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Case Details (Sorted by Vaccination Date)

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VAERS ID:308359 (history)  Vaccinated:2008-03-26
Age:9.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Male  Submitted:2008-03-26, Days after onset: 0
Location:Connecticut  Entered:2008-03-27, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: History of allergy; Influenza; history of egg allergy; CHP - VSD
Diagnostic Lab Data: Face again. Itchy right arm.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1494U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest discomfort, Pruritus, Rash pruritic, Rhinorrhoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 2-3 minutes after administering Varicella SC vaccine - child had profuse nasal discharge, feeling chest discomfort. Hives face - 125/5 EPI 0.3cc SC right arm 8AM - 3:40PM. 15cc Benadryl PO.

VAERS ID:308425 (history)  Vaccinated:2008-03-26
Age:0.2  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 1
Location:Missouri  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not Applicable
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Not Applicable
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2800AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF238AB0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273-20SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC492710IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1460U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying, Immediate post-injection reaction, Pain, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Infant given Rotateq before other vaccinations administered. Rotateq given orally over about 45 seconds. Infant calm and quiet. Infant had projectile vomiting within 20 seconds of completion of Rotateq vaccine. After initial vomitus infant crying, and was inconsolable even by mom and dad. Infant appeared to be in pain. Infant then had another episode of projectile vomiting. Infant still appeared to be in pain and continued to cry inconsolably for about 15 minutes after final vomitus. After waiting for five minutes final vaccinations given. Infant finally able to be consoled by parents.

VAERS ID:308503 (history)  Vaccinated:2008-03-26
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-28
Location:North Carolina  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:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2156BA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2423AA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Physician ordered Tdap but patient was administered DTaP.

VAERS ID:308510 (history)  Vaccinated:2008-03-26
Age:1.4  Onset:2008-03-28, Days after vaccination: 2
Gender:Male  Submitted:2008-03-28, Days after onset: 0
Location:Florida  Entered:2008-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2798AA3IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1775U0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling noted to Left thigh two days after vaccine was given.

VAERS ID:308519 (history)  Vaccinated:2008-03-26
Age:15.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 0
Location:North Carolina  Entered:2008-03-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data: Blood Pressure 102/52
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Pallor, Tonic clonic movements
SMQs:, Convulsions (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient''s lips, toes and fingers turned white in color and had tonic-clonic seizure lasting approximately 20-30 seconds.

VAERS ID:308522 (history)  Vaccinated:2008-03-26
Age:4.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Male  Submitted:2008-03-28, Days after onset: 1
Location:Washington  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: Amoxicillin - vomiting Penicillins = Vomiting
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA4IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB340AA2IMUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB214AA0IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURZ05473IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0748U1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1366U1SCUN
Administered by: Military     Purchased by: Military
Symptoms: Blood pressure, Body temperature, Erythema, Heart rate normal, Injection site erythema, Injection site pruritus, Learning disability, No reaction on previous exposure to drug, Pain, Rash macular, Respiratory rate, Skin lesion, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Vitals Written @ 28 Mar 2008 1346 PDT BP: 90/54, HR: 95, RR: 18, T: 98.1 °F, WT: 40.75 lbs, Pain Scale: 4/5 Hurts Whole Lot, Pain Scale Comments: head Comments: Pt shows age related barriers to learning. SO Note Written @ 28 Mar 2008 1507 PDT Chief complaint The Chief Complaint is: Rash following immunizations on 3/26/08. History of present illness The Patient is a 4 year old male. He reported: Skin lesion(s): 4 yo male received immunizations 26-Mar-08 - IPV, MMR, Varicella, DTAP, Heb B, and Hep A. Patient has received all of these immunizations except Hep A in the past without adverse reaction. Mother reports she noted a large area of redness on the child''s R. anterior thigh at the injection site, a rash on the child''s abdomen, and redness and swelling in the child''s face the following morning. No fever. No cough, SOB, or wheezing. Rash resolving with hydrocortisone. Child c/o itching at injection site. No reaction at site on L. thigh where immunizations given. Child with previous history of rash with PCN and Amoxicillin. Past medical/surgical history Reported History: No past medical history reported current medications: Hyrocortisone. Surgical / procedural: No surgical / procedural history. Personal history Behavioral history: No tobacco use No second hand smoke exposure. Family history No hypertension No hyperlipidemia No diabetes mellitus. Review of systems Systemic symptoms: Not feeling tired or poorly. No fever and no recent weight change. Physical findings Vital signs: ° Current vital signs reviewed. General appearance: ° Well-appearing. ° Awake. ° Alert. ° Well developed. ° Well nourished. ° In no acute distress. Oral cavity: ° Normal. Pharynx: Oropharynx: ° Posterior pharyngeal wall was normal. Lymph Nodes: ° Cervical lymph nodes were not enlarged. ° Submandibular lymph nodes were not enlarged. ° Consistency was normal. ° Mobile. Lungs: ° Respiratory movements were normal. ° Clear to auscultation. ° No wheezing was heard. ° No rhonchi were heard. ° No rales/crackles were heard. Cardiovascular system: Heart Rate And Rhythm: ° Normal. Heart Sounds: ° S1 normal. ° S2 normal. Neurological: Gait And Stance: ° Normal. Skin: • Skin: approximately 3 X 3 inch area of raised erythema on R. anterior thigh at site of injections. No iduration or warmth. No tenderness to palpation. Faint erythematous/macular rash on abdomen. Faint erythema above R. eyebrow. No swelling in face. Hair: ° Normal. Nails: ° Normal. A/P Written @ 28 Mar 2008 1511 PDT 1. ALLERGIC REACTION: possible allergic reaction to immunizations. ? Hep A. Site specific immunizations not recorded in medical record. Referral placed to allergy clinic for further evaluation. Consult(s): -Referred To: ALLERGY/IMMUNOLOGY (Routine) Specialty: Clinic: ALLERGY CLINIC Primary Diagnosis: ALLERGIC REACTION Disposition Written @ 28 Mar 2008 1511 PDT Released w/o Limitations Follow up: as needed . Discussed: Diagnosis, Medication(s)/Treatment(s), Alternatives, Potential Side Effects with Patient who indicated understanding. Administrative Options: Consultation requested Signed By (ARNP (Family Nurse Practitioner), MAMC) @ 28 Mar 2008 1521 Note Written @ 28 Mar 2008 1520 PDT (Added after encounter was signed.) Discussed symptomatic treatment for localized skin reaction. May continue hydrocortisone PRN. OTC Benadryl PRN _________________________________________________________________________________________________________ CHANGE HISTORY The following Signature(s) No Longer Applies because this Encounter Was Opened for Amendment @ 28 Mar 2008 1520 PDT: Signed (ARNP (Family Nurse Practitioner), MAMC) @ 28 Mar 2008 1511 The following Vitals Entry Was Overwritten @ 28 Mar 2008 1351 PDT: Vitals Written @ 28 Mar 2008 1346 PDT BP: 90/54, HR: 95, T: 98.1 °F, WT: 40.75 lbs, Pain Scale: 4/5 Hurts Whole Lot, Pain Scale Comments: head

VAERS ID:308525 (history)  Vaccinated:2008-03-26
Age:4.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 2
Location:Alaska  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: Impetigo
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSACI4KB051AA4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01693IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Within 5-10 minutes of receiving MMR #2, pt. developed erythema and induration of approximately 4-5cm surrounding vaccination site. Pt. received 3 other vaccinations at the same time, none of which developed this rxn. Pt was given 12.5mg diphenhydramine po and within 20 minutes, her symptoms had improved. Pt. was discharged home 30 minutes after receiving diphenhydramine. No further need for medical tx has been reported since.

VAERS ID:308587 (history)  Vaccinated:2008-03-26
Age:11.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Missouri  Entered:2008-03-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256BA1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2566AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0778N1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red, warm, tender raised area approximately 5cm x 3cm to back of right upper arm. Benadryl every 6 hours PRN.

VAERS ID:308589 (history)  Vaccinated:2008-03-26
Age:41.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 2
Location:Arizona  Entered:2008-03-31, 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:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pruritus, Rash, Rash generalised, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Received Tdap 3-26-08. (A documented Td was given 7-22-02, but patient did not disclose. 8/07 Td given because it wasn''t documented). Reports that 45 minutes after injection developed rash on neck, chest, abdomen, small area of upper arms anterior to axillae that was itchy. Had mild respiratory wheezing. After using an inhaler and 2 doses of Benadryl taken at different times, felt relief. Also had a headache. Today small amount diffuse like red rash remains on left neck.

VAERS ID:308649 (history)  Vaccinated:2008-03-26
Age:13.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 5
Location:California  Entered:2008-03-31
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: Amoxicillin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2375BA UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1502U SCRA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: "Wheals" at injection site immediately after given, resolved in approximately 3 hours. Woke 3/27/08 with red lump, 5x6cm mildly indurated red patch - right arm on 3/27. Slight itch, no pain + color at 10AM. RX - Bactrim DSI BID x 7 days, Benadryl 25mg q 6 hours prn.

VAERS ID:308921 (history)  Vaccinated:2008-03-26
Age:1.0  Onset:2008-03-28, Days after vaccination: 2
Gender:Female  Submitted:2008-03-31, Days after onset: 3
Location:Ohio  Entered:2008-04-04, 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: Started Claritin 3/27/08.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSHAHAVB171A0IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.H0775U0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHHB54013F3IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient''s mother called the following week (5 days) post injections. Patient developed hive on left thigh about 2-3 days after injection. Patient also saw physician 1 day after injection and started Claritin at that time. As of today hives were going away.

VAERS ID:308948 (history)  Vaccinated:2008-03-26
Age:12.0  Onset:2008-03-29, Days after vaccination: 3
Gender:Female  Submitted:2008-04-04, Days after onset: 6
Location:California  Entered:2008-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none PMH: cold s/s week before Family Hx: stroke, epilepsy, diabetes
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.C2767AA0IDRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2553AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1793U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial palsy, Headache, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: VACCINES GIVEN ON 3/26/2008. (MENACTRA, VARIVAX, ADACEL, GARDASIL. Patient Presented with Bells Palsy to ED on 3-29-08. Treated with Acyclovir and Prednisone. 4/22/08 Reviewed ER medical records from PCP of 3/29/08. FINAL DX: Bell''s Palsy Records reveal patient experienced left facial droop & numbness, HA, & unable to wrinkle forehead x 1 day. Tx w/antiviral, steroids, eye ointment & taping.

VAERS ID:308980 (history)  Vaccinated:2008-03-26
Age:64.0  Onset:2008-03-30, Days after vaccination: 4
Gender:Female  Submitted:2008-04-03, Days after onset: 4
Location:California  Entered:2008-04-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Humira; Methotrexate 7.5mg
Current Illness:
Preexisting Conditions: RA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU19530A0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness, slight tenderness to left arm.

VAERS ID:308983 (history)  Vaccinated:2008-03-26
Age:1.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 5
Location:Pennsylvania  Entered:2008-04-04, 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: Infants Tylenol
Current Illness: N/A
Preexisting Conditions: Idiopathic infantile scoliosis; gross motor developmental delay
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Five episodes of vomiting within a 2-hour time period. Onset approx. 5 hours after vaccines given. No fever, no diarrhea; no concurrent illness. No treatment administered - self-limited episode.

VAERS ID:309016 (history)  Vaccinated:2008-03-26
Age:5.0  Onset:2008-03-28, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:California  Entered:2008-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2933AB4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.174702SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.177401SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm red, edematous, tender, warm to touch.

VAERS ID:309120 (history)  Vaccinated:2008-03-26
Age:15.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 5
Location:Missouri  Entered:2008-04-08, 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: BCP
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: Blood work, X Rays, Cat scan, EKG done. Few slightly abn-not significant per mom.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U2IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC290AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Blood test, Chest pain, Computerised tomogram, Electrocardiogram, Headache, Nausea, Pyrexia, X-ray
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Per mother rec''d imm 3-26-08 3:30 pm. Around 6pm taken to ER with continued N, HA, low grade fever, stomach pain, chest pain. Dr said side effect from Tdap. On 3-28-08 2pm back to ER with fever, severe HA (headache). Tx with migraine pain medicine. Dr said could be Tdap or HPV. 3-31-08 still with some HA, fever.

VAERS ID:309199 (history)  Vaccinated:2008-03-26
Age:5.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Male  Submitted:2008-03-28, Days after onset: 1
Location:Colorado  Entered:2008-04-09, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1848A1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling around injection site 3/27 left upper arm from pt of shoulder to mid-arm, blotchy erythema, scratch marks, warm to touch. No significant nodes.

VAERS ID:309489 (history)  Vaccinated:2008-03-26
Age:1.2  Onset:2008-04-08, Days after vaccination: 13
Gender:Female  Submitted:2008-04-08, Days after onset: 0
Location:Minnesota  Entered:2008-04-14, 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: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF237AA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0865U0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1122U0UNRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Injection site rash, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Fussy and feverish x 3 days. Was seen in ER 2 days ago with same symptoms. She has a small rash on the right thigh with pain, leg rash confirmed as site of Varivax injection on 3/26/08.

VAERS ID:309512 (history)  Vaccinated:2008-03-26
Age:1.0  Onset:2008-04-12, Days after vaccination: 17
Gender:Female  Submitted:2008-04-15, Days after onset: 3
Location:Ohio  Entered:2008-04-15
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: prematurity (36 wks gestation)
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0984U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70143D3IMRL
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Child developed fever $g103 then 3-5 min. generalized seizure, emesis x3 after seizure.

VAERS ID:310370 (history)  Vaccinated:2008-03-26
Age:0.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Unknown  Submitted:2008-04-14, Days after onset: 19
Location:New York  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': WAES0803USA04435
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse concerning a 5 day old patient who on 26-MAR-2008 was vaccinated with a dose of Rotateq. No adverse experience was related to this event. There was no product quality complaint. Additional information has been requested.

VAERS ID:310685 (history)  Vaccinated:2008-03-26
Age:14.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 19
Location:Ohio  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Attention deficit disorder
Preexisting Conditions: Unknown
Diagnostic Lab Data: 02/17/2010 Blood pressure, 03/26/08, 102/60 mmHg; blood pressure 03/26/08, 118/70 mmHg, 5 minutes later; total heartbeat count, 03/26/08, 76 bpm, 5 minutes later; total heartbeat count, 03/26/08, 70bpm.
CDC 'Split Type': WAES0803USA04558
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Attention deficit/hyperactivity disorder, Dry skin, Eye rolling, Flushing, Headache, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 26-MAR-2008 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported). On 26-MAR-2008 the patient fainted 1 minute after receiving the vaccination. The patient sought unspecified medical attention by speaking to a nurse. Subsequently, the patient recovered (duration not specified). Additional information has been requested. 02/17/2010 Information has been received from a physician and a healthcare professional, concerning a 14 year old female patient, a student with attention deficit disorder, who on 26-MAR-2008 at 4:00 pm, was vaccinated IM in the right deltoid, with the first dose 0.5ml, of GARDASIL (lot # 655327/1287U), The patient stepped off of the table, sat in a chair and "within approx. 10 seconds," stated "my head hurts." Her face became flushed, her eyes rolled back, and "she experienced a syncopal episode which lasted approx 10 se." She was assisted to the table. Vital sign lincluded blood pressure of 102/60 mmHg, heart rate 70. In 5 minutes, her BP was 118/70 mmHg and heart rate with 76. She stated she felt fine, her skine was pale and dry, and after 30 minutes, she left the office. The patient was considered to haver recovered the same day. Additional information is not expected.

VAERS ID:310697 (history)  Vaccinated:2008-03-26
Age:12.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 19
Location:Unknown  Entered:2008-04-23, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA04651
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IJUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a "12 year old" female with no known drug allergies and known drug allergies and no past medical history who on 26-MAR-2008 was vaccinated with her first of three doses of GARDASIL (lot# unspecified, sit not reported.). Concomitant therapy included MENACTRA. The physician reported that the patient fainted after receiving the vaccination. Subsequently, the patient recovered. No additional information was provided. Additional information has been requested. Follow-up information received from the office worker on 12-May-2008 indicated that she was unable to identify the patient who had this event. No additional information is expected.

VAERS ID:311238 (history)  Vaccinated:2008-03-26
Age:35.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Unknown  Submitted:2008-04-25, Days after onset: 29
Location:Indiana  Entered:2008-04-29, 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: I got a injury at work cut my hand open
Preexisting Conditions: I have had 12 surgery
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD1931UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Mass, Pain in extremity, Weight bearing difficulty
SMQs:
Write-up: I got a nail in my hand and it cut me open so they gave me a tetanus shot after that, about 2 to 3 weeks my arm hurts like I can''t hold anything in that arm the lump from the shot finally went away but my arm is still hurting and I told the nurse and they didn''t do nothing for me. What can I do because I still hurt.

VAERS ID:311688 (history)  Vaccinated:2008-03-26
Age:53.0  Onset:2008-03-28, Days after vaccination: 2
Gender:Female  Submitted:2008-05-05, Days after onset: 38
Location:Florida  Entered:2008-05-06, 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: Candidiasis; Chronic obstructive pulmonary disease; Rhinitis allergic; Vertigo; Smoker; Hyperlipidaemia; Hypertension; Meniere''s disease; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: chest computed axial, with chronic obstructive pulmonary disease without any other findings; pulmonary function test, showed mild obstructive disease; blood culture, 03/30?/08, Negative for any bacteria; MRSA test, 03/30?/08, Negative
CDC 'Split Type': WAES0804USA05772
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0963U0IMGM
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Chills, Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Condition aggravated, Drug administered at inappropriate site, Dyspnoea, Erysipelas, Hyperglycaemia, Hyperthyroidism, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling, Methicillin-resistant Staphylococcus aureus test negative, Pain, Palpitations, Pulmonary function test abnormal, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hyperthyroidism (narrow)
Write-up: Information has been received from a health professional and hospital record concerning a 53 year old female inspector with vertigo, chronic obstructive pulmonary disease, allergic rhintiis, hyperlipidemia, hypertension, candidiasis and drug hypersensitivity to codeine, chronic Meniere''s disease and he was a chronic smoker who smoked half to one pack a day. She denied any use of alcohol and social drug. On 26-MAR-2008 at 02:00 PM he was vaccinated IM into left buttock area with a first dose of Pneumovax 23 (lot # 658451/0963U). Concomitant therapy included aspirin, ADVAIR, NASONEX, montelukast sodium (MSD), MAXZIDE, DIAZEPAM, LIPITOR, KLONOPIN and atenolol. On 28-MAR-2008 at 08:00 AM, forty eight hours after vaccination the patient started noticing increasing pain, redness, swelling of the left buttock, associated with fever, chills and body aches. She was seen in the clinic and was started on LEVAQUIN 750 mg oral which did not really help in terms of the redness and swelling. She was presented to the emergency room (ER) complaining of increasing redness and pain. She was admitted to the hospital on 30-MAR-2008 and started on empiric intravenous (IV) VANCOMYCIN for possible methicillin resistant staphylococcus species (MRSA). Infectious disease was consulted. She had blood cultures drawn and were negative for any bacteria. The MRSA screen also was negative. The patient eventually was switched to IV ANCEF and her redness in her left buttock had markedly improved. The final diagnosis was erysipelas. The patient still had some pain especially with palpation around the area but certainly her symptoms had been markedly improved. During her stay in the hospital she had bouts of shortness of breath. She was referred to the pulmonary service and was diagnosed as having an acute exacerbation of chronic obstructive pulmonary disease (COPD). She had been doing well with her respiratory medication which included DUONEB and also after being started on IV SOLU-MEDROL. She was on long-acting bronchodilators with steroids, along with montelukast sodium (MSD) and short acting bronchodilators. The patient however, developed steroid-induced hyperglycemia during her hospital stay and as the steroids had been tapered, her sugars returned to baseline normal readings. Her discharge diagnoses included: Left buttock erysipelas, Chronic obstructive pulmonary disease, Hyperglycemia which is steroid and Subclinical hyperthyroidism with normal T3, T4, and free thyromxine levels. She was doing well and was discharged to home on 03-APR-2008. Her activity will be as tolerated except that she had been instructed to stay off her feet since she spends a large amount of time standing at work as a bag screener. She got clearance from her primary care physician as to when she was to able to return to work full time. Discharge medications included: proventil metered, fluticasone propionate (+) salmeterol xinafoate, montelukast sodium (MSD0, atorvastatin calcium ad hydrochlorothiazide (+) triamterene. She also got prescription for levofloxacin to be taken daily at home that she would continue to use after discharge. Other medications are: Mometasone furoate, aspirin, tapering doses of prednisone for two weeks and albuterol sulfate (+) ipratropium bromide nebulized solutions to be used with her nebulizer. Followup will be with physician within the next 5 to 7 days and also she will undergo pulmonary function testing in about one or two weeks. On an unspecified date the patient recovered from left buttock erysipelas. The outcome for worsening COPD, hyperglyemia, hyperthyroidism, and erysipelas were not reported. Additional information was received from the physician''s nurse via phone call. The patient did not have a culture of the left buttock as it was closed and not draining. No additional information is expected. All medical records will be provided upon request.

VAERS ID:312764 (history)  Vaccinated:2008-03-26
Age:0.2  Onset:2008-03-27, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 48
Location:Indiana  Entered:2008-05-16, 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: Gastrooesophageal reflux disease
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory, 03/27/08
CDC 'Split Type': WAES0804USA04022
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1692U0PO 
Administered by: Other     Purchased by: Unknown
Symptoms: Laboratory test, Rotavirus infection
SMQs:
Write-up: Information has been received from a physician concerning an 8 week old female with no pertinent medical history or drug allergies who on approximately 26-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# not provided). The next day on approximately 27-MAR-2008, the patient experienced rotavirus. The patient sought unspecified medical attention. Lab diagnostic studies were performed, but unspecified. No further information was provided. There was no product quality complaint. Follow-up information indicated that the patient had a past medical history of gastroesophogeal reflux disease (GERD) upon vaccination with the first dose of ROTATEQ (lot# 659855/1692U). No other information is available at this time. Additional information has been requested. This is one of several reports from the same source.

VAERS ID:313469 (history)  Vaccinated:2008-03-26
Age:50.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Male  Submitted:2008-05-14, Days after onset: 49
Location:Rhode Island  Entered:2008-05-27, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0041U1UNLA
Administered by: Other     Purchased by: Public
Symptoms: Blood pressure, Dizziness, Flushing, Heart rate
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Pt. c/o feeling faint & flushed 5 min after Hep B injection to L deltoid area. Pulse & BP checked q 5 min x 30 min; pt sat near open window to cool down. 2nd Hep B in series of 3.

VAERS ID:317242 (history)  Vaccinated:2008-03-26
Age:10.0  Onset:2008-03-27, Days after vaccination: 1
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Texas  Entered:2008-06-24, Days after submission: 88
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLERAN INJECTION
Current Illness: NONE
Preexisting Conditions: SEASONAL ALLERGIES - ON ALLERGY INJECTIONS WEEKLY
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERU1954AB4IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 3"X4" AREA OF REDDNESS & SWELLING - WARM TO TOUCH - PT. TEMPERATURE 99'' ON 3-27-08, ICE APPLIED, ADVIL TAKEN PO.

VAERS ID:317407 (history)  Vaccinated:2008-03-26
Age:0.4  Onset:2008-03-27, Days after vaccination: 1
Gender:Female  Submitted:2008-06-25, Days after onset: 90
Location:Michigan  Entered:2008-06-25
Life Threatening? No
Died? Yes
   Date died: 2008-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: Child born at 28 weeks gestation. Had hx of RSVP. Had been treated for e-coli & strep infection in past. Low birth wt. Periods of apnea in past. Reported at Child Death Review Meeting of immunizations day before death.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B126AA1IM 
HIBV: HIB (ACTHIB)SANOFI PASTEURUF229 AA1IM 
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499181IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Premature baby, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: See box 19 for information. Baby alive at 5:30 AM & died approx. 6:00 AM. 7/7/08-autopsy report received-COD:Sudden Unexplained Infant Death. Complications of Prematurity.

VAERS ID:320170 (history)  Vaccinated:2008-03-26
Age:18.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 111
Location:Maryland  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA08354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a laboratory assistant concerning an 18 year old female patient who on 26-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot #659964/1978U) and on 26-MAR-2008 she received her second dose of GARDASIL vaccine (yeast) (lot # 660393/0067X). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid). The reporter reported that the patient fainted briefly after receiving the first dose of GARDASIL vaccine (yeast). She recovered from the fainting on the same day. She did not faint after the second injection. Additional information has been requested.

VAERS ID:327654 (history)  Vaccinated:2008-03-26
Age:72.0  Onset:2008-03-26, Days after vaccination: 0
Gender:Female  Submitted:2008-09-24, Days after onset: 182
Location:Unknown  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA02280
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1874U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash, Tenderness
SMQs:, Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a patient who on approximately 11-APR-2008 (also reported as two months ago) was vaccinated with ZOSTAVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). Right after the administration of vaccine the patient developed a rash at the injection site. Rash was elongated, and the reporter regarded it as an allergic reaction. Unspecified medical attention was sought. Subsequently, the patient recovered from the event. No complain of product quality was involved. Follow-up information was received on 07-JUL-2008 from the pharmacist concerning a 72 year old female with penicillin and sulfa allergies who on 26-MAR-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659762/1874U). On 26-MAR-2008 upon administration, the patient complained of minor burning sensation which subsided within a few minutes. Policy required the patient to site down in front end of pharmacy for at least 15 minutes. Subsequently the patient developed red rash around injection site. The redness was oval about 2 inches long and 1 inch wide with some itching. The rash was not raised. The patient also had tenderness. The patient stayed in pharmacy for about 30 minutes after vaccination. After 30 minutes,the patient felt fine. The itchiness was subsiding and the rash was slightly less red. The next day the pharmacist called the patient. The patient reported that the rash was completely gone. Some tenderness still existed, but probably due to the soreness of receiving an injection. The pharmacist thought that no medical follow up required. The reaction was minor and resolved itself within a few hours. Additional information is not expected.

VAERS ID:335050 (history)  Vaccinated:2008-03-26
Age:1.7  Onset:0000-00-00
Gender:Female  Submitted:2008-11-26
Location:South Dakota  Entered:2008-12-11, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1250U0SCLA
Administered by: Private     Purchased by: Public
Symptoms: Rash, Scab
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mild eruption on trunk and arms, all in crust stage currently. * Not happen after vaccine

VAERS ID:344737 (history)  Vaccinated:2008-03-26
Age:25.0  Onset:2008-04-18, Days after vaccination: 23
Gender:Female  Submitted:2009-04-14, Days after onset: 361
Location:Georga  Entered:2009-04-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 4/18/2008); Asthma; Anxiety
Preexisting Conditions: Normal delivery; Vaginal disorder; Disease complication
Diagnostic Lab Data: diagnostic laboratory, group B strep positive (baby); beta-human chorionic, 06/10/08, positive; Apgar score, 8/9, baby; complete blood cell, 9 bands;bandemia (baby); serum C-reactive protein, negative (baby); blood culture, negative (baby)
CDC 'Split Type': WAES0806USA02242
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified medical assistant for the Pregnancy Registry for GARDASIL concerning a female who on 26-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). There was no concomitant medication. On 28-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported) and was pregnant. The patient''s LMP was approximately 15-APR-2008. Subsequently the patient experienced no known symptoms. The patient has a positive pregnancy test on 10-JUN-2008. The patient''s outcome was not reported. Follow-up information has been received from a physician for the Pregnancy Registry for GARDASIL concerning the 25 year old female with asthma and anxiety, a history of 1 pregnancy and 1 normal delivery and a history of vaginal disorder and some complication on 26-MAR-2008 was vaccinated IM with the first dose GARDASIL, on 28-MAY-2008 was vaccinated with the second dose and on 11-MAR-2009 was vaccinated with the third dose (lot #: 660553/0070X). The patient became pregnant in April 2008, the date of last menstrual period was 18-APR-2008, estimated delivery date was 25-JAN-2009. On 22-JAN-2009 the patient delivered a normal, female infant with no congenital anomalies. The baby''s weight was 7 LB 14.5 ounce, length was 21.75 inch, head circumference was 14.25 inch. Apgar test score was 8/9. On an unspecified date, group B strep test of the infant was positive. Initial complete blood count secondary to group B strep positive was 9 band. C-reactive protein test was negative and blood culture was negative. At the time of this report, bandemia resolved. No further information is available.

VAERS ID:347086 (history)  Vaccinated:2008-03-26
Age:45.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-15
Location:Arizona  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: None
Current Illness:
Preexisting Conditions: Chickenpox; Exposure to communicable disease
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0803USA04437
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)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 nurse concerning a 45 year old, non-pregnant female physician with probable recurrent exposures to wild type disease (patient is pediatrician), no significant past medical history, denied immunocompromise, cancer, and history of chickenpox at approximately 4 years of age, who on 26-MAR-2008 had a small amount of VARIVAX (dose and lot number not provided) splashed in her right eye. There was no concomitant medication. The eye was flushed with sterile saline solution, and the physician complained of burning a little bit. No other symptoms were reported. It was unknown if the physician sought medical attention. There was no product quality complaint. Additional information has been requested.

VAERS ID:380113 (history)  Vaccinated:2008-03-26
Age:1.3  Onset:2008-04-02, Days after vaccination: 7
Gender:Male  Submitted:2010-01-29, Days after onset: 667
Location:Unknown  Entered:2010-02-03, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Egg allergy; Food allergy
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0902USA04542
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEA: MEASLES (ATTENUVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Adverse event, Coeliac disease, Diarrhoea, Drooling, Dysuria, Erythema, Gait disturbance, Staring
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a consumer concerning her 15 year old son with allergy to eggs and oatmeal and patient''s mother with SJOREN''S syndrome who on 26-MAR-2008 was vaccinated with the first dose of measles virus vaccine. There was no concomitant medication. On 02-APR-2008, "seven days after receiving his first dose", the patient developed a hot, red face, limping, gait, decreased urination, loose stools, increased drooling. The patient also exhibited "unusual behavior" such as staring and rocking as well as hitting his arms and legs. The patient was examined by his unspecified physician but no treatment was recommended. The symptoms resolved without treatment in one month. The mother also reported that subsequently the patient exhibited similar symptoms seven days after receiving is first dose of VARIVAX (Merck) (WAES # 0903USA00002). Follow-up information received from the patient''s mother which reported that in approximately March 2009, "recently", her son was diagnosed with celiac disease and this might be the reason he experienced the adverse event. The mother reported in follow up that her other son had a similar reaction when he got HIB (OMPC) and PREVENAR concomitantly (WAES# 0903USA02851). No further information is available.

VAERS ID:419454 (history)  Vaccinated:2008-03-26
Age:1.7  Onset:2008-03-26, Days after vaccination: 0
Gender:Male  Submitted:2011-03-25, Days after onset: 1094
Location:Georga  Entered:2011-03-25
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Anaphylactic allergy to dairy (both casein and whey); additional food allergies to egg and peanut
Diagnostic Lab Data:
CDC 'Split Type': Cumming
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURCZ7981AA3IMLG
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1791U0SCLG
Administered by: Unknown     Purchased by: Private
Symptoms: Cow's milk intolerance, Dyspnoea, Rhinorrhoea, Urticaria, Vomiting projectile
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Hives over entire body, projectile vomiting, copious amounts of mucous coming from nose, labored breathing

VAERS ID:453027 (history)  Vaccinated:2008-03-26
Age:14.0  Onset:2008-04-01, Days after vaccination: 6
Gender:Female  Submitted:2012-04-04, Days after onset: 1464
Location:Arizona  Entered:2012-04-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: MRI-negative spinal tap- negative heart monitors - showed 180 per minute several medications with no help or worse side effects
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3UNLA
Administered by: Private     Purchased by: Other
Symptoms: Alopecia, Back pain, Cardiac monitoring abnormal, Cervix carcinoma, Convulsion, Dizziness, Fatigue, Headache, Lumbar puncture normal, Neck pain, Nuclear magnetic resonance imaging normal, Palpitations, Papilloma viral infection, Skin lesion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.

VAERS ID:308417 (history)  Vaccinated:2008-03-27
Age:13.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:Michigan  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0052X2IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1493U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Immediate post-injection reaction
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: WITHIN SECONDS OF RECEIVING THE HPV VACCINE CHILD GOT LIGHTHEADED AND NEEDED TO LIE DOWN

VAERS ID:308432 (history)  Vaccinated:2008-03-27
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-27
Location:California  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Gaze palsy, Mydriasis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Within a minute of Gardasil Vaccine she fainted with eyes open and dilated at full extend, started convulsing for 5 seconds, eyes started to shake also.

VAERS ID:308437 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:North Carolina  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: Unknown
Current Illness: None known
Preexisting Conditions: Allergic to PCN, sulfa drugs, pollen, cat hair, red ants, mold and dust mites.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2393BA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Eye swelling, Hypersensitivity, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Mother of client called and reported "she had an allergic reaction. Her eyes swelled and her throat was closing up". Reports client took Benadryl, but had to go to clinic for treatment. States "She''s ok now".

VAERS ID:308438 (history)  Vaccinated:2008-03-27
Age:13.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:Minnesota  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies: sulfa
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Pharyngeal oedema, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Approximately 20-30 minutes after vaccine given pt c/o dizziness, throat swelling, hard to breath. Had hives/rash on head, neck and upper chest.

VAERS ID:308445 (history)  Vaccinated:2008-03-27
Age:4.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Male  Submitted:2008-03-27, Days after onset: 0
Location:New York  Entered:2008-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1943U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Chills, Generalised erythema, Pruritus, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: 4 year old male received booster MMR at 11:30AM 3/27/08. Within 10 minutes he had multiple episodes of vomiting, followed by generalized erythema, urticarial hives and pruritis. Thereafter, he developed chills. He was given Antihistamine with no improvement followed 45 minutes later by doctor. He improved within 1 hour.

VAERS ID:308489 (history)  Vaccinated:2008-03-27
Age:55.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:California  Entered:2008-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: childhood DPT
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURUF303AA0IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURA052220SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphagia, Hypersensitivity, Pharyngeal oedema
SMQs:, Angioedema (narrow), Anticholinergic syndrome (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), Hypersensitivity (narrow)
Write-up: Severe allergic reaction after 1 hour of administration (throat swelling and difficulty swallowing-911 activated-to local ER for epinephrine and Benadryl-client recovered fully.

VAERS ID:308497 (history)  Vaccinated:2008-03-27
Age:11.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:California  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: BP 116/74 TIME OF VACCINE ADMIN IN 10 IS APPROXIMATE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB216AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.028U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2419AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC277700AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Immediate post-injection reaction, Injection site pain, Loss of consciousness, Pallor, Pyrexia, Syncope, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Nurse noted few minutes after shot - Pallor, Shaking, LOC for 40 seconds - syncope. Called doctor and had patient lay down. Given oxygen by mask. BP normal, no bronchospasm or respiratory distress on examination. Responsive to name and able to answer questions. Felt better with improved color and able to ambulate on own w/in minutes. F/U call in few hours, patient had low grade fever, soreness in arm where other shot given, but felt well w/o dizziness.

VAERS ID:308518 (history)  Vaccinated:2008-03-27
Age:52.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-28
Location:South Carolina  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:
Preexisting Conditions:
Diagnostic Lab Data: N/A
CDC 'Split Type': SC0802
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B024CA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:
Write-up: Provider administered Tdap Boostrix to this adult client instead of Adacel Tdap.

VAERS ID:308527 (history)  Vaccinated:2008-03-27
Age:1.5  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-03-29, Days after onset: 1
Location:New York  Entered:2008-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: The child was coughing and had a runny nose and her mother felt that she really should not have immunizations at that time.
Preexisting Conditions: There is a strong family history of allergies as well as lupus (SLE) in the family.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)BERNA BIOTECH, LTD    
PPV: PNEUMO (PNU-IMUNE)PFIZER/WYETH    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Local swelling, Pyrexia, Somnolence
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The child developed a fever of 102 degrees by Friday, March 28 at 4:00 p.m., she had no appetite, she seemed extremely sleepy and kept pulling at her ear. By Saturday morning, at 11:00 A.M. her neck was observed to be swollen--the first time this has ever happened to this child. At the time this report is being filed, this previously healthy child has no appetite, is whimpering as if in severe pain and is being taken to the hospital emergency room again.

VAERS ID:308531 (history)  Vaccinated:2008-03-27
Age:3.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Male  Submitted:2008-03-29, Days after onset: 1
Location:California  Entered:2008-03-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COUGH AND FEVER
Preexisting Conditions: LEFT ARM FRACTURE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB213AA1IMRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631112IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Induration, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: WAS VACCINATED 03/27/2008. 24 HOURS LATER DEVELOPED FEVER OF 103F. TODAY A 2 X 2.5 OF ERYTHEMOUS, INDURATED, PAINFUL AREA NOTED ON RIGHT UPPER ARM (DELTOID AREA).

VAERS ID:308618 (history)  Vaccinated:2008-03-27
Age:82.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:California  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: Zocar; Zerta; Detral; Calver; Lovenox; Calain
Current Illness: Pneumonia
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.97221062IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness at site. Applied heat.

VAERS ID:308625 (history)  Vaccinated:2008-03-27
Age:42.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-03-31, Days after onset: 3
Location:Missouri  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: arrythmia
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Cellulitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad)
Write-up: Received an Adacel, IM, 0.5 ml in left deltoid on Thursday, March 27, 2008. Developed cellulitis, fever, painful joints. Placed on antibiotics on Monday, March 31, 2008.

VAERS ID:308626 (history)  Vaccinated:2008-03-27
Age:28.0  Onset:2008-03-29, Days after vaccination: 2
Gender:Male  Submitted:2008-03-31, Days after onset: 2
Location:California  Entered:2008-03-31
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: MRI
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERUNK3UNUN
Administered by: Military     Purchased by: Military
Symptoms: Headache, Injection site pain, Nausea, Nuclear magnetic resonance imaging
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: H/A, Nausea, achy in shoulder where the shot was give (#4). DX H/A. se 2 Anthrax.

VAERS ID:308634 (history)  Vaccinated:2008-03-27
Age:11.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Male  Submitted:2008-03-31, Days after onset: 4
Location:Arizona  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illness at time of vaccination
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Pt was given a clean bill of health and was feeling good before we went to the doctors. Within 45 mins of the shot. He began severely fatigue, throat started to hurt, fever and glands start to become swollen. He slept almost 48 hours waking to drink and going to the rest room he tried to eat but really didn't feel like eating. His first really meal that he ate was Sunday evening. He continued to have a low grade fever until Monday. Today is Monday and he is still only about 55% back to his normal self. He has never had this sever of a reaction to a vaccine before.

VAERS ID:308645 (history)  Vaccinated:2008-03-27
Age:44.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Michigan  Entered:2008-03-31, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Diarrhoea, Injection site pain, Pain, Pain of skin, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient started getting achy, running temperature of 100 degrees, arm soreness at injection site, vomiting and diarrhea 1 time in early am, diarrhea again 1 time in late morning. Skin "hurts". Taking Ibuprofen as needed.

VAERS ID:308691 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Missouri  Entered:2008-04-01, 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: Pt was taking Multivitamins and Seasonique
Current Illness:
Preexisting Conditions: Pt is allergic to PCN.
Diagnostic Lab Data: No testing done.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Dizziness, Fall, Loss of consciousness, No reaction on previous exposure to drug
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt was given Gardasil injection. About 5 min after getting vac, pt got light headed and passed out, falling to the floor. Pt lost consciousness for less than 30 seconds. Pt''s BP after the fainting spell was 92/50. Pt was given water and crackers and was moved to recliner located in office. 15 minutes after event, pt''s BP had returned to normal 100/64. Lot # 1487U, exp 05AUG10. This was the pt''s second Gardasil. Pt had no problems with 1st. Pt reports that she had not ate anything yet when Gardasil given at 10:00 a.m.

VAERS ID:308729 (history)  Vaccinated:2008-03-27
Age:5.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Male  Submitted:2008-03-28, Days after onset: 1
Location:North Carolina  Entered:2008-04-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: temp 99 but no sx
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB215AA IMRL
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt left office after vaccination & returned 5 hours later with fever at home 103 given Tylenol -$g fever 101 in our office. Somnolent and vomited.

VAERS ID:308744 (history)  Vaccinated:2008-03-27
Age:17.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-28, Days after onset: 1
Location:Tennessee  Entered:2008-04-01, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Ras~Vaccine not specified (no brand name)~2~0~In Patient
Other Medications: CONCERTA 18 mg Q a.m.; ADVIL
Current Illness: None
Preexisting Conditions: ADD, Allergic to shrimp and codeine, rash following hepatitis B vaccines
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA05220IMUN
Administered by: Other     Purchased by: Private
Symptoms: Alopecia, Dizziness, Hallucination, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: c/o hallucinations-spider and roaches crawling and fever hair coming out 4 hours post vaccination. C/O mild dizziness s/sx lasted approximately 4 hours. Client took vaccine on empty stomach. Next a.m. completely resolved.

VAERS ID:308757 (history)  Vaccinated:2008-03-27
Age:13.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:Massachusetts  Entered:2008-04-02, 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: PPD
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: finger stick for sugar, 104.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B00UNLA
Administered by: Private     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Heart rate decreased, Hyperhidrosis, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: ten minutes after received vaccines. pt felt dizziness, diaphoric and extremely cold. BP 64/40, pulse 55. Pt felt better after OJ given. Pt has vagus reaction. At 4:30 pm, BP 88/59 p 60. Pt is feeling better. A&Ox3. D/C pt home.

VAERS ID:308763 (history)  Vaccinated:2008-03-27
Age:13.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-02, Days after onset: 6
Location:Indiana  Entered:2008-04-02
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0928U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Mother called the next day 3-28-08, stating that after daughter received the HPV vaccine that she was up all night throwing up.

VAERS ID:308806 (history)  Vaccinated:2008-03-27
Age:0.3  Onset:2008-03-29, Days after vaccination: 2
Gender:Female  Submitted:2008-04-01, Days after onset: 3
Location:Pennsylvania  Entered:2008-04-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: hemacult done in office; none at this time
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF355AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04741SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB97283A1IMRL
Administered by: Private     Purchased by: Private
Symptoms: Faeces discoloured, Frequent bowel movements, Haematochezia, Mucous stools, Occult blood, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: 48 hrs from vaccine increased stools. 72 hrs increased stools with mucous/stringy blood. At 4 days stools now yellow seedy, no mucous, no gross blood but hemacult positive. No vomit, pleasant, nursing well.

VAERS ID:308812 (history)  Vaccinated:2008-03-27
Age:33.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Male  Submitted:2008-04-03, Days after onset: 6
Location:Unknown  Entered:2008-04-03
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: (Lt) Knee reconstruction; s/p IED Blast
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1763UNRA
Administered by: Military     Purchased by: Military
Symptoms: Abscess, Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Anthrax shots #2, 4 localized abscess with surrounding erythema, required I & D. No reaction with 1,3.

VAERS ID:308853 (history)  Vaccinated:2008-03-27
Age:27.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-04-03, Days after onset: 6
Location:North Dakota  Entered:2008-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: STREP
Preexisting Conditions: ALLERGY TO COMPAZINE PMH: Marfan''s syndrome, MVP & regurgitation, scoliosis w/rods, hysterectomy.
Diagnostic Lab Data: LABS: WBC 16,600 (H). ESR peak 77 (H). Chemistry WNL. ASO titer 715 (H).CSF WNL: WBC 10, lymphs 86%, neutros 12%, glucose 61, protein 24, PCR enterovirus neg. UA WNL. EMG/NCS WNL. Blood & CSF c/s neg. Right knee aspiration c/s neg. Echocardiogram WNL. TEE revealed MVP & ejection fraction 50%.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Aspiration joint, Asthenia, Blood culture negative, CSF culture negative, CSF test normal, Cardiac murmur, Culture negative, Echocardiogram, Echocardiogram normal, Ejection fraction decreased, Electromyogram normal, Gait disturbance, Hypokalaemia, Hyporeflexia, Inflammation, Joint swelling, Laboratory test normal, Leukocytosis, Muscular weakness, Nerve conduction studies normal, Pain in extremity, Paraesthesia, Pyrexia, Red blood cell sedimentation rate increased, Rheumatic fever, Streptococcus identification test, Synovitis, Urine analysis normal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Arthritis (narrow)
Write-up: On 3-27-2008 client received Tdap vaccine and was hospitalized on 3-30-2008 with possible Guillain-Barre syndrome. She remains in the hospital at this time. 5/2/08 Reviewed hospital medical records of 3/30- 4/8/2008. FINAL DX: Rheumatic fever; questionable viral myositis; LE pain & weakness; questionable Guillain Barre syndrome; elevated ESR & leukocytosis; hypokalemia. Records reveal patient experienced sore throat. Seen in ER 3/26 & dx w/strep throat. Tx w/antibiotics & steroids. Seen by PCP next day & received booster vaccination. Developed tingling, pain & weakness on 3/28 in both legs which progressed to making it difficult to ambulate. On admit, reflexes & strength in LEs diminished. Neuro, ID & rheum consults done. Spiked fever on 4/2 w/knee swelling. Developed multiple joint inflammatory synovitis & diastolic murmur. Tx w/PCN, steroids & antiinflammatory meds. Improved & d/c to home on antiinflammatory meds & IM PCN to f/u w/rheum.

VAERS ID:308869 (history)  Vaccinated:2008-03-27
Age:  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-03, Days after onset: 7
Location:Georga  Entered:2008-04-03
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nitrofurantoin
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history and no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC 'Split Type': A0719182A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVBB094AA1UNLA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure increased, Flushing, Hypertonia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of elevated blood pressure in a female subject aged between 20 and 29 years old who was vaccinated with Twinrix (GlaxoSmithKline). Concurrent medications included low dose MACRODANTIN. On 27 March 2008 at 10:10 the subject received 2nd dose of Twinrix at 1.0 ml in the left arm. On 27 March 2008, 30 minutes after vaccination with Twinrix, the subject experienced elevated blood pressure, facial flushing, hypertonic sensations (defined as shaking and tremors) and tremor. This was considered to be a systemic reaction. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject did not experience rash or respiratory symptoms. The subject had received her 1st dose of Twinrix 7 days earlier and did not experience any symptoms. The subject denied any nausea or fatigue. The events were indicated as unresolved and probably related to treatment with Twinrix.

VAERS ID:308900 (history)  Vaccinated:2008-03-27
Age:15.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-27, Days after onset: 0
Location:Tennessee  Entered:2008-04-04, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE Family HX: sister w/MS PMH: morbid obesity, hospitalized w/pneumonia at 3 yo
Diagnostic Lab Data: Taken back to the Dr. Office next day, from Dr. office we were sent to the ER at Hostial where she was admitted 4 days after being in hostipal the swelling in face and hand leave and now has strenth in right hand but still not equal to left side. 5th day in the hospital swelling in right leg goes down but right foot is still numb when leaving hospital on the 6th day. LABS: creatinine 0.72 (H), INR 1.02 (H). CXR WNL. CT head revealed possible lacunar infarct. MRI/MRA WNL. EKG WNL. Echocardiogram & TEE WNL. US of legs
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U1UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2236AA1UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC2862AA4UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood creatinine increased, Chest X-ray normal, Chest pain, Computerised tomogram abnormal, Conversion disorder, Dyspnoea, Echocardiogram, Echocardiogram normal, Electrocardiogram normal, Eye disorder, Fatigue, Gait disturbance, Grip strength decreased, Headache, Hemiparesis, Hypoaesthesia, International normalised ratio increased, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Oedema peripheral, Sensation of heaviness, Sensory disturbance, Swelling face, Type I hypersensitivity, Ultrasound scan normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: Shortness of breath, chest pain 1 hour after shots were given. 5 hours after shots right side of face swells right arm and hand swells. 9 hours after shots whole right side of body numb weak and swollen not able to walk with out help. 4/25/08 Reviewed hospital medical records of 3/28-4/2/2008. FINAL DX: Lower extremity weakness. Neuro consult stated probable conversion disorder. ID consult stated probable Type 1 hypersensitivity reaction. Records reveal patient experienced sudden onset chest pain & SOB. Did not resolve w/NSAIDS. Awoke from sleep w/swelling right side face, weakness & numbness or right side, ambulating w/limp, HA, heavy feeling pain, fatigue. Exam revealed droopy eyes, right arm/leg weakness w/dininished sensation, weak right hand grip. Neuro, ID & cardio consults done. Improved & d/c to home w/continued PT. Follow-up: August 13, 2008-Conversation with patient''s mother. Patient is doing somewhat better. Can now walk without cane. Still some numbness-more tingly-"like feeling trying to come back". Still in physical therapy three times per week. Nerve conduction studies-normal. Patient''s primary care physician has now been changed. (Since patient has not been in our office since March 28, 2008, more recent information could probably be obtained from Dr. Mother states that an egg allergy was noted in patient at an outing in May, 2008. After eating spinach dip which contained egg, she developed shortness of breath, chest pain, and weakness, which resembled her reaction after the immunizations. A similar reaction occurred later when she ingested eggs again. She has not been offered eggs since then. Patient''s working diagnosis as of the time she was last seen in our office is a "probable Type I Hypersensitivity Reaction secondary to an immunization."

VAERS ID:308928 (history)  Vaccinated:2008-03-27
Age:42.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-04-01, Days after onset: 4
Location:Tennessee  Entered:2008-04-04, 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: Tricor; Detrol LA; Ibuprofen
Current Illness: Routine follow-up visit
Preexisting Conditions: Allergies: PCN; Sulfa; ASA; Prevacid
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Glossodynia, Limb discomfort, Skin warm, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Received vaccination 3-27-08; on 3-28-08 left arm sore and fevered; patient woke on 3-29-08 and states tongue swollen and sore, by day of report swelling had reduced, but continued to be sore.

VAERS ID:308933 (history)  Vaccinated:2008-03-27
Age:10.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Tennessee  Entered:2008-04-04
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: Inst father to monitor. Rtc or ER if not better 24 hrs.
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA4IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated

VAERS ID:308939 (history)  Vaccinated:2008-03-27
Age:10.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-04-04, Days after onset: 7
Location:Pennsylvania  Entered:2008-04-04
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
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Dose
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2546AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0783U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, 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 and swelling on left upper arm, lateral aspect, about 2 inches in diameter, warm to touch.

VAERS ID:308986 (history)  Vaccinated:2008-03-27
Age:5.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Male  Submitted:2008-03-31, Days after onset: 4
Location:Massachusetts  Entered:2008-04-04, 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: No
Preexisting Conditions: Allergic to Cefzil; ASD (resolved)
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Dose
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Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355AA4UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1218F1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Erythema, Induration, Insomnia, Musculoskeletal pain, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pt had c/o pain in shoulder on day of administration and had difficulty sleeping. Day after imm., had 8 x 11 cm area warm, erythema, firm. ? Cellulitis.

VAERS ID:309010 (history)  Vaccinated:2008-03-27
Age:16.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-03-31, Days after onset: 4
Location:Wisconsin  Entered:2008-04-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: nka
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Approx. 15 min after receiving the vaccine, the client experienced numbness in her fingertips and her two fingers on the outer side of her rt hand. The mother was contacted the next day and she stated that this lasted all night; in the morning the client was fine. The client received her 1st dose of HPV on Jan 15, 2008, the mother stated that after that dose her left hand was numb for several hrs but then resolved itself.

VAERS ID:309030 (history)  Vaccinated:2008-03-27
Age:23.0  Onset:2008-04-05, Days after vaccination: 9
Gender:Female  Submitted:2008-04-07, Days after onset: 2
Location:Alaska  Entered:2008-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: ALLERGIES: BACTRIM
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1740SCRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0OTLA
Administered by: Military     Purchased by: Military
Symptoms: Skin lesion
SMQs:
Write-up: Multiple lesions on L shoulder (1.5 cm and .5 cm) and one lesion on L cheek (1.5 cm). Possible lesion beginning on R cheek. No other lesions noted on body. No recent illnesses.

VAERS ID:309129 (history)  Vaccinated:2008-03-27
Age:43.0  Onset:2008-03-31, Days after vaccination: 4
Gender:Female  Submitted:2008-04-01, Days after onset: 1
Location:Texas  Entered:2008-04-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase, Clarinex D
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Injection site erythema, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Normal soreness days 2-4 after injection. Erythema left deltoid day 5. Increased redness w/ induration, warmth & increased pain day 6. Given Xyzal, Medrol dose pack & Keflex day 6.

VAERS ID:309159 (history)  Vaccinated:2008-03-27
Age:39.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Male  Submitted:2008-04-02, Days after onset: 5
Location:Texas  Entered:2008-04-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS4380117C0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Plasma donor reported by phone a rash that developed the morning after a rabies immunization was performed. The pt reported the rash was similar to "chicken pox" in its appearance and feel. Pt stated he had.

VAERS ID:309185 (history)  Vaccinated:2008-03-27
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-08
Location:New Mexico  Entered:2008-04-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B018AB6UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Incorrect dose administered, No adverse event
SMQs:
Write-up: No adverse effects reported. Given extra dose of Tdap.

VAERS ID:309227 (history)  Vaccinated:2008-03-27
Age:6.0  Onset:2008-04-04, Days after vaccination: 8
Gender:Male  Submitted:2008-04-09, Days after onset: 5
Location:Unknown  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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.178741SCUN
Administered by: Private     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: probable chickenpox lesions

VAERS ID:309394 (history)  Vaccinated:2008-03-27
Age:36.0  Onset:2008-04-10, Days after vaccination: 14
Gender:Female  Submitted:2008-04-11, Days after onset: 1
Location:California  Entered:2008-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data: Home pregnancy test (+) 14 days post MMR.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0416U SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Pt rec''d imms 3/27/08 and at time denied pregnancy. On 4/10/08 home pregnancy test (+). Pt has no PCP and no OB/GYN MD. Advised husband to find PCP or OB/GYN and have confirmatory blood test for pregnancy.

VAERS ID:309383 (history)  Vaccinated:2008-03-27
Age:0.4  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-04-13, Days after onset: 16
Location:Wisconsin  Entered:2008-04-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: "slight cough"
Preexisting Conditions: none. PMH: none. NKDA.
Diagnostic Lab Data: Labs and Diagnostics: 3/28/08-WBCs 16.7, otherwise labs unremarkable. Labs and Diagnostics: CBC with WBCs 21.8 with left shift. Blood cx (-). Head CT (-). Brain MRI (+) for signal in the L Basal Ganglia. Chemistry WNL. CSF with 10% lymphs (L) and 57% macrophages, (+) RBCs. CSF HSV (-). CSF AAs show no significant abnormalities. CSF no bacteria, fungi, or viruses found. UA (-). UC (-). Carnitine WNL. Urine Organic Acids Abnormal (high 2-Hydroxyglutaric Acid and Lactic Acid, and Creatinine).
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF297AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ100921SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54014D1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1388U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amino acid level normal, Basal ganglia infarction, Blood culture negative, Body temperature increased, CSF lymphocyte count abnormal, Electroencephalogram abnormal, Full blood count, Grand mal convulsion, Herpes simplex serology negative, Irritability, Laboratory test normal, Nuclear magnetic resonance imaging brain abnormal, Postictal state, Red blood cells CSF positive, Scan brain, Somnolence, Staring, Tremor, Unresponsive to stimuli, Urine analysis abnormal, Urine lactic acid increased, White blood cell count increased
SMQs:, Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic cerebrovascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Malignant lymphomas (broad)
Write-up: Day after vaccination infant had a generalized tonic-clonic seizure. Recovered spontaneously and completely. Had another generalized seizure 4/12/08 and admitted for further evaluation. CT, LP, chemistries normal. Evaluation proceeds; is still hosptialized. 4/22/2008 ER record received for DOS 3/28/2008 with DX: Seizure, presenting to ER post-ictal. Infant found in crib staring with arms and legs shaking. Unresponsive to parent. Shaking continued 5-10 minutes. PE WNL except T=100.1''F. 5/12/2008 MR received for DOS 4/13-15/2008 with Final DX: Seizure. Infant presented to ER with 2nd generalized seizure in 3 weeks. Admitted for w/u. PE (+) for somnolence alternating with irritability, otherwise WNL. Pt had no subsequent seizures and remained afebrile. Follow-up: Continues to have a seizure disorder. Neurodevelopmental status, otherwise, appears to be normal.

VAERS ID:309610 (history)  Vaccinated:2008-03-27
Age:75.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-04-07, Days after onset: 10
Location:Colorado  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient
Other Medications: Aggrenox 2x day; Triamt-HCTZ; Simvastol
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.60701420SCUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dysphonia, Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nasal congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad)
Write-up: Completely feeling fine prior to receiving shingles virus shot. Took 2 Tylenol. At 2 AM bad headache, took 2 more Tylenol. Site of shot became red, pain & swelled. Became hoarse & started cough, then nose congestion & achy body muscles. Still ongoing now. Temp. was not taken.

VAERS ID:310422 (history)  Vaccinated:2008-03-27
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-02
Location:Pennsylvania  Entered:2008-04-21, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride
Current Illness: None
Preexisting Conditions: (+) Murmur; (L) Lazy eye, Bilat lateral rectus recession.
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR210693IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0282U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1781U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:310506 (history)  Vaccinated:2008-03-27
Age:19.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-15, Days after onset: 19
Location:Missouri  Entered:2008-04-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; Seasonique
Current Illness: None
Preexisting Conditions: Patient allergic to penicillin
Diagnostic Lab Data: BP post Gardasil et blackout was 92/50.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient became light headed and passed out after receiving Gardasil.

VAERS ID:310548 (history)  Vaccinated:2008-03-27
Age:5.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Female  Submitted:2008-03-28, Days after onset: 0
Location:Tennessee  Entered:2008-04-22, Days after submission: 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 PASTEURC2935AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04903UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1669U1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1768U1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Red area with warmth to left upper arm, (+) itch treated with Clindamycin- change Augmentin ES

VAERS ID:311104 (history)  Vaccinated:2008-03-27
Age:65.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-28, Days after onset: 32
Location:Michigan  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: Testosterone or Vitamins, Mins.
Current Illness: None
Preexisting Conditions: Gluten; dairy; eggs; TCN; PCN.
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB5268A0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: All over itching and wheezing starting the evening of the injection.

VAERS ID:311173 (history)  Vaccinated:2008-03-27
Age:11.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 18
Location:Michigan  Entered:2008-04-29, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': WAES0804USA00960
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Crying, Dizziness
SMQs:, Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning an 11 year old female who on 27-MAR-2008 was vaccinated with GARDASIL (659964/1978U). Concomitant therapy included HAVRIX (lot# not reported). On 27-MAR-2008 the patient experienced wooziness and began crying. Subsequently, the patient recovered from the wooziness and crying. The patient''s sister had the same AE after receiving GARDASIL. See SR# 1-2774239749. Additional information has been requested.

VAERS ID:312815 (history)  Vaccinated:2008-03-27
Age:11.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 48
Location:Michigan  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA01009
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a health professional concerning an 11 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a second dose given intramuscularly into the left deltoid of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:00 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.

VAERS ID:312818 (history)  Vaccinated:2008-03-27
Age:15.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 48
Location:Michigan  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA01032
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a health professional concerning a 15 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a first dose intramuscularly given into the left deltoid on the same day at 14:00 of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:10 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.

VAERS ID:312836 (history)  Vaccinated:2008-03-27
Age:25.0  Onset:2008-03-29, Days after vaccination: 2
Gender:Female  Submitted:2008-05-14, Days after onset: 46
Location:Texas  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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA01311
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back crushing, Back pain, Chest X-ray, Discomfort, Dyspnoea, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a medical assistant concerning a 26 year old female who last week (approximately 27-March 2008), was vaccinated with the first dose of GARDASIL. The patient developed back pains post vaccination. The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe. Medical attention was sought through a call to the medical assistant. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a medical assistant concerning a 25 year old female with no known drug allegies who on 27 March 2008, was vaccinated with the first dose of GARDASIL (Lot # 1757O). On 28-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 1757O). On 29-MAR-2008 the patient developed back pains post vaccination. The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe. It was later reported that the pateint had back discomfort/spasms which the patient determined at the time of the second injection of GARDASIL that signs of complications from the first injection might not have been caused from GARDASIL. The patient had a folt to the body several days before the first injection patient was aware of possible reaction being reported to Merck. The back discomfort lasted 1-2 days. Unspecified medical attention was sought through a call to the medical assistant. The patient had a chest x-ray. Patient outcome was recovered approximately 1-2 days after onset. Additional information has been requested.

VAERS ID:314132 (history)  Vaccinated:2008-03-27
Age:27.0  Onset:2008-03-31, Days after vaccination: 4
Gender:Male  Submitted:2008-05-29, Days after onset: 59
Location:D.C.  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: NKDA, acne
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1633SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2484AA UNLA
Administered by: Military     Purchased by: Military
Symptoms: Axillary pain, Injection site erythema, Injection site oedema, Subcutaneous nodule, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received his 4th anthrax vaccine (FAV163, in left deltoid, also received MENACTRA in left arm) on 3/27/08. In clinic on 3/31 with complaints of tender sub-q nodule (about 2 cm), slight erythema surrounding vaccination site (<1.5), and mild axillary point tenderness, but no enlarged lymph nodes. No systemic symptoms. When I spoke to him briefly on 4/8/08, he said the vaccine site symptoms were decreasing. Symptoms: Edema at injection site 30-50mm, Erythema, Nodule, subcutaneous, Tenderness.

VAERS ID:319548 (history)  Vaccinated:2008-03-27
Age:23.0  Onset:2008-03-29, Days after vaccination: 2
Gender:Female  Submitted:2008-07-17, Days after onset: 110
Location:Minnesota  Entered:2008-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lo-overal
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Activities of daily living impaired, Crying, Depression, Inappropriate schedule of drug administration, Thinking abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow)
Write-up: On February 21st of 2008 I received my first hpv and first hepatitis b vaccines and was told to come back in one month for my 2nd hepatiits b shot and then the following month I''d receive my 2nd hpv shot. So on the 27th of March I recieved what I though to be my second hepatitis b shot. With in days I had dropped into a very bad depression. I was crying all the time, could hardly function and had no idea what was causing all of this. I wanted to die and I didn''t know why it got so bad I started to call help lines and tried to decide if I should see about getting some medical help. It was the worst I have ever felt in my life, I felt completely out of control. Finally after about 3 weeks of what I can only describe as hell, I started to feel a little better, then I received a bill I was being charged for my 2nd hpv shot not my 2nd hepatitis b! After talking to my mother and putting dates and everything together I believe that my deep depression was soley caused by receiving my 2nd hpv shot a month sooner than I''d expected. We immediatly made an appointment with the clinic to discuss there huge error. They refused to admit any mistake on their part due to that fact that the recommended time inbetween dosing on the hpv serious had change. They would only admit that they should have also given me the 2nd hepitis b shot as well as the 2nd hpv shot I''d received. No one told me that day that the plan had changed that I would be recieving the 2nd hpv shot a month sooner than planned. Not only do I think the clinic was inapt in their communicating my course of treatment but I believe that the 2nd hpv shot sent me into at least 3 weeks of severe depression that with out the help and support of my family and a close friend I don''t know if I''d have made it through on my own. After thinking about everything I feel it is my responsiblitiy to tell you the reaction that I had from my 2nd shot, in hopes that maybe others have come forward and it will stop anyone else in the futre from suffering the same horrible side effect.I had

VAERS ID:324222 (history)  Vaccinated:2008-03-27
Age:74.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 125
Location:Florida  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: homeopathic medications, SYNTHROID, PRILOSEC
Current Illness: Hypothyroidism, Diverticulitis
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804USA00388
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1537U0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial and follow-up information has been received from a licensed practical nurse concerning a 74 year old female with hypothyroidism and diverticulitis, with no illness at the time of the vaccination and no drug reactions/allergies who on 27-MAR-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 659010/1537U) 0.5 mL IM in the right deltoid. Concomitant medication included homeopathic medications (unspecified), levothyroxine sodium (SYNTHROID) and omeprazole (PRILOSEC). The nurse reported that on 28-MAR-2008 the patient developed a swollen arm at the injection site. The patient had no record of previous vaccination with pneumococcal 23v polysaccharide vaccine. The patient applied heat to the site. The onset of the adverse event was 27-MAR-2008 at 10:30AM. On Saturday 29-MAR-2008 the patient''s injection site arm turned black, was swollen and painful. On 01-APR-2008 the patient sought unspecified medical attention. On 01-APR-2008 the injection site arm was better but not recovered. At the time of reporting the patient was recovered on an unspecified date. There was no other information to report. Additional information is not expected.

VAERS ID:326117 (history)  Vaccinated:2008-03-27
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2008-09-10
Location:Michigan  Entered:2008-09-25, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF075AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08721IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC391861IMRL
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: DTAP-HIB combo given before 15 months of age. No side effects reported.

VAERS ID:334714 (history)  Vaccinated:2008-03-27
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2008-11-20
Location:Michigan  Entered:2008-12-09, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Jaundice
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURUF075AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURC391861IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHZ08721IMLL
Administered by: Other     Purchased by: Public
Symptoms: No adverse event
SMQs:
Write-up: DTaP-Hib combo given before 15 months of age. No side effects reported.

VAERS ID:336862 (history)  Vaccinated:2008-03-27
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-12
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 3/3/2008); Group B betahaemolytic streptococcal positive; Drug exposure before pregnancy
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 07/21/08, normal survey; Beta-human chorionic, 04/02/08, pregnant; Serum alpha-fetoprotein, 04/18/08, within normal limit (negative)
CDC 'Split Type': WAES0804USA01350
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Hepatic enzyme increased, Pregnancy induced hypertension, Premature baby, Proteinuria, Ultrasound scan normal
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Systemic lupus erythematosus (broad), Tumour markers (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Chronic kidney disease (broad)
Write-up: Information has been received from a 22 year old female consumer with no pertinent medical history or drug allergies, for the Pregnancy Registry for GARDASIL, concerning the consumer who on 27-MAR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL. Concomitant therapy included "petrocyclin." On 02-APR-2008 the consumer took a pregnancy test, and discovered that she was pregnant. The date of LMP was 03-MAR-2008, the estimated date of delivery was 08-DEC-2008. The patient would discontinue the rest of the series until the pregnancy was over. No further information was provided. The patient sought unspecified medical attention. Follow-up information was received from the patient who reported that she saw certified nurse midwife and she was well, not having any problems and her EDD was 08-DEC-2008. Follow-up information on 24-NOV-2008 from a Certified Nurse Midwife who reported that on 27-MAR-2008, the patient who was a positive Group B streptococcus carrier and with no previous pregnancies was vaccinated with the first dose of GARDASIL. Concomitant therapy included unspecified therapy. On 18-APR-2008, the patient underwent serum alpha-fetoprotein test and result was within normal limit (negative). On 21-JUL-2008, the patient underwent ultrasound for tetracycline exposure and family history of Meckel and result was normal. On 03-NOV-2008, the patient delivered a normal infant (Weeks from LMP: 35). There were no congenital anomalies. The patient experienced pre term dilation, pregnancy induced hypertension, elevated liver enzymes, and positive proteinuria during the pregnancy. Tetracycline was used for dermatologic reason during the pregnancy prior to knowledge. At the time of reporting, the outcomes were unknown. Additional information was requested.

VAERS ID:400578 (history)  Vaccinated:2008-03-27
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Unknown  Entered:2010-09-08, Days after submission: 35
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: Unknown
Diagnostic Lab Data: Pap test, ?/?/08, positive for low grade human papilloma virus (HPV)
CDC 'Split Type': WAES0909USA02797
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a nurse practitioner concerning an approximately 22 year old female patient who on 27-MAR-2008 was vaccinated with a second dose of 0.5 ml of GARDASIL (LOT# 659182/1757U), intramuscularly. The patient was diagnosed with low grade human papilloma virus (HPV). Papanicolaou tests were performed in 2008, which were positive for low grade HPV. The patient sought medical attention at a clinic. At the time of the report, the outcome of the patient was unknown. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.

VAERS ID:432203 (history)  Vaccinated:2008-03-27
Age:20.0  Onset:2010-08-01, Days after vaccination: 857
Gender:Female  Submitted:2011-08-04, Days after onset: 368
Location:Alabama  Entered:2011-08-09, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Pap test, abnormal
CDC 'Split Type': WAES1103USA03613
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Information has been received from a mother concerning her daughter, a 23 year old female with no pertinent medical history and no drug reactions or allergies who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (route not provided). On 21-NOV-2007 the patient received her second dose of GARDASIL (route and lot number not provided) and the third dose of GARDASIL was received on 27-MAR-2008. (Lot number provided with unspecified information corresponds to each patient as below: 659437/1266U; 657736/0389U; 659182/1757U; 656051/0244U; 657617/0384U). Concomitant therapy included an unspecified drug for "birth control". The patient switched from YAZ to the unspecified birth control. The mother reported her daughter''s two consecutive pap swears were abnormal. Third pap smears had been scheduled to check patient current status. If their follow up pap smear is abnormal the treatment being discussed/recommended is to freeze the cervix. Laboratory diagnostics studies included a yearly physical in August 2010, results not reported. The patient sought unspecified medical attention. Upon the time of report, the patient was not recovered. Follow up information has been received from a physician concerning a 23 year female who on 25-MAY-2007 was vaccinated in left arm with the first dose of GARDASIL (lot number: 657736/0389U). On 21-NOV-2007 the patient received the second dose of GARDASIL in left arm (Lot number: 659437/1266U) and on 27-MAR-2008 received the third dose of GARDASIL (Lot number: 659182/1757U) in left arm. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:432207 (history)  Vaccinated:2008-03-27
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2011-08-04
Location:Alabama  Entered:2011-08-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: drug hypersensitivity
Preexisting Conditions: Flu; bronchitis
Diagnostic Lab Data: cervical smear, abnormal test
CDC 'Split Type': WAES1103USA03612
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:
Write-up: Information has been received from a consumer concerning her 21 year old female daughter allergic to codeine and a history of flu and bronchitis who on 25-MAR-2007, 21-NOV-2007, and 27-MAR-2008 was vaccinated with a dose of GARDASIL respectively (Lot number provided with unspecified information corresponds to each patient as below: 659437/1266U; 657736/0389U; 659182/1757U; 656051/0244U; 657617/0384U). Concomitant therapy included YAZ birth control previously and switched to new unspecified birth control. The mother had a list of the lot numbers and dates of administration, however she was unsure of which dates corresponded to this patient. The information she had came from a doctor''s office where the patient received the vaccines. On an unspecified date, the patient experienced two abnormal pap smears and was scheduled for a third pap smear to determine current status. The patient sought medical attention. Laboratory diagnostics studies included a yearly physical in August 2010, results not reported. No treatment for the adverse event was given, however close monitoring was being executed. If the patient continued to receive abnormal pap smear results, it had been suggested that she had her cervix frozen through an in-office procedure. At the time of the report the patient was not recovered. This is one of two reports received from the same source. Additional information has been requested.

VAERS ID:309241 (history)  Vaccinated:2008-03-27
Age:29.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2008-04-09, Days after onset: 13
Location:Foreign  Entered:2008-04-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA01786
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.NG04520 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Immediate post-injection reaction, Muscle rigidity, Muscle spasms, Mydriasis, Pulse abnormal, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 29 year old female who on 27-MAR-2008 was vaccinated with a dose of RECOMBIVAX HB (lot# NG04520), thimerosal free. On 27-MAR-2008, immediately after immunization, the patient experienced faint, rigidity of limbs, muscular spasm, dilated pupils, thready pulse, labored breathing and unresponsive to verbal stimuli. The events lasted 3 to 4 minutes. The patient has fully recovered. The reporter considered this to be a serious reaction. Relevant history: The patient is currently being investigated for an allergy although the trigger has not been identified. The patient gets a rash associated with the allergy. Other business partner numbers include: E2008-02837.

VAERS ID:310901 (history)  Vaccinated:2008-03-27
Age:14.0  Onset:2008-03-31, Days after vaccination: 4
Gender:Male  Submitted:2008-04-24, Days after onset: 24
Location:Foreign  Entered:2008-04-25, 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: Immunisation
Diagnostic Lab Data: diagnostic laboratory test: swabs; diagnostic laboratory test: serum; diagnostic urinalysis test
CDC 'Split Type': WAES0804USA04096
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0934F0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test, Measles post vaccine, Urine analysis
SMQs:
Write-up: Information has been received from an agency (Case# PE12008004479) concerning a 14-year-old male who was vaccinated with a first dose of MMR II (lot# 655104/0934F, batch# NE52520) (site and route not reported) on 27-Mar-2008. On 31-MAR-2008 the patient experienced not further specified symptoms which were suspected to be measles post vaccine. He was admitted to the hospital on an unspecified date. Swabs, serum and urine samples were done, no results were provided. Symptoms were ongoing at the time of report. Previous non specified vaccinations were well tolerated. Other business partner numbers included: E2008-03593.

VAERS ID:312640 (history)  Vaccinated:2008-03-27
Age:0.3  Onset:2008-04-01, Days after vaccination: 5
Gender:Male  Submitted:2008-05-20, Days after onset: 49
Location:Foreign  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 02Apr2008, See text
CDC 'Split Type': B0520012A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abdominal rigidity, Crying, Enema administration, Feeding disorder of infancy or early childhood, Haematochezia, Hyperhidrosis, Intussusception, Irritability, Pallor, Screaming, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority ((clinical) # 016761344) and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 March 2008, the subject received unspecified dose of ROTARIX (oral, lot number not provided). On 1 April 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The patient showed crying and screaming in intermittent episodes, pallor and sweating. The abdomen was hard and painful to palpation in right hemi-abdomen. He also showed vomiting, irritability with delay in his feedings and bloody stools. For these reasons he was taken to the Emergency room. The subject was hospitalised. On 2 April 2008, abdominal X-ray was performed and showed compatible findings with intestinal intussusception. Opaque enema was performed: Ileo-ceco-colic intussusception was reduced by hydrostatic pressure, with good oral tolerance 20 hours later. On 3 April 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ROTARIX. No further information is expected as this is the only information the Regulatory Authority has, therefore this case has been considered closed.

VAERS ID:316966 (history)  Vaccinated:2008-03-27
Age:0.2  Onset:2008-04-03, Days after vaccination: 7
Gender:Male  Submitted:2008-06-23, Days after onset: 81
Location:Foreign  Entered:2008-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, Apr2008, Fluid level; Rotavirus test, 06Apr2008, Positive; Ultrasound abdomen, Apr2008, IS
CDC 'Split Type': B0525608A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Breast feeding, Familial risk factor, Gastrointestinal sounds abnormal, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Lethargy, Pallor, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case is one of 4 cases collected through a study occurring post ROTARIX vaccination since August 2007. The subject was born at term. The subject''s birth weight is 4.22 Kg. The subject had no history of intussusception. The subject had no previous significant illness/ hospitalisations/ operations. The subject had a family history of intussusception. Feeding history: The subject currently fed breast milk and formula. There was no change to the subject''s diet in the last week. The subject had no feeding intolerance or food sensitivities. The subject received current medications or traditional medicines. Previous and/or concurrent vaccination included Hib (manufacturer unspecified; unknown) given on an unspecified date; DTaP (manufacturer unspecified; unknown) given on an unspecified date; Hep B (manufacturer unspecified; unknown) given on an unspecified date; pneumococcal vaccine, unspecified (manufacturer unspecified; unknown0 given on an unspecified date. On 27 March 2008, the subject received the 1st dose of ROTARIX (unknown). On 3 April 2008, 7 days after vaccination with ROTARIX, the subject experienced intussusception; He experienced the following symptoms: abdominal pain, vomiting, lethargy, pallor, irritability, intestinal obstruction; acute abdominal distention and abnormal or absent bowel sounds. Abdominal X-ray showed fluid level. The diagnosis of intussusception was made based on abdominal ultrasound exam (site of IS: Hepatic flexure; Type of IS: ileocaecal). On 06 April 2008, faeces''s sample was collected; RNA Rotavirus test was positive. The subject required surgical resection. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:321010 (history)  Vaccinated:2008-03-27
Age:18.0  Onset:2008-04-05, Days after vaccination: 9
Gender:Female  Submitted:2008-07-31, Days after onset: 117
Location:Foreign  Entered:2008-08-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Cervical smear, 05Apr08, revealed a carcinoma in situ.
CDC 'Split Type': WAES0807USA05445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Carcinoma in situ, Cervical conisation, Smear cervix abnormal
SMQs:, Malignant tumours (narrow)
Write-up: Information has been received from a general practitioner concerning an 18 year old adult female who on 27-MAR-2008 was vaccinated with her second dose of GARDASIL IM. 9 days later on 05-APR-2008 a cervical smear performed revealed a carcinoma in situ. The patient was treated with conization on 05-MAY-2008 and recovered without any sequelae. She had no concomitant treatment. Upon internal review, the event was considered to be an other important medical event. Other business partner numbers include E2008-07096. Additional information is requested.

VAERS ID:321558 (history)  Vaccinated:2008-03-27
Age:5.0  Onset:2008-03-28, Days after vaccination: 1
Gender:Male  Submitted:2008-08-07, Days after onset: 132
Location:Foreign  Entered:2008-08-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0531212A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 27 March 2008, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site, lot number not provided). On 28 March 2008, 1 day after vaccination with INFANRIX, the subject experienced a local reaction with inflammation, induration, pain and erythema at injection site from shoulder to elbow. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 30 March 2008, the subject went to his pediatrician and he was treated with ibuprofen (Dalsy), prednisolone steaglate (Estileona) and amoxicillin trihydrate + potassium clavulanate (Augmentin (oral)). On 2 April 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX. No further information was expected as this was the only information the foreign regulatory authority had, so this case has been considered closed.

VAERS ID:352108 (history)  Vaccinated:2008-03-27
Age:1.3  Onset:2009-01-15, Days after vaccination: 294
Gender:Male  Submitted:2009-07-22, Days after onset: 187
Location:Foreign  Entered:2009-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Stool rotavirus antigen positi, Jan2009, positive
CDC 'Split Type': D0062358A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test positive
SMQs:
Write-up: This case was reported by a public health agency and described the occurrence of Rotavirus infection in an 18-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unknown date in 2007 the subject received the first dose of ROTARIX (0.5 ml, oral). On 28 November 2007 the subject received the second dose of ROTARIX (0.5 ml, oral). More than one year post vaccination with the first dose of ROTARIX and approximately 14 months post vaccination with the second dose of ROTARIX, on 12 February 2009, the subject experienced Rotavirus infection. Stool Rotavirus antigen was tested positive. The subject had received complete vaccination with two doses of ROTARIX. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the event was unspecified. No further information will be available.

VAERS ID:414391 (history)  Vaccinated:2008-03-27
Age:14.0  Onset:2008-03-27, Days after vaccination: 0
Gender:Female  Submitted:2011-01-07, Days after onset: 1016
Location:Foreign  Entered:2011-01-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of convulsions and an allergy to Penicillin (anaphylactic).
Diagnostic Lab Data:
CDC 'Split Type': 201100011
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2558A IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Anxiety, Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Heart rate increased, Hyperhidrosis, Nausea, Pallor, Restlessness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: A line listing of 16 cases was received on 31 December 2010 from a physician at the Public Health Agency in response to a follow-up request for additional information concerning a report of some cases of anaphylaxis following the administration of ADACEL (lot number C3244AA). The line listing contained 16 cases of anaphylaxis following the administration of ADACEL (various lot numbers). ADACEL had been administered between 2002 and 2010, in unspecified provinces. The reference number for this case is V0809099 and it had been reported by a nurse. A 14 year old female patient, with a history of convulsions and an allergy to Penicillin, received a left arm intramuscular 0.5 ml injection of ADACEL (lot number C2558AA) on 27 March 2008 at approximately 14:45. Within 5 minutes, the patient returned, experiencing dizziness, nausea, and stomach cramps. Over the next one to three minutes, the symptoms progressed to include tightness in chest, shortness of breath, and difficulty swallowing. The patient was restless, anxious, sweating and pale. Her pulse was rapid. Epinephrine 0.5 ml was administered subcutaneously in the right deltoid. Symptoms improved. The patient went to the emergency room by ambulance. She received treatment for two hours and was released. The patient fully recovered. The other 15 cases in the line listing are captured in cases 2010-07027, 2011-00002 through 2011-00010, and 2011-00012 through 2011-00016.

VAERS ID:445731 (history)  Vaccinated:2008-03-27
Age:17.0  Onset:2009-09-01, Days after vaccination: 523
Gender:Female  Submitted:2011-12-16, Days after onset: 836
Location:Foreign  Entered:2011-12-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1110USA01665
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Asthenia, Depressed mood, Depression, Fatigue
SMQs:, Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Case received from Health Authorities on 02-SEP-2011, via reference number MA20111680. Case medically confirmed. A 16-year-old female patient had received 3 injections of GARDASIL (Lot # 1201U, Batch # NG41880 of the second injection (also reporter as N641880)), batch number not reported for first and third injections) on 27-MAR-2008, 24-APR-2008 and 01-OCT-2008 respectively. Since vaccination (no further specified) her mother reported that the patient presented with tiredness, anxiety and unhappiness. The physician specified that the patient had left high school for university. This report was made by the physician on demand of the mother following the media coverage of recent events related to GARDASIL in July 2011. The Health Authorities assessed the causal relationship between the reported reactions and vaccinations as doubtful according to the Foreign method of assessment. Follow-up received on 20-OCT-2011, the Health Authorities confirmed that the correct batch number for the second dose of GARDASIL was NG41880, lot number: 1201U. Follow-up received from the Health Authorities on 07-DEC-2011, under the reference MA20112473. Case had been upgraded by the Health Authorities. The Health Authorities received the follow-up information from the treating physician of the patient, who was 17-year-old, when the first symptom started (and not 16 as previously reported). He confirmed the symptoms that the patient''s mother previously reported. The patient experienced an anxiodepressive syndrom since September 2009 accompanied by asthenia, low spirits and anxiety. Anxiodepressive syndrome flared up approximately once a month for 2 years. The patient had been put on STRESAM since August 2011. The patient had received the first dose of GARDASIL (batch number not reported) on 27-MAR-2008 and the second dose of GARDASIL (lot number: 1201U, batch number NG41880) on 24-MAY-2008 (and not on 24-APR-2008 as previously reported). The vaccination schedule had been followed as recommended (0, 2 and 6 month). At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the following adverse event" "Asthenia" and "Anxiety" which was mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction (s) and vaccination as doubtful according to the Foreign method of assessment. Asthenia and Anxiodepressive syndrome were considered to be other important medical events by the Agency. Other business partner numbers included: E2011-05794. No further information is available.

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