JUL-2009, at 40 5/7 weeks from LMP. The baby experience fetal macrosomia and reduced fetal movement but was a normal newborn (WAES 0812USA02810B1). During the pregnancy, the following complications were noted: maternal obesity (contributing factor) and intermittent gross hematuria of unknown etiology. The following diagnostic tests were carried out: On 12-JUN-2009, a renal ultrasound was performed which showed mild hydronephrosis of right kidney (possibly secondary to pregnancy). No renal stones were identified. The patient had a group B strep infection, which was treated with clindamycin after delivery. Other medication used during pregnancy included cyclobenzaprine (started on 04-FEB-2009) for the treatment of muscle spasm/shoulder strain, metronidazole (From 09-MAR-2009 to 16-MAR-2009, dose 500mg BID) for the treatment of bacterial vaginosis and sulfamethoxazole (+) trimethoprim (from 05-JUN-2009 to 09-JUN-2009, dose 800/160mg BID) for presumed UTI, culture negative. It was noted that after delivery the patient was referred to urology for further evaluation of hematuria (cytoscopy). Follow up information was received from a pharmacist concerning a 23 year old female patient with penicillin allergy who on 04-DEC-2008 was vaccinated into the left deltoid with the first dose of GARDASIL (lot number 661044/0548X). It was reported that the intended vaccine was influenza virus vaccine (unspecified). The patient delivered a live born infant on 17-JUL-2009 without problems. A routine pregnancy ultrasound was performed on 24-DEC-2008 (results not provided). It was noted that the patient received prenatal vitamins, sulfamethoxazole (+) trimethoprim, cyclobenzaprine and metronidazole during her pregnancy. No further information is available.

VAERS ID:398125 (history)  Vaccinated:2008-12-04
Age:  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy; Obesity
Preexisting Conditions: Postpartum depression
Diagnostic Lab Data: Apgar score, 07/17/09, 8 (1 minute); Apgar score, 07/17/09, 9 (5 minutes)
CDC 'Split Type': WAES0812USA02810B1
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0548X0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Drug exposure during pregnancy, Foetal disorder
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 pharmacist concerning a male baby who was born from a 23 year old female with penicillin allergy and obesity with a history of 1 pregnancy and 1 full term live birth with no birth defects or infant complications in previous pregnancies and a history of postpartum depression after first pregnancy, who on 04-DEC-2008 was vaccinated into the left deltoid with first dose of GARDASIL (dose and route not provided) (lot number 661044/0548X). Concomitant therapy included prenatal vitamins (unspecified) for supplement. It was reported that the patient''s mother gave birth to a normal male infant with no congenital anomalies, weighing 9 pounds and 13.9 ounces (length 22 inches; head circumference 36.3cm) on 17-JUL-2009, at 40 5/7 weeks from LMP. The baby experience fetal macrosomia and reduced fetal movement but was a normal newborn. Medications the mother used during pregnancy included cyclobenzaprine (started on 04-FEB-2009) for the treatment of muscle spasm/shoulder strain, metronidazole (From 09-MAR-2009 to 16-MAR-2009, dose 500mg BID) for the treatment of bacterial vaginosis and sulfamethoxazole (+) trimethoprim (from 05-JUN-2009 to 09-JUN-2009, dose 800/160mg BID) for presumed UTI, culture negative. Follow up information was received from a pharmacist. It was reported that the intended vaccine for the mother was influenza virus vaccine (unspecified). The patient''s mother delivered a live born infant on 17-JUL-2009 without problems. It was noted that the patient''s mother received prenatal vitamins, sulfamethoxazole (+) trimethoprim, cyclobenzaprine and metronidazole during her pregnancy. The mother''s experience during pregnancy is reported in WAES 0812USA02810. No further information is available.

VAERS ID:432086 (history)  Vaccinated:2008-12-04
Age:18.0  Onset:2008-12-08, Days after vaccination: 4
Gender:Female  Submitted:2011-08-04, Days after onset: 968
Location:Texas  Entered:2011-08-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1008USA04036
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0947X1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Muscle spasms, Oedema peripheral, Rash erythematous, Rash macular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # no reported). Concomitant therapy included NUVARING. On 04-DEC-2008 the patient experienced red spots, swollen hands and achy joints. Also, she experienced cramps while on NUVARING. The physician reported that on 08-DEC-2008 the patient visited the hospital but was not hospitalized. At the time of the report, therapy with GARDASIL was discontinued. The outcome of the patient was no reported. Follow-up information was received from a physician concerning a 20 year old female patient who on 04-DEC-2008 was vaccinated intramuscularly with the second dose of GARDASIL (Lot # 0947X) in the left arm. On 08-DEC-2008 (previously reported as 04-DEC-2008) the patient was seen in ER, and experienced swollen hands, joint aches and red splotches. The patient recovered from these events. No further information is available.

VAERS ID:335710 (history)  Vaccinated:2008-12-04
Age:16.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 15
Location:Foreign  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Brain computerized tomography, Dec2008, Normal; Electroencephalogram, Dec2008, Normal; Neurological examination, Dec2008, Normal
CDC 'Split Type': B0550397A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B019ED IMLA
Administered by: Other     Purchased by: Other
Symptoms: Electroencephalogram normal, Fall, Head injury, Neurological examination normal, Presyncope, Scan brain, Tonic clonic movements
SMQs:, Anticholinergic syndrome (broad), Convulsions (narrow), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (foreign regulatory agency # 92671) and described the occurrence of probable syncopal convulsion in a 16-year-old female subject who was vaccinated with DITANRIX, GlaxoSmithKline, MMRVAXPRO, non-GSK. On 4 December 2008, the subject received unspecified dose of DITANRIX (intramuscular, unknown injection site), unspecified dose of MMRVAXPRO (MMR vaccine, intramuscular, unknown injection site). On 4 December 2008, less than one day after vaccination with DITANRIX and MMRVAXPRO, the subject experienced episode of lipothymia with tonic-clonic contractions with consequent cranial trauma due to fall. The subject was referred to the emergency room where the diagnosis was: episode of probable convulsive syncope. This case was assessed as medically serious by GSK. The patient underwent EEG and brain CT scan which resulted normal. Neurological objective examination resulted normal too. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with DITANRIX and MMRVAXPRO.

VAERS ID:335830 (history)  Vaccinated:2008-12-04
Age:9.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2008-12-19, Days after onset: 15
Location:Foreign  Entered:2008-12-22, 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:
Preexisting Conditions: None
Diagnostic Lab Data: body temp, 05Dec08, 38.8 centi-degree; body temp, 06Dec08, 39.7 centi-degree
CDC 'Split Type': WAES0812CHN00012
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1222F IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Hyperpyrexia, Injection site erythema, Injection site pain, Injection site swelling, Poor quality drug administered
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a mother whose son was a 9 year old male and on 04-DEC-2008 was vaccinated with PNEUMOVAX 23 (Batch# J2065, Lot#656657/1222F, expiration date was FEB-2009). There was no concomitant medication. On 04-DEC-2008 the patient experienced injection site red, injection site swelling and injection site pain after vaccinating. On 05-DEC-2008 the patient experienced hyperpyrexia which was 38.8 centi-degree. After given some therapies his body temperature was not decreased but increased to 39.7 centi-degree. He was hospitalized 05-DEC-2008. On 7-DEC-2008 the patient recovered from hyperpyrexia, injection site red, injection site swelling and injection site pain after taking dexamethasone and some antibiotic for two days. The reporter told that before vaccinating she found the color of the vaccine was yellow. No further information is available.

VAERS ID:335833 (history)  Vaccinated:2008-12-04
Age:68.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-19, Days after onset: 15
Location:Foreign  Entered:2008-12-22, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypersensitivity
Preexisting Conditions: Meningoencephalitis; Obstructive chronic bronchitis
Diagnostic Lab Data: blood pressure measurement, 04Dec08, 96/74 mmHg; blood pressure measurement, 04Dec08, 108/76 mmHg; total heartbeat count, 04Dec08, 112
CDC 'Split Type': WAES0812USA03490
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0969F IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, Heart rate increased, Hyperhidrosis, Lymphoedema, Oedema peripheral, Pain in extremity, Peripheral vascular disorder
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: Information has been received from a general practitioner that a 68-year-old female patient with history of meningoencephalitis (years ago) was vaccinated with a first dose of PNEUMOVAX 23 (lot # 656016/0969F; batch # NF00260) IM into the left upper arm on 04-DEC-2008. On 04-DEC-2008, two hours p.v., the patient developed severe sweating and severe pain in the left arm. Blood pressure showed decreased values (96/74 mmHg). On 04-DEC-2008 she presented to an outpatient department. She was treated with NOVALGIN, SOLUDECORTIN and morphine. On 07-Dec-2008 she presented again due to ongoing symptoms. On 08-Dec-2008 she was examined by the reporter. Her left arm was swollen down to the wrist joint. She was recovering from other symptoms. The reporter considered the case serious. Additional information received on 15-Dec-2008. It was reported by the general practitioner that the patient with history of chronic obstructive bronchitis and allergies (not otherwise specified) was vaccinated I.M. into the left deltoid muscle. The patient was treated with dexamethasone, diclofenac, tilidin (andolor), doxycycline (Doximucol), erythromycin (Roxithromycin) and novalgin. On 04-Dec-2008 she additionally developed lymphedema and peripheral circulatory disorder. Her blood pressure was 108/76 and pulse rate 112. On 11-Dec-2008, the patient presented to a surgeon. Arthritis of the shoulder area (clavicle, scapula, acromioclavicular, shoulder and sternoclavicular joint) was diagnosed. The patient was treated also with cool packs, RIVANOL and LYMPHDIARAL. The symptoms improved, but the patient had not recovered at the time of reporting. Other business partner numbers included E2008-11412. Additional information is expected.

VAERS ID:336253 (history)  Vaccinated:2008-12-04
Age:16.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-26, Days after onset: 22
Location:Foreign  Entered:2008-12-30, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electroencephalography, 04Dec08, within limits; head computed axial tomography, 04Dec08, negative
CDC 'Split Type': WAES0812USA04307
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B019ED IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0923U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram head, Computerised tomogram normal, Electroencephalogram normal, Fall, Head injury, Neurological examination normal, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from Health Authority (case n. 92671) concerning a 16 year old female who on 04-DEC-2008 was vaccinated with the second dose of MMR II (lot# 656756/0923U) and concomitant with the booster dose of DITANRIX (AC12B019ED). On the same day she presented with an episode of lypothimia with tonic-clonic contractions followed by falling with head trauma. She was sent to emergency room and was released the same day with diagnosis of "episode due to likely convulsive syncope". Neurological consultation was within normal limits. An EEG was performed and was within normal limits. Brain CT scan result was negative. At the time of reporting the patient''s condition had improved. The final outcome was not reported. The case was reported as not serious by both Health Authority and the reporter but upgraded to serious by company. Syncope convulsive was determined to be an other important medical event. Other business partner numbers include: E2008-11664 and IT521/08. No further information is available. The case is closed.

VAERS ID:336360 (history)  Vaccinated:2008-12-04
Age:63.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 27
Location:Foreign  Entered:2009-01-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Osteoporosis; Bronchitis
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812KOR00027
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J6605 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Injection site swelling, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a physician concerning a 63 year old female with a history of osteoporosis and bronchitis who on 04-DEC-2008 was vaccinated with PNEUMOVAX (lot number J6605). On 04-DEC-2008 before going home after vaccination, the patient experienced injection site swelling. On the next day on 05-DEC-2008, the patient visited the clinic again and complained of injection site swelling and pneumonia (symptoms: chill and fever). The patient was treated with antibiotics but was not recovered (specific generic name was not reported). The patient was hospitalized to other hospital. Subsequently, after 3 days, the patient was discharged from the hospital. The patient was recovered from injection site swelling and pneumonia on 10-DEC-2008. The reporter felt that injection site swelling and pneumonia were related to therapy with PNEUMOVAX 23. Information regarding lot number validation of PNEUMOVAX 23 (lot number J6605) has been requested. Additional information has been requested.

VAERS ID:336957 (history)  Vaccinated:2008-12-04
Age:35.0  Onset:2008-12-09, Days after vaccination: 5
Gender:Female  Submitted:2009-01-09, Days after onset: 31
Location:Foreign  Entered:2009-01-09
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': B0552322A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB114AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eyelid ptosis, Facial palsy, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: This case was reported by a regulatory authority (Regulatory Agency #93022) and described the occurrence of probable Bell''s paralysis in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 4 December 2008, the subject received unspecified dose of TWINRIX (intramuscular, unknown injection site). On 9 December 2008, 5 days after vaccination with TWINRIX, the subject experienced probable Bell''s paralysis (eyelid ptosis and paraesthesia of right hemiface). The subject underwent neurological visit on 11 December 2008 and the diagnosis was: probable Bell''s paralysis. This case was assessed as medically serious by GSK. The subject was treated with corticosteroids. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with TWINRIX.

VAERS ID:337816 (history)  Vaccinated:2008-12-04
Age:15.0  Onset:2008-12-08, Days after vaccination: 4
Gender:Female  Submitted:2009-01-20, Days after onset: 43
Location:Foreign  Entered:2009-01-21, 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: Dysplasia
Diagnostic Lab Data: diagnostic laboratory test, showed normal findings; hemoglobin, 31Dec08, 12.1 g/dl; serum ANA, 31Dec08, IgG negative; serum B. burgdorferi Western blot IgG Ab, 31Dec08, negative; serum B. burgdorferi Western blot IgM Ab, 31Dec08, negative;
CDC 'Split Type': WAES0901USA01069
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Arthralgia, Blood immunoglobulin G normal, Blood lactate dehydrogenase abnormal, Borrelia burgdorferi serology, Haemoglobin decreased, Laboratory test normal, Rheumatoid factor decreased
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Information has been received from a pediatrician that a 15 year old female patient was vaccinated with a third dose of GARDASIL (lot# not reported) approximately 4 weeks ago. "Shortly" p.v. the patient developed increasingly severe diffuse-spreading joint pain. Blood sample (not otherwise specified) showed normal findings. A rheumatological disease could be ruled out. The patient was remitted to a hospital for further clarification on 07-JAN-2009, symptoms were ongoing. Follow up information was received on 09-JAN-2009. The reporting form and laboratory findings were sent by the pediatrician: The patient with history of dysplasia of the elbows and wrists was vaccinated with a third dose of GARDASIL, lot #, site and route not reported, on 04-DEC-2008. On 08-DEC-2008 the patient developed joint pain of the large and small joints (knee, hip, shoulder, elbow, wrists and fingers). Symptoms increased and the patient was unable to walk. According to the reporter, the events occurred independently from the preexisting dysplasia of the elbows and wrists. Clinical findings were negative, no signs of inflammation, neither redness nor swelling. On 31-DEC-2008, Laboratory findings revealed normal values for ANA IgG (negative). RF (rheumatoid factor) -IgM (quantitative): 5.2 IU/ml (normal up to 15), Borrelia b. (Lyme) IgG and IgM antibodies: negative and Antistreptolysin (quantitative): 31U/ml (normal up to 150). Hemoglobin 12.1 g/dl (normal range 12.8-16.8 g/dl), LDH 148 U/L (normal range 160-278 U/L). Other routine laboratory findings showed normal results. Despite treatment with ibuprofen the patient has not recovered at the time of reporting. The first dose and the second dose of GARDASIL given on 12-JUN-2008 and on 12-AUG-2008 were well tolerated. Other business partner numbers include E200900064.

VAERS ID:338735 (history)  Vaccinated:2008-12-04
Age:1.4  Onset:2008-12-05, Days after vaccination: 1
Gender:Male  Submitted:2009-01-30, Days after onset: 56
Location:Foreign  Entered:2009-01-30
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: Body temperature, 05Dec2008, 40Deg C
CDC 'Split Type': B0555459A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA472A SCRL
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA472A SCRL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA472A SCRL
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Mobility decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (PL-URPL-OCR-20081222005) and described the occurrence of decreased mobility in a 16-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). On 4 December 2008, the subject received 4th dose of INFANRIX-IPV/HIB (unknown arm, subcutaneous instead of intramuscular). On 5 December 2008, 24 hours after vaccination with INFANRIX-IPV/HIB, the subject experienced decreased mobility of the hand (the arm was loosely falling) with hardness edema redness and pain at the injection site and fever (38.8-40 Deg C). The subject was treated with SUMAMED and analgesic. The decreased mobility lasted 2 days. The hardness edema redness and pain at injection site lasted about 3 days. After 3 days, as the subject still experienced fever, he was hospitalised. At the time of reporting the fever was improved. No follow-up is expected as this was the only information the regulatory authority had.

VAERS ID:338865 (history)  Vaccinated:2008-12-04
Age:4.0  Onset:2008-12-05, Days after vaccination: 1
Gender:Unknown  Submitted:2009-02-02, Days after onset: 59
Location:Foreign  Entered:2009-02-03, 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: Not reported
Diagnostic Lab Data: not reported
CDC 'Split Type': 200900308
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2733A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Case received from the Health Authority on 27 January 2009 under the local reference number PL-URPL-OCR-20090113005. A 04-year-old patient (gender and initials not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C2733AA, on 04 December 2008. On 05 December 2008, i.e. the following day post-vaccination, the patient experienced oedema and redness of the left arm (approximately 10 cm in diameter) with a local tenderness. There were no local lymph nodes or fever. The patient''s skin at the injection site was normal. A small, punctuated redness in the greater tuberculum of the left humerus area may have been found (?). The patient''s general health condition was good. the patient was hospitalized on unspecified dates. The patient''s symptoms were resolving at the time of the report.

VAERS ID:339609 (history)  Vaccinated:2008-12-04
Age:3.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-02-13, Days after onset: 71
Location:Foreign  Entered:2009-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0558942A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB269CE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hyperaemia, Neutropenia
SMQs:, Haematopoietic leukopenia (narrow), Anticholinergic syndrome (broad)
Write-up: This case was reported by a regulatory authority # 94576 and described the occurrence of neutropenia in a 3-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 4 December 2008 the subject received unspecified dose of HAVRIX (intramuscular). On 4 December 2008, less than one day after vaccination with HAVRIX, the subject experienced hyperemia. Three to four days after vaccination she presented neutropenia. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. On 23 December 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX.

VAERS ID:342087 (history)  Vaccinated:2008-12-04
Age:67.0  Onset:2008-12-04, Days after vaccination: 0
Gender:Female  Submitted:2009-03-18, Days after onset: 103
Location:Foreign  Entered:2009-03-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to bee sting
Preexisting Conditions: Osteochondrosis
Diagnostic Lab Data: physical examination, 04Dec08, normal results; blood pressure measurement, 04Dec08, 150/90 mmHG; arterial blood O2 saturation, 04Dec08, 97%; total heartbeat count, 04Dec08, 68/min
CDC 'Split Type': WAES0903USA02398
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Blood pressure increased, Chest pain, Flushing, Hyperhidrosis, Oxygen saturation normal, Physical examination normal
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Case received from health authority on 12-MAR-2009 under HA reference no. PEI2009004588. It was reported that a 67-year-old female patient with a history of osteochondrosis and allergy to bee venom was vaccinated with PNEUMOVAX 23 SC (lot# and injection site not reported) on 04-DEC-2008. 2 minutes after vaccination, the patient experienced thoracic pain, flush, sweating and increase of blood pressure. Anaphylaxis was assumed and the patient was presented to an emergency room. She recovered after 30 minutes. Physical examination showed normal results. Blood pressure 150/90 mmHG, pulse rate 68/min, oxygen saturation 97%. The patient was monitored (duration not reported, no inpatient stay). Nothing was reported about treatment. Other business partner numbers include: E2009-02148. Case is closed.

VAERS ID:342586 (history)  Vaccinated:2008-12-04
Age:0.6  Onset:2008-12-04, Days after vaccination: 0
Gender:Male  Submitted:2009-03-24, Days after onset: 109
Location:Foreign  Entered:2009-03-25, 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: The patient has a past history of convulsion due to meningitis enteroviral. The time of the meningitis enteroviral was unknown but it was reported that the first two doses PREVENAR and INFANRIX HEXA were well tolerated and the patient did not experience any adverse events in temporal connection to the vaccinations.
Diagnostic Lab Data: In Dec-2008 test results were: polymerase chain reaction (results: unknown); electroencephalogram (results: unknown); and CSF test (results: unknown).
CDC 'Split Type': DEWYEG03342009
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA466A2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH330602IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test, Condition aggravated, Convulsion, Electroencephalogram, Epilepsy, Polymerase chain reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 7-month-old male patient who experienced generalised convulsion and suspected Watanabe epilepsy. The patient received the third dose on 04-DEC-2008. Additional suspect medication included INFANRIX HEXA which was administered on the same day. The patient experienced once generalised convulsion on 04-Dec-2008 and twice on 05-Dec-2008. The convulsion lasted for 2 minutes in each case and Watanabe epilepsy was suspected. The patient was hospitalized and an EEG, CSF test and PCR was performed. The result of each test was unknown. The patient received a medicinal treatment and since the beginning of the treatment the patient did not experience additional convulsions. However, the outcome was unknown. This case is being treated according to the foreign infection act.

VAERS ID:344288 (history)  Vaccinated:2008-12-04
Age:1.4  Onset:2008-12-05, Days after vaccination: 1
Gender:Unknown  Submitted:2009-04-16, Days after onset: 131
Location:Foreign  Entered:2009-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, Dec2008, 38.8-40.0 deg. C
CDC 'Split Type': B0569183A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA472A3SCUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA472A3SCUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA472A3SCUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Erythema, Hypotonia, Induration, Injected limb mobility decreased, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (#PL-URPL-OCR-20090108010) and described the occurrence of upper extremity edema in a 17-month-old subject of unspecified gender who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). On 4 December 2008, the subject received 4th dose of INFANRIX-IPV/HIB (subcutaneous, unknown injection site). On 5 December 2008, 24 hours after vaccination with INFANRIX-IPV/HIB, the subject experienced upper extremity edema, tenderness, erythema and fever. There was a big edema of arm-painful, hard, red (diameter above 10cm, lasting over 3 days). For two days child was limiting extremity movements (arm was flaccid, falling down) despite analgesics, fever was 38.8-40 deg C, Sumamed was administered, after 3 days fever was still present; child was directed to hospital. The subject was hospitalised. At the time of reporting the events were improved. No further information could be obtained in a proactive way; this case has therefore been closed.

VAERS ID:345526 (history)  Vaccinated:2008-12-04
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-01
Location:Foreign  Entered:2009-05-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0904USA04283
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ageusia, Fall, Hypotonia, Loss of consciousness, Muscular weakness, Nystagmus, Paraesthesia, Reaction to previous exposure to any vaccine, Sensation of heaviness, Sensory loss, Vertigo, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from the a health professional regarding her daughter, a 14 year old female who was administered on the 04-DEC-2008 the second dose of GARDASIL (Batch #, route and site of administration not reported). After receiving the second dose of GARDASIL, dates have not been reported, the patient presented with loss of consciousness (even while seated), blurry vision, vertigo, nystagmus, weakness of legs, loss of muscular tone, loss of posture (the patient while walking would lean to the left side losing control of her posture). Two months later after vaccine administration the patient had to be hospital admitted (admission date has not been reported) due to symptoms. No information has been reported concerning medications used to treat events, performed tests or test results. The patient was discharged from hospital on March 2009, exact date not reported, the patient has improved. She has not suffered vertigo, dizziness or nystagmus for the last month. The patient sometimes felt heaviness in her legs and has not recovered her muscle tone completely. Four months after the administration of the second dose of GARDASIL the patient had lost sense of taste, causing a difficulty detecting salty taste. Also the patient had lost sensitivity to temperature, it was noticed that the patient showered with very hot water, not being able to detect the high temperature of the water. This had also improved lately. It was also reported that after receiving the first dose of the vaccine on 19-SEP-2008 the patient experienced an injection site inflammation and fever (reaching 40 degrees C). Ibuprofen was used to treat adverse events. The patient was taken to the emergency room due to high fever where she was diagnosed with an otitis which was treated with AUGMENTIN. The patient had refused to have the third dose of vaccine. Other business partner numbers include: E2009-03555. This is one of several cases from the same source. No further information is available.

VAERS ID:350532 (history)  Vaccinated:2008-12-04
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2009-06-30
Location:Foreign  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': A0792657A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA202AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Stupor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a nurse via regulatory authority (# V0809411) and described the occurrence of convulsion in a subject of unspecified age and gender who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 4 December 2008 the subject received unspecified dose of FLUVIRAL (unknown). At an unspecified time after vaccination with FLUVIRAL, the subject experienced convulsion and stupor. The subject had a emergency room visit. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.

VAERS ID:361880 (history)  Vaccinated:2008-12-04
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2009-10-20
Location:Foreign  Entered:2009-10-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KALETRA; COMBIVIR; Zidovudine; Nadroparine calcium
Current Illness: HUMAN IMMUNODEFICIENCY VIRUS INFECT; WOLFF-PARKINSON-WHITE SYNDROME
Preexisting Conditions: Cesarean section; Elective interruption of pregnancy
Diagnostic Lab Data: Hemoglobin, Jul2009, 6.8mmol/l
CDC 'Split Type': D0059858A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia postoperative, Beta haemolytic streptococcal infection, Caesarean section, Drug exposure during pregnancy, Haemoglobin decreased
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This prospective case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Adverse events were reported for the mother on follow-up. Concurrent medical conditions included human immunodeficiency virus infection. On an unspecified date the subject received 1st dose of TWINRIX (unknown route and application site). This was in early pregnancy. At the time of reporting the outcome of pregnancy was unknown. Follow-up information was received on 23 December 2008 from a physician (gynaecologist). The subject showed immunity to rubella. The subject had two former pregnancies with one birth of a healthy child. The outcome of the second pregnancy was not reported. On 4 December 2008 the subject received 1st dose of TWINRIX (1 ml, subcutaneous, unknown injection site). The subject was pregnant after normal conception. Her last menstrual period occurred on 31 October 2008. The estimated date of delivery was 06 August 2009. At the time of follow-up the subject was in 6+6 weeks of pregnancy. Follow-up information was received on 13 October 2009. The subject had two former pregnancies with one elective interruption in 2002 and a primary cesarean section in 2008. Concurrent medical conditions included human immunodeficiency virus infection (HIV) and WOLFF-PARKINSON-WHITE syndrome. Concurrent medications included KALETRA, COMBIVIR, perioperative injection of RETROVIR, FRAXIPARIN for thrombosis prophylaxis. It was unclear if HIV medication was received for delivery only or already before. At an unspecified time the subject experienced vaginal group b streptococcal infection. This case was assessed as medically serious by GSK. The case was upgraded to serious. The outcome of the event was not reported. From 20 to 24 July 2009 the subject was hospitalised for caesarean section, because of the known HIV infection. On 21 July 2009 at 08:43, after 37+5 weeks of pregnancy the patient gave birth to a healthy male infant

VAERS ID:456197 (history)  Vaccinated:2008-12-04
Age:0.2  Onset:2008-12-13, Days after vaccination: 9
Gender:Female  Submitted:2012-05-24, Days after onset: 1257
Location:Foreign  Entered:2012-05-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperthermia; Soft stools
Preexisting Conditions:
Diagnostic Lab Data: stool analysis, virus stool test: was norovirus negative
CDC 'Split Type': WAES1205USA04217
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gastroenteritis, Viral test negative
SMQs:, Noninfectious diarrhoea (broad)
Write-up: Case described in the final clinical study report provided by the sponsor of the study on 11-MAY-2012, under the reference number 200900051. Case medically confirmed. A 10 week old female patient, with a medical history of hyperthermia and soft stools, had received a dose of ROTATEQ (batch number not reported) on 04-DEC-2008 and, on 13-DEC-2008, she experienced gastroenteritis. The patient was hospitalized on 13-DEC-2008. Aetiological investigations were performed. On an unspecified date, virus stool test was norovirus negative. The patient recovered from gastroenteritis on 15-DEC-2008. She received a dose of ROTATEQ (batch number not reported) on 02-FEB-2009. The assessment for gastroenteritis was expected. The investigator considered that gastroenteritis was not related. The sponsor considered that gastroenteritis was related. Other business partner numbers include E2012-03266. No further information is available.

VAERS ID:456342 (history)  Vaccinated:2008-12-04
Age:0.2  Onset:2008-12-13, Days after vaccination: 9
Gender:Female  Submitted:2012-05-25, Days after onset: 1258
Location:Foreign  Entered:2012-05-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Premature birth
Diagnostic Lab Data: ultrasound, 13Dec08, normal; diagnostic laboratory test, negative test for virus (VRS); body temp, 13Dec08, 38.5 Celsius; serum C-reactive protein, 13Dec08, 78 mg/l; serum hemoglobin test, 9.5 g/dl, anemia
CDC 'Split Type': WAES1108USA01069
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Bronchiolitis, C-reactive protein increased, Haemoglobin decreased, Pyelonephritis, Pyrexia, Ultrasound scan normal, Viral test negative
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Case described in the intermediate clinical study report provided by the sponsor of the study on 22-JUN-2011 under the reference number 201100211. Case medically confirmed. A 2 months old female patient with medical history of premature birth. She had been treated with ROTATEQ (batch number, dose not reported) from 04-DEC-2008 to 11-FEB-2009. On 13-DEC-2008, the patient experienced pyelonephritis. The patient was hospitalized on 13-DEC-2008. Etiological investigations were performed: normal renal function. Anemia was noted (hemoglobin was 9.5 g/dL). The event recovered after 10 days of gentamycine with ceftriaxone. At admission, medical report that no other vaccination was administered. On 18-DEC-2008, in hospital unit, the baby experienced acute bronchiolitis with negative test for virus (VRS). The event was considered as expected because starting in hivernal season. The event was treated with physical treatment and local antiseptic drugs. Outcome: The patient had recovered from pyelonephritis on 20-DEC-2008. The investigator considered that pyelonephritis was not related. The sponsor considered that pyelonephritis was possibly related. Relevant Tests (date/test/results/units/normal low range/normal high range): 13-DEC-2008, pyrexia 38.5 Celsius / 13-DEC-2008 C-reactive protein (CRP) increased 78 mg/L /13-DEC-2008, ultrasound scan normal. Follow up information received through the final clinical study report provided by the sponsor of the study on 11-MAY-2012 under the reference 201100211. The pyelonephritis appeared 9 days after the first dose of ROTATEQ and the patient was hospitalized during 8 days for this infection. The second and third doses of ROTATEQ were administered without problem. No further information is available. Other business partner number included: E2011-04810.

VAERS ID:335064 (history)  Vaccinated:2008-12-05
Age:11.0  Onset:2008-12-08, Days after vaccination: 3
Gender:Female  Submitted:2008-12-11, Days after onset: 3
Location:Unknown  Entered:2008-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None at this time
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.66019-0106-011IN 
Administered by: Unknown     Purchased by: Private
Symptoms: Anorexia, Fatigue, Myalgia, Nasal congestion, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: 3 days after nasal administration of vaccine, patient developed persistent fever to 103.7, myalgias, nasal congestion, anorexia, fatigue. So far, this has lasted for 4 days.

VAERS ID:335651 (history)  Vaccinated:2008-12-05
Age:64.0  Onset:2008-12-13, Days after vaccination: 8
Gender:Female  Submitted:2008-12-18, Days after onset: 5
Location:New York  Entered:2008-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Cold symptoms~Influenza (Fluzone)~1~63~In Patient
Other Medications: Non-contributory
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2755AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Pain, Sensation of heaviness
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Throbbing in deltoid area on and off. Heaviness and pain from left deltoid region extending to left palm intermittent since getting FLUZONE. Once above where injection was asymptomatic.

VAERS ID:339085 (history)  Vaccinated:2008-12-05
Age:2.0  Onset:2008-12-06, Days after vaccination: 1
Gender:Male  Submitted:2009-02-04, Days after onset: 60
Location:West Virginia  Entered:2009-02-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reactive airways disease; Seasonal allergy; Asthma
Preexisting Conditions: Premature birth
Diagnostic Lab Data: chest X-ray, no active disease; body temp, 12/06/08, 103 F; nasopharyngeal RSV, negative
CDC 'Split Type': WAES0812USA01983
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1317X1SCUN
Administered by: Other     Purchased by: Public
Symptoms: Body temperature increased, Bronchial hyperreactivity, Chest X-ray normal, Condition aggravated, Dyspnoea, Pyrexia, Respiratory syncytial virus test negative, Seasonal allergy, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a licensed practical nurse (L.P.N.) concerning a 24 month old premature born male (2 month early) with asthma who was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX "at one year old" (in approximately November 2007). On 05-DEC-2008 the patient received a second dose of VARIVAX. On the same day, he also received a dose of "flu shot" (manufacturer unknown). On 06-DEC-2008 the patient developed fever as high as 103 degrees F, wheezing and shortness of breath. He was seen at an urgent care center and was given antibiotics and "mini-neb" treatments. It was reported that no lab diagnostics studies were performed. The patient was seen in a physician''s office since the events had not improved "over the weekend". At the time of the report, 08-DEC-2008, the patient had not recovered. Follow-up information received on 02-FEB-2009 from the L.P.N. indicated that the patient was a premature baby born at 31 weeks gestation. On 05-DEC-2008, at 15:30, the patient was vaccinated in the right thigh with a second dose of VARIVAX (Lot #661008/1317X). It was reported that illness at the time of vaccination included reactive airway disease (RAD) and seasonal allergies. In the afternoon of 06-DEC-2008, the patient developed RAD, fever of 103 and vomited once. Respiratory Syncytial Virus (RSV) test was negative. Chest x-ray showed no active disease. The patient was treated with AUGMENTIN, albuterol (via nebulizer), PEDIAPRED and TYLENOL. It was reported that the patient recovered. His last visit was on 12-DEC-2008. The reporter considered the patient''s events to be other important medical events. Additional information has been requested.

VAERS ID:345774 (history)  Vaccinated:2008-12-05
Age:  Onset:2008-12-12, Days after vaccination: 7
Gender:Female  Submitted:2009-03-27, Days after onset: 104
Location:Indiana  Entered:2009-04-08, Days after submission: 12
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': WAES0901USA00314
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a physician concerning a female patient who on 05-DEC-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # not provided). On 12-DEC-2008 the patient experienced rash on her wrist on the arm she was vaccinated. The patient was diagnosed with shingles and was prescribed VALTREX. Additional information has been requested.

VAERS ID:355574 (history)  Vaccinated:2008-12-05
Age:55.0  Onset:2008-12-05, Days after vaccination: 0
Gender:Male  Submitted:2008-12-08, Days after onset: 3
Location:Kentucky  Entered:2009-08-13, Days after submission: 247
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007598
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500568P OTUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A spontaneous non-serious report of inadvertently administered FLUMIST to a 55 year old male has been received from a nurse. Medical history and concomitant medications were not reported. On 05-Dec-2008, the patient received FLUMIST. Shortly after the nurse administered FLUMIST, she discovered that the drug was not approved for the patient''s age group. The patient did not experience any apparent changes in medical/health status. There was no adverse event associated with this medication error, therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.

VAERS ID:421315 (history)  Vaccinated:2008-12-05
Age:25.0  Onset:2009-01-03, Days after vaccination: 29
Gender:Male  Submitted:2011-04-19, Days after onset: 835
Location:Florida  Entered:2011-04-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Headache
Diagnostic Lab Data: Initial EEG indicated epilepsy. Subsequent EEG''s did not until this year a sleep deprivation EEG did.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1495IM 
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500556P1IN 
Administered by: Military     Purchased by: Military
Symptoms: Back injury, Chest pain, Electroencephalogram abnormal, Epilepsy, Grand mal convulsion, Headache
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: On 1/3/2009, post vaccine day 29, he suffered a new onset grand mal seizure. He deployed abroad 3 days prior. He was airlifted finally to home. The seizure was felt to be caused by Mefloquine prescribed 12/9/2008. He developed severe headaches, chest pain and suffered injuries to his back.

VAERS ID:335711 (history)  Vaccinated:2008-12-05
Age:0.3  Onset:2008-12-10, Days after vaccination: 5
Gender:Male  Submitted:2008-12-19, Days after onset: 9
Location:Foreign  Entered:2008-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 11Dec2008, Abnormal
CDC 'Split Type': B0550536A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Barium double contrast, Gastrointestinal disorder, Intussusception, X-ray abnormal
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: This case was reported by a consumer and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 5 December 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 10 December 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. On 11 December 2008, the subject was hospitalised. Abdomen X-ray was performed twice and revealed intestinal swelling. The subject was transferred to another hospital on 13 December 2008 where he was treated with air enema. The subject was hospitalised for 5 days. On 15 December 2008, the events were resolved and the subject was discharged from hospital.

VAERS ID:339003 (history)  Vaccinated:2008-12-05
Age:0.4  Onset:2008-12-05, Days after vaccination: 0
Gender:Female  Submitted:2009-02-03, Days after onset: 60
Location:Foreign  Entered:2009-02-04, 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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC 'Split Type': IDWYEH07983809
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH33891 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dehydration, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 5-month-old female patient who experienced dehydration and profuse vomiting. The patient received a dose on 05-Dec-2008. On 05-Dec-2008, the patient experienced dehydration and profuse vomiting requiring hospitalization. Treatment included intravenous solution (unspecified). The patient recovered on an unspecified date. No additional information was available at the time of this report.

VAERS ID:339733 (history)  Vaccinated:2008-12-05
Age:0.9  Onset:2008-12-07, Days after vaccination: 2
Gender:Male  Submitted:2009-02-17, Days after onset: 72
Location:Foreign  Entered:2009-02-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 07Dec2008, elevated; Laboratory test, Dec2008, normal; Scan brain, Dec2008, normal; December 2008 Infectious work-up (nos) : negative.
CDC 'Split Type': B0558782A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Brain scan normal, Febrile convulsion, Hypotonia, Laboratory test normal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (# RN20090017 and RN0900004) and described the occurrence of febrile convulsion in a 11-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline) and combined MMR vax, (non-GSK). The subject had no relevant medical history. ON 05 December 2008, the subject received a 3rd dose of ENGERIX B (intramuscular, batch and injection site unknown) and an unspecified dose of MMR vax (intramuscular, batch and injection site unknown). On 07 December 2008, 2 days after vaccination with ENGERIX B and MMR vax, the subject experienced febrile convulsion with right hemibody hypotonia. Brain scan was normal, laboratory test (NOS) and infectious work-up (NOX) were negative. The subject was hospitalised. At the time of reporting the events were resolved. The agency considered febrile convulsion as possibly related vaccination with ENGERIX B and MMR vax, according to the foreign method of imputability.

VAERS ID:341590 (history)  Vaccinated:2008-12-05
Age:11.0  Onset:2008-12-10, Days after vaccination: 5
Gender:Female  Submitted:2009-03-11, Days after onset: 90
Location:Foreign  Entered:2009-03-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Acetylcholine receptor antibody test, antiacetycholine receptor antibody positive
CDC 'Split Type': WAES0903USA01007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antiacetylcholine receptor antibody positive, Myasthenia gravis, Thymus enlargement
SMQs:, Neonatal disorders (broad)
Write-up: Initial information received on the 05-MAR-2009 by Health Authority (reference number ES-AGEMED-93082440) regarding an 11 year-old female who was administered on the 05-DEC-2008 a dose of a GARDASIL (lot# and batch# not reported) by intramuscular route (site of administration not reported). It is reported that 6 days after vaccination, on the 10-DEC-2008 the patient presented a myasthenia gravis. It is reported in the narratives of the report sent by Health Authorities but it hasn''t been coded in the report, that the adverse event involves acetylcholine anti-receptors and enlarged thymus (start/stop dates have not been reported). It is reported that the patient was hospital admitted but admission and discharge dates have not been reported. Outcome is unknown. No further information reported. Other business partner numbers include: E2009-01971.

VAERS ID:360129 (history)  Vaccinated:2008-12-05
Age:1.8  Onset:0000-00-00
Gender:Male  Submitted:2009-10-08
Location:Foreign  Entered:2009-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0596297A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B101AC3IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC20B101AC3IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH301532IMUN
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion, Gaze palsy, Hypertonia, Loss of consciousness, Otitis media, Pallor, Pyrexia, Skin warm
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (NL-LRB-91406) and described the occurrence of febrile convulsion in a 21-month-old male subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline), PREVENAR (non-gsk). The subject had no relevant medical history and was under no concomitant medication. On 5 December 2008, the subject received 4th dose of INFANRIX-IVP (intramuscular, unknown injection site), 3rd dose of PREVENAR (intramuscular, unknown injection site). In December 2008, 8 hours after vaccination with INFANRIX-IPV and PREVENAR, the subject experienced fever. Thirteen hours after vaccination, the subject experienced febrile convulsion with unconsciousness, eyeballs raise upward, hypertonia, warm skin and paleness of skin. The following day, an otitis media was diagnosed, leading to treatment with antibiotics. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-IPV and PREVENAR. No further information could be obtained. This case has therefore been closed.

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