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Case Details (Sorted by Vaccination Date)

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VAERS ID:291397 (history)  Vaccinated:2007-09-26
Age:24.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-09-26, Days after onset: 0
Location:California  Entered:2007-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0017U1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2419AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Bruxism, Crying, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Post HPV (1st dose), Menactra (2nd dose), HEP A (2nd dose) Petite mal seizure occurred-clenched teeth no fists x 30 seconds-post sobbing, no vomiting or defraction following impact.

VAERS ID:291511 (history)  Vaccinated:2007-09-26
Age:45.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-09-27, Days after onset: 0
Location:Florida  Entered:2007-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 100mg PO QD, Synthroid .005 mg, Alieve otc 220 mg po bid, Calcium 600 mg + vit D one tab po qd, Activella, one po qd,
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2444AA3IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Condition aggravated, Erythema, Pain, Pruritus, Rash vesicular, Sensation of heaviness, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypersensitivity (narrow)
Write-up: Intense itch and exaserbation of scar tissue from poison oak contracted in 2004 on the right forearm, distal from the vaccin, arm heavy and small fluid filled blisters are noteed on the arm, some have been broken due to scratching. Also generalized aching, some tachycardia up to 24 + hours after injection. Skin on arm is red and there is also generalized itching, No respriatory symptoms. Applied cortizone otc cream 12 hours after injection, upon waking with the intense itching. This reactin is similar to a reaction seen on this patient upon recieving PPD injection...the skin gets red but not endurated. Also, pt took 50 mg of benadryl at hs the night of the injection (Approx. 7 hours after).

VAERS ID:291518 (history)  Vaccinated:2007-09-26
Age:29.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-09-27, Days after onset: 1
Location:Louisiana  Entered:2007-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Singular
Current Illness: None
Preexisting Conditions: Allergy induced Asthma
Diagnostic Lab Data: Oxygen saturation was 97% on room air. No other diagnostic tests done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS784791IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Feeling hot, Oxygen saturation normal, Pruritus
SMQs:, Anaphylactic reaction (narrow), Hypersensitivity (broad)
Write-up: 15 minutes post injection c/o feeling "hot", itching to trunk and hands, tightness in chest area

VAERS ID:291607 (history)  Vaccinated:2007-09-26
Age:1.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-09-28, Days after onset: 2
Location:Texas  Entered:2007-09-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations: seizures~Measles + Mumps + Rubella (no brand name)~1~1~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: Neonatal hypoglycemia. Failure to thrive at age 6 mon. GERD. Bronchiolitis. S/P circumcision. Family hx of seizure in paternal G-grandmother and maternal Grandmother.
Diagnostic Lab Data: Labs and Diagnostics; MRI brain with no focal abnormality to account for seizures. Possible bilat mastoid effusions. Chemistry with BUN 19.0. Cl 19.0. AST 55.0. Alk Phos 261.0. CBC unremarkable.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0413U0SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0855U0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood chloride decreased, Blood urea increased, Convulsion, Crying, Dyskinesia, Full blood count, Gaze palsy, Immediate post-injection reaction, Immunisation reaction, Laboratory test abnormal, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Postictal state, Staring
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: MMR + Varicella vaccine administered at 1000 a.m. and had seizure 60 seconds later. Child admitted to hospital and had seizure approximately 1600. Child transferred to another hospital. 10/05/2007 MR received for DOS 9/27-29/2007 for DX of Acute seizure after receiving MMR vaccination. Immediately after receiving MMRV child cried and then eyes rolled back and jerking was noted in his arms. Episode lasted several minutes. Transfered by EMS to local ER and admitted for observation. That pm had another episode of seizure like activity with eyes rolling back and stiffness, lasting 30-40 sec. Sleepy post-ictal. Transfered to current facility where another seizure occured similar to the first with additional staring episode noted.

VAERS ID:291616 (history)  Vaccinated:2007-09-26
Age:  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-09-28, Days after onset: 1
Location:Virginia  Entered:2007-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZMIN
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2142AA0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Headache, Oedema, Pain, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Local erythema, edema, pain, itching and HA. Benadryl 250mg PO q4-6 hours PRN, Tylenol PRN. Cool compresses to site.

VAERS ID:291619 (history)  Vaccinated:2007-09-26
Age:5.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Male  Submitted:2007-09-28, Days after onset: 1
Location:Virgin Islands  Entered:2007-09-28
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: Hgbsc
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0601F0IMRA
Administered by: Public     Purchased by: Other
Symptoms: Heat therapy, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Client c/o pain starting at upper arm and then in the fingers and mother noticed arm swollen the next day. Mom said she did apply warm compress then visited private doctor temperature is normal.

VAERS ID:291620 (history)  Vaccinated:2007-09-26
Age:13.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-09-28, Days after onset: 1
Location:Virgin Islands  Entered:2007-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Nil
Preexisting Conditions: Hgbsc
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0601F0IMRA
Administered by: Public     Purchased by: Other
Symptoms: 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: Client c/o pain starting at injection site 9/26/07 but get more swollen and painful 9/27/07. Applied with compress x 1. Seen by private MD had fever x 2 days receive treatment of Zinnat 212 500mg and Motrin PRN. Temp normal.

VAERS ID:291622 (history)  Vaccinated:2007-09-26
Age:4.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-09-27, Days after onset: 0
Location:Florida  Entered:2007-09-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2650AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ05483IMRL
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: Swelling and redness at site of vaccination 3cm x 3cm.

VAERS ID:291648 (history)  Vaccinated:2007-09-26
Age:66.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-09-28, Days after onset: 2
Location:New Mexico  Entered:2007-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0200U IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Erythema, Edema, Pain- Benadryl, Zantac, Prednisone.

VAERS ID:291675 (history)  Vaccinated:2007-09-26
Age:0.5  Onset:2007-09-28, Days after vaccination: 2
Gender:Male  Submitted:2007-09-28, Days after onset: 0
Location:California  Entered:2007-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2657AA3IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0224U1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01091SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC351683IMRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Looks like an insect bite, hand to touch and red. Low grade fever.

VAERS ID:291706 (history)  Vaccinated:2007-09-26
Age:59.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-10-01, Days after onset: 5
Location:Texas  Entered:2007-10-01
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: history of heart attack
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS800607IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0888F0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Discomfort, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: States that 2 hours after receiving pneumococcal vaccine, his right arm became red & swollen at the injection site. State that he took Tylenol & used a heating pad for relief. States that redness & discomfort lasted about 48 hours, then all symptoms resolved.

VAERS ID:291714 (history)  Vaccinated:2007-09-26
Age:63.0  Onset:2007-10-01, Days after vaccination: 5
Gender:Female  Submitted:2007-10-01, Days after onset: 0
Location:New Mexico  Entered:2007-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS9897 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0991U IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0887U SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Half dollar sized erythematous area around injection site.

VAERS ID:291744 (history)  Vaccinated:2007-09-26
Age:84.0  Onset:2007-09-28, Days after vaccination: 2
Gender:Female  Submitted:2007-09-28, Days after onset: 0
Location:Washington  Entered:2007-10-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2453AA1IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0959E0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Inflammation, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever at least up to 2 days after injection. Redness of upper arm, not at injection site. Arm is sore and inflamed.

VAERS ID:291754 (history)  Vaccinated:2007-09-26
Age:7.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-09-26, Days after onset: 0
Location:Connecticut  Entered:2007-10-01, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data: 2nd dose Epi, IV Benadryl, and Decadron in ED
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1011U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Cough, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Acute onset of cough, SOB, facial swelling w/i 5 minutes of receiving vaccine. Received Epi-pen, Benadryl, O2 in office. Transferred to ED via ambulance.

VAERS ID:291770 (history)  Vaccinated:2007-09-26
Age:2.0  Onset:0000-00-00
Gender:Male  Submitted:2007-09-28
Location:Michigan  Entered:2007-10-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB115CA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB0867AD0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: The pt was given adult Hep A. No adverse reactions were reported.

VAERS ID:292163 (history)  Vaccinated:2007-09-26
Age:35.0  Onset:2007-09-30, Days after vaccination: 4
Gender:Female  Submitted:2007-10-01, Days after onset: 1
Location:Maine  Entered:2007-10-04, 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: Marina IUD
Current Illness: None
Preexisting Conditions: No prior allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2689AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash macular, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Onset blotchy, warm sensation to neck on 09/30 then outbreak w/hives on 10/1/07 located on (L) arm, shoulder, along waistband arms hips on back, right thigh.

VAERS ID:292164 (history)  Vaccinated:2007-09-26
Age:26.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-10-01, Days after onset: 4
Location:New Jersey  Entered:2007-10-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reactions to antibiotics
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.074242IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Aprox 24 hr after 3rd Gardasil Nausea Cover in sweat chills-Rash down arm and upper body "I feel like I have the flu" This is in follow-up to report (s) previously submitted on 11/14/2007. Initial and follow up information has been received from two licensed practical nurses, concerning a 26 year old female paralegal with an allergic reaction to antibiotics (also specified as no known drug allergies), who on 02-FEB-2007 was vaccinated IM in the left deltoid, with the first dose (lot #654702/0011U), on 13-APR-2007 was vaccinated IM in the left deltoid, with the second dose (lot #656539/0742U), and on 26-SEP-2007 was vaccinated IM in the left deltoid, with the third dose, 0.5 ml of GARDASIL vaccine (lot #654539/0742U). Following the third dose on 27-SEP-2007 ("within 24 hours"), the patient stated that she "felt something" and developed a rash around her upper body. She also experienced nasuea, chills, and stated she felt like she had the "flu". Treatment with BENADRYL was prescribed. At the time of this report, the outcome of the event was recovered (duration not specified). This is one of two reports received fromthe same source (WAES #5710USA00457). Additional information is not expected.

VAERS ID:292190 (history)  Vaccinated:2007-09-26
Age:3.0  Onset:2007-10-03, Days after vaccination: 7
Gender:Male  Submitted:2007-10-04, Days after onset: 1
Location:Colorado  Entered:2007-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC, basic metabolic profile and blood culture are pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0304U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood culture, Full blood count, Metabolic function test, Purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Patient developed purpura on lower extremities and buttocks 1 week after immunization with Hepatitis A vaccine from Merck.

VAERS ID:292298 (history)  Vaccinated:2007-09-26
Age:47.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-10-05, Days after onset: 8
Location:Florida  Entered:2007-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TB SKIN TEST WAS GIVEN ON THE SAME DAY
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2769AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Axillary mass, Fatigue
SMQs:
Write-up: 09/26/2007 - VACCINE GIVEN IN LEFT DELTOID 09/27/2007 - FATIGUE AND NOTICED LUMP AND TENDERNESS IN LEFT AXILLARY.

VAERS ID:292343 (history)  Vaccinated:2007-09-26
Age:12.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-10-05, Days after onset: 9
Location:Michigan  Entered:2007-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Started on acyclovir 10-5-2007
Current Illness: Healthy office visit for Well Child Check on 9-26-2007.
Preexisting Conditions: History of seizure, unspecified /stable
Diagnostic Lab Data: No lab tests.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0245U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Burning sensation, Herpes zoster, Rash, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Received Tdap and HPV4 vaccines on 9-26-07, same day developed a burning rash on the left side of neck and chest. Has been afebrile and attending school. Presented in office today, 10-05-2007, with c/o rash and burning. Has a H/O varicella disease as a small child and varicella vaccine on 6-1-1998. Has raised blisters with red base, lesions vertically descend from neck to left side of chest. Dr. diagnosed Pt with Shingles.

VAERS ID:292368 (history)  Vaccinated:2007-09-26
Age:12.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-09-27, Days after onset: 1
Location:North Carolina  Entered:2007-10-05, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: soreness at site, low grade fever~HPV (Gardasil)~1~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Lymphadenopathy, Myalgia, Pyrexia, Tonsillitis
SMQs:, Rhabdomyolysis/myopathy (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Muscle pain, weakness, fever (102), lymphadenopathy, tonsillitis, improved next day with Abx.

VAERS ID:292569 (history)  Vaccinated:2007-09-26
Age:31.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-10-03, Days after onset: 7
Location:Georgia  Entered:2007-10-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Sulfa drugs
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2559AA UNLA
Administered by: Public     Purchased by: Other
Symptoms: Muscle spasms, Pain in extremity
SMQs:, Dystonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Tdap vaccine administered approx 10 AM. Employee c/o (L) lower leg cramping around 5 pm. Employee c/o pain in (L) lower leg also.

VAERS ID:292570 (history)  Vaccinated:2007-09-26
Age:  Onset:0000-00-00
Gender:Female  Submitted:2007-10-03
Location:Georgia  Entered:2007-10-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Benadryl, Penicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2559AA UNRA
Administered by: Public     Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Employee c/o pain in (R) thigh several hours after Tdap vaccine injection.

VAERS ID:292576 (history)  Vaccinated:2007-09-26
Age:54.0  Onset:2007-09-28, Days after vaccination: 2
Gender:Female  Submitted:2007-10-03, Days after onset: 5
Location:Indiana  Entered:2007-10-10, 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: Codeine
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythematous from site of injection around arm - mid section of bicep/arm is 1.5 cm larger than opposite arm. Warm to touch. Pt instructed to use ice, Tylenol for any discomfort.

VAERS ID:292733 (history)  Vaccinated:2007-09-26
Age:0.4  Onset:2007-09-28, Days after vaccination: 2
Gender:Male  Submitted:2007-10-11, Days after onset: 13
Location:California  Entered:2007-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Triaminic cc .10ml for the cough
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B069AA2 LL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF200AA2 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08666D2 LL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0779F2PO 
Administered by: Public     Purchased by: Public
Symptoms: Nodule, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: With in 2 days of immunization a fine red rash spread all over from face to feet, knots were also note on Lt VL. No respiratory distress.

VAERS ID:293997 (history)  Vaccinated:2007-09-26
Age:4.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-10-22, Days after onset: 25
Location:North Carolina  Entered:2007-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B115AA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0279F1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08679A1IMRL
Administered by: Private     Purchased by: Public
Symptoms: Contusion, Erythema, Nodule
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (broad)
Write-up: Large 4 x 2cm bruise and erythemic nodule lasting greater than 1 week.

VAERS ID:294042 (history)  Vaccinated:2007-09-26
Age:64.0  Onset:2007-09-29, Days after vaccination: 3
Gender:Female  Submitted:2007-10-17, Days after onset: 18
Location:Texas  Entered:2007-10-22, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2690AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rash and redness around site and down arm stopping at elbow with itching - started 3 days after injection, lasted approx 14 days.

VAERS ID:294140 (history)  Vaccinated:2007-09-26
Age:28.0  Onset:2007-10-03, Days after vaccination: 7
Gender:Female  Submitted:2007-10-23, Days after onset: 20
Location:Colorado  Entered:2007-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: synthroid, multivitamin
Current Illness: none
Preexisting Conditions: hypothyroidism
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0728U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia
SMQs:, Arthritis (broad)
Write-up: joint pains in fingers for 3 weeks

VAERS ID:294478 (history)  Vaccinated:2007-09-26
Age:3.0  Onset:2007-10-04, Days after vaccination: 8
Gender:Female  Submitted:2007-10-19, Days after onset: 15
Location:New Jersey  Entered:2007-10-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2446A IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB16BA IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema multiforme, Sick relative
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow)
Write-up: Erythema Multiforme 8 days after receiving Fluvax and Hep A brother also ill at the time with presumed 5th disease.

VAERS ID:294608 (history)  Vaccinated:2007-09-26
Age:13.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-09-27, Days after onset: 1
Location:Indiana  Entered:2007-10-27, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Reglan; Prevacid; Librex
Current Illness:
Preexisting Conditions: Irritable Bowel Syndrome .... extensive testing (bowels)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018CA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient received Tdap vaccine at approximately 11:50am without complications. Mother called office at 1:30pm stating child had rash on bilateral ankles/feet and in groin area. C/O itching. No difficulty with breathing. Rec take Benadryl and contact primary care MD for f/u ---$g next day patient pc to patient ---$g "did not go to PCP, rash gone"

VAERS ID:294731 (history)  Vaccinated:2007-09-26
Age:14.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-10-23, Days after onset: 26
Location:Alabama  Entered:2007-10-29, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: ANA 165-drawn on 9/28/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2461BA2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1094U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain in (L) arm 2 days after vaccine, now entire body aches, muscle aches

VAERS ID:296580 (history)  Vaccinated:2007-09-26
Age:65.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-10-15, Days after onset: 19
Location:West Virginia  Entered:2007-11-13, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WV0731
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA0IMUN
Administered by: Public     Purchased by: Public
Symptoms: Medication error, Wrong drug administered
SMQs:
Write-up: No adverse events following vaccine. Pt. turned 65 9/1/07, given Tdap instead of Td on 9/26/07.

VAERS ID:299953 (history)  Vaccinated:2007-09-26
Age:17.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 49
Location:Ohio  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Vaginal yeast infection
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA01055
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Rash maculo-papular
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 17 year old female who on 26-SEP-2007 was vaccinated with the second dose of GARDASIL intramuscularly in the glute. On 27-SEP-2007 the patient experienced a macular papular rash on both cheecks of the face. Subsequently, the patient recovered on 27-SEP-2007 from macular papular rash on both cheeks of the face. The patient sought unspecified medical attention when her mother called the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 17 year old female who on 25-SEP-2007 was vaccinated with her second dose of GARDASIL vaccine intramuscularly in the left glute (lot# 658664/0928U). The patient had a vaginal yeast infection for 7 days at the time of the injection. She had not taken DIFLUCAN yet. On 26-SEP-2007 the patient broke out in a fine, pink, macular papular rash over both cheeks "where you would place hands if holding head." Subsequently, the patient recovered completely after 2 hours on 26-SEP-2007 from macular papular rash on both checks of face. The patient sought unspecified medical attention when her mother called the office. The patient returned to school and was not keen to be examined. The plan is to keep the patient for 1 hour in office after 3rd injection on 26-JAN-2008. Additional information has been requested.

VAERS ID:297997 (history)  Vaccinated:2007-09-26
Age:0.3  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-11-28, Days after onset: 63
Location:Texas  Entered:2007-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: n/a~ ()~~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B096CA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF116AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB0868IE1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0507U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Per report from mom during 6mo WCC, pt had temperature of 100.5 after vaccines last time. Pt went to ER for evaluation. Upon clarification, mom stated the temperature was 105. Pt was otherwise acting normally, no other symptoms. Urine was obtained - no infection.

VAERS ID:302048 (history)  Vaccinated:2007-09-26
Age:  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 86
Location:Florida  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04557
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a female who on 16-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 26-SEP-2007 the patient developed a large welt around the injection site. The patient sought medical attention via a phone call with the physician. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:302080 (history)  Vaccinated:2007-09-26
Age:70.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-12-21, Days after onset: 86
Location:Arkansas  Entered:2007-12-28, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 09/26?/07, slight temperature
CDC Split Type: WAES0710USA00642
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning an approximately 70 year old male who on approximately 26-SEP-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck). On approximately 29-SEP-2007 the patient''s wife called the office and stated that the patient''s arm was red and swollen several inches around the injection site. The physician reported that the patient''s wife was a nurse and stated that the patient may also have had a slight temperature. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:302150 (history)  Vaccinated:2007-09-26
Age:79.0  Onset:2007-09-28, Days after vaccination: 2
Gender:Female  Submitted:2007-12-21, Days after onset: 84
Location:Unknown  Entered:2007-12-28, 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: therapy unspecified
Current Illness: Drug hypersensitivity; Diabetes
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA02449
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a female (age not reported) with diabetes and allergy to "lots of medication, cholesterol and high blood pressure medications" who on approximately 26-SEP-2007 "about two weeks ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX. Concomitant therapy included therapy unspecified (insulin "an antibiotic"). On approximately 28-SEP-2007, "2-3 days after vaccination", the patient experienced pain in her left arm that are ''similar to the pains from a heart attack" and a "heaviness" in her chest. The patient reported that "it comes and goes" and "it has been getting less severe." The patient did not seek medical attention. No laboratory diagnostic tests were performed. The patient''s status was reported as recovering. There was no product quality complaint involved. Follow up information was received from a health care professional who noted that as of the time of reporting the patient had not notified them of any reaction or symptoms. No further information is available.

VAERS ID:318693 (history)  Vaccinated:2007-09-26
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-08
Location:Pennsylvania  Entered:2008-07-10, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F2UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Amnesia, Anorexia, Back pain, Blindness, Chills, Fatigue, Headache, Nausea, Pallor, Pollakiuria, Pyrexia, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pale skin, Daily headaches, blurred to no vision, fatigue, loss of appetite, severe back pain, nausea, fever, chills, increased urination, loss of memory.

VAERS ID:324925 (history)  Vaccinated:2007-09-26
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-14
Location:Texas  Entered:2008-08-18, 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: [therapy unspecified]
Current Illness:
Preexisting Conditions: Depression; Anxiety; Termination of pregnancy - elective
Diagnostic Lab Data: Apgar score, 02/07/08, 9/9
CDC Split Type: WAES0711USA06548
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Delivery, Drug exposure during pregnancy, Pregnancy induced hypertension
SMQs:, Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Initial and follow-up information has been received through the Merck pregnancy registry from a physician and a licensed vocational nurse (LVN) concerning a 19 year old female with a history of depression and anxiety. The patient had a history of an elective termination of 1 previous pregnancy. On 26-SEP-2007, the patient was vaccinated with her first dose of GARDASIL (Lot # 0530U). Concomitant therapy included "CLONAZEPAK" (therapy unspecified). Subsequently, the patient found out she was pregnant. The patient''s last menstrual period (LMP) was 02-OCT-2007, with an estimated delivery date of 09-JUL-2008. The patient sought medical attention. On 16-JUN-2008, the patient was treated with VISTARIL 50 mg, 1 every 6 hours PRN for anxiety. During the pregnancy, the patient had complication of mild pregnancy induced hypertension (PIH). On 02-JUL-2008, 39 weeks from LMP, the patient delivered a normal female infant with Apgar score of 9/9. Additional information is not expected.

VAERS ID:330185 (history)  Vaccinated:2007-09-26
Age:81.0  Onset:2008-09-27, Days after vaccination: 367
Gender:Female  Submitted:2008-10-27, Days after onset: 30
Location:Pennsylvania  Entered:2008-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient was admitted to the hospital for acute ischemic stroke. On admission, patient was assessed for previous history of vaccine administration.
Preexisting Conditions: Latex; Codeine; Percocet
Diagnostic Lab Data: N/A. Cellulitis diagnosed through physical exam by physician. (All times documented are approximate)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.099IU1SCLA
Administered by: Military     Purchased by: Unknown
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient received the Pneumovax vaccine on Sept 26, 2008. Approximately 1 day later, the patient developed a "red, circular, edematous area on the left upper extremity that was tender to the touch," as reported by the nurse taking care of the patient. This area was where the vaccine was administered. All other infectious causes of cellulitis were ruled out; therefore the infection was attributed to Pneumovax. Cephalexin 250 mg po q6h was initiated.

VAERS ID:335116 (history)  Vaccinated:2007-09-26
Age:50.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Male  Submitted:2007-10-01, Days after onset: 4
Location:California  Entered:2008-11-13, Days after submission: 409
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: EKG, normal; CBC, normal; Glucose, 74
CDC Split Type: 200703270
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2441A IMLA
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Blood glucose normal, Cold sweat, Dizziness, Electrocardiogram normal, Full blood count normal, No reaction on previous exposure to drug, Pallor
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial report received from a health care provider on 28 September 2007. A 50-year-old male patient, who is a physician, had received an intramuscular left deltoid injection of FLUZONE, lot number U2441AA on 26 September 2007 and 24 hours later, experienced dizziness, lightheadedness, pallor and felt clammy. Blood pressure - pulse readings: lying - 110/70, 56, sitting - 118/70, 60 and standing - 130-90, 72. He was unable to continue seeing patients and was driven home. Five hours after the onset of symptoms, the patient stated they felt 80 percent better. The patient was reported to have received their flu vaccinations annually and had no prior events with prior flu vaccinations received. The patient had not been ill at the time of vaccination and had no pre-existing medical conditions. The patient had recovered from the event on 28 September 2007. No further information was provided.

VAERS ID:342736 (history)  Vaccinated:2007-09-26
Age:6.0  Onset:2009-03-24, Days after vaccination: 545
Gender:Female  Submitted:2009-03-24, Days after onset: 0
Location:Virginia  Entered:2009-03-26, 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
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2457FA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash papular, Varicella
SMQs:
Write-up: rash - scattered papules -$g Probable chickenpox *Child rec''d 2 doses of VARIVAX dose #1 age 12 mos. dose #2 age 6 yr.

VAERS ID:351394 (history)  Vaccinated:2007-09-26
Age:82.0  Onset:2009-02-04, Days after vaccination: 497
Gender:Male  Submitted:2009-06-24, Days after onset: 139
Location:Illinois  Entered:2009-07-13, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA04014
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a physician concerning an 82 year old male patient who on 26-SEP-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 04-FEB-2009, the patient developed shingles after receiving ZOSTAVAX (Merck). On an unspecified date, the patient recovered from shingles. The patient sought medical attention, the physician saw the patient. Additional information has been requested.

VAERS ID:292886 (history)  Vaccinated:2007-09-26
Age:0.2  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-10-11, Days after onset: 15
Location:Foreign  Entered:2007-10-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None Provided.
CDC Split Type: ITWYEG00438007
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B052CA IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Hypotonia, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 2-month-old female patient who experienced hypotonia, pallor, uncontrollable crying and lipothymia. The patient received the first dose on 26-Sep-2007. The patient experienced hypotonia, pallor, uncontrollable crying and lipothymia on 26-Sep-2007. The events involved or prolonged inpatient hospitalization. The patient definitely recovered on 26-Sep-2007. No additional information was available at the time of this report.

VAERS ID:292903 (history)  Vaccinated:2007-09-26
Age:66.0  Onset:2007-09-27, Days after vaccination: 1
Gender:Female  Submitted:2007-10-12, Days after onset: 15
Location:Foreign  Entered:2007-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin hydrochloride
Current Illness: Unknown
Preexisting Conditions: DIABETES MELLITUS, HYPERCHOLESTEROLEMIA
Diagnostic Lab Data: UNK
CDC Split Type: D0054693A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA292AC0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cardiovascular disorder, Dizziness, Gastrointestinal pain, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of severe nausea in a 66-year-old female subject who was vaccinated with Influsplit SSW 2007/2008 (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included diabetes mellitus and hypercholesterolemia. Concurrent medications included Metformin. On 26 September 2007 the subject received for the first time a dose of Influsplit SSW 2007/2008 (0.5 ml, intramuscular, left deltoid). Approximately one day post vaccination with Influsplit SSW 2007/2008, on 27 September 2007, the subject experienced severe nausea, vomiting, dizziness, gastrointestinal pain and circulation disorder. The reporting physician considered that the events were clinically significant requiring intervention. The subject was treated with Vomex and homeopathic medication (Vertigoheel: anamirta cocculus + conium maculatum + ambergris + petroleum). On an unknown date end of September 2007 or early in October 2007 the events were resolved. No further information will be available.

VAERS ID:293280 (history)  Vaccinated:2007-09-26
Age:0.3  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2007-10-15, Days after onset: 19
Location:Foreign  Entered:2007-10-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Respiratory tract infection
Preexisting Conditions:
Diagnostic Lab Data: None Provided.
CDC Split Type: NLWYEG00445907
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Mastoiditis, Surgery
SMQs:
Write-up: Information regarding Prevenar was received from a consumer regarding a 3-month-old female patient who experienced infection of the mastoid bone, with lop ear as symptom. The patient received the second dose on 26-Sep-2007. The patient''s concurrent illness includes respiratory tract infection. Concomitant medications were not reported. The patient experienced infection of the mastoid bone, with lop ear as symptom on 26-Sep-2007. The child was treated with surgery of the mastoid bone under full narcosis. The outcome is unknown. According to the reporters the respiratory tract infection may have contributed to the occurrence of the event. No additional information was available at the time of this report.

VAERS ID:295379 (history)  Vaccinated:2007-09-26
Age:0.8  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-10-31, Days after onset: 35
Location:Foreign  Entered:2007-11-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Diagnostic Lab Data: Lab tests showed platelets count decreased 98.0 X 10^9/L (100
CDC Split Type: 200703650
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURZ1155 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Platelet count decreased, Pyrexia, Upper respiratory tract infection
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad)
Write-up: Case received from a healthcare professional on 29 October 2007. A 09-month-old male patient with no reported medical history, experienced upper respiratory tract infection on 26 September 2007, i.e. the same day after receiving his1st intramuscular dose of Act-Hib, batch number Z1155-1, in the right deltoid. On 26 September 2007, 1 hour post-vaccination, the patient experienced fever at 39C. The patient received an unknown treatment from 26 September 2007 to 27 September 2007 as an out-patient without any improvement. He was hospitalized on 28 September 2007. Lab tests showed platelets count decreased 98.0 X 10^9/L (100

VAERS ID:297068 (history)  Vaccinated:2007-09-26
Age:71.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Male  Submitted:2007-11-15, Days after onset: 50
Location:Foreign  Entered:2007-11-16, 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: LANTUS Unk - Unk; NOVORAPID Unk - Unk; ZOCOR 24Jul06 - Unk; gliclazide Unk - Unk
Current Illness: Diabetes; Drug hypersensitivity; Hypertension
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01613
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0533R IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Chills, Dyspepsia, Feeling cold, Gait disturbance, Hyperhidrosis, Malaise
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Arthritis (broad)
Write-up: Initial and follow-up information has been received from a health professional concerning a 71 year old male with diabetes, hypertension and an allergy to naproxen who on 26-SEP-2007 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (Lot #652718/0533R and Batch #ND05370). Concomitant therapy included, gliciazide (MSD), insulin glargine (LANTUS), metformin (MSD), insulin aspart (NOVORAPID), perindopril and simvastatin (MSD). On 26-SEP-2007, in the evening shortly after vaccination, the patient felt unwell and began to feel shivery, cold and sweaty. All the patient''s joints became painful and weak. The patient was in bed for three days which gradually improved over the next week. The patient found it difficult to walk and had to crawl around for three days after vaccination with Pneumovax 23. On 03-OCT-2007, the patient was still unwell and contacted the nurse. On 04-OCT-2007, eight days post vaccination, the patient saw the general practitioner, who diagnosed heartburn. At the time of the report the patient was recovering. Both the reporter and the RA considered difficulty in walking, heartburn, painful joints, joint disorder, feeling unwell and chills to be a serious reaction due to an other important medical event. No further information is available. Other business partner numbers included E2007-07488 and 60685.

VAERS ID:297880 (history)  Vaccinated:2007-09-26
Age:43.0  Onset:2007-10-17, Days after vaccination: 21
Gender:Female  Submitted:2007-11-27, Days after onset: 41
Location:Foreign  Entered:2007-11-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lapatinib; Capecitabine
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Full blood cell count, urea and electrolytes - normal; chest x-ray - normal; urine microscopy - negative
CDC Split Type: B0494315a
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blood electrolytes normal, Blood urea normal, Breast cancer, Chest X-ray normal, Dehydration, Diarrhoea, Fatigue, Full blood count normal, Metastasis, Urine analysis normal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Malignant tumours (narrow), Breast malignant tumours (narrow), Noninfectious diarrhoea (narrow)
Write-up: This 43 year old female subject was enrolled in an open-label study for the treatment of metastatic breast cancer. The subject received oral lapatinib at 1250 mg per day from 26 September 2007 and oral capecitabine at 1800 mg twice per day from 25 September 2007 to 31 October 2007. On 17 October 2007, the subject developed grade 2 diarrhea. On 31 October 2007, the subject developed grade 2 fatigue. On an unknown date, the subject was hospitalised. The subject also experienced weakness due to mild dehydration. Treatment with lapatinib was continued. At the time of reporting, the diarrhea had resolved on 01 November 2007 and the fatigue had improved. The subject was discharged on 01 November 2007. The investigator considered that there was a reasonable possibility that the diarrhea and fatigue may have been caused by lapatinib and capacetabine and that the events were possibly due to a concomitant medication (flu vaccine). Follow up information received 19 November 2007: The subject was admitted with generalised weakness due to mild dehydration, which was exacerbated by recent flu injection and diarrhea. On an unknown date the subject received intravenous fluids for 24 hours. Full blood cell count, urea, electrolytes and chest x-ray were normal. The urine microscopy was negative. On 01 November 2007, the subject was discharged with diarrhea resolved. On 07 November 2007, the fatigue was reported as resolved. Lapatinib treatment was unchanged throughout the clinical course and course three of capecitabine was started on 08 November 2007 with a 25% dose reduction for grade II diarrhea.

VAERS ID:301148 (history)  Vaccinated:2007-09-26
Age:0.1  Onset:2007-09-26, Days after vaccination: 0
Gender:Unknown  Submitted:2007-12-26, Days after onset: 91
Location:Foreign  Entered:2007-12-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200704338
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906001C SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA06007 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURZ07871 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Convulsion, Crying, Hypotonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Initial report received from health authorities on 14 December 2007 under the reference number: PLURPLOCR20071128007. A 1-month-old patient of unspecified gender and medical history experienced first episode of convulsions of the lower limbs without fever (lasted for 1 minute), hypotonic-hyporesponsive episode, hypotonia (lasted 10 minutes), pallor (lasted for 10 minutes) with reduced tension, loss of consciousness, anxiety and crying on 26 September 2007 at 16.00 hrs the day she/he received single dose of Hib vaccine (Act-Hib), lot no: Z0787-1, single dose of DTP and 2 doses of EUVAX B. Five hours after vaccination the pediatrician diagnosed the convulsions of the lower limbs, without fever. After that the patient was conscious, the skin was rosy. After the medical examination the patient was "OK", she/he had been admitted to a hospital for observation. The symptoms resolved 6 hours after the vaccination.

VAERS ID:301152 (history)  Vaccinated:2007-09-26
Age:0.1  Onset:2007-09-26, Days after vaccination: 0
Gender:Unknown  Submitted:2007-12-26, Days after onset: 91
Location:Foreign  Entered:2007-12-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200704339
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906001B SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER06015 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Hypotonic-hyporesponsive episode
SMQs:, Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: Initial report received from health authorities on 14 December 2007. A 1-month-old healthy child of unspecified gender and medical history experienced hypotonic-hyporesponsive episode and started crying on 26 September 2007 at 13.00 hrs the day she/he received single dose of Act-HIB, lot no: Z0787-1, single dose of DTP and 2 doses of EUVAX B in the morning. After around 3-4 hours started crying inconsolably which was difficult to stop. It was the first episode of such a cry. After one hour parents admitted the patient to a hospital where Luminal (suppository) was administered and he/she recovered within an unspecified time frame. Upon internal review on 26 December 2007, a new version created to correct the lot number of Act-Hib to A9712 and to correct EUVAX B to vaccine instead of drug.

VAERS ID:312069 (history)  Vaccinated:2007-09-26
Age:18.0  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2008-05-09, Days after onset: 226
Location:Foreign  Entered:2008-05-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electrocardiogram, 26?Sep07, 5.3 mmol/L; serum glucose, 26?Sep07, 5.3 mmol/L
CDC Split Type: WAES0805AUS00039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0734U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Blood glucose, Electrocardiogram normal, Feeling abnormal, Hypotonia, Malaise, Nausea, Pulse pressure decreased, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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), Generalised convulsive seizures following immunisation (broad)
Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and Public Case Details form, concerning an 18 year old female who on 26-SEP-2007 was vaccinated intramuscularly with GARDASIL, Batch No. J2926, expiry date 13-MAR-2010, Lot No. 658214/0734U). Subsequently, on 26-SEP-2007 the patient experienced nausea, amnesia, feeling abnormal, hypotonia, syncope and was unresponsive to stimuli, described as "patient reported feeling ill and collapsed. Suppine and unresponsive to verbal stimuli for 30 minutes, pulse faint, floppy, nauseated and spaced out. The patient had no memory of the event". The patient was admitted to the Accident and Emergency department of hospital and was treated with oxygen and IV fluids. Results of laboratory investigations showed serum glucose of 5.3 mmol/L and an electrocardiogram (ECG) was normal. At the time of reporting to the agency on 17-OCT-2007 the patient had recovered from nausea, amnesia, feeling abnormal, hypotonia, syncope and being unresponsive to stimuli. The agency considered that nausea, amnesia, feeling abnormal, hypotonia, syncope and being unresponsive to stimuli were possibly related to therapy with GARDASIL. The original reporting source was not provided. Subsequently, the patient''s adverse experiences were reported in an article. Additional information is not expected.

VAERS ID:315925 (history)  Vaccinated:2007-09-26
Age:25.0  Onset:2007-09-28, Days after vaccination: 2
Gender:Female  Submitted:2008-06-10, Days after onset: 256
Location:Foreign  Entered:2008-06-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: FEMIGOA; BISOPROLOL; DIPYRONE; METOCLOPRAMIDE HCl; LOPERAMIDE HYDROCHLORIDE; DUSPATAL; OMEPRAZOLE; H2 antagonist
Current Illness: Gastric complaint, stress, vitamin B12 deficiency
Preexisting Conditions: Gastroenteritis, increased heart frequency, (tachycardia)
Diagnostic Lab Data: examination on 22 February 2008 Reiber graph, oligoclonal IgG-bands, mild disturbance of blood liquor barrier
CDC Split Type: D0057221A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB101BA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain lower, Blood homocysteine, Borrelia burgdorferi serology, Brain stem auditory evoked response, CSF immunoglobulin increased, CSF oligoclonal band present, CSF test normal, Central nervous system lesion, Demyelination, Diagnostic procedure, Encephalitis, Endoscopy upper gastrointestinal tract, Eructation, Flatulence, HIV antibody negative, Hypoaesthesia, Leukoencephalomyelitis, Myopia, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Optic atrophy, Paraesthesia, Physical examination abnormal, Post lumbar puncture syndrome, Posture abnormal, Rubella, Ultrasound abdomen, Ultrasound scan normal, Visual disturbance, Visual evoked potentials, Vitamin B12 deficiency, Weight decreased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of possible multiple sclerosis in a 25-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). In autumn 2007 primary course of TWINRIX adult (unknown route and application site) was started. In the end of January 2008, less than 4 months after vaccination with TWINRIX adult, the subject experienced symptoms of multiple sclerosis. The subject was hospitalised in February and March 2008. During hospitalization 1st manifestation of demyelinating disease was diagnosed. The vaccination course with TWINRIX adult was continued on 6 May 2008. Follow-up information was received on 2 June 2008 by a general practitioner and included several examination and hospital reports. Subject''s medical history included stress, nervous gastric complaints and gastroenteritis due to Noro- and adenovirus. The subject suffered from vitamin B12 deficiency of undetermined origin. Previously, on 9 March 2007 the subject showed ergometric hyperdynamic frequency behaviour, otherwise an exercise electrocardiogram was normal. Concurrent medications included FEMIGOA and CONCOR COR since 1 January 2007 as well as BERLOSIN, GASTROSIL, LOPEDIUM, DUSPATAL, omeprazole and H2 blocker if required. On 26 September 2007 and 1 November 2007 the subject received 1st and 2nd dose of TWINRIX (intramuscular, left deltoid). On 28 September 2007, 2 days after 1st vaccination with TWINRIX the subject experienced serologic proved rubella infection. In January 2008, 2 months after 2nd vaccination with TWINRIX the subject developed demyelinating encephalomyelitis, which was improved at the time of reporting. The subject was treated with unspecified high-dosed corticosteroids. The general practitioner considered causality of vaccination to demyelinating encephalomyelitis as not assessable. The subject was hospitalised from 21 to 29 February 2008 and the general practitioner considered the events were disabling. The vaccination course with TWINRIX was continued

VAERS ID:324952 (history)  Vaccinated:2007-09-26
Age:38.0  Onset:2008-06-14, Days after vaccination: 262
Gender:Female  Submitted:2008-09-11, Days after onset: 89
Location:Foreign  Entered:2008-09-12, 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: Pregnant, LMP date: 01/SEP/07. Sex: Female. None reported.
Diagnostic Lab Data:
CDC Split Type: E200707236
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA06510UNUN
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURA06510UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ0482 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Caesarean section, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This is a case of pregnancy follow up. This case was initially reported by a health care professional on 17-Oct-2007. This case concerns a 38 year old female patient. The patient received REVAXIS, batch number A0651-1, and TYPHIM Vi, batch number Z0482-2, on 26-Sep-2007. The patient was subsequently found to be pregnant. Her LMP was 01-Sep-2007. No adverse effect was reported. Follow up received from the initial reporter on 05-Sep2008: Case upgraded to serious. The patient received a booster dose of REVAXIS and dose 1 of TYPHIM Vi at more than 4 weeks gestation. The patient did not have any additional diagnostic tests performed during pregnancy other than routine scans. On 14-Jun-2008 the patient delivered a male baby weighing 3.30 kg. The patient underwent an emergency caesarian following a failed ventouse and forceps delivery. The reporter considered the complications to be non serious. There were no malformations or anomalies diagnosed at birth.

VAERS ID:328677 (history)  Vaccinated:2007-09-26
Age:1.1  Onset:2008-10-07, Days after vaccination: 377
Gender:Female  Submitted:2008-10-15, Days after onset: 8
Location:Foreign  Entered:2008-10-16, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
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: None
CDC Split Type: WAES0810USC00039
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acne, Body temperature increased, Convulsion, Cough, Death, Drug toxicity, Malaria, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Drug abuse and dependence (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from an investigator concerning a 13-month-old female with no previous medical history who entered a study, title as stated above. On 26-SEP-2007, 24-OCT-2007, and 21-NOV-2007 the patient was vaccinated with the first, second, and third doses of blinded therapy. There was no concomitant medication. On 07-OCT-2008 the patient was seen by the field worker during a weekly visit when the mother explained that the child had some "boutons" (pimples) on her body. The field worker suggested she bring the patient to the health center for a consultation, which she did on 09-OCT-2008. Her temperature was 39.4 degrees Celsius, the physical exam was normal and she did not have diarrhea or vomiting. She was prescribed injectable quinine 0.2 mg and injectable aspegic 0.5 mg for presumed malaria, though no thick smear for malaria was performed. A nurse at the health center administered the medication and immediately afterwards the patient started to cough and convulse with salivation. The nurse brought her to the doctor''s office but he was not present. They then took the child to a neighboring center with help from the CVD staff where she was noted to have died. It was concluded that the patient died secondary to a toxic reaction to either the quinine or aspegic medication that was administered. An autopsy was not performed and the death certificate was pending. The reporting investigator felt that malaria was of moderate intensity and not related to study therapy and that toxic reaction to medication was of severe intensity. At this time, relationship of toxic reaction to medication to study therapy is unknown. Additional information has been requested.

VAERS ID:353085 (history)  Vaccinated:2007-09-26
Age:  Onset:2007-09-26, Days after vaccination: 0
Gender:Female  Submitted:2009-08-03, Days after onset: 677
Location:Foreign  Entered:2009-08-04, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 39 C
CDC Split Type: WAES0907USA05052
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Headache, Myalgia, No reaction on previous exposure to drug, Photophobia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a health authority concerning a female of unknown age. The patient had received the first two doses of GARDASIL on 12-FEB-2007 and an unspecified date with no adverse effect. The patient received the third dose of GARDASIL (batch number not reported, intramuscularly), on 26-SEP-2007. On 26-SEP-2007, the same day as vaccination, the patient experienced a high temperature (39 C) with headache, muscle pain and mild photophobia. The patient recovered after 8-10 hours on 27-SEP-2007. The patient received all three doses of the vaccine and the reaction only occurred after the third dose. There was no confirmation of diagnosis and there was no other reason for the high fever which resolved so quickly. The reporter considered the events to be medically significant. Other business partner''s numbers included: E2009-06802 and ADR 20185610. No further information is available. The case is closed.

VAERS ID:415018 (history)  Vaccinated:2007-09-26
Age:26.0  Onset:2008-07-22, Days after vaccination: 300
Gender:Female  Submitted:2011-01-19, Days after onset: 911
Location:Foreign  Entered:2011-01-20, Days after submission: 1
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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1101USA01453
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervix carcinoma, Laser therapy
SMQs:, Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow)
Write-up: Information was obtained on a request by the Company from the agency, via a Public Case Detail, concerning a 26 year old female who on 26-SEP-2007 was vaccinated IM with the first dose of GARDASIL. On 05-MAY-2010, the patient was vaccinated IM with the third dose of GARDASIL. Normal recommended dosage regime (0, 2, 6 months) not followed. On 22-JUL-2008, two month later, the patient was diagnosed with cervical cancer. The patient was treated with laser. At time of this report, the patient had not recovered. The agency considered cervix cancer was possibly related to therapy with GARDASIL. The cervical cancer was considered to be immediately life-threatening. The original reporting source was not reported. No further information is available.

VAERS ID:442372 (history)  Vaccinated:2007-09-26
Age:40.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-10
Location:Foreign  Entered:2011-11-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201110794
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER06081530UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case report is part of a batch of several hundred reports associated with Rabies Vaccine, that was received on 27 October 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT-2011-4321). A female patient, whose medical history and concomitant therapies were not reported, had received her 1st dose of Rabies Vaccine (manufacturer not reported, batch number "0608153", route and anatomical site of administration not reported) associated with more than one vaccine (names, manufacturers and batch numbers not reported) on 26 September 2007. The suspect vaccine was reported as "RC", i.e. Rabies Vaccine - cellular culture. On an unspecified timeframe post-vaccination, the patient experienced paresthesia. The patient''s symptoms lasted for 10 days. She recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized for 12 days. The status of this case was "confirmed" (the Ministry of Health assessed the adverse events as related to the vaccine). There was no recommended "conduct". Documents held by sender: none.

VAERS ID:497663 (history)  Vaccinated:2007-09-26
Age:25.0  Onset:2007-10-01, Days after vaccination: 5
Gender:Female  Submitted:2013-07-25, Days after onset: 2124
Location:Foreign  Entered:2013-07-25
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1307ESP010896
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0840F SCUN
Administered by: Other     Purchased by: Other
Symptoms: Multi-organ failure, Septic shock
SMQs:, Agranulocytosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Tumour lysis syndrome (broad)
Write-up: Case received from the Health Authorities (reported to them by a physician) on 15-JUL-2013 under the reference number: ES-AGEMED-905756244. Case medically confirmed. A 25 year-old female patient with no medical history reported had received a dose of a MMRVAXPRO (batch number: NE42340, lot number 0840F) via subcutaneous on 26-SEP-2007 and 5 days later, on 01-OCT-2007, the patient presented with septic shock and multiple organ failure and 15 days later the patient recovered, on 15-OCT-2007. Case reported as serious by the Health Authorities with life threatening as criteria. No further information reported.

VAERS ID:292144 (history)  Vaccinated:2007-09-27
Age:49.0  Onset:2007-10-04, Days after vaccination: 7
Gender:Female  Submitted:2007-10-04, Days after onset: 0
Location:Alaska  Entered:2007-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Norinyl 1/35
Current Illness: None
Preexisting Conditions: hx seasonall allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC28251AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: (L) lower deltoid 3in oval reddened area. pt c/o itching @ site started yesterday noticed red area this am.

VAERS ID:292148 (history)  Vaccinated:2007-09-27
Age:11.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-04, Days after onset: 7
Location:Pennsylvania  Entered:2007-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: residual bronchospasm
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.U2408AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2408AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2826AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Child fainted 5 minutes after receiving vaccines

VAERS ID:292152 (history)  Vaccinated:2007-09-27
Age:63.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-02, Days after onset: 5
Location:New Hampshire  Entered:2007-10-04, 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: Allegra 180 mg, Nasacort, Omega 3, Zocor 29 mg, Glucosamine
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.0585U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dizziness, Presyncope
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient received Zostavax Lot 0585U exp. 30 Sep 08 on 9/27/07 at 9:30 am. Within 8 hours, reported weakness and dizziness. Reported almost fainting twice on Friday, 28 Sep 07. Reported feeling much better on 29 Sep 07 and completely normal by 30 Sep 07.

VAERS ID:292157 (history)  Vaccinated:2007-09-27
Age:14.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-09-27, Days after onset: 0
Location:California  Entered:2007-10-04, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI
Preexisting Conditions: NKDA
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB200AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2171AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0782U1SCLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: student had immunizations, was told to wait 10 min after for observation. complained of dizziness and SOB. mom at Bedside. Epi 0.4 ml SQ, given 50 mg Benadryl, as per Dr. Paramedics called. Student with 4L O2/N and transported by Paramedics to medical center.

VAERS ID:292179 (history)  Vaccinated:2007-09-27
Age:13.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-04, Days after onset: 7
Location:Texas  Entered:2007-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Claritin, Nasonex
Current Illness: none
Preexisting Conditions: history of shingles, previously diagnosed with asthma
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.038400IMLA
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt developed fever of 101.0 1 hour after vaccine administration. She began vomiting shortly after and has now been vomiting at least 3 times a day each day since vaccine administration. Her fevers have continued with a maximum temperature of 101.2. Vomiting continues but is not associated with abdominal pain or diarrhea; she also has no nausea but only a sudden intense urge to vomit.

VAERS ID:292281 (history)  Vaccinated:2007-09-27
Age:8.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Female  Submitted:2007-10-01, Days after onset: 2
Location:Pennsylvania  Entered:2007-10-05, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0797U0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1100U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash papular, Rash pustular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Diffuse red welts appeared two days after shots. Pustules - none; one or two papules rash appearing in face, hands, arms, feet, chin, stomach and back.

VAERS ID:292395 (history)  Vaccinated:2007-09-27
Age:63.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Male  Submitted:2007-10-03, Days after onset: 4
Location:Utah  Entered:2007-10-08, Days after submission: 5
Life Threatening? No
Died? Yes
   Date died: 2007-09-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0740U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Cardiac arrest, Coronary artery disease, Coronary artery occlusion, Death, Fatigue, Hypertension, Myocardial fibrosis, Myocardial ischaemia, Sleep apnoea syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Respiratory failure (broad)
Write-up: vaccine given 9/27/07 died in sleep 9/29/07 presumed cardiac arrest by autopsy. 1/15/08 Reviewed autopsy report which states COD as occlusive coronary artery disease with HTN & sleep apnea as contributing factors. Findings at autopsy included: RCA 70% occluded; LAD 80-90% occluded; LCA 70% occluded; microscopic evidence of ischemic heart disease w/increased fibrosis in tissue; fatty infiltration into RV wall of heart; and chronic HTN. Patient died in his sleep after recently c/o being tired.

VAERS ID:292405 (history)  Vaccinated:2007-09-27
Age:56.0  Onset:2007-09-30, Days after vaccination: 3
Gender:Female  Submitted:2007-10-01, Days after onset: 1
Location:North Carolina  Entered:2007-10-08, 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: Clonazepam; Lipitor
Current Illness: None
Preexisting Conditions: High cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA0IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0015U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
SMQs:
Write-up: 3-4 days after receiving Zostavax developed herpes zoster in V. nerve distribution.

VAERS ID:292567 (history)  Vaccinated:2007-09-27
Age:19.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-02, Days after onset: 5
Location:Florida  Entered:2007-10-10, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro x 1 dose
Current Illness: None
Preexisting Conditions: Allergic rhinitis, anxiety, low back pain
Diagnostic Lab Data: CBC, CMP - normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2439AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Full blood count, Headache, Laboratory test normal, Nausea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Rash, vomiting, dizzy, headache, nausea, light-headed.

VAERS ID:292571 (history)  Vaccinated:2007-09-27
Age:36.0  Onset:2007-09-28, Days after vaccination: 1
Gender:Female  Submitted:2007-09-28, Days after onset: 0
Location:Colorado  Entered:2007-10-10, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Anxiety, PMS
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Sudden onset fever (101.0), myalgias 24 hours post vaccine.

VAERS ID:292579 (history)  Vaccinated:2007-09-27
Age:75.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-04, Days after onset: 7
Location:Michigan  Entered:2007-10-10, 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: Pentasa; Nexium; Vytorin; Fosamax
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Skin lesion
SMQs:
Write-up: 1 pox on left shoulder/back.

VAERS ID:292658 (history)  Vaccinated:2007-09-27
Age:14.0  Onset:2007-10-01, Days after vaccination: 4
Gender:Male  Submitted:2007-10-04, Days after onset: 3
Location:New Jersey  Entered:2007-10-10, 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: Advil for pain
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1100U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Neck pain, Rash vesicular
SMQs:, Hypersensitivity (narrow), Arthritis (broad)
Write-up: (R) neck pain 5 days after Varivax booster. Vesicular eruption (R) neck and (R) chin 1 wk after Varivax.

VAERS ID:292660 (history)  Vaccinated:2007-09-27
Age:1.9  Onset:2007-10-03, Days after vaccination: 6
Gender:Female  Submitted:2007-10-04, Days after onset: 1
Location:Ohio  Entered:2007-10-10, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF112AA3IMLL
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Scattered hives and wheals - treated with oral steroid q. Doubt related to vaccine; suspect food allergy but reporting to be safe.

VAERS ID:292928 (history)  Vaccinated:2007-09-27
Age:74.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Female  Submitted:2007-10-12, Days after onset: 13
Location:Iowa  Entered:2007-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium 40mg daily, calcium daily, multivitamin daily
Current Illness: None
Preexisting Conditions: GERD. adverse drug reaction to codeine causes upset stomach
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0885U0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Injection site pruritus, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: large, red, swollen circle appeared 2 days after receiving vaccination. the area throbbed and later in the course started to itch. this cleared up on 10/5/07. the patient took benadryl at bedtime each night until cleared.

VAERS ID:292972 (history)  Vaccinated:2007-09-27
Age:57.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Male  Submitted:2007-10-14, Days after onset: 17
Location:Arkansas  Entered:2007-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~NULL~~In Patient
Other Medications: MULTIPLE
Current Illness: NA
Preexisting Conditions: ESR
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLAO37AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Renal failure chronic, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow)
Write-up: ON 9/27/07 1145 RECEIVED VACCINE WHILE AT DAILYSIS CENTER AT 1730 WIFE NOTICED WHELPS DEVELOPED ON PATIENT FACE THAT WORSEN AND THEN GEGAN TO RESOLVE NEAR 2000, RESOLVED ON SKILL NURSE VISIT 9/28/07

VAERS ID:293128 (history)  Vaccinated:2007-09-27
Age:76.0  Onset:2007-10-11, Days after vaccination: 14
Gender:Female  Submitted:2007-10-15, Days after onset: 4
Location:Kansas  Entered:2007-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine; metoprolol; lisinopril/HCTZ; LIPITOR; amlodipine
Current Illness: None
Preexisting Conditions: Hypertension; supraventricular tachycardia; hypothyroidism
Diagnostic Lab Data: None at present.
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0885U0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Face oedema, Herpes simplex, Herpes zoster, Skin lesion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: ZOSTAVAX given 9-27-07, SQ. Left side of nose developed lesion, left face puffy, left lower lip lesion: 10-11-07. Saw me (primary physician) 10-15-07. Lesions consistent with herpes zoster or herpes simplex of left face. Treated with FAMVIR 500 mg tid x 7 days.

VAERS ID:293132 (history)  Vaccinated:2007-09-27
Age:71.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Female  Submitted:2007-10-12, Days after onset: 13
Location:New Jersey  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Diovan; Vytorin; Levothyroxine
Current Illness: None
Preexisting Conditions: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF097AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 9/27/07 Received Yellow Fever vaccination. TC on 10/11/07 c/o 2 days post vaccine itching to buttocks, breasts, legs. Has hx of hives. F/U with MD 10/24/07.

VAERS ID:293282 (history)  Vaccinated:2007-09-27
Age:57.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Male  Submitted:2007-10-09, Days after onset: 12
Location:Florida  Entered:2007-10-16, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperhidrosis, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad)
Write-up: Patient was administered Pneumovax and immediately after receiving vaccine he became diaphoretic and tachycardic. Patient was transported via ambulance to the ER for evaluation. Symptoms: 1. Tachycardia (2) diaphoresis.

VAERS ID:293325 (history)  Vaccinated:2007-09-27
Age:45.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Male  Submitted:2007-10-10, Days after onset: 13
Location:Alaska  Entered:2007-10-16, 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: ASA, Zocor, Lisinopril, Ezetimibe, Tinolol
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Left arm became sore and swollen that evening with an area of redness about 3 inches in diameter. Red spots appeared on abdomen two days alter. Spots gone by 10/10/07.

VAERS ID:293477 (history)  Vaccinated:2007-09-27
Age:11.0  Onset:2007-09-28, Days after vaccination: 1
Gender:Female  Submitted:2007-10-03, Days after onset: 5
Location:Maine  Entered:2007-10-17, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Foreign body plantar foot
Preexisting Conditions: NKDA; Functional abd pain,
Diagnostic Lab Data: None
CDC Split Type: ME01107
Vaccination
Manufacturer
Lot
Dose
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad)
Write-up: Immunization given 9/27 afternoon. Awoke 9/28 AM with T = 104 and red, sore (L) deltoid. Tylenol. Fever resolved 9/28 and saw her 9/29 afternoon - arm red and painful, but not hot or tender. No evidence infection.

VAERS ID:293840 (history)  Vaccinated:2007-09-27
Age:10.0  Onset:2007-10-12, Days after vaccination: 15
Gender:Female  Submitted:2007-10-19, Days after onset: 7
Location:Missouri  Entered:2007-10-19
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: no chronic illness or regular medications. S/p adenotonsillectomy 2002 resection of neck and chest mass 2003. Father has history of tuberculosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Conjunctivitis, Exposure to communicable disease, Rash maculo-papular, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow)
Write-up: First dose of HPV given 3/19/07 without sequelae, second dose given 09/27/07. 1 year old sibling accompanied patient to the visit and received MMR, Varicella and Hep A vaccine. On 10/12/2007, broke out in pruritic macular/papular rash on chest, spread to arm and today 10/19 is faint, coalescent and continues to be pruritic. Mother has given diphenhydramine without substantial decrease in itching or rash. Mild conjunctivitis noted today as well. No fever, no headache, no nausea/vomiting, abdominal pain. No joint pain. No urticaria noted. Has had exposure to viral illnesses at school. Has been provided with Atarax to see if this helps with rash.

VAERS ID:293995 (history)  Vaccinated:2007-09-27
Age:70.0  Onset:2007-09-30, Days after vaccination: 3
Gender:Female  Submitted:2007-10-15, Days after onset: 15
Location:Maryland  Entered:2007-10-22, 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: Simvastatin; Tramadol; Fosamax
Current Illness: None
Preexisting Conditions: Hay Fever, No, None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0620U SCLA
Administered by: Private     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: Varicella rash

VAERS ID:293996 (history)  Vaccinated:2007-09-27
Age:65.0  Onset:2007-10-01, Days after vaccination: 4
Gender:Male  Submitted:2007-10-15, Days after onset: 14
Location:Maryland  Entered:2007-10-22, 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: Plavix-75 mg, Aspirin-325 mg, Hydralazine 25 mg 2X, Metoprolol 25 mg, Enalapril Maleate 20 mg, Amlodipine Besylate 10 mg, Flomax 0.4 mg, Protonix 40 mg, Lovastatin 40 mg, Bupropion HCL 150 mg
Current Illness: None
Preexisting Conditions: None, None, Hi BP, Cor Art. Dis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0620U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: Varicella Rash

VAERS ID:294228 (history)  Vaccinated:2007-09-27
Age:18.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-10-23, Days after onset: 26
Location:Missouri  Entered:2007-10-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: urinalysis 10/13?/07; blood culture 10/13?/07; complete blood cell 10/13?/07; thyroid function test 10/13?/07 - elevated TSH
CDC Split Type: WAES0710USA03861
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood culture, Blood thyroid stimulating hormone increased, Full blood count, Malaise, Pain in extremity, Thyroid function test abnormal, Urinary tract infection, Urine analysis
SMQs:, Hypothyroidism (broad), Hyperthyroidism (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician, concerning an 18 year old female patient with no pertinent medical history and no known allergies, who on 22-JUN-2007 was vaccinated IM with the first dose, on 15-AUG-2007 with the second dose, and on 27-SEP-2007 ("43 days later") with the third dose of Gardasil (lot # not provided). There was no concomitant medication. Following the third dose on 27-SEP-2007 the patient experienced arm pain and reported not feeling well. On approximately 14-OCT-2007 ("three weeks after" and on "Sunday night") the patient developed a urinary tract infection and was hospitalized on an observation basis. Treatment included trimethoprim/ sulfamethoxazole (BACTRIM). Diagnostic labs included a blood culture, complete blood cell count, urinalysis (results not provided), and a thyroid function test that indicated an elevated thyroid stimulating hormone (TSH) (value not provided). The following day ("Monday"), she was discharged. At the time of this report, the patient had recovered from the urinary tract infection; the outcome of arm pain, not feeling well, and elevated TSH was unknown. Additional information has been requested.

VAERS ID:294661 (history)  Vaccinated:2007-09-27
Age:0.2  Onset:2007-09-27, Days after vaccination: 0
Gender:Male  Submitted:2007-10-29, Days after onset: 32
Location:Michigan  Entered:2007-10-29
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: Blood and urine cultures negative
CDC Split Type:
Vaccination
Manufacturer
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DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B12AA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0205U0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300H0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0410U0PO 
Administered by: Public     Purchased by: Public
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Immunizations given at 10:30 am. Mom reports that baby felt warm at 3pm, but she did not take his temperature until 5pm and it was 103. Baby went to ER and had blood and urine cultures done and was given tylenol and pedialyte. No infection found and no further follow up done.

VAERS ID:294841 (history)  Vaccinated:2007-09-27
Age:63.0  Onset:2007-09-28, Days after vaccination: 1
Gender:Male  Submitted:2007-10-30, Days after onset: 32
Location:Georgia  Entered:2007-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATRIPLA, LABETALOL, LISINOPRIL, LOPERAMIDE, LORATIDINE, FLUVASTATIN, NIFEDIPINE, CLONAZEPAM, CODEINE
Current Illness: R ELBOW ARTHRITIS/BURSITIS
Preexisting Conditions: HIV, HTN, GLAUCOMA, ALCOHOL ABUSE
Diagnostic Lab Data: nONE
CDC Split Type:
Vaccination
Manufacturer
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Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA294FA10IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1084U2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold compress therapy, Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: LOCAL ERYTHEMA AND PAIN, MANAGED WITH IBUPROFEN AND COLD COMPRESSES

VAERS ID:299724 (history)  Vaccinated:2007-09-27
Age:14.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 48
Location:Tennessee  Entered:2007-11-15, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA05575
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNK0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reaction/allergies, who on 27-SEP-2007 was vaccinated with the first dose of Gardasil vaccine (0.5 mL). There was no concomitant medication. On 27-SEP-2007 the patient experienced Guillain-Barre Syndrome and was hospitalized. Hospitalization time was unknown. No further details were provided. The Guillain-Barre Syndrome was considered to be immediately life-threatening and disabling. At the time of this report, the patient was recovering.

VAERS ID:300133 (history)  Vaccinated:2007-09-27
Age:27.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Female  Submitted:2007-11-14, Days after onset: 46
Location:Arizona  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA01993
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.658563/1063U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Stomach discomfort, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 27 year old female who on 02-AUG-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (lot# 658084/0524U). On 27-SEP-2007 the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) (lot# 658563/1063U). On 29-SEP-2007 the patient was breaking out in hives all over her body, feeling sun burned and experienced an upset stomach. The patient sought medical attention by calling the doctor''s office and was instructed to take diphenhydramine hydrochloride (Benadryl). Subsequently, the patient recovered from hives, feeling sun burned and upset stomach. The patient did not experience any adverse events after Dose 1 of GARDASIL vaccine (yeast). Additional information has been requested.

VAERS ID:303685 (history)  Vaccinated:2007-09-27
Age:20.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 110
Location:Unknown  Entered:2008-01-21, 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: OMEGA-3
Current Illness: Pregnancy NOS: Pregnancy NOS (LMP = 9/26/2007); Radiation exposure; Alcohol use; Intravenous drug user (IVDU); Cosmetic body pie
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 11/21/07 IUP x 1 HR= + 169 BPM
CDC Split Type: WAES0712USA06271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Ultrasound uterus, Upper respiratory tract infection
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with a history of radiation exposure, alcohol use and IV drug use who on 27-SEP-2007 was vaccinated with her first dose of Gardasil (Lot #1063U/Batch #658563) intramuscularly in the left deltoid. Concomitant therapy included OMEGA-3). On 10 19-OCT-2007 the patient tested positive for Chlamydia. On 05-DEC-2007 the patient had a upper respiratory infection and was treated with ZITHROMAX Z-Pack). The patient was also taking prenatal vitamins (unspecified). Her estimated date of confinement is 25-JUN-2008 and LMP was 26-SEP-2007. The patient also had an ultrasound on 21-NOV-2007 which showed intrauterine pregnancy x 1 with a heart rate of 169 beats/minute. There are no other details. The nurse reported that a patient who received one dose of Gardasil was pregnant. No symptoms reported. Additional information has been requested.

VAERS ID:304694 (history)  Vaccinated:2007-09-27
Age:58.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2008-02-11, Days after onset: 137
Location:California  Entered:2008-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: penicillin
Diagnostic Lab Data: To date only xray of left shoulder and upper arm.
CDC Split Type:
Vaccination
Manufacturer
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Dose
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2453AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia, Periarthritis, X-ray limb
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pain in left arm lasted for over 1 month feeling like shot was just given. Then progressed to shooting pains in left arm, numbness and pins and needles in arm and face on left side. Wake at night with left upper arm pain and left hand asleep. Now feeling some pins and needles in left lower leg also. Shoulder is frozen decreased range of motion. Dr. took x-ray and it looked normal. Prescribed Gabapentin, 100 mg 3 x a day. No relief from medication. Have been referred to physical therapy for loss of range of motion. Have not had first appointment yet.

VAERS ID:306123 (history)  Vaccinated:2007-09-27
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Florida  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: computed axial
CDC Split Type: WAES0802USA00300
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, Headache
SMQs:
Write-up: Information has been received from a physician concerning a female who on 27-SEP-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, approximately one to one and an a half months after receiving the first dose of GARDASIL the patient developed a headache that lasted approximately one month. The physician does not believe this adverse experience is related to the vaccine and therefore does not wish to be contacted regarding this event. It is unknown at this time whether or not the patient will receive the second and third doses. No further information was provided. Additional information is not expected.

VAERS ID:305403 (history)  Vaccinated:2007-09-27
Age:5.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-14
Location:New Hampshire  Entered:2008-02-21, Days after submission: 38
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Molluscion Contagiosium/Allergic Rhinitis
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA4UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08733UNRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.029941SCLA
Administered by: Private     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: After receiving MMR vaccination, child''s arm became red and swollen from shoulder to elbow.

VAERS ID:305476 (history)  Vaccinated:2007-09-27
Age:60.0  Onset:2007-11-03, Days after vaccination: 37
Gender:Female  Submitted:2008-02-22, Days after onset: 111
Location:Ohio  Entered:2008-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: codeine-causes stomach upset; hypertension benign essential, GERD, diabetes mellitus type 2, postmenopausal, colon polyps
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1406F0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Hypoaesthesia, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: 1 week after getting vaccine, pt had numbness of nerve that goes under left side of ribcage. No blisters. Some itching and some tingling. Itched for 1 week. All symptoms then disappeared without treatment. 02/12/2010 Information has been received from a 60 year old female with no medical history or allergies who in fall 2007 was vaccinated with 0.65 ml dose of ZOSTAVAX. Concomitant therapy included MOBIC, NEXIUM, MSD and diabetic medications (unspecified). In 2007, about 3 weeks after vaccination the patient experienced itching from middle of back to abdomen for about 10 days. The patient also stated that her husband had shingles in the past and took Rofecoxib which cured the shingles. No diagnostic laboratory tests were under taken. At the time of report the patient had recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information received from VAERS (Temp, VAERS E-Report Number E21047) indicating that the patient has a drug hypersensitivity to codeine, benign essential hypertension, gastroesophageal reflux disease, type 2 diabetes mellitus, postmenopause and colonic polyp, who on 27-Sep-2007 the patient received a dose of ZOSTAVAX (lot# 654604/1406P) subcutaneously in the left arm. Concomitant therapy included MOBIC, NEXIUM, losartan potassium-HCTZ, sitagliptin phosphate and alavastatin. On 03-Nov-2007, the patient had numbness of nerve that goes under left side of ribcage. No blisters, some itiching and tingling. Itched for one week. All symptoms then disappeared without treatment. Additional information has been requested.

VAERS ID:312049 (history)  Vaccinated:2007-09-27
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-01-28
Location:Utah  Entered:2008-05-01, Days after submission: 93
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no concurrent illnesses, pre-existing medical history, or use of other medications at the time of the vaccination on 27 September 2007. It was unknown if the patient had received any other vaccinations within four weeks prior to 20 September 2007.
Diagnostic Lab Data:
CDC Split Type: 200703511
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA02081IMUN
Administered by: Other     Purchased by: Private
Symptoms: Epstein-Barr virus infection, Migraine
SMQs:
Write-up: Initial report received on 17 October 2007, and follow-up information was received on 23 October 2007, and 24 October 2007 from a physician. A female patient (demographics not provided), who had no previous history of migraines, no concurrent illnesses, no pre-existing medical history, or use of other medications, had received a second intramuscular dose of IMOVAX (lot number A0208-2) in the deltoid muscle on 27 September 2007. The patient had received the first dose of IMOVAX on 20 September 2007. The indication for IMOVAX was preparation for the patient to be a donor for Rabies Immune Globulin. Twenty-four hours post-vaccination of the second dose of IMOVAX on 27 September 2007, the patient developed migraine type headaches. She was treated with over the counter analgesics and was to follow-up with her own health care provider. On 23 October 2007 and on 24 October 2007 additional information was received from the physician stating the patient had been diagnosed with Epstein-Barr and the headaches were considered to be secondary to the Epstein-Barr diagnosis. The patient recovered from the headaches on 23 October 2007 (approximately 25 days after onset). Additional information has been requested. The reporter for this case is the same as for case 2007-03512. 28 January 2008: A corrective version was created with the same latest received date as the last version (17 October 2007) for the sole purpose of adding the term "cluster" to the narrative as per internal guidelines. This case is part of a cluster of two cases that came from the same reporter, case 2007-03512 involves a patient who received IMOVAX, lot number A0208-2, and developed migraine type headaches. No other relevant medically significant information was added to the case.

VAERS ID:312923 (history)  Vaccinated:2007-09-27
Age:5.0  Onset:2008-05-20, Days after vaccination: 236
Gender:Male  Submitted:2008-05-21, Days after onset: 1
Location:California  Entered:2008-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1002U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised, Vaccination failure, Varicella
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow)
Write-up: PATIENT CAME INTO THE OFFICE TODAY WITH A RASH ALL OVER HIS BODY. THE DOCTOR DX''D HIM WITH HAVING THE CHICKENPOX. PATIENT HAS RECIEVED BOTH DOSES OF THE VACCINE.

VAERS ID:313931 (history)  Vaccinated:2007-09-27
Age:11.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 232
Location:Maryland  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA01036
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SC 
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia, Varicella post vaccine
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a physician concerning an 11 year old female who on 27-SEP-2007 was vaccinated with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). On 27-SEP-2007, the patient developed a chicken pox rash that started on the patient''s scalp and then moved to her face, chest, arms and legs. The patient also developed a fever of 101 degrees F. No further information was available. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information has been received from a physician concerning an 11 year old female with no pre-existing allergies, or medical conditions who on 23-MAR-1998 was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (658293/1102U). Concomitant vaccine therapy administered within four weeks of varicella virus live included a first dose of Gardasil administered intramuscularly (IM) (Lot #656372/0243U), a sixth dose of Tripedia (Lot # C2770AA) administered IM into the left arm and a first dose of Menactra (Lot # N2339AA), administered IM. On 27-SEP-2007, at 10:00, the patient developed a rash on her scalp, and moved to her face, chest, arms and legs. The patient complained of severe itching. the patient was seen at the doctor''s office for a history of a fever up to 101 F. Observations at that time included a vesicular papular rash all over her face, arms, legs, chest and abdomen. The patient was advised to remain off from school at home, and isolated from siblings. No follow up was required unless problems should arise. No diagnostics labs studies obtained. There was no concomitant therapy. Medical attention was sought. There was not illness at the time of vaccination. There were no adverse events following previous vaccinations. At the time of reporting the patient''s status was unknown (previously reported as recovered). Additional information is not expected.

VAERS ID:335117 (history)  Vaccinated:2007-09-27
Age:64.0  Onset:2007-09-29, Days after vaccination: 2
Gender:Female  Submitted:2008-01-08, Days after onset: 101
Location:California  Entered:2008-11-13, Days after submission: 310
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had been "feeling a little sick" at the time of vaccination. The patient is allergic to doxycycline. It was unknown if the patient had been receiving any concomitant medications.
Diagnostic Lab Data: Not reported
CDC Split Type: 200703355
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2454A IMLA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Dizziness, Headache, Palpitations, Tremor, Urticaria, Vertigo
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from a health care professional on 03 October 2007. A 64-year-old female patient with a medical history of a doxycycline allergy complained of dizziness, vertigo, headache, hives, heart palpitations, shakiness and weakness two to three days after she had received an intramuscular left deltoid injection of FLUZONE, lot number U2454AA. The reporter stated that the patient was "feeling a little sick" at the time of vaccination. It was unknown if the patient had received any vaccinations during the four weeks prior to vaccination or if the patient had been taking any concomitant medications. The patient was not evalutated by their physician and corrective treatments had not been reported. The patient had not experienced any adverse events following receipt of prior doses of FLUZONE. The patient''s recovery status was listed as not recovered at the time of the report. Follow-up informatio was received from a health care professional on 07 January 2008. According to the reporter, they reviewed the case and had no additional information to provide at this time. The patient''s recovery status remained as not recovered fromthe event. The reporting facility in this case is the same as in case 2007-03356.

VAERS ID:333855 (history)  Vaccinated:2007-09-27
Age:17.0  Onset:2007-12-11, Days after vaccination: 75
Gender:Female  Submitted:2008-11-14, Days after onset: 339
Location:Virginia  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP-12/11/2007)
Preexisting Conditions: Ventricular septal defect; general symptom; Penicillin allergy; Attention deficit/hyperactivity disorder; Asthma; Heart enlarged; Sulfonamide allergy
Diagnostic Lab Data: Ultrasound, 02/18/2008, 11; serum alpha-fetoprotein, negative; Apgar score 9/9
CDC Split Type: WAES0802USA00481
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein, Apgar score normal, Chlamydial infection, Drug exposure during pregnancy, Gonorrhoea, Ultrasound scan, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a consumer and a physician, for pregnancy registry for GARDASIL, concerning a 17 year old female patient with penicillin allergy, sulfonamide allergy, attention deficit/hyperactivity disorder, left side of heart enlarged and asthma and a history of ventricular septal defect and USD, who on 27-SEP-2007, was vaccinated with the first dose of GARDASIL, and was pregnant (LMP- sometime around 11-DEC-2007, ECD- 07-SEP-2008). Concomitant therapy included ADHA medication, heart medication. Other medications used during pregnancy were albuterol on 18-AUG-2008 for wheezing. Subsequently, the patient experienced gonorrhea and chlamydia infection. AFP was performed with the result of negative, and fetal scan was also performed. On 12-DEC-2007, the patient was vaccinated with the second dose of GARDASIL. On 09-SEP-2008, the patient had a normal male infant. The Apgar score was 9/9. No congenital anomalies or complications were noted. Additional information is not expected.

VAERS ID:343886 (history)  Vaccinated:2007-09-27
Age:75.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Female  Submitted:2009-06-24, Days after onset: 636
Location:Pennsylvania  Entered:2009-04-08, Days after submission: 77
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: Chickenpox
Diagnostic Lab Data: body temp 01/??/09 98.1 degrees F -
CDC Split Type: WAES0901USA03668
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0888U0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Herpes zoster, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 77 year old female patient with no known allergies and no pertinent medical history, who on 27-SEP-2007 was vaccinated with ZOSTAVAX (Lot not provided). There was no concomitant medication. The patient developed (on an unspecified date) painful shingles around face, scalp and forehead. She also experienced shooting pain, chills and fever. She was prescribed VALTREX for the treatment. As of 26-JAN-2009 the patient hadn''t recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009. Follow up information has been received from a registered nurse and a completed questionnaire, concerning a 78 year old female patient with a history of chickenpox in 1938, who on 27-SEP-2007 was vaccinated with 0.5 mL the first dose of ZOSTAVAX (Merck) (Lot 658084/0888U) subcutaneously in the left arm at 2:15 pm. It was reported the patient had no illness at time of vaccination. The reporter stated a failure in the ZOSTAVAX (Merck) vaccine. On 26-Jan-2009, the patient developed shingles. The patient had a maximum of body temperature of 91.8 degrees F, with a pain degree of 5 (0 lest to 10 most), she also had trouble with vision and went to see the ophthalmologist. The nurse reported the patient had had no recent exposure to chicken pox or herpes zoster. A direct fluorescent antibody test was not done and no specimen was collected for PCR. On an unspecified date the patient recovered. Additional information is not expected.

VAERS ID:385133 (history)  Vaccinated:2007-09-27
Age:5.0  Onset:2007-09-27, Days after vaccination: 0
Gender:Male  Submitted:2010-04-15, Days after onset: 931
Location:North Carolina  Entered:2010-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none reported
Preexisting Conditions: asthma
Diagnostic Lab Data: unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2290AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ087323SCLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0651U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Auricular swelling, Lip swelling, Rash, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: facial rash, swollen lips and tongue and ears within 10 minutes after receiving vaccines

VAERS ID:388073 (history)  Vaccinated:2007-09-27
Age:10.0  Onset:2009-09-23, Days after vaccination: 727
Gender:Male  Submitted:2010-05-14, Days after onset: 233
Location:New York  Entered:2010-05-18, 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: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0909USA03760
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1103U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Secondary transmission, Varicella post vaccine
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a male patient with allergic reaction to antibiotics (name and manufacturer unspecified) who on 15-JAN-1998, when 11 month old, was vaccinated with the first dose of VARIVAX (Merck) (lot number not reported). On 27-SEP-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 658294/1103U). On 23-SEP-2009, when 12 year old, the patient developed mild case on chicken pox. It was also mentioned that week ago the patient was exposed to someone who had chicken pox. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. Follow-up information received from a healthcare professional concerning the 12 year old male patient with allergy to BIAXIN who on 27-SEP-2007, at 16:30 pm was vaccinated IM with the second dose of VARIVAX (Merck) (lot number 658294/1103U). On 23-SEP-2009, at 9:00 am the patient''s mother called the office stated that the patient had "chicken pox". The patient had blister like sports on back. The mother described what sounded like chicken pox-also the patient exposed to someone 2 week prior that was diagnosed with chicken pox. The patient was not seen for diagnosis. On 30-SEP-2009 the patient recovered. Additional information is not expected.

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