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Found 502657 cases in entire database

Case Details (Sorted by Vaccination Date)

This is page 1709 out of 2011

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VAERS ID:464009 (history)  Vaccinated:2012-09-04
Age:30.0  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-09-04, Days after onset: 0
Location:Colorado  Entered:2012-09-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denies
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURE103112IMRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope X 2.

VAERS ID:464390 (history)  Vaccinated:2012-09-04
Age:11.0  Onset:2012-09-05, Days after vaccination: 1
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:Virginia  Entered:2012-09-06
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21071IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.0535AE1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4254AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4247AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site haematoma, Injection site oedema, Injection site pruritus, Injection site vesicles, Injection site warmth, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: On 9/4/12 Tdap was given in (L) deltoid. One day later some swelling, redness, itching noted. 2 days later (9-6-12) came back to office with increased edema, erythema, warmth, bruising, small blister at site of injection increased pruritus. Pt received Hep A and Mening in (R) deltoid the same day.

VAERS ID:468775 (history)  Vaccinated:2012-09-04
Age:  Onset:2012-09-04, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-06, Days after onset: 2
Location:Unknown  Entered:2012-09-06
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: WAES1209USA001827
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0933Z IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 (lot # 667912/0933Z, exp. 25-FEB-2012) on 04-SEP-2012. No adverse effect reported. The outcome of patient was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.

VAERS ID:464330 (history)  Vaccinated:2012-09-04
Age:11.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2012-09-07, Days after onset: 1
Location:Maryland  Entered:2012-09-07
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: DOWN''S SYNDROME; HYPOTHYROID; GERD; OBSTRUCTED SLEEP APNEA; HEARING LOSS
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA690AA8IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA110320IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B092EA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: SWELLING AND REDNESS TO ARM 5 INCHES BY 4 INCHES.

VAERS ID:464403 (history)  Vaccinated:2012-09-04
Age:3.0  Onset:2012-09-05, Days after vaccination: 1
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:California  Entered:2012-09-07
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU3497CA3IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AB2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF629233IMRL
Administered by: Public     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria like rash, and hives.

VAERS ID:468103 (history)  Vaccinated:2012-09-04
Age:  Onset:2012-09-04, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-09, Days after onset: 5
Location:Michigan  Entered:2012-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA002422
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0547AA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with expired lot # (669475/0547AA) dose 1 oral ROTATEQ (expired date 1-SEP-2012) (dose and route were unknown) on 04-SEP-2012. No adverse symptoms reported. Additional information has been requested.

VAERS ID:464549 (history)  Vaccinated:2012-09-04
Age:42.0  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-09-10, Days after onset: 6
Location:Massachusetts  Entered:2012-09-10
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: CBC; Metabolic Panel ordered 9/10/12
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4188AA IMLA
Administered by: Military     Purchased by: Private
Symptoms: Full blood count, Lymph node palpable, Metabolic function test, Pain in extremity
SMQs:
Write-up: Extreme pain left arm extending up to neck, palpable lymph node, left supra clavicular, seen 9/7/12, refused medical attention. Seen by PCP 9/10/12 labs ordered, pending at present time.

VAERS ID:464578 (history)  Vaccinated:2012-09-04
Age:56.0  Onset:2012-09-07, Days after vaccination: 3
Gender:Male  Submitted:2012-09-10, Days after onset: 3
Location:California  Entered:2012-09-10
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 allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4152AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left upper arm red, swollen, and warm to touch. Patient reports soreness into axilla. Advised by Dr. to use ice and Benadryl.

VAERS ID:464660 (history)  Vaccinated:2012-09-04
Age:0.2  Onset:2012-09-04, Days after vaccination: 0
Gender:Male  Submitted:2012-09-06, Days after onset: 2
Location:Maryland  Entered:2012-09-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4193AA0UNRL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC093BA1UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF511820UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0042AE0PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Constant, nonstop crying from time vaccine was given until the next day as per mom. Child was seen at hospital emergency room. No rx given.

VAERS ID:464817 (history)  Vaccinated:2012-09-04
Age:0.2  Onset:2012-09-05, Days after vaccination: 1
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:North Carolina  Entered:2012-09-11, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: Guaiac (+) 9/6/12 (from stool 9/5/12)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B344CA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.H0097510IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF429020IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0207AE0PO 
Administered by: Private     Purchased by: Private
Symptoms: Haematochezia, Irritability, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Pt received routine 2 month vaccinations on 9/4/12. PEDIARIX, HIB, PREVNAR 13 & ROTATEQ. On 9/5, pt had one episode of mild hematochezia with fussiness.

VAERS ID:465205 (history)  Vaccinated:2012-09-04
Age:74.0  Onset:2012-09-04, Days after vaccination: 0
Gender:Male  Submitted:2012-09-07, Days after onset: 3
Location:Florida  Entered:2012-09-17, Days after submission: 10
Life Threatening? Yes
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 PASTEURUH7164B IMUN
Administered by: Other     Purchased by: Private
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Nasal congestion, Pain, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Stuffy nostrils, sneezing, chills & sweat, head pain, shortness of breath, body aches 2 day duration.

VAERS ID:465403 (history)  Vaccinated:2012-09-04
Age:3.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2012-09-10, Days after onset: 4
Location:Florida  Entered:2012-09-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Aortic Valve Dysplasia; Dev/Speech Delay
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21080IN 
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Admitted to hospital for severe rash (urticarial) & febrile illness.

VAERS ID:469323 (history)  Vaccinated:2012-09-04
Age:  Onset:2012-09-04, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-17, Days after onset: 13
Location:Minnesota  Entered:2012-09-17
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: WAES1209USA002904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC. 1IMUN
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 certified medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the first 0.5 ml dose of VAQTA (lot # not reported) on 23-MAR-2012. The medical assistant reported that the patient was vaccinated intramuscularly with the second 0.5 ml dose of VAQTA (lot # not reported) on 04-SEP-2012, which was a little earlier than the recommended interval of 6 months. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.

VAERS ID:466245 (history)  Vaccinated:2012-09-04
Age:3.0  Onset:2012-09-11, Days after vaccination: 7
Gender:Male  Submitted:2012-09-25, Days after onset: 14
Location:Georgia  Entered:2012-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Topiramate; Leveteracitam
Current Illness: None
Preexisting Conditions: Seizure disorder
Diagnostic Lab Data: EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA688AA2IMLL
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Convulsion, Electroencephalogram, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Recurrent seizures and vomiting.

VAERS ID:466920 (history)  Vaccinated:2012-09-04
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-29
Location:Texas  Entered:2012-09-29
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
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204801 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMLA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: As of 9/5/12-arm is red and warm. It hurts all the way down arm. Pinky finger has some numbness and tingling. On 9/29/12-patient reported that she was fine.

VAERS ID:473123 (history)  Vaccinated:2012-09-04
Age:  Onset:2012-09-07, Days after vaccination: 3
Gender:Female  Submitted:2012-10-11, Days after onset: 34
Location:Unknown  Entered:2012-10-11
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: WAES1209USA004416
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions or allergies and no pertinent medical history. On 04-SEP-2012, the patient was vaccinated with ZOSTAVAX. Lot number and the dosing details were not reported. No concomitant medications were reported. On 07-SEP-2012, the patient experienced redness around injection site after receiving ZOSTAVAX. No treatment was given. No laboratories diagnostic test were performed. The patient sought medical attention spoke with the pharmacist. The outcome of redness around injection site was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:470110 (history)  Vaccinated:2012-09-04
Age:57.0  Onset:2012-09-05, Days after vaccination: 1
Gender:Female  Submitted:2012-10-11, Days after onset: 36
Location:Illinois  Entered:2012-10-16, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: DM II; Depression; Nerve pain; Hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SYRUN
Administered by: Other     Purchased by: Private
Symptoms: Herpes zoster, Injection site pustule
SMQs:
Write-up: - Breakout of shingles, pustules at site of injection.

VAERS ID:476263 (history)  Vaccinated:2012-09-04
Age:75.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2012-11-26, Days after onset: 81
Location:Kentucky  Entered:2012-12-03, 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:
Diagnostic Lab Data: 9/12/12 Severe (R) hand pain; Bil hand films
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Pain in extremity
SMQs:
Write-up: Within 2 days pain began in both hands and got worse until referred to specialist.

VAERS ID:556767 (history)  Vaccinated:2012-09-04
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2014-11-19
Location:Illinois  Entered:2014-11-19
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: Asthma
Diagnostic Lab Data: On an unspecified date, level 1 fetal ultrasound showed normal growth.
CDC Split Type: WAES1302USA007455
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous pregnancy report as received from a physician refers to an 18 year old female patient with no drug reactions/allergies. The patient''s medical history included asthma. On 04-SEP-2012 the patient was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) while she was pregnant. The fetal gestational age was 4 week (LMP:07-AUG-2012; due date: 14-MAY-2013) when VARIVAX (Merck) was administered. Gestation was 26 weeks 6 days. No adverse effect reported. The patient sought medical attention by office visit. No treatment was given for the AE. Level 1 fetal ultrasound showed normal growth. Follow up information has been received from a Licensed Practical Nurse. The reporter did not have much information report at this time. On 24-APR-2013, the patient had a live fetus, 37.1 gestation age at birth, 6 pounds 10 ounces. There was no notation of the baby''s health at birth or if the patient had any complications during her pregnancy. The reporter also stated she was not showing any information that VARIVAX (Merck) was given during the patient''s pregnancy. No further information is available at this time. Additional information has been requested. Patient, event and narrative were updated.

VAERS ID:464669 (history)  Vaccinated:2012-09-04
Age:  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 7
Location:Foreign  Entered:2012-09-11
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: Body temperature, 04Sep2012, 39deg C
CDC Split Type: B0828817A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161BA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of fever in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX (GlaxoSmithKline) given on 29 November 2010 and 28 December 2010. On 4 September 2012 the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 4 September 2012, 2 hours after vaccination with CERVARIX, the subject experienced fever and chills. The body temperature rose to 39 deg C 30 minutes later. The physician considered the events were clinically significant (or requiring intervention). On 5 September 2012, her body temperature was 37 deg C. The subject was treated with solita T. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:465228 (history)  Vaccinated:2012-09-04
Age:25.0  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 13
Location:Foreign  Entered:2012-09-17
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209DNK006078
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN43360 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Case received from a Health Care Professional via the Health Authorities in a foreign country on 10-Sep-2012 under the reference numbers DK-DKMA-ADR-21835604 and EFO3213. Case medically confirmed. A 25-years-old female patient (weight 60 kg, height 170 cm) had received injection of GARDASIL (batch number G009615; lot number NN43360, intramuscular, dose 1) on 04-Sep-2012 and 5 minutes post vaccination she developed anaphylaxis, difficult to breathe and dizziness. At the time of reporting the outcome was recovering for anaphylaxis and unknown for difficult to breathe and dizziness. The patient did not receive any other medication. No causality assessment was provided. No further information expected.

VAERS ID:465320 (history)  Vaccinated:2012-09-04
Age:0.3  Onset:2012-09-10, Days after vaccination: 6
Gender:Female  Submitted:2012-09-17, Days after onset: 7
Location:Foreign  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 10Sep2012, no abnormality; Adenovirus test, 10Sep2012, not provided; Blood test, 10Sep2012, not provided; Respiratory syncytial virus te, 10Sep2012, not provided; Rotavirus test, 10Sep2012, not provided; Stool analysis, 10Sep2012, not provided; Ultrasound abdomen, 10Sep2012, invagination of; Urine analysis, 10Sep2012, not provided
CDC Split Type: B0830674A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA429BA PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Adenovirus test, Blood test, Gastroenteritis rotavirus, Haematochezia, Intussusception, Pallor, Respiratory syncytial virus test, Rotavirus test, Stool analysis, Ultrasound abdomen abnormal, Urine analysis, Vomiting, X-ray normal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician and described the occurrence of rotavirus gastroenteritis in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 4 September 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral). 10 September 2012, in the morning, 6 days after vaccination with ROTARIX, the subject experienced bloody stool and vomiting. She was worn out and experienced ill complexion. Thus, she was taken to a nearby pediatric hospital, where she was diagnosed as having invagination of intestine and referred to the hospital. On 10 September 2012 at 10:30, the subject was taken to the hospital. A diagnosis of invagination of intestine was made as a result of abdominal ultrasonography. The following examinations were performed: analysis of the bloody stool (which was noted in the morning), blood test, urine analysis, adenovirus test, respiratory syncytial (RS) virus test and rotavirus test. Drip infusion was administered. Balloon reduction was performed and the subject''s condition was observed. The subject was not given milk and was administered drip infusion. On 10 September 2012, at 14:30, the subject experienced bloody stool. On 10 September 2012, at 17:00, abdominal X-ray showed no abnormality. On 10 September 2012, around 17:00, the subject was fed with milk and experienced no vomiting. On 11 September 2012, the subject was discharged from the hospital and the events were resolved. The physician considered that invagination of intestine was related to vaccination with ROTARIX. It was possible that the event developed spontaneously. However, the causal relationship between the event and the drug could not be ruled out.

VAERS ID:466410 (history)  Vaccinated:2012-09-04
Age:1.1  Onset:2012-09-04, Days after vaccination: 0
Gender:Male  Submitted:2012-09-24, Days after onset: 20
Location:Foreign  Entered:2012-09-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood gas performed to get pH, glucose and lactate (unknown date); pH (unknown date): 7.32 (no units provided) - decreased; Lactate (unknown date): 2.4 (no units provided) - increased; Blood glucose (unknown date): 6.9 (no units provided) - increased; Unspecified blood test (unknown date): fine, including electrolytes; Urea (unknown date): 8.2 (no units provided)
CDC Split Type: 2012231961
Vaccination
Manufacturer
Lot
Dose
Route
Site
MENHIB: MENINGICOCCAL CONJUGATE + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood electrolytes, Blood glucose increased, Blood lactic acid increased, Blood pH decreased, Blood test normal, Blood urea increased, Hypotonia, Induration, Pallor, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician. This is a report received from Regulatory Agency. Regulatory authority report number ADR 21844318. A 13-month-old male patient received PREVENAR, intramuscular on 04Sep2012 at single dose, MENITORIX, intramuscular on 04Sep2012 at a single dose, and measles, mumps and rubella vaccine, intramuscular on 04Sep2012 at a single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 04Sep2012, 3 hours post vaccination; the patient had a floppy episode lasting 5 minutes, was pale, had a hard abdomen and experienced repeated vomiting, which required hospitalization. The vaccinations were given at the reporter''s surgery. The batch and dose were unavailable. On an unknown date, blood gas was performed to get a pH, glucose and lactate and the results were as follows; decreased pH at 7.32, increased lactate at 2.4 and increased glucose at 6.9. An unspecified blood test was fine, apart from urea at 8.2, including electrolytes. The clinical outcome of the events, floppy episode lasting 5 minutes, pale, hard abdomen, and repeated vomiting, were considered resolved on 05Sep2012. The agency considered the events, a floppy episode lasting 5 minutes, pale, hard abdomen, and repeated vomiting, serious for an unspecified reason. No follow up attempts possible. No further information expected.

VAERS ID:466958 (history)  Vaccinated:2012-09-04
Age:1.1  Onset:2012-09-04, Days after vaccination: 0
Gender:Male  Submitted:2012-09-28, Days after onset: 24
Location:Foreign  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Blood glucose, 6.9 (increase); Blood test- normal apart from urea including electrolytes; Lactate, 2.4 (increase); PH, 7.32 (decrease); Urea, 8.2 Blood glucose, 6.9, increased; Blood lactic acid, 2.4, increased; Blood urea, 8.2; pH body fluid, 7.32 decreased
CDC Split Type: WAES1209GBR011537
Vaccination
Manufacturer
Lot
Dose
Route
Site
MENHIB: MENINGICOCCAL CONJUGATE + HIB (UNKNOWN)UNKNOWN MANUFACTURER  IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Blood lactic acid increased, Blood pH decreased, Blood test normal, Blood urea increased, Hypotonia, Induration, Pallor, Vomiting
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: This case was received from the Health Authority on 19-Sep-12 under the reference number GB-MHRA-ADR 21844318. This case is medically confirmed. A 13 month old male patient with an unreported history and concomitant medication received a dose of measles, mumps and rubella vaccine (Manufacturer, batch number not reported) intramuscularly, site not reported on 04-Sep-12. The patient also received a dose of MENITORIX (batch number not reported) intramuscularly, site not reported and a dose of PREVENAR (batch number not reported) intramuscularly, site not reported on 04-Sep-12. The vaccinations were given at the patient''s surgery. On 04-Sep-12, three hours post vaccination, the patient experienced a floppy episode, was pale, had a hard abdomen and experience repeated vomiting leading to hospitalisation. The floppy episode lasted for five minutes. A blood gas was performed to get PH, glucose and lactate. The blood glucose was increased at 6.9 (units not reported), a blood test was normal apart from urea 8.2 (units not reported) and electrolytes (no values or units provided), increased lactate 2.4 (units not reported), decreased PH 7.32. It is unknown if the patient received any corrective treatment. The patient recovered on 05-Sep-12. The MHRA coded the events of distended abdomen, muscle tone flaccid, pale and vomiting. Both the reporter and the MHRA considered the events to be serious due to hospitalisation.

VAERS ID:467619 (history)  Vaccinated:2012-09-04
Age:0.1  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2012-10-04, Days after onset: 28
Location:Foreign  Entered:2012-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood gases, normal; Electroencephalogram, 12Sep2012, epileptic potent; Nuclear magnetic resonance ima, normal; Ultrasound skull neonatal, normal; Virus stool test positive, rotavirus
CDC Split Type: D0077251A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Blood gases normal, Electroencephalogram abnormal, Infantile apnoeic attack, Nuclear magnetic resonance imaging brain normal, Rotavirus test positive, Ultrasound skull normal
SMQs:, Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Neonatal disorders (narrow)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2012046671) and described the occurrence of infantile apneic attack in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 4 September 2012 the subject received unspecified dose of ROTARIX (oral). On 6 September 2012, 2 days after vaccination with ROTARIX, the subject experienced infantile apneic attack. The subject was hospitalised. Electroencephalogram (EEG) showed clearly epileptic potentials. Late sepsis was excluded. Newborn screening had been normal. Blood gases, magnetic resonance tomogram (MRT) of head and sonogram of head were without pathologic findings. Stool test was positive for rotavirus, but negative for other virus. The subject was treated with levetiracetam. On 13 September 2012, the event was resolved and the subjects had no further attacks. No further information will be available.

VAERS ID:468411 (history)  Vaccinated:2012-09-04
Age:0.6  Onset:2012-09-10, Days after vaccination: 6
Gender:Male  Submitted:2012-10-07, Days after onset: 27
Location:Foreign  Entered:2012-10-09, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Resolved on unknown date, Pyelonephritis
Diagnostic Lab Data: 10-SEP-2012, Body temperature, 38.8 Centigrade; 11-SEP-2012, Body temperature, 39.1 Centigrade; 10-SEP-2012, C-reactive protein, 0.7 mg/dl; 11-SEP-2012, C-reactive protein, 3.8 mg/dl; 10-SEP-2012, White blood cell count, 10200/mm3; 11-SEP-2012, White blood cell count, 14500/mm3
CDC Split Type: 2012223252
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH12B02A SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, C-reactive protein normal, Pharyngitis, Pyrexia, White blood cell count normal
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow)
Write-up: This is a spontaneous report from a contactable physician. This physician reported similar events for three patients. This is the second of three reports. Only this case is serious. A 7-month old male patient received a single dose of PREVENAR (Lot number: 12B02A) subcutaneously on 04Sep2012. Relevant medical history included pyelonephritis. Concomitant medications were not provided. On 10Sep2012, the patient experienced pyrexia with a body temperature of 38.8 degrees Centigrade. Relevant lab tests included white blood cell (WBC) of 10200/mm3 and c-reactive protein (CRP) of 0.7 mg/dL. on 10Sep2012. The patient was observed without treatment. On 11Sep2012, pyrexia continued with a body temperature of 39.1 degrees Centigrade. Relevant lab tests revealed WBC of 14500/mm3 and CRP of 3.8 mg/dL. The patient was admitted to another hospital considering his history of pyelonephritis on 11Sep2012. The patient was diagnosed with acute pharyngitis. Therapeutic measures were taken as a result of the events, pyrexia and acute pharyngitis and included treatment with antibiotics. The outcome of the events, pyrexia and acute pharyngitis, were recovered on 15Sep2012. The patient was discharged on 15Sep2012. The reporting pediatrician reassessed the events as unrelated to the pneumococcal 7-valent conjugate vaccine. Follow-up (14Sep2012): New information received from the same contactable physician via a Pfizer sales representative included: patient data (initials, age and gender), drug data (lot number, date of vaccination), seriousness (serious) and causality (probably related) assessments. Follow-up (01Oct2012): New information reported by the same contactable pediatrician through a Pfizer sales representative included relevant history, clinical course, relevant lab data, outcome information, treatment details, hospitalization dates, and causality.

VAERS ID:469462 (history)  Vaccinated:2012-09-04
Age:6.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Female  Submitted:2012-10-12, Days after onset: 36
Location:Foreign  Entered:2012-10-12
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: B0835593A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B139AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a health professional via a regulatory authority (# ES-AGEMED- 122322447) and described the occurrence of injection site induration in a 6-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 4 September 2012, the subject received an unspecified dose of INFANRIX (0.5 ml, intramuscular, unknown injection site). On 6 September 2012, 2 days after vaccination with INFANRIX, the subject experienced injection site induration (10 cm), injection site inflammation and injection site redness. The regulatory authority reported that the events were clinically significant (or requiring intervention). The regulatory was treated with AMOXICILLIN, ibuprofen and ice. On 19 September 2012, the events were improved but a slight darkness at injection site has remained. The regulatory authority reported that the events were probably related to vaccination with INFANRIX. Follow-up information received on 9 October 2012: It was confirmed that injection site induration (10 cm), injection site inflammation and injection site redness were improved and the darkness at injection site was unresolved.

VAERS ID:473557 (history)  Vaccinated:2012-09-04
Age:0.3  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-11-07, Days after onset: 64
Location:Foreign  Entered:2012-11-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012272619
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC3742AA IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF68183 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Erythema, Feeling hot, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: This is a spontaneous report from an Healthcare professional received from the contactable Regulatory Authority, under reference GB-MHRA-ADR 21896554. A 3 months old female patient received PEDIACEL (lot number C3742AA) on 04Sep2012 and intramuscular PREVENAR 13 (lot number: F68183) on 04Sep2012 (first set of immunisations). On 04Sep2012 the infant developed cross bilateral leg swelling to the feet, was hot and red and had blue feet. She recovered from the events on 05Sep2012. The reporter considered the events to be serious as they were medically significant. The agency considered the events to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:478283 (history)  Vaccinated:2012-09-04
Age:0.4  Onset:2012-09-04, Days after vaccination: 0
Gender:Female  Submitted:2012-12-14, Days after onset: 101
Location:Foreign  Entered:2012-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Prophylaxis
Diagnostic Lab Data:
CDC Split Type: WAES1212AUS004167
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF95819 UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0337AE PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Hypotonia, Pallor, Respiratory arrest, Resuscitation, Slow response to stimuli, Staring, Tremor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail (agency # 306407, local reference # AUS/12/2705) concerning a 4 months old female patient who on 04-SEP-2012, was vaccinated orally with a dose of ROTATEQ (batch # 0337AE). Other suspect vaccines included INFANRIX HEXA (batch # A21CB371A) intramuscular, and PREVNAR 13, batch # F95819, route not reported). On 04-SEP-2012, whilst at swimming pool (not swimming) patient''s mother noticed left leg tremor when mother looked at child''s face patient was pale, floppy, non responsive with fixated stare. Patient was not breathing, therefore mother commenced mouth-to-mouth, gave a few puffs. Child began to become slowly more responsive, and began crying. Ongoing crying for at least 10 minutes. Ambulance was called and the patient was taken to emergency department. Was admitted for 1 night. Mother stated resolved after mouth-to-mouth resuscitation. Episode lasting approx. 2-5 minutes. On 04-SEP-2012, the patient was recovered. The agency considered the relationship between ROTATEQ and non responsive with fixated stare/not breathing was possible related. The original reported source was not provided. Additional information is not expected.

VAERS ID:482440 (history)  Vaccinated:2012-09-04
Age:0.2  Onset:2012-09-04, Days after vaccination: 0
Gender:Unknown  Submitted:2013-01-22, Days after onset: 140
Location:Foreign  Entered:2013-01-24, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201300777
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURERZOP11001A IMRL
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUFA11006 IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURG9974 IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case received from the Health Authorities through the local affiliate on 15 January 2013 under the reference number N1030/2012. A 3 month-old patient (gender not reported), with no reported medical history, had received an intramuscular injection of ACT-HIB (batch number G9974-1) in the left thigh concomitantly with an intramuscular injection of EUVAX B (batch number UFA 11006) in the left thigh and an intramuscular injection of DTP (other manufacturer, batch number ZOP11001A) in the right thigh on 04 September 2012 at 10:00. On 04 September 2012 at 17:30, the patient experienced fever from 39.0 degrees C to 39.4 degrees C. Fever lasted less than 48 hours. This event was considered as a serious post-vaccinal reaction. The vaccines were stored in a refrigerator before vaccination. There were stored properly. Aseptic technique was maintained during vaccination. The technique of vaccination was correct. The patient did not experience any post-vaccinal reaction in the past. The patient had not been hospitalized. He completely recovered less than 48 hours after apparition of fever. The adverse post-vaccination reaction did not occur as a result of "non considering contraindication for the vaccination." Approximately 800 people received DPT vaccine in the same area, 2500 received EUVAX B in the same area and 400 received ACT-HIB in the same area. One reaction has already been reported in one patient who received the same ACT-HIB lot number. This case was reported as serious, i.e. as other medical important condition. List of documents held by sender: none.

VAERS ID:482717 (history)  Vaccinated:2012-09-04
Age:1.7  Onset:2012-09-05, Days after vaccination: 1
Gender:Unknown  Submitted:2013-01-25, Days after onset: 142
Location:Foreign  Entered:2013-01-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history
Diagnostic Lab Data: Not reported
CDC Split Type: 201300973
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001C3IMLA
HIBV: HIB (ACTHIB)SANOFI PASTEURH80933IMLG
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG71583IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Injection site reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from the Health Authorities through the local affiliate in 16 January 2013 under the reference number N1132/2012. A 21-month-old patient (gender not reported), with no reported medical history, had received the fourth intramuscular dose of IMOVAX (batch number G7158-2) in the right arm concomitantly with the fourth dose of ACT-HIB (batch number H8093-1) in his thigh and the fourth intramuscular dose of DTP (other manufacturer, batch number 20911001C) in the left arm, on 04 September 2012 at 1pm. No post-vaccinal reaction was reported in the patient in the past. The report stated that the vaccines were stored properly, at 6 degrees C and that an asceptic technique was maintained during the vaccination. There was also a correct technique of vaccination. On 05 September 2012, at 8 am, the patient experienced a very strong reaction at the injection site, fever with highest temperature between 38 degrees C, and a first episode of convulsions. The qualification from the Health Authorities was "serious post-vaccinal reaction". The patient was hospitalized for 3 days due to post-vaccinal reaction. It was also mentioned that, in the opinion of an employee of the Sanitory and Epidemiological Station, the adverse post-vaccination reaction did not occur as a result of non-considering contraindications for the vaccination. In the given area, 15 people have been vaccinated with the same vaccine lot of DTP and of IMOVAX. No reactions have been reported in other people vaccinated with the same vaccine lot. One week after diagnosing the post-vaccination reaction the patient was completely recovered. It was also indicated that the reporting form was completed based on case history, doctor who managed the patient was absent. Documents held by sender: none.

VAERS ID:482865 (history)  Vaccinated:2012-09-04
Age:1.6  Onset:2012-09-05, Days after vaccination: 1
Gender:Unknown  Submitted:2013-01-28, Days after onset: 145
Location:Foreign  Entered:2013-01-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No post-vaccinal reaction occurred in this patient in the past
Diagnostic Lab Data: Not reported
CDC Split Type: 201301008
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)SANOFI PASTEUR20911001C3IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURG958613UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG715812IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Decreased appetite, Decreased eye contact, Hyperhidrosis, Hypotonic-hyporesponsive episode, Injection site pain, Pallor, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: Case received from the Health Authorities through the local affiliate in a foreign country on 16 January 2013 under the reference number N122/2012. A 20-month-old patient (gender not reported), with no reported medical history, had received the third intramuscular dose of IPV vaccine (batch number G7158-1) in the right deltoid concomitantly with the fourth dose of ACT-HIB (batch number G9586-1) in the right thigh and the fourth dose of DTP vaccine (other manufacturer, batch number 20911001C) on the left thigh on 04 September 2012 at 11. No post-vaccinal reaction occurred in the patient in the past. The report stated that the vaccine were stored properly, at 5C and that an aseptic technique was maintained during the vaccination. There was also a correct technique of vaccination. On 05 September 2012, at 9 am, the patient experienced a hypotonic-hyporeactive episode and fever with highest temperature between 38.5 and 38.9 C. The patient also developed pain in the leg at the injection site and decreased appetite. On 06 September 2012 in the morning, the patient was pale, sweaty, very weak, and according to the mother had poor contact without loss of consciousness. The qualification from the Health Authorities was "serious post-vaccinal reaction". The patient was hospitalized for 7 days due to post-vaccinal reaction. The patient''s outcome was not reported. It was also mentioned that, in the opinion of an employee of the agency, the adverse post-vaccination reaction did not occur as a result of non-considering contraindications for the vaccination. No reactions have been reported in other people vaccinated with the same vaccine lot. Documents held by sender: none.

VAERS ID:490964 (history)  Vaccinated:2012-09-04
Age:1.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-06
Location:Foreign  Entered:2013-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305GBR001492
Vaccination
Manufacturer
Lot
Dose
Route
Site
MENHIB: MENINGICOCCAL CONJUGATE + HIB (UNKNOWN)UNKNOWN MANUFACTURERA76CA1768 IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.G016393 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion, Pyelonephritis, Sepsis
SMQs:, Agranulocytosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was received from the health authority in 26-Apr-2013. GB-MHRA-ADR 22088056. This case is medically confirmed as it was reported by a physician. A 1 year old female patient, with no medical history reported, received on 04-Sep-2012 an injection of MMRVAXPRO (batch n. G016393, dose and site of administration not reported) intramuscularly and an injection of Hib and meningococcal group c conjugate (other mfr, batch n. A76ca1768, dose and site of administration not reported) intramuscularly. On an unknown date, the patient experienced febrile convulsion three times, hospitalised subsequently and treated for sepsis for one week. Cause is not clear and currently been assumed to be due to pyelonephritis. The outcome for sepsis was unknown. The patient recovered from febrile convulsion seizure on unknown date. The outcome for pyelonephritis was not reported. The MHRA considered that case serious due to hospitalisation. Upon internal review, the company decided to considered "pyelonephritis" as an adverse event.

VAERS ID:496094 (history)  Vaccinated:2012-09-04
Age:0.2  Onset:2012-09-04, Days after vaccination: 0
Gender:Male  Submitted:2013-07-05, Days after onset: 304
Location:Foreign  Entered:2013-07-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: In the past, no post-vaccinal reactions. He had received his 1st intramuscular dose of EUVAX B, batch number UVA11009 (exp. 04/2014), in the left thigh on an unknown date.
Diagnostic Lab Data: Not reported
CDC Split Type: 201307459
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001D IMLL
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA11009 IMRA
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Decreased appetite, Injection site induration, Injection site mass, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities on 27 June 2013 under the reference number PL-URPL-N1075/2012. A 02-month-old male patient, with no reported medical history, had received his intramuscular dose of ACT-HIB, batch number G9965-1, in the right thigh, concomitantly with his intramuscular dose of EUVAX B (other manufacturer, batch number UVA11009) in the right arm, and his intramuscular dose of DTP vaccine (other manufacturer, batch number 20911001D) in the left thigh, on 04 September 2012, at 11:00. On 04 September 2012, at 16:00, the patient experienced severe injection site reaction (3 x 3 cm) as well as persisted crying. It was also described that the patient developed inconsolable crying, temperature at 36.6 degrees C, right thigh induration at the injection site (3 x 3 cm in diameter) without redness. After receiving his DTP vaccine, the patient did not eat. The patient was not hospitalized. The Health Authorities coded "appetite suppression", "persistent crying", "injection site reaction" and "injection site lump". The patient fully recovered. This case reported by the HAs as a medically significant condition. Reporter''s comment: "In the past there was no post-vaccinal reactions. I EUVAX B dose (date unknown) 0.5 ml, i.m., left thigh, lot UVA11009/ exp 04/2004." Sender''s comment: "Crying is expected after all of the vaccines above. Post-vaccinal reaction occurred at the ACT-HIB injection site it is expected adverse reaction. The time relation indicates causal relationship. Due to persistent crying case was assessed as serious". Documents held by sender: none.

VAERS ID:525172 (history)  Vaccinated:2012-09-04
Age:25.0  Onset:2012-11-06, Days after vaccination: 63
Gender:Female  Submitted:2014-03-06, Days after onset: 485
Location:Foreign  Entered:2014-03-06
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: Creatine phosphokinase, 12Sep2012, 11.6mg/l; Erythrocyte sedimentation rate, 12Sep2012, 24mm/hr; Hepatitis B surface antigen, 06Nov2012, 10 to 50
CDC Split Type: B0949527A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC089BB2SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Blood creatine phosphokinase, Fatigue, Fibromyalgia, Hepatitis B surface antigen positive, Myalgia, Red blood cell sedimentation rate increased, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Liver infections (narrow), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported by a consumer and described the occurrence of acute viral illness in a 27-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B adult (unknown route, injection site). At an unspecified time after vaccination with ENGERIX B adult, the subject experienced an unspecified adverse event. At the time of reporting, the outcome of the event was unspecified. Follow up received on 16 January 2014 from the lawyer: On 15 February 2012, 13 March 2012 and 4 September 2012, the subject received 1st, 2nd and 3rd doses of ENGERIX B adult (left deltoid, unknown route). On 6 November 2012, the subject was tested for hepatitis B surface antigen which was 10 to 50. CPK also was check but results were unspecified. On an unspecified date, the subject experienced muscle pain. At the time of reporting, the muscle pain was improved. Follow up received on 24 February 2014 from the physician: At an unspecified date, shortly after vaccination with 3rd dose of ENGERIX B adult, the subject experienced arthralgia, myalgia and fatigue. The subject also experienced fibromyalgia. The subject visited a rheumatologist, who diagnosed post viral phenomenon due to the vaccine. The subject was diagnosed with acute viral illness, but was unsure whether it was secondary to the vaccine. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:539148 (history)  Vaccinated:2012-09-04
Age:41.0  Onset:2012-09-06, Days after vaccination: 2
Gender:Male  Submitted:2014-08-06, Days after onset: 699
Location:Foreign  Entered:2014-08-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: All other therapeutic products (Con.); Nebivolol (Con.); Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Essential hypertension, 30AUG2007
Diagnostic Lab Data: Anti-aquaprin test performed was negative; The conclusion was a diagnosis of multiple sclerosis; MRI, 23APR2013, probable demyelinating disease
CDC Split Type: 2014SA105011
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER3001975 UNUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG7158 IMUN
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURG0199 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anti-aquaporin-4 antibody negative, Asthenia, Demyelination, Feeling of body temperature change, Multiple sclerosis, Myelitis, Neurological examination normal, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Case was imported from SPMSD under the reference number E2014-06768. Case received from health authority (case n. 262205) on 29-JUL-14. Case initially reported by a physician. Case medically confirmed. A 41 year old male patient, with medical history of essential hypertension since 30-AUG-07, was vaccinated on 04-SEP-12 with an injection of IMOVAX POLIO (batch number G7158-9) i.m., an injection of IMOVAX TETANO (batch number G0199-1) i.m. and with an injection of EPAXAL (batch number 3001975.04) route not reported, doses in series and sites of administration not reported, and on 06-SEP-12, the patient experienced paraesthesia in left extremities with spontaneous regression after 5 or 6 days. It was reported 4 or 5 similar episodes. At Christmas 2012, the patient experienced paraesthesia of left side of face, followed by neurological examination during which he was asymptomatic. In APR-13, the patient traveled where he experienced new episode of paraesthesia in left extremities, subsequent clinical deterioration with extensive paraesthesia also in lower right extremities and extremity and associated tactile, pain and temperature sensitivity of left extremities and loss of strength, perineal region. On 23-APR-13, MRI performed suggested demyelinating disease. The patient was admitted to hospital, took a cycle of steroid therapy with clinical improvement. He was discharged with the diagnosis of myelitis in probable demyelinating disease. After 9 days, the patient was readmitted for worsening of symptoms, concomitantly with worsening of brain resonance. A new cycle of intravenous steroid was performed with partial subjective improvement. At the time of reporting, the patient still experienced paraesthesia of upper left and lower right extremities fluctuating with slight loss of strength. Anti-aquaporin test performed was negative. The conclusion was a diagnosis of multiple sclerosis. The patient received concomitant treatment with FRAGOR 30 mg + 10 mg tablet 1 dosage form orally and NEBIVOLOL ACTAVIS 5 mg tablet 5 mg orally for hypertension. At the time of reporting, the patient had not recovered. The case was considered serious due to the patient''s hospitalization and disability. Upon medical review, the company judged relevant to add the adverse event multiple sclerosis; which was the diagnosis of the reaction and not coded by HA. The case is closed.

VAERS ID:464094 (history)  Vaccinated:2012-09-05
Age:20.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-05, Days after onset: 0
Location:Pennsylvania  Entered:2012-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B094BA UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: After vaccine, pt became "a little lightheaded". Pt. was given TDAP (BOOSTRIX) pt asked to remain seated for approx 10-15 min. Dr came in to evaluate pt. before leaving. Sxs lasted approx 15 min.

VAERS ID:464149 (history)  Vaccinated:2012-09-05
Age:34.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 0
Location:Massachusetts  Entered:2012-09-05
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4383AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, Swelling, warm area

VAERS ID:464153 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 0
Location:Florida  Entered:2012-09-05
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: Alopecia arreata
Diagnostic Lab Data: None. Will call the patient later.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11078 IMLA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient was given shot and was walking out the door when four marks showed up on her skin. They look a little like insect bites but they where not there before the shot. We had the patient come back into the exam room and listened for wheezing. As I sat and watched her 4 more hive broke out. No redness around the inject site or hives, but two hives broke out on her side and then two more on her chest. We set a timer and keep reassess her. No more hive broke out and 25 minutes after the shot her lung were clear and no addition rash. I gave 5mg of Claritin at about 10 minutes after the shot.

VAERS ID:464158 (history)  Vaccinated:2012-09-05
Age:31.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 0
Location:Unknown  Entered:2012-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO ILLNESS WAS REPORTED AT TIME OF VACCINATION
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3100IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG154110IDLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: OVER THE COURSE OF TEN MINUTES FOLLOWING VACCINATION, PATIENT STATED SHE WAS FEELING LIGHTHEADED, BEGAN TO SWEAT PROFUSELY AND NEARLY FELL UNCONSCIOUS.

VAERS ID:464175 (history)  Vaccinated:2012-09-05
Age:50.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-06, Days after onset: 1
Location:Texas  Entered:2012-09-06
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: Benadryl was taken to relieve symptoms
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dyspnoea, Eyelid oedema, Flushing, Hyperhidrosis, Lymph node pain, Lymphadenopathy, Pyrexia, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.

VAERS ID:464228 (history)  Vaccinated:2012-09-05
Age:52.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:Texas  Entered:2012-09-06
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH730AB IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Dysphagia, Feeling abnormal, Influenza like illness, Nausea, Oropharyngeal pain, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: By 1700 "feels really bad" c/o sore throat, difficulty swallowing, flu like symptoms, body aches, chills and nausea. Taken to ED and given Epinephrine sq, benadry and ibuprofen.

VAERS ID:464230 (history)  Vaccinated:2012-09-05
Age:1.3  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:Michigan  Entered:2012-09-06
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4127AA IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4481BA IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB605CA IMRL
Administered by: Public     Purchased by: Public
Symptoms: Rash generalised, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Rash all over lower body, swelling tongue.

VAERS ID:464235 (history)  Vaccinated:2012-09-05
Age:1.6  Onset:0000-00-00
Gender:Female  Submitted:2012-09-06
Location:Idaho  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B138AA3IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4481CD2IMRL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0628AA0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: 0.5ml of influenza vaccine given instead of 0.25ml.

VAERS ID:464257 (history)  Vaccinated:2012-09-05
Age:7.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-06, Days after onset: 0
Location:Illinois  Entered:2012-09-06
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: Allergic rhinitis suspected
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21400IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Malaise
SMQs:
Write-up: Mother called to state child is very sick after flu vaccine and was called from school.

VAERS ID:464264 (history)  Vaccinated:2012-09-05
Age:56.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:Pennsylvania  Entered:2012-09-06
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: Fibromyalgia; Osteoarthritis; Reactive airway disease
Diagnostic Lab Data: None as of yet
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Axillary pain, Fatigue, Injection site pain, Lymph node pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Unusual fatigue; went to bed early. Woke up next morning, my entire R armpit was painfully sore. I took 2 Arthritis Strength Tylenol around 6:00 AM, some relief, but by 10:30 AM, it was painful again. Entire site of injection painful and in glands under armpit, it is 2:30 PM.

VAERS ID:464272 (history)  Vaccinated:2012-09-05
Age:20.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-06
Location:Missouri  Entered:2012-09-06
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4464AA0IDLA
Administered by: Other     Purchased by: Other
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient returned to pharmacy 24 hours after injection. She woke up the morning after and noticed she had a rash on her arms, legs and chest. I intstructed her to take Benadryl and contact her primary care doctor. She was not having any trouble breathing, just was itching due to rash.

VAERS ID:464277 (history)  Vaccinated:2012-09-05
Age:14.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-06, Days after onset: 0
Location:Washington  Entered:2012-09-06
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: Asperger''s; Obesity; Anxiety
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling and itchiness at site. Swollen area is 2 cm x 3 cm.

VAERS ID:464361 (history)  Vaccinated:2012-09-05
Age:12.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-06, Days after onset: 0
Location:North Carolina  Entered:2012-09-06
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE1SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4292AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0570AE1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Skin lesion
SMQs:
Write-up: Pt came in this am with a 3 cm lesion on (L) upper arm round in shape red in color, arrangement isolated and localized distribution, status is stable, pt had varicella # 2 in (L) upper arm yesterday reaction to site per Dr.

VAERS ID:464364 (history)  Vaccinated:2012-09-05
Age:5.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Maine  Entered:2012-09-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4127AA4IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt received DTaP at about 9:15 am on 9/5/12 & later the same afternoon developed hives on lower back, buttocks & behind one knee - mom gave BENADRYL & called office 9/16 to report.

VAERS ID:464486 (history)  Vaccinated:2012-09-05
Age:39.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-06, Days after onset: 1
Location:New York  Entered:2012-09-06
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: OCP; Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4464AA IDRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4247AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Injection site induration, Nausea, Nuchal rigidity, Photophobia, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: High fever, nuchal rigidity, injection site induration, nausea, severe headaches, photophobia.

VAERS ID:464344 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-07, Days after onset: 1
Location:California  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNRA
Administered by: Public     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: Redness and swelling of the entire upper arm where the DTaP was given.

VAERS ID:464355 (history)  Vaccinated:2012-09-05
Age:39.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:New York  Entered:2012-09-07
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; Only allergy is to Pollen
Diagnostic Lab Data: CBC;MP; Blood cultures done in ER
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0446AA SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU444384AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Blood culture, Body temperature increased, Dizziness, Full blood count, Headache, Lymphadenopathy, Metabolic function test, Myalgia, Nausea, Oropharyngeal pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: Temp 102.8 F, nausea, vomiting, severe headache, dizziness, weakness, myalgias, sore throat with swollen glands.

VAERS ID:464402 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:Louisiana  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1305 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria. Benadryl PO, Methylprednisone IM.

VAERS ID:464405 (history)  Vaccinated:2012-09-05
Age:61.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Ohio  Entered:2012-09-07
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Contusion, Erythema, Feeling hot, Mass, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: A lump, bruising, warmth, itching, swelling, redness. Treatment includes Diphenhydramine HCL (25mg) and 1% hydrocortisone ointment.

VAERS ID:464474 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Connecticut  Entered:2012-09-07
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; NKFA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4718AA IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1354 IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Got DAPTACEL (L) deltoid 9/5/12, came to office 9/7 c/o itching that started on 9/6/12. Parent tried OTC hydrocortisone & BENADRYL creams to relieve itching.

VAERS ID:464476 (history)  Vaccinated:2012-09-05
Age:15.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Guam  Entered:2012-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinusitis w/ acute bronchitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AA0UNRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522BA0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4022AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0073281SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt felt swelling, stinging pain, redness & warm sensation on (L) arm 9/6/12 at school around 9 AM. "Swelling & redness got bigger 9/7/12" as per pt. Measured firm swelling 2 x 2 inches as of 9/07/12 4:00 PM. Advised to apply warm compress, TYLENOL for fever & to watch for blisters. Advised to go clinic 9/8/12 if worsens.

VAERS ID:464493 (history)  Vaccinated:2012-09-05
Age:16.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-06, Days after onset: 1
Location:Texas  Entered:2012-09-07, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4261AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3922AA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Apnoea, Bradycardia, Endotracheal intubation, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient "collapsed" in grocery store; CPR initiated, ambulance called & was intubated. MD available - noted pt. to be apneic & bradycardic but responded to epinephrine. Transported to hospital & discharged home next day.

VAERS ID:464511 (history)  Vaccinated:2012-09-05
Age:69.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-09-07, Days after onset: 0
Location:Texas  Entered:2012-09-07
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: Lipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4492BA3IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0491AE0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Local swelling, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Local redness and swelling. Warm to touch. No tx.

VAERS ID:464513 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-07, Days after onset: 2
Location:Missouri  Entered:2012-09-07
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: Tetanus; Cod; PCN; Hydrocodone; BENADRYL; Latex; Tape; Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA727AB IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0709AE1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling left upper arm but minimal in the shoulder.

VAERS ID:464648 (history)  Vaccinated:2012-09-05
Age:1.9  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-07, Days after onset: 1
Location:Hawaii  Entered:2012-09-07
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4048AA2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451372IMLL
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Mother reported "Hives" 24 hours after vaccine administration - "Hives" on neck - chest - back. Denies fever, resp. distress. Mother gave child oatmeal baths. Mom reports hives dissipated after 6 hours.

VAERS ID:464649 (history)  Vaccinated:2012-09-05
Age:63.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-06, Days after onset: 0
Location:Oregon  Entered:2012-09-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA689AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site exfoliation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness & swelling at injection site. Mild peeling of skin (superficial) where swelling is most prominent. Warm compress to site.

VAERS ID:464652 (history)  Vaccinated:2012-09-05
Age:9.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:Kansas  Entered:2012-09-07
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0074511SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injection site rash, Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Arm became red, swollen, rash at injection site the afternoon after receiving vaccine in AM. Was painful/itchy. Took BENADRYL.

VAERS ID:464418 (history)  Vaccinated:2012-09-05
Age:71.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-08, Days after onset: 2
Location:Colorado  Entered:2012-09-08
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: Rheumatoid arthritis; Heart disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0087AE IMRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash at injection site. Rash slowly spread over the day.

VAERS ID:464701 (history)  Vaccinated:2012-09-05
Age:57.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-07, Days after onset: 0
Location:Colorado  Entered:2012-09-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0563AE0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Local swelling, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen area, redness, itching slightly painful.

VAERS ID:464555 (history)  Vaccinated:2012-09-05
Age:30.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-10, Days after onset: 5
Location:Delaware  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU4383AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0217AE0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Dizziness, Headache, Injection site pain, Insomnia, Local swelling, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Severe headache, dizziness. Fever, nausea and localized swelling. Pain at injection site that kept her awake and precluded any activity for 5 days.

VAERS ID:464556 (history)  Vaccinated:2012-09-05
Age:49.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-10, Days after onset: 4
Location:Michigan  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0225AE0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Fatigue, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Temp 101-104, temple. Achy, tired, arm swollen.

VAERS ID:464562 (history)  Vaccinated:2012-09-05
Age:67.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-10, Days after onset: 5
Location:Pennsylvania  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Patient had shivers and body was shaking. No known fever. Last about an 1/2 hour.

VAERS ID:464576 (history)  Vaccinated:2012-09-05
Age:2.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-10, Days after onset: 3
Location:California  Entered:2012-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: RASH LEFT LEG 3 DAYS
Preexisting Conditions: NONE KNOWN
Diagnostic Lab Data: MRI since-tranverse myelitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4482BA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dysstasia, Mobility decreased, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
SMQs:, Parkinson-like events (broad), Guillain-Barre syndrome (broad), Demyelination (narrow)
Write-up: Unable to stand /use leg.

VAERS ID:468154 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-10, Days after onset: 5
Location:Unknown  Entered:2012-09-10
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: WAES1209USA002304
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0933Z IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated with a 0.5 ml dose of PNEUMOVAX23 (lot # 667912/0933Z expiration date 25-FEB-2012) IM on 05-SEP-2012. No adverse effects were reported. Additional information has been requested.

VAERS ID:464790 (history)  Vaccinated:2012-09-05
Age:24.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Virginia  Entered:2012-09-11, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204901 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Patient experienced pain around inj site 9.5.12 around 5 pm 09.06.12 patient experienced shooting pain from injection site, thru elbow to wrist and last 2 fingers of left hand. Fingers are numb.

VAERS ID:464873 (history)  Vaccinated:2012-09-05
Age:47.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-10, Days after onset: 4
Location:Florida  Entered:2012-09-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hay fever
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AB0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: On Thursday (1 day after vaccine was administered) pt. developed a red area near injection site 2-3" dia. and itches. It resolves as for Saturday but still itches. Pt took ALLERGR. She states no allergies to latex or other ingredient.

VAERS ID:464874 (history)  Vaccinated:2012-09-05
Age:76.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-11, Days after onset: 4
Location:Kansas  Entered:2012-09-11
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: ENTEX; BIAXIN; Sulfa; KEFLEX; DARVOCET; Tramadol; Amoxicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1258AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Tenderness, redness, warmth around the site. Ibuprofen instructed to apply ice to the area; take as needed.

VAERS ID:464909 (history)  Vaccinated:2012-09-05
Age:67.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-11, Days after onset: 6
Location:Missouri  Entered:2012-09-11
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR04490AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Burning sensation, Chills, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Chills, NV, sore arms, burning sensation w/pneumonia shot, IV fluids.

VAERS ID:464911 (history)  Vaccinated:2012-09-05
Age:52.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-11, Days after onset: 6
Location:Missouri  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4490AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.947AA UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Abasia, Aphagia, Arthralgia, Burning sensation, Chills, Diarrhoea, Diplopia, Nausea, Pyrexia, Throat irritation, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Fever (high), chills, couldn''t walk, couldn''t eat, vomiting, nausea. Gave IV fluids, & anti nausea meds, joint pain, double vision throat burning. Pneumonia shot left burning sensation, diarrhea.

VAERS ID:464916 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-11, Days after onset: 6
Location:Missouri  Entered:2012-09-11
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4490AA0UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Chills, Injection site pain, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: Chills, muscle aches, nausea, sick to stomach site soreness, pt said never vomited.

VAERS ID:464918 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-10, Days after onset: 4
Location:Virginia  Entered:2012-09-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: H/O RAD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4035AA4UNRA
Administered by: Private     Purchased by: Private
Symptoms: Cough
SMQs:, Anaphylactic reaction (broad)
Write-up: Per mom, child coughed at night, nonstop sounded like a "whoop" when taking a breath.

VAERS ID:464920 (history)  Vaccinated:2012-09-05
Age:1.4  Onset:2012-09-09, Days after vaccination: 4
Gender:Male  Submitted:2012-09-11, Days after onset: 2
Location:Georgia  Entered:2012-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: "had a cold" (per Grandmother)
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB513AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0184AE0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0073280SCLA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Received MMR, VZV, HAP 9/5/2012. Grandmom states "ran fever on the 9th and started breaking out on 10th that morning". Grandmom states "put aloe vera on it".

VAERS ID:464925 (history)  Vaccinated:2012-09-05
Age:69.0  Onset:2012-09-08, Days after vaccination: 3
Gender:Female  Submitted:2012-09-11, Days after onset: 3
Location:Illinois  Entered:2012-09-11
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Chest pain, Computerised tomogram normal, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Patient called paramedics because she was experiencing shortness of breath. She also felt pain in the chest and could not lie down on it. After a full cardiac work-up (EKG, CT scan, echo) her heart is fine.

VAERS ID:468162 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 6
Location:Unknown  Entered:2012-09-11
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: WAES1209USA002321
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1332Y IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a register nurse concerning a female patient of unknown age who on 05-SEP-2012 was vaccinated with an 0.5 ml., intramuscular dose of GARDASIL that had expired on 25-JUN-2012, lot number 665607/1332Y. No adverse events were reported. Additional information has been requested.

VAERS ID:464852 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-12, Days after onset: 7
Location:Pennsylvania  Entered:2012-09-12
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: Reported allergies to antihistamines, dye''s, and decongestants and injection site reaction to previous H1N1 flu shot
Diagnostic Lab Data: Patient was prescribed medrol dose pak.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0598AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient presented with mild injection site reaction 10 minutes after receiving zoster vaccine. Patient returned 48 hours after injection to show me reaction had progressed and area was red, hot, and raised around injection oval shape about the size of a silver dollar. She was experiencing pain that started 48 hours after the injection. She described severe pain from shoulder to finger tips and said it interferred with regular activities.

VAERS ID:464860 (history)  Vaccinated:2012-09-05
Age:57.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-12, Days after onset: 6
Location:California  Entered:2012-09-12
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS122204 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Contusion, Feeling abnormal, Local reaction, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This was a localized reaction with swelling down the left arm and bruising. She also felt very poorly on 9/06 and 9/07. She also felt weak. She went to see her MD, 9/7/12, who felt that she should be of work until he cleared her to return. She missed work 9/10 and 9/11 and was cleared to returen 9/12/12. MD advised pt. to not take flu shot next year.

VAERS ID:464886 (history)  Vaccinated:2012-09-05
Age:49.0  Onset:2012-09-09, Days after vaccination: 4
Gender:Female  Submitted:2012-09-12, Days after onset: 3
Location:Texas  Entered:2012-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA730AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Headache, Pain, Respiratory tract congestion
SMQs:
Write-up: Headache, congestion, body aches, fatigue

VAERS ID:464898 (history)  Vaccinated:2012-09-05
Age:0.5  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-12, Days after onset: 6
Location:Utah  Entered:2012-09-12
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound showed intussusception
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4267AA2IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0386AE2IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451352IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0206AE2PO 
Administered by: Private     Purchased by: Private
Symptoms: Intestinal resection, Intussusception, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Developed vomiting one day after receiving immunizations & was diagnosed with intussusception 2 days later. He required surgery & 5 inches of bowel was resected.

VAERS ID:464941 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-12, Days after onset: 7
Location:New Mexico  Entered:2012-09-12
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 UNRA
Administered by: Unknown     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: Patient received a PNEUMOVAX-23 vaccination on 9/5/12 around 5:40 pm - injection site was sore that evening - the next morning site was painful, swollen and red, warm patient was advised to go to ER - patient got antibiotic from ER.

VAERS ID:464948 (history)  Vaccinated:2012-09-05
Age:54.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-12, Days after onset: 7
Location:Minnesota  Entered:2012-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinus infection
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  IDRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMRA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Induration, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Large red welt (hard/quarter-sized), very hot; now itchy & still a red spot 7 days later (now penny sized).

VAERS ID:464950 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-12, Days after onset: 6
Location:Alaska  Entered:2012-09-12
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: Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B138AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13050SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1760AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1381AA1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Given DTAP on 9/5, next day redness at site of injection. Increased redness next day 3x4 cm, then larger next day 8x13 cm started on KEFLEX on 9/7, since worse next day taken to urgent care. Told to cont. KEFLEX, use ibuprofen & benadryl. Less red by 9/10. Pt never had fever, pain, still very ache.

VAERS ID:464971 (history)  Vaccinated:2012-09-05
Age:25.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 8
Location:Massachusetts  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses
Preexisting Conditions: NKFA; NKDA; Minor reaction to IV magnesium; Chronic daily migraine; Major depressive disorder; Fibromyalgia; Chronic fatigue syndrome
Diagnostic Lab Data: Just visual signs and touch
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AD IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received two shots in R deltoid, believe this is a reaction to flu, not pneumonia based on swelling sites (could be wrong). Day 1: pain increased from dull ache of average shots (two given in same arm) to persistent pain in R upper arm around shot site. Day 2-3: extreme pain in upper arm, thought it was an abnormal sensation with the fibromyalgia, reacting to nerve being hit, bad enough I required narcotics to move my arm at all (Percocet prescribed at 36 hrs after trying previously-prescribed Vicodin), not majorly swollen, did radiate some heat. Day 4: progressed to swollen and red, radiating heat, entire upper arm, not just deltoid muscle, even drew lines around it like cellulitis, no noticeable fever, very painful. Day 5-7: swelling lasted at least two full days before fading very slowly, shrinking in size and color before pain. Day 8: upper arm still tender to the touch but returned to normal, 3 cm lump under flu shot site, minor <1 cm bump at pneumonia shot site, some pain when using the arm, not sure if that''s the reaction or just lack of proper use for a week.

VAERS ID:465024 (history)  Vaccinated:2012-09-05
Age:72.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:New York  Entered:2012-09-13, 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: No acute illness
Preexisting Conditions: Allergic PCN; Sulfa; H/O diabetes; HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness and pain at site beginning evening after vaccine given and spreading to encompass anterior aspect of upper arm.

VAERS ID:465025 (history)  Vaccinated:2012-09-05
Age:14.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-05, Days after onset: 0
Location:Kentucky  Entered:2012-09-13, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0555AE0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: * Syncope episode 10 minutes after inj. * Provided O2 at 8L - x 10 -15 minutes - had pt lay flat. * Continued to complain of headache x 1 hour.

VAERS ID:465026 (history)  Vaccinated:2012-09-05
Age:1.9  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-13, Days after onset: 7
Location:Illinois  Entered:2012-09-13
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: Stool c/s, O & P
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0008AE0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0612AE0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Culture stool, Diarrhoea, Dysphemia, Parasite stool test, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 1) Diarrhea onset 9/6/12. 2) Fever onset 9/6/12. 3) Stuttering onset 9/10/12.

VAERS ID:469026 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-13, Days after onset: 8
Location:Unknown  Entered:2012-09-13
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: WAES1209USA002856
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0907Z SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant concerning a patient of unknown age and gender who on 05-SEP-2012 was vaccinated with subcutaneously with an expired dose of M-M-R II, lot number 67246/0907, expired date 09-JUL-2012. No adverse events were reported. Additional information has been requested.

VAERS ID:465193 (history)  Vaccinated:2012-09-05
Age:1.1  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Maine  Entered:2012-09-14, 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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9182423UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0610AE0SCRL
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Leg red, swelling, Temp 101.9 axillary.

VAERS ID:465238 (history)  Vaccinated:2012-09-05
Age:15.0  Onset:2012-09-09, Days after vaccination: 4
Gender:Male  Submitted:2012-09-14, Days after onset: 5
Location:Massachusetts  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1218AA0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Rash erythematous, Tracheal ulcer, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Erythematous hive rash over palms of hands, viral ulcerative lesion (R) pharynx.

VAERS ID:467895 (history)  Vaccinated:2012-09-05
Age:74.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 9
Location:Unknown  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity DONATAL; OMNICEF; LEVAQUIN; NEURONTIN; Sulfa; SPARIVA; ASMANEX
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005619
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Mobility decreased, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Hypersensitivity (broad)
Write-up: This spontaneous report was received from a 74 year old female patient concerning herself. The patient s concurrent condition included allergies (unspecified) and drug allergies to penicillin, atropine sulfate, Hyoscyamine sulfate, Phenobarbital, DONNATAL, OMNICEF, LEVAQUIN, NEURONTIN, SULFA, SPRIVA and ASMANEX. On 05-SEP-2012 the patient was vaccinated with PNEUMOVAX 23 IM (injection site not mentioned). On the same day the patient also received AFLURIA (injection site not mentioned). Concomitant medications included omeprazole, estrogens (unspecified) and terbinafine. On 05-SEP-2012, after getting PNEUMOVAX 23 and AFLURIA. The patient experienced extreme pain and itching in her arm and she could not moved her arm. Her whole arm down to the elbow turned red. The patient sought medical attention by phone call and office visit. No lab test performed. She received treatment with ice packs and BENADRYL and prednisone. At the time of reporting, the patient was recovering from the events. Additional information has been requested.

VAERS ID:469172 (history)  Vaccinated:2012-09-05
Age:49.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 9
Location:Unknown  Entered:2012-09-14
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: WAES1209USA002887
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AB IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC53B08AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 05-SEP-2012, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX23 (lot number 669579/0595AA) that was expired. The vaccine expired on 30-AUG-2012. The patient was not experiencing any known symptoms. Additional information has been requested.

VAERS ID:469176 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-14, Days after onset: 9
Location:Unknown  Entered:2012-09-14
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: WAES1209USA002972
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Syringe issue
SMQs:
Write-up: This spontaneous report as received from a pharmacy student refers to a patient of unknown age. The pharmacy student reported the patient was inadvertently administered a 0.3 ml dose of PNEUMOVAX 23 (IM) (lot # was unknown) on 05-SEP-2012 due to leakage between the needle hub and the syringe. No adverse effects reported. Additional information is not expected.

VAERS ID:465150 (history)  Vaccinated:2012-09-05
Age:21.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-16, Days after onset: 10
Location:South Carolina  Entered:2012-09-16
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: Didn''t have the patients corredt date of birth.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMUN
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen and red from the elbow to the bicep.

VAERS ID:469171 (history)  Vaccinated:2012-09-05
Age:68.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Female  Submitted:2012-09-16, Days after onset: 6
Location:Massachusetts  Entered:2012-09-16
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: Prophylaxis; Rosacea; Hypercholesterolaemia
Preexisting Conditions: Herpes zoster
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005158
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0493AE0IMLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Oedema peripheral, Rash macular
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a healthcare worker (C.M.A.) refers to a 68 years old female patient with hypercholesterolemia and rosacea. The patient''s medical history included shingles. The patient had "no known allergies" to drug. On 07-SEP-2012 the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot # not reported) intramuscularly into the left deltoid. It was reported that the patient also received a dose of TDAP into the right arm during the same visit. On 10-SEP-2012 the patient sought for medical attention by calling the practice to report that she was experiencing redness, blotchiness, and pain at the PNEUMOVAX23 injection site, and a swollen left hand. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.

VAERS ID:465260 (history)  Vaccinated:2012-09-05
Age:33.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-17
Location:North Carolina  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG1541 IMLA
Administered by: Military     Purchased by: Military
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Provider drew 0.1cc of Typhoid instead of the PPD vaccination. The Typhoid was then administered to the Left Forearm of the patient where the PPD should have been placed. Pt had no reaction to the vaccination that was placed.

VAERS ID:465272 (history)  Vaccinated:2012-09-05
Age:61.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 12
Location:New York  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to Sulfur; Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH713AB IMRA
Administered by: Public     Purchased by: Private
Symptoms: Diarrhoea, Headache, Pain, Sensation of pressure, Sneezing
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Patient who is allergic to sulfur received flu vaccine on 9/05/2012. Patient states that at 10:30 PM sneezing, awoke at 3:30 AM with horrible headache at the top of head. Felt pressure, spasm like pain. Patient took Claritin at 5:00 AM. Went back to sleep, got up at 10:30 AM still had a headache. Took a Bentyl. Had diarrhea X 1 at 2:00 PM (odor of sulfur).

VAERS ID:465274 (history)  Vaccinated:2012-09-05
Age:16.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-17, Days after onset: 10
Location:Virginia  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ADHD; Anxiety/Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0101231IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4397AD1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Vaccination site cellulitis, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:
Write-up: Cellulitis at vaccination site 7cm x 9cm, warm, tender indurated swollen area. Treated with Keflex 500, 2 PO BID x10 days.

VAERS ID:465281 (history)  Vaccinated:2012-09-05
Age:13.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 12
Location:Maryland  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB550CA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0459AE0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4262AC0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0074511SCRA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope and fainting for a few seconds, recovered quickly and was ambulatory upon discharge from clinic.

VAERS ID:465282 (history)  Vaccinated:2012-09-05
Age:14.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 12
Location:Maryland  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H007451 SCLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Long recovery to feet post vaccination. Symptoms consists of nausea, sweating, and lightheadedness. Ambulatory upon leaving clinic after recovering in office.

VAERS ID:465342 (history)  Vaccinated:2012-09-05
Age:34.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-11, Days after onset: 6
Location:Michigan  Entered:2012-09-17, 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: Asthma; ax to ROCEPHIN
Diagnostic Lab Data: See attached ER reports
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH711AA SYRRA
Administered by: Other     Purchased by: Private
Symptoms: Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Wheezing approximately 2 hours after injection of FLUZONE.

VAERS ID:465379 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:New York  Entered:2012-09-17, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4186AA3IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13543IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0681AE1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0309AE1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site warmth, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vaccines given 9/5/12. Parent noted local reaction (L) arm site of DTaP and VARIVAX approximately 50mm soft, & tender, warm.

VAERS ID:465380 (history)  Vaccinated:2012-09-05
Age:1.4  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-07, Days after onset: 0
Location:New York  Entered:2012-09-17, 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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B154BA IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH574AA IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1064AA SCRL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Red welts noted on arms & upper torso - reported via telephone by mother.

VAERS ID:468424 (history)  Vaccinated:2012-09-05
Age:15.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 12
Location:Unknown  Entered:2012-09-17
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: WAES1209USA002658
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA1IMLA
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 certified medical assistant refers to a male patient of unknown age who on 12-AUG-2011, was vaccinated with the first dose of GARDASIL (route and lot# not reported). On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (route and lot# not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.

VAERS ID:469320 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Female  Submitted:2012-09-17, Days after onset: 7
Location:Unknown  Entered:2012-09-17
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: Drug hypersensitivity
Preexisting Conditions: Codeine, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA004146
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a Doctor of pharmacy refers to a 65 years old female patient with codeine allergy and no pertinent medical history. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (Lot # not reported) IM on 05-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 10-SEP-2012, the patient experienced redness, swelling and warmth at the injection site, and was having difficulty moving her arm. The patient was recommended to take ADVIL and TYLENOL. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.

VAERS ID:469336 (history)  Vaccinated:2012-09-05
Age:60.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Unknown  Submitted:2012-09-17, Days after onset: 11
Location:Texas  Entered:2012-09-17
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: WAES1209USA003640
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0422AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report was received from a registered pharmacist refers to a 60 years old patient with no pertinent medical history and no drug reactions or allergies, who on 05-SEP-2012, was vaccinated "possibly intramuscularly" with one 0.65 ml dose of ZOSTAVAX (lot number 0422AE, Exp. Date: 27-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. On 06-SEP-2012, the patient developed bruising and redness at injection site area after possible intramuscular administration of ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for patient developed bruising and redness at injection was unknown for ZOSTAVAX. Additional information is not expected.

VAERS ID:469338 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 11
Location:Texas  Entered:2012-09-17
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: WAES1209USA003539
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Oral pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) last Wednesday (on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that a couple of days after she had gotten the vaccine she felt that the left side of her mouth inside and out was hurting. The patient also felt that her jaw was swollen. No rash was reported. The patient sought medical attention by talking to the pharmacist. No treatment information was reported. The outcome of left side of her mouth inside and out was hurting and felt that her jaw was swollen was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.

VAERS ID:465398 (history)  Vaccinated:2012-09-05
Age:20.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 13
Location:California  Entered:2012-09-18
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: WAES1209USA004974
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE2IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This spontaneous report as received from a physician refers to a 20 years old female patient. On 12-OCT-2007 the patient was vaccinated with dose 1 GARDASIL (Dose not reported) (Lot # 01714 Exp 29-JUN-2009) (IM). On 12-DEC-2007 the patient was vaccinated with dose 2 GARDASIL (Dose not reported) (Lot # 12674 Exp 18-JUL-2010) (IM). On 05-SEP-2012 the patient was vaccinated with dose 3 GARDASIL (Dose not reported) (Lot # 0101AE Exp 10-OCT-2014) (IM). Concomitant medications included: MENACTRA. The physician stated that a patient began having seizures around the time of her first doses of GARDASIL, the reporter was unsure if this seizure activity occurred in 2007 or at a later time. The patient suffered from a grand mal seizure after receiving her last dose of the product. The patient sought unspecified medical attention. At the time of the report, the patient was under the care of a neurologist. The patient was put on treatment with anti seizure medication (unspecified). At the time of the report the patient was recovering from seizure. Additional information has been requested. Upon internal review seizures and Grand mal seizure were considered medically significant.

VAERS ID:465411 (history)  Vaccinated:2012-09-05
Age:59.0  Onset:2012-09-08, Days after vaccination: 3
Gender:Male  Submitted:2012-09-18, Days after onset: 10
Location:Texas  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: Chronic back pain; HTN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH713AA IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injected limb mobility decreased, Injection site joint pain
SMQs:, Arthritis (broad)
Write-up: Left shoulder joint pain/soreness (same arm as where vaccine was given). Pain worsened over 10d period. Pain limited range of motion. No neurological deficits. No treatment initially, then when patient presented at day 10 recommended rest, ice, NSAIDs prn.

VAERS ID:465485 (history)  Vaccinated:2012-09-05
Age:1.1  Onset:2012-09-13, Days after vaccination: 8
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:California  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None. I don''t know name of manufacturer that the Clinic uses.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Took into Pediatrician to figure out what was going on. Dr. said she is in the small percentage of patients that receive MMR shot that develop this reaction.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRL
Administered by: Public     Purchased by: Other
Symptoms: Measles, Pyrexia, Rash erythematous, Rash generalised, Rhinorrhoea, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 8 days after MMR/Pox shot patient developed high fever, runny nose. Fever broke, but she has had 5 days now red bump rash all over body with Kopliks in throat.

VAERS ID:465502 (history)  Vaccinated:2012-09-05
Age:23.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 13
Location:Unknown  Entered:2012-09-18
Life Threatening? Yes
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: Blood pressure, Decreased, drop; 09/05/2012, Blood pressure, Decreased, drop
CDC Split Type: WAES1209USA005438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blood pressure decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: This spontaneous report as received from a licensed practical nurse refers to a 23 years old female patient. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on an unspecified date and was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot # not provided) last week (approximately on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient experienced reactions after both her 1st shot and 2nd shot of GARDASIL. After the first dose, the patient experienced a drop in blood pressure and fainted. She was weak and had slurred speech. She recovered in 30 minutes. The patient received the second dose and again experienced a drop in blood pressure and felt weak last week (approximately on 05-SEP-2012). The patient was seen in an urgent care office. No treatment was given for the events. The vaccine series was discontinued. It was reported that drop in blood pressure and felt weak was (after second dose) had improved after therapy was stopped. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.

VAERS ID:465524 (history)  Vaccinated:2012-09-05
Age:32.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-07, Days after onset: 2
Location:Utah  Entered:2012-09-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH715AA7IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Influenza, Pain
SMQs:
Write-up: Normal tightness and mild soreness by next morning. Friday (9-7-12) showed signs and symptoms of nerve damage? pain worsened. Recovered using hot compresses and menthol ointment, mild flu symptoms.

VAERS ID:465548 (history)  Vaccinated:2012-09-05
Age:42.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-07
Location:New York  Entered:2012-09-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHAVC064AD2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797AA1SCRA
Administered by: Private     Purchased by: Other
Symptoms: Vaccination site erythema
SMQs:
Write-up: Developed local erythema at vaccine site approximately 7 x 4 cm. Advised ice/TYLENOL.

VAERS ID:469534 (history)  Vaccinated:2012-09-05
Age:71.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-18, Days after onset: 12
Location:Unknown  Entered:2012-09-18
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: WAES1209USA002926
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a healthcare worker refers to a 71 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route not reported) in 2006; and the patient was vaccinated with another dose of PNEUMOVAX 23 (lot #, dose and route not reported) on 05-SEP-2012). No other co-suspects were reported. There were no concomitant medications. The healthcare worker reported that a patient received the vaccination and then developed an injection site reaction that involved the arm. The patient called the office on 06-SEP-2012 reporting that the arm where the vaccination was administered was red, swollen and warm to the touch from the shoulder to the elbow. The exact time frame from vaccination to development of the injection site reaction that involved the arm was unspecified. The events were treated with ADVIL and cold compress. No lab diagnostic tests were performed. This is one of several reports from the same source. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested,.

VAERS ID:469538 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-10, Days after vaccination: 5
Gender:Male  Submitted:2012-09-18, Days after onset: 8
Location:Illinois  Entered:2012-09-18
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: WAES1209USA006802
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dysphemia
SMQs:
Write-up: This spontaneous report was received from a patient''s mother reporting to her son of unknown age who on 05-SEP-2012, was vaccinated with a dose of MMR II (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The patient''s mother reported that five days later, on approximately 10-SEP-2012, her son began to stutter. No treatment information was reported. At the time of the report, the patient had not recovered. It was unspecified if the patient sought medical attention. The relatedness for stuttering was unknown for MMR II. Additional information is not expected.

VAERS ID:469563 (history)  Vaccinated:2012-09-05
Age:70.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 13
Location:Unknown  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Osteopenia; Blood cholesterol increased
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA003318
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0491AE IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Hyperhidrosis, 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: This spontaneous report as received from a medical assistant refers to a 70 years old female patient with high cholesterol and osteopenia. The patient had no drug allergy. On 05-SEP-2012, the patient was vaccinated with PNEUMOVAX23 by intramuscularly (lot # 0491AE, expired date: 15-SEP-2013). No other co-suspects were reported. Concomitant medications included calcium with vitamin D (unspecified), aspirin and metronidazole lotion. On 05-SEP-2012 "later that day", the patient experienced fever, sweats, chills, and also swelling at the site of injection. The physician prescribed ibuprofen and TYLENOL for the events. At time of the report, the patient''s outcome is recovering. A lot check was requested. The patient sought medical attention by phone to the physician''s office. Additional information has been requested.

VAERS ID:465604 (history)  Vaccinated:2012-09-05
Age:29.0  Onset:2012-09-08, Days after vaccination: 3
Gender:Female  Submitted:2012-09-19, Days after onset: 11
Location:Tennessee  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: XGeva every 3 months injection; Coumadin; Vitamin B-12; Vitamin B Complex; Vitamin E; Digoxin; Rampril; Xanax; Effexor XR; Calcium; Vitamin D; Colace; Lasix; Multi Vitamin; Ambien??; Arimedix
Current Illness: NONE
Preexisting Conditions: Breast cancer; CHF during chemotheraphy; Completed chemo on 1/2012
Diagnostic Lab Data: EKG; Echocardiogram; Lab work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4329AA1IMRA
Administered by: Public     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test, Lymphadenopathy, Nausea, Pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Shortness of breath, fast heart rate, redness, swelling, fever on injection site, weakness, nausea, diarrhea, sore joints, swollen glands, pain.

VAERS ID:465607 (history)  Vaccinated:2012-09-05
Age:45.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Female  Submitted:2012-09-19, Days after onset: 9
Location:Texas  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA730AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash over abdomen and chest.

VAERS ID:465608 (history)  Vaccinated:2012-09-05
Age:73.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-19, Days after onset: 13
Location:New York  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: UNKNOWN
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203801 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105152IMRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Itchiness, achy pain, redness 2-2 1/2 inches around it is ound arm from incection site.

VAERS ID:465655 (history)  Vaccinated:2012-09-05
Age:80.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 14
Location:Missouri  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Drug hypersensitivity; Drug hypersensitivity
Preexisting Conditions: Herpes zoster; Arterial therapeutic procedure; morphine, Drug hypersensitivity; K FLEX, Drug hypersensitivity; penicillin (unspecified), Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005221
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Eyelid ptosis, Hypoaesthesia, Hypoaesthesia oral, Pruritus, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a 80 years old female patient reporting on herself with penicillin allergy, K-flex allergy and morphine allergy. The patient''s medical history included carotid artery surgery and shingles in the past. On 05-SEP-2012, the patient was vaccinated SC with a dose of ZOSTAVAX (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included FLUZONE, losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), MAXIDE, simvastatin (manufacturer unknown), naproxen, omeprazole and aspirin. On 06-SEP-2012, the patient experienced that her face was swollen, and her right eye was droopy. She also experienced intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand. Her skin was itchy at times too. The patient was admitted to a hospital from 07-SEP-2012 to 07-SEP-2012. On an unspecified date, unspecified blood work, electrocardiogram (EKG) and Computerised axial tomography (CAT) was performed (results not provided). The patient sought medical attention by a phone call. At the time of the report, the outcome of her skin was itchy, intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand, her right eye was droopy and face was swollen was reported as not recovered/not resolved. Additional information has been requested.

VAERS ID:465701 (history)  Vaccinated:2012-09-05
Age:28.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-20, Days after onset: 13
Location:New Jersey  Entered:2012-09-20
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: Rheumatoid arthritis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.C4173AA IDLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Headache, Musculoskeletal stiffness, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Patient had PNEUMOVAX left arm on 9/5/12, called physician on 9/7/12 to report local redness 8 to 9 inches, hot, headache, neck stiffness, fever 101.8 patient was instructed to go to ED to R/O cellulitis and antibiotics.

VAERS ID:465702 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-14, Days after onset: 8
Location:Colorado  Entered:2012-09-20, 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: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1209521 UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158AA UNLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site swelling, Rash, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient had swelling on upper left arm and rash on arm. Warm to touch (according to patient). She came in 7 days later and swelling/redness visible, but fading. Gave BENADRYL and told her to take 1 later.

VAERS ID:465732 (history)  Vaccinated:2012-09-05
Age:5.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-07, Days after onset: 1
Location:Oregon  Entered:2012-09-20, 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 known
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: OR201215
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B193DA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1884AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1088AA1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Mom states child with father at 6 PM child was OK on 9/5/12 on 9/6/12 10 AM father noticed red area & rash at site of KINRIX that PM had vomiting / fever on 9/7/12 child was OK redness of arm only.

VAERS ID:465815 (history)  Vaccinated:2012-09-05
Age:25.0  Onset:2012-09-19, Days after vaccination: 14
Gender:Male  Submitted:2012-09-19, Days after onset: 0
Location:Georgia  Entered:2012-09-20, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3100IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG11300IMRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Pain, Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Numerous 1-3 mm vesicular erythematous lesions on both hands. Slightly painful. Itchy.

VAERS ID:465818 (history)  Vaccinated:2012-09-05
Age:75.0  Onset:2012-09-09, Days after vaccination: 4
Gender:Female  Submitted:2012-09-19, Days after onset: 10
Location:Massachusetts  Entered:2012-09-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart Disease ongoing
Preexisting Conditions: None known
Diagnostic Lab Data: X-ray, negative, for dx arm pain.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH734AB0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Crying, Injection site nodule, Myalgia, Pain, Pain in extremity, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad)
Write-up: Sept. 5, 2012 received FLUZONE vaccine. Sept. 9, 2012 awoke with pain in (L) after, crying in sleep 9/9 - present day arm black and blue down past elbow and up to shoulder, and is "achey" with muscle aches & "knot" where injection was given.

VAERS ID:466005 (history)  Vaccinated:2012-09-05
Age:11.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-18, Days after onset: 12
Location:Michigan  Entered:2012-09-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0022AE0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0074511SCLA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Oedema peripheral, Pyrexia, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient vaccinated on 9.5.12 with HPV4 & VARICELLA. Mom states on 9.6.12 he came home from school with swollen (L) arm & warm to touch with a fever. Mom states she took him to ER where they measured swelling of 9 x 9 dx him with cellulitis & prescribed KEFLEX & BENADRYL. Mom states swelling increased so she took him back to ER on 9.7.12 & states ER measured swelling at 14 x 13. They prescribed BACTRIM & prednisone.

VAERS ID:466011 (history)  Vaccinated:2012-09-05
Age:11.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-09-17, Days after onset: 10
Location:North Carolina  Entered:2012-09-21, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.G0075801SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness & swelling at injection site.

VAERS ID:466187 (history)  Vaccinated:2012-09-05
Age:92.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-16, Days after onset: 11
Location:Indiana  Entered:2012-09-24, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A1IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Haematoma, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad)
Write-up: Hematoma located several inches lower than where shot was given. Hematoma extended to approx 1/2 of pts arm. Pt has muscle pain extending to her elbows.

VAERS ID:470686 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-24, Days after onset: 19
Location:Unknown  Entered:2012-09-24
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: VARIVAX, No adverse event, "First dose"
Diagnostic Lab Data:
CDC Split Type: WAES1209USA002306
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Information has been received from a Licensed practical nurse (L.P.N.) concerning a patient of unknown age and sex. On 05-SEP-2012, the patient was inadvertently vaccinated subcutaneously with a single dose of ZOSTAVAX (dose, route and frequency were not reported) (lot# not reported), while patient was intended to received the second dose of VARIVAX (Merck). There were no adverse effects. At the time of the report, the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:470696 (history)  Vaccinated:2012-09-05
Age:27.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-24, Days after onset: 19
Location:Unknown  Entered:2012-09-24
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:
CDC Split Type: WAES1209USA002341
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1251AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered pharmacist concerning a 27 year old female patient. On 05-SEP-2012, the patient was vaccinated with a dose of M-M-R II (Lot #: 1251AA; Expiration date: 01-AUG-2013) intramuscularly instead of subcutaneously. Pharmacist reported that when the patient received the M-M-R II, she reported that she experienced some stinging at the injection site on 05-SEP-2012 which quickly resolved. The patient did not seek medical attention. No treatment was given for the event. On the same date "05-SEP-2012", the patient had recovered from the stinging at the injection site. Additional information has been requested.

VAERS ID:470709 (history)  Vaccinated:2012-09-05
Age:67.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-24, Days after onset: 19
Location:Unknown  Entered:2012-09-24
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: WAES1209USA008675
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from the patient''s husband refers to his wife who was a 67 years old female patient. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# unspecified) on 05-SEP-2012, "two weeks ago". The reporter explained that his wife developed a red rash at the injection site after receiving ZOSTAVAX on 05-SEP-2012, "two weeks ago". The patient did not sought medical attention. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as recovering/resolving. Additional information is not expected.

VAERS ID:466224 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-25, Days after onset: 20
Location:New Mexico  Entered:2012-09-25
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
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLA
Administered by: Unknown     Purchased by: Private
Symptoms: Chills, Mobility decreased, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad)
Write-up: Began with severe pain in arm and unable to move in any direction - followed by chills and fever and body aches. The pain is now manageable but I still have limited movement and am unable to lie on the side of admin. [left] since that time. Other symptoms gone in two days.

VAERS ID:466316 (history)  Vaccinated:2012-09-05
Age:63.0  Onset:2012-09-09, Days after vaccination: 4
Gender:Female  Submitted:2012-09-25, Days after onset: 16
Location:Minnesota  Entered:2012-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HYPOTHYROIDISM NOS; PLANTAR FIBROMATOSIS; ANKLE ENTHESOPATHY NEC; Myopia; PVD (Posterior Vitreous Detachment) left eye; Osteopenia
Preexisting Conditions: Past Medical History: Thyroiditis, unspecified; PVD (Posterior Vitreous Detachment) left eye 7/8/2009; Fibromyalgia; Varicose veins
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AC7IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH350AA0SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Itching began on 9/9 & on 9/23 she went to the ER for IV benadryl, oral predisone. Patient reports she is beginning to feel better.

VAERS ID:470554 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-25, Days after onset: 20
Location:Indiana  Entered:2012-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA002890
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Information has been received from a pharmacist concerning a patient, who on 05-SEP-2012 was inadvertently vaccinated with a dose of VARIVAX (Merck), 0.65ml, subcutaneously, instead of ZOSTAVAX due to a staff error. No adverse effect was reported. Additional information has been requested.

VAERS ID:466395 (history)  Vaccinated:2012-09-05
Age:53.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-25, Days after onset: 20
Location:Ohio  Entered:2012-09-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT44678A0IDUN
Administered by: Public     Purchased by: Private
Symptoms: Blister, Erythema, Lethargy, Nodule, Pain, Rash, Swelling, Tongue blistering
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Arm broke out. Redness, swelling about size of 50 cent piece, knot - lethargy, pain. Blisters under tongue & bilateral ears.

VAERS ID:466401 (history)  Vaccinated:2012-09-05
Age:94.0  Onset:2012-09-08, Days after vaccination: 3
Gender:Male  Submitted:2012-09-17, Days after onset: 9
Location:South Carolina  Entered:2012-09-26, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4491AA0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Contusion, Injection site haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)
Write-up: Client came by the pharmacy on 9/12/12 PM and showed a big bruise on his right arm. The bruise is about the size of a fist and located below the flu vaccine injection site. Bruising also on LA but not as big as RA''s bruise.

VAERS ID:466525 (history)  Vaccinated:2012-09-05
Age:12.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-26, Days after onset: 21
Location:Arkansas  Entered:2012-09-26
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: Vital signs stable
CDC Split Type: AR1220
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B092DA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0071411SCLA
Administered by: Public     Purchased by: Public
Symptoms: Head injury, Nodule, 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: Child reported fainting after last vaccine. Child received Tdap and Varicella vaccine and was watched for approx. 10 minutes, child displayed no problems and left clinic. Child fainted in parking lot when leaving. Hit back of head, right side on asphalt producing a plumb size knot with no laceration or bleeding. Child was observed for another 45 minutes with vitals every 15 minutes with no problems, then allowed to go home. Family member was told to watch for the next few hours due to knot on back of head and to notify nurse if any further problems

VAERS ID:466528 (history)  Vaccinated:2012-09-05
Age:10.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-09-26, Days after onset: 20
Location:Arkansas  Entered:2012-09-26
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: None
CDC Split Type: AR1219
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB591AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0070841SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Area of redness with local temp at site of varicella vaccine.

VAERS ID:469642 (history)  Vaccinated:2012-09-05
Age:42.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-26
Location:Unknown  Entered:2012-09-26
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: WAES1209USA002365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1332Y0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a licensed practical nurse reporting on a patient of unknown age and gender who on an unspecified date was vaccinated with an expired dose of GARDASIL (lot# not reported, exp June/July 2012). No other co-suspects were reported. No concomitant medications were reported. No adverse reaction was reported. Additional information has been requested.

VAERS ID:466640 (history)  Vaccinated:2012-09-05
Age:39.0  Onset:2012-09-24, Days after vaccination: 19
Gender:Female  Submitted:2012-09-27, Days after onset: 3
Location:Texas  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: remains in hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH730AB IMRA
Administered by: Private     Purchased by: Private
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Nausea, Paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow)
Write-up: Taken to ED with c/o numbness tingling to hands, feet & face nausea and vomiting. Was treated for symptoms and sent home. Brought back to ED on 9/26 with same and increasing symptoms and was admitted to neuro unit with preliminary dx of Guillain Barre syndrome.

VAERS ID:466686 (history)  Vaccinated:2012-09-05
Age:39.0  Onset:2012-09-08, Days after vaccination: 3
Gender:Male  Submitted:2012-09-27, Days after onset: 19
Location:Texas  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: Demerol, Tylenol with codeine, Vicodin Allergy - pt is asthmatic
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12048011IMLA
Administered by: Other     Purchased by: Public
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: Client returned to facility, stating she received fu shot on 9/6/12 and is now having a reaction. Nurse reports site is red, slightly raised, warm to touch, tender and approx. 5cm in diameter. Patient advised to use Tylenol/ibuprofen as needed.

VAERS ID:466698 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-27, Days after onset: 22
Location:Indiana  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Client has a brain tumor
Preexisting Conditions: Client has a brain tumor
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0895 IMLA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Erythema, Malaise, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Felt ill, fever of 102 degrees, weakness and body aches, red and swollen.

VAERS ID:466798 (history)  Vaccinated:2012-09-05
Age:80.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 21
Location:Maryland  Entered:2012-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: SYNTHROID; BETA BLOCKERS
Current Illness:
Preexisting Conditions: The patient received previous doses of "2 trad flu vaccines 2009 and 2009." The patient had no illness at time of vaccination. The past medical history included hypothyroidism, hypolipidemia, pacemaker for sick sinus syndrome, left carotid endarterectomy, and blindness in the left eye.
Diagnostic Lab Data: Laboratory tests included a chest x-ray (clear), CT of head (normal)
CDC Split Type: 201208804
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU504490AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Chest X-ray normal, Coagulation test normal, Computerised tomogram head normal, Culture urine negative, Dehydration, Laboratory test normal, Mental status changes, Pyrexia, Viral infection, White blood cell count increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad)
Write-up: Initial report was received from a healthcare professional on 19 September 2012. An 80-year-old female patient received an intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE (lot number not reported) on 05 September 2012. On the same day, the patient experienced a fever of 103.8 degrees Fahrenheit (39.9 degrees Celsius), altered mental status, and dehydration. The patient was hospitalized and treated with IV fluids. The discharge diagnosis was transient fever secondary to viral syndrome. The patient received previous doses of "2 trad flu vaccines 2009 and 2009." The patient had no illness at the time of vaccination. The past medical history includes hypothyroidism, hypolipidemia, pacemaker for sick sinus syndrome, left carotid endarterectomy, and blindness in the left eye. The patient is on betablockers and SYNTHROID. Laboratory tests included a chest x-ray (clear), CT of head (normal), urine culture (negative), blood culture (negative), coagulation studies (normal), blood chemistry (normal), and a white blood cell count of 11.6. The patient''s outcome was reported as recovered. Documents held by sender: None.

VAERS ID:466850 (history)  Vaccinated:2012-09-05
Age:14.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 12
Location:Connecticut  Entered:2012-09-28, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21391IN 
Administered by: Private     Purchased by: Private
Symptoms: Urticaria papular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Papular urticaria on chest, arms & back - developed same day as FLUMIST given - seen in office 9/6/12 - ZYRTEC advised. Seen in hospital ER 9/6/12 - BENADRYL & DECADRON given.

VAERS ID:467134 (history)  Vaccinated:2012-09-05
Age:30.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-09-10, Days after onset: 3
Location:Louisiana  Entered:2012-10-01, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinus infection (untreated)
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0232AE1SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Friday 9/7/12 pt noted increase in pain & swelling to (L) deltoid. Called hotline Saturday but no answer. Feels swollen under arm & at site warm to touch. Referred to clinic for tx. Pt would like to delay tx. 1 more day. Taking ADVIL & ice pack. 9/11/12 Left msg for f/u. 9/12/12 Left msg for f/u. 9/16/12 Patient had no treatment & symptoms resolved.

VAERS ID:467201 (history)  Vaccinated:2012-09-05
Age:76.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-09-14, Days after onset: 7
Location:Virginia  Entered:2012-10-01, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient reported swollen arm with redness and warm to touch. Patient never had a reaction in the past to flu shots. Pt reported to MD - found to be localized reaction.

VAERS ID:467222 (history)  Vaccinated:2012-09-05
Age:56.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Male  Submitted:2012-09-14, Days after onset: 4
Location:Virginia  Entered:2012-10-01, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Procardia; Ciprofloxacin; Clindamycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AA IMLA
Administered by: Private     Purchased by: Other
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: Patient reported swollen, red, itchy arm, but stated it was "getting" better on day of report.

VAERS ID:467445 (history)  Vaccinated:2012-09-05
Age:59.0  Onset:2012-09-29, Days after vaccination: 24
Gender:Female  Submitted:2012-10-03, Days after onset: 4
Location:Georgia  Entered:2012-10-03
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: Hashimoto''s
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0567AE0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Blister, Injection site pruritus, Scab
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Zostavax on 9/5/12. On 9/25/12 was prescribed and started taking Valtrex for a facial peel to be done 9/26/12. On 9/29/12, developed multiple clusters of fluid filled blisters that drain, scab over then she gets more of them. No pain, only itching at site.

VAERS ID:467472 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-12, Days after vaccination: 7
Gender:Female  Submitted:2012-10-03, Days after onset: 21
Location:Texas  Entered:2012-10-03
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: Bacterial infection
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204901 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Bacterial infection, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain, swelling in the left arm. Went to the ER.

VAERS ID:472456 (history)  Vaccinated:2012-09-05
Age:47.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-10-03, Days after onset: 28
Location:Unknown  Entered:2012-10-03
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: WAES1209USA002230
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: The pharmacist reported that on 05-SEP-2012, the patient received a dose of PNEUMOVAX 23 (Lot# 669579/0595AA) that expired on 30-AUG-2012. The PNEUMOVAX 23 was ordered for the patient by the physician. At the time of this report the patient was not reporting or demonstrating any adverse effects. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. Additional information has been requested.

VAERS ID:472474 (history)  Vaccinated:2012-09-05
Age:26.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-03
Location:Unknown  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastrooesophageal reflux disease
Preexisting Conditions:
Diagnostic Lab Data: 09/08/2012, Pregnancy test, Positive
CDC Split Type: WAES1209USA004441
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, Maternal exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 23 years old female patient with gastrooesophageal reflux disease. The patient''s history of previous pregnancies and live births is not known. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 12-NOV-2007, 21-JAN-2011 and 05-SEP-2012. No other co-suspects were reported. Concomitant medications included: ZANTAC. The patient became pregnant with an LMP of 01-AUG-2012 and an EDD of 09-MAY-13 before receiving the third dose of vaccine. The pregnancy was discovered via home pregnancy test on 08-SEP-2012. The patient was exposed to GARDASIL during trimester 1. The patient is still pregnant. The patient had sought medical attention via seeing the nurse practitioner. Additional information has been requested.

VAERS ID:472622 (history)  Vaccinated:2012-09-05
Age:51.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-10-04, Days after onset: 29
Location:Arizona  Entered:2012-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin; BENICAR; LIPITOR
Current Illness: Drug hypersensitivity; Type 1 diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA003355
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0933Z UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Immediate post-injection reaction, Pain in extremity, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a consumer refers to her husband, a 51 years old male patient with insulin-dependent type 1 diabetic and aspirin allergies. The patient was vaccinated with lot # (667912/0933Z exp date 25-FEB-2012), 0.5 ml PNEUMOVAX 23 (IM or SubQ) for routine vaccination on 05-SEP-2012 2:30 pm. Concomitant medications included insulin, BENICAR and LIPITOR. After vaccination, on 05-SEP-2012, the patient immediately had severe arm pain, followed by severe chest congestion and coughing that occurred 12 hours after. The patient did not seek medical attention, (2) extra strength TYLENOL was given for the adverse events. None lab diagnostics was performed, the adverse events were not improved. The outcome of severe chest congestion, coughing that occurred 12 hours after and severe arm pain was reported as not recovered/not resolved. Additional information has been requested.

VAERS ID:467860 (history)  Vaccinated:2012-09-05
Age:35.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2012-10-05
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:
Diagnostic Lab Data: Pt w/ h/o passing out after injections
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA1IMUN
Administered by: Other     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt passed out after Tdap administration ambulance were called. Pt stated he always pass out after injections. Pt stated NKDA and no health conditions prior to adm. Pt refused to be taken to hospital.

VAERS ID:468028 (history)  Vaccinated:2012-09-05
Age:34.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Female  Submitted:2012-10-06, Days after onset: 30
Location:California  Entered:2012-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No. Notified nurse who administered the flu vaccine from employee health and she dismissed this adverse reaction.
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRAR
Administered by: Unknown     Purchased by: Other
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Sharp achy pain that started day after flu shot administered. Pain rated 9/10 is at and surrounding injection site worsened with lifting of arm. Has progressively worsened despite anti-inflammatory and muscle relaxant medication. Currently affecting activity of daily living, as I am unable to lift my arm without significant pain radiating to forearm. Unable to hold and lift things. It was been a month and pain is only getting worse.

VAERS ID:468485 (history)  Vaccinated:2012-09-05
Age:11.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-10, Days after onset: 5
Location:Washington  Entered:2012-10-08, Days after submission: 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC052AA1UNRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB523AA1UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13302UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4079AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080DA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0607AE0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Upon completion of giving MMR vaccine, pt developed a raised wheal the size of a 50 cent piece. Around area skin was red and hot to the touch.

VAERS ID:470010 (history)  Vaccinated:2012-09-05
Age:24.0  Onset:2012-09-19, Days after vaccination: 14
Gender:Female  Submitted:2012-10-09, Days after onset: 20
Location:Unknown  Entered:2012-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Renal disorder
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA000305
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: Information has been received from a physician concerning a 24 years old female patient with unspecified kidney issue, who on 05-SEP-2012 was vaccinated with the first dose of GARDASIL 0.5 ml (route and lot # not reported). No other co-suspects were reported. Concomitant medications included: MIRENA. The physician informed that on 19-SEP-2012, while on GARDASIL, the patient experienced joint pain in her chest, arms, legs and back. On an unknown date the patient recovered from the events. No treatment was given for the events (also reported that AE improve on therapy). The patient did not seek medical attention. The relatedness for the events was unknown for GARDASIL. Additional information has been requested.

VAERS ID:473125 (history)  Vaccinated:2012-09-05
Age:65.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-11, Days after onset: 36
Location:Unknown  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VYTORIN; BENADRYL
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound: performed to check for blood clots, results were negative
CDC Split Type: WAES1209USA009779
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Injection site rash, Mobility decreased, Pain, Pyrexia, Swelling, Ultrasound Doppler normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with drug reaction or allergy to codeine. The patient was vaccinated with a dose of PNEUMOVAX 23 on 05-SEP-2012 (lot number reported as 1947AA with expiration date 20-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included VYTORIN and BENADRYL. It was reported that on 05-SEP-2012, the patient developed a fever that persisted for 3 days, pain, swelling, inflammation that extended to the patient''s shoulder, difficulty in moving her arm and rash around the injection site after receiving PNEUMOVAX 23. On an unknown date, ultrasound was performed to check for blood clots, results were negative. FLEXERIL, ADVIL and MEDROL dosepak were given as treatment for the adverse events. The outcome of inflammation that extended to the patient''s shoulder, rash around the injection site, pain, swelling and difficulty in moving her arm was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved (persisted for 3 days). The relatedness for inflammation that extended to the patient''s shoulder, pain, swelling, rash around the injection site, difficulty in moving her arm and fever is unknown for PNEUMOVAX 23. Additional information has been requested.

VAERS ID:469387 (history)  Vaccinated:2012-09-05
Age:29.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-12, Days after onset: 37
Location:New Mexico  Entered:2012-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient reports having mild cold sx.
Preexisting Conditions: Egg and mushroom allergy. Patient reports no previous flu vaccine. Patient reports previous MMR vaccine with no complications.
Diagnostic Lab Data: Mumps (neg titer 03Oct2012). Varicella (pos titer 03Oct2012).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0076990SCRA
Administered by: Military     Purchased by: Military
Symptoms: Antibody test positive, Injection site pruritus, Mumps antibody test negative, Pyrexia, Rash, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (broad), Hypersensitivity (narrow)
Write-up: At 8PM pt felt itchy at vaccine site. Pt felt multiple bumps on multiple areas on her body. The bumps were circular. The next day at noon; pt had fever of 102 degrees Fahrenheit. Fever went down after 3 days.

VAERS ID:473374 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-15, Days after onset: 40
Location:Unknown  Entered:2012-10-15
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA006236
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This spontaneous report was received from a pharmacist concerning a 66 year old female patient. On an unknown date in July 2012 (reported as late July 2012), the patient was vaccinated with a 1st dose of PNEUMOVAX 23 (dose, route, lot number unspecified). On 05-SEP-2012, the patient was revaccinated with a second dose of PNEUMOVAX 23, 0.5 milliliter, once, intramuscularly to the left deltoid. Lot number H009826 is an invalid lot number for PNEUMOVAX 23. Expiry date was reported as 11-FEB-2014. No concomitant medications were reported. After she received the vaccination in the pharmacy on 05-SEP-2012 as directed by a prescription, she experienced soreness on the left arm, at the injection site (approximately 05-SEP-2012). The patient saw a physician for the event. The patient was unaware at the time of second dose of PNEUMOVAX 23 that she had received the initial dose of PNEUMOVAX 23. The outcome of soreness on the left arm, at the injection site was unknown. The relatedness for soreness on the left arm, at the injection site was unknown for PNEUMOVAX 23. Additional information has been requested.

VAERS ID:475616 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-19, Days after onset: 44
Location:Unknown  Entered:2012-10-19
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: WAES1209USA006382
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. It was reported that the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number unknown) on 05-SEP-2012, which had expired on 31-AUG-2012. No concomitant medications were reported. No adverse effect was reported. Additional information is not expected.

VAERS ID:476251 (history)  Vaccinated:2012-09-05
Age:66.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-24, Days after onset: 49
Location:Unknown  Entered:2012-10-24
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: Drug hypersensitivity; Pathogen resistance
Preexisting Conditions: Morphine, Drug hypersensitivity; Erythromycin, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1210USA006598
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1072AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia, Rash generalised
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 (narrow)
Write-up: This spontaneous report as received from a pharmacy intern refers to a 66 years old female patient with allergy to erythromycin, macrolides and morphine and without pertinent medical history. The patient was inadvertently received her second dose of 0.5 ml PNEUMOVAX 23 (lot number not provided) intramuscularly on 05-SEP-2012 after receiving first dose in January 2012. No other co-suspects were reported. There were no concomitant medications. Patient did not experience any adverse effects after the first dose in January but after the second dose, she experienced swelling around the injection site which went away in a couple of days but on approximately 26-SEP-2012 about 3 weeks after second injection in September 2012, patient came down with rash all over her body and swelling of lymph nodes and high fever. Patient went to see internist and dermatologist (name of physicians unspecified) but they could not find anything wrong with the patient. Patient received some kind of treatment (unspecified) and all the symptoms were resolved at the reporting time. No laboratory diagnostics studies were performed. Additional information has been requested.

VAERS ID:471659 (history)  Vaccinated:2012-09-05
Age:40.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-25, Days after onset: 50
Location:Ohio  Entered:2012-10-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Mirtazapine; Lamotrigine; Lisinopril; Ibuprofen; Diazepam; Gabapentin; Naltrexone; Citalopram; Ranitidine; Trazodone
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204001 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMRA
Administered by: Other     Purchased by: Public
Symptoms: Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Pt. reported severe pain in left arm several hours after FLUVIRIN shot. Pt. called on 10-25-12 and still reports pain in left arm/shoulder, but she feels it is getting better.

VAERS ID:472807 (history)  Vaccinated:2012-09-05
Age:33.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-11-03, Days after onset: 59
Location:New York  Entered:2012-11-03
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) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Pain, Sleep disorder
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Extraordinary pain in the shoulder at the site of the injection. The injection was for an influenza vaccine. Pain is felt intensely with any movement. Very difficult and painful to put on a shirt. Impossible to sleep on the side the shot was given on. Very painful and symptoms have been recurring for 2 months now. Symptoms started immediately after recieving the flu shot.

VAERS ID:473255 (history)  Vaccinated:2012-09-05
Age:61.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-11-02, Days after onset: 58
Location:Washington  Entered:2012-11-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1268AA SCAR
Administered by: Other     Purchased by: Private
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Large raised welt around injection site approximately 1 1/2" in diameter. Painful and itchy. Hydrocortisone cream applied. Still visible as of 11/2/12 - 2 months later.

VAERS ID:472897 (history)  Vaccinated:2012-09-05
Age:25.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-11-05, Days after onset: 61
Location:Utah  Entered:2012-11-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: Allergy to penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1223SP1IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Pain in extremity, Weight bearing difficulty
SMQs:
Write-up: Pain, Immobility. Day 1-5: Complete immobility of right and shoulder. Severe pain. Inability to sleep due to stabbing pains in the arm. Day 6-19: Mobility returns to about 85%, pain receded to a bearable state. Day 20: Complete immobility and severe pain as in days 1-5. No signs of amnesia. Day 21 - 30: Mobility returns to about 85%, pain receded to a bearable state. Day 31-60: Mobility returns to about 90-95%. Pain present during movements at a certain angle and/or with extra weight on the arm. Pain varies each day, but is on a bearable level. Visit to a physician postponed due to a 2.5 month trip abroad. Waiting to get back (11/18/12) to visit a physician. Long-term/permanent damage expected.

VAERS ID:473610 (history)  Vaccinated:2012-09-05
Age:0.2  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-10-25, Days after onset: 48
Location:Arizona  Entered:2012-11-05, 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: GERD
Preexisting Conditions: Susp coco milk allergy
Diagnostic Lab Data: Hx of GERD and milk sens
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B344DA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0213AE0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451370IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB294A0PO 
Administered by: Private     Purchased by: Private
Symptoms: Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)
Write-up: Vaccine admin on 9/5/12. Small hematemesis on 9/7/12.

VAERS ID:475802 (history)  Vaccinated:2012-09-05
Age:87.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-12, Days after onset: 7
Location:Georgia  Entered:2012-11-09, Days after submission: 58
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: Patient''s history included Alzheimer''s like symptoms. Concomitant medications were not reported.
Diagnostic Lab Data: None.
CDC Split Type: 201208111
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Initial information received from a healthcare professional on 05 September 2012. A 87-year-old female patient whose medical history included Alzheimer''s like symptoms and with no reported concomitant medications received an intramuscular dose of FLUZONE (Batch lot number UH721AB) on left deltoid on 05 September 2012. The reporter stated that the patient experienced headache, numbness of face, after receiving FLUZONE on 05 September 2012. The patient was observed in office for 20 mins and discharged without complaint on the same day i.e. 05 September 2012. Corrective treatment was not reported. The events were resolved on 05 September 2012. Documents held by sender: none.

VAERS ID:475803 (history)  Vaccinated:2012-09-05
Age:92.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-12, Days after onset: 7
Location:Georgia  Entered:2012-11-09, Days after submission: 58
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: The patient had a history of TIA. Risk factors and adverse event to previous vaccinations were not reported. The patient ongoing illness included as none.
Diagnostic Lab Data: None
CDC Split Type: 201208115
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Initial information received from a healthcare professional on 05 September 2012. A 92-year-old female patient with a history of TIA (Transient Ischemic Attack) had received an intramuscular (IM) dose of FLUZONE injection (lot number UH721AB) in left deltoid on 05 September 2012. On 05 September 2012, the patient experienced "HA", numbness of face, after FLUZONE, observed in office 20 mins, and discharged without complaint on 05 September 2012. The patient ongoing illness included as none. Laboratory details and corrective treatment included none. The patient''s outcome was recovered on 05 September 2012.

VAERS ID:474314 (history)  Vaccinated:2012-09-05
Age:9.0  Onset:2012-10-04, Days after vaccination: 29
Gender:Female  Submitted:2012-10-25, Days after onset: 21
Location:Colorado  Entered:2012-11-14, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Alopecia areata; urticaria; vesicoureteral reflux
Diagnostic Lab Data: Abnormal CSF; nl Brain MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AC IMRA
Administered by: Private     Purchased by: Private
Symptoms: Ataxia, CSF test abnormal, Diplopia, Encephalitis, Nuclear magnetic resonance imaging brain normal, Opsoclonus myoclonus
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Ocular motility disorders (narrow)
Write-up: On 10-4-12 pt seen for ataxia & double vision. Pt admitted to hospital initial Dx of cerebellitis. Pt worsened, readmitted now with Dx of Myoclonus-opsoclonus ataxia. Pt is profoundly impaired and her prognosis is very uncertain.

VAERS ID:474928 (history)  Vaccinated:2012-09-05
Age:22.0  Onset:2012-09-27, Days after vaccination: 22
Gender:Female  Submitted:2012-11-19, Days after onset: 53
Location:Oklahoma  Entered:2012-11-19
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0690AA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Client reports having a miscarriage.

VAERS ID:475401 (history)  Vaccinated:2012-09-05
Age:56.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-27
Location:South Carolina  Entered:2012-11-27
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) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Mobility decreased, Oral pain, Pain in extremity
SMQs:, Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Left arm is painful, sore, unable to raise it, rash, sore mouth, and unable to turn wrist.

VAERS ID:475407 (history)  Vaccinated:2012-09-05
Age:72.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Female  Submitted:2012-11-27, Days after onset: 78
Location:Utah  Entered:2012-11-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR   LA
PER: PERTUSSIS (NO BRAND NAME)EMERGENT BIOSOLUTIONS   RA
Administered by: Public     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: After receiving a higher dose of flu vaccine plus whooping cough vaccine I broke out with Shingles within a week. Dr. prescribed antiviral med. As of Nov 26, 2012 I still have symptoms.

VAERS ID:480045 (history)  Vaccinated:2012-09-05
Age:71.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-12-28, Days after onset: 112
Location:Ohio  Entered:2013-01-02, 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: SYNTHROID .125; LANTUS 12IU; Metoprolol 50 mg; Amitriptyline 25 - 1 per day; aspirin 325 at 1 per day
Current Illness:
Preexisting Conditions: Weak heart; Diabetes; only 1 kidney; allergic to COUMADIN, PLAVIX, Statins, TYLENOL, metronidazole, LEVAQUIN, clindamycin, TRICOR, ZETIA, penicillin
Diagnostic Lab Data: SED rate on 9-26-12 = 56 at Dr. 11-8-12 at Dr blood test for SED rate = 71
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH716AD IMRA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Joint swelling, Movement disorder, Pain in extremity, Red blood cell sedimentation rate increased
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: 2 days after receiving flu shot, my knees swelled & continued to swell. Lot of pain in knees & legs. Very difficult to get up & down on 11-8-12 & went to Dr. He said flu shot caused problems as did another Dr. Dr drew 30cc of fluid off of right knee. Not able to do lift knee and on 11-21-12 he started me on prednisone which I still am taking. Not able to lay in bed and sleep for over 2 months. Improving now but not fully recovered.

VAERS ID:481824 (history)  Vaccinated:2012-09-05
Age:51.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2013-01-18, Days after onset: 135
Location:D.C.  Entered:2013-01-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COZAAR 50MG
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data: CELLULITIS
CDC Split Type:
Vaccination
Manufacturer
Lot
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0567AE0SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Cellulitis, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: RIGHT DELTOID SWOLLEN AND MOVING TO LOWER ARM JUST ABOVE ELBOW. DR STARTED PATIENT ON KEFLEX WITH SOME IMPROVEMENT. SIZE 70MMX50MM CELLULITIS.

VAERS ID:484078 (history)  Vaccinated:2012-09-05
Age:72.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-24
Location:Florida  Entered:2013-02-11, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to IMODIUM; Allergy to KEFLEX
Preexisting Conditions: No concomitant vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0996318A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA739AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site swollen in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to IMODIUM and allergy to KEFLEX. On 5 September 2012 the subject received 1st dose of FLULAVAL (.5 unknown, intramuscular, right arm). On an unspecified date in September 2012, at an unspecified time after vaccination with FLULAVAL, the subject experienced injection site swollen and injection site pain. The subject received FLULAVAL and complained to the healthcare professional about injection site being swollen, sore and painful. At the time of reporting the outcome of the injection site swollen and injection site pain were unspecified. The healthcare professional reported the office had up to 10 subjects or possibly more, with injection site swelling, soreness and pain, in some cases induration size of coin. Please see case A0996526A.

VAERS ID:484974 (history)  Vaccinated:2012-09-05
Age:2.0  Onset:2012-09-09, Days after vaccination: 4
Gender:Female  Submitted:2012-10-03, Days after onset: 24
Location:Virginia  Entered:2013-02-20, Days after submission: 140
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012SE71205
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ20243IN 
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: A report has been received from a Physician concerning a 2 year old, Female subject, Height: 39.5 IN; Weight: 38.5 LB, who had been receiving Nasal FLUMIST, 2.0 Millilitres, Once/Single administration. FLUMIST started on 05-Sep-2012. The patient experienced HEADACHE, FEVER and RUNNY NOSE which started on 09-Sep-2012. The patient recovered from the event of HEADACHE, FEVER and RUNNY NOSE on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 03-Oct-2012: new reporter, vaccinated by reporter; patient details; vaccine details; outcome of the adverse event added.

VAERS ID:485871 (history)  Vaccinated:2012-09-05
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-01
Location:Texas  Entered:2013-03-01
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA013160
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0365AE SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Rash pruritic, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient experienced itchy rash 5 to 10 days after vaccination which was diagnosed as chicken pox. The outcome of the reported event was unknown. Additional information has been requested.

VAERS ID:486536 (history)  Vaccinated:2012-09-05
Age:41.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2013-03-09, Days after onset: 185
Location:Massachusetts  Entered:2013-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine; Cytomel; Lyrica; Provigil; Metformin; Tradjenta; Deplin; Fluoxetine; Seroquel; Cymbal; Klonopin; Lithium Carbonate; Tranderm; BuTrans Vitamin D3; Fish Oil; Probiotics
Current Illness: None
Preexisting Conditions: Chronic Lyme Disease; Heart block level 1; White matter brain disease.
Diagnostic Lab Data: None. I was told it would eventually resolve on its own. I was also told I might have some radiologic tests performed, but I cannot afford it right now.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR  IDLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Non-stop pain at injection site. (And I have never had a problem with injections, including prior flu-shots. Over the next few days post-injection, (and increasing over the next several months), the pain spread throughout my tricep. The pain was at the surface of my skin and deep in the tissue. Even a normal shower was too painful to bear at the site for many months. Eventually, the pain radiated to my left shoulder. Now I have chronic pain in deep in my tricep and in my left shoulder. I cannot sleep on that side of my body.

VAERS ID:486955 (history)  Vaccinated:2012-09-05
Age:  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2013-03-14, Days after onset: 190
Location:Maine  Entered:2013-03-14
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: WAES1303USA006508
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report was received from a certified medical assistant who administers vaccines concerning a patient of unknown age and gender. On 09-NOV-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 13-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.

VAERS ID:487957 (history)  Vaccinated:2012-09-05
Age:  Onset:2013-02-27, Days after vaccination: 175
Gender:Female  Submitted:2013-03-28, Days after onset: 28
Location:Unknown  Entered:2013-03-28
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: WAES1303USA011992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: This spontaneous report as received from a other health professional refers to a female patient of unknown age with no reported medical history. On 27-FEB-2012 the patient was vaccinated with GARDASIL dose 1 (route, dose and lot number unknown). On 05-SEP-2012 the patient was vaccinated with GARDASIL dose 2 (route, dose and lot number unknown). No other suspect therapies or concomitant medications were reported. On 31-MAR-2013 the patient is in the office to receive her third dose. 27-FEB-2013, 367 days after onset therapy the patient experienced received first dose on 02/27/2012, second on 09/05/2012 is unknown (inappropriate schedule of vaccine administered). Additional information is not expected.

VAERS ID:491351 (history)  Vaccinated:2012-09-05
Age:34.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-29
Location:Indiana  Entered:2013-05-10, Days after submission: 100
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin human antirabies
Current Illness:
Preexisting Conditions: The patient''s illness at the time of vaccination included bat bite. The patient had Food allergies and was allergic to Flu vaccine, FLONASE, DEMEROL, Codeine and CIPRO; and had medical history of Fibromyalgia, Blindness, GERD, Cataracts, orthostatis, Pituitary Adenoma, Ehlers-Danlos Syndrome Type III.
Diagnostic Lab Data: Follow-up information received on 23 January 2013. The initial titer was drawn two weeks after the last IMOVAX dose and has since been drawn again and the patient ended up achieving a good titer (exact level was not reported).
CDC Split Type: 201210271
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antibody test abnormal
SMQs:, Vasculitis (broad), Hypersensitivity (broad)
Write-up: Initial report received from a healthcare professional on 01 November 2012. A 34-year-old female patient received IMOVAX rabies vaccine (lot number, route and site of vaccination was not reported) and also received RIG manufacturer unknown (lot number, route and site of vaccination was not reported) on 05 September 2012. The patient''s illness at the time of vaccination includes bat bite. The patient had Food allergies and was allergic to Flu vaccine, FLONASE, DEMEROL, Codeine and CIPRO; and had medical history of Fibromyalgia, Blindness, GERD, Cataracts, "orthostatis", Pituitary Adenoma, Ehlers-Danlos Syndrome Type III. The patient also had received an intramuscular dose of IMOVAX rabies vaccine (lot number H1180-1) in right deltoid on 08 September 2012 and on 12 September 2012; and received an intramuscular dose of IMOVAX rabies (Lot number: H1091-1) on the left deltoid on 19 September 2012 and 03 October 2012. After completion of a post exposure series for Bat bite, on an unknown date the rabies IgG serum titer was checked and was found to be low "0.4 international unit/ml". Laboratory investigations and corrective treatments were not reported. The patient''s outcome was reported as recovered. Documents held by sender: none. Follow-up information received from healthcare professional on 23 January 2013. The reporter''s facility administered last four doses of the vaccine. According to the reporter, the patient was very anxious and did not feel that she was treated well at the initial facility. The patient also may have had an allergic reaction to the RIG because she had no issues after each of the four vaccines administered at the reporter''s facility. The initial titer was drawn two weeks after the last IMOVAX dose and has since been drawn again and the patient ended up achieving a good titer (exact level was not reported). No treatments were provided.

VAERS ID:503485 (history)  Vaccinated:2012-09-05
Age:1.1  Onset:2012-12-31, Days after vaccination: 117
Gender:Female  Submitted:2013-01-31, Days after onset: 31
Location:Ohio  Entered:2013-09-20, Days after submission: 231
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE07818
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Ear infection, Influenza
SMQs:
Write-up: A report has been received from physician concerning a 2 years old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. Patient had been receiving nasal FLUMIST given on 05-Sep-2012. The patient experienced Influenza A, Influenza B, and ear infection which started on 31-Dec-2012. The outcome of all the events were unknown. The reporter considered all of the events to be non-serious.

VAERS ID:513833 (history)  Vaccinated:2012-09-05
Age:0.0  Onset:2013-05-01, Days after vaccination: 238
Gender:Female  Submitted:2013-11-19, Days after onset: 202
Location:Unknown  Entered:2013-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA007991
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Birth mark, Congenital anomaly, Foetal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This spontaneous report as received from a nurse practitioner refers to a 1 day old female patient who was born from a 23 years old female patient with gastrooesophageal reflux disease. The mother''s history of previous pregnancies and live births was not known. The patient''s mother was vaccinated with the first, second and third dose of GARDASIL (Lot # unspecified) intramuscularly on 12-NOV-2007, 21-JAN-2011 and 05-SEP-2012, respectively. No other co-suspects were reported. Concomitant medications included: ZANTAC. The patient''s mother was exposed to GARDASIL during first trimester of pregnancy. The patient was born in May 2013 and was doing fine. The patient had an unspecified birthmark on her leg. The patient was healthy and happy and had no problems at all. Upon internal review, birth mark on the leg was considered congenital anomaly. Additional information has been requested.

VAERS ID:558685 (history)  Vaccinated:2012-09-05
Age:11.0  Onset:2012-09-20, Days after vaccination: 15
Gender:Female  Submitted:2014-12-09, Days after onset: 810
Location:Illinois  Entered:2014-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: On no other meds at time of vacciantion
Current Illness: None
Preexisting Conditions: No allergies, ststes had to wear helmet as infant/child for a protrusion from forehead-has resolved-no other effects.
Diagnostic Lab Data: C/T Scan with- without contrast was normal, R/O allergies
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Public     Purchased by: Public
Symptoms: Computerised tomogram normal, Headache, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: About 2 wks after #2 GARDASIL patient began having short, severe headaches N5 min in length x1/wk. H/A progressed to frequency of dly and lasting a full day-pain progressively got more severe to where patient would pass out. Many Dr visits-put on meds-tried several types- ELAVIL, Topiramate. R/O other causes. Dr felt from her vaccination.

VAERS ID:465511 (history)  Vaccinated:2012-09-05
Age:1.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Male  Submitted:2012-09-18, Days after onset: 12
Location:Foreign  Entered:2012-09-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Acute bronchiolitis; Acute pneumonia; Acute respiratory insufficiency; Otitis
Diagnostic Lab Data: 06-SEP-2012, Body temperature, 39 Centigrade
CDC Split Type: 2012226571
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF144220IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Productive cough, Pyrexia, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 12-months-old male patient (ethnicity unspecified) received the first dose of intramuscular PREVENAR 13 on 05Sep2012, in the deltoid muscle. Medical history included acute bronchiolitis form an unknown date and unknown if ongoing, acute pneumonia from an unknown date and unknown if ongoing, acute respiratory insufficiency from an unknown date and unknown if ongoing, acute otitis from an unknown date and unknown if ongoing acute. The patient''s concomitant medications were unknown. On 06Sep2012, the patient experienced fever 39 degrees Celsius, wheezing, productive cough, vomiting, semisolid stool. In response to the events, the patient was hospitalized for 5 days. Therapeutic measures were taken as a result of the events and consisted in the administration of antibiotic medication, bronchodilating aerosol, cortisone, antipyretic medication, anti-diarrhea medication (specific medications were unknown). The patient had recovered from the events on 10Sep2012. The patient will return at the physician''s office for the second dose.

VAERS ID:465662 (history)  Vaccinated:2012-09-05
Age:13.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-19, Days after onset: 14
Location:Foreign  Entered:2012-09-19
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: Familial risk factor
Preexisting Conditions: Family history (elder sister and younger sister) of syncope due to injection
Diagnostic Lab Data: 09/05/2012, Blood pressure diastolic, 70 mmHg; 09/05/2012, Blood pressure systolic, 120mmHg; 09/05/2012, Heart rate, 80/ min
CDC Split Type: WAES1209JPN003180
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Ammonia, Balance disorder, Blood electrolytes, Blood ethanol, Blood glucose, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from agency (local agency number PMDA-2012/09) via physician (local reference # A201208086) concerning a 13 year 3 month old female patient with no primary disease/concurrent conditions, no previous history of developmental disorder, loss of consciousness, heart disorder, epilepsy, metabolic abnormality or allergy and a family history (elder sister and younger sister) of syncope due to injection. The patient received no vaccination or developed diseases, etc. within one month. On 05-SEP-2012 (at 17:45), the patient was intramuscularly vaccinated with GARDASIL, 0.5 mL once a day, into left upper arm (Lot number not reported). The patient did not receive any medication recently which might affect the episode. No other vaccine was injected at the same time. No information on concomitant medications was provided. On 05-SEP-2012, there were no warming symptoms related to the episode. At 17:45, immediately after the patient was injected GARDASIL into her left upper arm muscle (within few seconds) in a sitting position, she lost her consciousness and her body lost balance and she developed tonic convulsion (generalized) for 1-2 seconds. After loss of consciousness accompanied by convulsion for few seconds, she was immediately laid down and then, she opened her eyes, her consciousness became clear and recovered. Heart rate was 80. After lying down for 15 minutes, she went home to maintain the condition at the hospital visit. The patient did not receive any medication as treatment (procedure) of the events. After recovery from loss of consciousness, there was no development of the symptoms or recurrence of the episodes. Risk factor of vasovagal syncope: yes (fear, anxiety and nervousness to injection). Body position at the time of onset: sitting position (round chair with a back support). Situation at the time of onset: after injection. Movement: tonic. Duration of the movement: few seconds. Arrhythmia: no. Skin color: pale. Breathing pattern: no abnormality. Tongue biting: no. Complete loss of consciousness: yes (few seconds). Abnormal vital signs: no. Blood pressure: (17:45) 127/70. Pulse: (17:45) 80. Levels of blood glucose, electrolyte, ammonia and ethanol: not reported. Any special examinations such as electroencephalogram, head magnetic resonance imaging (MRI) (or computed tomography (CT) or electrocardiogram: not performed. Recovered in supine position or head down position?: yes. Cause of loss of consciousness: vasovagal reflex. Possibility of anaphylaxis: no. The reporting physician felt that syncope (vasovagal reflex) was definitely related to GARDASIL and judged that there was no possibility of other factor (other diseases, etc.). The physician did not comment on the causal relationship between convulsion-like (generalised) attack and GARDASIL. The reporting physician considered that syncope (vasovagal reflex) was non-serious. The physician did not comment on the seriousness of convulsion-like (generalised) attack. Upon internal review, convulsion-like (generalised) attack was determined to be serious as an important medical event. Comment: The patient''s elder sister and younger sister have a history of developing syncope due to injection. Additional information is not expected.

VAERS ID:466032 (history)  Vaccinated:2012-09-05
Age:3.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-09-20, Days after onset: 15
Location:Foreign  Entered:2012-09-24, 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: Cough
Diagnostic Lab Data: 05-SEP-2012, Body temperature, 36.4 Centigrade
CDC Split Type: 2012220417
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEVX: JAPANESE ENCEPHALITIS (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Hyperhidrosis, Injection site pain, Loss of consciousness, Pallor, Presyncope
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), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a contactable physician based on the information obtained through the agency under the regulatory authority report number PREVENAR 581. A 3-year-old male patient received the first dose of PREVENAR subcutaneously and the first dose of encephalitis vaccine subcutaneously on 05Sep2012 at 12:00PM. His body temperature before the immunization was 36.4 degrees Centigrade on 05Sep2012. Relevant medical history included cough. Relevant concomitant medications were not reported. The patient developed vasovagal reaction on 05Sep2012 at 12:05PM characterized by sweatiness, bradycardia, facial pallor, and loss of consciousness. No urticaria was noted. The patient lay on his bed with leg elevation. Therapeutic measures were taken 30 minutes after the event and included treatment with fluid infusion. Subsequently, the patient''s symptoms improved on the same date. The outcome of the event, vasovagal reaction, was recovered on 05Sep2012, about 30 minutes after event onset. The reporting physician classified the event was non-serious and possibly related to the pneumococcal 7-valent conjugate vaccine and encephalitis vaccine. The reporting physician commented as follows: The combination of an extreme state of tension prior to vaccination and the pain of the simultaneous vaccinations likely triggered the vasovagal reaction. Thus, it was difficult to consider the event as a drug-induced adverse reaction. Follow-up (11Sep2012): New information reported by the same contactable physician through a Pfizer sales representative included event causality. Follow-up (18Sep2012): New information reported by the same contactable physician through a Pfizer sales representative included patient demographics, clinical course, treatment details, and causality.

VAERS ID:466598 (history)  Vaccinated:2012-09-05
Age:27.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 21
Location:Foreign  Entered:2012-09-27, 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: No information reported
Diagnostic Lab Data:
CDC Split Type: E201206057
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blindness, Decreased appetite, Lymph node pain, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad)
Write-up: This case was received from the Health Authority on 17-Sep-12 under the reference number GB-MHRA-ADR 21837129. This case is not medically confirmed as the case was originally reported by a consumer. A 27 year old female patient with an unreported medical history and concomitant medication received a dose of typhoid vaccine (Manufacturer, batch number not reported) route and site not reported and a yellow fever vaccine (Manufacturer, batch number not reported) route and site not reported on 05-Sep-12. On 05-Sep-12, the same day as the vaccination, the patient experienced lost appetite, loss of vision, lymph node pain, muscle ache and nausea. The patient stated that after suffering the side effects the patient was checked over by a paramedic who assessed the patient as not needing hospital treatment. The patient recovered from all the events on 05-Sep-12. Both the reporter and the agency considered the events to be serious due to other medically significant reason.

VAERS ID:467065 (history)  Vaccinated:2012-09-05
Age:1.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Female  Submitted:2012-10-01, Days after onset: 21
Location:Foreign  Entered:2012-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALPOL
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: Immunisation
CDC Split Type: WAES1210GBR000427
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature, Decreased appetite, Malaise, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was received by the Health Authority on 26-Sep-12 under the reference number GB-MHRA-ADR 21852350. This case is not medically confirmed as it was reported to the agency by a consumer. A one-year-old female patient with an unreported medical history and who was receiving CALPOL for an unreported indication, received a dose of a measles, mumps and rubella vaccine (Manufacturer, batch number not reported) route and site not reported on 05-Sep-12. On 10-Sep-12, five days post vaccination, the patient experienced a temperature, rash, loss of appetite and was generally unwell. It is unknown if the patient received any corrective treatment. At the time of reporting, the patient was recovering. Both the reporter and the agency considered the events to be serious due to other medically significant condition.

VAERS ID:467391 (history)  Vaccinated:2012-09-05
Age:12.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-10-03, Days after onset: 28
Location:Foreign  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0833842A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B062AO IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Epistaxis, Face injury, Headache, Presyncope, Screaming
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician via a regulatory authority (2012-014436) and described the occurrence of vasovagal-episode in a 12-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject had no concomitant medications. Concurrent vaccination included unspecified vaccines (manufacturer unspecified) given on an unspecified date. There was no problem associated with these vaccinations. On 5 September 2012, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). On 5 September 2012, less than one day after vaccination with BOOSTRIX, the subject experienced an atypical vasovagal-episode, acute exacerbation of headache, minor nose injury, nosebleed, loud screaming and persistent dizziness. The subject was hospitalised. The events lasted for approximately 5 hours.

VAERS ID:467811 (history)  Vaccinated:2012-09-05
Age:0.1  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2012-10-04, Days after onset: 29
Location:Foreign  Entered:2012-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: CT-scan, NMR, ECG and unspecified laboratory tests were performed on unspecified date and the diagnosis was tuberous sclerosis and cardiac rhabdomyoma.
CDC Split Type: 2012242807
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB256A2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF639632IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Laboratory test, Nuclear magnetic resonance imaging, Rhabdomyoma, Tuberous sclerosis
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This is a spontaneous report received from a foreign Regulatory Authority. Regulatory Authority report number 177153. An unspecified Health Care Professional (contactable through Regulatory Authority only) referred that a 5-weeks-old female patient received the 3rd dose of PREVENAR 13 (lot # F63963) 0.5 ml intramuscular on 05Sep2012 and 3rd dose of INFANRIX HEXA (lot # A21CB256A) 0.5 ml intramuscular on 05Sep2012. The patient medical history was not reported. No concomitant medications was reported. On 05Sep2012 the patient experienced convulsions, rhabdomyoma and tuberous sclerosis considered as serious by the reporter. The reporter added that the patient was transported to the Emergency Room after a convulsive crisis and immediately transferred to the hospital where she was hospitalized on 05Sep2012 in the infective disease department and was discharged on 10Sep2012. During the hospitalization the medical staff diagnosed a tuberous sclerosis and a cardiac rhabdomyoma resulted from CT-scan, NMR, ECG and unspecified laboratory tests performed on unspecified date. The outcome of the events was reported as recovering.

VAERS ID:469739 (history)  Vaccinated:2012-09-05
Age:4.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-10-14, Days after onset: 39
Location:Foreign  Entered:2012-10-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body temperature, 39.2 Centigrade
CDC Split Type: 2012249334
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Delirium febrile, Injection site erythema, Pyrexia, Vaccination site swelling
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This is a spontaneous report from a contactable non-healthcare professional (an employee of a municipal healthcare center) via the Ministry of Health. Regulatory Authority Number PREVENAR 601. A 4-year-old male patient received the first dose of PREVENAR 0.5 mL via subcutaneous route of administration on 05Sep2012. Relevant medical history and concomitant medications were not reported. On 07Sep2012, the patient experienced pyrexia of 39.2 degrees Centigrade (C) and local site erythema and vaccination site swelling. The patient went home. Thereafter, the patient experienced febrile delirium on 07Sep2012. The second visit was made. After his armpit was cooled down, the symptom calmed down. The patient went home. Thereafter, the patient presented to another hospital. The patient received an unspecified treatment. The patient recovered from delirium on 07Sep2012. On 07Sep2012, the patient recovered from the events pyrexia of 39.2 degrees C and local site erythema and vaccination site swelling The reporter classified pyrexia non-serious, and assessed the event possibly related to pneumococcal 7-valent conjugate vaccine. The reporter reported the local site erythema as non-serious. Follow-up (10Oct2012): New information reported from a contactable public health nurse through a Pfizer sales representative includes: product data and reaction data.

VAERS ID:469977 (history)  Vaccinated:2012-09-05
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-16
Location:Foreign  Entered:2012-10-16
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: B0837673A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA162DA0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased
SMQs:
Write-up: This case was reported by a physician and described the occurrence of injected limb mobility described in an 16-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 September 2012, the subject received 1st dose of CERVARIX (intramuscular, unknown arm). In September 2012, less than one month after vaccination with CERVARIX, the subject experienced injected limb mobility decreased (inability to raise the arm for 10 days after the vaccination). The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were resolved. On 10 October 2012, the subject visited the hospital to receive the second vaccination of CERVARIX. Due to the events occurred after the first vaccination, the physician decided to not perform the second vaccination. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:471838 (history)  Vaccinated:2012-09-05
Age:0.2  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-10-24, Days after onset: 49
Location:Foreign  Entered:2012-10-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012258631
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC3742AA IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF81982 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Feeling hot, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report from the contactable Regulatory Agency received under reference number: GB-MHRA-ADR 21879959. A 8 week old male infant received intramuscular PREVENAR 13, lot number F81982 and co-suspect PEDIACEL both on 05Sep2012. The medical history and concomitant medication were not reported. On 05Sep2012, approximately 4 hours after vaccination, the child was hot with diarrhoea and vomiting. The action taken with PREVENAR 13 and PEDIACEL was not applicable. The patient recovered from the events on 06Sep2012. The reporter considered the case to be serious as the events were medically significant and the agency considered the case to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:472539 (history)  Vaccinated:2012-09-05
Age:52.0  Onset:2012-09-17, Days after vaccination: 12
Gender:Male  Submitted:2012-11-01, Days after onset: 45
Location:Foreign  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Epilepsy; Hypertension; Brain injury
Diagnostic Lab Data:
CDC Split Type: WAES1210DEU014477
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.G011621 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Conjunctivitis, Erysipelas, Erythema, Eyelid oedema, Herpes zoster ophthalmic, Pain of skin, Scab, Secretion discharge, Trigeminal nerve disorder
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Conjunctival disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular infections (narrow), Hypersensitivity (narrow)
Write-up: Case was received from the Health Authorities on 25-Oct-2012 (reference number PEI2012052774). Case is medically confirmed. A 52-year-old male patient with a medical history of brain damage in early childhood, arterial hypertension and epilepsy, received a first dose of PNEUMOVAX 23 (lot-no. G011621) IM into the left upper arm on 05-Sep-2012. Twelve days later, on 17-Sep-2012, he developed herpes zoster of right ophthalmic nerve, beginning erysipelas at his face and conjunctivitis of the right eye leading to hospitalisation the same day. Contradictory to the reporting form it was reported on admission that he developed very painful skin changes at the right eye and right forehead few days earlier. At that time he was treated with ZOSTEX once / day per os. On admission dermatological investigation showed multiple grouped vesicles on red ground with serous scab covered erosions at right trigeminal nerve, V1 region (ophthalmic nerve area). Right eyelids were swollen. The patient received following treatment: IV aciclovir (750 mg), clindamcycin (600 mg), sodium chloride compresses, gentamicin sulfate and SULMYCIN Ointment with CELESTAN-V, LINOLA SEPT cream, aciclovir eye ointment on right eye, FLOXAL eye drops, paracetamol and TALVOSILEN FORTE orally. Thereunder symptoms notedly improved and the patient was discharged on 25-Sep-2012. On 15-Oct-2012 the patient had completely recovered. Previous unspecified vaccinations were generally well tolerated. CASE IS CLOSED.

VAERS ID:473687 (history)  Vaccinated:2012-09-05
Age:9.0  Onset:0000-00-00
Gender:Male  Submitted:2012-11-08
Location:Foreign  Entered:2012-11-08
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: Gastrointestinal disorder
Diagnostic Lab Data:
CDC Split Type: WAES1211NLD003626
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Gastrointestinal pain, Injection site erythema
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Case received from the Health Authorities in a foreign country on 06-Nov-2012 under the reference number NL-LRB-144463. Medically confirmed. Initial source was a consumer. Case reported as serious by the Lareb (criterion: hospitalisation). A 9-year-old male patient (weight: 36 g, height not reported), had received the second dose of MMRVAXPRO (batch number G015813, administration site: upper arm) on 05-Sep-2012 in the Childhood Immunisation Programme. On the same day the male patient received the sixth dose of DTP-NVI (batch number 144B). Concomitant medication was not reported. On the day of vaccination the patient developed injection site redness, lasting for two days. Ten days after vaccination the patient developed gastrointestinal pain. Medical history: The patient suffered from gastrointestinal complaints before and had been admitted to the hospital because of this a few month before vaccination. First dose of MMRVAXPRO given on an unspecified date, toleration not reported. Dose 1 - 5 of DTP vaccine given on an unspecified dates, toleration not reported. Outcome: the patient had recovered from injection site redness, gastrointestinal pain was resolving at the time of reporting. Causality for gastrointestinal pain was considered unlikely related to the vaccinations as comparable complaints occurred already before the vaccination. For injection site redness no causality was provided. No further information expected.

VAERS ID:474216 (history)  Vaccinated:2012-09-05
Age:1.4  Onset:2012-09-05, Days after vaccination: 0
Gender:Unknown  Submitted:2012-11-14, Days after onset: 70
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? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC Split Type: 201210411
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001C IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURG7158 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Febrile convulsion, Lividity, Loss of consciousness, Pyrexia
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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from the Health Authorities on 06 November 2012 under the reference number PLURPLOCR20120917002. A 05-month-old patient (gender not reported), with no reported medical history and concomitant therapies, had received an intramuscular dose of IMOVAX POLIO (batch number G7158-2, site of administration not reported), an intramuscular dose of ACTHIB (batch number G9965-1, site of administration not reported) and an intramuscular dose of DTP vaccine (other manufacturer, batch number 20911001C, site of administration not reported) on 05 September 2012 around 01:00pm. On 05 September 2012, around 03:00pm the patient developed fever at 38-39 degrees C. Near 04:00pm, the patient experienced fever at 39 degrees C and febrile convulsion with loss of consciousness and lips lividity. The patient was treated with antipyretics then convulsion resolved spontaneously. Because of recurrence of fever, the patient was brought to hospital on 06 September 2012 around 01:00am. The patient was admitted to hospital. The patient was recovering and was still hospitalized at the time of reporting. The Health Authorities coded pyrexia, convulsion febrile and lividity.

VAERS ID:475428 (history)  Vaccinated:2012-09-05
Age:12.0  Onset:2012-09-15, Days after vaccination: 10
Gender:Female  Submitted:2012-11-26, Days after onset: 72
Location:Foreign  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Brain computerized tomography, Sep2012, normal; Electroencephalogram, Sep2012, normal; Electroencephalogram, Oct2012, see text; Electromyogram, Sep2012, normal
CDC Split Type: B0846307A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA179AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram head, Computerised tomogram normal, Electroencephalogram abnormal, Electromyogram normal, Epilepsy, Grand mal convulsion, Hypotonia, Slow response to stimuli, Staring
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a physician and described the occurrence of epilepsy in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 5 September 2012, the subject received 3rd dose of CERVARIX (administration site and route unknown). On 15 September 2012, 10 days after vaccination with CERVARIX, the subject experienced hypotonia unspecified, staring and decreased responsiveness. No loss of consciousness. The subject was hospitalised. An electromyogram, an electroencephalogram and a brain computerized tomography were performed. All the results were normal. The neurologist suggested therefore that the events could be related to CERVARIX. Guillain-Barre Syndrome was ruled out and after 1 week of hospitalisation, the events were resolved and the subject was discharged. On 22 October 2012, 47 days after vaccination with CERVARIX, the subject experienced a new episode of staring with tonic-clonic seizures focalized on the right upper limb. The subject was hospitalised. The electroencephalogram confirmed the diagnosis of epilepsy due to discharges of spikes complex found at the end of the study. The subject was treated with levetiracetam. On 27 October 2012, the subject was discharged. The reporter didn''t consider the events were related to CERVARIX. The event was considered as a new onset of epilepsy. On 9 November 2012, the subject had a new episode that occurred during the treatment with levetiracetam. No hospitalisation was needed. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:475429 (history)  Vaccinated:2012-09-05
Age:0.2  Onset:2012-09-07, Days after vaccination: 2
Gender:Male  Submitted:2012-11-26, Days after onset: 80
Location:Foreign  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood methemoglobin, 07Sep2012, normal; Full blood count, 07Sep2012, normal; Laboratory test, 07Sep2012, normal
CDC Split Type: B0845362A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0UNLG
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Blood methaemoglobin, Full blood count normal, Injection site reaction, Laboratory test normal, Livedo reticularis, Rash macular, Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a pediatrician and described the occurrence of blotchiness of skin in a 2-month-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline) and INFANRIXQUINTA (GlaxoSmithKline). Concurrent vaccination included PREVENAR (non-gsk) given on 05 September 2012. Co-suspect medication included EMLA patch. On 05 September 2012, the subject received 1st dose of INFANRIX HEXA (batch and route unknown, unknown thigh) and one dose of PREVENAR (batch, route and injection site unknown) with EMLA patches. About 48 hours later, on 07 September 2012, the subject presented with mottled skin on vaccinated thigh; this spread to homolateral thorax and arm. Skin had a purplish color. The subject was hospitalized. Work-up, including full blood count and methemoglobin, was normal. The child was doing well. Event resolved in September 2012. On 10 October 2012, the subject received a 2nd does of INFANRIXQUINTA (batch and route unknown, unknown thigh) without EMLA patch. About 48 hours later. event recurred. The subject was not hospitalized. The event resolved within an unspecified timeframe. At the time of reporting, both occurrence of the event were resolved. The reporter''s assessment was not provided.

VAERS ID:476283 (history)  Vaccinated:2012-09-05
Age:0.2  Onset:2012-09-05, Days after vaccination: 0
Gender:Male  Submitted:2012-12-03, Days after onset: 89
Location:Foreign  Entered:2012-12-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012297426
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cow's milk intolerance, Dehydration, Diarrhoea, Enterocolitis, Haematochezia, Hypersensitivity, Infection, Neutropenia, Somnolence, Urinary tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 183255. A consumer (contactable through Regulatory Authority only) reported that a 2-month-old male patient received a dose of PREVENAR 13 (lot number F83420) and INFANRIX HEXA (lot number A21CB170A) at an unknown dosage, both injection solutions on 05Sep2012 intramuscularly. Patient''s medical history and concomitant medications were not reported. On 05Sep2012, the patient experienced diarrhea, haematochezia, somnolence, continuous vomiting with immediate dehydration. Urgent hospitalization was required. The events was reported as serious as per hospitalization. Before admission due to the adverse reactions, the patient was in good health condition. Unspecified drugs were to treat the adverse reactions that were reported affecting patient''s quality of life for a value of 8. The child was discharged with a diagnosis of moderate neutropenia with a probable post-infectious nature, urinary tract infection, suspected intolerance to cow''s milk protein not IgE medicated (clinical picture compatible with allergic enterocolitis). Actually the child was on a diet without cow''s milk protein. The outcome of the events was reported as recovered with sequel.

VAERS ID:476701 (history)  Vaccinated:2012-09-05
Age:17.0  Onset:2012-09-07, Days after vaccination: 2
Gender:Female  Submitted:2012-12-05, Days after onset: 89
Location:Foreign  Entered:2012-12-05
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:
CDC Split Type: WAES1212IRL001589
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124500IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Hypoaesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: This case was received from the health authority in a foreign country on 27-Nov-2012. IMB REF 2012-015476. This case is medically confirmed. A 17 year old female patient with no reported medical history and who was not taking any concomitant medication received dose one of GARDASIL (batch number G005669, lot number NN12450, expiration date 09-JUL-2013), IM, site not reported, on 05-Sep-2012. On 07-Sep-2012, 48 hours post vaccination, the patient developed blurring of vision with a headache and found that the tips of her fingers on both hands felt numb. The symptoms lasted three days and spontaneously disappeared. The patient recovered on an unreported date. The IMB considered the events to be medically important.

VAERS ID:481293 (history)  Vaccinated:2012-09-05
Age:5.0  Onset:2012-09-06, Days after vaccination: 1
Gender:Unknown  Submitted:2013-01-14, Days after onset: 130
Location:Foreign  Entered:2013-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 06Sep2012, 38 to 38.4deg. C
CDC Split Type: B0858429A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B132BL0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Extensive swelling of vaccinated limb, Injection site lymphadenopathy, Injection site oedema, Injection site pain, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (# N1086/2012) and described the occurrence of pharyngitis in a 5-year-old subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On 5 September 2012, the subject received 1st dose of INFANRIX (.5 ml, intramuscular, right arm). On 6 September 2012, 1 day after vaccination with INFANRIX, the subject experienced pharyngitis and fever (38-38.4 deg. C). The subject was treated with Antibiotic. On 7 September 2012, 2 days after vaccination with INFANRIX, the subject experienced extensive swelling of vaccinated limb described as large oedema on arm and forearm reaching beyond the nearest joint with a diameter more than 10 cm, injection site pain and injection site lymphadenopathy (increased on local lymph node). The subject was hospitalised because of severe pharyngitis and postvaccinal reaction. No specific information about the hospitalisation were given. At the time of reporting the events were unresolved. The subject was under the treatment at home. No further information is expected, the Regulatory Authority has provided us with all the available information for the time being, if they ever get any further they will send it to us.

VAERS ID:481604 (history)  Vaccinated:2012-09-05
Age:55.0  Onset:2012-09-05, Days after vaccination: 0
Gender:Female  Submitted:2013-01-16, Days after onset: 133
Location:Foreign  Entered:2013-01-16
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: No alcohol or tobacco use. There was no history of previous vaccine reaction or allergic reactions. There were no pre-existing medical conditions or risk factors.
Diagnostic Lab Data: X-ray, 2012, showed calcified; X-ray, 14Sep2012, shoulder
CDC Split Type: A0996171A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B077AC UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Calcification of muscle, Extensive swelling of vaccinated limb, Injection site pain, Injection site reaction, Injection site swelling, Insomnia, Joint range of motion decreased, Muscle injury, Muscle spasms, Muscular weakness, Musculoskeletal pain, Nausea, Neck pain, Nerve injury, Oedema peripheral, Pain, Product quality issue, Tendon calcification, Tendonitis, Vomiting, X-ray abnormal, X-ray limb
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Arthritis (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in a 55-year-old female subject who was vaccinated with BOOTRIX (GlaxoSmithKline). On 5 September 2012 the subject received unspecified dose of BOOSTRIX (unknown). On 5 September 2012, less than one day after vaccination with BOOSTRIX, the subject experienced burning pain at injection site, neck pain, shoulder pain, nausea, vomiting, pain spread, limited range of motion, muscle spasm, pain, unable to sleep on left side, extensive swelling of injected limb, hand swollen and pharmaceutical product complaint. The events were further described as left shoulder severe pain, burning radiating to the back of the neck had limited use of arm (range of motion (ROM). Continued to have muscle spasms at night. Took FLEXERIL, TYLENOL, and Ibuprofen for pain control. Unable to sleep on left side. According to the healthcare professional the vaccine was administered in the same doctor''s office, all from lot AC37B066AC. Approximately 14 doses were administered and 26 were left unused. The subject had no previous vaccine reactions, allergic reactions, pre-existing medical conditions or risk factors. The subject had noticeable diffuse injection site swelling, increased circumference of the injected limb "yes- swelling hand"; a diffuse reaction of whole injected limb "yes-shoulder/neck pain". Relevant test results included an x-ray performed on left shoulder on 14 September 2012, results not provided. At the time of results included an x-ray performed on left shoulder on 14 September 2012, results not provided. At the time of reporting the outcome of nausea and vomiting were resolves; burning pain at injection site, neck pain, shoulder pain were unresolved; unable to sleep on left side, radiating pain, muscle spasm, pain, extensive swelling of injected limb, hand swollen were unspecified. The healthcare professional considered the events of neck pain, shoulder pain, nausea, vomiting and burning pain at injection site as probably related to vaccination with BOOSTRIX. The healthcare professional initially reported 13 subjects experienced events, on 26 September 2012 healthcare professional clarified that all recipients had experienced some adverse events, but found out that there were only five subjects with significant reactions. This the second of five subjects who experienced adverse events with BOOSTRIX; please see cases A0993364A, A0996172A - A0996174A. According to product complaint investigation results reported by GSK Biologicals quality assurance on 26 September 2012, the product complaint was assessed to be unsubstantiated. Follow-up information was received on 08 October 2012 via Quality Assurance. BOOSTRIX vaccine lot AC37B066AC had been checked by GSK Biologicals QA and Quality Control. There was no deviation that could impact the quality of the product, no deviation or incident that could be linked to the adverse event has been recorded during warehousing activities; no deviation that could impact the quality of the product has been reported during the distribution and cold chain. The check of the final container product retain samples and of the final packaging retain samples batch AC37B066AC were checked and no defect that could impact the quality of the product has been detected. This lot had been produced in compliance with the Good Manufacturing Practices and meets the requirements of our specifications. Follow-up information was received on 10 October 2012 via healthcare professional who reported an additional event of the subject showing a three millimeter of calcification in the muscle at site of injection. The healthcare professional considered the events non-serious. Additional Quality Assurance results received on 22 October 2012 via GSK Biologicals quality assurance, stated sample was returned (27 syringes). All samples conformed to the specification for the description. After the sedimentation test, they indi

VAERS ID:482358 (history)  Vaccinated:2012-09-05
Age:5.0  Onset:2012-09-10, Days after vaccination: 5
Gender:Male  Submitted:2013-01-23, Days after onset: 135
Location:Foreign  Entered:2013-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Azithromycin
Current Illness: Birth mark; Enteroviral infection
Preexisting Conditions:
Diagnostic Lab Data: Absolute neutrophil count, 3.13X10E9/l; Alanine aminotransferase, 20Nov2012, 1.42; Alanine aminotransferase, 0.36ukat/l; Aspartate aminotransferase, 20Nov2012, 1.42; Aspartate aminotransferase, 0.49ukat/l; Basophils, 0.0%; Blood glucose, 4.5mmol/l; Blood pressure, 13Nov2012, 97/76; Body temperature, Sep2012, 39Deg. C; Body temperature, 39.2Deg. C; C-reactive protein, 0.0mg/l; Complement factor C3, 1.2g/l; Complement factor C4, 0.28/l; Culture throat, Expected; Eosinophils, 1.5%; Erythrocyte sedimentation rate, 5.62X10E12/L; Gamma-glutamyltransferase, 20Nov2012, 0.38; Heart rate, 13Nov2012, 108bpm; Hematocrit, 40.0%; Hemoglobin, 20Nov2012, 132; Hemoglobin, 14.1g/gl; Immunoglobulin G, 11.74g/l; Immunoglobulin M, 0.62g/l; Lymphocytes, 53.2%; M
CDC Split Type: B0850380A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B209AC UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase, Aspartate aminotransferase normal, Bacterial test positive, Basophil percentage decreased, Blister, Blood bilirubin normal, Blood cytokine test, Blood glucose normal, Blood immunoglobulin G, Blood immunoglobulin M, Borrelia test negative, C-reactive protein decreased, Complement factor C3, Complement factor C4, Cough, Crystal urine present, Culture stool positive, Culture throat, Diarrhoea, Eosinophil count normal, Eosinophil percentage, Erythema, Fungal infection, Gamma-glutamyltransferase, Glucose urine absent, Haematocrit normal, Haemoglobin normal, Headache, Hyperaemia, Increased upper airway secretion, Injection site inflammation, Lip swelling, Lymphadenitis, Lymphadenopathy, Lymphocyte count increased, Lymphocyte percentage increased, Macule, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean platelet volume normal, Monocyte percentage, Mycoplasma test,