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Found 468973 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:471822 (history)  Vaccinated:2012-10-25
Age:20.0  Onset:2012-10-25, Days after vaccination: 0
Gender:Female  Submitted:2012-10-25, Days after onset: 0
Location:Texas  Entered:2012-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma; Anemia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1205301 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010575 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dyspnoea, Feeling hot, Flushing
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.

VAERS ID:473738 (history)  Vaccinated:2012-10-25
Age:79.0  Onset:2012-10-25, Days after vaccination: 0
Gender:Male  Submitted:2012-11-08, Days after onset: 14
Location:Foreign  Entered:2012-11-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes mellitus type II; Arterial hypertension
Diagnostic Lab Data:
CDC 'Split Type': 2012033863
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED098622902 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cheilitis, Nausea, Pain of skin, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This medically confirmed report (initial receipt 30-Oct-2012) concerns a 79-year-old male patient, who had a medical history of diabetes mellitus type IIb and arterial hypertension. Concomitant medications included ANTI-DIABETICS, METOPROLOL TARTRATE, TORASEMIDE, OMEPRAZOLE and ANTIHYPERTENSIVES all given since 23-Jun-2009. On 25-Oct-2012, the patient received 1 ampoule intramuscular AFLURIA (upper arm left site) (BATCH no: 098622902). On 25-Oct-2012 (about 14:00h), the patient developed nausea, skin pain, rash (legs, upper body, arms, lips and cheeks) and swelling. On 29-Oct-2012 he was treated with Cortison and Prednisolon (60mg), and on 30-Oct-2012 with Prednisolon (40gm). Outcome: recovered on 30-Oct-2012. Flu vaccination with another brand on 10-Oct-2011 was tolerated well.

VAERS ID:474095 (history)  Vaccinated:2012-10-25
Age:50.0  Onset:2012-10-26, Days after vaccination: 1
Gender:Female  Submitted:2012-11-13, Days after onset: 18
Location:Foreign  Entered:2012-11-14, 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: Pregnant: No
Diagnostic Lab Data:
CDC 'Split Type': 2012033868
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED098622103 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This medically confirmed report (initial receipt 05-Nov-2012) concerns a 50-year-old female patient with a normal anamnesis regarding vaccinations. On 25-Oct-2012 at 09:30 am, the patient was intramuscularly vaccinated in the left upper arm with one AFLURIA (batch no. 098622103). On 26-Oct-2012, next day after the vaccination, she developed a muscular weakness left (weakness in leg). The weakness in the leg lasted at least until 31-Oct-2012 but end date was not known. The patient was advised to contact the general practitioner for treatment of the event. Outcome: unknown. Reporter''s comment: The reporter considered the muscular weakness left as serious (other medically important condition: secondary damage) and causality to vaccination with AFLURIA as possible.

VAERS ID:474227 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-10-26, Days after vaccination: 1
Gender:Female  Submitted:2012-11-14, Days after onset: 19
Location:Foreign  Entered:2012-11-15, 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 had no family history. Her gestational age was 35 weeks, 0 days. Her birth weight was 2.288kg.
Diagnostic Lab Data:
CDC 'Split Type': 201210417
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR 0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein, Injection site erythema, Poor sucking reflex, Vaccination site swelling, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Neonatal disorders (narrow)
Write-up: Report received from the Health Authorities (Case ID: # HIB-452) on November 2012. A 2-month-old female patient, with no family medical history, had received her first subcutaneous injections of ACTHIB (batch number H1050) on the left upper arm and her first subcutaneous injections of PREVENAR (batch number not reported) on the right upper arm on 25 October 2012, at 14:30. Body temperature before the vaccination was 37.0 degrees C. The patient''s gestational age was 35 weeks, 0 days. Her birth weight was 2.288kg. In the early morning of 26 October 2012, the patient''s body temperature was of 38 degrees C. She became inactive and her suck became weak, thus she was taken to the reporting physician''s hospital. There were redness and swelling at the vaccination site of PREVENAR. Hematological and biochemical examinations were performed, and the results were: WBC 13300 and CRP 2.4. Early stage of microbial infection could not be denied, thus she was referred to the hospital and was hospitalized on 26 October 2012. At the time of report, corrective treatments and patient''s outcome were not reported. Physician''s comment: Causality between the event and ACTHIB was assessable. There was no likely cause of the event other than the vaccination.

VAERS ID:476510 (history)  Vaccinated:2012-10-25
Age:4.0  Onset:2012-10-27, Days after vaccination: 2
Gender:Male  Submitted:2012-11-15, Days after onset: 19
Location:Foreign  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: 04/12/2012, varicella vaccine, no adverse event
Diagnostic Lab Data:
CDC 'Split Type': WAES1211DEU005976
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.G0198901SCUN
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Hypotonia, Lumbar puncture
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case was received from a healthcare professional in a foreign country on 08-Nov-2012. Case is medically confirmed. A 4-year-old male patient received a second dose of VARIVAX (lot-no. G019890) on 25-Oct-2012, injection route and site not reported. Two days later, on 27-Oct-2012, he presented with gait disturbance and hypotonia. The patient was hospitalised. A lumbar puncture was carried out on 08-Nov-2012, the results were not available at the time of reporting. At the time of the report, the patient had not recovered. Patient received a first dose of an unspecified varicella vaccine on 12-Apr-2012, which was well tolerated.

VAERS ID:475029 (history)  Vaccinated:2012-10-25
Age:0.1  Onset:2012-10-25, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-20, Days after onset: 26
Location:Foreign  Entered:2012-11-21, 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:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201210698
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911002A UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER11011UFA UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURHPO97 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Convulsion, Cyanosis, Hypotonic-hyporesponsive episode, Lividity, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from the Health Authorities on 14 November 2012 under the reference number PL-URPL-N1244/2012. An 01-month-old patient (gender not specified), with no reported medical history, had received a dose of ACT-HIB, route and anatomical site of administration not reported, batch number "HPO97-1", a dose of EUVAX B (other manufacturer, route and anatomical site of administration not reported, batch number 11011UFA) and a dose of DTP vaccine (other manufacturer, route and anatomical site of administration not reported, batch number 20911002A) on 25 October 2012. On 25 October 2012, post-vaccination, the patient experienced convulsions, sialorrhea/salivation, hypotonic-hyporesponsive episode with apnea as well as cyanosis/lividity of the limbs. The patient was hospitalized on unspecified dates. No further information was reported. The Health Authorities coded "convulsions", "salivation", "hypotonic-hyporesponsive episode" and "cyanosis". The outcome was recovering at the time of the report. Documents held by sender: none.

VAERS ID:475440 (history)  Vaccinated:2012-10-25
Age:4.0  Onset:2012-10-26, Days after vaccination: 1
Gender:Male  Submitted:2012-11-21, Days after onset: 26
Location:Foreign  Entered:2012-11-21
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': B0846354A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B142DN UNLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site erythema, Injection site extravasation
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a physician via a regulatory authority (# CZ-CZSUKL-12001886) and described the occurrence of injection site infiltration in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject was a healthy child without allergy. On 25 October 2012, the subject received unspecified dose of INFANRIX (0.5 ml, parenteral, left arm). On 26 October 2012, 1 day after vaccination with INFANRIX, the subject experienced injection site infiltration, injection site redness spreading to the left arm reaching the neck. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 30 October 2012, the events were resolved.

VAERS ID:475430 (history)  Vaccinated:2012-10-25
Age:34.0  Onset:2012-10-26, Days after vaccination: 1
Gender:Male  Submitted:2012-11-26, Days after onset: 31
Location:Foreign  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Myelitis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0845501A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA744AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Influenza like illness, Loss of control of legs, Muscular weakness, Peripheral coldness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a pharmacist, via a foreign regulatory authority, and described the occurrence of flu-like symptoms in a 34-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included myelitis and pain. Concurrent medications included Tramadol. On 25 October 2012 the subject received an unspecified dose of FLUARIX (.5 ml, one dose, intramuscular, batch number AFLUA744AB). On 26 October 2012, 9 hours after vaccination with FLUARIX, the subject experienced flu-like symptoms. Two hours later the subject tried to get out of bed and his legs gave way. The subject also experienced numbness in the head which lasted for 24 hours. The subject also experienced coldness in the left hand. The regulatory authority reported that the events were disabling. At the time of reporting the head numbness was resolved and the outcome of the flu-like symptoms, cold hand and lower extremity weakness was unresolved. Agency Verbatim Text: Approximately 9 hours after vaccination, flu-like symptoms started. Then 2 hours later, tried to get out of bed and legs gave way. Numbness in head which lasted for 24 hours but patient still feels coldness in left hand.

VAERS ID:475759 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-10-27, Days after vaccination: 2
Gender:Female  Submitted:2012-11-30, Days after onset: 34
Location:Foreign  Entered:2012-11-30
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: Low birth weight baby; Premature baby; Twin pregnancy
Diagnostic Lab Data: Adenovirus test, Negative; Culture stool, Negative
CDC 'Split Type': WAES1211GRC011794
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0514AE PO 
Administered by: Other     Purchased by: Other
Symptoms: Adenovirus test, Culture stool negative, Haematochezia, Laboratory test normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: Case received from the Health Authorities in a foreign country on 23-Nov-2012 under the reference number GR-EOF-2012118. Contractual partner reference number SPV12053. The primary reporter was a physician. Case medically confirmed. This case is linked with case E2012-09621 (patients are twin sisters, same vaccine, same reaction). A 2-month-old female patient had received a dose of ROTATEQ (batch number 0514AE) orally on 25-OCT-2012 and subsequently on 27-Oct-2012 she experienced blood in stools. The reaction lasted 7 days. Symptoms gradually improved and the patient recovered without sequelae on 03-Nov-2012. Stool culture and advenovirus test were negative. The patient''s medical history included twin pregnancy, premature baby and low birth weight baby. No concomitant medications were reported. The Health Authority considered this case as serious due to other medically significant condition.

VAERS ID:475806 (history)  Vaccinated:2012-10-25
Age:12.0  Onset:2012-10-25, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 35
Location:Foreign  Entered:2012-11-30, 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: Personal and family medical history: not reported.
Diagnostic Lab Data: On an unspecified date, neurological investigation was performed (details not provided).
CDC 'Split Type': 201211231
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3620AEB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Nerve injury, Neurological examination, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)
Write-up: Initial case received from Health Authority (HA''s number: HU-OGYT-131812) on 22 November 2012. A 12-year-old male patient, with no reported medical history and concomitant therapies, had received a dose of ADACEL (batch number C3620AEB, route and site of administration not reported) on 25 October 2012. On 25 October 2012, 1 hour postvaccination, the patient experienced numbness, hypoesthesia, and paraesthesia of the left arm. The patient could hardly lift his left arm. The patient was referred to hospital where neurological investigation was performed (details not provided). However the symptoms resolved within a couple of hours, the patient was hospitalized overnight for observation. The diagnosis of transient neuropraxia was set up. The following day the patient completely recovered and discharged. The reporting physician concluded that the adverse event was moderately serious and possibly related to the vaccine. Sender''s comment: "This case is considered serious. Paraesthesia, hypoesthesia and muscle weakness are listed adverse reactions of ADACEL. However the diagnosis of neuropraxia (mild form of nerve injury/transient episode of motor paralysis) is not a listed adverse reaction of which condition may be a result of a penetrating injury causing peripheral nerve damage and temporary loss its conductor function suggest an accidental vaccination error which cannot be ruled out." The Health Authority coded "neuropraxia", "numbness of upper arm", "paraesthesis", "hypoaesthesia" and "muscle weakness upper limb". The Health Authority assessed this case as serious, i.e. as a medically significant condition. Upon internal review, the company assessed also this case as serious due to hospitalization. Documents held by sender: none.

VAERS ID:476021 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-11-04, Days after vaccination: 10
Gender:Female  Submitted:2012-12-03, Days after onset: 29
Location:Foreign  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: Low birth weight baby; Premature baby; Twin pregnancy
Diagnostic Lab Data: Adenovirus test, Negative; Culture stool, Negative
CDC 'Split Type': WAES1211GRC011777
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Adenovirus test, Culture stool negative, Haematochezia, Laboratory test normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: Case received from the Health Authorities on 23-Nov-2012 under the reference number GR-EOF-2012117. Contractual partner reference number SPV12052. The primary reporter was a physician. Case medically confirmed. This case is linked with case E2012-09624 (patients are twin sisters, same vaccine, same reaction). A 2-month-old female patient had received a dose of ROTATEQ (batch number 0514AE) orally on 25-Oct-2012 and subsequently on 04-Nov-2012 she experienced blood in stools. The reaction lasted 4 days. On the third day the symptoms worsened and then they improved: the patient recovered without sequelae on 07-Nov-2012. Stool culture and adenovirus test were negative. The patient''s medical history included twin pregnancy, premature baby and low birth weight baby. No concomitant medications were reported. The Health Authority considered this case as serious due to other medically significant condition.

VAERS ID:476060 (history)  Vaccinated:2012-10-25
Age:1.4  Onset:2012-10-26, Days after vaccination: 1
Gender:Unknown  Submitted:2012-11-29, Days after onset: 34
Location:Foreign  Entered:2012-12-03, 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: 25-OCT-2012, Body temperature, 39 Centigrade
CDC 'Split Type': 2012298570
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0UNRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Laboratory test, Pallor, Pyrexia, Trismus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This is a spontaneous report from a contactable physician from a foreign country. Regulatory Authority report number PL-URPL-N1319/2012. A 16-month-old patient of an unspecified ethinicity and gender started to receive PREVENAR, via an unspecified route of administration from 25Oct2012 to an unspecified date at dose 0.5 ml single vaccine given in left arm for immunization and INFANRIX HEXA, originally reported as INFANRIX HEXA, via an unspecified route of administration from 25Oct2012 to an unspecified date at dose 0.5ml 12; vaccine given in right arm for immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fever (39 degrees celsius), lockjaw, pallor and convulsions generalized with pallor reported as all medically significant on 26Oct2012. The outcome of all events was reported as recovered. Reported as generalized convulsion attack with pallor of skin surface. From the interview, it lasted about 15 minutes with lockjaw and fever 39 Celsius degrees. The patient underwent lab tests and procedures which included pyrexia on 25Oct2012, 39 Celsius degrees. No follow-up activities possible. No further information expected.

VAERS ID:476441 (history)  Vaccinated:2012-10-25
Age:15.0  Onset:2012-10-26, Days after vaccination: 1
Gender:Female  Submitted:2012-12-04, Days after onset: 39
Location:Foreign  Entered:2012-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Intermittent rhinitis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0849302A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA135AI2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Acute respiratory failure, Bronchospasm
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case reported by a pharmacist via a regulatory authority (# ES-AGEMED-525957241) and described the occurrence of bronchospasm in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included intermittent rhinitis. The subject was a non-smoker and had no past medical history of asthma or respiratory disease. No relevant family medical history was reported. On 25 October 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown site of injection). On 26 October 2012, 1 day after vaccination with CERVARIX, the subject went to the health center due to a bronchospasm and acute respiratory failure/insufficiency unremitting with Bronchodilator and oxygen. The subject was admitted to the hospital. The subject was discharged in the second day of treatment FORMODUAL 2inh/12h, Azitromycin 500mg/24h (3 days) and prednisone 10mg. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 29 October 2012, the events were resolved. 10 days after the onset of the events, the subject was totally recovered. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX. No further information could be obtained from the regulatory authority since all available information have been provided. Therefore, this case has been closed.

VAERS ID:478628 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-10-28, Days after vaccination: 3
Gender:Male  Submitted:2012-12-18, Days after onset: 51
Location:Foreign  Entered:2012-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anogenital dysplasia
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 28Oct2012, 23IU/L; Alanine aminotransferase, 29Oct2012, 31IU/L; Alanine aminotransferase, 31Oct2012, 35IU/L; Albumin, 28Oct2012, 4.1g/dL; Albumin, 29Oct2012, 4.3g/dL; Albumin, 31Oct2012, 3.9g/dL; Alkaline phosphatase, 28Oct2012, 469IU/L; Alkaline phosphatase, 29Oct2012, 486IU/L; Alkaline phosphatase, 31Oct2012, 478IU/L; Amylase, 28Oct2012, 11IU/L; Amylase, 29Oct2012, 13IU/L; Amylase, 31Oct2012, 11IU/L; Aspartate aminotransferase, 28Oct2012, 29IU/L; Aspartate aminotransferase, 28Oct2012, 44IU/L; Aspartate aminotransferase, 31Oct2012, 40IU/L; Atypical lymphocytes, 31Oct2012, 3%; Band neutrophil count, 31Oct2012, 0%; Basophils, 31Oct2012, 0%; Bilirubin total, 28Oct2012, 0.7mg/dL; Bilirubin total, 29Oct2012, 0.6mg/dL;
CDC 'Split Type': B0841851A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase normal, Amylase increased, Aspartate aminotransferase normal, Band neutrophil count decreased, Basophil percentage decreased, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose increased, Blood lactate dehydrogenase normal, Blood magnesium increased, Blood phosphorus increased, Blood potassium normal, Blood sodium normal, Blood urea decreased, Blood uric acid decreased, C-reactive protein increased, Diarrhoea, Eosinophil percentage increased, Erythroblast count, Haematocrit decreased, Haemoglobin decreased, Lymphocyte morphology abnormal, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal, Metamyelocyte percentage, Monocyte percentage, Myeloblast percentage, Myelocyte percentage, Neutrophil percentage decreased, Platelet count normal, Promyelocyte count, Protein total decreased, Pyrexia, Red blood cell count decreased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of fever in a 9-week-old male subject who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-GSK manufacturer; subcutaneous) given on 25 October 2012; pneumococcal vaccine (non-GSK manufacturer; subcutaneous) given on 25 October 2012. On 25 October 2012 the subject received unspecified dose of ROTARIX liquid formulation (1.5 ml, oral). Lot number not provided. On 28 October 2012, 3 days after vaccination with ROTARIX liquid formulation, the subject experienced fever and diarrhea. The subject was hospitalised. On 29 October 2012, the events were resolved. Follow-up information received on 11 December 2012: Follow-up information received on 11 December 2012: Concurrent medical conditions included anogenital dysplasia (the subject had been observed for perianal tumor since around 2 weeks of age). Concurrent medications included Fosfomycin from 26 to 28 October 2012. On 28 October 2012, in the morning, the subject developed pyrexia and diarrhea. At 15:30, the subject was admitted to hospital for observation. After the hospital admission, frequent episodes of diarrhea were observed. On 29 October 2012, in the morning, pyrexia resolved and the frequency of diarrhea also grandually decreased. From 29 October 2012 to 8 November 2012, the subject was treated with lactic-acid-producing organisms (Biofermin-R). On 31 October 2012, the subject recovered his usual condition at around the discharge. The physician considered the events fever and diarrhea were related to vaccination with ROTARIX liquid formulation. However, C-reactive protein (CRP) also increased and consequently common cold could also be considered.

VAERS ID:479096 (history)  Vaccinated:2012-10-25
Age:0.3  Onset:2012-10-27, Days after vaccination: 2
Gender:Male  Submitted:2012-12-21, Days after onset: 55
Location:Foreign  Entered:2012-12-21
Life Threatening? No
Died? Yes
   Date died: 2012-10-27
   Days after onset: 0
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': B0854222A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA759A0UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF336150UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autopsy, Death, Muscle rigidity, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Neonatal disorders (narrow)
Write-up: This case was reported by another health professional via a regulatory authority (# NO-NOMAADVRE-FHI-2012-15225) and described the occurrence of sudden infant death in a 3-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline) and (non-gsk) PREVENAR 13. On 25 October 2012, the subject received 1st dose of INFANRIX-POLIO-HIB (parenteral, administration site unknown) and 1st dose of PREVENAR 13 (parenteral, unknown). On 27 October 2012, 2 days after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, the subject was found dead in his bed. Rigor mortis was present. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX-POLIO-HIB and PREVENAR 13. The subject died on 27 October 2012 from sudden infant death. An autopsy was performed. Further information has been expected included autopsy report.

VAERS ID:479580 (history)  Vaccinated:2012-10-25
Age:  Onset:2012-10-28, Days after vaccination: 3
Gender:Female  Submitted:2012-12-27, Days after onset: 60
Location:Foreign  Entered:2012-12-27
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': B0854786A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSYFLUA734AA SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Ear pain, Headache, Neuritis
SMQs:, Peripheral neuropathy (narrow)
Write-up: This case was reported by a healthcare professional/physician via a sales representative and described the occurrence of facial neuritis in a female subject aged between 30 and 39 years old who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2012, the subject received unspecified dose of FLUARIX (unknown route and injection site). On 28 October 2012, 3 days after vaccination with FLUARIX, the subject experienced ear pain (pain behind ear) and headache. On 30 October 2012, facial neuritis was diagnosed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:482412 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-10-25, Days after vaccination: 0
Gender:Female  Submitted:2013-01-21, Days after onset: 88
Location:Foreign  Entered:2013-01-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness:
Preexisting Conditions: The patient was brought to the Emergency Room because of repeated episodes of fainting, immediately after the vaccination.
Diagnostic Lab Data: Electrocardiogram (ECG) (27Oct2012): normal for the patient age
CDC 'Split Type': 2013018147
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB343A0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF989480IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Agitation, Apnoea, Crying, Electrocardiogram normal, Erythema, Hyporesponsive to stimuli, Hypotonia, Injection site swelling, Mucous membrane disorder, Pain, Pharyngeal erythema, Plagiocephaly, Posture abnormal, Tachycardia, Tympanic membrane disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: This is spontaneous report received from the Regulatory Authority. Regulatory Authority report number 188456. A physician (specialist) (contactable through Regulatory Authority only) reported that a 11-weeks-old female patient received the first dose of PREVENAR 13 (Lot F98948, Exp. Date 31Dec2014) intramuscular on 25Oct2012 at 0.5 ml and the first dose of INFANRIX HEXA (Lot A21CB343A, Exp. Date 30Apr2014) intramuscular on 25Oct2012 at 0.5 ml, both as vaccination. The patient medical history was not reported. The patient''s concomitant medications included folic acid. At the time of reporting, she was in therapy with folic acid 1/4 tablets 7.5 mg. The patient experienced apnea, hypotonia, tachycardia and hyporesponsive to stimuli. The patient was hospitalized due to apnea, hypotonia, tachycardia and hyporesponsive to stimuli. It was reported that in on 25Oct2012 morning, at 11, the child had received the vaccinations (two injections). After the vaccine the child cried a lot, sought to be comforted by his mother. The child appeared less reactive and presented 3-4 episodes of apnea and hypotonia, no sneezing, no rashes, no changes in color. Brought back to visit at the Vaccination Center the child appeared alert, was crying a lot and was tachycardic. It was recommended to go the Emergency Room. At the Emergency Room the child was alert and responsive, she had a strong cry with tears, slight clouding of the tympanic membraines, pharynx rosy, normal cardiorespiratory activity, abdomen treatable. 15 drops of TACHIPIRINA were administered orally. A physician was contacted to inform him about the occurred events. It was reported that according to the results it could be an episode of Hypotonic Hypo-responsive Episode, the apnea resulted from the pain caused by vaccination and was therefore recommended to put the patient under observation for 24 hours. The child also had colic. The full discharge assistant included the following: PHYSICAL EXAMINATION: The young patient was awake, crying and reactive. She had rosy skin and mucous membranes. Tachycardic cardiac activity. Heart rate 201 bpm. No bronchostenosis on auscultation. Blood pressure 120/75. 26Oct2012 at 9:30: Rosy. Cardiac auscultation in the standard, as far as possible assess due to the agitation of the patient. Al chest Murmur Vesicular normally transmitted. Abdomen treatable. Hypochondriac organs within limit. Pharynx rosy. Swelling at the level of the thigh bilaterally, site of the vaccination. Left plagiocephaly with a tendency to maintain the head slightly inclined to the left. The anterior fontanelle was normotensive, Reactivity adequate. Heart rate 150/160 bpm at rest, Saturation 02 99%. No critical episodes 26Oct2012 at 15:00: Heart rate 170-180 bpm at rest (not constant). An electrocardiogram (ECG) was requested. 26Oct2012 at 18:45: ECG was performed. Cardiac auscultation performed when the child was quiet. A cardiac murmur 1/6 was found. The Cardiology Department was contact to perform a cardiological evaluation and an echocardiography. 27Oct2012 at 15.15: Good conditions. Rosy, Heart systolic murmur 1/6, Chest: sour breath spread, abdominals treatable, hypochondriac organs within the limits, vital signs normal, tachycardia has not been reported. ECG normal for age 27Oct2012 at 18:15: the patient was discharged with a request for cardiological assessment with echocardiography. DIAGNOSIS AT DISCHARGE: Temporary alteration (or loss) of consciousness. SUGGESTED HOME THERAPY: TACHIPRIINA at 15 drops. The patient completely recovered on 26Oct2012. No follow-up attempts needed. No further information expected.

VAERS ID:483156 (history)  Vaccinated:2012-10-25
Age:53.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-31
Location:Foreign  Entered:2013-01-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Polymerase chain reaction, Significant, Positive
CDC 'Split Type': PHHY2013DE006861
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS126202A IMAR
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2013DE006861, is an initial spontaneous report received from a foreign health authority (reference number: DE-PEI-PEI2013003322) on 23 Jan 2013. This was also a quality complaint report (QA reference number: 260460). This report refers to a 54-year-old female patient. Her current condition and her concomitant medication were not reported. On 25 Oct 2012, she was vaccinated with BEGRIPAL (batch number: 126202A) intramuscularly. On an unknown date, 80 days after vaccination the patient had influenza A virus infection and vaccination failure. Diagnosis was confirmed by PCR (result: positive Influenza A). The event outcome was reported as complete recovery at the date of reporting. The causality of the events was not reported.

VAERS ID:484369 (history)  Vaccinated:2012-10-25
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-12
Location:Foreign  Entered:2013-02-13, 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': 201301773
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER109VFA090Z0UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER109VFA090Z0UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER109VFA090Z0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the foreign Ministry of Health. A female patient (age reported as 15-year-old), whose medical history and concomitant therapies were not reported, had received her 1st dose of Influenza Vaccine (MFR UNK), Yellow Fever and Td vaccine, "The lot number is reported as "109VFA090Z" but it is not mentioned which vaccine this batch number refers to", (route and anatomical site of administration were not reported) on 25 October 2012. On an unspecified date post-vaccination the patient experienced angioedema and generalized urticaria. The patient''s outcome was recovered ("cure") without sequelae. The action regarding next vaccinations is reported as: no conduct. The resolution was reported as "indefined". The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:487463 (history)  Vaccinated:2012-10-25
Age:55.0  Onset:2013-01-02, Days after vaccination: 69
Gender:Male  Submitted:2013-03-21, Days after onset: 77
Location:Foreign  Entered:2013-03-21
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: Lumbar puncture, see text
CDC 'Split Type': B0874998A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA713BB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, CSF cell count increased, CSF monocyte count increased, CSF protein increased, Dizziness, Encephalomyelitis, Headache, Lumbar puncture abnormal, Multiple sclerosis, Myelitis transverse, Neck pain, Neuromyelitis optica, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Pain, Paraplegia, Pleocytosis, Pyrexia, Quadriparesis, Urinary retention
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: This case was reported by a physician via a regulatory authority (# 130310) and described the occurrence of encephalomyelitis in a 55-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2012, the subject received an unspecified dose of FLUARIX (administration site and route unknown). On an unspecified date, approximately 6 weeks after vaccination with FLUARIX, the subject experienced transient fever, nautical dizziness, headache and general sensation of pain in body. On 2 January 2013, 69 days after vaccination with FLUARIX, the subject woke up with neck pain and urinary retention followed by progressing tetraparesis. On 21 January 2013, 88 days after vaccination with FLUARIX, the subject was paraplegic with urinary retention. The subject was hospitalised. The magnetic resonance imaging brain, throat and chest showed spread partial contrast charged spinal changes and multiple white substance changes in brain (demyelinating changes). Encephalomyelitis was diagnosed. The imaging showed too widespread very elongated spinal changes to be multiple sclerosis. Rather neuromyelitis optica or acute disseminating encephalomyelitis or idiopathic acute transversal myelitis but no confirmation was provided. The lumbar puncture showed pleocytosis with 72 mono, 4 poly, barrier effect with spinal protein rose 917. At the time of reporting, the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX.

VAERS ID:487972 (history)  Vaccinated:2012-10-25
Age:90.0  Onset:2013-03-01, Days after vaccination: 127
Gender:Male  Submitted:2013-03-27, Days after onset: 25
Location:Foreign  Entered:2013-03-28, 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: No other medications
Current Illness: Unknown
Preexisting Conditions: Haemodialysis
Diagnostic Lab Data: Influenza virus test, significant, vaccination failure
CDC 'Split Type': PHHY2013DE029261
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERA15 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2013DE029261, is an initial spontaneous report received from Foreign Health Authorities (DE-PEI-PEI2013015882) on 22 Mar 2013: This report refers to 90-year-old male patient. His medical history included hemodialysis. Concomitant medication was not reported. On 25 Oct 2012, he was vaccinated with "first or second or other dose" of seasonal influenza vaccine (batch number A15 and manufacturer: unknown). On 01 Mar 2013, 4 months after vaccination the patient developed influenza and vaccination failure, lasting for 5 days. The patient was hospitalized. Diagnosis was confirmed by influenza virus test. The outcome of the event was recovered on 06 Mar 2013. Causality of the event was not reported. No follow-up information was available.

VAERS ID:489065 (history)  Vaccinated:2012-10-25
Age:1.2  Onset:2012-11-03, Days after vaccination: 9
Gender:Male  Submitted:2013-04-12, Days after onset: 160
Location:Foreign  Entered:2013-04-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Gastroenteritis rotavirus; Hospitalisation
Diagnostic Lab Data: EEG (4-NOV-2012): Negative; Haemoculture (7-NOV-2012): Negative; Urine analysis (unknown date): Negative; Serology NOS (unknown date): Infectious; Neurological examination (6-NOV-2012): no anomalies (good and symmetric body movements, good sensibility, symmetric osteotendinous reflexes, good ocular motricity with pupillary reflexes, cutaneous plantar reflexes, no clonus, coordination in walking, the patient played and smiled easily). At admission (??-NOV-2012), general condition was good. Cardiovascular examination was normal (B1B2, no heart murmur), Capillary Refill Time normal. Respiratory examination was normal: eupneic, free and symmetric normal breath sounds. Cutaneous examination was normal: normal skin hydration and coloration. No sk
CDC 'Split Type': WAES1304BEL005560
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Abdomen scan normal, Abnormal faeces, Blood culture negative, Capillary nail refill test, Diarrhoea, Electroencephalogram normal, Febrile convulsion, Gaze palsy, Neurological examination normal, Pharyngeal erythema, Posture abnormal, Pyrexia, Regurgitation, Serology negative, Skin test negative, Urine analysis normal, Urine output decreased
SMQs:, Acute renal failure (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow)
Write-up: Serious case received from the Health Authorities under the reference number DHH-N2013-61523 on 02-Apr-2013. Initial reporter was a Paediatrician. Medically confirmed. A 14-month-old male patient (height 75 cm, weight 9.260 kg) had received a unique dose of MMRVAXPRO (batch number G013992, via subcutaneous route, expiry date Oct-2013) on 25-Oct-2012. It was reported that the patient had developed febrile convulsion on 03-Nov-2012. The patient was hospitalized from 04-Nov-2012 till 07-Nov-2012 in the Paediatry department of the hospital. On 03-Nov-2011, just before his bath, the patient had his eyes turning backwards with hyperextension of the head. This happened several times. There were no limb movements. Duration was 5-6 seconds. Then generalised hypotonia and persistency of the eyes turning backwards. This episode repeated 4 times with a total duration of 2-3 minutes. Post-critical period of 10 minutes afterwards. One hour before this, body temperature was 38.7 degrees C. NUROFEN had been administered. Temperature at arrival of the ambulance was 37.5 degrees C. There was no vomiting, no hypersalivation. Patient had never experienced such an episode before (to be noted that this episode was mentioned as second episode in hospital report convulsion, to be clarified). At admission, general condition was good. Cardiovascular examination was normal (B1B2, no heart murmur), Capillary Refill Time normal. Respiratory examination was normal: eupneic, free and symmetric normal breath sounds. Cutaneous examination was normal: normal skin hydration and coloration. No skin eruption. Ear-nose-throat examination was normal besides a red throat. Abdominal examination was normal, besides a higher transit: supple abdomen, without pain. Nervous system examination: patient conscious. No anomalies. Normal tonus. EEG was negative. During hospitalisation: Cold biology without any particularities, negative haemoculture at day 4, negative urine test, infectious serology and naso-pharyngeal aspiration were performed. The patient had presented with fever since 4 days, with a maximum temperature of 39 degrees C. There was no rhinorrhea, no cough. The patient ate and drank less. He did not vomit, but regurgitated. He had diarrhoea for about 6 days, stools were odourous and liquid 1-3 per day, no presence of blood, nor mucus. Decrease of urination. The patient''s medical history was without any particularly, he was born at 39 weeks with a birth weight of 2.900 kg. He was hospitalised at the age of 6 months for a rotavirus gastroenteritis. He had no known allergies. Vaccination schedule had been followed normally. Febrile convulsion in grandmother (mother side). Treatment administered was NUROFEN and DAFALGAN. Probiotics. VALIUM intra rectal if required. Evolution during hospitalisation: normal general condition, no fever during hospitalisation, no further episodes of febrile convulsion. The patient ate well but less than usual. Neurological and clinical examination on 06-Nov-2012 was normal: good and symmetric body movements, good sensibility, symmetric osteotendinous reflexes, good ocular motricity with pupillary reflexes, cutaneous plantar reflexes, no clonus, coordination in walking, the patient played and smiled easily. Physician''s advice: no further treatment as EEG was normal. Follow-up of the evolution of the neurological state as further episodes might occur. The outcome was reported as recovered without sequelae. MMR vaccination schedule was stopped. No further information expected.

VAERS ID:492683 (history)  Vaccinated:2012-10-25
Age:0.2  Onset:2012-11-06, Days after vaccination: 12
Gender:Male  Submitted:2013-05-28, Days after onset: 202
Location:Foreign  Entered:2013-05-28
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: Alanine aminotransferase, 07Nov2012, 26IU/L; Aspartate aminotransferase, 07Nov2012, 46IU/L; Bilirubin total, 07Nov2012, 1.7mg/dl; Cl, 07Nov2012, 105mEq/l; Hemoglobin, 07Nov2012, 11; Platelet count, 07Nov2012, 459k; Potassium, 07Nov2012, 5.3mEq/l; Sodium, 07Nov2012, 132mEq/l; White blood cell count, 07Nov2012, 15270; 09 Nov 2012: Neck sonography: cellulitis, probably diffuse soft tissue swelling with increased echogenecity right upper lateral neck; 12 Nov 2012: echography: normal anatomy, normal coronary artery
CDC 'Split Type': B0893996A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood bilirubin increased, Blood chloride normal, Blood potassium normal, Blood sodium decreased, Cellulitis, Erythema, Haemoglobin normal, Immunoglobulin therapy, Kawasaki's disease, Lymphadenopathy, Platelet count normal, Pyrexia, Rash, Swelling, Ultrasound scan abnormal, Ultrasound scan normal, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: This male subject was enrolled in a study. On 25 October 2012 and 31 December 2012, he received the 1st and 2nd dose of INFANRIX-IPV, IM). Concomitant medications included UROLIN, TYLENOL and ceftriaxone. On 06 November 2012, 12 days after the 1st dose of INFANRIX-IPV, this two-month-old subject developed Kawasaki disease. The subject was hospitalised. The subject was treated with normal immunoglobulin and aspirin. The event resolved on 11 November 2012. Investigator causality was unknown at the time of reporting but the investigator considered that the event was possibly due to INFANRIX-IPV. Investigator comments: fever for 6 days, right neck cervical lymphadenopathy, skin rash, hand and foot erythema and swelling.

VAERS ID:494624 (history)  Vaccinated:2012-10-25
Age:1.3  Onset:2012-11-19, Days after vaccination: 25
Gender:Female  Submitted:2013-06-20, Days after onset: 212
Location:Foreign  Entered:2013-06-20
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: 11/19/2012, Body temperature, 39.0-39.4
CDC 'Split Type': WAES1306POL008711
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0083490SCRA
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Fall, Gait disturbance, Hyperaesthesia, Peripheral sensorimotor neuropathy, Polyneuropathy, Pyrexia, Rash macular, Rash rubelliform
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: The information has been received from Agency (HA), the primary source was physician. On 25-OCT-2012, 15 months old female patient was vaccinated with first dose of MMR VAX PRO (lot# H008349, EXP 12/04/2014), 0.5 ml subcutaneous injection in right arm. On 19-NOV-2012 patient experienced fever 39.0-39.4 Celsius degrees longer than 72 hours and rubella-like rash (confluent, thick-macular rash all over body from 05-NOV-2012 to 12-NOV-2012- inconsistency with data on the reporting form) and peripheral sensorimotor neuropathy. In the narrative section the physician reported that on 17-NOV-2012 mother went to a hospital with her child because the child was falling over, probably it stopped walking. At pediatrics clinic on 19-NOV-2012 the child was standing, but unsteady walking on wide posture, it falls on right leg. Muscle tone normal and equal on both sides. The child was referred to hospital for observation and treatment for diagnosis of post-vaccine reaction. According to reporting form, post-vaccine reaction occurred on 19-NOV-2012 (inconsistency with the physician description). The child is during rehabilitation (active-passive rehabilitation treatment advised by orthopedist). The child was hospitalized for 3 days (19-NOV-2012 to 21-NOV-2012). The reason for hospitalization was suspicion of polyneuropathy; simultaneously with motor disorders rash all over body occurred, during admission the child demonstrated hypersensitivity of the skin to touch, it was not walking but myotatic contractions were normal, no symptoms of central motor neurone damage was observed, after introduced treatment on second day of hospitalization the symptoms clearly diminished and on third day resolved completely (outcome of fever 39.0-39.4 Celsius degrees longer than 72 hours and rubella-like rash and peripheral sensorimotor neuropathy was also reported as recovering). The treatment included: hydrocortisone, ZYRTEC, calcium and hydroxyzine. Additional information is not expected.

VAERS ID:500022 (history)  Vaccinated:2012-10-25
Age:  Onset:2013-02-14, Days after vaccination: 112
Gender:Male  Submitted:2013-08-16, Days after onset: 182
Location:Foreign  Entered:2013-08-21, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic myeloid leukaemia
Preexisting Conditions:
Diagnostic Lab Data: Polymerase chain reaction, Positive, Influenza A virus infection
CDC 'Split Type': PHHY2013DE023338
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS126202A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2013DE023338, is an initial spontaneous report received from health authority (DE-PEI-PEI2013012794) on 07 Mar 2013, with a follow up received from QA department (reference number: 215471) on 11 Mar 2013, with another follow-up received from agency on 12 Mar 2013 and a follow up report from the QA department received on 10 Apr 2013 with another follow-up from the health authority on 09 Aug 2013: This report refers to an elderly male patient. His medical history included chronic myeloid leukemia (CML). Concomitant medication was not reported. He was vaccinated with BEGRIPAL (batch number: 126202A, expiry date: May 2013), intramuscularly into the upper arm on 25 Oct 2012. On 14 Feb 2013, the patient developed influenza A virus infection and vaccination failure. The influenza A virus infection lasted for an unknown duration. The patient was hospitalized. Diagnosis was confirmed by PCR (result: positive, unit: NA). The outcome of the events was unknown as of 07 Mar 2013. The QA investigation report for the reference number 215471 received on 10 Apr 2013 stated that based on the review, this BEGRIPAL batch number 126202A was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received from QA department on 11 Mar 2013: Updated QA reference number. Follow up received from agency (Health Authority) on 12 Mar 2013: Batch number for BEGRIPAL was updated. Follow up report from the QA department received on 10 Apr 2013: The QA investigation report was updated. Follow up received from agency (Health Authority) on 09 Aug 2013: Start date of events was updated.

VAERS ID:500106 (history)  Vaccinated:2012-10-25
Age:14.0  Onset:2012-10-25, Days after vaccination: 0
Gender:Female  Submitted:2013-08-22, Days after onset: 301
Location:Foreign  Entered:2013-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation; Asthma exercise induced
Preexisting Conditions: GARDASIL, Immunisation
Diagnostic Lab Data:
CDC 'Split Type': WAES1308SWE009122
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0069671IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Nausea, Rash erythematous, Tremor
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case received from a health care professional via Health Authority on 14-Aug-2013 under reference number 132806. Case serious and medically confirmed. A 14 year old female patient had received an injection of GARDASIL (dose 2, batch number H006967, route intramuscular and site not reported) on 25-Oct-2012 and later on, the vaccination day, (onset date: 25-Oct-2012) she developed an anaphylactic reaction, heavy breathing, dizziness, nausea, shaking, red rash. According to the reporter the patient received the GARDASIL vaccination at 11:30 am, shortly post vaccination she developed dizziness, nausea, shaking and red rash. She received 0, 15 mg ANAPEN (mfr other) with successful effect. At 12:00 pm she also received BETAPRED (mfr other) 5 mg and TAVEGYL (mfr other) 1 mg by the ambulance team and when she arrived at the hospital she was no longer heavy breathing but she was still feeling dizzy and shaky. She was hospitalized for observation. At 21:00 pm she was discharged from hospital and returned to her home, at that time she was completely recovered and stable circulatory and respiratory. The patient has previously been vaccinated with GARDASIL (batch number, route and site not reported), date of vaccination not reported. The patient also has a disease history of asthma exercise induced, ongoing. Upon medical review the company judged relevant to code the following adverse events: dizziness, nausea, shaking, red rash and heavy breathing which were mentioned by the HA in the narrative, but not coded. At the time of reporting, the outcome was recovered.

VAERS ID:503625 (history)  Vaccinated:2012-10-25
Age:13.0  Onset:2013-02-14, Days after vaccination: 112
Gender:Male  Submitted:2013-03-22, Days after onset: 35
Location:Foreign  Entered:2013-09-20, Days after submission: 182
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: Influenza A virus test, positive
CDC 'Split Type': 2013SE19656
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AF2105 IN 
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction
SMQs:
Write-up: A report was received from a physician via Regulatory Authority (PEI) concerning a 13 years old male patient. Medical history and concomitant medications were not reported. On 25-Dec-2012, patient received nasal FLUENZ vaccination. On 14-Feb-2013, despite the vaccination, patinet suffered from influenza A (PCR positive). After one week, the events resolved. The company physician assessed the events to be serious as an important medical event.

VAERS ID:471689 (history)  Vaccinated:2012-10-26
Age:22.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-26, Days after onset: 0
Location:California  Entered:2012-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2026 IN 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B092EA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Vasovagal.

VAERS ID:471700 (history)  Vaccinated:2012-10-26
Age:43.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-26, Days after onset: 0
Location:Arizona  Entered:2012-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: NA
Diagnostic Lab Data: Unknown. Seen in Emergency Room, treated, and released.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12065011IMRA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain lower, Dizziness, Dyspnoea, Hyperhidrosis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Dizziness, sweating, shortness of breath, lower abdominal pain, vomiting.

VAERS ID:471924 (history)  Vaccinated:2012-10-26
Age:15.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-26, Days after onset: 0
Location:Maine  Entered:2012-10-26
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 listed on consent
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AB IMRA
Administered by: Other     Purchased by: Public
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Temp pre vaccine (97.5) within minutes of receiving vaccine injection student became hot feeling, sweaty, and pale - helped her to the floor and put her head towards her lap felt slight nausea. Last ate 6 hours prior to vaccine dose. Gave OJ. BP 96/60 HR 80 RR 20 at 11:50 after resting moved via w/c to cot and felt better. BP 94/60 11:58 at 1215 92/60-72-20 feels fine ate a bagel & went home with her mother. Mother was advised to notify the student''s PCP.

VAERS ID:471932 (history)  Vaccinated:2012-10-26
Age:16.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-26, Days after onset: 0
Location:Ohio  Entered:2012-10-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH745AD1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0106490IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Fall, Gaze palsy, Pallor, Tremor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient fell back, lost color, eyes rolled back and he was shaky and unresponsive for about 1/2 a minute. He remained dizzy, but conscious for about 10 minutes after.

VAERS ID:471972 (history)  Vaccinated:2012-10-26
Age:0.2  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-26, Days after onset: 0
Location:Arizona  Entered:2012-10-26
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: Premature 35 wk; Circumcise 2 wk prior; Twin (no issue)
Diagnostic Lab Data: Pulse Ox 99-100; Glucose finger stick, 115
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4211AA0IMLA
HIBV: HIB (ACTHIB)SANOFI PASTEURUH686AB0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13540IMRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF654420IMRA
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0034AE0PO 
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose, Pallor, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt became pale in the face and nonresponsive for about 5 min. Color and responsiveness returned after 5-15 min.

VAERS ID:471706 (history)  Vaccinated:2012-10-26
Age:36.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-27, Days after onset: 1
Location:New York  Entered:2012-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergies to NSAIDS and penicillin
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  IMLA
Administered by: Public     Purchased by: Other
Symptoms: Dyspnoea, Palpitations, Pruritus
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Severe reaction resulting in 911 call and paramedic transport to hospital. Numbness, racing heart, shortness of breath, itching.

VAERS ID:471709 (history)  Vaccinated:2012-10-26
Age:33.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-27, Days after onset: 1
Location:Missouri  Entered:2012-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1SYRRA
Administered by: Private     Purchased by: Other
Symptoms: Dysphagia, Dyspnoea, Injection site erythema, Ocular hyperaemia, Pharyngeal oedema, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Throat swelling; Trouble swallowing and breathing; Fever; Redness in my eyes, especially on the side of the injection; Redness around injection site. Treated with Benadryl.

VAERS ID:471714 (history)  Vaccinated:2012-10-26
Age:74.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-27, Days after onset: 1
Location:Pennsylvania  Entered:2012-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO.
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU44988A0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Chills, Cough
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad)
Write-up: PATIENT STATES THAT AROUND BEDTIME (10/26/12) SHE BEGAN SUFFERING FROM TERRIBLE CHILLS. SHE STATES THE CHILLS LASTED THROUGHOUT THE NIGHT. IN THE MORNING HER TEMPERATURE WAS ~99 DEGREES. UPON FOLLOW UP HER TEMPERATURE IS APPROX 100 DEGREES AT 3:45PM (10/27/12). THE PATIENT ALSO STATES THAT SHE HAS HAD A COUGH SINCE THE VACCINE.

VAERS ID:471719 (history)  Vaccinated:2012-10-26
Age:33.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-27, Days after onset: 0
Location:Texas  Entered:2012-10-27
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: 26 weeks pregnant
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Stomach cramps for over 12 hours.

VAERS ID:471724 (history)  Vaccinated:2012-10-26
Age:65.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-27, Days after onset: 1
Location:Indiana  Entered:2012-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to penicillin and neomycin; Asthma, high blood pressure, underactive thyroid
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4498BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chest discomfort, Injection site pain, Pruritus, Rhinorrhoea, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Extreme runny nose...tightness in chest....wheezing....some itching...soreness around shot area.

VAERS ID:472035 (history)  Vaccinated:2012-10-26
Age:63.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-27, Days after onset: 0
Location:Texas  Entered:2012-10-27
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12042011IMAR
Administered by: Unknown     Purchased by: Other
Symptoms: Lip swelling, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 10/27/12 at 4:00pm swollen lips, puffy fingers, possible swollen tongue.

VAERS ID:471737 (history)  Vaccinated:2012-10-26
Age:51.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-28, Days after onset: 2
Location:California  Entered:2012-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to Demerol, Penicillin, Sulfur based antibiotics, Td booster, cat and dog dander, dust mites, grasses, Oak and Walnut trees; I have fibromyalgia, rheumatoid and osteoarthritis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR 0IDLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal discomfort, Dizziness, Eye discharge, Eye swelling, Fatigue, Nasal congestion, Nausea, Ocular hyperaemia, Oropharyngeal pain, Respiratory tract congestion, Sensation of foreign body, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Felt like lumps developed in throat that hurt, started wheezing, and slight nasal congestion. 2 hours after that my eyes swelled, had green discharge from them, throat continued to hurt and congestion worsened. Felt extremely fatigues, went to bed and slept for 3 hours, woke up with eyes partially closed and red, sore throat went away and had slight congestion. Went back to bed and slept for another 7 hours. Got up and went to work. Starting feeling dizzy, stomach got upset 2 hours afterwards, started vomiting. There was only 1 incident of vomiting. Drove back home and slept another 3 hours. Felt queasy the rest of the day. Went to bed and felt much better on Sunday morning as I''m typing this.

VAERS ID:471754 (history)  Vaccinated:2012-10-26
Age:49.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Male  Submitted:2012-10-29, Days after onset: 2
Location:California  Entered:2012-10-29
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: Ibuprofen allergy
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLL2727AB1UNLA
Administered by: Public     Purchased by: Other
Symptoms: Ligament sprain, Pain
SMQs:, Accidents and injuries (narrow)
Write-up: Lower back Sprain. Rest for an hour. Pain subdued but still painfully until this time of reporting (1 and half day after onset). I can bend my back a little bit (40%). Took Tylenol.

VAERS ID:471869 (history)  Vaccinated:2012-10-26
Age:45.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Missouri  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH755AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Heart palpitation followed by syncopal episode lasting about 15 minutes.

VAERS ID:471880 (history)  Vaccinated:2012-10-26
Age:55.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:Michigan  Entered:2012-10-29
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
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURC3991AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness & Itchiness to site.

VAERS ID:471934 (history)  Vaccinated:2012-10-26
Age:22.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Illinois  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Obesity, Anemia
Diagnostic Lab Data: Recovering, symptoms currently present
CDC 'Split Type':
Vaccination
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TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B093BA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Edema and erythema at site of injection - 4 mm x 7 mm of induration.

VAERS ID:471937 (history)  Vaccinated:2012-10-26
Age:80.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Missouri  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Diabetes
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4491AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Injection site swelling, Myalgia, Oedema peripheral, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Patient states the evening of the day she got her flu shot, her left arm became swollen, red, hot to touch. Swelling went from the injection site down to her elbow. Reports having muscle aches up the left side of her neck. Patient reported these symptoms on 10-29-2012 and states she has an appointment to see her physician today in the afternoon. Patient has been taking Tylenol and applying ice pack alternating with heating pad to her injection site to left deltoid.

VAERS ID:471968 (history)  Vaccinated:2012-10-26
Age:11.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-29, Days after onset: 3
Location:Michigan  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4283AA IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC3898BA IM 
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Dizziness, Heart rate irregular, Hypotension, Mydriasis, Pallor, Somnolence, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Paleness, dizziness, blurring of vision, sleepiness, weakness & loss of strength in extremities, dilated pupils, low BP, & irregular heart rate & rhythm. Laid pt down, used ammonia salts as inhalant, gave juice and bite of cheese, cold cloth (pt not diaphoretic) & continued to take VS. Third party called 911 to get EMTs here. Worked with pt for approximately 40 min before EMTs arrived. EMTs called because of pt continued to have loss of strength in extremities and sleepiness.

VAERS ID:471980 (history)  Vaccinated:2012-10-26
Age:52.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:Indiana  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa (sulfonamide Antibiotics) RASH; Celebrex Nausea And Vomiting
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Erythema, Injection site reaction, Pyrexia, Rash erythematous, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: I had a small reaction to the shot some redness and swelling and a slight fever and chill. However, the there are clusters of small red bumps at the site of where the shot was given. Please advise.

VAERS ID:471983 (history)  Vaccinated:2012-10-26
Age:34.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-29, Days after onset: 3
Location:California  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
Administered by: Unknown     Purchased by: Private
Symptoms: Chest discomfort, Chills, Conjunctivitis infective, Flushing, Headache, Malaise, Pyrexia, Throat irritation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: Flushed face, tight chest, throat irritation. Then followed by pink eye 1 hour later, then later chills/fever, general malaise and headache. Next morning only headache and general malaise.

VAERS ID:471999 (history)  Vaccinated:2012-10-26
Age:51.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:Wisconsin  Entered:2012-10-29
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: Graves Disease/ Graves Opthalmopathy; High Blood Pressure; Depression
Diagnostic Lab Data: I am still sick at the time of this report.
CDC 'Split Type':
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Fatigue, Myalgia, Oral herpes, Pruritus, Pyrexia, Throat irritation, Tremor, Upper-airway cough syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Hand tremors in morning, later in the day fever, post nasal drip, muscle pain, backache, general extreme fatigue. 10/29 symptoms persisting, with added scratchy throat, itchy ears and a cold sore eruption on lower lip.

VAERS ID:472132 (history)  Vaccinated:2012-10-26
Age:1.3  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Montana  Entered:2012-10-29
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: NKA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4527AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425AE0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0077040SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Irritability, Local reaction, Vaccination complication
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad)
Write-up: Soon after vaccination developed warm red area at site of MMR and VARIVAX shots. Child fussy no hives. Borders marked in ink; observed for 30 min. no increase in size of red area. Local vaccine reaction.

VAERS ID:472135 (history)  Vaccinated:2012-10-26
Age:4.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-29, Days after onset: 3
Location:Massachusetts  Entered:2012-10-29
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':
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2025 IN 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1883AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0110861SCLA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 10/29/12 I spoke with Mom, broke out in hives evening of 10/26. Had rec''d MMR #2, VARIVAX #2 and Flu earlier in the day. No resp. s/sx.

VAERS ID:472160 (history)  Vaccinated:2012-10-26
Age:11.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-29, Days after onset: 3
Location:Arkansas  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atopic dermatitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB591BA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4285AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Lt arm swollen, red. c/o itching; started the evening of shots 10/26/12. BENADRYL tid for 5 days.

VAERS ID:472164 (history)  Vaccinated:2012-10-26
Age:60.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-28, Days after onset: 1
Location:Missouri  Entered:2012-10-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130240SCUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient called to say next day woke up w/ 2 inch red, hard knot where shot was & said it itches too. I told her to use ice & BENADRYL if worsens to call her Dr.

VAERS ID:472166 (history)  Vaccinated:2012-10-26
Age:62.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:Virginia  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Exam by physician
CDC 'Split Type':
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VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Dyspnoea, Erythema, Pain
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: (L) deltoid area 3 x 4" area bright redness, then faint redness around area 7 x 6" & going bilateral side of arm 15 x 7. No induration. Pt had (+) pain, burning (+) shortness of breath. Seen today.

VAERS ID:472072 (history)  Vaccinated:2012-10-26
Age:44.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Male  Submitted:2012-10-29, Days after onset: 2
Location:North Carolina  Entered:2012-10-30, 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: Asthma; Migraine H/A; Hyperlipidemia
Diagnostic Lab Data: See attached
CDC 'Split Type':
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012521 SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Condition aggravated, Headache, Pyrexia, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Developed fever, rigors, H/A, and visual disturbances the day after injection. Admitted overnight for observation.

VAERS ID:472102 (history)  Vaccinated:2012-10-26
Age:26.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-10-30, Days after onset: 1
Location:North Dakota  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Repeated vomiting & diarrhea, upset stomach, headache. Lasted beyond 24 hours. Treated by resting and drinking fluids.

VAERS ID:472202 (history)  Vaccinated:2012-10-26
Age:62.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-26, Days after onset: 0
Location:Arizona  Entered:2012-10-30, 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: Morphine
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12052010IMAR
Administered by: Other     Purchased by: Private
Symptoms: Dysphagia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Pt developed tingling in face & difficulty swallowing about 15 min after receiving the flu vaccination. BENADRYL 50 mg was administered and pt recovered quickly within 15 mins.

VAERS ID:472273 (history)  Vaccinated:2012-10-26
Age:54.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:California  Entered:2012-10-30, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
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HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC039AA1IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 1 cm erythematous patch at site of injection, at 24 hours surrounding 7.5 cm erythema 48-72 hours. No systemic symptoms. No blisters. No fevers.

VAERS ID:472541 (history)  Vaccinated:2012-10-26
Age:50.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2012-10-30
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':
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Manufacturer
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1231230SYRLA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Local reaction at injection site. Redness, warm to touch. Itching. Pt had these symptoms for 5 days.

VAERS ID:472560 (history)  Vaccinated:2012-10-26
Age:54.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-30, Days after onset: 4
Location:Illinois  Entered:2012-10-30
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: Sciatica; Migraine; Depression
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4468BA0IDRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Day of vaccine - vaccine given at 3pm, and at 7 pm she started feeling lightheaded, dizzy, nauseous, headache, body ache. Came on gradually throughout evening. 5 days later still having symptoms - mainly dizziness, nausea and headache.

VAERS ID:472567 (history)  Vaccinated:2012-10-26
Age:33.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-30, Days after onset: 4
Location:Alabama  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4472AA0IDLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at injection site, erythema, induration 1x1 cm with larger area of erythema 10x10. Tx - antihistamine, 0.1% triamcinolone.

VAERS ID:472402 (history)  Vaccinated:2012-10-26
Age:12.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-31, Days after onset: 5
Location:Arizona  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to amoxicillin, seasonal allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever of 103, aches.

VAERS ID:472410 (history)  Vaccinated:2012-10-26
Age:39.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-31, Days after onset: 5
Location:California  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Site of injection became swollen, red, very tender (even to the touch of a shirt sleeve moving) and HOT. This lasted until Sunday Evening.

VAERS ID:472765 (history)  Vaccinated:2012-10-26
Age:31.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Female  Submitted:2012-10-30, Days after onset: 2
Location:Massachusetts  Entered:2012-10-31, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH746AC0IMUN
Administered by: Public     Purchased by: Other
Symptoms: Eye swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt received flu shot on 10/26/12. Broke out with hives on 10/28/12. Hives were on legs & all over torso by 10/29/12. Her primary care MD told her to take BENADRYL 50mg every 4 hours. Seemed to help. Left eye was swollen.

VAERS ID:472855 (history)  Vaccinated:2012-10-26
Age:65.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-31, Days after onset: 5
Location:Idaho  Entered:2012-10-31
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: Asplenia; Environmental allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP502081IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Eye irritation, Nausea, Ocular hyperaemia, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: Within 3 hrs, she experienced eye irritation, eye redness, blurry vision, nausea.

VAERS ID:472942 (history)  Vaccinated:2012-10-26
Age:17.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-10-30, Days after onset: 1
Location:South Carolina  Entered:2012-10-31, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H013830UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4288AA1UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0073291UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8 x 3 area of erythema with slight edema at the right upper arm.

VAERS ID:475482 (history)  Vaccinated:2012-10-26
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2012-10-31
Location:Virginia  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1210USA013738
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a physician refers to a patient of unknown age. It was reported that "three years ago'', in 2009 the patient was administered "the first two doses in the GARDASIL (lot # not reported) vaccination schedule". This physician noted the patient would be administered intramuscularly the third dose in the GARDASIL (lot # not reported) vaccination schedule on 26-OCT-2012. No adverse effect reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.

VAERS ID:475494 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-31, Days after onset: 5
Location:Unknown  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1210USA013791
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare student refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL in March 2011 and the second dose in November 2011 and the third dose on 26-OCT-2012. Lot numbers of the vaccines were not reported. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.

VAERS ID:472484 (history)  Vaccinated:2012-10-26
Age:47.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 6
Location:North Carolina  Entered:2012-11-01
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: Multiple Sclerosis
Diagnostic Lab Data: Due to have upcoming allergen testing 11/5/2012
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Broke out in hives all over body.

VAERS ID:472591 (history)  Vaccinated:2012-10-26
Age:21.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-01, Days after onset: 5
Location:Washington  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS 0 RA
Administered by: Public     Purchased by: Public
Symptoms: Chest discomfort, Diarrhoea, Headache, Influenza, Malaise, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 11/01/2012 patient is still sick with all possible flu symptoms such as: low grade fever, body aches, headaches, sinus congestion / stuffy nose, sore throat, chest pressure, and infrequent diarrhea.

VAERS ID:473173 (history)  Vaccinated:2012-10-26
Age:2.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 6
Location:Oklahoma  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma - week before received steroid medication
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B154BA3UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB591AA1UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site rash, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: (R) arm at site of injection Hep A noticed after Band Aid removed round circle of raised bumps. Appx size of a quarter. Has become bigger since vaccination. Had slight fever x 1 day 10/26/12. No respiratory problem.

VAERS ID:472767 (history)  Vaccinated:2012-10-26
Age:26.0  Onset:2012-10-30, Days after vaccination: 4
Gender:Male  Submitted:2012-11-02, Days after onset: 3
Location:Washington  Entered:2012-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None addressed
Diagnostic Lab Data: Prescribed antibiotics by Dr
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0129730IMRA
Administered by: Military     Purchased by: Military
Symptoms: Axillary mass, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: On 2 Nov 12 member came in to clinic presenting concern with raised red round bump underneath left arm. Member denies chest pain, fever, but states underarm swollen and feels like a bruise. Seen by Dr.

VAERS ID:477089 (history)  Vaccinated:2012-10-26
Age:0.6  Onset:2012-10-26, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-02, Days after onset: 7
Location:Unknown  Entered:2012-11-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1210USA013903
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a 6 months old patient of unknown gender. The patient was inadvertently vaccinated IM with dose 1 of VAQTA (dose and lot # not reported) on 26-OCT-2012. No adverse effect was reported. Additional information has been requested.

VAERS ID:473424 (history)  Vaccinated:2012-10-26
Age:70.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-10-29, Days after onset: 0
Location:Pennsylvania  Entered:2012-11-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130240SCUN
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local red swelling at site of injection. 2 inches x 3 inches in size. Taking ZYRTEC 10mg daily, Hydrocortisone cream 1% topically. Shingles vaccine given 10/26/12.

VAERS ID:472937 (history)  Vaccinated:2012-10-26
Age:12.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-11-05, Days after onset: 10
Location:New York  Entered:2012-11-05
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: BP immediately following the incident was 60/30, within 20 minutes repeat BP was 101/66, HR 70
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS    
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Private     Purchased by: Private
Symptoms: Fall, Feeling abnormal, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After administering influenza and Gardasil vaccines, labs were immediately drawn from the child. After removal of the needle for blood collection, the patient fell to her left side, a cabinet breaking her fall. A nurse was able to stop her from falling onto the floor. The patient completely lost consciousness for about 30 seconds. She awoke with no recollection of the incident, feeling as though she had just fallen asleep. BP immediately following the incident was 60/30, within 20 minutes repeat BP was 101/66, HR 70. Mother obtained juice and candy for the child to eat. No bruises or araisions noted. Left office about 30 minutes later feeling well.

VAERS ID:473435 (history)  Vaccinated:2012-10-26
Age:32.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-05, Days after onset: 9
Location:Arizona  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. c/o nausea and vomiting the following day for 24-48 hours. Since resolved.

VAERS ID:473437 (history)  Vaccinated:2012-10-26
Age:1.9  Onset:2012-10-27, Days after vaccination: 1
Gender:Male  Submitted:2012-11-05, Days after onset: 9
Location:Arizona  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH4526AA0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. had nausea and vomiting the following day for 24-48 hours. Since resolved.

VAERS ID:473454 (history)  Vaccinated:2012-10-26
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2012-10-26
Location:Maine  Entered:2012-11-05, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: (L) torn rotator cuff
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA707BA1UNRA
Administered by: Public     Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:
Write-up: Patient''s mother signed the consent form & requested that patient be vaccinated at the school based clinic. Patient received the influenza vaccine on 10-26-12. Mother called & reported that patient had received the flu vaccine a wk. prior during P.E. & she forgot to notify us to let us know.

VAERS ID:473455 (history)  Vaccinated:2012-10-26
Age:60.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-05, Days after onset: 9
Location:Maine  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Torn rotator cuff
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA707BA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased
SMQs:
Write-up: Patient reports that she is unable to extend her (L) arm ever since she had her influenza vaccine on 10-26-12. She has a history of torn rotator cuff.

VAERS ID:473583 (history)  Vaccinated:2012-10-26
Age:57.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 6
Location:Illinois  Entered:2012-11-05, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Current bladder infection / antibiotics complete
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash, Swollen tongue, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow)
Write-up: Treated in ED with BENADRYL for c/o blurry vision. Rash on hands & back / tongue swollen.

VAERS ID:473655 (history)  Vaccinated:2012-10-26
Age:39.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Virginia  Entered:2012-11-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH731AB IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Induration, Local reaction, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: (R) arm 8 x 12 cm red, hot induration itching - local reaction. No anaphylaxis. No generalized reaction.

VAERS ID:473659 (history)  Vaccinated:2012-10-26
Age:27.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-30, Days after onset: 4
Location:Illinois  Entered:2012-11-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Chest discomfort, Dizziness, Eye discharge, Eye irritation
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Corneal disorders (broad), Vestibular disorders (broad)
Write-up: Chest tightness, eyes burning, dizziness, weakness, overall fast onset of symptoms; goop out of her eyes.

VAERS ID:473661 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Utah  Entered:2012-11-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1231231IMLA
Administered by: Other     Purchased by: Private
Symptoms: Bursitis, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad)
Write-up: Bursitis like pain in upper deltoid restricting use of shoulder.

VAERS ID:473662 (history)  Vaccinated:2012-10-26
Age:56.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Male  Submitted:2012-10-28, Days after onset: 1
Location:Michigan  Entered:2012-11-05, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12242P1IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0117801IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Pain, Pain of skin
SMQs:, Arthritis (broad)
Write-up: Joint pains, body ache, aches in hair follicle, scalp.

VAERS ID:473717 (history)  Vaccinated:2012-10-26
Age:77.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 3
Location:Kansas  Entered:2012-11-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA; CAD; HTN; HLP; Allergic rhinitis
Diagnostic Lab Data: CBC with Diff; Comp; CRP; D-Dimer
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4497AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0117800IMRA
Administered by: Public     Purchased by: Private
Symptoms: C-reactive protein, Contusion, Differential white blood cell count, Fibrin D dimer, Full blood count, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Local reaction, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt went to ER about 21:27, Dx with localized reaction to pneumonia vaccine. Pain started about 2 hours after inj. Contusion at shot site & swelling, tender warmth, erythema from elbow to delt. noted by ER doctor. Home to rest. NORCO - pain. Apply warm moist cloth TID. Pt improved 70% 2315, pt not found in room at 2310.

VAERS ID:473162 (history)  Vaccinated:2012-10-26
Age:44.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-06, Days after onset: 10
Location:Utah  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 102 lasting until 10/29/2012.

VAERS ID:473282 (history)  Vaccinated:2012-10-26
Age:55.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Female  Submitted:2012-11-06, Days after onset: 9
Location:South Carolina  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to morphine and codeine. Severe allergy to penicillin.
Diagnostic Lab Data: Saw our WC Dr, prescribed 800mg ibuprofen 2x daily
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4463AA IDLA
Administered by: Public     Purchased by: Other
Symptoms: Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Warmth and swelling left upper extremity, traveling into axillary area, including left trapezius area.

VAERS ID:473621 (history)  Vaccinated:2012-10-26
Age:21.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-01, Days after onset: 5
Location:Wisconsin  Entered:2012-11-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: WBC 23.1 10-29-12; blood culture 10-29-12 = negative; 11-1-12 WBC = 8.7
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH746AA1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0138470SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood culture negative, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Fever, redness, pain, warmth at injection site.

VAERS ID:473634 (history)  Vaccinated:2012-10-26
Age:1.0  Onset:2012-11-03, Days after vaccination: 8
Gender:Female  Submitted:2012-11-06, Days after onset: 3
Location:Pennsylvania  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AC0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646AB0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0496AE0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0146270SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Pt developed a maculopapular rash & fever 9 days after administration of the MMR vaccine.

VAERS ID:473829 (history)  Vaccinated:2012-10-26
Age:85.0  Onset:2012-11-03, Days after vaccination: 8
Gender:Female  Submitted:2012-11-05, Days after onset: 2
Location:California  Entered:2012-11-06, 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:
Current Illness: None
Preexisting Conditions: KLOR-CON
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AA1IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0087AE1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Pain in extremity
SMQs:, Arthritis (broad)
Write-up: Per pt, week ago arm''s hurting then went to hands (left) then now both knees hurt especially right knee (very bad). Two days ok, but now hurting (pneumonia shot).

VAERS ID:476143 (history)  Vaccinated:2012-10-26
Age:17.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-06, Days after onset: 10
Location:New York  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ZOFRAN; Minocycline; Cow protein; warts
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB646BA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Excoriation, Lip swelling, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Accidents and injuries (broad), Hypersensitivity (narrow)
Write-up: Pt received Hepatitis A vaccine on 10/26/12 at 455pm. The pt. awoke the next day with itching, rash on (L) arm & lip swelling. Was seen at health center. Was given Prednisone. Patient is a 17-year-old female. NAD, not toxic. Left posterior upper arm with fine excoriations. No rash on neck, face, back UE or LE X2. Slight swelling of midline upper and lower lips, no macroglossia, throat widely patent.

VAERS ID:477597 (history)  Vaccinated:2012-10-26
Age:59.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Male  Submitted:2012-11-06, Days after onset: 9
Location:Florida  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Thyroid hormone replacement; Arthritis; Hypertension
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA001175
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a consumer refers to a 59 years old male patient with high blood pressure, arthritis and thyroid replacement medication. On 26-OCT-2012 the patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported). Concomitant medications included MOBIX, omeprazole, diltiazem hydrochloride, levothyroxine sodium, citalopram hydrobromide and amlodipine. On 28-OCT-2012 the patient broke out in a rash at the injection site after having ZOSTAVAX. The patient sought for unspecified medical attention. Patient''s status was unknown. The caller would like to know if the patient should be around pregnant women or infants at all. Additional information is not expected.

VAERS ID:474482 (history)  Vaccinated:2012-10-26
Age:43.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-07, Days after onset: 12
Location:Maryland  Entered:2012-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN --$g stop breathing; Reported hx of asthma; Hx of pneumonia (x2); GERD; Menorrhagia
Diagnostic Lab Data: 31 Oct 2012, CBC w/ diff, WBC blood 11.6, RBC blood 4.48, Hemoglobin blood 12.6, Hematocrit blood 37.6, MCV blood 84.0, MCH blood 28.2, MCHC blood 33.5, RDW CV blood 13.9, Platelets blood 369, MPV blood 8.1, Neutrophils blood 71.3, Lymphocytes blood 18.4, Monocytes blood 8.9, Eosinophils blood 1.0, Basophils blood 0.4, Neutrophils blood 8.2, Lymphocytes blood 2.1, Monocytes blood 1.0, Eosinophils blood 0.1, Basophils blood 0.0; 29 Oct 2012, Lactate plasma, 0.8; 29 Oct 2012, Blood cultures (x2), bacteriology result: no growth to date, bacteriology result: 11/04/12 aerobic and anaerobic blood cultures negative at 5 days; 29 Oct 2012 1834, CBC w/ diff, WBC blood 20.4, RBC blood 4.08, Hemoglobin blood 11.7, Hematocrit blood 34.4, MCV blood 84.4
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP50708 UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0492AE UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094DA UNRA
Administered by: Military     Purchased by: Military
Symptoms: Alanine aminotransferase normal, Anion gap decreased, Aspartate aminotransferase normal, Band neutrophil count, Basophil percentage decreased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal, Blood lactic acid, Blood potassium normal, Blood sodium decreased, Blood urea decreased, Carbon dioxide normal, Chest X-ray normal, Chills, Eosinophil count, Fatigue, Feeling cold, Feeling hot, Glomerular filtration rate, Haematocrit decreased, Haemoglobin decreased, Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Lethargy, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte percentage decreased, Neutrophil count increased, Neutrophil percentage increased, Night sweats, Oedema peripheral, Pain, Pain in extremity, Platelet count normal, Protein total normal, Pyrexia, Red blood cell count decreased, Red cell distribution width normal, Skin warm, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: 43 y/o F received BOOSTRIX vaccine in her RUE. She denies any significant local reaction at this site. She also received the PNEUMOVAX and AFLURIA vaccines the same day, in her LUE. She received her vaccines around 1330-1400. After supper that pm, she felt feverish and had a pounding headache on the top of her head that she rated at a pain intensity level of 9-10/10 using a pain scale of 0 (= no pain) to 10 (=worst pain ever experienced). She describes this headache as a "pneumonia" headache (similar to others she has had when diagnosed with pneumonia). She self treated with MOTRIN 800 mg with some decrease in pain. She went to bed & awoke around 0130-0200 with chills. Her teeth were chattering, she was shaking, & "never felt so cold". She covered up with more blankets & went back to sleep. When she awoke on 27 OCT, she felt hot & her linens and night clothes were soaked with perspiration. She also reports continued headache, fatigue, aching, & lethargy. Throughout the weekend, she stayed in bed and rested. She continued to experience chills alternating with sweats & fever. No nasal congestion, post-nasal drainage, or cough. She checked her temperature throughout the week-end and reports temperatures ranging between 98 to 102 degrees F, with highest temperature reading of 102.8 degrees F. She continued to self treat with MOTRIN. On 28 OCT, she used a space heater with multiple blankets to stay warm but she was still shivering. Also on Sunday, pt noted some tenderness & a pink area (not at vaccination sites) on her mid-anterior left upper arm, with irregular borders, approximately 4"x3". She denies N/V/D or anorexia. While she did eat during the weekend, she did not push fluids. She denies respiratory symptoms or hives. On 29 OCT, after 72 hours of symptoms, pt''s husband noted a significantly reddened area on her left upper arm, between her left anterior shoulder & her elbow. Monday afternoon pt sought evaluation in the ER. In the ER, pt''s heart rate was 137 bpm & her temp was elevated. She c/o malaise, fever/chills/sweats, headache (6/10) & LUE and redness (see photo - 29 OCT). She received 2 liters of IV fluids, 1 dose of MOTRIN, & later, a dose of TYLENOL during the 5-6 hours she was in the ER. She had a normal CXR, but her WBC was elevated to 20.4 with elevated neutrophils and decreased lymphocytes. By the time she was released from the ER, she reports she was starting to feel better. She was instructed to alternate MOTRIN & TYLENOL and follow up with her PCM. The following day, 30 OCT, pt continued to experience headaches, fatigue, generalized aching, as well as redness, warmth & pain of LUE. The chills and shivering had resolved, & her sweats occurred only during the course of the night. She noted some improvement following medications & she also applied ice to her left upper arm. She followed up with her PCM on 31 OCT. At that time, she was afebrile. She had treated her headache that morning with MOTRIN followed by TYLENOL within 2 hours, & by the time she arrived in the clinic, her headache was gone. She noted an increase in her energy level & her body aches had almost completely dissipated. Her LUE was still red, sore, warm & swollen (see photo - 31 OCT). Since then, her primary complaint is ongoing tenderness, swelling, warmth & some redness of her LUE, as well as continued night sweats. She has resumed light housework & ADLS. Pt was feeling fine prior to vaccine receipt & denies a history of recent infection or viral symptoms. No recent trauma or bites to LUE. She denies prior vaccine reactions, except following receipt of the flu vaccine in OCT 2010. Reports she received the flu vaccine after having a viral illness x1 week. Within 3-4 days of receiving the flu vaccine, she experienced lethargy, fever, chills, body aches & headache, as well as chest tightness and a productive cough. She was evaluated & dx''d with pneumonia, & she was treated with antibiotics IM, as well as prescribed a Z-pack.

VAERS ID:473818 (history)  Vaccinated:2012-10-26
Age:49.0  Onset:2012-10-30, Days after vaccination: 4
Gender:Female  Submitted:2012-11-09, Days after onset: 10
Location:California  Entered:2012-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Rheumatoid arthritis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701 IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4335AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: LUE cellulitis with erythema, induration 18 cm in length on left lateral deltoid. Pt admitted to hospital x2 days with IV antibiotic administration.

VAERS ID:473865 (history)  Vaccinated:2012-10-26
Age:67.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-12, Days after onset: 16
Location:Illinois  Entered:2012-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0SYRLA
Administered by: Other     Purchased by: Public
Symptoms: Arthralgia, Chills, Hyperaesthesia, Influenza like illness, Injection site erythema, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Pneumonia vaccine. 24 hours after injection, flu like joint/muscle pain, sensitive skin, chills during evening (8-10 PM). 4 inch x 3 inch oval redness as site of pneumonia vaccine injection, which lasted 4 days. Flu symptoms lasted approximately 36 hours. Took aspirin to start and then Benadryl. Applied Benadryl cream to arm/site of injection.

VAERS ID:473932 (history)  Vaccinated:2012-10-26
Age:27.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-12, Days after onset: 17
Location:Washington  Entered:2012-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12265P2IMRA
Administered by: Public     Purchased by: Private
Symptoms: Arthralgia, Discomfort, Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Red and warm hard knot at injection site. (Right side). Right side joint pain and body felt heavy. Currently still knot and painful to touch/itchy but not as bad today (10/29).

VAERS ID:477967 (history)  Vaccinated:2012-10-26
Age:63.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-11-12, Days after onset: 14
Location:Unknown  Entered:2012-11-12
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:
CDC 'Split Type': WAES1211USA000076
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013020 SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Headache, Nodule
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient was vaccinated with ZOSTAVAX on 26-OCT-2012, via injection in the back of the arm. The dosing regimen was not reported. The patient''s medical history and past history were not reported. No other co-suspects were reported. No concomitant medications were reported. On 29-OCT-2012 the patient reported to the pharmacy that she experienced headache, furthermore the whole back of her arm was red. The patient had experienced a knot in her arm, from which she had recovered at the time when she reported the events. The onset dates were not reported. The outcome of the redness of the back of arm and the headache were unknown. No treatment information was reported. The reported relatedness for all reported events was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:474399 (history)  Vaccinated:2012-10-26
Age:72.0  Onset:2012-11-01, Days after vaccination: 6
Gender:Female  Submitted:0000-00-00
Location:Arizona  Entered:2012-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Run high fever
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Arm two times it size. High fever. Aches, very red. BENADRYL and aspirin.

VAERS ID:474401 (history)  Vaccinated:2012-10-26
Age:49.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:Utah  Entered:2012-11-13, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies to penicillin; Lactose intolerant; Has migraines
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4051PA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Erythema, Injection site swelling, Pain, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient reporting fever, chills, pain, redness, warmth, swelling at injection site. Will seek medical attention from physician.

VAERS ID:474402 (history)  Vaccinated:2012-10-26
Age:40.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-31, Days after onset: 5
Location:Utah  Entered:2012-11-13, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR3792 IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.37591SCUN
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Malaise, Pyrexia, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, (3-4 inches long 2 inches wide), feeling ill, swollen, a little bit warm no fever. Lasted 3-4 days took BENADRYL the next day & started feeling better.

VAERS ID:476761 (history)  Vaccinated:2012-10-26
Age:52.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-10-30, Days after onset: 4
Location:Texas  Entered:2012-11-13, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic hepatitis C; HIV; Substance abuse
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4196AA23SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Reports that he developed lip swelling after receiving the Tdap injection 3 days ago. No difficulty with breathing. The lip swelling has now improved. Presents for further eval. PE shows mild swelling of the lower lip. Otherwise all other systems are normal. He is currently in no distress and is able to breathe normally. May be related to the vaccine he received on 10/26. Will treat with a course of BENADRYL.

VAERS ID:474133 (history)  Vaccinated:2012-10-26
Age:22.0  Onset:2012-11-09, Days after vaccination: 14
Gender:Male  Submitted:2012-11-14, Days after onset: 5
Location:New Jersey  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH346AA0SCRA
Administered by: Military     Purchased by: Military
Symptoms: Vaccination complication
SMQs:
Write-up: Pt received smallpox vaccine on 26 Oct 12. After 19 days pt has multiple satellite lesions on L arm. Only Tx has been gauze and tegaderm placed on the affected skin and then changed out every morning.

VAERS ID:474433 (history)  Vaccinated:2012-10-26
Age:81.0  Onset:2012-11-05, Days after vaccination: 10
Gender:Female  Submitted:2012-11-06, Days after onset: 1
Location:Washington  Entered:2012-11-14, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None - chronic conditions
Preexisting Conditions: HTN; Depression; Osteoporosis; Glucose impairment; Hypothyroidism; Tobaccoism; Psoriasis; Insomnia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA738AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: Pt. rec''d 2 flu vaccines - pt did not recall receiving 1st vaccine 9-21-12, so she requested another vaccine 10-26-12 & received that one as well. Pt. denies any adverse effects no known injury.

VAERS ID:478137 (history)  Vaccinated:2012-10-26
Age:66.0  Onset:2012-11-02, Days after vaccination: 7
Gender:Female  Submitted:2012-11-14, Days after onset: 12
Location:Unknown  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease; Diabetes mellitus; Asthma
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA002785
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013017 SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with asthma, diabetes and chronic obstructive pulmonary disease (COPD). On 26-OCT-2012, the patient was vaccinated subcutaneously in the left arm with a dose of 0.65 ml of ZOSTAVAX (lot# reported as H013017, expiry 09-OCT-2013). Patient received unspecified concomitant medications. On 02-Nov-2012, the patient called the pharmacy and stated that she has itchy rash at injection site. No treatment was given. The patient sought medical attention (called the pharmacy on 02-NOV-2012). The outcome of itchy rash at injection site was reported as not recovered. The pharmacist stated he would have the patient follow-up with her health provider if needed. Additional information is not expected.

VAERS ID:478138 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 19
Location:Unknown  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Osteoarthritis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA005330
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Myalgia, Paraesthesia, Varicella
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This spontaneous report was received from a female consumer of unknown age reporting on herself with osteoarthritis. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 26-OCT-2012. Other suspect therapies included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on 20-OCT-2012. No concomitant medications were reported. The consumer reported that when she received her ZOSTAVAX injection on 26-OCT-2012, "by the time she had walked to the parking lot," she had the sensation that she was being electrocuted. She reports that the sensation lasted for about 4-5 minutes. She reported that as soon as she got home she called the pharmacist who gave her the vaccination. The pharmacist (unspecified by reporter) told her to see her physician (unspecified by reporter), and she stated her physician drew unspecified blood samples (results not provided). Consumer had a medical history of osteoarthritis, but reported she had unusual pain in her arm muscles, in areas that she had not had experienced pain before. Consumer reported that 2 days after receiving her ZOSTAVAX vaccination (on 28-OCT-2012), she had an outbreak of chickenpox. No treatment information was reported. The event of had the sensation that she was being electrocuted resolved within 5 minutes and the outcome of had unusual pain in her arm muscles and outbreak of chickenpox was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX and Influenza Virus Vaccine (manufacturer unknown). Additional information is not expected.

VAERS ID:474259 (history)  Vaccinated:2012-10-26
Age:52.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-11-15, Days after onset: 17
Location:Texas  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH751AB IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Fatigue, Flushing, Headache, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: (Self described by physician/pt) "got very ill, developed low grade fever, headache, arthralgia, myalagia, fatigue, and flushed" symptoms started to subside on 11/01/2012.

VAERS ID:474497 (history)  Vaccinated:2012-10-26
Age:34.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Female  Submitted:2012-11-14, Days after onset: 16
Location:Idaho  Entered:2012-11-15, 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:
Current Illness: None per pt.
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH733AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Dysarthria, Dystonia, Posture abnormal, Slow speech
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: 3 days after getting FLUZONE she started with dystonic hand, arm, head shaking. 1 week later started with slowed/slurred speech. No resolution yet as of 11-13-12.

VAERS ID:474959 (history)  Vaccinated:2012-10-26
Age:49.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-20, Days after onset: 24
Location:Michigan  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions:
Diagnostic Lab Data: Chest x ray, CBC, Lytes, CT of chest and ECHO of the heart
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH746AC0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood electrolytes, Chest X-ray, Chest pain, Computerised tomogram thorax, Dizziness, Echocardiogram, Full blood count, Heart rate decreased, Hypertension, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Nausea, low heart rate (40) high blood pressure, dizzy, chest pain,

VAERS ID:475246 (history)  Vaccinated:2012-10-26
Age:44.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-30, Days after onset: 4
Location:Oregon  Entered:2012-11-20, Days after submission: 21
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: ADD
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AC0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Myalgia, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad)
Write-up: Swelling at injection site/pain. Generalized myalgia. General upper respiratory sx''s.

VAERS ID:475093 (history)  Vaccinated:2012-10-26
Age:34.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-11-21, Days after onset: 26
Location:Virginia  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No allergies
Diagnostic Lab Data: No lab work done.
CDC 'Split Type': VA12009
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3874BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Parkinson-like events (broad)
Write-up: Client received vaccine on 10/26/12. Started having shoulder & arm pain that night. Saw MD on 11/11/12, given steroid injection. Has not been able to work-out or use arm in normal capacity. There was no redness or rash associated at site. Pain improved with steroid but now returning as steroid is wearing off. Still having arm pain - not able to move arm to full extent.

VAERS ID:477351 (history)  Vaccinated:2012-10-26
Age:55.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-11-21, Days after onset: 26
Location:California  Entered:2012-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Kaiser E.R. doctor diagnosis, nerve injury
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1786AA SYRUN
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Nerve injury
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Right arm pneumonia shot. Smarted upon injection Pain and numbness grew intolerance within hours, E.R. doc. prescribed PERCOCET for pain. That was almost 4 weeks ago!

VAERS ID:475356 (history)  Vaccinated:2012-10-26
Age:50.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2012-11-23, Days after onset: 27
Location:New York  Entered:2012-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinusitis chronic
Preexisting Conditions: Sjogren''s
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH722AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pain in jaw
SMQs:, Osteonecrosis (broad)
Write-up: The patient has experienced jaw pain since receiving her flu shot.

VAERS ID:475134 (history)  Vaccinated:2012-10-26
Age:45.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-24, Days after onset: 29
Location:North Carolina  Entered:2012-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1205301 IMRL
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Body temperature fluctuation, Chills, Dizziness, Full blood count normal, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Approximately 2 hours after getting the shot I began to get very dizzy. I was unable to walk, I was even dizzy laying down with my eyes closed. I was taken to my family doctor where they checked my out. While I was there I began having severe tremors or what they called rigors. When I first got there I told them that the nurse at work took my blood pressure where it was 96/60 (mine usually runs quite low) but when I got th the doctors office my heart rate went up to 140. They also took my temp right when I got there and it was 97 degrees (mine again runs low) after the rigors started they took temp again and it was 100 degrees. They took blood and my CBC was normal. They watched me for a while and by the time I left my blood pressure was normal as well as my temperature. The dizziness continued for the rest of the day but otherwise everything else stopped. The next day I was back to normal.

VAERS ID:475258 (history)  Vaccinated:2012-10-26
Age:65.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-26, Days after onset: 31
Location:Michigan  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denies
Preexisting Conditions: Neutrophillic Panniculitis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4524AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Client states left upper arm has sharp pain with movement that started the evening of vaccination. States she is still having pain in upper arm with movement 11/26/2012. Denies any arm redness or edema.

VAERS ID:477533 (history)  Vaccinated:2012-10-26
Age:56.0  Onset:2012-10-29, Days after vaccination: 3
Gender:Male  Submitted:2012-11-26, Days after onset: 28
Location:California  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUH682AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4397AC0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0126500IMRA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Nausea, vomiting, diarrhea started 3 days after vaccines, lasted 3 days but after 2 wk. has occ. diarrhea.

VAERS ID:475543 (history)  Vaccinated:2012-10-26
Age:30.0  Onset:2012-10-28, Days after vaccination: 2
Gender:Female  Submitted:2012-11-16, Days after onset: 19
Location:Missouri  Entered:2012-11-27, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12231P0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Feeling abnormal, Pain, Pruritus, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (narrow)
Write-up: Flu vaccine taken 10/26/12 at 1130 am & awoke w/ a red, raised macular rash 10/28/12 on chest. Rash spread up her neck to face & down both arms to fingers. Extremely itchy & painful. Treated w/ prednisone, topical cream, Hydroxyzine. Didn''t feel good for 3 weeks, but fine now.

VAERS ID:477637 (history)  Vaccinated:2012-10-26
Age:64.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-29, Days after onset: 34
Location:Massachusetts  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No allergies; Depressive Disorder; MVP; Hyperlipidemia
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H011427 UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Blister, Erythema, Pruritus, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt received ZOSTAVAX Lot # H011427 in her (R) upper arm 10/26. She was seen for a different issue 11/28 and mentioned she had a reaction which lasted 2 1/2 wks including redness, itching, blisters & swelling.

VAERS ID:479127 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 35
Location:Unknown  Entered:2012-11-30
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:
CDC 'Split Type': WAES1211USA011069
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, Unevaluable event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 26-OCT-2012 07:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479388 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011236
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 12:03, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479389 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011233
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 06:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479390 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011238
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 21:42, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479393 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011237
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 at 13:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479394 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011232
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 02:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479395 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011235
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 26-OCT-2012 at 10:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:479396 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-12-03, Days after onset: 38
Location:Unknown  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011234
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 26-OCT-2012 09:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:476915 (history)  Vaccinated:2012-10-26
Age:72.0  Onset:2012-11-15, Days after vaccination: 20
Gender:Male  Submitted:2012-12-07, Days after onset: 22
Location:Missouri  Entered:2012-12-07
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, diabetes
Preexisting Conditions: Same as above
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1206201 IMLA
Administered by: Other     Purchased by: Public
Symptoms: Blood test, Computerised tomogram, Ear pain, Eye pain, Eyelid oedema, Eyelid ptosis, Headache, Hyperaesthesia, Nuclear magnetic resonance imaging, Pain in jaw, Scan with contrast, Temporal arteritis, Ultrasound Doppler, Ultrasound Doppler abnormal, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vasculitis (narrow), Periorbital and eyelid disorders (narrow), Osteonecrosis (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow)
Write-up: Blurry vision in right eye-several days later developed pain and sensitivity on right side of head, behind eye, drooping swollen right eyelid, pain in ear and jaw. Eye doctor sent patient to emergency room-after blood tests, CT scan, contrast MRI, Doppler ultra sound on carotid artery, patient was diagnosed with temporal arteritis--prescribed 80 mg prednisone daily. Patient is still on reduced dose prednisone and is feeling better.

VAERS ID:477548 (history)  Vaccinated:2012-10-26
Age:26.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 35
Location:Colorado  Entered:2012-12-11, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: IMITREX; BIOXIN; PCN; MUCINEX; RELPAX; Codeine; TYLENOL
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP5090880IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: C/o severe redness and swelling (L) upper arm 2 hours after receiving Flu vaccine. She visited doctor in occupational health office and was followed there.

VAERS ID:478180 (history)  Vaccinated:2012-10-26
Age:22.0  Onset:2012-11-02, Days after vaccination: 7
Gender:Female  Submitted:2012-12-14, Days after onset: 42
Location:North Carolina  Entered:2012-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UN 
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Face swelling: face becomes apparently greater in size with slight red coloring. Hives: big red rash-like bumps formed whenever I scratched the surface of my skin. These have been reappearing for the past 7 weeks or since the flu was received.

VAERS ID:478382 (history)  Vaccinated:2012-10-26
Age:69.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-11, Days after onset: 46
Location:Idaho  Entered:2012-12-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMAR
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Flu shot given at 9AM. Rash/hives began at 10:30 PM. BENADRYL taken 10:45 PM. Rash resolved 11:15 PM.

VAERS ID:478421 (history)  Vaccinated:2012-10-26
Age:32.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Male  Submitted:2012-12-17, Days after onset: 52
Location:Florida  Entered:2012-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No obvious illness
Preexisting Conditions: None. However patient did run 1.5 miles, 85 pushups and 80 situps, about 1 hour prior to receiving the Flumist vaccine.
Diagnostic Lab Data: 26 Oct 12 @ 1856 (Coll) PLASMA cTnI. . . . . . . . . . 4.19 H* (0-0.034) ng/mL CK. . . . . . . . . . 943 H (55-170) U/L CK-MB . . . . . . . . . 35.1 H (0-2.37) ng/mL CK-MB IDX . . . . . . . 3.7 INDEX For comments: (R, or I), press
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2024 IN 
Administered by: Military     Purchased by: Military
Symptoms: Acute coronary syndrome, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest discomfort, Chest pain, Troponin I increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Patient developed chest pressure which prompted him to visit the ER. Patient was treated for Acute Coronary Syndrome. He was ultimately shown to have an elevation of Troponin I. Chest pain began about 15 minutes after Flumist vaccine.

VAERS ID:478446 (history)  Vaccinated:2012-10-26
Age:61.0  Onset:2012-10-30, Days after vaccination: 4
Gender:Female  Submitted:2012-12-17, Days after onset: 48
Location:California  Entered:2012-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Test: nm bone scan whole body, full complete blood panel, bone density test, nerve conducting test.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  SYRLA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Bone densitometry, Bone scan normal, Full blood count, Hypoaesthesia, Joint range of motion decreased, Movement disorder, Musculoskeletal pain, Musculoskeletal stiffness, Nerve conduction studies, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Pain started in left shoulder, right shoulder. Could not lift arms. All the way to the wrist could not turn wrist anyway to open door. No strength in muscles. Pain down throughout my lower body. Woke the next day right hand and three fingers numb, stiff and painful.

VAERS ID:479013 (history)  Vaccinated:2012-10-26
Age:60.0  Onset:2012-11-01, Days after vaccination: 6
Gender:Male  Submitted:2012-12-21, Days after onset: 50
Location:California  Entered:2012-12-21
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS665210115100IMLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Beginning a week after the flu vaccination, I experienced arthritis-like pain in the upper left arm and shoulder. About a month after the vaccination the pain spread to tenderness in the joints of my left thumb. I have no history of prior arthritic pain.

VAERS ID:479116 (history)  Vaccinated:2012-10-26
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2012-12-19
Location:North Carolina  Entered:2012-12-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Primary hemochromatosis; Hypertension; Barrett''s Esophagus
Diagnostic Lab Data: Normal ESR, CPK, CMP - 4Dec2012
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AB0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0126500IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood creatine phosphokinase, Fatigue, Metabolic function test, Myalgia, Red blood cell sedimentation rate normal
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Several days after injection began to experience moderate myalgias, fatigue especially to deltoid regions. No fever, tingling or weakness to lower extremities.

VAERS ID:479345 (history)  Vaccinated:2012-10-26
Age:0.2  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-12-26, Days after onset: 61
Location:Georga  Entered:2012-12-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: GERD; Eczema
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4232AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF724950IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0106900PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad)
Write-up: Excessive crying x 1 night after immunization; fever of 101-102 x 1 night.

VAERS ID:481107 (history)  Vaccinated:2012-10-26
Age:35.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 35
Location:Missouri  Entered:2013-01-10, Days after submission: 41
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': 2012033816
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: This medically confirmed spontaneous report (initial receipt 26-Oct-2012) concerns a 35-year-old female patient. On 26-Oct-2012 the patient received AFLURIA (batch number was not provided) injection intramuscularly in left deltoid. AFLURIA was drawn up from a vial and placed into one of the syringes. When administering AFLURIA, the syringe came apart and only half of the dose was administered to the patient. Some of the vaccine leaked onto the patient''s arm. No adverse effects reported.

VAERS ID:482040 (history)  Vaccinated:2012-10-26
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:North Dakota  Entered:2013-01-22
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4184AB1IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC052BA1IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182461IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS1465AA1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: Influenza U4547CA 6/30/13 given too early 10/26/12. Influenza U4547CA 6/30/13 given too early 11/27/12.

VAERS ID:483085 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Unknown  Submitted:2013-01-31, Days after onset: 97
Location:Unknown  Entered:2013-01-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1301USA014272
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0294AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report as received form a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/029AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 26-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines tha that been stored incorrectly. Additional information is not expected.

VAERS ID:484417 (history)  Vaccinated:2012-10-26
Age:25.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2013-02-13, Days after onset: 110
Location:Unknown  Entered:2013-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNKNOWN
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA740AA IMLA
Administered by: Public     Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Participant felt numbness and tingling in left arm, both legs and right side by waist after receiving flu vaccination. Symptoms did not subside, 911 was called and participant was taken to the local hospital.

VAERS ID:487549 (history)  Vaccinated:2012-10-26
Age:15.0  Onset:2012-11-02, Days after vaccination: 7
Gender:Male  Submitted:2013-03-21, Days after onset: 139
Location:Texas  Entered:2013-03-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Naproxen; Vitamins (not A)
Current Illness: Vomited x1; H. pylori
Preexisting Conditions: Seasonal; Osteochondritis
Diagnostic Lab Data: MRI, MRV - wnl; CSF, wnl; Lumbar puncture OP = 39, repeat 25 when on DIAMOX; (-) Lyme; (-) vit A elevation, no acne meds
CDC 'Split Type':
Vaccination
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Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ2143 IN 
Administered by: Private     Purchased by: Private
Symptoms: Borrelia test negative, CSF test normal, Headache, Intracranial pressure increased, Intraocular pressure increased, Lethargy, Memory impairment, Nuclear magnetic resonance imaging normal, Oesophagogastroduodenoscopy, Venogram normal, Vitamin A normal
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Depression (excl suicide and self injury) (broad)
Write-up: After intranasal flu vaccine, had EGD 1 wk later, prolonged lethargy, increasing to 16 hrs/day, headache, mild deficits of memory, severe headache. Developed idiopathic intracranial hypertension. OP = 39.

VAERS ID:487991 (history)  Vaccinated:2012-10-26
Age:84.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2013-03-24, Days after onset: 149
Location:Florida  Entered:2013-03-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Blood pressure medication - unknown
Current Illness: None
Preexisting Conditions: High blood pressure: controlled
Diagnostic Lab Data: Patient had spinal tap done - nothing was abnormal
CDC 'Split Type':
Vaccination
Manufacturer
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0130170SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Lumbar puncture normal, Mobility decreased, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Severe stiffness of neck and spine. Patient could not move soon after the vaccine was given and it lasted for 4 weeks.

VAERS ID:488378 (history)  Vaccinated:2012-10-26
Age:68.0  Onset:2012-11-01, Days after vaccination: 6
Gender:Female  Submitted:2013-03-28, Days after onset: 147
Location:Pennsylvania  Entered:2013-04-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspir-Low; CRESTOR; Calcium; CENTRUM SILVER ULTRA WOMENS
Current Illness:
Preexisting Conditions: The patient''s allergies included Amoxicillin, Erythromycin and BACTRIUM. The patient''s concomitant medications and illness at the time of vaccination were not reported. Follow-up on 18 March 2013, reported allergies as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as BACTRIUM) (reaction not reported). The patient was a non-smoker and denied alcohol use.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201210382
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4313AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site macule, Injection site warmth, Oedema peripheral, Pain in extremity, Pruritus, Rash, Vaccination site rash, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from a non-healthcare professional on 05 November 2012. A 68-year-old female patient, whose allergies included Amoxicillin, Erythromycin and Bactrium and concomitant medications and illness at the time of vaccination were not reported, had received an intramuscular dose of ADACEL vaccine in left deltoid (batch number: C4313AA) on 26 October 2012. The reporter stated that, after vaccination the patient returned to the office on 01 November 2012 with rash, redness, swelling at vaccination site and sore arm. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Follow-up information received from a health care professional on 18 March 2013. Based upon the new information provided, this case has been upgraded to serious due to diagnosis of cellulitis. The patient also received a dose of Influenza vaccine, Novartis, lot number 1204101, (route not reported) in the deltoid (side not reported) on 05 October 2012 (within four weeks date of ADACEL Vaccine). The patient had allergies reported as Amoxicillin causes rash, Erythromycin causes stomach ache, and BACTRIM (previously reported as Bactrium) (reaction not reported). Concomitant medications included Aspir-Low, CRESTOR, Calcium, and CENTRUM SILVER ULTRA WOMEN''S vitamin. The patient was a non-smoker and denied alcohol use. The patient had an office visit on 01 November 2012 and she presented with rash on her left arm. According to medical record, the patient had received a dTap vaccine two days ago (date of ADACEL vaccine was reported as 26 October 2012), (which makes latency six days), but the redness and swelling was getting worse and arm was reported as swollen and itchy. The patient had no fever or systemic symptoms (sx) and denied pain. She did report some itchiness. The patient''s height was reported as 59.75 inches (150 centimeters) and weight was reported as 155 pounds (lbs), (70 kilograms). The patient''s vital signs were reported as: temperature 98.9 (37.1 degrees Celsius); blood pressure 130/80 and pulse 72. Review of symptoms was negative. Physical exam was normal, except for skin: 6 X 6 centimeter (cm), erythematous and warm macular lesion over left upper arm and elbow area, reported as exam consistent with a cellulitis. There was no open wound. The patient was diagnosed with cellulitis and abscess. Treatment included KEFLEX 500 milligram (mg) one tablet (tab) three times a day (tid) for seven days and ice. The patient was instructed to return to office (RTO), if not improving or systemic sx. The patient''s outcome remained recovered on an unspecified date. List of documents held by sender: Medical Record.

VAERS ID:489127 (history)  Vaccinated:2012-10-26
Age:40.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2013-04-06, Days after onset: 161
Location:South Carolina  Entered:2013-04-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM; TOPAMAX; Estradiol; VALIUM
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Ankle fracture, Blood creatine phosphokinase decreased, Burning sensation, Dysstasia, Fall, Gait disturbance, Hypoaesthesia, Lumbar puncture normal, Pain, Paraesthesia, Walking aid user
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow)
Write-up: 10/26/12 received Flu Vaccine. 10/27/12 Awoke in AM unable to stand, legs numb from knees down, stabbing pains, burning in feet. Father carried her to car and transported her to ER. After six hours diagnosed her with paresthesia and sent her to Hospital for MRI which showed no injury to spine. Sent her home to follow up with doctor who gave flu shot. She became wheelchair bound. 10/31/12 Returned to Dr.''s office where flu shot was given. He did blood work and became suspect of Guillain Barre since she showed low levels of Creatine Kinase. Referred her to a neurologist for testing. Two weeks later Neurologist ruled out Guillain Barre "since she was not on a ventilator". Frustrated her family made appt. with a clinic in another state for further treatment. 11/5/12 Dr. at pain management ordered physical therapy, fentanyl patch and cream for burning, stabbing pain in feet. He would later put her on the drug GRALISE. 11/8/12 Physical Rehabilitation began physical therapy two to three times a week. By this time she had regained use of right leg and could stand on right leg with help to enter shower and bed. She was able to interchange between the wheel chair and a walker for short distances with a high stepping gait to clear her left foot. Without the walker she needs assistance to keep her balance. Goes up and down stairs by using her arms crawling on her bottom. She also has PT exercises to perform at home. Nov 12-Dec 12 Clinic in another state, under the care of Neurologists, she had numerous testing which included a lumbar puncture which ruled out MS, MD and Guillain Barre. In final notes which are included, they state that there is a possibility that this represented some kind of reaction to the flu vaccine. Suggested that she remain there for further treatment or return home for physical therapy under her doctor''s care at home. 12/20/12 Returned home for further treatment. Her leg was extremely unstable and she fell fracturing her left ankle. Delayed PT until Jan 29th. Presently still under care of Pain Management for pain and Physical therapy. Making small steps of gaining use of legs.

VAERS ID:493103 (history)  Vaccinated:2012-10-26
Age:43.0  Onset:2013-01-21, Days after vaccination: 87
Gender:Female  Submitted:2013-06-03, Days after onset: 132
Location:Georga  Entered:2013-06-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Diabetes
Diagnostic Lab Data: Blood work, CAT scans x 3.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH748AA5IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Fatigue, Gingival swelling, Inflammation, Influenza, Lymphadenopathy, Nausea, Nodule, Stomatitis, Weight decreased
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Came down with influenza, after 5 days, never recovered from symptoms, had enlarged lymphnodes, extreme tiredness and painful knots all over body. I have been to oncologist and had CAT scans and blood work, was sent to infectious disease doctor who thinks that all of my side effects stem from flu vaccine that started a severe reaction in my body that has caused inflammation all over. I still have swollen lymph nodes and sores in my mouth and swollen gums, weight loss, nausea, and abdominal pain.

VAERS ID:498928 (history)  Vaccinated:2012-10-26
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-08
Location:Georga  Entered:2013-08-08
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: Eczema
Diagnostic Lab Data: Pregnancy test, Positive; 10/26/2012, Pregnancy test urine, Negative
CDC 'Split Type': WAES1211USA006616
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine negative
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 years old female patient with no drug allergies. The other medical history included eczema. The patient''s history of previous pregnancies and live births was not known. The patient was vaccinated with dose 2 0.5 ml VARIVAX (Merck) (lot# was reported as HQ4272, expiration date not reported) subcutaneously on 26-OCT-2012. There was no concomitant medications. The patient was pregnant when received dose vaccine. A urine pregnancy test was done during the same office visit and it was negative. However, a serum pregnancy test was done at a later time and the result came back on 12-NOV-2012 and it was positive. The first dose of The VARIVAX (Merck)(lot# and expiration date were unknown) was provided by a different provider on an unspecified date. LMP was on approximately November 2012 and EDD will be approximately in August 2013. The patient was exposed to VARIVAX (Merck) during trimester 1. The patient sought medical attention through office visit and no treatment was given. Additional information has been requested. Lot number HQ4272 is an invalid lot number for VARIVAX.

VAERS ID:499842 (history)  Vaccinated:2012-10-26
Age:3.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2013-08-13, Days after onset: 290
Location:Idaho  Entered:2013-08-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pre-existing seizure disorder
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC1B13AA2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1576AA0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0140740SCLL
Administered by: Private     Purchased by: Public
Symptoms: Convulsion
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: Patient received DTaP vaccine on 10/5/09. On 10/14/19 developed seizure activity and was diagnosed with a seizure disorder. Received DTaP vaccine again 10/26/12 and had s subsequent generalized seizure on 10/27/12.

VAERS ID:503727 (history)  Vaccinated:2012-10-26
Age:23.0  Onset:2012-10-27, Days after vaccination: 1
Gender:Female  Submitted:2013-09-23, Days after onset: 331
Location:Michigan  Entered:2013-09-23
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: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA690AA0SYRRA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain, Lethargy, Pain, 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: Severe body aches, fever up to 102 lasting four days, headache, chills/sweating, lethargy/fatigue, injection site pain for weeks.

VAERS ID:508855 (history)  Vaccinated:2012-10-26
Age:58.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2013-10-22, Days after onset: 361
Location:Wisconsin  Entered:2013-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: ALLERGIC TO SULFA, NSAIDS
Diagnostic Lab Data: CHEST XRAY; BLOOD TESTS
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Private
Symptoms: Asthma, Blister, Blood test, Chest X-ray normal, Cough, Nervousness, Rash, Sinusitis, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: AN HOUR AFTER I RECEIVED THE FLU SHOT STARTED FEELING SHAKY. BY THE TIME I GOT HOME ABOUT 5:15PM, I WAS BREAKING OUT IN A RASH FROM NECK TO UPPER BACK. I STARTED ON BENADRYL RIGHT AWAY EVERY 4 HOURS. I THEN DEVELOPED WELTS OR BLISTERS ON MY HEAD. SHORTLY AFTER THAT I HAD AN ASTHMA ATTACK. FROM THEN ON I FEEL LIKE I WENT DOWN HILL. I WAS BATTLING ASTHMA ATTACKS. FELT LIKE I COULDN''T BREATHE. I PUT UP WITH THIS FOR A MONTH OR SO. FINALLY MY DAUGHTER BEGGED ME TO GO TO DR. I WAS DX WITH A SINUS INFECTION & ASTHMA. GIVEN SEVERAL INHALERS. STARTED DOING NEUBULIZER TREATMENTS. THEN I DEVELOPED AN AWFUL COUGH. I HAD THAT COUGH FROM DEC THROUGH APRIL. IT WAS SO BAD THEY DID CHEST XRAY TO RULE OUT PNEUMONIA. PEOPLE @ WORK TEASED MY I WAS COUGHING UP A LUNG.

VAERS ID:520314 (history)  Vaccinated:2012-10-26
Age:  Onset:2012-10-26, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-22, Days after onset: 453
Location:Unknown  Entered:2014-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1401USA008616
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012576 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours, 20 min. On 26-OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.

VAERS ID:472059 (history)  Vaccinated:2012-10-26
Age:38.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-10-30, Days after onset: 4
Location:Foreign  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Patient is on steroid therapy 10/30/2012 to see if there is any improvement.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4247A0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: My right arm is immobile and pain on top of shoulder.

VAERS ID:473748 (history)  Vaccinated:2012-10-26
Age:0.9  Onset:2012-10-27, Days after vaccination: 1
Gender:Male  Submitted:2012-11-08, Days after onset: 12
Location:Foreign  Entered:2012-11-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Personal medical history: acute illness including common cold. Family medical history and history of adverse event to previous administration of vaccine/drug: not
Diagnostic Lab Data: On 27 October 2012, slight fever at 37.5 degrees Celsius. On 29 October 2012: CRP at 0.086 mg/dL, white blood cell count at 11 100/microliters, platelet count at 3 000/microliter. Virus and bacteria tests were not performed.
CDC 'Split Type': 201210351
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURH05221UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein normal, Immunoglobulin therapy, Platelet count decreased, Purpura, Pyrexia, Rhinorrhoea, White blood cell count normal
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad)
Write-up: Case reported during the Early Post-marketing study. Initial report received from a Healthcare Professional on 01 November 2012 and follow-up information received on 05 November 2012. A 11-month-old male patient with no reported family history and with personal history of acute illness including common cold had received his first dose of IMOVAX POLIO (Batch number H0520, route and site of injection unknown) on 04 October 2012 simultaneously with a dose of Hepatitis B vaccine (manufacturer, batch number, route and site of injection unknown). He had received his second dose of IMOVAX POLIO (Batch number H0522, route and site of administration unknown) on 26 October 2012. On 27 October 2012, i.e 1 day post-vaccination, the patient developed purpura, nasal discharge and slight fever at 37.5 degrees Celsius. The patient visited a nearby hospital. On 29 October 2012, a blood test showed platelet count at 3 000/uL, CRP at 0.086 mg/dL, white blood cell count at 11 100/uL. Virus and bacteria tests were not performed. There was no adenopathy. Blood tests had not been performed before the vaccinations. The patient was hospitalized on 29 October 2012. Gamma globulin were given as corrective therapy. The patient fully recovered on 05 November 2012 and was discharged on the same day. Reporter''s case assessment: "This case was serious (hospitalization) and causality between the event and IMOVAX POLIO was not assessable." Document held by sender: none.

VAERS ID:474272 (history)  Vaccinated:2012-10-26
Age:12.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-14, Days after onset: 19
Location:Foreign  Entered:2012-11-14
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': B0841597A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA164AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Pallor, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of loss of consciousness in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 26 October 2012, the subject received unspecified dose of CERVARIX (intramuscular, left shoulder). On 26 October 2012, less than one day after vaccination with CERVARIX, the subject experienced syncope and fall. On 26 October 2012, the events were resolved. The physician considered the events were related to vaccination with CERVARIX. This case was upgraded to serious upon follow-up information received on 7 November 2012; The subject had no family history or her own medical history such as cardiac disease, epilepsy, metabolic abnormality (such as diabetes mellitus) or allergy (such as vaccine-induced allergy, vaccine-component-induced allergy, food allergy, allergic rhinitis, eczema or asthma, etc.). The subject had no painful/emotional stimulus before the onset of the event, no predisposing factor, no triggering event, no sign or warning associated with the episode and no sweat or warmth feeling before the event. On 26 October 2012, immediately after the vaccination with CERVARIX, the subject was in the sitting position and experienced pallor, knelt, fell down and lost consciousness completely for approximately 15 seconds. There was no abnormality in the subject''s respiratory pattern and she had no particular movement. The subject mad no movement in association with the fall and she had no tongue biting. The subject did not receive any oral medical treatment or medication. The events resolved before the measurement of vital signs. No symptom did develop after the subject recovered from loss of consciousness. Regarding loss of consciousness, the subject remembered that everything ahead of her became black. The subject did not undergo any special test. The events did not recur. The physician considered the events were clinically significant (or requiring intervention). On 26 October 2012, the events were resolved.

VAERS ID:475019 (history)  Vaccinated:2012-10-26
Age:0.2  Onset:2012-10-26, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-20, Days after onset: 25
Location:Foreign  Entered:2012-11-21, 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: Personal and family medical history: not reported.
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201210719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA11005 IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURG9967 IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, Lividity, Oedema peripheral, Pallor, Restlessness
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Case received from the Health Authorities through the local affiliate on 15 November 2012 under the reference number PLURPLN1277/2012. A 1-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of EUVAX B, batch number UVA11005, in the right thigh concomitantly with an intramuscular dose of ACT-HIB, batch number G9967-1, in the right thigh and an intramuscular dose of "PIX360326" vaccine (other manufacturer, batch number 20910001B), in the right thigh on 26 October 2012. This is a misuse due to inappropriate age at ACT-HIB administration. On 26 October 2012, one hour post-vaccination (also reported 5 hours), the patient fell asleep and slept for near 2 hours. The patient was very pale. After wake up very restless, the mother noticed oedema and lividity of the lower limbs especially right one. On the examination in the outpatient clinic, the patient was still pale, the oedema was smaller without lividity (illegible). The patient recovered on an unspecified date. Sender''s comments: "The child could be sleepy after EUVAX B vaccine, after which this reaction is expected (for others vaccines unexpected). Oedema may appear after administration of all vaccines. It is known and expected reaction. Similar situation with restlessness. Lividity of the limbs and pallor of the skin is an unexpected reaction." The Health Authorities coded "somnolence", "anxiety", "oedema peripheral" and "lividity". This case was reported as serious, i.e. as a medically important condition. Documents held by sender: none.

VAERS ID:476035 (history)  Vaccinated:2012-10-26
Age:31.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 35
Location:Foreign  Entered:2012-11-30
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: Blood test, not provided; Diagnostic ultrasound, not provided
CDC 'Split Type': B0847522A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA744AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood test, Delivery, Exposure during pregnancy, Jaundice, Live birth, Liver injury, Premature labour, Ultrasound abdomen normal
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This retrospective pregnancy case was reported by a physician via a regulatory authority (DK-DKMA-EFO3697) and described the occurrence of liver damage in a 31-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 26 October 2012, the subject received an unspecified dose of FLUARIX (intramuscular, unknown injection site) while she was pregnant. Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the third trimester. On 26 October 2012, 15 days after vaccination with FLUARIX, the subject experienced severe abdominal pain, liver damage and icterus. Pre-eclampsia was not likely. Gallstone was suspected but not seen on ultrasound. The subject also experienced premature labor. The subject was hospitalised in pregnancy week 36 + 1. At the time of reporting, events were improved. On an unspecified date, the subject gave birth to a live infant, by unknown delivery method.

VAERS ID:479606 (history)  Vaccinated:2012-10-26
Age:75.0  Onset:2012-12-17, Days after vaccination: 52
Gender:Male  Submitted:2012-12-27, Days after onset: 10
Location:Foreign  Entered:2012-12-28, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Influenza A virus test positive, Significant, Positive for Influenza A
CDC 'Split Type': PHHY2012DE118815
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS032031A SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2012DE118815 is a combined initial and follow-up spontaneous report received from foreign Health authority (reference number: DE-PEI-PEI2012065671) and from the quality assurance department (quality reference number: 201493) on 21 Dec 2012: This case refers to a 75-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with OPTAFLU (batch number: 032031A) on 26 Oct 2012. On 17 Dec 2012 the patient displayed influenza A infection and vaccination failure. The result was confirmed by positive polymerase chain reaction (PCR) test for influenza A. The patient was hospitalized due to this event on an unknown date. The outcome was reported as complete recovery on an unknown date. The causality was not reported. No other information was available.

VAERS ID:481790 (history)  Vaccinated:2012-10-26
Age:53.0  Onset:2012-11-08, Days after vaccination: 13
Gender:Female  Submitted:2013-01-17, Days after onset: 70
Location:Foreign  Entered:2013-01-18, 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 received a first injection of Rabies BP vaccine (batch no. G1391) 0.1 mL intradermally on 19-Oct-2012. No reported medical history or concomitant medications
Diagnostic Lab Data:
CDC 'Split Type': E201300148
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER 1IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect route of drug administration, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)
Write-up: This case was received from the health authority on 08-Jan-2013. GB-MHRA-ADR 21971154. This case is medically confirmed. The primary reporter is a physician. A 53-year-old female patient, with no reported medical history or concomitant medications, received an injection of Rabies vaccine BP, (dose 2, batch no. H1073, site of administration not reported) 0.1 mL intradermally on 26-Oct-2012 and an injection of influenza vaccine (manufacturer unknown; batch no;, route, dose and site of administration not reported) on 01-Nov-2012. On 08-Nov-2012, one week after the influenza vaccination and 12 days after the second rabies vaccination, the patient developed palmar and plantar paresthesia. On an unreported date she also experienced peripheral sensory symptoms. The patient received a first injection of Rabies BP vaccine (batch no. G1391) 0.1 mL intradermally on 19-Oct-2012. The patient had attended the travel clinic for the two rabies vaccines and the influenza vaccination was given elsewhere in interim. Upon internal review the company decided to code only the seconc dose of rabies vaccine as suspect and to add the first dose in the patient''s history. Upon internal review the company decided to add the adverse event "incorrect route of vaccination" as the rabies vaccine was given intradermally instead of intramuscularly. At the time of reporting the patient had not recovered. The reporter indicated that the rabies vaccine course was not completed due to report of new development of peripheral sensory symptoms. The reporter considered this case to be medically significant as the patient was asked to consult her GP. He stated that it was an unsual reaction post vaccination. The agency considered this case to be serious as an other medically important condition.

VAERS ID:482992 (history)  Vaccinated:2012-10-26
Age:24.0  Onset:2012-11-07, Days after vaccination: 12
Gender:Female  Submitted:2013-01-30, Days after onset: 84
Location:Foreign  Entered:2013-01-30
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: No
Diagnostic Lab Data: UNK
CDC 'Split Type': B0861494A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Micturition urgency, Musculoskeletal chest pain, Urinary retention, Urinary tract infection
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00096907) and described the occurrence of urinary tract infection in a 24-year-old female subject who was vaccinated with Hep B. On 26 October 2012 and 7 January 2013 the subject received unspecified doses of Hep B (1 IU Axa). On 7 November 2012, 12 days after the 1st vaccination with Hep B, the subject experienced urinary tract infection, feeling of residual urine, low back pain and urinary urgency. At an unspecified time after the 2nd vaccination with Hep B, the subject experienced feeling of residual urine, low back pain and urinary urgency. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. Verbatim Text: Urinary tract infection. Pain at my lower back and by my ribcage, wanting to wee all the time, the feeling of not being able to empty my bladder. First course of antibiotics was trimethropin 200mg take one twice a day and then I had nitrofurantoin 50mg caps taking one four times a day.

VAERS ID:483144 (history)  Vaccinated:2012-10-26
Age:24.0  Onset:2012-11-07, Days after vaccination: 12
Gender:Female  Submitted:2013-02-01, Days after onset: 86
Location:Foreign  Entered:2013-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Injury associated with device
Diagnostic Lab Data:
CDC 'Split Type': WAES1301GBR014758
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Musculoskeletal chest pain, Pollakiuria, Urinary retention, Urinary tract infection
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad)
Write-up: This case was received from the health authority on 22-Jan-2013. GB-MHRA-ADR 21985164. This case is not medically confirmed as it was reported by a consumer. A 24 year old female patient (weight: 82.55 kg), received injections of hepatitis b vaccine (manufacturer unknown, batch number, dose, site and route of administration not reported) on 26-Oct-2012 and 07-Jan-2013. On 07-Nov-2012, the patient experienced urinary tract infection. On an unreported date, the patient presented pain at lower back and pain in ribcage, wanted to wee all the time, felt of not being able to empty her bladder. Her first course of corrective treatment with antibiotics was trimethoprim (written trimethropin in the HA report) 200 mg took one twice a day and then she received nitrofurantoin 50 mg capsules took one four times a day. The patient''s medical history included accidental needle stick. Upon internal review the company coded "pain in ribcage" which was mentioned by the health authority but not coded. At the time of reporting, the patient was recovering from urinary tact infection and the outcome was unknown for "pain at lower back", "pain in ribcage", "wanting to wee all the time" and "feeling of not being able to empty bladder". The agency considered that case serious due to be medically significant. To be noted that the agency coded both doses of hepatitis B vaccine in suspect.

VAERS ID:484800 (history)  Vaccinated:2012-10-26
Age:65.0  Onset:2012-12-25, Days after vaccination: 60
Gender:Male  Submitted:2013-02-18, Days after onset: 55
Location:Foreign  Entered:2013-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Chronic lymphocytic leukaemia
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1302GBR007104
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERJ7166 IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H012185 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Meningitis pneumococcal
SMQs:
Write-up: This case was received from the health authority in a foreign country on 05-Feb-2013. GB-MHRA-ADR 21999277. This case is medically confirmed. The primary reporter is a physician. A 65-year-old male patient, with a history of chronic lymphoid leukaemia, was vaccinated on 26-Oct-2012 with an injection of influenza vaccine (batch no. J7166, dose in series and site of administration not reported) one dosage form intramuscularly and an injection of PNEUMOVAX II (batch no. reported as "H0121850102AE" but entered in product screen as "H012185") according to the batch number format, dose in series and site of administration not reported) one dosage form intramuscularly. Sixty days post vaccination, on 25-Dec-2012, he experienced pneumococcal meningitis. The influenza vaccine was considered concomitant by the agency but, upon internal review, it was decided to consider it as suspect because the two vaccines were given at the same time. The reporter stated that it was unknown if there was a link between pneumococcal vaccination and the adverse event. At the time of reporting the patient was recovering. The agency considered this case to be serious due to hospitalisation (no more details reported).

VAERS ID:486038 (history)  Vaccinated:2012-10-26
Age:75.0  Onset:2013-02-04, Days after vaccination: 101
Gender:Female  Submitted:2013-03-01, Days after onset: 25
Location:Foreign  Entered:2013-03-01
Life Threatening? Yes
Died? Yes
   Date died: 2013-02-09
   Days after onset: 5
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Diagnostic Lab Data: H1N1 Influenza PCR positive, 09Feb2013, positive
CDC 'Split Type': D0078940A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA692DA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death, Influenza, Influenza A virus test positive
SMQs:
Write-up: This case was reported by a health professional, via local health authority, via a foreign regulatory authority (# DE-PEI-PEI2013009993) and described the occurrence of influenza A (H1N1) infection in a 75-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included multiple myeloma type IgA. On 26 October 2012 the subject received an unspecified dose of INFLUSPLIT SSW (unknown route and application site). On 4 February 2013, 101 days after vaccination with INFLUSPLIT SSW, the subject experienced influenza A (H1N1) infection. The subject was hospitalised for 6 days since 04 February 2013. The regulatory authority reported that the events were life threatening. Influenza A (H1N1) infection was confirmed by PCR. The subject died on 9 February 2013 from influenza a (h1n1) infection. It was unknown whether an autopsy was performed. Foreign regulatory authority has requested further information.

VAERS ID:492671 (history)  Vaccinated:2012-10-26
Age:55.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-28
Location:Foreign  Entered:2013-05-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013036043
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Influenza like illness, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad)
Write-up: This report from Health Authority (initial receipt 13-May-2013) concerns a 55-year old male patient. On 26-Oct-2012 the patient was vaccinated with Influenza purified antigen (brand name, dosing and lot number unknown) and with DTP-POLIO vaccine at the same day. The influenza vaccination is not recorded in The Immunisation Registry. Vaccination date for the other vaccines is 26-Oct-2012. 3-4 days after vaccination there occurred influenza-like symptoms and pain in the right forearm. After some more time there was also pain in right leg, from hip and downwards. After recovery another episode of influenza-like symptoms occurred in the middle of November. He felt loss of energy and aggravation of pain in right forearm and leg, as well as feeling of weakness, most pronounced in the right forearm and right leg, but also in the left forearm. Recovery after some months, but still pain in left forearm when he is catching something. This is a preliminary report. Agency will ask for vaccine specifications from the health care centre.

VAERS ID:516347 (history)  Vaccinated:2012-10-26
Age:21.0  Onset:2012-11-03, Days after vaccination: 8
Gender:Female  Submitted:2013-12-11, Days after onset: 403
Location:Foreign  Entered:2013-12-11
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': WAES1312DNK005066
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebral thrombosis, Disturbance in attention, Fatigue, Impaired work ability, Muscle spasms, Pain in extremity
SMQs:, Ischaemic cerebrovascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was received from Sanofi Pasteur MSD as part of a contractual agreement (DK-1577272925-E2013-10505). Case received from agency via the Health Authorities in a foreign country on 06-Dec-2013 under the reference DK-DKMA-ADR 22341012. Case is not medically confirmed. Primary source was a lawyer. A 22-year-old female patient (height, weight not reported) with no medical history reported had received the first injection of GARDASIL (batch number unknown) via not reported route and site of administration on 26-Oct-2012. On 03-Nov-2012, the patient developed blood clot in brain, pain in right leg, spasm in right leg, increased tiredness and increased concentration impaired. The patient was hospitalized and had undergone rehabilitation since end of Nov-2012 for one month. Patient was on sick leave from 04-Nov-2012 until summer 2013. At the time of reporting, the patient had recovered with sequelae from blood clot in brain and not recovered from all the other events. No causality assessment was provided. D2 of GARDASIL (batch number H018411) was given on 21-Dec-2012 and D3 of GARDASIL (batch number J000160) was given on 19-Apr-2013, toleration was not reported. Both vaccinations were given via not reported route and site of administration.

VAERS ID:527603 (history)  Vaccinated:2012-10-26
Age:23.0  Onset:2012-12-18, Days after vaccination: 53
Gender:Female  Submitted:2014-04-04, Days after onset: 471
Location:Foreign  Entered:2014-04-04
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Presyncope
Diagnostic Lab Data: Tilt table test, not reported
CDC 'Split Type': WAES1404DNK003388
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0117510IMUN
Administered by: Other     Purchased by: Other
Symptoms: Presyncope, Syncope, Tilt table test, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Case was received from a health professional via the Health Authorities on 31-MAR-2014 under the reference DK-DKMA-ADR22447154 and DK-DKMA-EFO8373 from SANOFI PASTEUR MSD (reference # DK-1577272925-E2014-02954) on 03-APR-2014. Case is medically confirmed. Primary source was a physician. A 23-year-old female patient (weight 60 kg, height 175 cm) with a medical history of presyncope received the second dose of GARDASIL (batch/lot no. H018411, expiration date 31-MAR-2015) via intramuscular route into not reported site of administration on an unspecified date. On 18-DEC-2012, the patient developed lipothymia events/fainting and visual disturbance. The patient previously had near syncope for several years, but after D2 it became more worse with visual disturbance and usual fainting. No other medicines were given. The patient was examined by a neurologist who referred the patient to investigation with tilt table test. At the time of reporting, the patient had not recovered. D3 of GARDASIL (batch/lot no. J000160, expiration date 30-JUN-2015) was given on 13-JUN-2013. Toleration was not reported. Previous dose of GARDASIL (D1, batch no. H011751) was received via intramuscular route into not reported site of administration on 26-OCT-2012. Toleration was not reported.

VAERS ID:471730 (history)  Vaccinated:2012-10-27
Age:15.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-28, Days after onset: 1
Location:Massachusetts  Entered:2012-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO Had menses at time consisting of some menstrual cramping per report of patient and mother.
Preexisting Conditions: Asthma and allergic rhinitis. Not symptomatic with URI nor asthmatic episode at the time.
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AB9IMRA
Administered by: Private     Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Dizziness, Feeling hot, Flushing, Headache, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Mom called after hours telecommunications for office practice to inform clinician that patient had a prolonged episode of tremors/shaking which continued in same intensity for at least an hour then gradually started to diminish over the next couple hours until resolution. Asymptomatic by mid afternoon/evening. Patient describes being alert at the time but unable to control the shaking. Felt a hot sensation, and had flushed cheeks as noted by her dance instructor and other dancers. Brief period of time whereby she did not dance, but was able to do some activity while continuing the tremor. Denies chest pain nor difficulty breathing. Had a headache, some transient dizziness, and a stomach ache. Felt stomach ache could be related to menstrual cramps she had at the time. Had breakfast that morning. Did not have any seizure activity, No LOC. At the time of occurrence, mom informed but did not connect that her symptoms could be related to the influenza vaccine. Called telecommunications at 7:01 pm on 10/27/2012 to report event. Discussed bringing patient to the ER, but mom felt symptoms resolved by the time. Mom described plans to consult with patient''s primary provider.

VAERS ID:471733 (history)  Vaccinated:2012-10-27
Age:36.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-28, Days after onset: 0
Location:Pennsylvania  Entered:2012-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR 0IDLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Induration, Injection site pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pain at injection site. Large (2 inch diameter) area that is red, hard and warm to touch.

VAERS ID:472032 (history)  Vaccinated:2012-10-27
Age:54.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-10-28, Days after onset: 1
Location:New York  Entered:2012-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH730AA1SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Fatigue, Malaise, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Administered flu shot 10/27/12 at 10 AM. After 20 mins, began to feel uneasy - at night felt increased fever - 100 degrees, tired, achy, sore throat, chills through night till about 10 AM 10/28/12 - still feel tired.

VAERS ID:471881 (history)  Vaccinated:2012-10-27
Age:63.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:Florida  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1207201A1IMRA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Chills, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Rash on face, painful joints, chills.

VAERS ID:471945 (history)  Vaccinated:2012-10-27
Age:61.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:Texas  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: PATIENT RECEIVED FLUVIRIN VACCINE IN LEFT DELTOID WITH NO COMPLAINTS...NOW PRESENTS WITH A RED BRUISING AROUND VACCINATED/INJECTED AREA
Preexisting Conditions: UNKNOWN
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12051011IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site haematoma, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: RED CIRCULAR BRUISE AROUND INJECTION SHOT, IT WAS HOT ON 10/28/12. BUT NOT AT 1:10PM ON 10/29/12.

VAERS ID:472133 (history)  Vaccinated:2012-10-27
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Michigan  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AB UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB667BB UNRL
Administered by: Private     Purchased by: Public
Symptoms: Cyanosis, Nausea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient came out in the hallway and sat by the garbage can. I told him to go sit in the room with it. Nurse went in and said he was pale with blue lips. She laid him down, put his arm above his head. He was on his right side. After a minute or so his color started returning and nausea went away.

VAERS ID:472142 (history)  Vaccinated:2012-10-27
Age:56.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:Ohio  Entered:2012-10-29
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: No
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AC IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Induration, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Received flu shot at flu clinic in AM. Noticed reaction 10 pm 10/27/12 - reddened area 60 x 65 mm noted firm, sore, warm to touch. No other s/s.

VAERS ID:472144 (history)  Vaccinated:2012-10-27
Age:11.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Michigan  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB667BB UNLL
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA10126 UNRL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085AA UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0096351UNRL
Administered by: Private     Purchased by: Public
Symptoms: Fall, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: He fainted fell out of chair was pale, lasted for maybe a minute. Woke up when on floor. We elevated legs put coat under his head. He kept saying "how did I end up on the floor". I got Dr. and he checked his breathing and heart asked how he felt.

VAERS ID:472179 (history)  Vaccinated:2012-10-27
Age:66.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:Illinois  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1207201 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.413581 IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient reported swelling and redness in left arm that stretches from administration site to elbow and wraps around arm. Patient''s primary physician was not in, nurse advised to go to ER then informed us.

VAERS ID:472196 (history)  Vaccinated:2012-10-27
Age:53.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:New Mexico  Entered:2012-10-29
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1205301 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt. had flu shot 10/27. Came into store 10/29 to show me red arm. Redness about 3" wide, 4" long near injection site. Pt. reported it was hot and itchy. I recommended ice and topical diphenhydramine. Pt. told me she is allergic to thimerosal.

VAERS ID:472057 (history)  Vaccinated:2012-10-27
Age:42.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-30, Days after onset: 2
Location:Massachusetts  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Patient is still being treated. MRI does not show abscess or myositis.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0162951IMLA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Chills, Injection site erythema, Injection site induration, Injection site swelling, Nuclear magnetic resonance imaging normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling, induration of site, continued expansion despite antibiotics, fever and chills and generalized weakness.

VAERS ID:472100 (history)  Vaccinated:2012-10-27
Age:46.0  Onset:2012-10-29, Days after vaccination: 2
Gender:Female  Submitted:2012-10-30, Days after onset: 1
Location:Texas  Entered:2012-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: MIGRAINES, ULCERATIVE COLITIS?, SMALL AVEOLI DAMAGE?
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12051010IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site rash
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: RED BRUISING/RASH AND PAIN IN AND AROUND INJECTION SITE.

VAERS ID:472198 (history)  Vaccinated:2012-10-27
Age:62.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-29, Days after onset: 1
Location:Tennessee  Entered:2012-10-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED06499221A1IMAR
Administered by: Other     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Next day - chills, sweaty palms and feet. Tingling in hands. No symptoms at injection site. Symptoms subsiding on day 2.

VAERS ID:472262 (history)  Vaccinated:2012-10-27
Age:78.0  Onset:2012-10-29, Days after vaccination: 2
Gender:Female  Submitted:2012-10-29, Days after onset: 0
Location:South Carolina  Entered:2012-10-30, 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:
Current Illness:
Preexisting Conditions: PCN; Sulfa
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4530AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left arm inflamed at site.

VAERS ID:472369 (history)  Vaccinated:2012-10-27
Age:31.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-31, Days after onset: 4
Location:California  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No Active Illnesses at time of Vaccination.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP503080IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness and itching at site of injection from Afluria Influenza Vaccine (R Deltoid). Pt. C/O itching on both arms after injection. Symptoms & redness diminished after being treated with Benadryl 25 mg P.O. times 1, S&S resolved within 20 minutes. Pt. was monitored in clinic total of 2 hours as she remained stable. Pt was discharged to home in stable condition, itching resolved. Vital Signs Stable, with OTC RX: Benadryl 25 mg 1 q- 6 PRN. Telephone call F/U 2 days later pt. stated she was feeling great had no additional concerns or questions.

VAERS ID:472397 (history)  Vaccinated:2012-10-27
Age:42.0  Onset:2012-10-29, Days after vaccination: 2
Gender:Female  Submitted:2012-10-31, Days after onset: 2
Location:Arizona  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: ASTHMA, HYPERTENSION
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07549211A IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4313AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient called clinic, left word that she had a reaction to vaccine received 2 days prior. States she felt pain at time of flu injection, two days later arm became very painful, unable to raise arm, very red and swollen at injection site. She received flu and pneumonia vaccines in left deltoid but believed it was the flu she reacted to. (Received Tdap in right deltoid). Saw PCP 10/29/12, he prescribed Tylenol with Codeine for pain, ibuprofen for inflammation, promethazine for nausea.

VAERS ID:472927 (history)  Vaccinated:2012-10-27
Age:58.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-31, Days after onset: 3
Location:Oregon  Entered:2012-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Environmental allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0125190SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine administered 10/27/12. On 10/30/12 patient called to report she has a 1/4" raised, hot, palm-sized swelling at site of injection. Itches.

VAERS ID:472569 (history)  Vaccinated:2012-10-27
Age:56.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-30, Days after onset: 3
Location:Virginia  Entered:2012-11-01, 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: None
Preexisting Conditions: Hypothyroid
Diagnostic Lab Data: Saw PMD 10/29 tests ordered - results unknown.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH753AA3IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Dyspnoea, Laboratory test, Malaise, Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: 10/27 Vaccination given (L) deltoid approximately 5 PM. At 7 PM employee reported "shortness of breath, chills, low grade fever felt very ill all throughout night. Noted red raised diffuse rash on trunk, back did not seek medical care. Saw PMD 10/29.

VAERS ID:472594 (history)  Vaccinated:2012-10-27
Age:74.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 5
Location:Indiana  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: None noted
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12045011IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Rash and hives. Itching over 70% of body.

VAERS ID:472601 (history)  Vaccinated:2012-10-27
Age:39.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 5
Location:Arizona  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: None Noted
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12049011IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0133941IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Feeling faint, shaky, vomited a small amount. 911 called. Patient recovered and requested to go home.

VAERS ID:472953 (history)  Vaccinated:2012-10-27
Age:44.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-28, Days after onset: 1
Location:Tennessee  Entered:2012-11-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Allergic reaction
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07049221A UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4137AA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Hypersensitivity, Nasal congestion, Pruritus, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Head started feeling real stuffy, took a DAYQUIL about 15 mins after the palms of hands started itching and burning. Within mins it had spread to all my body. Took a cold shower but still kept itching. Went to firehall, they called hospital, went to hospital and they gave BENADRYL.

VAERS ID:473207 (history)  Vaccinated:2012-10-27
Age:7.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-10-29, Days after onset: 2
Location:North Carolina  Entered:2012-11-02, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH759AB5IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm swelling and red - began the day of the vaccine - stable after 1 day. No treatment.

VAERS ID:472798 (history)  Vaccinated:2012-10-27
Age:7.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-03, Days after onset: 7
Location:California  Entered:2012-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Undergoing treatment for Strep bacteremia, but had documented culture clearance.
Preexisting Conditions: Sickle cell disease.
Diagnostic Lab Data: Blood culture negative.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood culture negative, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling at the vaccine site, over the entire deltoid, collarbone, and down to antecubital fossa. Patient then developed fevers for ~48 hr post-vaccine.

VAERS ID:473648 (history)  Vaccinated:2012-10-27
Age:5.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Male  Submitted:2012-10-31, Days after onset: 3
Location:Connecticut  Entered:2012-11-05, 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: No
Preexisting Conditions: Asthma; OMNICEF allergy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4482AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
SMQs:
Write-up: The patient received his flu vaccine on 10/27/12 & returned to the office with a 3x2 1/2 inch erythematous, warm, swollen area at the site of the vaccination.

VAERS ID:477273 (history)  Vaccinated:2012-10-27
Age:67.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-05, Days after onset: 9
Location:Georga  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA000590
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H013020 SCRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with not known allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number H013020, expiration date: 09-OCT-2013) 0.65 ml into the right arm on 27-OCT-2012. Other suspect therapies included influenza virus vaccine (unspecified) (manufacturer unknown) (Lot number, dose and route not reported) into the left arm, on an unspecified date. No concomitant medications were reported. Pharmacist reported that in approximately 27-OCT-2012, the patient developed a lump at the injection site of right arm. No treatment information was reported. At the time of the report, the patient had not recovered from lump at the injection site of right arm. The relatedness for lump at the injection site of right arm was not reported for ZOSTAVAX and influenza virus vaccine (unspecified) (manufacturer unknown). Additional information has been requested.

VAERS ID:473291 (history)  Vaccinated:2012-10-27
Age:1.1  Onset:2012-11-04, Days after vaccination: 8
Gender:Female  Submitted:2012-11-06, Days after onset: 2
Location:New York  Entered:2012-11-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.    
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Other
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash all over body.

VAERS ID:473728 (history)  Vaccinated:2012-10-27
Age:41.0  Onset:2012-10-29, Days after vaccination: 2
Gender:Female  Submitted:2012-11-01, Days after onset: 3
Location:California  Entered:2012-11-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High blood pressure
Diagnostic Lab Data: White blood cells high; Chest x-ray clear
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12046012UNRA
Administered by: Other     Purchased by: Private
Symptoms: Chest X-ray normal, Erythema, Headache, Hyperhidrosis, Pain, Swelling, Viral infection, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Aching, swelling, redness (not rash). No treatment tried. Noticed 10-29-2012 on awakening. Sweating, headache. Patient went to hospital; turns out she also has a viral infection.

VAERS ID:473765 (history)  Vaccinated:2012-10-27
Age:54.0  Onset:2012-10-28, Days after vaccination: 1
Gender:Female  Submitted:2012-10-31, Days after onset: 3
Location:West Virginia  Entered:2012-11-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP50408 IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0125770SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: About 24 after injection patient had redness, tender, warmness at injection site of ZOSTAVAX. Prescriber gave patient BACTRIM DS for 5 days.

VAERS ID:477700 (history)  Vaccinated:2012-10-27
Age:35.0  Onset:0000-00-00
Gender:Unknown  Submitted:2012-11-07
Location:Unknown  Entered:2012-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA002985
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER0496AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with MMR II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to MMR II. (Lot # 0496AE) on 10/27/2012 that expired on 10/26/2012. NO adverse effect has been observed or reported. No additional information currently available.

VAERS ID:474037 (history)  Vaccinated:2012-10-27
Age:42.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-08, Days after onset: 12
Location:Pennsylvania  Entered:2012-11-08
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Patient received Flu shot on 10/27/12 and noticed pain in shoulder shortly following administration. Patient called today to inquire since pain still exists and may be getting worse with difficulty raising arm - no rash present.

VAERS ID:477963 (history)  Vaccinated:2012-10-27
Age:68.0  Onset:2012-10-29, Days after vaccination: 2
Gender:Female  Submitted:2012-11-11, Days after onset: 13
Location:Unknown  Entered:2012-11-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA002538
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Herpes zoster, Injection site erythema, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This spontaneous report as received from a 68 years old patient refers to herself. On 27-OCT-2012 the patient was vaccinated subcutaneously with one dose of ZOSTAVAX (Lot# and dose not reported). Concomitant medications included metoprolol and lisinopril. "About a week ago" on approximately 29-OCT-2012 the patient experienced injection site pain and redness, nausea and diarrhea after receiving ZOSTAVAX. Patient stated that she had shingles outbreak at this time, in about November 2012. Patient did not seek for medical attention. No treatment was given. No lab diagnostic studies were performed. Adverse events were not improved. At the time of this report the patient had not recovered. Additional information has been requested.

VAERS ID:474058 (history)  Vaccinated:2012-10-27
Age:1.1  Onset:2012-10-29, Days after vaccination: 2
Gender:Male  Submitted:2012-11-13, Days after onset: 15
Location:New Jersey  Entered:2012-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRL
Administered by: Private     Purchased by: Other
Symptoms: Blister, Decreased appetite, Dermatitis diaper, Irritability, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (broad)
Write-up: Fever started on 10/29/2012, peaked at 102.5 at 10:00PM. Our son continued to have a low fever for two days, was very fussy and lost his appetite. He continued to drink a lot of water. He developed blisters on his fingers and toes over the next few days. He developed a bad diaper rash. By 11/2/2012, he had no fever and his appetite returned. The blisters are now dried up.

VAERS ID:474476 (history)  Vaccinated:2012-10-27
Age:65.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2012-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Depression (Husband passed away)
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4498BA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Patient states that her flu shot was painful upon administration and that her pain level over past 2 weeks has been a 7 out of 10 on pain scale. She states her doctor''s office suggested ALEVE OTC and to make an appointment if pain persists. Patient also states that her left arm (flu-shot arm) has sharp pain shoots down to elbow and she cannot lift if more than half way and cannot unhook her bra. She never expressed this amount of pain at administration or previously.

VAERS ID:474168 (history)  Vaccinated:2012-10-27
Age:37.0  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-15, Days after onset: 19
Location:Texas  Entered:2012-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 10IMLA
Administered by: Private     Purchased by: Other
Symptoms: Burning sensation, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Vaccine provider had difficulty pushing in flu shot to left deltoid using 23g 1" needle. Then, when finally pushed with much needed pressure, I had immediate immense pain/burning/tingling up neck that lasted hours. Now having shoulder pain, decrease ROM in shoulder, getting worse.

VAERS ID:478760 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011242
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478802 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011241
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478813 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011239
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 11:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478816 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011240
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 11:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478817 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011245
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:38, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478818 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 13:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478823 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011247
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 18:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478833 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011246
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 18:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:478836 (history)  Vaccinated:2012-10-27
Age:  Onset:2012-10-27, Days after vaccination: 0
Gender:Female  Submitted:2012-11-29, Days after onset: 33
Location:Unknown  Entered:2012-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1211USA011243
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0385E UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage