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Case Details (Sorted by Vaccination Date)

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VAERS ID:340816 (history)  Vaccinated:2008-02-24
Age:3.0  Onset:2008-02-25, Days after vaccination: 1
Gender:Female  Submitted:2009-02-24, Days after onset: 365
Location:Florida  Entered:2009-02-26, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None Known
Current Illness: No known
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B116AB0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1366X1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1536X1SCRL
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Heart rate increased, Immediate post-injection reaction, Lip oedema, Swollen tongue, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: 5-8 min after receiving CODEINE child''s tongue started swelling, vomited, HR increase, lips edematous, SOB, unresponsive EPI PEN given IM, O2 started, paramedics called child, transported to hospital approx 20 mins later, child more responsive at this time, asking for mother.

VAERS ID:306119 (history)  Vaccinated:2008-02-25
Age:15.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 11
Location:Connecticut  Entered:2008-02-19, 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:
Preexisting Conditions: Hypersensitivity; Drug hypersensitivity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA00140
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Syncope, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female who on approximately 31-JAN-2008 was vaccinated with the first dose of Gardasil (lot number not reported). Concomitant therapy included MENACTRA. Subsequently the night of the injection the patient experienced hives. The patient was reported to be recovering. No further information is available. 07/08/08 Information has been received from a physician concerning a 14 year old female with an allergy to cats and SEPTRA, who on 25-Feb-2008 was IM vaccinated with the third dose of GARDASIL (lot number 659653/1448U) in the left deltoid. Original documentation indicated concomitant therapy included MENACTRA, however follow up information did not confirm this. Approximately 4 minutes after the vaccine injection the patient felt faint and fell to the floor hitting right side of her head on the hard floor. It last only a few seconds. Ice was applied to her head and the patient was seen by a physician. She complained of headache. Patient was monitored for 1.75 hours after incident. Patient was sent home with instructions to go to ER if condition worsened. The patient recovered on the same day. No further information is available.

VAERS ID:305573 (history)  Vaccinated:2008-02-25
Age:0.4  Onset:0000-00-00
Gender:Female  Submitted:2008-02-25
Location:Ohio  Entered:2008-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B126AA1IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF163AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC391861IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Patient inadvertently given Hepatitis A vaccine.

VAERS ID:305730 (history)  Vaccinated:2008-02-25
Age:4.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-02-26, Days after onset: 1
Location:Georgia  Entered:2008-02-26
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: bp 100/50 R30 T98.8 P110 2:20pm
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217BA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1101U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Body temperature, Erythema, Heart rate, Pruritus, Rash, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt in clinic for wic & immunization services. approximately 1 hr after receiving varicella and hepatitis A vaccines pt developed red blotchy rash initially on arms which progressed to lower back, and legs. Vital signs bp 100/50, pulse 110, R 30 T 98.8. 9.5ml diphenhydramine given po no wheezing or respiratory distress noted. after 15-20 minutes no visible improvement of rash noted and pt was observed scratching. Pt referred to facility.

VAERS ID:305740 (history)  Vaccinated:2008-02-25
Age:45.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-26, Days after onset: 0
Location:Massachusetts  Entered:2008-02-26
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: ''bad knees and shoulders''
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB521AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Body temperature, Dizziness, Headache, Heart rate, Malaise
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: 2-26-08 EE rcv''d the Hep B vaccine yesterday ~2p. EE seen in Health Services ~ 12:40p. States he has a h/a, is dizzy, feels ''lousy'' over the past 4 hours. Feels like he''s getting worse. States he felt fine prior to that. Many ee''s have been sick w/flu, etc. BP 120/86, P-88/reg. T-97.5.

VAERS ID:305759 (history)  Vaccinated:2008-02-25
Age:15.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-26, Days after onset: 1
Location:Florida  Entered:2008-02-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mono 3 wks ago
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2545AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None Stated

VAERS ID:305869 (history)  Vaccinated:2008-02-25
Age:2.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-27, Days after onset: 1
Location:Indiana  Entered:2008-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None listed on health history form.
Preexisting Conditions: Allergic to Fish
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2606AA3IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70143H3IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gait disturbance, Injection site erythema, Injection site mass, Injection site swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient had three immunizations on 2/25/08. He received two immunizations in the left thigh and one in the right thigh. He awoke on 2/26/08 with a hard red bump at the top immunization site on the left thigh. The thigh then became progressively more red and now the child has a red bump the size of a baseball according to the mother. The thigh is also swollen and painful. The child does not want to walk on the affected leg. There is no fever but the child has a decreased appetite. Mother advised to apply cool compresses to area. Mother advised she was administering Motrin as directed every four to six hours. Mother advised to call physician for further instructions. Mother advised she had called the physician and was waiting for him to return her call. She just wanted to know what immunizations were done in the affected thigh so she could advise the physician. I requested the mother call back to let us know the outcome of this situation once she spoke to the physician.

VAERS ID:305888 (history)  Vaccinated:2008-02-25
Age:9.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-26, Days after onset: 1
Location:Michigan  Entered:2008-02-27, 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: Pediculosis
Preexisting Conditions: Penicillin;
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS808230IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB213AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.149301SCLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Left outer arm red and warm slight induration 2" x 1"2"

VAERS ID:305889 (history)  Vaccinated:2008-02-25
Age:1.3  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-27, Days after onset: 1
Location:Arizona  Entered:2008-02-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355BA3UNRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site reaction, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Reaction to Dtap, swelling. Apply warm compress.

VAERS ID:305895 (history)  Vaccinated:2008-02-25
Age:2.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-28, Days after onset: 2
Location:Indiana  Entered:2008-02-27, 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: None.
Current Illness: None
Preexisting Conditions: tongue tied at birth
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU17233C3IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0223F2IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225BB1IMRL
Administered by: Public     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right thigh swollen, red. Patient fussy, slight fever, 99deg; Family Physician prescribed antibiotics. Red and swollen from hip to above knee (inner thigh to hip area); dx: cellulitis

VAERS ID:306065 (history)  Vaccinated:2008-02-25
Age:14.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-28, Days after onset: 2
Location:California  Entered:2008-02-28
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0012U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2342CA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC2384AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Listless, Musculoskeletal stiffness, Pyrexia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Arthritis (broad)
Write-up: Patient states she experienced headache, ringing of ears, stiff neck, listlessness and fever the day after receiving vaccines.

VAERS ID:306078 (history)  Vaccinated:2008-02-25
Age:36.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-28, Days after onset: 2
Location:Massachusetts  Entered:2008-02-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis
Preexisting Conditions: Emycen; Augmentin; Motrin.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD1821UNLA
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received Td on 2/25/08, reported increasing pain, fever, swelling, induration left injection site 1 day after receiving vaccine. Doctor diagnosis cellulitis. Treated with Levaquin 500mg for 7 days.

VAERS ID:306199 (history)  Vaccinated:2008-02-25
Age:3.0  Onset:2008-02-29, Days after vaccination: 4
Gender:Male  Submitted:2008-02-29, Days after onset: 0
Location:Wisconsin  Entered:2008-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132AA2IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0073U2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1070P0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016D2IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1094U0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis
SMQs:
Write-up: Development of cellulitis at vaccine site

VAERS ID:306230 (history)  Vaccinated:2008-02-25
Age:65.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Iowa  Entered:2008-02-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies to PCN, Bactrim, Zyrtec, Lisinopril. Hx eczema and alopecia totalis and hypothyroidism.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0856U0UNLA
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: Pt returned for recheck appt. of other problem - showed injection site (L) upper arm - red and swollen.

VAERS ID:306235 (history)  Vaccinated:2008-02-25
Age:13.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-25, Days after onset: 0
Location:Pennsylvania  Entered:2008-02-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Syncope - vasovagal episodes
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Stomach discomfort
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), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After receiving Hep A injection, pt felt dizzy and stomach "felt funny". Pt laid down on exam table and "passed out" for a couple of seconds and waited in room for 10 minutes. Pt recovered quickly. BP was taken 90/60. Pt left with mother feeling well.

VAERS ID:306267 (history)  Vaccinated:2008-02-25
Age:26.0  Onset:2008-02-29, Days after vaccination: 4
Gender:Female  Submitted:2008-03-03, Days after onset: 3
Location:Texas  Entered:2008-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Common Cold, runny nose
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Fatigue, Injection site induration, Injection site pain, Injection site warmth, Rash
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Intense soreness at injection site for 2 days after vaccine. The day after vaccine complaints of fatigue and weakness. Four days after vaccine noticed red rash about 3 inches below injection site. Site is warm to touch and tight. No temperature at time she came to clinic.

VAERS ID:306320 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-27, Days after onset: 1
Location:Illinois  Entered:2008-03-03, 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: Nuvaring
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB438AA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Flushing, Oedema, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Patient stated itching approximately 27 hours after vaccine. Returned to have edema and flushing approximately 5" in diameter from IM site. Patient denies any pain or discharge.

VAERS ID:306392 (history)  Vaccinated:2008-02-25
Age:15.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-28, Days after onset: 2
Location:Alabama  Entered:2008-03-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2730AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1578U0SCRA
Administered by: Public     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 (posterior aspect of right upper arm). [Varicella vaccine site].

VAERS ID:306401 (history)  Vaccinated:2008-02-25
Age:14.0  Onset:2008-02-27, Days after vaccination: 2
Gender:Male  Submitted:2008-02-29, Days after onset: 2
Location:North Carolina  Entered:2008-03-04, 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: Osgood-Schlatters Dis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2565AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Herpes zoster, Rash papular
SMQs:
Write-up: Onset papular rash (L) arm involving deltoid to forearm area 2 days following injection-compatible with H. Zoster

VAERS ID:306409 (history)  Vaccinated:2008-02-25
Age:19.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-28, Days after onset: 2
Location:Maryland  Entered:2008-03-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0013X1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1506U0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature, 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: Patient noticed redness and swelling at injection site with itching - area 7cm x 5cm, red and raised. Temperature 99.

VAERS ID:306411 (history)  Vaccinated:2008-02-25
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2008-02-27
Location:South Carolina  Entered:2008-03-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Neurosensory hearing deficit; both hearing aids.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2523AA1SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1310U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351693IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1652U0IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: Flu vaccine given SQ while Varivax vaccine given IM. Doctor spoke with the parent, explained situation, told them what to look for (signs and symptoms), and offered to regive vaccines at later date. Dad declined.

VAERS ID:306412 (history)  Vaccinated:2008-02-25
Age:13.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-26, Days after onset: 0
Location:Pennsylvania  Entered:2008-03-04, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U2UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1464U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Woke up with large erythematous circle at injection site. Tender and warm to touch 7.5 cm x 5 cm.

VAERS ID:306418 (history)  Vaccinated:2008-02-25
Age:1.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-27, Days after onset: 1
Location:Michigan  Entered:2008-03-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1965CA2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2477DA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0676U2IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02732SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70143A2IMRL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Mom called 13 hours after vaccination - child woke with fever 103 - given oral Motrin with reduction in fever 75 minutes later - afebrile since then. This was child''s 1st flu shot.

VAERS ID:306422 (history)  Vaccinated:2008-02-25
Age:2.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-26, Days after onset: 0
Location:Arizona  Entered:2008-03-04, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: leg swelling~DTaP (no brand name)~3~2~In Patient
Other Medications: None
Current Illness: URI, (B) otitis
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA3UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB2111AA1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (R) deltoid red, warm, swollen continually tender

VAERS ID:306423 (history)  Vaccinated:2008-02-25
Age:4.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-28, Days after onset: 2
Location:Pennsylvania  Entered:2008-03-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1310U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Erythema 8x9 cm, induration at site, minimal pain. No treatment needed.

VAERS ID:306426 (history)  Vaccinated:2008-02-25
Age:24.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-27, Days after onset: 2
Location:Nebraska  Entered:2008-03-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TB skin test 2/25/08
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0874U0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, 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: Noted approximately 2100 2/25/08 noted soreness and warmth at injection site. The next morning noted swelling, warm to touch, soreness, and when lifting arm away from body site is painful. Injection site has a "pimple" like spot. Didn''t check for fever at home.

VAERS ID:306427 (history)  Vaccinated:2008-02-25
Age:9.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-02-27, Days after onset: 1
Location:California  Entered:2008-03-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225BB0IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01113SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1594U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 90mm red, swollen, area at injection site- No fever; mild tenderness- treated with cold packs and Motrin.

VAERS ID:306429 (history)  Vaccinated:2008-02-25
Age:5.0  Onset:2008-02-27, Days after vaccination: 2
Gender:Male  Submitted:2008-02-28, Days after onset: 1
Location:Vermont  Entered:2008-03-04, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA2UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01692UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526U1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1471U1UNRA
Administered by: Private     Purchased by: Public
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: Large, warm, red, swelling at site. Approximately 10cm long, 6cm wide.

VAERS ID:306497 (history)  Vaccinated:2008-02-25
Age:63.0  Onset:2008-03-01, Days after vaccination: 5
Gender:Female  Submitted:2008-03-05, Days after onset: 4
Location:California  Entered:2008-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB096AA0IMRA
MEN: MENINGOCOCCAL (MENOMUNE)SANOFI PASTEURUF157AB0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash, Rash pustular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: On March 5, 2008 patient called pharmacy to say she had developed a rash on her legs about 4 to 5 days after receiving vaccinations. The rash stopped on her legs but continued up to her trunk. She described the rash as tiny, bumpy with pustules. She said it did not bother her but I informed her she could use diphenydramine (Benadryl) cream or hydrocortisone cream on any "closed" pustules.

VAERS ID:306501 (history)  Vaccinated:2008-02-25
Age:5.0  Onset:2008-02-29, Days after vaccination: 4
Gender:Female  Submitted:2008-03-05, Days after onset: 5
Location:Virginia  Entered:2008-03-05
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 PASTEURC2799AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0984U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: 15 vesicular lesions over abdomen, back, hairline. 1 lesion in left eye. Lesions appeared within 4 days of vaccination.

VAERS ID:306507 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-03-03, Days after vaccination: 7
Gender:Male  Submitted:2008-03-05, Days after onset: 2
Location:Oklahoma  Entered:2008-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760IDLA
Administered by: Military     Purchased by: Military
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large local reaction around injection site with 8x8 cm area of erythema, swelling and TTP 1 week after administration. Area swelling and redness did not extend beyond shoulder or elbow. Pt was restricted from some duties becuase of arm pain.

VAERS ID:306614 (history)  Vaccinated:2008-02-25
Age:5.0  Onset:2008-02-28, Days after vaccination: 3
Gender:Female  Submitted:2008-02-02, Days after onset: 26
Location:California  Entered:2008-03-06, Days after submission: 33
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B13AA2UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.08U1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1585U1UNRL
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Large red raised area on rt thigh.

VAERS ID:306585 (history)  Vaccinated:2008-02-25
Age:71.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-03-06, Days after onset: 9
Location:New York  Entered:2008-03-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: recent cardiac bypass surgery, atherosclerotic heart disease, hypothyroidism, essential hypertension, hyperlipidemia.
Diagnostic Lab Data: Check with Hospital. Labs and Diagnostics: WBC 15.8, Hgb 9.5, Hct 28. Troponin 0.08. CPK 80. CXR WNL. Urine cx (+) for Gram (-) rods.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.154100IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Asthma, Blood creatine phosphokinase increased, Breath sounds abnormal, Cellulitis, Chest pain, Chills, Confusional state, Culture urine positive, Depressed level of consciousness, Dyspnoea, Egobronchophony, Feeling abnormal, Goitre, Haematocrit decreased, Haemoglobin decreased, Hyperhidrosis, Injection site erythema, Injection site pain, Lethargy, Pyrexia, Somnolence, Sputum purulent, Troponin, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: About 30 hours after administration of vaccine (2/26), patient complained of pain at the site of injection. Pain worsened over the next 24 hours. Patient slept almost the entire day, lost his appetite, seemed dazed and somewhat confused. By 9 P.M. it was difficult to rouse patient. Called 911. Patient admitted to hospital with cellulitis of the left upper arm and possible pneumonia. Pneumonia ruled out after 48 hours. Augmentin therapy started 2/29, P.M. Patient released from hospital 3/2. Still on augmentin therapy. Still experiencing mild pain. 03/12/2008 MR received for DOS 2/27 to 3/2/08. Pt presented with onset of increased somnolence and lethargy, SOB, sweats, fever, chills, purulent sputum and chest pain. Redness at site of recent Pneumovax. Cellulitis of the L arm and R leg noted on PE, as well as thyromegaly and decreased breath sounds and egophony. 4/17/2008 D/C summary recd with D/C Dx: Cellulitis of the R leg and Left arm, asthmatic bronchitis, hyperlipidemia, atherosclerotic heart disease s/p bypass, well controlled essential hypertension, hypothyroidism, BPH, use of anti-coagulants, atrial fibrillation and DM Type II-diet controlled

VAERS ID:306630 (history)  Vaccinated:2008-02-25
Age:0.3  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-03-03, Days after onset: 7
Location:New Jersey  Entered:2008-03-07, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: no chemistry, no resp distress, no hypoxia LABS: chemistry WNL. CBC WNL w/neutros 51% (H), monos 1.5% (H). EKG revealed sinus rhythm w/RV hypertrophy. Echocardiogram WNL. Holter monitor revealed mostly bradycardia w/some tachycardia, n
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF342AB1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04741IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54014D1IMRL
Administered by: Private     Purchased by: Private
Symptoms: Bradycardia, Cold sweat, Cyanosis, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Full blood count normal, Hypotonia, Hypotonic-hyporesponsive episode, Laboratory test normal, Lethargy, Monocyte percentage increased, Neutrophil percentage increased, Oxygen supplementation, Pallor, Right ventricular hypertrophy, Tachycardia, Unresponsive to stimuli, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt had vaccine in morning. That evening approx 6pm-Mom noted that child became, pale, lethargic with lips "Blue" lasted 6-8 minutes, called 911, EMT arrivesd noted limp infant with blue lips. O2 given. Sent to hospital for eval and observation. Recovered to nl state. Observed for 24 hrs. 3/11/08 Hospital medical records of 2/25-2/26/2008. FINAL DX: hypotonic-hyporesponsive episode as adverse immunization reaction Records reveal patient experienced unresonsiveness, lips blue, pale, limpness, clamminess lasting 8-10 min several hours s/p vaccination on day of admission. Similar episode s/p 2 mo vax but accompanied by hysterical screaming then apnea & cyanosis for less than 1 min. Neuro, cardio & ID consults done.

VAERS ID:306695 (history)  Vaccinated:2008-02-25
Age:52.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-06, Days after onset: 9
Location:Georgia  Entered:2008-03-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~Tdap (no brand name)~1~51~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Headache, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Reported pain, redness and swelling, feverish, body aches and headaches; Rx Alvelox; Administrator of vaccine notified of reaction on 3-6-08. Issue completely resolved at that time.

VAERS ID:306770 (history)  Vaccinated:2008-02-25
Age:62.0  Onset:2008-02-27, Days after vaccination: 2
Gender:Female  Submitted:2008-03-03, Days after onset: 5
Location:Montana  Entered:2008-03-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin, Levothyroxine, Hyzaar, Hydroxychloraquine, Metformin, Carbidopa, Levodopa, arthrotec.
Current Illness: None
Preexisting Conditions: Diabetes, Hyperlipidemia, RLS, hypothyroid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.3045U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2-25-08 Zostavax vaccine administered SQ arm. 3-3-08 Pt called and said 2 days after vaccine administered, pt report arm started to itch that evening and got hot, raised and reddened about "the length of a hotdog" at injection site. No hives, SOB, etc. Reaction at injection site only. Pt stated someone told her she should report this to the clinic.

VAERS ID:306779 (history)  Vaccinated:2008-02-25
Age:60.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-03-03, Days after onset: 7
Location:Massachusetts  Entered:2008-03-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Right hand itchy rash
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0185U SCLA
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD182 IMLA
Administered by: Other     Purchased by: Public
Symptoms: Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Generalized itchy rash in entire body the night after MMR injection on 2/25/08.

VAERS ID:306809 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-10, Days after onset: 12
Location:Massachusetts  Entered:2008-03-11, 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: None
Current Illness: Asthma; Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA00362
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Joint range of motion decreased, Pain, Pruritus, Pyrexia, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a licensed practical nurse concerning her 18 year old daughter, with "possible asthma" and an allergy to sulfamethoxazole (+) trimethoprim (SEPTRA), who on 25-FEB-2008 was vaccinated with the third dose of Gardasil. There was no concomitant medication reported. On 26-FEB-2008 the patient experienced a systemic reaction about "24 hours after vaccination with her third dose of Gardasil." The reaction was not anaphylactic. Her daughter developed hives, swelling, itching, pain, fever and had difficulty moving her joints. She was taken to the emergency room and given prednisone and diphenyhydramine hydrochloride (BENADRYL). No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Hives, swelling, itching, pain, fever, and difficulty moving her joints were considered to be other important medical events. Additional information has been requested.

VAERS ID:306836 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-02-28, Days after onset: 3
Location:Missouri  Entered:2008-03-11, 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: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest discomfort, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Patient calls on phone 2-26-08 stating she had hives several hours after injection. She took Benadryl and used hydrocortisone cream. By the next morning these were better. She then developed some intermittent chest discomfort and shortness of air. Instructed patient to go to ER. Patient did not go. Spoke to her on 2-27-08, was better.

VAERS ID:306846 (history)  Vaccinated:2008-02-25
Age:1.0  Onset:2008-03-03, Days after vaccination: 7
Gender:Female  Submitted:2008-03-04, Days after onset: 1
Location:Michigan  Entered:2008-03-11, 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 known
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B127AA2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR I)MERCK & CO. INC.0283U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016C2IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1767U0SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: Red and swollen at site with fever.

VAERS ID:306923 (history)  Vaccinated:2008-02-25
Age:1.3  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-06, Days after onset: 9
Location:New Mexico  Entered:2008-03-12, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54013D3UNLL
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Excoriation, Skin warm
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (broad), Hypersensitivity (broad)
Write-up: Quarter size red area with knot, warm to touch 1/2" away from injection site of left thigh. Benadryl, Tylenol, Motrin to be given as needed.

VAERS ID:306966 (history)  Vaccinated:2008-02-25
Age:0.3  Onset:2008-02-27, Days after vaccination: 2
Gender:Male  Submitted:2008-03-11, Days after onset: 12
Location:Wyoming  Entered:2008-03-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Club feet
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSB08702H1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF144AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHAC1B125AB1IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash on torso (anterior and posterior). Hydroxyzine.

VAERS ID:307034 (history)  Vaccinated:2008-02-25
Age:28.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-03-13, Days after onset: 16
Location:California  Entered:2008-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cellcept 1g PO QD; Prednisone 6 mg PO QOD
Current Illness:
Preexisting Conditions: Pemphigus
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2835AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Rash/hives to limbs and trunk 8-10 hr after vac. 50 mg Benadryl PO; Pepcid 40 mg PO; Prednisone 30 mg PO

VAERS ID:307133 (history)  Vaccinated:2008-02-25
Age:14.0  Onset:2008-03-06, Days after vaccination: 10
Gender:Male  Submitted:2008-03-14, Days after onset: 7
Location:Massachusetts  Entered:2008-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Lumbar Puncture: Spinal fluid with protein of 143, 7 white blood cells (78% lymphocytes, and 10% monocytes), 0 red blood cells, glucose of 60). MRI of brain and spine was normal. LABS: MRI brain & spine WNL. CSF protein 143 (H), glucose 60, c/s neg. Unable to complete EMG/NCS. WBC 3.53 (L). ESR 29 ( H).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Areflexia, Blood product transfusion, CSF culture negative, CSF glucose abnormal, CSF lymphocyte count abnormal, CSF monocyte count decreased, CSF protein increased, CSF white blood cell count increased, Fall, Fatigue, Gait disturbance, Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulins, Influenza like illness, Lumbar puncture, Micturition urgency, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Pallor, Penis disorder, Red blood cell sedimentation rate increased, Sensation of heaviness, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Malignant lymphomas (broad)
Write-up: Guillain-Barre Syndrome 4/25/08 Reviewed hospital medical records of 3/11-3/20/2008. FINAL DX: Guillain Barre syndrome. Records reveal patient experienced fatigue, pallor, urinary urgency, progressive difficulty walking w/pain & heaviness in his legs, penis & back x 2 weeks resulting in several falls. Immediately s/p vaccine, experienced flu-like symptoms which resolved w/n 24 hours. While hospitalized developed increased LE weakness, areflexia. Neuro consult done. Tx w/IVIG x 5 days. D/C to inpatient rehab facility for continued PT.

VAERS ID:307196 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2008-03-17
Location:Pennsylvania  Entered:2008-03-17
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
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Pt administered first Rotavirus vaccine at 12 weeks and 2 days; automatic warning was not triggered; spoke with mom and informed her; no adverse events noted.

VAERS ID:307448 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-03-14, Days after onset: 17
Location:Washington  Entered:2008-03-17, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA05572
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1731U0PO 
Administered by: Other     Purchased by: Other
Symptoms: Drooling, Infantile spitting up, Regurgitation
SMQs:, Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Neonatal disorders (narrow)
Write-up: Information has been received from a registered nurse concerning a 9 week old male with no pertinent medical history or drug allergies who on 25-FEB-2008 was vaccinated PO with his first dose of Rotateq (lot# 659856/1731U). There was no concomitant medication. After vaccination the patient vomited an amount more than the dose that was given. Medical attention was sought in the physician''s office. No labs or diagnostic studies were performed. The nurse would not consider this type of action as "vomiting" but rather as normal drool or spitting up of some of the medication. Also the nurse does not feel this event was attributable to the Rotateq. Therefore, there was no more information to follow with regards to "an unspecified number of children who received Rotateq that have also vomited." On that same day, the patient recovered. There was no product quality complaint. Additional information has been requested.

VAERS ID:307263 (history)  Vaccinated:2008-02-25
Age:78.0  Onset:2008-03-05, Days after vaccination: 9
Gender:Female  Submitted:2008-03-13, Days after onset: 7
Location:California  Entered:2008-03-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.1835U0SC 
Administered by: Other     Purchased by: Private
Symptoms: Formication, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Injection administered 2/25/08 at Safeway pharmacy. Patient states fine first week. Second week rash on upper chest; she treated with Lidx cream. Now has "rash" on right temple by eye and has "crawling" sensation under skin on face. No pain experienced.

VAERS ID:307296 (history)  Vaccinated:2008-02-25
Age:66.0  Onset:2008-02-28, Days after vaccination: 3
Gender:Female  Submitted:2008-03-18, Days after onset: 18
Location:Massachusetts  Entered:2008-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: Quiescent asthma and collagenous colitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuralgic amyotrophy
SMQs:
Write-up: The patient developed a painful brachial neuritis (Parsonage Turner syndrome) in the left arm three days after administration of Tdap in the left deltoid. Slight improvement to date on prednisone therapy; ultimate recovery unknown.

VAERS ID:307305 (history)  Vaccinated:2008-02-25
Age:1.6  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-03-18, Days after onset: 21
Location:Illinois  Entered:2008-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: pneumonia with reactive bronchospasm - resolved
Preexisting Conditions:
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA3IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0223U2IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA1IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Received Dtap and Hep A in right thigh on 2/25/08. Mother called 2/26/08 stated that swelling in leg since last night. Examined in clinic right anterior thigh with erythema, edema, warmth. Treated for cellulitis with Bactrim 40/200/5ml 1 1/2 tsp bid x 10 days. Mother states swelling redness resolved in 3 days.

VAERS ID:307995 (history)  Vaccinated:2008-02-25
Age:23.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lo Estrin
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Stool O and P negative; stool culture negative 2/29/08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Culture stool negative, Diarrhoea, Parasite stool test negative
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea started 1 day after getting Gardasil vaccine, associated with abdominal pain and possible bloody stool. Seen at urgent care on 2/29/08 (same address as above)

VAERS ID:308324 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:2008-03-17, Days after vaccination: 21
Gender:Female  Submitted:2008-03-26, Days after onset: 9
Location:Unknown  Entered:2008-03-27, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory - positive rotavirus
CDC Split Type: WAES0803USA03522
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Dehydration, Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 12 week old female with no medical history or allergies who was vaccinated with ROTATEQ 2 ML PO first dose on 25-FEB-2008. There was no concomitant medication. The physician reported that the patient received the first dose of ROTATEQ and three weeks later experienced diarrhoea and vomiting. The patient was seen in the office and was dehydrated. The patient was sent to the hospital for blood tests and was positive for rotavirus. The patient was hospitalized overnight. The physician reported that the patient is: "She''s good today( 20-MAR-2008)" The patient sought medical attention. The physician reported that the rotavirus caused the hospitalization and was an other important medical event. Additional information has been requested.

VAERS ID:308483 (history)  Vaccinated:2008-02-25
Age:36.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-02-28, Days after onset: 2
Location:Florida  Entered:2008-03-28, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1634SCLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ11023IMRA
Administered by: Military     Purchased by: Military
Symptoms: Local swelling, Nodule, Pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized swelling and pain with underlying nodule. (L) arm.

VAERS ID:308648 (history)  Vaccinated:2008-02-25
Age:22.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 30
Location:Oregon  Entered:2008-03-31, 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: Levaza 28; Iron; Macrodatin
Current Illness: None
Preexisting Conditions: Penicillin; Recurrent UTI; Anemia - Iron def
Diagnostic Lab Data: CBC, CMP, CRP, ESR, UA Dip
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein, Full blood count, Headache, Laboratory test, Myalgia, Pyrexia, Red blood cell sedimentation rate, Throat tightness, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Extreme joint pain, sore muscles, headache, stomach ache, fever, throat tightness.

VAERS ID:309145 (history)  Vaccinated:2008-02-25
Age:31.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-04-02, Days after onset: 35
Location:Pennsylvania  Entered:2008-04-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Congested nasally. Difficulty breathing.

VAERS ID:309469 (history)  Vaccinated:2008-02-25
Age:9.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-18, Days after onset: 20
Location:Michigan  Entered:2008-04-14, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: constipation
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1469U1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9 y.o. girl received booster varicella vaccine. Mother called the next day stating that upper arm was quite swollen surrounding injection site (and red) - about size of an orange. Also tender. After 1 day -$g arm was back to normal per mother.

VAERS ID:310474 (history)  Vaccinated:2008-02-25
Age:16.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 47
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Allergy to vaccine
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA04092
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Information has been received from a consumer concerning her 16 year old daughter with a history of "sensitivity to vaccines" who about a month ago on approximately 25-FEB-2008 was vaccinated with her first dose of Gardasil (lot# unspecified, injection site and route not reported). There was no concomitant medication. The patient experienced pain at the site of injection and developed arthralgia after receiving her her first dose. The arthralgia developed about 24 hours after receiving Gardasil and lasted 48 hours. The patient sought medical attention by speaking with the physician. The physician''s name is "Dr." No other information about the physician was available. The patient recovered on an unspecified date. Additional information is not expected.

VAERS ID:310692 (history)  Vaccinated:2008-02-25
Age:16.0  Onset:2008-02-27, Days after vaccination: 2
Gender:Female  Submitted:2008-04-14, Days after onset: 46
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA02134
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician''s wife concerning a 16 year old female who on 25-FEB-2008 was vaccinated with the third dose of Gardasil (lot number: 659182/1757U). On approximately 27-FEB-2008 the patient experienced a hive-like eruption at the injection site within 48 hours post vaccination. It was reported by the physician''s wife that the patient called the office on 27-FEB-2008 to report her symptoms and the patient was then treated with Benadryl 25mg and cold compress until the symptoms resolved. Subsequently, the patient recovered from hive-like eruption. No further information is available. This is in follow-up to report (s) previously submitted on 4/14/2008. Follow-up information was received which indicated that the patient had received the 3rd dose of the GARDASIL and experienced a local reaction redness and swelling which lasted for 4 days. No further information is available.

VAERS ID:310341 (history)  Vaccinated:2008-02-25
Age:1.0  Onset:2008-03-07, Days after vaccination: 11
Gender:Male  Submitted:2008-04-21, Days after onset: 44
Location:Colorado  Entered:2008-04-21
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 known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0747U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54015D3IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0764U0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash erythematous, Rash morbilliform
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Two weeks after MMR & Varicella vaccination. Red rash on chest, legs, neck and face. Physician diagnosed as "measles" rash. Also a raised rash on face, neck and ears. Child was put on Motrin. Resolved in two weeks.

VAERS ID:310534 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:2008-03-18, Days after vaccination: 22
Gender:Female  Submitted:2008-04-11, Days after onset: 24
Location:North Carolina  Entered:2008-04-22, 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: None
Current Illness:
Preexisting Conditions: None. PMH: none. NKDA.
Diagnostic Lab Data: "EKG, UGI, echo and EEG were normal limits." Labs and Diagnostics: Abd X-ray c/w IS. Barium enema (+) for Ileocolic IS. Upper GI WNL. CXR (+) for low lung volumes. EEG normal. 2D Echo normal except fpr a small PFO. CBC WNL
CDC Split Type: NC08044
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451510IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0876U0PO 
Administered by: Public     Purchased by: Public
Symptoms: Abdominal X-ray, Apnoea, Barium enema abnormal, Crying, Cyanosis, Diarrhoea, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Enema administration, Faeces discoloured, Full blood count normal, Intussusception, Irritability, Urinary system X-ray, Vomiting, X-ray with contrast upper gastrointestinal tract
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Patient developed vomiting episodes for days and irritable. Followed by watery black stools. Evaluated at "hospital - Pediatric (3-18-08) ED. KUB done (consisted with intussusception) ileocolic intussusception reduced with pneumatic reduction. Apnea episode (brief, did not require O2/stimulation only). EKG, UGI, echo and EEG were normal limits. Apnea episode occurred after reduction and when sleep; IV infiltrated. Discharged home in 2 days. 04/28/2008 MR received for DOS 3/18-20/2008 with D/C DX: Intussusception s/p reduction, apnea spell x1. Pt presented to ER with 3 day hx of vomiting after every meal, irritability, crying, and dark watery stool. PE WNL. Ileocolic Intussusception noted on and reduced by Barium Enema. Pt had an episode of cyanosis s/p reduction. W/u WNL.

VAERS ID:310760 (history)  Vaccinated:2008-02-25
Age:1.5  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-04-23, Days after onset: 57
Location:Texas  Entered:2008-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355CA3UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: No fever. Entire thigh swelled from groin to knee. Sx noted on 2/25/08. Leg was red & swollen. Pt was seen 2/27/08 - thigh diameter 25 cm.

VAERS ID:311761 (history)  Vaccinated:2008-02-25
Age:45.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 70
Location:Hawaii  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: Left arm cellulitis s/p vaccination. Fever.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS808220IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.66521110100IMLA
Administered by: Public     Purchased by: Public
Symptoms: Cellulitis, Dyspnoea, Erythema, Gait disturbance, Malaise, Pyrexia, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Left deltoid with erythemic area of 4 inches in circumference tender to touch/warm. Fever of 102.4. c/o: Malaise, SOB, difficult breathing, difficult ambulating.

VAERS ID:312778 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-05-14, Days after onset: 78
Location:Michigan  Entered:2008-05-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA06148
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1621U0PO 
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a healthcare professional concerning a 2-month-old male, with no pertinent medical history or allergies, who on 25-FEB-2008 was vaccinated orally with his first dose of ROTATEQ (lot # 659708/1621U). Concomitant vaccines included PEDIATRIX, PREVNAR and ACTHIB. On 25-FEB-2008, post vaccination, the patient experienced diarrhea, vomiting and fever. The patient''s mother sought medical attention via a call to the physician. Two months later during an office visit with the physician the patient had fully recovered, but the second dose of ROTATEQ was not given. No diagnostic labs were performed. A product quality complaint was not involved. Additional information is not expected.

VAERS ID:313429 (history)  Vaccinated:2008-02-25
Age:64.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-16
Location:Minnesota  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA05529
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCUN
Administered by: Private     Purchased by: Private
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Information has been received from a pharmacist concerning a 60 year old female who was scheduled to receive ZOSTAVAX (Oka/Merck) inadvertently received VARIVAX (Oka/Merck). The patient was not experiencing any known symptoms. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/16/08. Information has been received from a pharmacist concerning a 64 year old male, weight 118.4 kg, who on the morning of 25-FEB-2008 was scheduled to receive ZOSTAVAX (Oka/Merck) but inadvertently received VARIVAX (Oka/Merck) (MSD) subcutaneously. The patient was not experiencing any known symptoms. A product quality complaint was not reported. Additional information is not expected.

VAERS ID:317964 (history)  Vaccinated:2008-02-25
Age:43.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-06
Location:Oregon  Entered:2008-06-19, Days after submission: 44
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness:
Preexisting Conditions: The patient had no illness at the time of the vaccination on 25 February 2008. Past medical history included increased cholesterol that is being treated with LIPITOR. The patient had not received any other vaccinations within four weeks of 25 February 2008.
Diagnostic Lab Data: None
CDC Split Type: 200801363
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB517AA IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ0960 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Rash maculo-papular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Initial report received on 30 April 2008 from a nurse. A 43-year-old male (also reported as 44-year-old) patient whit no concurrent illnesses, had received on 25 February 2008 an intramuscular left deltoid injection of ADACEL (lot # C2904AA); an intramuscular left deltoid of TYPHIX Vi (Lot # Z0960-2) an intramuscular right deltoid injection of "HEP A" vaccine (manufacturer GlaxoSmithKline, Lot # AHBAB171AA); and an intramuscular right deltoid injection of "HEP B" vaccine (manufacturer GlaxoSmithKline, Lot # AHBVB517AA). The trade name for "HEP A" and "HEP B" vaccine were not provided. Twenty-four hours post-vaccination, the patient''s left arm became red and tender at the injection site. Several days later the patient developed dime and nickel sized red, raised and dried plaques of skin on the left deltoid, legs, abdomen, and forearms. The patient was evaluated by a physician and prescribed BENADRYL with no results. The patient received further treatments, but also did not experience any change in her condition. No relevant diagnostic tests/laboratory data were performed. At the time of this report, the patient had not recovered.

VAERS ID:319149 (history)  Vaccinated:2008-02-25
Age:66.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 119
Location:Unknown  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NASONEX, SINGULAIR
Current Illness: Asthma, Mycotic allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA05916
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Fatigue, Headache, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a 66 year old white female consumer (62 in 174 lb) with asthma and allergies to mold who on 25-FEB-2008 was vaccinated subcutaneously with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD) and mometasone furoate (NASONEX). On 25-FEB-2008 the patient developed pain (also reported as soreness) at the injection site with no redness and a mild headache that was different from usual. She also felt tired and had no energy for about 24 hours. (previously reported as no other symptoms noted). The patient did not seek medical attention and no diagnostic labs were performed. At the time of the report the patient''s status was recovering. A product quality complaint was not involved. Additional information is not expected.

VAERS ID:319183 (history)  Vaccinated:2008-02-25
Age:62.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 119
Location:Louisiana  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR, ZIAC
Current Illness: Cholesterol, Hypertension
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA00390
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Herpes zoster
SMQs:
Write-up: Information has been received from a 62 year old female consumer with no known allergies, cholesterol and hypertension who on 25-FEB-2008 was vaccinated with 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and bisoprolol fumarate/HCTZ (ZIAC). On the same day that she was administered zoster vaccine live (Oka/Merck), 25-FEB-2008 the patient developed shingles. On 01-MAR-2008 patient reported she started taking famciclovir (FAMVIR) and experienced a headache. Unspecified medical attention was sought. There were no lab studies performed. The patient''s outcome was not reported. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:319364 (history)  Vaccinated:2008-02-25
Age:51.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Male  Submitted:2008-07-16, Days after onset: 140
Location:Michigan  Entered:2008-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Patient had gone to the ER because he had fallen down a flight of stairs and hit his head.
Preexisting Conditions:
Diagnostic Lab Data: The doctors are unable to determine the cause of his pain and numbness. Even after multiple MRIs and CT scans.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Burning sensation, Computerised tomogram, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: He has had numbness and pain radiating from his left shouler down to his thumb and fingers. The pain is constant. He occasionally complains of "stinging" and "burning" sensations throughout his arm. He thumb is continously numb. He has significant weakness in this extremity. He is unable to perform many of the daily tasks that he was once able to do. These problems began within hours of receiving the vaccination.

VAERS ID:320484 (history)  Vaccinated:2008-02-25
Age:48.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-07-25, Days after onset: 149
Location:Iowa  Entered:2008-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NKA
Current Illness: NKA
Preexisting Conditions: NKA
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: developed fever 101 24-48 hours after injection with body aches. sore/red deltoid (injection site)5-30mm red warm blotches

VAERS ID:323549 (history)  Vaccinated:2008-02-25
Age:  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 155
Location:New York  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to antibiotics; Drug hypersensitivity
Preexisting Conditions: Bronchitis
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA05776
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1381U1ID 
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning a female (age unknown) with a history of bronchitis and allergies to erythromycin and LORTAB, who, on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 25-FEB-2008, the patient was vaccinated intradermally with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659147/1381U). On 25-FEB-2008, the patient developed redness, warmth and pain at the injection site. The patient was seen at an office visit. No laboratory diagnostics were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information is not available.

VAERS ID:321524 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-30
Location:Virginia  Entered:2008-08-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: stress fractures of shins. seasonal allergies. facial staph infection. acne. Family hx: anxiety, depression, arthritis, bipolar, DM2, cancer, HTN, kidney failure, migraines.
Diagnostic Lab Data: LABS: EEG WNL. Brain MRI WNL except opacified right maxillary sinus. ESR 26(H). Alk phos 45(L).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Acute sinusitis, Arthralgia, Back pain, Blood alkaline phosphatase decreased, Dysuria, Electroencephalogram normal, Haematuria, Lymphadenopathy, Myalgia, Nuclear magnetic resonance imaging brain normal, Rash generalised, Rash pruritic, Red blood cell sedimentation rate increased, Rhinitis allergic, Sinus congestion, Sinus disorder, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: C/O myalgias in joint. W/U by rheum/neuro. ANA-Neg, Lyme-Neg, B12-Normal, Sed rate-26. 9/23/08 Reviewed PCP medical records of 2/25-7/17/2008. FINAL DX: lymphadenopathy; allergic urticaria; acute sinusitis; allergic rhinitis Records reveal patient experienced tender lump on throat, sore throat & difficulty swallowing, frequent HA x 1 week on the day of vaccination. Exam revealed swollen turbinates, shotty tender cervical lymph nodes. RTC 6/14 w/itchy rash all over x 2 days. Had started Topamax 2 wks prior & was on accutane as well. Tx w/steroids. RTC 7/9 w/dysuria, hematuria & lower back pain x 4 days. Tx w/antibiotics. RTC 7/17 w/allergy s/s, sinus congestion. Reported having myalgias & athralgias s/p 1st HPV injection 2/21/08. Tx w/antibiotics & received Menactra that day. 10/3/08 Reviewed neuro medical records of 6/5-8/5/2008. FINAL DX: none provided Records reveal patient experienced multi neuro symptoms: sleep disturbance since childhood, mild sleep apnea, excessive fatigue x 1 year, chronic nausea, HA, tremor, joint & muscle pain, feeling out of it, depression, anxiety & mood disturbance. Stated contraception 1 year prior. Referred for MRI, EEG & labs. Responded to tx w/meds.

VAERS ID:329105 (history)  Vaccinated:2008-02-25
Age:0.6  Onset:2008-09-08, Days after vaccination: 196
Gender:Female  Submitted:2008-10-13, Days after onset: 35
Location:California  Entered:2008-10-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: stool culture, 09/18/08, posit, rotavirus
CDC Split Type: WAES0810USA00039
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2PO 
Administered by: Other     Purchased by: Other
Symptoms: Culture stool positive, Diarrhoea, Rotavirus test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 13 month old female patient with no pertinent medical history who on 25-FEB-2008 was vaccinated with a third dose of ROTATEQ. The first dose was administrated on 01-OCT-2007 and the second dose on 21-DEC-2007. On 08-SEP-2008 the patient developed diarrhea. The patient was seen by the physician on 18-SEP-2008 and a stool culture was obtained. The stool culture came back positive for rotavirus. At the time of the report the patient''s status was unknown. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:337380 (history)  Vaccinated:2008-02-25
Age:76.0  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-12-23, Days after onset: 302
Location:Virginia  Entered:2008-12-29, 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: INNOPRAN; ZOCOR; MICARDIS
Current Illness: Cholesterol high; Hypertension; Ventricular tachycardia; Sinus tachycardia; Urticaria chronic; Sulfonamide allergy; Drug hyperse
Preexisting Conditions:
Diagnostic Lab Data: neurological, 08/25/08, radial nerve conduction test and appointment with neurologist showed mild bilateral carpal tunnel syn
CDC Split Type: WAES0809USA02155
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1613U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Carpal tunnel syndrome, Myalgia, Nerve conduction studies abnormal, Neurological examination abnormal, Pain in extremity, Radial nerve palsy, Tenderness, Tendonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad)
Write-up: Information has been received from a nurse concerning a 76 year old female with cholesterol high, hypertension, ventricular tachycardia, sinus tachycardia and urticaria chronic and a history of unspecified allergies to ACE inhibitors, sulfa, PROCARDIA and Rofecoxib (MSD, WAES # 0809USA03423) who on 25-FEB-2008 was vaccinated with ZOSTAVAX (Merck) (Lot # 659323/1613U) via SC route. Concomitant therapy included INNOPRAN, simvastatin (MSD), and MICARDIS. On 09-APR-2008, the patient visited the physician''s office and stated that she had pain in her left arm since receiving the vaccine and her shoulder burns if she lays on her left side. Point of tenderness at deltoid, treated with steroid injection for tendonitis and nerve palsy radial. She stated injection did not help. On 30-JUL-2008 she was seen stating she had deltoid muscle pain with some pain with reduction resistance. Radial nerve conduction test and appointment with neurologist on 25-AUG-2008 showed mild bilateral carpal tunnel syndrome, more on right than left, with slightly prolonged latencies on right. Patient called office on 04-SEP-2008 stating the pain is continuing. Started on CELEBREX for 7 days and MEDROL dose pack. Referred to orthopedist and had appointment on 06-AUG-2008, no report received, and another appointment for 17-SEP-2008. Additional information has been requested.

VAERS ID:338386 (history)  Vaccinated:2008-02-25
Age:  Onset:2008-08-01, Days after vaccination: 158
Gender:Female  Submitted:2009-01-26, Days after onset: 178
Location:Florida  Entered:2009-01-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: LE cell, positive for lupus
CDC Split Type: WAES0901USA03131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: LE cells, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)
Write-up: Information has been received from a physician concerning a female patient who on 25-FEB-2008 was vaccinated with the third dose of GARDASIL. No lot number was provided. The physician reported that the patient had a positive lab test for lupus about six months (August 2008) after the date of the third dose of GARDASIL. Physician does not wish to be contacted. The patient sought unspecified medical attention. Upon internal review, lupus was determined to be an other important medical event. No further information is available.

VAERS ID:344728 (history)  Vaccinated:2008-02-25
Age:77.0  Onset:2009-01-26, Days after vaccination: 336
Gender:Female  Submitted:2009-03-27, Days after onset: 59
Location:Florida  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension; hyperlipidaemia
Preexisting Conditions: Palpitations
Diagnostic Lab Data: None
CDC Split Type: WAES0902USA00269
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0886U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 78 year old female with hypertension, hyperlipidaemia and a history of palpitations who on 25-FEB-2008 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot number 658208/0886U) 0.65ml subcutaneous (site not reported). On 26-JAN-2009 the patient developed a very mild case of shingles on her head. The patient was seen in the office. The patient''s shingles was recovering. Additional information has been requested.

VAERS ID:347095 (history)  Vaccinated:2008-02-25
Age:3.0  Onset:2008-03-11, Days after vaccination: 15
Gender:Female  Submitted:2009-05-15, Days after onset: 430
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Ear infection
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04691
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1775U0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a licensed vocational nurse concerning a 39 month old female who on 25-FEB-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot #659351/1775U) 0.5 ml via subcutaneous administration. The patient was experiencing ear infection when vaccine was given. On 11-MAR-2008 the patient experienced an injection site reaction, had a red indurated area. The patient sought medical attention by speaking with the nurse. Subsequently, the patient recovered. Additional information has been requested.

VAERS ID:349935 (history)  Vaccinated:2008-02-25
Age:4.0  Onset:2008-04-12, Days after vaccination: 47
Gender:Male  Submitted:2009-05-29, Days after onset: 412
Location:Pennsylvania  Entered:2009-06-17, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: ultrasound 04/12/08 epidi -
CDC Split Type: WAES0806USA00655
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Epididymitis, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: Information has been received from a physician concerning a 4 year old male child who on 25-FEB-2008 was vaccinated with a second dose of MMR II (Merck). The date of the first vaccination was not provided. On 12-APR-2008 the patient was seen in the emergency room and an ultrasound showed epididymitis. The patient was treated with an "unnamed antibiotic." At the time of the report the patient''s status was unknown. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:356757 (history)  Vaccinated:2008-02-25
Age:27.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-08
Location:Unknown  Entered:2009-09-09, 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: Unknown 9/16/09 Received medical records w/PMH: Allergy: PCN. PMH: Sinus infection, migraine.
Diagnostic Lab Data: magnetic resonance, 05/01/09, abnormal. LABS and DIAGNOSTICS: CT Brain - Abnormal. MRI Brain - Abnormal. Blood Glucose 94-183 mg/dl (H). CK 112 SI (H). ANA (+).
CDC Split Type: WAES0909USA00318
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U2IMGM
Administered by: Private     Purchased by: Other
Symptoms: Antinuclear antibody positive, Asthenia, Blood creatine phosphokinase increased, Blood glucose increased, CSF oligoclonal band absent, Computerised tomogram abnormal, Condition aggravated, Convulsion, Demyelination, Dizziness, Drug administered at inappropriate site, Electrocardiogram abnormal, Fatigue, Headache, Hypertension, Hypoaesthesia, Loss of consciousness, Lumbar puncture, Migraine, Nausea, Nuclear magnetic resonance imaging brain abnormal, Oral contraception, Paraesthesia, Scan brain, Syncope, Vision blurred, Visual impairment, Vitamin B12 deficiency, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a health professional concerning a 28 year old female who on 28-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 658558/1061U) into her left buttocks. Not long after first dose, migraine headache started. On 25-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (lot# 654539/0742U) into her left gluteus and on 25-FEB-2008, was vaccinated with the third dose of GARDASIL (lot# 655327/1287U) into her left gluteus. Concomitant therapy included ALESSE. On 01-MAY-2009, the patient passed out and was hospitalized, a spinal tap was performed. The patient had migraine headache started not long after the first injection. The patient was seeing a neurologist. A MRI performed showed abnormal results. The patient developed demyelination in brain. Questionable Lupus. Upon internal review, questionable lupus was determined to be an other important medical event. Additional information has been requested. 9/16/09 Received vaccine & GYN medical records. Records reveal patient experienced wt loss & fatigue. On 5/1 had seizure, hospitalized & neuro eval done. 10/6/09 Neurological consult received service dates 5/1/09 to 5/21/09. Assessment: Migraine Presented with c/o severe bifrontal headache and episode of syncope. Transient loss of consciousness. Episodes of weakness associated with headaches, visual disturbance, migraine headaches for past year associated with use of oral contraceptives.

VAERS ID:364968 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-05-22, Days after vaccination: 87
Gender:Female  Submitted:2009-11-03, Days after onset: 530
Location:Unknown  Entered:2009-11-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: None Allergies: NKDA
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA03932
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1570X3IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia facial, Pain in jaw, Wheelchair user
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad)
Write-up: Information has been received from a consumer concerning a female family friend who on unspecified date was vaccinated with GARDASIL (dose number, lot number not reported). The patient developed numbness and was in a wheelchair after vaccination. The patient saw a neurologist. It was unknown if there were lab studies performed. At the time of the report, the outcome of the patient was not reported. Upon internal review, being in a wheelchair was considered to be disabling. This is one of several reports from the same source. Additional information has been requested.11/23/2009 PCP records 7/23 and 5/30/2008, patient with c/o''s facial numbness. rt lip numbness, jaw soreness and clenching. No tx noted. no labs noted

VAERS ID:395430 (history)  Vaccinated:2008-02-25
Age:9.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-10
Location:Michigan  Entered:2010-08-17, 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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Breast malformation
SMQs:, Congenital, familial and genetic disorders (narrow)
Write-up: Mom alleges that child''s breast asymmetry was caused by HPV vaccine (left breast smaller).?

VAERS ID:412721 (history)  Vaccinated:2008-02-25
Age:60.0  Onset:2010-11-24, Days after vaccination: 1003
Gender:Female  Submitted:0000-00-00
Location:Ohio  Entered:2010-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1820U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: ZOSTAVAX administered 2-25-08. Patient presented with dermatomal rash on 11-30-10. Culture proved this was due to Varicella Zoster Virus.

VAERS ID:427132 (history)  Vaccinated:2008-02-25
Age:19.0  Onset:2011-06-01, Days after vaccination: 1192
Gender:Female  Submitted:2011-07-11, Days after onset: 40
Location:Massachusetts  Entered:2011-07-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Diagnostic Lab Data:
CDC Split Type: 201104195
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bordetella test positive, Cough, Dehydration, Pertussis, Post-tussive vomiting
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Initial case received from a consumer on 06 July 2011. A 19-year-old female patient, with no reported medical history, received an injection of ADACEL (lot not reported) on 25 February 2008. Three years post-vaccination, on 20 June 2011, the patient presented to her physician with a 3-week history of coughing. She returned to her physician on 22 June 2011 with ongoing symptoms, and was prescribed Z-PAK. Laboratory testing at that time serologically confirmed pertussis. She was subsequently admitted to the hospital due to dehydration secondary to post-tussive vomiting. Outcome was not reported.

VAERS ID:306481 (history)  Vaccinated:2008-02-25
Age:0.3  Onset:2008-02-25, Days after vaccination: 0
Gender:Female  Submitted:2008-03-04, Days after onset: 8
Location:Foreign  Entered:2008-03-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USC00095
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pneumonia aspiration
SMQs:
Write-up: Information has been received from an investigator concerning a 22-week-old female patient who entered a study, title as stated above. The patient was placed on blinded therapy, (date of dosages not reported). On 25-FEB-2008, 35 days after receiving the third dose, the patient was admitted to the hospital and diagnosed with aspiration pneumonia. At the time of this report, the outcome of aspiration pneumonia was unknown. The intensity and relationship to study drug were unknown. The patient is in the safety cohort. Additional information has been requested for a completed SAE form.

VAERS ID:306909 (history)  Vaccinated:2008-02-25
Age:17.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-03-11, Days after onset: 13
Location:Foreign  Entered:2008-03-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: body temp, 26Feb08, 40.6 C; WBC count, 27Feb08, 2630 /mL; lymphocyte count, 27Feb08, 237, i.e. 9%; monocyte count, 27Feb08, 9%; neutrophil count, 27Feb08, 80%, neutrophilic leukocytes
CDC Split Type: WAES0802USA06423
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Delirium, Lymphadenopathy, Lymphocyte count decreased, Lymphocyte percentage decreased, Malaise, Monocyte percentage increased, Neutrophil percentage increased, Pyrexia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad)
Write-up: Information has been received from a general practitioner concerning a 17 year old female with no relevant medical history who on 25-FEB-2008 was vaccinated with a first dose of Gardasil (batch # NG41880) IM in the deltoid. On 26-FEB-2008 the next day the patient developed a fever, which reached 40.6 degrees Celsius during the night, with "slight" delirium. On 27-FEB-2008, blood tests were performed because the patient was not feeling well. Tests found leukocytes at 2630/mL, lymphocytes at 237, ie 9%, monocytes at 9% and neutrophilic leukocytes at 80%. No clinical sign was observed. Small axillary adenopathies were on the vaccinated side of the body, however the physician did not worry about them. No reaction was observed at the site of the injection. At the end of the day, the patient was not in good clinical condition and would possibly be hospitalized. At the time of reporting, she had not recovered. The events were considered as medically significant by the reporter. Additional information is not available. Other business partners included are: E2008-01718.

VAERS ID:307063 (history)  Vaccinated:2008-02-25
Age:0.3  Onset:2008-02-25, Days after vaccination: 0
Gender:Male  Submitted:2008-03-12, Days after onset: 15
Location:Foreign  Entered:2008-03-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None
CDC Split Type: SEWYEG01219408
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Hypotonia, Hypotonic-hyporesponsive episode, Pallor, Respiratory arrest, Screaming
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 3-month-old patient who experienced not breathing and hypotonic-hyporesponsive episode. The patient received a dose on 25-Feb-2008. The patient experienced hypotonic-hyporesponsive episode on 25-Feb-2008. The boy was initially given an injection with Pentavax and cried but stopped. After this the Prevenar injection was given and the boy screamed again. When the needle was pulled out the boy turned pale, flaccid and hyporesponsive. He was not breathing. The child was shaken as he was lying in his mother''s lap. He was put on a nursing table and his legs were raised. After a few moments the boy looked up again. He was first pale and quiet but then started to cry. The boy was transported in ambulance to the hospital and was admitted for an unknown time. The boy recovered. No additional information was available at the time of this report.

VAERS ID:308913 (history)  Vaccinated:2008-02-25
Age:16.0  Onset:2008-03-01, Days after vaccination: 5
Gender:Male  Submitted:2008-04-03, Days after onset: 32
Location:Foreign  Entered:2008-04-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Symptoms of a mild URI for 4 weeks up until day of immunization. Otherwise, healthy. Received Adacel on multiple previous occasions. No foreign travel, no history of exposure to Lyme Disease.
Diagnostic Lab Data: The patient was referred for blood work, ECG, throat swab, and echocardiogram.
CDC Split Type: 200800892
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody negative, Arthralgia, Blood test, C-reactive protein increased, Culture throat, Culture urine negative, Echocardiogram, Electrocardiogram, Erythema, Joint swelling, Joint warmth, Mononucleosis heterophile test negative, Polyarthritis, Rheumatoid factor negative, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (narrow)
Write-up: Initial report received on 27 March 2008 from a physician. A 16 year old healthy male received on 25 February 2008 an injection of ADACEL (lot # not reported) and MENJUGATE-C (manufacturer and lot # not reported). Dose, route and site of administration for each vaccine were not reported. On the day of vaccination, the patient had symptoms of a mild upper respiratory infection (URI) which had started four weeks prior. Five days post vaccination; the patient experienced migrating arthralgias and warm, red, swelling of his right knee (for 2 days), his left elbow (began one day after the right knee and lasted 2 days), then the right elbow, the left knee (one day later), then the right hip, the right calf and lastly the left elbow. On 12 March 2008, the patient was assessed by the physician. The diagnosis was Migrating Arthritis with differential diagnoses of Vaccine ADR, Juvenile onset RA, and Rheumatic Fever. Corrective treatment was Tylenol PRN. The patient was referred for blood work electrocardiogram, throat swab, echocardiogram, and then return to clinic (RTC) 2 weeks later. Tests were ESR 4, elevated CRP 5.8, negative rheumatoid factor, negative mono tests, negative ANA, negative streptogyne, negative anti-d s DNA, and negative urine C&S. Serology results were pending for E-B virus, OMV and toxoplasmosis. On 26 March 2008, the patient was reassessed by the physician. All migrating arthritis had resolved by 15 March 2008. The final assessment was "Unequivocal Vaccine ADR" which the physician felt was due to Menjugate since the patient "had received ADACEL on multiple pervious occasions". No further investigations, treatment, or follow-up were planned. At the time of the report, 27 March 2008, the patient had recovered.

VAERS ID:312165 (history)  Vaccinated:2008-02-25
Age:0.3  Onset:2008-02-28, Days after vaccination: 3
Gender:Male  Submitted:2008-05-12, Days after onset: 73
Location:Foreign  Entered:2008-05-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test 28Feb08 rotavirus infection
CDC Split Type: WAES0805USA01276
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Enteritis, General physical health deterioration, Laboratory test abnormal, Pyrexia, Rotavirus infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a physician concerning a 11 week old male who on 25-FEB-2008 was vaccinated PO with a first dose of ROTATEQ. On 28-FEB-2008, the patient experienced fever and a reduced general condition. He was admitted to the hospital with enteritis and laboratory testing showed a rotavirus infection. The patient completely recovered under treatment with glucose-electrolye-solution. The patient was discharged from the hospital on 02-MAR-2008. Other business partner numbers included E2008-03996. No further information was provided.

VAERS ID:313138 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-05-22, Days after onset: 85
Location:Foreign  Entered:2008-05-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA00567
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Eye rolling, Influenza like illness, Lip discolouration, Loss of consciousness, Muscle contracture, Nausea, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a pharmacist concerning an eighteen year old female patient who received a first dose of GARDASIL (batch number not reported) on 25-FEB-2008, administered intramuscularly in the left arm. The morning after on 26-FEB-2008, during her breakfast, the patient looked white, had nausea and had a loss of consciousness. The patient''s mother reported an impressive reaction. The patient went to the emergency at the hospital and the diagnosis was a vagal malaise. Follow up information indicated that the patient had loss of consciousness, eye rolling and black lips 23 hours after injection. She also experienced contractures in the arms and the body and abdominal pain, "like in flu-like syndrome", 28 hours after injection. Contractures were reported as moderate and abdominal pain was reported as severe. The three events were reported as serious and severe. The events of nausea and pallor were no longer mentioned. One hour after her syncope, the patient was transferred to the emergency unit where vasovagal syncope was diagnosed. The patient recovered (date not reported). The reporter considered the patient''s vagal reaction, contracture and abdominal pain as other important medical events. Other business partner numbers included E2008-02391.

VAERS ID:314022 (history)  Vaccinated:2008-02-25
Age:18.0  Onset:2008-02-26, Days after vaccination: 1
Gender:Female  Submitted:2008-05-28, Days after onset: 91
Location:Foreign  Entered:2008-05-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA04956
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Gaze palsy, Influenza like illness, Lip discolouration, Loss of consciousness, Malaise, Nausea, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a pharmacist concerning an 18 year old female who on 25-FEB-2008 was vaccinated with a dose of GARDASIL (batch # was unknown because the package was discarded after the injection) IM in the left arm. On 26-FEB-2008, the morning after vaccination during her breakfast, the patient looked white, had nausea, and had a loss of consciousness. The patient''s mother reported an impressive reaction. The patient went to the emergency unit at the hospital and the diagnosis was a vagal malaise. The patient recovered. Follow-up information was received on 13-MAY-2008. The case was upgraded to serious: the reporter considered the loss of consciousness, rolling eyes and black lips as serious events (Other Important Medical Events). The three events were reported as serious and severe. She also experienced contractures in the arms and body 28 hours after injection, and abdominal pain like in flu-like syndrome. Contractures were reported as moderate and abdominal pain was reported as severe. The events of nausea and pallor were no longer mentioned. One hour after her syncope, the patient was transferred to the emergency unit where vasovagal syncope was diagnosed. The patient recovered. The case is closed. Other business partner numbers included: E2008-02391. No further information is expected.

VAERS ID:314407 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2008-05-30
Location:Foreign  Entered:2008-05-30
Life Threatening? Yes
Died? Yes
   Date died: 2008-03-01
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Premature baby
Preexisting Conditions: The subject''s mother was 15-year-old and the subject''s father-18-year-old. The subject was a premature baby, born after 31 weeks of amenorrhea. At birth, he weighted 1.665 kg. The same day, the subject was hospitalized in intensive care unit 19 December 2007. Then, from 31 December 2007 to 10 January 2008, the subject was hospitalized for respiratory syncytial virus bronchiolitis.
Diagnostic Lab Data: Blood culture, 01Mar2008, Negative; Body temperature, 01Mar2008, 30.5Celsius deg; C-reactive protein, 01Mar2008, 6mg/1; CSF culture, 01Mar2008, Negative; Cerebrospinal fluid white cell, 01Mar2008, 567/mm3; Epstein-Barr virus serology, 01Mar
CDC Split Type: B0522161A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Autopsy, Blood culture negative, Body temperature decreased, Brain scan normal, C-reactive protein normal, CSF cell count increased, CSF culture negative, CSF white blood cell count increased, Conjunctivitis, Cough, Crying, Culture stool negative, Epstein-Barr virus test negative, Lividity, Mononucleosis heterophile test negative, Platelet count decreased, Red blood cell count decreased, Red blood cells CSF positive, Respiratory syncytial virus serology, Rhinitis, Sudden death, Trismus, White blood cell count normal, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported by the regulatory authority (AFSSaPS, PV20080111) and described the occurrence of sudden death in a 2-month-old male subject who was vaccinated with INFANRIXQUINTA (GlaxoSmithKline) and PREVENAR (Wyeth labs). The subject''s mother was 15-year-old and the subject''s father 18-year-old. The subject was a premature baby, born after 31 weeks of amenorrhea. At birth, he weighted 1,665 kg. The same day, the subject was hospitalized in intensive care unit 19 December 2007. Then, from 31 December 2007 to 10 January 2008, the subject was hospitalized for respiratory syncytial virus bronchiolitis. On 25 February 2008, he was vaccinated with a dose of INFANRIX QUINTA (batch number not available, intramuscular). On 27 February 2008, he was vaccinated with a dose of PREVENAR (batch number not available, intramuscular). On 29 February 2008, four days after the vaccination with INFANRIX QUINTA, the subject consulted for rhinitis and cough for several days (NOS). A diagnosis of conjunctivitis was made and a treatment with eye drops was initiated. During the night, from 29 February 2008 to 01 March 2008, the subject experienced severe cough. At the end of the night, he cried. After a rhinopharyngeal disobstruction, the subject was put to be on his back. At 08:30, the subject was found lifeless (sudden unexpected death). Several intensive care manoeuvres were performed and he was transferred to hospital. He had 43 weeks of amenorrhea (corrected age), weighted 3.7 kg and measured 53 cm. His cranial perimeter was at 38 cm and body temperature was at 30.5 degrees Celsius. He presented with post-mortem lividity of the right hemibody and of the face. The mouth examination was impossible due to a trismus. There was a clear red serosity in the right nostril. No hepato-splenomegaly, no suspect lesion, no ecchymosis and no sign of physical abuse and trauma was observed. Leukocytes count was at 11 800/mm3, red blood cell count at 860 000/mm3, platelets at 145 000/mm3 and C-reactive protein at 6 mg/1. The electrocyte cou

VAERS ID:315018 (history)  Vaccinated:2008-02-25
Age:0.2  Onset:2008-04-22, Days after vaccination: 57
Gender:Female  Submitted:2008-06-04, Days after onset: 43
Location:Foreign  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 23Apr2008, Abnormalunit; Barium enema, 23Apr2008, intussusceptionunit; Hematocrit, 23Apr2008, 35%; Hemoglobin, 23Apr2008, 12g/dl; Lymphocytes, 23Apr2008, 26%; Neutrophils, 23Apr2008, 73%; Platelet count, 23Apr2008, 543000/m
CDC Split Type: B0522112A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Barium enema abnormal, Enema administration, Flatulence, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal mass, Intestinal obstruction, Intussusception, Lymphocyte percentage, Neutrophil percentage increased, Platelet count increased, Pyrexia, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. She was healthy at the time of vaccination. Previous and/or concurrent vaccination included pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 2 April 2008. On 25 February 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 22 April 2008, 57 days after vaccination with ROTARIX, the subject experienced five times vomitings and fever. On 23 April 2008, the subject was hospitalised. The physical examination revealed a distended painful abdomen without peristalsis and palpable intestinal loop. The rectal tact revealed a mass and showed bloody stool on the explorer finger. The X-ray abdomen showed air-fluid levels and distended intestinal loop of superior left side. The diagnosis of intestinal obstruction by intussusception was made based on clinical data and abdomen X-ray. The fluoroscopic control revealed the ileocolic intussusception. The colon barited enema was successfully performed. The subject was hospitalised for 4 days. The subject was treated with paracetamol. The clinical evolution was favourable. On 26 April 2008, the events were resolved and the subject was discharged from hospital. The physician considered the events were unrelated to vaccination with ROTARIX.

VAERS ID:450905 (history)  Vaccinated:2008-02-25
Age:14.0  Onset:2008-06-01, Days after vaccination: 97
Gender:Male  Submitted:2012-03-01, Days after onset: 1369
Location:Foreign  Entered:2012-03-01
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: HbA1C, 11Jul2008, 13.6%; Hemoglobin, 11Jul2008, 162G/L; Insulin C-peptide, 11Jul2008, 0.09NMOL/L; Ketones, 11Jul2008, +++; Urine Glucose, 11Jul2008, +++
CDC Split Type: R0000639A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Glucose urine present, Glycosylated haemoglobin increased, Haemoglobin increased, Insulin C-peptide decreased, Pollakiuria, Thirst, Type 1 diabetes mellitus, Urine ketone body present, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad)
Write-up: This male subject was enrolled in a prophylactic study which is open or single blind according to communities. On 04 February 2008, 25 February 2008 and 02 September 2008, the subject received the 1st, 2nd and 3rd dose of control ENGERIX B (10 mcg, IM deltoid). On 01 June 2008, 97 days after the 2nd dose of ENGERIX B, this 15-year-old subject experienced type I diabetes mellitus. The subject was hospitalised and the event was life-threatening and clinically significant (or requiring intervention). The subject was treated with intermediate/long-acting insulin and insulin aspart. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the type I diabetes mellitus may have been caused by ENGERIX B and that the event was possibly due to an incidental illness. Previously, this case has been considered as not related but on 16 December 2011, the investigator has reviewed the case and considered it as related to study vaccine. Investigational Comments: Referral to the hospital because of tiredness, pollakiuria, thirst and weight loss lasted since 01jun2008. Dg; Diabetes mellitus type I. In hospital from 11jul2008 to 18jul2008. Medication with insulin started. Follow-up at at the outpatient clinic for diabetics. Follow-up report 28oct2008: No family history of DM. The cousin of father is the closest one, who has DM. The patient has been at control visit because of DM yesterday. The glucose balance is good and the patient is in good condition. PHONE CONTACT BECAUSE OF 12 MONTHS FOLLOW-UP 27JAN2009: The patient was in good condition. The glucose balance quite good. Last B-Hb-A1C on 16feb2009 8.7 %. Follow up on 27Dec2011: relationship to investigational product: Yes.

VAERS ID:307255 (history)  Vaccinated:2008-02-26
Age:1.5  Onset:2008-03-06, Days after vaccination: 9
Gender:Male  Submitted:2008-03-17, Days after onset: 10
Location:Foreign  Entered:2008-03-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01866
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.WL000254771SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Lividity, Peripheral coldness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from an investigator. This case occurred during the Clinical Study MRV01C concerning a 18 month old male with no relevant history. On 26-FEB-2008 the patient was vaccinated SC in the left deltoid at 9:10 with a second 0.5 mL dose of ProQuad (Oka/Merck upgrade process) (Refrigerator-stable formulation ProQuad (Oka/Merck upgrade process)) manufactured with rHA, batch number: WL00025477). On 06-MAR-2008, 9 days after receiving the vaccine, the patient experienced moderate cyanosis (central and acrocyanosis of both hands). The patient suddenly developed lip cyanosis, ice-cold hands, and livid-blue discoloration and was admitted to the hospital for cyanosis. The investigator assessed the relation between the study vaccine and this event was possible. Further information was expected. Other business partner numbers included: E2008-02299.

VAERS ID:307637 (history)  Vaccinated:2008-02-26
Age:1.4  Onset:2008-03-06, Days after vaccination: 9
Gender:Male  Submitted:2008-03-19, Days after onset: 12
Location:Foreign  Entered:2008-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA02622
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.WL000254771SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Peripheral coldness, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from an investigator concerning a 17-month-old male, with no relevant medical history, who entered a study. On 26-FEB-2008 at 9:10 the patient was vaccinated subcutaneous in the left deltoid with a second 0.5 ml of ProQuad (batch # WL00025477). On 06-MAR-2008 the subject experienced moderate cyanosis (central and acrocyanosis of both hands), 9 days post vaccination. On 06-MAR-2008 the subject suddenly developed lip cyanosis, ice-cold hands, and livid-blue discoloration and was admitted to the hospital the same day for cyanosis. The reporting investigator felt that cyanosis was possibly related to study therapy. Other company numbers included: E2008-02299. Additional information has been requested.

VAERS ID:308209 (history)  Vaccinated:2008-02-26
Age:54.0  Onset:2008-02-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-25, Days after onset: 27
Location:Foreign  Entered:2008-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Asthma; osteoporosis
Preexisting Conditions: Liver function test abnormal
Diagnostic Lab Data: diagnostic laboratory test, results not provided
CDC Split Type: WAES0803USA01172
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0355F0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test, Local reaction, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health care professional concerning a 54 year old female with no reported medical history who on 26-FEB-2008 was vaccinated IM with the first dose of PNEUMOVAX 23 (batch # NE26590, lot # 654974/0355F). There was no concomitant medication. On 26-FEB-2008 the patient experienced painful local reaction making the arm very painful to move. It is not known if the patient has recovered. The reporter considered this to be a non serious reaction. Follow up received from the initial reporter on 18-MAR-2008. This case is upgraded to serious. The patient had a medical history of asthma, osteoporosis and abnormal liver function tests. The patient was not taking any concomitant medication. The patient was vaccinated subcutaneously in the left arm with the first 0.5 mL dose of PNEUMOVAX 23 (batch # NE26590, lot # 654974/0355F). The patient experienced severe pain in the upper left arm and intense swelling and was unable to move her left shoulder. The patient was treated with tramadol and co-dydramol. The patient had an unspecified blood test at the hospital. No results were provided. The patient recovered from the events of pain, swelling and was able to move her shoulder again. At the time of reporting the patient still had tenderness at the injection site. The reporter considered the events to be medically significant. Other business partner numbers include: E2008-01707 and 66042. No further information is available.

VAERS ID:308825 (history)  Vaccinated:2008-02-26
Age:96.0  Onset:2008-03-05, Days after vaccination: 8
Gender:Female  Submitted:2008-04-02, Days after onset: 27
Location:Foreign  Entered:2008-04-03, 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: CONIEL 18Dec07 - Mar08; MIKELAN 18Dec07 - Mar08; (therapy unspecified) 18Dec07 - Mar08; alfacalcidol 18Dec07 - Mar08
Current Illness: Hypertension; Angina pectoris; Osteoporosis; Hospitalisation; Back pain
Preexisting Conditions: Carotid artery aneurysm
Diagnostic Lab Data: chest x-ray 05Mar08: results not reported; computed axial tomography 05Mar08: results not reported
CDC Split Type: WAES0803USA04182
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Pleural fibrosis, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from an physician as part of a postmarketing surveillance study concerning a 96 year old female inpatient with hypertension, angina pectoris, osteoporosis, back pain and a history of right carotid artery aneurysm who on 26-FEB-2008 was vaccinated SC with a 0.5 mL dose of Pneumovax 23. Concomitant therapy included MIKELAN, 15 mg daily, PO from 18-DEC-2007 to March 2008, CONIEL, 4 mg daily, PO from 18-DEC-2007 to March 2008, unspecified therapy, 5 mg, transdermal, 18-DEC-2007 to March 2008 and alfacalcidol, 0.25 mg, TID, PO from 18-DEC-2007 to March 2008. On 05-MAR-2008 the patient developed bilateral pleural thickening, dyspnea and wheezing in the morning. A chest x-ray and computed tomography were immediately performed (results not reported). At the time of the report, the outcomes were unknown. The reporting physician considered bilateral pleural thickening, dyspnea and wheezing as serious requiring prolonged hospitalization. The physician felt that bilateral pleural thickening, dyspnea and wheezing were definitely related to Pneumovax 23. Additional information has been requested.

VAERS ID:310116 (history)  Vaccinated:2008-02-26
Age:5.0  Onset:2008-02-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-18, Days after onset: 51
Location:Foreign  Entered:2008-04-18
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eczema
Preexisting Conditions: No previous reactions to vaccines and antibiotics, no food allergies, asthma or rhinitis. Previous eczema.
Diagnostic Lab Data: 31 March 2008: Skin prick test to peanuts was negative
CDC Split Type: B0514602A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Pharyngolaryngeal pain, Rash generalised, Skin test, Sneezing, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of sneezing in a 5-year-old female subject who was vaccinated with ACWY vax (GlaxoSmithKline), Havrix and Typhim. On 26 February 2008 the subject received unspecified dose of ACWY vax (1 injection), unspecified dose of Havrix (1 injection) and unspecified dose of Typhim (1 injection). On 26 February 2008, approximately 10 minutes after vaccination with ACWY vax, Havrix and Typhim, the subject experienced sneezing and developed a sore throat and approximately an hour later developed rash all over body. At the time of reporting the events were resolved. Verbatim text received: On the 31st of March 2008 a doctor reported that a brother and sister were given Havrix junior, ACWY and Typhim at the same time, 10 minutes later the patients started sneezing, developed a sore throat and a hour later they both developed a rash all over the body. The doctor stated that their symptoms had now resolved. Follow up information received 16 April 2008: The reporting doctor stated that the patient had no previous reactions to vaccines, antibiotics, no food allergies, asthma or rhinitis but did have eczema previously. The patient had had a skin prick test to peanuts on 31 March 2008 where the test result was negative. The patient received the first doses of ACWY vax, Havrix and Typhim. On 26 February 2008, the patient experienced an anaphylactic reaction and swelling of the face and tongue. The reporting physician considered the events to be serious as they were life threatening. The events resolved on 26 February 2008. The events were considered to be possibly related to the vaccines. It was reported that Engerix B was given "successfully after testing".

VAERS ID:310591 (history)  Vaccinated:2008-02-26
Age:8.0  Onset:2008-02-26, Days after vaccination: 0
Gender:Male  Submitted:2008-04-22, Days after onset: 55
Location:Foreign  Entered:2008-04-22
Life Threatening? Yes
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: 31 March 2008: Skin prick test to grass, tree, cat, peanut, hazelnuts, walnut, latex - Negative
CDC Split Type: B0514601A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test negative, Anaphylactic reaction, Pharyngolaryngeal pain, Rash generalised, Skin test, Sneezing
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of sneezing in a 8-year-old male subject who was vaccinated with meningococcal polysaccharide groups A, C, W and Y vaccine (ACWY vax, GlaxoSmithKline), HAVRIX and TYPHIM. On 26 February 2008 the subject received unspecified dose of ACWY vax (1 injection), unspecified dose of HAVRIX (1 injection) and unspecified dose of TYPHIM (1 injection). On 26 February 2008, approximately 10 minutes after vaccination with ACWY vax, HAVRIX and TYPHIM, the subject experienced sneezing and developed a sore throat and approximately an hour later developed rash all over body. At the time of reporting the events were resolved. Verbatim text received: On the 31st of March 2008 a doctor reported that a brother and sister were given HAVRIX junior, ACWY and TYPHIM at the same time, 10 minutes later the patients started sneezing, developed a sore throat and a hour later they both developed rash all over the body. The doctor stated that their symptoms had now resolved. Follow up information received on 16 April 2008: The subject did not have any previous reactions to vaccine or antibiotics. The subject did not experience eczema, food allergies, asthma or rhinitis. On 31 March 2008, skin prick test was performed to grass, tree, cat, peanut, hazelnuts, walnut, latex which was negative. The subject was diagnosed with anaphylactic reaction which was considered life threatening. The event resolved on 26 February 2008. The physician considered the event was possibly related to treatment with Mencevax ACWY, HAVRIX and TYPHIM. The subject received ENGERIX B successfully after testing.

VAERS ID:311429 (history)  Vaccinated:2008-02-26
Age:0.2  Onset:2008-02-28, Days after vaccination: 2
Gender:Male  Submitted:2008-05-02, Days after onset: 63
Location:Foreign  Entered:2008-05-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0511448A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA429A PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Diarrhoea, Faecal volume increased, Pallor, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of pallor in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. On 26 February 2008, the subject received the 1st dose of ROTARIX (oral). On 28 February 2008 (afternoon), 2 days after vaccination with the 1st dose of ROTARIX, the subject experienced diarrhea, the baby was maudlin. On 29 February 2008, the baby vomited once and produced more faeces than normal. On 01 March 2008, the baby experienced fever (37.8 deg C), he was very pale and he was not as active as normally. In the following night also the mother suffered from vomiting and diarrhea. Treatment of the adverse event was not necessary. On 4 March 2008, the mother and her baby were healthy again. On 4 March 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up information received from a regulatory authority on 25 March 2008: This case was also reported by a regulatory authority (#27.496/1-12/03/08) and described the occurrence of pallor in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. On unspecified date, the subject received unspecified dose of ROTARIX. On unspecified date, 2 days after vaccination with ROTARIX, the child cried a lot. On the 3rd day, he had more faeces than usual and vomiting. On the 4th day, he had fever and he was pale. On the 5th day, the subject''s mother experienced acute diarrhea and vomiting, after 2 days resolved. At time of reporting the events were resolved. The regulatory authority reported that the events were clinically significant (or requiring intervention).

VAERS ID:311477 (history)  Vaccinated:2008-02-26
Age:5.0  Onset:2008-02-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 63
Location:Foreign  Entered:2008-05-02, Days after submission: 2
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The reporting doctor stated that the patient had no previous reactions to vaccines antibiotics, no food allergies, asthma or rhinitis.
Diagnostic Lab Data:
CDC Split Type: E200803912
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Pharyngolaryngeal pain, Rash generalised, Skin test, Sneezing, Swelling face, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: This case was initially reported to SPMSD by the Health Authority, ref no: 20250730 on 24-Apr-08. This case concerns a five year old female patient. The patient''s medical history included eczema. The reporting doctor stated that the patient had no previous reactions to vaccines, antibiotics, no food allergies, asthma or rhinitis. It is not known if the patient was receiving any concomitant medication. On 26-Feb-08, the patient received Typhim Vi, intramuscularly, batch number, route and site not reported. The patient also received ACWY Vax, intramuscularly, batch number, route and site not reported and Havrix, intramuscularly, route and site not reported on the same day. On 26-Feb-08, approximately ten minutes of receiving the immunisations, the patient experienced sneezing and a sore throat. An hour later, the patient developed a rash all over the body. The patient experienced an anaphylactic reaction with swelling of the face and tongue. It is not known if the patient received any treatment. The patient had a skin prick test to peanuts on 31-Mar-08 where the result of the test was negative. The patient recovered. It was reported that the patient received Engerix B successfully after testing. Both the reporter and the MHRA considered the events to be life threatening and possibly related to the vaccines. No more information is available, this case is closed. The short time to onset and the reported symptoms are in favor of allergic reaction to one of the vaccines components in a patient with a known history of eczema. Moreover, the patient received 3 vaccines at the same time and it is difficult to attribute the event to one particular vaccine.

VAERS ID:312275 (history)  Vaccinated:2008-02-26
Age:0.2  Onset:2008-03-01, Days after vaccination: 4
Gender:Female  Submitted:2008-05-13, Days after onset: 72
Location:Foreign  Entered:2008-05-13
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray 02Mar2008 See text; Calcium 06Mar2008 7.5mEq/L 8.8 (low) 11.2 (high); Hematocrit 02Mar2008 30.7% 29 (low) 42 (high); Hemoglobin 02Mar2008 9.6g/dl 10 (low) 13 (high); Lymphocyte percentage 02Mar2008 18% 41 (low) 71 (high); Pl
CDC Split Type: B0519415A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Blood calcium decreased, Blood potassium increased, Blood sodium normal, Gastrointestinal hypomotility, Gastrointestinal tube insertion, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal perforation, Intestinal resection, Intussusception, Lymphocyte count decreased, Mucous stools, Platelet count normal, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: This case was reported by a physician in the time frame of a study and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergies. Concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008 and pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008. On 26 February 2008 the subject received the 1st dose of ROTARIX (oral). On 1 March 2008, 4 days after vaccination with the 1st dose of ROTARIX, the subject experienced 4 vomiting, mucosanguinolent stools and abdominal distension. The subject was hospitalized. On 2 March 2008, laboratory tests were performed and showed the following: Hemoglobin 9.6 g/dL (normal range: 10-13); Leucocytes count: 18700/mm3 (normal range: 10000-15000); Platelets count: 179000/mm3 (normal range: 300000-700000); Hematocrit: 30.7% (normal range: 29-43); Lymphocytes percentage: 18% (normal range: 41-71). Abdominal X-ray was performed and showed big distension of intestinal loops and lack of air in rectal ampulla. Intussusception was suspected. The subject was sent to another hospital with pediatric attention. She was admitted at this hospital on 04 March 2008 with dates of more abdominal distension, nasogastric tube with billar material drainage, diminished peristalsis, painful abdominal mass on left side and more sanguinolent stools. Surgery was performed on 04 March 2008; intussusception in ileocecocolic position was found with small perforation (2cm). Resection of ischemic segment with term to term anastomosis (ileal-transverse-colon) was done without complication. After that the subject showed good recuperation without sepsis or complications. On 6 march 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (norma

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