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Found 485503 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:307299 (history)  Vaccinated:2008-03-18
Age:17.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 0
Location:Virginia  Entered:2008-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainted after receiving vaccine.

VAERS ID:307374 (history)  Vaccinated:2008-03-18
Age:29.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-03-19, Days after onset: 0
Location:New York  Entered:2008-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: psoriatic arthritis
Preexisting Conditions: no known allergies
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN IMLA
Administered by: Military     Purchased by: Military
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Psoriatic arthropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad)
Write-up: Pt is taking Etanercept (Immunosuppressing med) for psoriatic arthritis but was vaccinated by medic yesterday with Typhoid. PA was not aware of this patient as he was seeing patients during sickcall. Pt presented today with sore left shoulder and decreased ROM but no infection observed today only. Pt has hot compress and quarters. Pt doing well otherwise with stable vitals.

VAERS ID:307391 (history)  Vaccinated:2008-03-18
Age:33.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-19
Location:California  Entered:2008-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sinusitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2498AA IDRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect route of drug administration
SMQs:
Write-up: The Patient was given .1 ml of Influenza Virus Vaccine intradermally.

VAERS ID:307392 (history)  Vaccinated:2008-03-18
Age:13.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-19
Location:Georgia  Entered:2008-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ALLERGIC RHINITIS AND ALLERGIC CONJUNTIVITIS
Preexisting Conditions: THIS WAS THE PATIENT''S FIRST VISIT TO OUR OFFICE. WE HAD NO PREVIOUS MEDICAL RECORDS. GUARDIAN STATED THAT THE ONLY KNOWN ALLERGIES WERE TO KETCHUP AND ORANGES. ALSO HAD PREVIOUSLY BEEN TREATED FOR SEASONAL ALLERGIES. NO BIRTH DEFECTS.
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U5IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: No adverse reaction
SMQs:
Write-up: NO ADVERSE EVENT OCCURRED.

VAERS ID:307533 (history)  Vaccinated:2008-03-18
Age:8.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-03-20, Days after onset: 1
Location:California  Entered:2008-03-20
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1568U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: PT RECEIVED A CHICKEN POX INJECTION ON HIS LT ARM SUBCUT. ON 3-18-08. PT CAME IN ON 3-19-08 BECAUSE OF A RASH ON HIS LT ARM. PT HAS A 3CM X 4CM ELEVATED, ERYTHEMATOUS EXANTHEM ON LEFT ARM ON THE OUTER ASPECT, SITE OF THE VARICELLA INJECTION. RECOMMEND BENADRYL OTC, HYDROCORTISONE 1% CREAM FOR ITCHING.

VAERS ID:307772 (history)  Vaccinated:2008-03-18
Age:61.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 2
Location:New Hampshire  Entered:2008-03-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD; Glucophase 500mg 1 AM and 2 PM; Lantus 28 cc qd night; multi vitamin 1 qd
Current Illness: None
Preexisting Conditions: NKDA; Diabetes (DM); HTN
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Injection site pain, Nausea, Pain, Stomach discomfort, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Received TDaP vaccine around 2:30pm in left arm. At 5pm patient complained of "nausea, chills", (no rash). 7p-8p chills and achy all over. 12am-12:30am vomited x2, 5:30am vomited again. 9A-9:30A stomach still upset, by 12 noon felt better and ate some canned peaches. By 5pm - felt much better. No local redness - just soreness at site per patient.

VAERS ID:307784 (history)  Vaccinated:2008-03-18
Age:57.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-20, Days after onset: 1
Location:Massachusetts  Entered:2008-03-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, GERD, Restrictive lung disease, Kyproscoliosis, Polio-age 5, Diverticulosis
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.113261IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Axillary pain, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain at injection site (L) upper arm that radiates to (L) axilla and down her arm. Rash left - right side of trunk.

VAERS ID:307787 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 2
Location:Arkansas  Entered:2008-03-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2156AA4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB249AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1670U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1512U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Within 1 hour of vaccination, left arm became swollen, red, and warm to touch. Pt brought in following day. It appeared the same. Mom treated with ice, Motrin/Tylenol.

VAERS ID:307965 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-20, Days after onset: 2
Location:New York  Entered:2008-03-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD test
Current Illness: Conjunctivitis, URI
Preexisting Conditions: None
Diagnostic Lab Data: Seen by Dr 3/20/08 MRI ordered
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA1IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458913IMLL
Administered by: Public     Purchased by: Public
Symptoms: Nuclear magnetic resonance imaging, Viral infection, Walking disability
SMQs:, Parkinson-like events (broad)
Write-up: Mom brought child into clinic today 3/20/08 for PPD reading and stated since 3/18/08 has not been walking. No redness or swelling at injection site (L) thigh. Seen, by provider diag with viral syndrome. Rxd ice to area, a MRI

VAERS ID:307966 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-19, Days after onset: 1
Location:Arizona  Entered:2008-03-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B067AA4UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA0UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01103SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0746U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large swelling to left arm, measuring 3"x1 1/2". 24 hour injection.

VAERS ID:307974 (history)  Vaccinated:2008-03-18
Age:1.1  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-24, Days after onset: 6
Location:Ohio  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2291BA2IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0003U2IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAO27322IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0287U0SCRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH854013F2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1029U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt received immunizations on 03-18-2008. 3-4 hrs later pt developed hives on trunk and limbs.

VAERS ID:307985 (history)  Vaccinated:2008-03-18
Age:1.4  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-24, Days after onset: 6
Location:Tennessee  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: As above, patient was diagnosed with pneumonia.
Preexisting Conditions: None known
Diagnostic Lab Data: Blood cultures: no growth at 5 days; Complete Blood Count within normal limits; Complete Metabolic Profile acceptable, with the exception of Potassium 3.5 [4.1-5.3] and Sodium 135 [139-146]. Results of chest x-ray show possible upper left lobe pneumonia.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Blood sodium normal, Chest X-ray abnormal, Convulsion, Full blood count normal, Hypokalaemia, Metabolic function test normal, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient presented to the emergency department from home after mother called emergency medical services stating that the child was having a seizure. Upon arrival, patient was found to still be seizing. Patient received intravenous Ativan, after which the seizures stopped. Seizure-like activity did reappear, for which the patient received an additional dose of Ativan with good relief. The patient was transferred to Hospital for observation and treatment. Patient was found to be febrile at presentation (100.6 F), although mother had reported giving the child Children''s Tylenol (dose unknown). Patient was also found to have pneumonia as demonstrated on chest x-ray. PLEASE NOTE: Vaccines were identified based on VIS provided by mother, who reports she received them at appointment.

VAERS ID:308070 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-19, Days after onset: 1
Location:Michigan  Entered:2008-03-25, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Allergic Rxn~Influenza (no brand name)~4~4~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to: Amox (Rash), Demerol (stopped breathing), flu vaccine.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Angioedema, Auricular swelling, Eye swelling, Lip swelling, Oedema peripheral, Paraesthesia oral, Pruritus, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Received VARIVAX on 3/18/08 at 10:30 AM. By 10:50 AM, arms, lips, ears, face started swelling. Mom gave 1/2 tsp Benadryl and called office. Was instructed to give another 1/2 tsp Benadryl and take to urgent care. Arrived at urgent care at 11:50, was discharged at 1:30. Was given oral steroids. 3/26/08-records received for DOS 3/18/08-DX: anaphylasis rection to varivax, angiodedma to vaccine. C/O lips tingling, scratching, eyes swollen. Seen in PCP office on 3/19/08-recovered, but eyes remain swollen. referred to allergiest.

VAERS ID:308081 (history)  Vaccinated:2008-03-18
Age:12.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 0
Location:Pennsylvania  Entered:2008-03-25, 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: Vitiligo
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.175700UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797J0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hypoaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient got dizzy and felt like legs numb. Eyes closed and patient became syncopal. Patient vs stable. Drank juice and felt ok. Patient ambulated out of office.

VAERS ID:308086 (history)  Vaccinated:2008-03-18
Age:17.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 0
Location:Pennsylvania  Entered:2008-03-25, 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:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB253AA0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.175700UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B124AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Feeling abnormal, Gaze palsy, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Sitting in chair after vaccines and said "I don''t feel good." Head drooped, patient''s eyes rolled back and arms started shaking. Patient became syncopal. Laid down, drank juice. Patient states that she did not eat that day. Ok to ambulance.

VAERS ID:308091 (history)  Vaccinated:2008-03-18
Age:74.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-03-19, Days after onset: 0
Location:Montana  Entered:2008-03-25, 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: Celebrex, Vytorin, Warfarin, Lisinopril, Metoprolol
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data: Unknown
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1874U SCLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: ZOSTAVAX given 3/18/08. Pt called 3/19/08 describing a rash on abdomen confined mostly to left side (red, papular) with one site to the right of midline. The rash was not sore or itchy. Advised patient to contact physician immediately.

VAERS ID:308099 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-21, Days after onset: 2
Location:Illinois  Entered:2008-03-25, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2655AA4UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR210093UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1031F1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: At site of injection (right upper thigh) - 6.5cm x 5.5cm red, warm indurated lesion - tender to touch.

VAERS ID:308104 (history)  Vaccinated:2008-03-18
Age:0.5  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-19, Days after onset: 0
Location:Oregon  Entered:2008-03-25, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA2IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF237AD2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631112IMLL
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Myoclonus, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)
Write-up: Fussy since vaccines given yesterday. Slept well last night. Fussy again today after emesis times 2 and small spit-ups. For 1 hour period today had symmetic myoclonic movements of arms and legs, as well as head.

VAERS ID:308106 (history)  Vaccinated:2008-03-18
Age:10.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-03-25, Days after onset: 5
Location:Massachusetts  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1587U1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Feeling hot, Injection site pain, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Right upper arm 8 1/2 x 6 1/2 inch erythematous raised warm to touch patch with tenderness at site where injection given. No joint pain, swelling, qd ROM, negative streaking. Treated with Keflex 25015 1 tsp PO (0.10 x 10d with rev within 24-48 hours.

VAERS ID:308113 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 2
Location:California  Entered:2008-03-25, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2355AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR205273SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1799U1SCRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Induration, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Redness, firm to touch Rt upper arm - 11 cm length x 10 cm. Notice small redness. Child began to scratch Rt upper arm. Enlarged in size by evening. C/O pain eating (2-3). Instructed parent to apply cool compress, Tylenol 1.5 tsp Benadryl ointment.

VAERS ID:308126 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-03-25, Days after onset: 5
Location:Texas  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2354BA4IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0292U1SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHA2596F3SCRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling, heat to area of injection of MMRV. Site of IM injection near this site was normal.

VAERS ID:308150 (history)  Vaccinated:2008-03-18
Age:62.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-03-25, Days after onset: 5
Location:South Carolina  Entered:2008-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, Allegra, Nexium; Diovan; Asthmanox
Current Illness: None
Preexisting Conditions: Allergies: Tetanus shot, Nylon sutures; Radioactive isotope dye
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1413U SCLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Pt received vaccine 3/18/2008 - came to office on 3/20/2008 with local erythema/edema to area.

VAERS ID:308159 (history)  Vaccinated:2008-03-18
Age:0.4  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-25, Days after onset: 6
Location:California  Entered:2008-03-25
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC218137AA1UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF344AD1UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458941UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0942U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: slight erythema and swelling at site (Rt. thigh) of injection.

VAERS ID:308215 (history)  Vaccinated:2008-03-18
Age:14.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 2
Location:New Jersey  Entered:2008-03-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illnesses, or use of other medications at the time of the vaccination on 18 March 2008. The patient does have a history of cyclic vomiting. There were no reports of adverse events with prior vaccinations. The patient had not received any other vaccinations within four weeks of 18 March 2008.
Diagnostic Lab Data: No diagnostic tests were performed.
CDC 'Split Type': 200800836
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2562A IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899A IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Chest pain, Diarrhoea, Erythema, Local swelling, Pruritus, Rash macular, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 19 March 2008 from a nurse. A 14-year-old male patient, with past medical history of cyclic vomiting, and who had not received any other vaccinations with four weeks of 18 March 2008, had received an intramuscular, left deltoid dose of Adacel (lot # C2899AA); and an intramuscular, right deltoid dose of Menactra (lot # U2562AA) on 18 March 2008. Forty-five minutes post-vaccination, the patient complained of abdominal itching, abdominal pain, chest pain, and he had broke out in hives with red blotchy skin in the face and neck area. The patient also had swelling in the face and neck, and had episodes of diarrhea. The patient sought medical attention at the local emergency room and was treated with intravenous Solu-Medrol and was released the same day with a prescription of prednisone and Benadryl. No diagnostic tests were performed. As of 19 March 2008, the patient was feeling better, but had not fully recovered.

VAERS ID:308222 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 2
Location:North Carolina  Entered:2008-03-26, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355BA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0113SCLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0914U0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Local reaction, Rash pustular, Skin lesion
SMQs:, Hypersensitivity (narrow)
Write-up: Large local reaction - pustule on left arm site with lesions left leg. Local ice, Keflex PO.

VAERS ID:308228 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-22, Days after onset: 4
Location:Texas  Entered:2008-03-26, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acute asthma
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054BA4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03014UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U2UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1659U2UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Pain in extremity, Screaming
SMQs:, Hostility/aggression (broad), Arthritis (broad)
Write-up: Legs hurt, thighs and knees - child screams at night. Still hurting after 4 days. Tylenol and Motrin ineffective. No redness or swelling.

VAERS ID:308284 (history)  Vaccinated:2008-03-18
Age:10.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Male  Submitted:2008-03-26, Days after onset: 6
Location:Oregon  Entered:2008-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2844AA IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1796U SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Baseball sized swelling with redness. No pain afebrile with slight itching.

VAERS ID:308405 (history)  Vaccinated:2008-03-18
Age:6.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 2
Location:New Jersey  Entered:2008-03-27, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: The rash may have been a typical scarlet fever rash.
Preexisting Conditions:
Diagnostic Lab Data: (+) Rapid Ag strep test
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSB253AA1UNLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Streptococcus identification test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Intermittent urticaria appeared evening after administration. Fever was present before admin. of vaccine. Pt also had a (+) rapid Ag strep test on 3/20/08.

VAERS ID:308440 (history)  Vaccinated:2008-03-18
Age:35.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-27, Days after onset: 8
Location:Illinois  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None; pre-splenectomy
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data: Had blood cx''s (-); U/S arm (-)
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2528AA0UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0UNRL
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Pyrexia, Ultrasound scan normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Pt developed fever to 103 day after vaccine.

VAERS ID:308467 (history)  Vaccinated:2008-03-18
Age:  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 9
Location:Illinois  Entered:2008-03-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA03103
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure, Eye irritation
SMQs:, Corneal disorders (broad)
Write-up: Information has been received from a certified medical assistant concerning a female co-worker who on 18-MAR-2008 splashed ZOSTAVAX in her eye while administering the vaccine. The patient experienced burning, but it may have been due to flushing it with water. No other symptoms noted. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. The reporter considered the patient events to be an other important medical events. Additional information has been requested.

VAERS ID:308469 (history)  Vaccinated:2008-03-18
Age:24.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-19, Days after onset: 1
Location:North Carolina  Entered:2008-03-28, Days after submission: 9
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic to CEFZIL. No medical conditions.
Diagnostic Lab Data: ER has them.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0570U1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dizziness, Nausea, Pyrexia, Rash, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: After Hep B vaccine #3 was given, pt c/o nausea, fever, coughing, and dizziness within 2 min. Pt c/o tightness of throat about 50 min after the vaccine. No SOB. Pt was sent to ER for c/o tightness of throat. He has rash around his neck at the ER. He was given SOLU-MEDROL, BENADRYL, and EPINEPHRINE at ER.

VAERS ID:308473 (history)  Vaccinated:2008-03-18
Age:0.5  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-21, Days after onset: 2
Location:Texas  Entered:2008-03-28, 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:
Current Illness: (L) Otitis Media
Preexisting Conditions:
Diagnostic Lab Data: co existent OM, pharyngitis
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B138BA2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF343AD2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458922IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1731U2PO 
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Otitis media, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: R thigh swelling/tenderness pain (mild to moderate) fever. all after 2 days of imm.

VAERS ID:308479 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Male  Submitted:2008-03-24, Days after onset: 4
Location:California  Entered:2008-03-28, 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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA4UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10693SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1747U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.158541SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 3x3 redness, painful to touch on right deltoid area and down. 3x3 redness to lower right arm.

VAERS ID:308521 (history)  Vaccinated:2008-03-18
Age:45.0  Onset:2008-03-24, Days after vaccination: 6
Gender:Male  Submitted:2008-03-28, Days after onset: 4
Location:Colorado  Entered:2008-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: Pt. Has plan to see his primary care provider in the coming days. The rash reaction was irritating, but no pustules were visible.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1635SCRA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB521AA0IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A OTLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA0IMRA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30013390PO 
Administered by: Military     Purchased by: Military
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Localized, large Rash developed apprx 5-7 days after smallpox vaccination was administered. Rash was around parts of chest, but mostly located in the deltoid & armpit area of the vaccinated arm on the 7th day after vax was given. Rash was generalized, not one large rash, but several small outbreaks. Rash wasn''t raised.

VAERS ID:308576 (history)  Vaccinated:2008-03-18
Age:13.0  Onset:2008-03-21, Days after vaccination: 3
Gender:Male  Submitted:2008-03-21, Days after onset: 0
Location:California  Entered:2008-03-31, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2552AA0IMLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2826AA0IMLA
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: 3/21/08 Per Dr. w/ swelling + redness around injection site on left arm.

VAERS ID:308694 (history)  Vaccinated:2008-03-18
Age:43.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-03-31, Days after onset: 11
Location:Minnesota  Entered:2008-04-01, 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: CA++/vit D, Ferrous gluconate, gabapentin, ibuprofen, lantus, novolog, paroxetine, ranitidine
Current Illness: Type II DM
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Neuropathy peripheral, Radial nerve palsy, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)
Write-up: Right radial nerve neuropathy with decreased sensation dorsum of right hand and right wrist drop. Numbness noted the evening of the day of vaccination and wrist drop noted the next morning. Treatment: oral prednisone, physical therapy and wrist splint.

VAERS ID:308714 (history)  Vaccinated:2008-03-18
Age:64.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-01, Days after onset: 14
Location:California  Entered:2008-04-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Large area on arm swelled, hot, bright red and painful. Area approximately 5"x6". Headache. Duration approximately 2 weeks.

VAERS ID:308934 (history)  Vaccinated:2008-03-18
Age:14.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-03, Days after onset: 16
Location:Tennessee  Entered:2008-04-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA4IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling slightly with tenderness

VAERS ID:309019 (history)  Vaccinated:2008-03-18
Age:1.1  Onset:2008-03-20, Days after vaccination: 2
Gender:Male  Submitted:2008-04-01, Days after onset: 12
Location:Louisiana  Entered:2008-04-07, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: will refer to allergist for possible allergy testing
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSHAVB256AA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1483U0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1795U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Allergy test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: child received vaccination 3/18/08 (MMR Varivax, Hepatitis A). I saw her in the office on 3/27/08 with diffuse marked urticaria. Mom reported that the rash started on the day after he received his vaccines (within 48 hrs) and has continued so she brought him in.

VAERS ID:309083 (history)  Vaccinated:2008-03-18
Age:  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-04-07, Days after onset: 19
Location:North Carolina  Entered:2008-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension; Hyperlipidaemia; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA05029
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1835U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Blister, Herpes zoster, Rash erythematous, Skin burning sensation, Urinary tract infection
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a male consumer with hypertension, hyperlipidemia and allergies to "medications for hypertension and hyperlipidemia" who on 18-MAR-2008 was vaccinated with Zostavax (Oka/Merck) (lot # 659324/1835U). On 19-MAR-2008 the patient went to the ER for back pain. He was diagnosed in the ER with a urinary tract infection and was given CIPRO. The patient developed shingles on his right back and flank. The rash was erythematous blisters with burning that began on 26-MAR-2008. It was also noted that the patient was seen in the office. At the time of the report the patient has not recovered. There was no product quality complaint involved. The reporter considered the patient''s events to be other important medical events since he was seen in the ER and office. Additional information has been requested.

VAERS ID:309090 (history)  Vaccinated:2008-03-18
Age:44.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-08, Days after onset: 21
Location:Texas  Entered:2008-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: HX of motion sickness and shortness of breath at alt. over 6000 ft.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03422 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pt. started Oral Typhoid pills on 3/18/08 and took a pill on 3/20, 3/22, 3/24. Pt did experience Nausea and Diarrhea shortly after taking the first dose. Pt came to office today for Twinrix #3 accelerated and stated that she is exhausted and still having diarrhea daily. Instructed pt to go to her primary doctor.

VAERS ID:309210 (history)  Vaccinated:2008-03-18
Age:39.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 22
Location:California  Entered:2008-04-09
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: HTN, Dyslipidemia, Asthma, DM
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1132U IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Injection site erythema, Injection site pain
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: On follow up visit of 4/1/08 patient stated after vaccine experienced pain, redness at injection site and exacerbation of asthma symptoms with improved after using inhalers.

VAERS ID:309739 (history)  Vaccinated:2008-03-18
Age:10.0  Onset:2008-04-14, Days after vaccination: 27
Gender:Male  Submitted:2008-04-16, Days after onset: 2
Location:Pennsylvania  Entered:2008-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Amoxicillin gives rash
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1795U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Varicella and Hep A given 3/18/08. Facial symptom 4/14/08. Seen 4/15/08 diagnosed with (L) Facial Bell''s Palsy. Treated with steroids and Acyclovir.

VAERS ID:311166 (history)  Vaccinated:2008-03-18
Age:18.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 27
Location:Unknown  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': WAES0804USA00271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, No reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional concerning an 18 year old female who on 11-SEP-2007 was vaccinated with the first dose of Gardasil (657622/0388U). On 13-NOV-2007 the patient was vaccinated with the second dose of Gardasil (657622/0388U). On 18-MAR-2008 the patient was vaccinated IM with the third dose of Gardasil (658490/0802U). Subsequently, the patient developed pain at the injection site that has persisted. The patient sought unspecified medical attention. The patient did not experience a fever, swelling, redness, numbness, or weakness in the arm. All three injections were given in left arm. The patient did not have a reaction with the first two doses. Per the reporter, the patient is recovering. No additional information is available. Additional information has been requested.

VAERS ID:309860 (history)  Vaccinated:2008-03-18
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-31
Location:Massachusetts  Entered:2008-04-17, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: NONE. No adverse event occured. We were instructed to file thi by our local DPH immunization manager because Boostrix not Adacel.

VAERS ID:309872 (history)  Vaccinated:2008-03-18
Age:45.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 9
Location:North Carolina  Entered:2008-04-17, Days after submission: 21
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: Latex; corn; mushroom; pork; strawberries; tomatoes allergies.
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0867U SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Arthralgia, Dysphagia, Musculoskeletal stiffness, Oedema peripheral, Pain, Pharyngeal oedema, Pharyngolaryngeal pain, Pruritus, Pyrexia, Rash generalised
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Complained of left arm swelling, ache, joints pain, sore throat and swelling, fever 101-102 F, difficulty swallowing, itchiness. Generalized rash, and stiffness on neck on 3/18. Still complaining joints pain, stiffening of neck. Rash noted on chest. Takes OTC Benadryl, Tylenol, Ecotrin aspirin, and Valium for sleep 3-27-08.

VAERS ID:310498 (history)  Vaccinated:2008-03-18
Age:0.4  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: otitis media. NKDA
Diagnostic Lab Data: CSF, clear; CT head, no intracranial abnormalities. Labs and Diagnostics: Head CT WNL. CXR (-). LP WNL. Urine tox (-) except for benzos (given). Blood, urine and CSF cx all (-).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1069 IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB086708 IMRL
Administered by: Private     Purchased by: Public
Symptoms: Blood culture negative, Body temperature increased, CSF culture negative, CSF test, Chest X-ray normal, Computerised tomogram normal, Culture urine negative, Febrile convulsion, Foaming at mouth, Grand mal convulsion, Hypotonia, Lumbar puncture normal, Muscle twitching, Scan brain, Tonic clonic movements, Toxicologic test, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: generalized tonic-clonic seizure; frothing at mouth; twitching of limbs; temperature of 102.6 F 5/14/2008 MR received for DOS 3/19-21/2008 with D/C DX: Febrile Seizure. Pt presented to local ER after mother found infant making gurgling sounds, frothing at the mouth and limp and unresponsive. In ER infant had an episode of jerking which persisited ~30-40 minutes, initially unresponsive to Valium and Ativan. Temp was 102.6''F. Seizing stopped as fosphenetoin started. Transfered to current facility. No further seizures.

VAERS ID:311197 (history)  Vaccinated:2008-03-18
Age:34.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-18
Location:North Carolina  Entered:2008-04-23, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Recovering drug addict
Diagnostic Lab Data: None
CDC 'Split Type': NC08049
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB096AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Patient received TWINRIX and TDaP on 3-18-08. Soon after that, he noticed right upper arm became numb only at night. No tingling, no color change. Arm recovers in AM.

VAERS ID:311088 (history)  Vaccinated:2008-03-18
Age:0.5  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 41
Location:Texas  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Resolved OM
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132CA2UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF298AA1UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB97283A2UNUN
Administered by: Military     Purchased by: Military
Symptoms: Pyrexia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Description: 6 month infant received routine 6m vaccines on 18 March 2008 at approximately 11AM. She was little clingy the rest of the day but no medications were administered. At 8PM she was given a dose of Tylenol and put to bed. Approximately 1130PM she had onset of violent emesis, tactile fever and rash. The rash consisted of large hives on her trunk. She seemed to be very bothered by the rash. She was given Atarax with significant improvement in symptoms and able to return to sleep. In the morning the rash was essentially resolved with no recurrence of symptoms. She had ear infection 2 weeks prior to well baby visit-treated with Amoxicillin that was completed 3 days prior to well baby/immunizations. Had ear infections-followed up in peds that day for ear with resolution-temp. Symptom: Vomiting Start: 03/18/2008 End: 03/19/2008; Symptom: Hives Start: 03/18/2008 End: 03/19/2008: Symptoms: Fever Start: 03/18/2008 End: 03/18/2008 Comment: tactile

VAERS ID:311106 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 2
Location:New Mexico  Entered:2008-04-28, Days after submission: 39
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': NM040801
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01273IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1518U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness 6cm x 7cm, mild swelling, soreness, fever. Treated with Tylenol or Motrin PRN.

VAERS ID:311541 (history)  Vaccinated:2008-03-18
Age:50.0  Onset:2008-03-25, Days after vaccination: 7
Gender:Male  Submitted:2008-05-02, Days after onset: 38
Location:Massachusetts  Entered:2008-05-02
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
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA0IMLA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30013390PO 
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF300AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Loss of consciousness on 2 occasions had to be hospitalized for a check up.

VAERS ID:312536 (history)  Vaccinated:2008-03-18
Age:0.5  Onset:2008-04-10, Days after vaccination: 23
Gender:Male  Submitted:2008-05-16, Days after onset: 36
Location:Unknown  Entered:2008-05-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA01939
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2PO 
Administered by: Other     Purchased by: Other
Symptoms: Barium enema, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: Information has been received from a nurse concerning a 6 month old male who on 18-MAR-2008 was vaccinated orally with "one tube", a third and final dose of ROTATEQ. On 10-APR-2008 the patient was hospitalized with intussusception. The patient was treated twice with therapeutic barium enema. The patient recovered and was discharged on 13 APR 2008. The patient had two follow up visits "to the office" since discharge, and had no problems. Additional information has been requested.

VAERS ID:313071 (history)  Vaccinated:2008-03-18
Age:16.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 57
Location:Oklahoma  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 2/22/2008)
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory
CDC 'Split Type': WAES0804USA03252
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Injection site pain, Laboratory test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a physician for the merck pregnancy registry concerning a 16 year old female with no previous medical history or no drug allergies, who on 18-MAR-2008 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. On 14-Apr-2008 the patient found out that she was 7 weeks pregnant. The patient also experienced soreness at the injection site. Unknown medical attention was sought. The patient''s outcome was not reported. Additional information has been requested.

VAERS ID:312719 (history)  Vaccinated:2008-03-18
Age:0.2  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-05-20, Days after onset: 62
Location:D.C.  Entered:2008-05-20
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF3566AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08050IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451530IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1205U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Haematochezia, Mucous stools
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad)
Write-up: blood and mucous in stool 1 day after vaccine administered and lasted about 2 weeks

VAERS ID:313439 (history)  Vaccinated:2008-03-18
Age:14.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-05-21, Days after onset: 64
Location:South Carolina  Entered:2008-05-27, 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: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073 UNLA
Administered by: Private     Purchased by: Other
Symptoms: Hypoaesthesia, Metrorrhagia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad)
Write-up: Transient numbness in hands, metrorrhagia

VAERS ID:314138 (history)  Vaccinated:2008-03-18
Age:11.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-05-29, Days after onset: 71
Location:Indiana  Entered:2008-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: After receiving second HPV, later patient had a seizure.

VAERS ID:314661 (history)  Vaccinated:2008-03-18
Age:11.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-06-02, Days after onset: 75
Location:Florida  Entered:2008-06-03, 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: Convulsion; Brain lesion
Preexisting Conditions: Headache; Migraine
Diagnostic Lab Data: diagnostic procedure - spectrascopy test: normal
CDC 'Split Type': WAES0805USA04752
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Convulsion, Diagnostic procedure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a certified medical assistant concerning a 11 year old female with seizure activity, temporal lobe lesion (is taking topiramate), no history of drug reactions/allergies, and a history of headache and migraine who on 18-MAR-2008 was vaccinated with a first dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM In the left deltoid. Concomitant therapy also given on 18-MAR-2008 included MENACTRA, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Other concomitant therapy included TOPAMAX. On 19-MAR-2008, the day after the first dose of GARDASIL, the patient experienced seizure activity at school, but it was not reported to the doctor''s office at that time. On 19-MAY-2008, the patient was vaccinated with a second dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM in the left deltoid. That evening, the patient had a seizure. Medical attention was sought in the office. Spectrascopy test result was normal; unknown when the test was performed. There was no fever post vaccination. Subsequently, the patient recovered from the seizure. Upon internal review, the seizures were considered to be Other Important Medical Events. Additional information has been requested.

VAERS ID:315639 (history)  Vaccinated:2008-03-18
Age:8.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Male  Submitted:2008-06-09, Days after onset: 82
Location:Virginia  Entered:2008-06-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: seasonal allergies
Diagnostic Lab Data:
CDC 'Split Type': VA08008
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2435AA3IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Eyelid oedema, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Vaccines given on 3/18/08 with no problems. Mother brought child back to the health dept on 3/19/08 because child awakened with itching & redness on face with swollen eye lids. Rash on no other part of body. Mother gave benadryl at home with no improvement.

VAERS ID:316017 (history)  Vaccinated:2008-03-18
Age:0.3  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-06-11, Days after onset: 85
Location:Nebraska  Entered:2008-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None-I am filling out form , but was not invovled with the vaccines on 3-18-2008
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B141AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF238AE0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631140IMLL
Administered by: Public     Purchased by: Public
Symptoms: Abnormal behaviour, Body temperature, Crying, Diet refusal, Erythema, Hypotonia, Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: about 2 hours after pediarix, prevnar and Hib vaccine, became limp would not eat or interact, lasted for 2 hours then cried unconsolably for x''s 2 hours then red blotches that itched x''s 2 hours, then woke up limp again-total time of acting abnormal was 21 hours then normal, Temp 99. Suspect HHE due to Dtap. Gave DT on 6-10-08 without problems.

VAERS ID:316286 (history)  Vaccinated:2008-03-18
Age:11.0  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-06-13, Days after onset: 86
Location:Unknown  Entered:2008-06-16, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: computed axial, "was good"; diagnostic laboratory, "was good"; computed axial, "turned out fine"; magnetic resonance, "turned out fine"
CDC 'Split Type': WAES0806USA00950
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Laboratory test normal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a consumer concerning her 11 year old daughter, who, on an unspecified date, was vaccinated with a first dose of GARDASIL. The first dose was well tolerated. On 18-MAR-2008 at 11:00 the patient was vaccinated with a second dose of GARDASIL. On 19-MAR-2008 the patient experienced a seizure at school. The patient was taken to the hospital from school. A computed axial tomography (CAT) scan and blood work were performed and were both "good." The patient was seen by a neurologist who performed a computed axial tomography (CAT) scan and a magnetic resonance image (MRI) and both "turned out fine." The mother believed that the patient had the seizure due to the vaccination. It was reported that the patient was very healthy with no problems before the shot and has had no problems since the shot. The patient recovered on an unspecified date. Upon internal review the seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:316568 (history)  Vaccinated:2008-03-18
Age:16.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 92
Location:Pennsylvania  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen; Midol
Current Illness:
Preexisting Conditions: Severe dysmenorrhea
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Dysarthria, Memory impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Patient reported to Dr. office on 6/10/08 and reported dizziness, slurred speech and forgetfulness after first vaccine on 3/18/08, no report prior to 6/10/08.

VAERS ID:317705 (history)  Vaccinated:2008-03-18
Age:24.0  Onset:2008-03-25, Days after vaccination: 7
Gender:Female  Submitted:2008-06-26, Days after onset: 93
Location:Texas  Entered:2008-06-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance - brain, neck and spine; lesions found on spinal cord MRI; diagnostic laboratory - blood work (result not reported) 7/18/08-records received-CSF IgG index elevated, positive oligoclonal bands. CT and MRI of brain normal.
CDC 'Split Type': WAES0806USA07599
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1IDLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Blood test, CSF oligoclonal band present, Computerised tomogram normal, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging brain normal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Demyelination (narrow)
Write-up: Information has been received from a physician concerning a 24 year old female who was vaccinated with a second dose of GARDASIL. In March 2008, the patient experienced generalized numbness and weakness in her body after the vaccination. The patient''s condition was described as a transverse myelitis. Laboratory studies performed included "blood work" (result not reported) and magnetic resonance imaging of the brain, neck and spinal cord. Spinal cord lesions were found on the spinal cord magnetic resonance imaging. The patient sought medical attention by the physician. At the time of the report the patient had not recovered. Upon internal review the transverse myelitis was considered to be an important medical event. Additional information has been requested. 7/18/08-records received-6/18-7/14/08 presented with recent onset of arm and leg numbness, electrical shock like sensation with neck flexion. Impression:recent onset of transverse myelitis one week after receiving Gardasil vaccine.

VAERS ID:319158 (history)  Vaccinated:2008-03-18
Age:64.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-06-24, Days after onset: 96
Location:Maryland  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hyperlipidaemia; Scoliosis; Rhinitis allergic; Osteoporosis; Gastrooesophageal reflux disease; Hypersensitivity; Mitral valve prolapse; Depression; Carotid bruit; Sulfonamide allergy; Penicillin allergy
Preexisting Conditions: Chickenpox
Diagnostic Lab Data: body temp 98 degree - maximum temperature; VZV strain 03/26/08 - VZV WILD TYPE STRAIN
CDC 'Split Type': WAES0803USA03893
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1873U SCRA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature, Herpes zoster, Pain, Rash, Underdose, Viral DNA test positive
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a Licensed Practical Nurse concerning a 64-year-old female with hypertension, hyperlipidaemia, scoliosis, rhinitis allergic, osteoporosis, gastrooesophageal reflux disease, mitral valve prolapse, depression, left carotid bruit, and penicillin, MACROBID and BACTRIM allergies who on 18-MAR-2008 was vaccinated subcutaneously in the right deltoid with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 659759/1873U). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol, NEXIUM, LIPITOR, ZYRTEC, OMACOR and NASACORT. On 20-MAR-2008, the patient experienced a shingles like rash on the patient''s left shoulder. Medical attention was sought at the physician''s office. There were no laboratory or diagnostic tests performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up has been received from the L.P.N. concerning a patient with a history of chickenpox at the age of 7 who was vaccinated with a 0.6 mL (previously reported as 0.65 mL) dose of zoster vaccine live (Oka/Merck). It was reported that a rash had not occur at the site of injection or elsewhere within 42 days of the vaccination. Date of Herpes Zoster was reported as 20-Mar-2008. The patient rated the pain a 5-6 on a scale of 0-10 (10 being the most). Other symptoms included itching. There was no recent exposure to chickenpox. A direct fluorescent antibody was not done. Follow-up has been received from the L.P.N. and physician who indicated that additional concomitant therapy included cyclobenzaprine hydrochloride (MSD). On 20-Mar-2008, the patient developed a rash on the chest area above the left breast and shoulder. The patient''s maximum temperature was 98 degrees. There was no recent history of exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the Varicella Zoster Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The samples of the lesion were collected on 26-Mar-2008. The sample of #1 and #2 were taken from fluid from a vesicle (swab of vesicle). The PCR results for the specimen from the vesicle identified the presence of WT VZV. Additional information is not expected. This is in follow-up to report (s) previously submitted on 6/24/2008. A lot check has been iniciated. A standard lot check investigation was performed. All in-process quality checks for the lot# 659759/1873U were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release not all specifications. The lot met the requirements of the Center and was released. No further information is available.

VAERS ID:320869 (history)  Vaccinated:2008-03-18
Age:21.0  Onset:2008-04-25, Days after vaccination: 38
Gender:Female  Submitted:2008-07-30, Days after onset: 96
Location:California  Entered:2008-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.?2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Skin papilloma, Vaccine positive rechallenge
SMQs:
Write-up: After second vaccine patient developed one wart on hand. It was treated and resolved. After third vaccine, patient broke out prolifically with warts across knuckles and fingers of both hands. Multiple treatments have not been successful.

VAERS ID:321032 (history)  Vaccinated:2008-03-18
Age:84.0  Onset:2008-04-01, Days after vaccination: 14
Gender:Female  Submitted:2008-07-31, Days after onset: 121
Location:Unknown  Entered:2008-08-01, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0807USA00050
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a pharmacist concerning an 85 year old female with no known allergies, who on 18-MAR-2008 was vaccinated subcutaneously with "1 vial " of ZOSTAVAX. There was no concomitant medication. In April 2008 and again in May or June 2008, the patient developed shingles after receiving ZOSTAVAX. The patient saw the physician. No lab diagnostic studies were performed. At the time of reporting, the patient had recovered from the AEs (date not specified by the reporter). There was no product quality complaint. Follow up information was received from the physician concerning a 88 year old female with no medical history, no known allergies who was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced herpes zoster twice since the immunization. On 10-JUL-2008, the patient recovered. There was no illness at the time of vaccination. No laboratory/diagnostic tests were performed. The reporting physician felt that the patient''s herpes zoster was serious as an other important medical event. No further information is available.

VAERS ID:326248 (history)  Vaccinated:2008-03-18
Age:4.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Male  Submitted:2008-06-03, Days after onset: 75
Location:Nevada  Entered:2008-08-26, Days after submission: 84
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type': 200801683
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B069AA4UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03423UNUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial report received on 19 May 2008 from another manufacturer, report number A0723483A. The original reporter to the other manufacturer was a sales representative who received the report from a physician. A four-year-old male patient had received a fourth dose injection of IPOL, lot number A0342 (route/site not reported) and a fifth dose injection of Infanrix (Manufacturer GlaxoSmithKline), lot number AC14B069AA (route/site not reported) on 18 March 2008, and approximately two days later, experienced severe swelling in his left upper arm through his elbow. The physician indicated that the subject had received an unspecified treatment and the event resolved. According to the physician, the extensive swelling of the patient''s left arm was not considered to be possibly related to the use of IPOL. The reporter for this case is the same as for case number 2008-01358.

VAERS ID:323711 (history)  Vaccinated:2008-03-18
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-21
Location:Georgia  Entered:2008-08-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': GA08047
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: Child''s dose given TD an adult

VAERS ID:323714 (history)  Vaccinated:2008-03-18
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-21
Location:Georgia  Entered:2008-08-29, Days after submission: 130
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': GA08045
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: Child''s dose given to an adult. No event misadministration.

VAERS ID:323715 (history)  Vaccinated:2008-03-18
Age:27.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-21
Location:Georgia  Entered:2008-08-29, Days after submission: 130
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': GA08044
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0502F1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: Child''s dose given to an adult; No event; Misadministration

VAERS ID:325628 (history)  Vaccinated:2008-03-18
Age:1.6  Onset:2008-03-19, Days after vaccination: 1
Gender:Female  Submitted:2008-09-11, Days after onset: 176
Location:Minnesota  Entered:2008-09-19, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: 4wks prior treated for RSV + Strep
Preexisting Conditions: Bronchospasm with URI''s
Diagnostic Lab Data: Not in clinic
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451513UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.159140UNRL
Administered by: Private     Purchased by: Private
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient received vaccination (varicella) in March 2008 with dose of PREVNAR within 24 hours patient developed high ever and seizured. patient treated in ED.

VAERS ID:336977 (history)  Vaccinated:2008-03-18
Age:20.0  Onset:2008-04-22, Days after vaccination: 35
Gender:Female  Submitted:2009-01-05, Days after onset: 258
Location:Hawaii  Entered:2009-01-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 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.0572X0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA UNRA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Mood swings, Muscle spasms, Smear cervix abnormal, Tachycardia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad)
Write-up: Dizzy, lightheaded, tachycardia, intermittent tinnitus. Cramps not related to monthly cycle. Mood swings, abnormal pap smear.

VAERS ID:339194 (history)  Vaccinated:2008-03-18
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-11
Location:Unknown  Entered:2009-02-06, Days after submission: 301
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: ALLRED KNEE LT & SUNRISE POC Enc: #E786380 POC Fac: WAMC Status: Complete Procedure: KNEE LT & SUNRISE Event Date: 10-Mar-2008 08:32:00 Order Comment: NO BRIEF COMMENT Reason for Order: y/o AD CM with approx 3 wks of bilat knee pain
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV173 SCUN
RAB: RABIES (IMOVAX)SANOFI PASTEURA02092 IMUN
Administered by: Military     Purchased by: Military
Symptoms: Gait disturbance, Musculoskeletal stiffness, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: 31 y/o AD WM SM with pain and stiffness multiple joints after receipt of AVA #2 and HDCV #1 over seas on 2/11/08 prior to returning to military base on 2/19/08. Joint Pain, multiple joints start 03/18/2008. Gait abnormality start 03/18/2008 Walks slowly and stiffly, trying not to bend right knee

VAERS ID:339828 (history)  Vaccinated:2008-03-18
Age:54.0  Onset:2008-03-20, Days after vaccination: 2
Gender:Female  Submitted:2008-03-24, Days after onset: 4
Location:Washington  Entered:2009-02-18, Days after submission: 331
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injected limb mobility decreased, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt felt tingling in fingers, unable to lift arm over head.

VAERS ID:341522 (history)  Vaccinated:2008-03-18
Age:1.1  Onset:2009-03-09, Days after vaccination: 356
Gender:Female  Submitted:2009-03-11, Days after onset: 2
Location:Missouri  Entered:2009-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: healthy
Preexisting Conditions:
Diagnostic Lab Data: Tested for Influenza & Strep throat in office - all negative.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413373IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1770U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Cough, Influenza serology negative, Pruritus, Pyrexia, Rash pustular, Rhinorrhoea, Streptococcus identification test negative, Urticaria, Varicella
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Came in 3-9-09 with 101-102 degree fever for 5 days previous r. nose cough & 15 "spots" on torso. Mother called 3-10-09 to report at least 100 more "spots" that itch - no fluid in pustules. DX: Atypical Chicken Pox

VAERS ID:347069 (history)  Vaccinated:2008-03-18
Age:89.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 423
Location:New York  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA03716
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Information has been received from an 89 (also reported as 79 years old) year old retired physician. He reported that he was vaccinated with VARIVAX (Oka/Merck) (route, administration site, lot number not reported) in error instead of ZOSTAVAX (Oka/Merck) on 18-MAR-2008. The reporter felt fine and had no symptoms present at the time of the report. Additional information has been requested.

VAERS ID:370293 (history)  Vaccinated:2008-03-18
Age:1.3  Onset:2008-05-18, Days after vaccination: 61
Gender:Male  Submitted:2009-11-26, Days after onset: 557
Location:California  Entered:2009-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none we know
Preexisting Conditions: none we know
Diagnostic Lab Data: Several Developmental & speech delays. Mitochondrial dysfunction, Immune system dysregulation, Gastrointestinal distress.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1925UEX11/09PH0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Aphasia, Dermatitis diaper, Developmental delay, Malaise, Rhinorrhoea, Speech disorder developmental, Withdrawal syndrome
SMQs:, Dementia (broad), Drug withdrawal (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Several symptoms over a period of weeks to a month - loss of early speech, withdrawal, diaper rash, loss of immunity (always sick with runny nose). Resulted in & continues to result in several developmental & speech delays.

VAERS ID:393028 (history)  Vaccinated:2008-03-18
Age:1.0  Onset:2009-02-10, Days after vaccination: 329
Gender:Female  Submitted:2010-07-18, Days after onset: 522
Location:Illinois  Entered:2010-07-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: none
Diagnostic Lab Data: none, dx confirmed by dermatologist
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Autoimmune disorder, Sinusitis
SMQs:
Write-up: Developed an autoimmune pleva on her entire body. To date this has not cleared up. This developed after a sinus infection in which she took antibiotics.

VAERS ID:419640 (history)  Vaccinated:2008-03-18
Age:71.0  Onset:2009-04-29, Days after vaccination: 407
Gender:Female  Submitted:2011-03-28, Days after onset: 698
Location:Maine  Entered:2011-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cellulitis/Abscess of Finger
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNLA
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Patient has had a total of 4 Shingles outbreaks since vaccination.

VAERS ID:431749 (history)  Vaccinated:2008-03-18
Age:18.0  Onset:2008-03-18, Days after vaccination: 0
Gender:Female  Submitted:2011-08-04, Days after onset: 1234
Location:South Carolina  Entered:2011-08-09, 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: Fear of needles
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1007USA00690
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning an 18 year old female patient with "fear of needles" who on 18-MAR-2008, was vaccinated with the first dose of GARDASIL, on 19-MAY-2008, with the second dose of the vaccine, on 20-DEC-2008, with the third dose of the vaccine and on 29-JUN-2009, with a fourth dose of the vaccine. The nurse reported that the patient fainted right after receiving the first, second and third doses of GARDASIL and was fine after the 4th one. The event improved. The patient recovered the same day of vaccinations. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:307531 (history)  Vaccinated:2008-03-19
Age:13.0  Onset:2008-03-19, Days after vaccination: 0
Gender:Male  Submitted:2008-03-20, Days after onset: 1
Location:Florida  Entered:2008-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Not reported
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0874U1IMLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA027321SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1307U1SCRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU19558DA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1652U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt. recently moved here from another country. C/O fever 102-104, with vomiting. No rash reported.

VAERS ID:307986 (history)  Vaccinated:2008-03-19
Age:13.0  Onset:2008-03-20, Days after vaccination: 1
Gender:Female  Submitted:2008-03-24, Days after onset: 4
Location:New York  Entered:2008-03-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1510U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Induration, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: cellulitis with induration erythema and pain at injection site 5cm by 9 cm

VAERS ID:308080 (history)  Vaccinated:2008-03-19
Age:10.0  Onset:2008-03-20, Days after vaccination: 1
Gender:Male  Submitted:2008-03-31, Days after onset: 11
Location:Virginia  Entered:2008-03-25, 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: Claritin, Benadryl, Motrin
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B010AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Allergy to vaccine, Body temperature increased, Diet refusal, Injection site erythema, Injection site rash, Injection site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Client received Tdap vaccine at 10:00 AM. At approximately 12:30 AM, 3-20-08 client began vomiting and had increased temp of 102 F (PO). Vomited several times until 4 AM when mother noticed injection site was swollen with deep red rash approximately 6"x3". Clients primary care physician examined child on 3-20-08 and said child was "allergic" to the vaccine and should never receive it again. Child was prescribed Claritin, Benadryl, and Motrin. Temp 3-20-08 later in day was 101.4 (PO). Today child is subdued, not eating, but retaining all fluids.

VAERS ID:308610 (history)  Vaccinated:2008-03-19
Age:47.0  Onset:2008-03-21, Days after vaccination: 2
Gender:Male  Submitted:2008-03-26, Days after onset: 5
Location:Nebraska  Entered:2008-03-31, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin OTC
Current Illness: None
Preexisting Conditions: Seasonal allergies
Diagnostic Lab Data: None at this time
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB519AA0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea, Limb discomfort, Pruritus, Pyrexia, Rash papular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Sore arm - 2 days, itchy - 5 days, febrile - 1 day, diarrhea -1 1/2 days, bumps on forearms (Bilat) - 5 days

VAERS ID:309118 (history)  Vaccinated:2008-03-19
Age:15.0  Onset:2008-03-26, Days after vaccination: 7
Gender:Male  Submitted:2008-04-04, Days after onset: 9
Location:Arizona  Entered:2008-04-08, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2571AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: L sided facial (Bells) palsy. tx with prednisone & Valtrex.

VAERS ID:310631 (history)  Vaccinated:2008-03-19
Age:23.0  Onset:2008-03-19, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 26
Location:Iowa  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA03454
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a health professional concerning a 23 year old female who on 19-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659655/1486U) in the morning. In the evening of 19-MAR-2008 the patient experienced a fever, nausea, vomiting and diarrhea. The patient''s mother called the physician''s office and she was told to eat a diet of bananas, rice, applesauce and toast in additional to a dietary restriction of milk. The patient''s fever, nausea, vomiting and diarrhea persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. In follow up information it was reported that patient called on 20-MAR-2008 morning and complained of diarrhea, vomiting and nausea throughout the night and into morning of 20-MAR-2008. She was adviced no milk products, IMMODIUM for diarrhea and to keep hydrated with bananas, rice, (rice cereal), applesause and toast (B. P. A. T.). Patient called back to an only gave of the reaction. It seemed she was quite confused by the phone. The outcome was unknown. Additional information is not expected.

VAERS ID:312299 (history)  Vaccinated:2008-03-19
Age:0.5  Onset:2008-04-27, Days after vaccination: 39
Gender:Female  Submitted:2008-05-07, Days after onset: 10
Location:Wisconsin  Entered:2008-05-14, 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 PMH: recurrent OM x 4
Diagnostic Lab Data: Abdominal US/X-ray LABS: Abdominal x-ray & US c/w ileocolic IS.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA2IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF231AA2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499172IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1734U2PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Barium enema, Constipation, Enema administration, Intussusception, Laparoscopy, Otitis media, Restlessness, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Akathisia (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Intussusception 4/29/08 6/20/08 Reviewed hospital medical records of 4/29-5/1/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced restlessness, cramping intermittent abdominal pain, bilious emesis, constipation x 3-4 days. Air contrast enema was initially successful then IS recurred overnight. BE then was unsuccessful & taken to OR for laparoscopy. Improved & d/c to home on oral antibiotics for recent OM.

VAERS ID:314568 (history)  Vaccinated:2008-03-19
Age:77.0  Onset:2008-03-23, Days after vaccination: 4
Gender:Female  Submitted:2008-06-02, Days after onset: 71
Location:Vermont  Entered:2008-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CAT scan and MRI - results normal in both.
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1873U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Ageusia, Anosmia, Computerised tomogram normal, Diplopia, Nuclear magnetic resonance imaging normal
SMQs:, Taste and smell disorders (narrow), Ocular motility disorders (broad)
Write-up: Significant loss of sense of taste and of smell; some incidents of double vision in one eye.

VAERS ID:316096 (history)  Vaccinated:2008-03-19
Age:76.0  Onset:2008-04-22, Days after vaccination: 34
Gender:Female  Submitted:2008-06-09, Days after onset: 48
Location:Florida  Entered:2008-06-12, 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: None
Preexisting Conditions: (ALEVE, sulfa) Dx ankylosing spondylites
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1088U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:323690 (history)  Vaccinated:2008-03-19
Age:23.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-21
Location:Georgia  Entered:2008-08-29, Days after submission: 130
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': GA08053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: Child''s dose given to an adult - Hepatitis A; No event misadministration

VAERS ID:328256 (history)  Vaccinated:2008-03-19
Age:13.0  Onset:2008-05-19, Days after vaccination: 61
Gender:Female  Submitted:2008-10-10, Days after onset: 144
Location:Oklahoma  Entered:2008-10-13, 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: propranolol hydrochloride
Current Illness: Migraine
Preexisting Conditions: PMH: migraine HAs s/p MVA x 3, last on 6/9/08 w/o injury but severe HA. Family hx: migraine HAs, seizures, CVA.
Diagnostic Lab Data: X-ray, "fine"; Ophthalmological exam, 20/20 LABS: video EEG abnormal. MRI revealed Chiari I. MRA WNL. CT scan of neck WNL.
CDC 'Split Type': WAES0810USA00858
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Amnesia, Aphasia, Arnold-Chiari malformation, Complicated migraine, Computerised tomogram normal, Condition aggravated, Convulsion, Disorientation, Drooling, Electrocardiogram normal, Electroencephalogram abnormal, Fall, Gaze palsy, Hemiplegia, Migraine, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination normal, Posturing, Pregnancy test, Syncope, Toxicologic test normal, Unresponsive to stimuli, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a consumer concerning her daughter a 14 year old female with migraine who on 07-SEP-2007, 14-NOV-2008 and 19-MAR-2008 was administered her first, second and third doses with GARDASIL. Concomitant therapy included propranolol HCL. On 19-MAY-2008 the patient experienced seizure. On 20-MAY 2008 the patient "had another seizure in her sleep. Her eyes rolled back into her head", subsequently she was hospitalized for 5 days. On 23-AUG-2008 the patient came into the house "disoriented" after falling outside. Her mother suspected she had a seizure. The hospital did an X-ray which came out fine. Patient''s right arm could not move, she did not remember the falling incident, and she was not herself at all. One of her eyes would go off to the side and her other eye to the other side, her mouth was twisted, her right side paralyzed, and she could not walk or talk or feel her right side. Even though her vision was checked and was 20/20, the patient''s eyes still "kind of go off to the side when being talked to." Lab diagnostics studies performed included: MRI, MRA, EKG, EEG, X-ray, tests for drugs, heart problems diabetes, STD''s, and pregnancy (results not reported). The patient will see a neurologist 09-OCT-2008. The patient present status was unknown. No more information reported. Upon internal review, right side paralysis was considered to be an other important event. Additional information has been requested. 12/2/08 Reviewed hospital medical records of 5/20-5/24/2008. FINAL DX: right-sided weakness; possible seizures Records reveal patient experienced episodes of weakness & unresponsiveness. Had been picked up from school w/migraine HA. Had posturing movements, was unresponsive, & collapsed in restaurant. Taken to ER & released. Next AM had recurrent symptoms. Taken to peds clinic & admitted. Neuro consult done. 11/18/08 Reviewed neuro medical records of 06/12/2008. FINAL DX: Spell, seizure vs complex migraines vs non-epileptic/functional; HA migraines vs stress vs function

VAERS ID:336180 (history)  Vaccinated:2008-03-19
Age:26.0  Onset:2008-03-19, Days after vaccination: 0
Gender:Female  Submitted:2008-10-20, Days after onset: 215
Location:California  Entered:2008-12-29, Days after submission: 70
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 (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Local reaction, Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient reports having reaction 1.5 hrs after receiving vaccination. Described reaction as localized hives on right upper arm and shoulder and generalized itching. Patient reported to PH and was advised to go to ER. patient went to ER 3/19/08 pm and received BENADRYL shot.

VAERS ID:308580 (history)  Vaccinated:2008-03-19
Age:0.1  Onset:2008-03-20, Days after vaccination: 1
Gender:Male  Submitted:2008-03-28, Days after onset: 8
Location:Foreign  Entered:2008-03-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: physical examination 19-Mar-2008 normal
CDC 'Split Type': TWWYEH03235008
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH271580IMUN
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Otitis media, Physical examination normal, Purulent discharge
SMQs:
Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 6-week-old male patient who experienced otitis media, purulent discharge from both ears. The patient received the first dose on 19-Mar-2008. The patient also received the first dose of oral Rotateq on 19-Mar-2008. Relevant medical history was not provided. Concomitant medications were not reported. The patient was brought back to the clinic due to appearance of purulent discharge from the left ear, the day after his first immunizations with Prevenar and oral Rotateq. The doctor diagnosed otitis media on 20-Mar-2008. A clearance was performed and a second generation cephalosporin was prescribed. The next evening, on 21-Mar-2008, the mother noticed discharge from the patient''s right ear. The child was hospitalized. The outcome of the otitis media was unknown. No additional information was available at the time of this report. Physical examination (results: normal) was done on 19-Mar-2008.

VAERS ID:309500 (history)  Vaccinated:2008-03-19
Age:26.0  Onset:2008-03-19, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 26
Location:Foreign  Entered:2008-04-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804HUN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epilepsy, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 26 year old white female who on 19-MAR-2008 was vaccinated with GARDASIL. There was no concomitant medication. On 19-MAR-2008, the patient experienced epileptic seizure less than a minute after vaccination. Subsequently, the patient recovered from epileptic seizure. In the past the patient was vaccinated with different vaccines, according to a program and had never experienced any adverse reactions, but fainted several times when she had blood drawn for laboratory testing. Upon internal review, epileptic seizure was considered to be an other important medical event. No further information is available.

VAERS ID:312634 (history)  Vaccinated:2008-03-19
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-05-20
Location:Foreign  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Slipped disc
Diagnostic Lab Data: UNK
CDC 'Split Type': D0056836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNGM
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Nausea, Pain, Pyelonephritis
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: This case was reported by a consumer and described the occurrence of pain in a female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 19 March in an unspecified year the subject received a dose of TWINRIX adult (unknown route and application). At an unspecified time after vaccination with TWINRIX adult, the subject experienced severe pain till nausea. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 7 May 2008 by the consumer. The subject''s medical history included several slipped discs. On 19 March 2008 the subject received 1st dose of TWINRIX adult (unknown route, right gluteal). In between, at an unspecified time after vaccination pyelitis was diagnosed. Since then the subject suffered from pain in hip, but at the time of reporting it was unknown where the pain comes from. There was no syringe abscess. This case was assessed as medically serious by GSK. The consumer stated that source of trouble was not assessable, because there were more possibilities causing complaints.

VAERS ID:312643 (history)  Vaccinated:2008-03-19
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-05-20
Location:Foreign  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: SLIPPED DISC
Diagnostic Lab Data: UNK
CDC 'Split Type': D0056836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNGM
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Nausea, Pain, Pyelonephritis
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: This case was reported by a consumer and described the occurrence of pain in a female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 19 March in an unspecified year the subject received a dose of TWINRIX adult (unknown route and application). At an unspecified time after vaccination with TWINRIX adult, the subject experienced severe pain till nausea. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 7 May 2008 by the consumer. The subject''s medical history included several slipped discs. On 19 March 2008 the subject received 1st dose of TWINRIX adult (unknown route, right gluteal). In between, at an unspecified time after vaccination pyelitis was diagnosed. Since then the subject suffered from pain in hip, but at the time of reporting it was unknown where the pain comes from. There was no syringe abscess. This case was assessed as medically serious by GSK. The consumer stated that source of trouble was not assessable, because there were more possibilities causing complaints.

VAERS ID:315991 (history)  Vaccinated:2008-03-19
Age:0.1  Onset:2008-03-19, Days after vaccination: 0
Gender:Male  Submitted:2008-06-10, Days after onset: 83
Location:Foreign  Entered:2008-06-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Diagnostic Lab Data: Blood count was performed (as well as CRP, leucocytosis, full ionogram, level of glucose, bilirubin, transaminases, urea, creatinine), urine analysis, abdomen and head USG. Anemia has been found, the analysis were normal.
CDC 'Split Type': 200801830
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906003A0SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER04300461IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA97110IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Anxiety, Blood bilirubin normal, Blood count abnormal, Blood creatinine normal, Blood glucose normal, Blood urea normal, C-reactive protein normal, Crying, Injection site erythema, Leukocytosis, Ophthalmological examination normal, Transaminases, Ultrasound abdomen normal, Ultrasound skull normal, Urine analysis normal
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad)
Write-up: Initial report received from health authorities on 2 June 2008. A 1-month-old male patient with no reported medical history has been vaccinated with first dose of intramuscular ACT-HIB, 0.5 ml, batch A9711-1 expire date 09.2009, Second intramuscular dose of HEPAVAX-GENE, 0.5 ml, batch 0430046, expire date 15.08.2010 and first subcutaneous dose of DTP, 0.5 ml, batch 20906003, expire date June 2009, on 19 March 2008. "It was impossible to establish which vaccine has been given, because nurses don''t mark on the vaccination card site/places of injection". "According to the assessment, the medicines has been given correctly in compliance with aseptic, technical and injection site rules". Occurrence of adverse post-vaccination reaction: the child became anxious around 18 hours on 19 March 2008, when he woke up, mother took him and he started crying and anxiously moving his legs. She noticed, that on the left thigh at the injection site a redness 20mm occurred, on the right thigh redness was smaller, on the arm was visible just the sign after injection". "The child was crying non-stop, the mother was not able to calm him down". "At 22.30 hours, the parents came with the child to the hospital, where child was referred to the paediatric unit". At the unit, luminal suppository 15 mg and paracetamol 62.5 orally were administered to the child. The boy calmed down. "Blood count was performed (as well as CRP, leucocytosis, full ionogram, level of glucose, bilirubin, transaminasis, urea, creatinine), urine analysis, abdomen and head USG". "Anemia has been found, the other analysis were normal". Ophthalmological examination and laryngological examination were normal. The boy was discharged home on 21 March 2008 in a good health condition with a recommendation of anemia treatment and making a further vaccination against pertussis with acellular vaccine.

VAERS ID:322158 (history)  Vaccinated:2008-03-19
Age:19.0  Onset:2008-03-26, Days after vaccination: 7
Gender:Female  Submitted:2008-08-13, Days after onset: 140
Location:Foreign  Entered:2008-08-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory test, Laboratory findings on cardiotropic viruses were carried out, results not reported; electrocardiogram, results not reported; magnetic resonance imaging, results not reported; echocardiography, results not reporte
CDC 'Split Type': WAES0808USA01394
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology, Echocardiogram, Electrocardiogram, Nuclear magnetic resonance imaging, Sinus arrhythmia, Tachycardia paroxysmal, Thyroid function test, Viral test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow)
Write-up: Information has been received from an health authority (reference number PEI2008011501) concerning a 19 year old female with no relevant medical history reported who on 19-MAR-2008 was vaccinated with GARDASIL. On 26-MAR-2008 she developed paroxysmal tachycardia. Sinoatrial node dysfunction was diagnosed. On an unspecified date she was hospitalized. Myocarditis and hyperthyroidism (thyroid function test) were ruled out. Laboratory findings on cardiotropic viruses and Borrelia antibodies, (longterm) electrocardiogram (ECG), cardiologic magnetic resonance imaging (MRI) and echocardiography were carried out, and results were not reported. Since 25-APR-2008 she was treated with unspecified beta blocking agents and symptoms improved. On 02-APR-2008, she was vaccinated with hepatitis A and B vaccine (manufacturer unknown). Other business partner numbers included: E2008-07472. Additional information has been requested.

VAERS ID:333829 (history)  Vaccinated:2008-03-19
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-12-03
Location:Foreign  Entered:2008-12-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body temp, <40
CDC 'Split Type': WAES0811AUS00213
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21FA324A UNUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21FA324A UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21FA324A UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21FA324A UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH2810U UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1143U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Dehydration, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a female infant who on 19-MAR-2008 was vaccinated with ROTATEQ (Batch # 1143U, Lot # 657978/1143U). Concomitant therapy included INFANRIX HEXA (Batch # A21FA324A) and PREVENAR (Batch # 2810U). Subsequently after vaccination, the patient experienced diarrhoea, dehydration, pyrexia and vomiting and was hospitalised. It was described that the patient experienced diarrhoea, fever (<40), vomiting and was dehydrated. The patient was treated with IV fluids. At the time of reporting to the agency on 17-JUN-2008, the patient had recovered from diarrhoea, dehydration, pyrexia and vomiting. The agency considered that diarrhoea, dehydration, pyrexia and vomiting were possibly related to therapy with ROTATEQ. The original reporting source was not provided. Additional information is not expected.

VAERS ID:339597 (history)  Vaccinated:2008-03-19
Age:0.2  Onset:2008-03-23, Days after vaccination: 4
Gender:Male  Submitted:2009-02-13, Days after onset: 327
Location:Foreign  Entered:2009-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Common cold; Sore throat
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 23Mar2008, Elevated; Body temperature, Feb2009, increased; Body temperature, 01Feb2009, 37.5-37.7cel deg; C-reactive protein, Mar2008, 4N; Lumbar puncture, 23Mar2008, Negative; Parasite stool test, Feb2009, negative; Scan,
CDC 'Split Type': B0515161A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Anorexia, Appendicitis, Body temperature increased, C-reactive protein increased, Diarrhoea, Gastroenteritis, Lumbar puncture normal, Parasite stool test negative, Pyrexia, Rotavirus infection, Scan abnormal, Stool analysis abnormal, Surgery, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of diarrhea in a 8-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 19 March 2008, the subject received a 1st dose of ROTARIX (oral, unspecified batch reference). On 23 March 2008, 4 days after vaccination with ROTARIX, the subject experienced anorexia and mild fever without vomiting. The subject was hospitalised. Diagnosis of pyelonephritis, meningitis (after negative lumbar puncture) and pneumopathy was ruled out. On 24 March 2008, he experienced diarrhea without vomiting. Stool analysis was positive for rotavirus. At the time of reporting, diarrhea was unresolved and the outcome of anorexia and fever was unknown. The physician considered the events were possibly related to vaccination with ROTARIX. Upon follow-up received from a consumer (subject''s mother) on 09 February 2009: The subject''s medical history included some common cold and two sore throats until he was one-year-old. He was born at full term. According to the mother, on 22 March 2008, three days after vaccination with ROTARIX, the subject experienced gastroenteritis with diarrhea, abdominal pain and mild fever. He was hospitalized. Gastroenteritis was diagnosed. Diarrhea persisted for more than 10 days. White blood cells count and C reactive protein were at four times the normal. A scan (nos) revealed appendix abscess. The subject was transferred in another hospital for acute appendicitis surgery (resolution after an unspecified time). The second dose of ROTARIX was not administered. At the beginning of January 2009, the subject stopped CLAMOXYL treatment for a sore throat (resolved). Three weeks later, on 24 January 2009, the subject was vaccinated with PRIORIX (GlaxoSmithKline). On 01 February 2009, eight days after vaccination with PRIORIX, the subject presented with red papules on arms and then with pinkish macules on thorax, fever between 37.5 and 37.7 Celsius degrees, and glairy diarrhea. On 03 February 2009, swollen glands were detected at neck leve

VAERS ID:354210 (history)  Vaccinated:2008-03-19
Age:1.0  Onset:2009-04-01, Days after vaccination: 378
Gender:Female  Submitted:2009-08-13, Days after onset: 134
Location:Foreign  Entered:2009-08-14, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infection susceptibility increased
Preexisting Conditions: The patient was born in the 39.5 week of pregnancy and did not show any adjustment disorder postnatal. The patient''s concurrent illness includes infection susceptibility increased but the patient increased but the patient did not suffer from any allergy. The patient''s suffered from pollen allergy but the patient''s mother did not suffer from any diseases. In the mother''s family Crohn''s disease and diabetes mellitus type II are known and in the father''s family bronchial asthma was known. The mother experienced Epstein-Barr virus infection and genital mycosis during pregnancy.
Diagnostic Lab Data: Body height (results: birth height: 52cm) was done on 24-Mar-2007. In May-2009 test results were: ultrasound scan (results: control examination: open foramen ovale without haemodynamic relevance, previously finding structure was unverifiable); platelet count (results: thrombocytopenia with 181); mean cell haemoglobin concentration (results: mild increased -$g 21.3); neutrophil count (results: increased -$g 69%); monocyte count (results: monocytosis with 12%); lymphocyte count (results: lymphocytopenia with normal lymphocyte count of 13.7); prothrombin time (results: within normal range); activated partial thromboplastin time (results: within normal range); C-reactive protein (results: increases -$g 17.8); blood calcium (results: increased -$g 2
CDC 'Split Type': DEWYEG04026309
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH310811IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acid base balance abnormal, Activated partial thromboplastin time, Acute tonsillitis, Alanine aminotransferase normal, Aspartate aminotransferase normal, Atrial septal defect, Base excess negative, Blood bicarbonate, Blood calcium increased, Blood chloride normal, Blood creatinine normal, Blood culture positive, Blood glucose increased, Blood pH increased, Blood potassium normal, Blood sodium normal, Body temperature increased, Bronchitis, Bronchopneumonia, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Ear, nose and throat examination abnormal, Electrocardiogram normal, General physical health deterioration, Haemoglobin increased, Lymphocyte count decreased, Lymphocyte count normal, Malaise, Malnutrition, Mean cell haemoglobin increased, Microbiology test normal, Neutrophil count increased, Otitis media, Oxygen saturation normal, PCO2 decreased, PO2 increased, Petechiae, Physical examination abnormal, Platelet count decreased, Pneumococcal sepsis, Prothrombin time normal, Pyrexia, Respiratory rate increased, Somnolence, Ultrasound scan normal, Upper respiratory tract infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: This case was considered medically important. Additional information was received regarding patient''s demographics, vaccinations dates, patient''s and family medical history, lot number, additional events, course of events, treatment and lab results. Information regarding PREVENAR was received from a healthcare professional via sales representative regarding a 25-month-old patient who experienced petechia, fever, pneumococcal sepsis, purulent angina tonsillaris, bronchopneumonia and otitis media bilateral. The patient received the second dose on 19-Mar-2008. Prior to administration of the first dose of PREVENAR the patient experienced a lot of unspecified diseases so that the patient received the first dose of PREVENAR at the age of 9 months. In Apr-2009 the patient experienced an upper respiratory tract infection and in the middle of Apr-2009 the patient suffered from severe bronchitis. The patient received antibiosis, cough mixture and nose drops for treatment. During the last week of Apr-2009 the patient experienced again fever and purulent angina was diagnosed which was treated with PENICILLIN. On 19-May-2009 it was planned to administer the third vaccination but due to ascultatory rhonchi the vaccination was not performed. Furthermore the patient experienced malaise and reduced general condition. For treatment the patient received AMBROXOL and Emser Salt. In the night of hospitalization the patient vomited one time and only wanted to sleep while sitting. Furthermore the patient had a body temperature of 38.5 degrees C and fast and stertorous breathing. Treatment with PARACETAMOL was insufficient so that the patient was hospitalized. The patient was hospitalized due to dyspnoea, increased body temperature up to 40 degrees C and petechia as well. At hospital pneumococcal sepsis was diagnosed and the patient was monitored and the existing nutrition disorder was treated with intravenous substitution of fluid. The patient''s condition was described as life-threatening. The clinic and radiologic bronchopneumonia was treated intravenous with the administration of CEFUROXIM. S. pneumoniae of serotype 3 were detected by blood culture which were sensitive against CERFUROXIME so that therapy with CEFUROXIME continued. It was planned to discontinue therapy on 04-Jun-2009. Possible focus of the sepsis was otitis media. Furthermore NUROFEN and PERFALGAN were alternating administered and ACC was administered as mucolytic agent. Per ultrasound scan persistent foramen ovale was diagnosed. It was unknown of foramen ovale was unknown as well. The patient was discharged on 29-May-2009 and recovered from all other events.

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