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Case Details (Sorted by Vaccination Date)

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VAERS ID:284115 (history)  Vaccinated:2007-07-05
Age:23.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-07-09, Days after onset: 4
Location:Georgia  Entered:2007-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none present
Preexisting Conditions: none reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICS417011C1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Diarrhoea, Malaise, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: vaccine received 07/5/2007 received phone call 7/7/07 from pts husband stating that pt has been sick and they are concerned if related to rabies vaccine symptoms started two hrs after receiving vaccine pt has had chills, fever, diarrhea and has been vomitting. pt is taking motrin and immodium for pain and diarrhea. husband states they are concerned she is not improving. Husband states pt uses gwinnett clinic for medical care, encouraged to take pt to gwinnett clinic or emergency room. 07/09/2007 spoke with pt she reports she did not seek medical attention and is feeling better now.

VAERS ID:284124 (history)  Vaccinated:2007-07-05
Age:5.0  Onset:2007-07-06, Days after vaccination: 1
Gender:Male  Submitted:2007-07-09, Days after onset: 3
Location:Missouri  Entered:2007-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056BA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ03263IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0545U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 10 x 4cm mild erythema to left upper arm. OTC Ibuprofen - warm compress.

VAERS ID:284206 (history)  Vaccinated:2007-07-05
Age:20.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-07-10, Days after onset: 5
Location:Arkansas  Entered:2007-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Milk and ASA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Fatigue, Feeling hot
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Injection given on 7-5-07, pt left office after 15 min of inj. okay. Called back states she had immediate response felt very tired feverish and dizzy.

VAERS ID:284221 (history)  Vaccinated:2007-07-05
Age:0.4  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-07-05, Days after onset: 0
Location:Ohio  Entered:2007-07-10, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132BA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF163AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845H1IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Crying, Erythema, Immediate post-injection reaction, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Immediately after vaccine, pt screamed inconsolably for 20-25 mins and legs became beefy red B from knees down. no palpable urticaria. Pt was eventually calmed and given 6.25 mg Benadryl. Redness gradually faded in patches.

VAERS ID:284309 (history)  Vaccinated:2007-07-05
Age:1.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-07-11, Days after onset: 6
Location:California  Entered:2007-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations: Seizure~DTaP (no brand name)~3~1~In Patient
Other Medications: Kepra
Current Illness: none
Preexisting Conditions: Prior febrile seizure/ prematurity (29 weeks) 8/30/07-records received-HX: 29 week premie with known seizure disorder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0507F2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300A3IMRL
Administered by: Private     Purchased by: Private
Symptoms: Epilepsy, Febrile convulsion, Muscle twitching, Partial seizures, Pyrexia, Status epilepticus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Febrile seizure - focal for 20 minutes. Tx''d with Ativan, Dilantin 8/23/07-records received for DOS 7/5-7/8/07-DC DX:Epilepsia partialis continua. Febrile convulsions. admitted in status epilepticus. Developed fever to 38.5 on day of vaccine. Twitching on right side persisted for 2 hours.

VAERS ID:285186 (history)  Vaccinated:2007-07-05
Age:0.2  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-07-10, Days after onset: 5
Location:North Carolina  Entered:2007-07-19, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B101AA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0076U0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB588451A0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0508U PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Faeces discoloured, Screaming, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow)
Write-up: called on 7/10 to report child screamed x 3 hrs after 3 hr nap 7/5 began vomiting with each feeding (breast) green watery diarrhea x 3 days. No fever. Alert Did not call before now as thought it needed to run its course and not life threatening.

VAERS ID:285207 (history)  Vaccinated:2007-07-05
Age:1.3  Onset:2007-07-14, Days after vaccination: 9
Gender:Male  Submitted:2007-07-19, Days after onset: 5
Location:Florida  Entered:2007-07-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pharyngitis, URI
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1244F2 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1409F0 LA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash all over body, fever

VAERS ID:285236 (history)  Vaccinated:2007-07-05
Age:1.8  Onset:0000-00-00
Gender:Female  Submitted:2007-07-10
Location:Oregon  Entered:2007-07-19, Days after submission: 9
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2605AA3IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0002U2IMRL
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB149AA IMLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccines given 7/5/07 at well child exam within 24 hours LUT with red circle, later worse. Seen in clinic 7/9/07 was beginning to improve, no sign of local infection seen. (Also just starting URI sx).

VAERS ID:285242 (history)  Vaccinated:2007-07-05
Age:2.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-07-06, Days after onset: 1
Location:California  Entered:2007-07-19, 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: 1 tsp Ibuprofen prior to immunz.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2605AA3IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0360U1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1274F3IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5403K3IMRL
Administered by: Private     Purchased by: Private
Symptoms: Abasia
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad)
Write-up: Mom called at 440pm - stated son had imm 7/5/07 and now would not walk -, no swelling, no redness, no bruising

VAERS ID:285243 (history)  Vaccinated:2007-07-05
Age:9.0  Onset:2007-07-06, Days after vaccination: 1
Gender:Female  Submitted:2007-07-10, Days after onset: 4
Location:New York  Entered:2007-07-19, Days after submission: 9
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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0641U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Local reaction
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large local reaction 1.75 x 1.25 erythema and induration.

VAERS ID:285945 (history)  Vaccinated:2007-07-05
Age:0.2  Onset:2007-07-07, Days after vaccination: 2
Gender:Female  Submitted:2007-07-25, Days after onset: 18
Location:Georgia  Entered:2007-07-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: child given tylenol (80mg) after vaccinations. Polyvisol with iron drops given pm same day.
Current Illness: no illness.
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS 0IM 
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IM 
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1233F0PO 
Administered by: Private     Purchased by: Private
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Blood in stools twice on same day, two days after vaccine administered. No fever or other symptoms.

VAERS ID:288876 (history)  Vaccinated:2007-07-05
Age:20.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 40
Location:Unknown  Entered:2007-08-16, 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: Unknown
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA01394
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0389U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 20 year old female with a history of "aspirin-type reaction" who on 05-JUL-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot #657736/0389U). On 05-JUL-2007 the patient experienced fever and flu like symptoms. On an unspecified date the patient recovered from fever and flu like symptoms. There was no product quality complaint. No further information is available.

VAERS ID:289438 (history)  Vaccinated:2007-07-05
Age:24.0  Onset:2007-07-13, Days after vaccination: 8
Gender:Female  Submitted:2007-08-14, Days after onset: 32
Location:Texas  Entered:2007-08-16, 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: Vaginosis bacterial; Depression; Diabetes; Gastooesophageal reflux disease; Hypothyroidism; Psoriasis; Syncope
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA02368
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0524U0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a nurse practitioner concerning a 24 year old female who was vaccinated with Gardasil. After the patient received Gardasil, on 05-JUL-2007, she developed pain in the injection site on her arm, which she had for more than a week. As of 13-JUL-2007, the patient had not recovered from the pain in the injection site on her arm. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a nurse practitioner and a consumer concerning a 24 year old female with hypothyroidism, diabetes, gastrooesophageal reflux disease, psoriasis, syncope and depression, who on 05-JUL-2007 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (Lot # 658094/0524U). Illness at the time of the vaccine included bacterial vaginosis. Concomitant therapy included SYNTHROID, LANTUS, HUMALOG, DIFLUCAN, FLAGYL and REGLAN. On 13-JUL-2007 (previously reported as 05-JUL-2007) the patient experienced a sore left arm. There was no redness, swelling, warmth, or fever reported. The patient was taking TYLENOL per label and three ibuprofen three times a day for pain. The patient was informed to switch to ALEVE two times a day with food and to continue TYLENOL per the label. At the time of the report, the patient''s outcome was unknown. This is a consolidation of two reports concerning the same patient. Additional information is not expected.

VAERS ID:289780 (history)  Vaccinated:2007-07-05
Age:18.0  Onset:2007-07-06, Days after vaccination: 1
Gender:Female  Submitted:2007-08-14, Days after onset: 39
Location:Unknown  Entered:2007-08-16, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0707USA04621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0211U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who on 05-JUL-2007 was vaccinated with the first dose of Gardasil. (Lot # not provided). Subsequently on 06-JUL-2007 the patient developed a rash behind both ears. The patient was treated at a local center with Benadryl and an unspecified topical corticosteroid. Subsequently on an unspecified date the patient recovered from the rash. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007

VAERS ID:290333 (history)  Vaccinated:2007-07-05
Age:0.6  Onset:2007-09-04, Days after vaccination: 61
Gender:Male  Submitted:2007-09-06, Days after onset: 2
Location:Mississippi  Entered:2007-09-12, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: viral illness w/congestion & cough x approx 1 week. On antibiotics x 3-4 days prior to admit.
Diagnostic Lab Data: LABS: Abdominal x-ray & KUB revealed IS. Air contrast enema initially reduced IS but IS recurred.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B115CB2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08690F IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal pain, Crying, Dehydration, Enema administration, Haematochezia, Intussusception, Laparoscopy, Lethargy, Surgery, Urinary system X-ray, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Write-up: Pt seen in office with hx of bloody stool. Abdominal pain noted: pt lethargic, dehydrated (on 9-5-07). Referred to hospital by ambulance. Dx intussusception. 9/24/2007 Call placed to vaccine provider for verification per CDC request. Per vaccine provider, pt has not received any doses of Rotateq on that date or at any time. 9/25/07 Reviewed hospital medical records which reveal patient experienced unconsolable crying, abdominal pain, emesis & bloody stool x 1 day. Admitted 9/6-9/7/2007. Enema initially reduced IS but recurred & taken to OR for laparoscopic reduction of ileocecal IS. Did well postoperatively & d/c to home next day. FINAL DX: Intussusception, surgically reduced.

VAERS ID:295280 (history)  Vaccinated:2007-07-05
Age:  Onset:2007-07-07, Days after vaccination: 2
Gender:Female  Submitted:2007-09-24, Days after onset: 79
Location:Tennessee  Entered:2007-09-27, 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: Therapy unspecified
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA02390
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site erythema; injection site swelling. Information has been received from a physician concerning a female who on 05 JUL 2007 or JUL 2007 was vaccinated sc with a first single dose of zoster vaccine live (Oka/Merck). This patient was receiving unspecified concomitant therapy. Over the weekend of 07 JUL 2007 to 08 JUL 2007 the patient developed redness and swelling at the injection site. The patient visited the physician''s office for follow up and was treated with fexofenadine HCL (ALLEGRA) and a methylprednisolone dose pack (MEDROL). On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:295946 (history)  Vaccinated:2007-07-05
Age:79.0  Onset:2007-08-03, Days after vaccination: 29
Gender:Male  Submitted:2007-09-24, Days after onset: 52
Location:Unknown  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01445
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been from a family member of a patient with a history of allergies who approximately 05-JUL-2007 was vaccinated with a single first dose of ZOSTAVAX. On approximately 03-AUG-2007 the patient developed shingles. Unspecified medical attention was sought. There was no further information provided. There was no product quality complaint involved. Additional information is not expected.

VAERS ID:295998 (history)  Vaccinated:2007-07-05
Age:43.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-09-24, Days after onset: 81
Location:Texas  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA00826
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse (R.N.) concerning a, 43-year-old female housewife with no pre-existing allergies, birth defects or medical conditions who on 05-JUL-2007 was inadvertently vaccinated with a subcutaneous dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck). There were no illnesses at the time of vaccination. It is reported that this error was not due to product confusion but due to human error. It is unspecified if medical attention was sought. No adverse experience was related to this event. No further information is available. No product quality complaint was involved. Follow-up information received on 30-Jul-2007 via a telephone call from the registered nurse indicated that there has been no further contact from the female patient and there is no information about adverse experiences. The patient''s name was unknown, the physician involved was unavailable and the box of Zostavax (Oka/Merck) has since been emptied so the lot number could not be obtained. The nurse reported that the event happened because the nurse administering the vaccination thought she was grabbing a vile of generic varicella. The boxes were stored one in front of the other. No more information is expected.

VAERS ID:299678 (history)  Vaccinated:2007-07-05
Age:15.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 132
Location:Ohio  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA04882
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Hypoaesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who on 05-JUL-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On 05-JUL-2007 the patient experienced numbness in her arm and the patient felt faint. On 08-OCT-2007 the patient was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and the patient fainted. The patient sought unspecified medical treatment. Subsequently the patient recovered from numbness in her arm, feeling faint, and fainting on an unspecified date. Additional information has been requested.

VAERS ID:299812 (history)  Vaccinated:2007-07-05
Age:23.0  Onset:2007-07-10, Days after vaccination: 5
Gender:Female  Submitted:2007-11-14, Days after onset: 127
Location:Massachusetts  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA06648
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). On 10-JUL-2007 5 days later, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It is unknown if medical attention was sought. At the time of this report, the patient''s 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 11/14/2007. Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# reported as "09607"). Subsequently, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It was reported on 10-JUL-2007, the patient still had dizziness and some muscle ache. It was recommended that the patient not continue the series. At the line of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information is not expected.

VAERS ID:352338 (history)  Vaccinated:2007-07-05
Age:13.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2009-07-15, Days after onset: 741
Location:Pennsylvania  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: PENICILLIN allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0907USA00012
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Vaccination complication
SMQs:
Write-up: Information has been received from a nurse concerning a 13 year old female with AMOXICILLIN allergy who on 05-JUL-2009 was vaccinated with the first "standard dose" IM of GARDASIL (lot #657621/0387U). There were no concomitant medications. The nurse reported that the patient had a "reaction" after receiving the GARDASIL. The patient mentioned that she did not "feel good" after vaccination. The outcome was reported as recovered (date not reported). The patient did not seek medical attention. Additional information information has been requested.

VAERS ID:459598 (history)  Vaccinated:2007-07-05
Age:66.0  Onset:2012-03-01, Days after vaccination: 1701
Gender:Male  Submitted:2012-07-16, Days after onset: 136
Location:Ohio  Entered:2012-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1206USA04301
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0743U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blindness, Herpes zoster ophthalmic, Necrotising retinitis, Retinal detachment, Retinitis viral
SMQs:, Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Ocular infections (narrow)
Write-up: Information has been received from a physician concerning a 71 year old male patient with no pertinent medical history who on 05-JUL-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 658081/0743U; exp. 08-NOV-2008), 0.65ml. The physician mentioned that in March-2012 the patient had been diagnosed with acute retinal necrosis, which was later deemed to be zoster retinitis. This AE started in his right eye, then spread to his left eye, and his retina had since detached in his right eye. On approximately 22-JUN-2012 (reported as "now") the patient had some vision loss, but the doctor did not specify the extent of the loss. The patient went to the ER visit at an unspecified hospital for treatment and was given oral valacyclovir hydrochloride, prednisone and intraocular ganciclovir. The patient sought unspecified medical attention. The AE improved after stopping therapy. Therapy was not reintroduced. At the time of the report, the patient was recovering. Additional information was received from the registered nurse who indicated that the physisican has no further information to provide. Additional information is not expected.

VAERS ID:560934 (history)  Vaccinated:2007-07-05
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2015-01-11
Location:Unknown  Entered:2015-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 3 UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Papilloma viral infection
SMQs:
Write-up: Diagnosed with HPV.

VAERS ID:284656 (history)  Vaccinated:2007-07-05
Age:34.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-07-13, Days after onset: 8
Location:Foreign  Entered:2007-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0477935A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Nausea, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of fainting in a 34-year-old male subject who was vaccinated with Twinrix, GlaxoSmithKline, IPOL, Vaxigrip and Vaxigrip for prophylaxis. On 5 July 2007 the subject received unspecified dose of Twinrix (unknown), unspecified dose of IPOL (unknown arm), unspecified dose of Vaxigrip (right arm). The vaccine batch number was not provided. On 5 July 2007, shortly after vaccination with IPOL, Twinrix and Vaxigrip, the subject fainted. Then the subject vomited about 4 times over a couple of hours and felt nausea, fever and generally quite unwell. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:284662 (history)  Vaccinated:2007-07-05
Age:16.0  Onset:2007-07-06, Days after vaccination: 1
Gender:Male  Submitted:2007-07-13, Days after onset: 7
Location:Foreign  Entered:2007-07-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Minocycline hydrochloride, Stievamycin
Current Illness: PENICILLIN ALLERGY
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0662313A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Pruritus, Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of hives in a 16-year-old male subject who was vaccinated with Twinrix for prophylaxis. On 5 July 2007 the subject received primary course of Twinrix (unknown) and experienced hives on his hands. He was treated with Benadryl, but the hives returned in the morning of 6 July 2007. The event was unresolved at the time of reporting. Follow-up received on 06 July 2007 via the mother of the subject. She reported that the dose of Twinrix was received at 9:00 am and the subject immediately experienced the hives. He was treated with Benadryl and the following morning the subject experienced itching of his hands. Outcome not provided. Follow-up information was received from the reporting pharmacist, who was also the subject''s mother, on 10 July 2007. Concurrent medical conditions included penicillin allergy. The subject was previously vaccinated with Twinrix, with dose one administered on 20 June 2007 and dose two administered on an unspecified date after 20 June 2007, but prior to 05 July 2007. Concurrent medication included Minocycline hydrochloride and Stievamycin. The subject received the 3rd dose of Twinrix at 9:30 am on 05 July 2007. The subject developed "itch" at 3:00 AM on 06 July 2007 and hives started to develop by 4:00 AM. The hives were over his body (arms, legs, face, chest and back). The subject was treated with diphenhydramine 50 mg and the "reaction" subsided. The subject experienced itching again at 9:00 AM and was treated with diphenhydramine 25 mg. The subject was taken to the hospital. The physician stated that the subject''s hives were not severe enough to treat him with a steroid medication. The physician instructed the subject to use 50 mg of an unspecified medication every four hours until the reaction was gone. The reporting pharmacist considered the events jeopardized subject or required intervention. At the time of reporting, the events were unresolved, with the hives worse and the itch improved. The reporter considered it was pr

VAERS ID:286270 (history)  Vaccinated:2007-07-05
Age:24.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-07-30, Days after onset: 25
Location:Foreign  Entered:2007-07-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
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: WAES0707AUS00223
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0313U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 24 year old female who on 05-JUL-2007 was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date, 08-AUG-2009). On 05-JUL-2007 after vaccination with Gardasil the patient developed pruritus over trunk and arms and rash maculo-papular over trunk and arms. On 11-JUL-2007, the patient recovered from pruritus over trunk and arms and rash maculo-papular over trunk and arms. The agency considered that pruritus over trunk and arms and rash maculo-papular over trunk and arms were related to therapy with Gardasil. The original reporting source was not provided. Pruritus over trunk and arms and rash maculo-papular over trunk and arms were considered to be disabling by the agency. Additional information is not expected.

VAERS ID:287358 (history)  Vaccinated:2007-07-05
Age:17.0  Onset:2007-07-11, Days after vaccination: 6
Gender:Male  Submitted:2007-08-07, Days after onset: 27
Location:Foreign  Entered:2007-08-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Autoimmune thrombocytopenia; Testicular torsion; Haemolytic anaemia; Cystitis
Diagnostic Lab Data: brain imaging thrombosis of venous sinuses, cerebral haemorrhage and hypoperfusion
CDC Split Type: WAES0707USA02922
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Autoimmune disorder, Bacterial infection, Cerebral haemorrhage, Cerebral hypoperfusion, Condition aggravated, Cystitis, Epilepsy, Hypoaesthesia, Hypoperfusion, Intracranial venous sinus thrombosis, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain abnormal, Paresis, Urinary tract infection
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Information has been received from a health professional concerning a 17 year old male with a history of hemolytic anemia, autoimmune thrombocytopenia (2000) and testicular torsion who on 05-JUL-2007 was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg and an intramuscular booster dose of Repevax in the upper arm. Concomitant therapy included Cotrim. The same day in the evening, the patient experienced arthralgia of the ankles and wrists. The patient''s arthralgia persisted. Treatment with paracetamol did not lead to improvement. The patient recently underwent surgery due to torsion of the testis. At the time of reporting the patient additionally suffered from cystitis that was not considered to be related to the vaccine but to the torsion of testis. He was treated with Cotrim. At the time of reporting symptoms were still ongoing. Previous vaccinations were all well tolerated. Follow-up information received from a healthcare professional stated that the onset of cystitis was prior to vaccination. On 11-JUL-2007, the patient was hospitalized due to aggravation of cystitis (bloody urine, severe bladder pain) despite treatment with Cotrim. Treatment with intravenous antibiotics ciprofloxacin (CIPRO BAY) was started and lead to improvement. The hospital physicians stated that the cystitis/bacterial infection was cause of the arthralgia. A relation to the vaccine was not assumed. Follow-up information received from a healthcare professional stated that the child recovered from cystitis and arthralgia on 20-JUL-2007. The exact duration of blood in the urine and bladder pain was not reported. He was discharged from the hospital. Follow-up information stated that on 21-JUL-2007, in the afternoon, the patient developed numbness of the left arm followed by paresis of the left arm. On that same day, in the evening, he experienced an epileptic fit. He recovered within a short time and was readmitted to the hospital and then referred to a neurologic clinic. A cranial magnetic resonance imaging (MRI) showed thro

VAERS ID:288026 (history)  Vaccinated:2007-07-05
Age:22.0  Onset:2007-07-07, Days after vaccination: 2
Gender:Female  Submitted:2007-08-13, Days after onset: 37
Location:Foreign  Entered:2007-08-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA01385
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Optic neuritis retrobulbar
SMQs:, Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad)
Write-up: Information has been received from a health authority concerning a 22 year old female, with no pertinent medical history, who on 05-JUL-2007 was vaccinated with a first dose of Gardasil. On 07-JUL-2007 the patient experienced retrobulbar neuritis and was hospitalized on an unspecified date. As of 13-JUL-2007, the patient had not recovered. No further information is available. File is closed. Other business partner numbers include E2007-05171 and PEI2007007376.

VAERS ID:289385 (history)  Vaccinated:2007-07-05
Age:65.0  Onset:0000-00-00
Gender:Male  Submitted:2007-08-30
Location:Foreign  Entered:2007-08-30
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: Blood test results pending and an unspecified test result pending.
CDC Split Type: A0677055A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Dizziness, Epilepsy, Impaired driving ability, Impaired work ability, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a consumer and described the occurrence of epileptic attack in a 65-year-old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. On 5 July 2007, 5 February 2007 and 3 January 2007 the subject received 3rd dose, 2nd dose and 1st dose of Twinrix (unknown). In January 2007, approximately 1-2 days after vaccination with Twinrix, the subject experienced epileptic attack, absence attacks, dizziness, difficulty driving and inability to work. He experienced these symptoms after each dose. This case was assessed as medically serious. Relevant test results included [laboratory results/hospital investigations]. The subject was treated with unknown (Unspecified drug). At the time of reporting the events were unresolved.

VAERS ID:290106 (history)  Vaccinated:2007-07-05
Age:0.3  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-09-06, Days after onset: 63
Location:Foreign  Entered:2007-09-07, 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: AMOXICILLIN, 2.5 mL 3X per 1 Day, 15-Jun-2007 / 20-Jun-2007, CHLORAMPHENICOL, Unknown, 17-May-2007 / UNK
Current Illness: Urinary tract infection; Conjunctivitis
Preexisting Conditions:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYE245731AUG07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2522AA UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERC2522AA UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERC2522AA UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH23103 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Hypersensitivity, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was considered medically important. Information regarding Prevenar was received from a healthcare professional via regarding a 11-week-old female patient who experienced a possible allergic reaction after developing bilateral red swollen legs down to the feet after one injection on each thigh. The patient received a dose on 05-Jul-2007. The patient experienced patient a possible allergic reaction on 05-Jul-2007, after developing bilateral red swollen legs down to the feet after one injection on each thigh. The reporter stated that the patient responded to paracetamol, cooling and piriton and the events resolved after 5 hours. No additional information was available at the time of this report.

VAERS ID:290120 (history)  Vaccinated:2007-07-05
Age:6.0  Onset:2007-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-09-07, Days after onset: 64
Location:Foreign  Entered:2007-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood neutrophils Jul2007 Neutrophilia; Blood test Jul2007 Normal; Emergency care examination Jul2007 Normal; Plasma creatinine Jul2007 0.6mg/dL
CDC Split Type: B0485861A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B048AB IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood creatinine normal, Blood test normal, Injection site cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Neutrophil count increased, Neutrophilia
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of heat sensation at the injection site in a 6-year-old female subject who was vaccinated with Infanrix, GlaxoSmithKline for prophylaxis. Previous and/or concurrent vaccination MMR II (new strain) (GlaxoSmithKline, subcutaneous, unknown), given on 5 July 2007. On 5 July 2007 the subject received unspecified dose of Infanrix (intramuscular, left thigh). On 5 July 2007, less than one day after vaccination with Infanrix, the subject experienced heat sensation at injection site, pain at injection site and swelling at injection site (left thigh). The patient went to the emergency room 3 days after the vaccinations. Objective examination and blood tests showed no abnormalities. Initial cellulitis of the left thigh was diagnosed. Relevant laboratory data included a mild neutrophilia. This case was assessed as medically serious by GSK. The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin). At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:291380 (history)  Vaccinated:2007-07-05
Age:1.8  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-09-25, Days after onset: 82
Location:Foreign  Entered:2007-09-26, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Pharyngitis
Diagnostic Lab Data: Lumbar puncture 07-Jul-2007 no germ in the CSF 09-Jul-2007 no germ in the CSF
CDC Split Type: FRWYE334419SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH243593UNLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Altered state of consciousness, Encephalitis, Injection site oedema, Injection site pain, Lumbar puncture normal, Psychomotor skills impaired, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Initial information received on 19-Sep-2007, and follow-up received on 21-Sep-2007, regarding Prevenar was received from a healthcare professional via regulatory authority regarding a 21-month-old male patient who experienced severe reaction on the thigh with edema and pain, fulminant encephalitis, consciousness disorder with retardation of thought, and motor deficiciency. The patient received the fourth dose on 05-Jul-2007. The patient experienced severe reaction on the thigh with edema and pain on 05-Jul-2007. Then, on 07-JUL-2007, occurrence of fever, consciousness disorder with retardation of thought and motor deficiciency. The patient was hospitalized and diagnosed with fulminant encephalitis with involvement of the white matter on 07-Jul-2007. The patient did not experience coma, he had a poor cortical activity but his eyes were open. Lumbar puncture performed on 07-Jul-2007 and repeated lumbar puncture on 09-Jul-2007 did not find any germ in the CSF. However, a post-infectious encephalitis due to an unidentified germ was considered. Encephalitis, altered stated of consciousness and psychomotor skills impaired were considered to be life-threatening events. The patient was still hospitalized and had not recovered from encephalitis. The injection site reactions were also reported not recovered. Lumbar puncture (results: no germ in the CSF) was done on 07-Jul-2007. Lumbar puncture (results: no germ in the CSF) was done on 09-Jul-2007. No additional information was available at the time of this report.

VAERS ID:296836 (history)  Vaccinated:2007-07-05
Age:16.0  Onset:2007-08-15, Days after vaccination: 41
Gender:Female  Submitted:2007-11-14, Days after onset: 91
Location:Foreign  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA01877
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0859F0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amaurosis, CSF test normal, Inappropriate schedule of drug administration
SMQs:, Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Medication errors (narrow)
Write-up: Information has been received from a health professional concerning a 16 year old female patient who on 05-JUL-2007 was vaccinated in the left arm with the first dose of Gardasil (lot # 654740/0859F, Batch # NE29660). On 15-AUG-2007 the patient experienced amaurosis of the right eye. She was hospitalized on an unspecified date. Examinations of cerebrospinal fluid were normal. No cause for the disorder was found. On 22-AUG-2007 the patient completely recovered. The second dose of Gardasil was administered on 12-OCT-2007 and was well tolerated. Other business numbers include E-2007-07684.

VAERS ID:298176 (history)  Vaccinated:2007-07-05
Age:0.2  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2007-11-28, Days after onset: 146
Location:Foreign  Entered:2007-11-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYEG00656507
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERCR547AB IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERCR547AB IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERCR547AB IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH21757 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Depressed level of consciousness, Hypotonia
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was considered medically important. Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding an 8-week-old male patient who experienced crying, becoming unrousable and floppy. The patient received a dose on 05-Jul-2007. The patient experienced crying, becoming unrousable and floppy on 05-Jul-2007, it was also noted that the patient''s breathing was fine and colour tone had not changed. The patient recovered approximately 5 minutes later. The reporter considered the reaction to be medically significant as the child was unresponsive for approximately 5 minutes. No additional information was available at the time of this report.

VAERS ID:299045 (history)  Vaccinated:2007-07-05
Age:0.7  Onset:2007-07-06, Days after vaccination: 1
Gender:Male  Submitted:2007-12-06, Days after onset: 153
Location:Foreign  Entered:2007-12-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Blood test 07-Jul-2007 normal, Electroencephalogram 10-Jul-2007 the trace of awake EEG showed an isolated bitemporal spike considered not relevant so the EEG was normal
CDC Split Type: FRWYE215624AUG07
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Electrocardiogram, Electroencephalogram normal, Gaze palsy, Partial seizures, Somnolence
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)
Write-up: Follow-up information included therapy and event onset dates, medical history, event details leading to code additional events, and lab tests. Information regarding Prevenar was received from a healthcare professional regarding a an 8-month-old male patient who was sleepy and experienced recurrent eye revulsion reported as partial convulsion. The patient received the first dose on 05-Jul-2007. The patient had no personal or family history of partial convulsion. Concomitant medications were not reported. The patient did not receive concomitant vaccine. On 06-Jul-2007, the day after vaccination, during a car journey, the patient was very sleepy and experienced recurrent eye revulsion reported a partial convulsion. The patient was hosptialized on 07-Jul-2007. He had no fever. The same type of convulsion would have recurred once during hospitalization but did not recur thereafter. The patient was found with sensitive or motor deficiency. He was discharged with prescription of Valium (diazepam) for possible recurrence of convulsion. An awake EEG, performed, on 10-Jul-2007, was considered normal (see details in test results section). The patient was considered recovered without sequelae. Blood test (results: normal) was done on 07-Jul-2007. Electroencephalogram (results: the trace of awake EEG showed an isolated bitemporal spike considered not relevant so the EEG was normal) was done on 10-Jul-2007. No additional information was available at the time of this report.

VAERS ID:304543 (history)  Vaccinated:2007-07-05
Age:26.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-07
Location:Foreign  Entered:2008-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: phenprocoumon
Current Illness: THROMBOPHILIA
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0506273B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug interaction
SMQs:
Write-up: This case was reported by a regulatory authority and described the occurrence of drug interaction in a 26-year-old female subject who was vaccinated with Twinrix adult (GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included Thrombophilia. Concurrent medication included Marcoumar. See case B0506273A for tolerance to first dose of Twinrix adult given on 5 June 2007. On 5 July 2007, the subject received 2nd dose of Twinrix Adult (intramuscular, lot number not provided. At an unspecified time after vaccination with Twinrix adult, the subject experienced decreased effect of Marcoumar. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved.

VAERS ID:305027 (history)  Vaccinated:2007-07-05
Age:34.0  Onset:2007-08-28, Days after vaccination: 54
Gender:Male  Submitted:2008-02-15, Days after onset: 171
Location:Foreign  Entered:2008-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: citalopram
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure 05Dec2007 52/32mmHg; Blood pressure 05Dec2007 109/70mmHg; Blood pressure 05Dec2007 118/74mmHg; Blood pressure 05Dec2007 102/40mmHg
CDC Split Type: B0497706A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB253AB2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a nurse who described a 34-year-old male patient who received three doses of Engerix B (GlaxoSmithKline) for prophylaxis but a subsequent blood result stated that hepatitis B antibodies were not detected (not responding to therapy). On 5 July 2007, 18 February 2007, and 8 January 2007 the patient received 3rd dose, 2nd dose and 1st dose of Engerix B (20 mcg, intramuscularly). On 28 August 2007, the patient''s blood results stated that hepatitis B antibodies were not detected (not responding to therapy). The patient was started on a new Engerix B schedule receiving the first dose on the 24 September 2007. Verbatim text received: On the 29th of November 2007 a nurse reported that a patient had received a 0, 1, 6 month Engerix B schedule. The first dose was administered on the 8th of January 2007, the second on the 13th of February 2007 and the third dose on the 5th of July 2007. On the 28th of August 2007 the patient''s blood results stated that hepatitis B antibodies were not detected. The patient was started on a new Engerix B schedule receiving the first dose on the 24th of September 2007. Follow up information received 11 February 2008: Verbatim text received: On the 7th of February 2007 a nurse reported that a patient received the first dose of an Engerix B schedule on 24th of September 2007 and the second dose late on the 5th of December 2007 at 9.25am into his left deltoid. The nurse reported that 30 seconds later the patient had a vasovagal reaction and lay down. The patient''s blood pressure was 52/32 however his breathing wasn''t laboured and there was no change apart from pallor. The patient then came around. At 9.30am the patient''s blood pressure was 102/40, at 9.35am 118/74 and 109/70 at 9.45am. The patient then stayed at the surgery for a further 30 minutes. The patient had stopped citalopram 3 weeks prior to receiving the vaccine and had also been feeling dizzy in the last few weeks.

VAERS ID:307052 (history)  Vaccinated:2007-07-05
Age:16.0  Onset:2007-09-26, Days after vaccination: 83
Gender:Female  Submitted:2008-03-13, Days after onset: 169
Location:Foreign  Entered:2008-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01182
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1466F1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: No reaction on previous exposure to drug, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a pediatrician concerning a 16 year old female who on 02-MAY-2007 was vaccinated with a first dose of Gardasil (lot# 1341F; batch # NF12410) and was well tolerated. On 05-JUL-2007 the patient was vaccinated with a second dose of Gardasil (lot# 1466F; batch # NF 15720) IM into the upper arm. On 26-SEP-2007 the patient experienced tremor of right hand. The symptoms were ongoing at the time of reporting. On 09-NOV-2007 the patient was vaccinated with the third dose of Gardasil (lot# 0251U; batch # NF56480). No further information is available. The reporter felt that tremor of hand was an other medical event (OME). The other business partners included are: E2008-02049.

VAERS ID:308669 (history)  Vaccinated:2007-07-05
Age:17.0  Onset:2007-07-06, Days after vaccination: 1
Gender:Female  Submitted:2008-03-31, Days after onset: 269
Location:Foreign  Entered:2008-04-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Adenoidectomy; Cystoscopy
Diagnostic Lab Data: magnetic resonance imaging, 06?Jul07, synovitis with extensive inflammatory process; serum ANA, 07Sep07, 1:160, <1:8; serum cyclic citrulline peptide IgG Ab, 07Sep07, without pathologies; serum rheumatoid factor, 07Sep07, without pathologie
CDC Split Type: WAES0803USA04475
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1339F0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody increased, HLA marker study, Inflammation, Joint swelling, Juvenile arthritis, Knee operation, Nuclear magnetic resonance imaging abnormal, Rheumatoid factor negative, Synovectomy, Synovitis
SMQs:, Systemic lupus erythematosus (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a health authority concerning a 17 year old female patient with a surgical history of adenotomie (1995) and cystoscopy (1998), who on 05-JUL-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot# 1339F) (Batch # NF23310). On 06-JUL-2007 the patient developed swelling of right knee joint after physical exercise. An MRI (date not reported) was performed and a synovitis with extensive inflammatory processes was diagnosed. A therapy with antiphlogistics and orthopedic treatments were not successful. Diagnostic laboratory studies performed on 07-SEP-2007 included serology of rheumatoid factor, HLA-B 27 and anti-CCP antibodies were without pathologies. Anti- nuclear antibodies were 1:160 (normal range <1:8). On 16-JAN-2008 the patient had a knee joint operation with partial synovectomy and a resection of a particle in patella floating bearing was performed. On 30-JAN-2008 an examination during ambulant consultation showed an ongoing swelling of the right knee joint, all other joints were without pathologies. The diagnosis of juvenile chronic polyarthritis (oligoarticular) was established. A treatment of sulfasalazine, cryo- and physical therapy occurred. At the time of this report the patient''s symptoms were still ongoing. Synovitis, synovectomy and juvenile chronic polyarthritis were considered to be other important medical events. Other business partner numbers include: PEI2008002374 and E200802606. No further information is available.

VAERS ID:324290 (history)  Vaccinated:2007-07-05
Age:0.2  Onset:2007-07-05, Days after vaccination: 0
Gender:Male  Submitted:2008-09-04, Days after onset: 427
Location:Foreign  Entered:2008-09-05, 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: WAES0808USA05478
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Psychomotor retardation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 2 month old male who, on 05-JUL-2007, was vaccinated with ROTATEQ, oral route (lot number not reported). It was reported that, on the same day (05-JUL-2007), the patient presented with psychomotor retardation and pyrexia. The pyrexia lasted for 9 days; the patient recovered on 13-JUL-2007. The outcome of the psychomotor retardation is unknown. This case is considered to be medically relevant by the reporter. No further information available. The case is closed. Other business partner numbers included: E2008-08045.

VAERS ID:402268 (history)  Vaccinated:2007-07-05
Age:0.5  Onset:2007-07-22, Days after vaccination: 17
Gender:Female  Submitted:2010-10-06, Days after onset: 1172
Location:Foreign  Entered:2010-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 23 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Past vaccination included the first dose of PREVENAR. The patient was the first child of a 34-year-old father and a 31-year-old mother. The patient''s birth and the pregnancy were without any complications. The routine examinations were without any findings until the event onset date. No family medical history of neurological, neuro-metabolic or neurodegenerative disorders.
Diagnostic Lab Data: Blood smear test (results: no acanthocytes) was done in Aug-2007. On 14-Aug-2007 test results were: body height (results: 73 cm); weight (results: 7500 g); head circumference (results: 43 cm); urine analysis (results: neuro-metabolic urine screening: normal pattern for amino acids; purine and pyrimidine without any findings; succinat increased with 287 mmol/mol, increased creatinine, 3-hydroxybutyrate and acetoacetate); blood pressure (results: 76/42 mmHg); electroencephalogram (results: no foci of deceleration during the whole examination, no difference in sides, no epileptic-like potentials, normal sleep-EEG for the patient''s age to stage 3, no photosensitivity, no isolated kickback); electrocardiogram (results: normal sinus rhythm with 1
CDC Split Type: DEWYEG06734610
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH256801IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acoustic stimulation tests normal, Anion gap increased, Aspartate aminotransferase normal, Athetosis, Basal ganglion degeneration, Base excess decreased, Blood alkaline phosphatase increased, Blood alkaline phosphatase normal, Blood bicarbonate decreased, Blood creatine normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine decreased, Blood glucose normal, Blood immunoglobulin A increased, Blood immunoglobulin G decreased, Blood immunoglobulin G normal, Blood insulin decreased, Blood ketone body increased, Blood lactate dehydrogenase normal, Blood lactic acid increased, Blood pH normal, Blood smear test normal, Body temperature normal, CSF cell count normal, CSF lactate normal, CSF test normal, Chorea, Choreoathetosis, Developmental delay, Dyskinesia, Eating disorder, Echocardiogram normal, Electrocardiogram abnormal, Electroencephalogram normal, Exaggerated startle response, Haematocrit decreased, Haemoglobin normal, Hypotonia, Insulin C-peptide decreased, Motor dysfunction, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, PCO2 decreased, Platelet count decreased, Posture abnormal, Respiratory rate increased, Restlessness, Rhinitis, Rotavirus test negative, Speech disorder, Stool analysis normal, Tympanic membrane hyperaemia, Ultrasound scan normal, Urine analysis abnormal, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information regarding PREVENAR 7 was received from a healthcare professional via a regulatory authority (PEI) regarding a 7-month-old female patient who experienced developmental disturbance, motoric mouth developmental disorder, basal ganglion degeneration, hypotonia, athetosis, eating disorder, chorea, expressive speech disorder, choreoathetosis and expedited breathing. The patient received the second dose on 05-Jul-2007. Prior to the second vaccination with PREVENAR on 05-Jul-2007 the patient did not suffer from an infection or fever. On approximately 22-Jul-2007 the patient experienced increasing loss of motoric skills. Initially the patient was not able to "hold her head" and the abdominal position was not favoured as before. The patient did not play with her feet as before and the patient was not able to change the position from supine position to abdominal position by her own. The patient was more restless and startled more easily. The patient fixed, tracked, smiled and listened. During traction the patient''s head tilted backwards. The patient was hospitalized on 14-Aug-2007 and at hospital athetosis was diagnosed. The clinician watched videos and photos and recognized at the patient suffered from choreoathetoid movements for several months but the symptoms impaired. During hospitalization the patient''s weight did not rise and hypocaloric nutrition was diagnosed. The nutrition was changed and the patient''s weight increased. In addition physiotherapy was started. On 30-Aug-2007 the patient was discharged from hospital. On 17-Oct-2007 the patient was again hospitalized and it was reported that the patient''s condition improved under physiotherapy. The patient was able to move from supine to abdominal position by her own and vice versa. The patient opened her hand actively and practised the sitting position. The patient''s parents recognised an expedited breathing during the fasting time which resolved within several weeks as well as mouth motoric problems. At hospital chorea with unclear genesis was diagnosed. On 19-Oct-2007 the patient was discharged from hospital. On 23-Sep-2008 the patient was again hospitalized. The patient''s condition still improved but the patient still suffered from choreoathetoid movement pattern and she was not able to "sit free". The patient still suffered from hypotonia and she still moved involuntary. Initially mitochondriopathy was suspected but at hospital the diagnosis was not confirmed. Chorea, developmental disorder of mouth motoric, expressive speech disorder and choreoathetosis with unclear genesis were diagnosed. On 25-Sep-2008 the patient was discharged from hospital and in approximately May-2009 the patient was able to speak understandable single words and the patient''s prehensile behavior improved but the patient still suffered from nutritional disorder in form of vomiting one hour after eating. In Aug-2010 it was reported that the patient still suffered from hypotonia, choreoathetosis, degeneration of basal ganglion and developmental disturbance. Ketolysis disorder, peroxisomal disorder, mitochondrial fatty acid oxidation, cerebral organic acidemias, neurotransmitter defects, autoimmune disease, infection of mycoplasma and neurologic viruses were excluded. The outcome was reported as not recovered and resulting in persistent damage. This case is being treated according to the IFSG (Protection against Infection Act).

VAERS ID:284017 (history)  Vaccinated:2007-07-06
Age:12.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-06, Days after onset: 0
Location:Illinois  Entered:2007-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0211U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Within one minute of receiving HPV vaccine, pt. had a sycopal episode, with LOC for 1-2 minutes, immediately followed by vomiting. Pt. observed for 15 min. and made complete recovery.

VAERS ID:284111 (history)  Vaccinated:2007-07-06
Age:10.0  Onset:2007-07-08, Days after vaccination: 2
Gender:Female  Submitted:2007-07-09, Days after onset: 1
Location:Oklahoma  Entered:2007-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDRERALL
Current Illness:
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0518U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site rash, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: RASH ALL OVER BODY AND ALSO A SITE OF VACCINE

VAERS ID:284126 (history)  Vaccinated:2007-07-06
Age:0.2  Onset:2007-07-06, Days after vaccination: 0
Gender:Male  Submitted:2007-07-09, Days after onset: 3
Location:Washington  Entered:2007-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Newborn Acne
Preexisting Conditions: Mild neonatal jaundice
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2605AA0 RL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0758F1 RL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF104AA0 RL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ03060 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845C0 LL
Administered by: Other     Purchased by: Unknown
Symptoms: Skin discolouration
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: Baby''s mother stated patient/baby had purple discoloration of feet and face ---$g forehead - for 10 minutes. It happened about 4 hours after the vaccinations. No breathing or feeling difficulty or seizure activity noted. 1 Hour after the episode patient was seen in our office. Vital signs stable. Pulse Ox - 97%. He was clinically stable. He was then evaluated at ER.

VAERS ID:284233 (history)  Vaccinated:2007-07-06
Age:16.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-10, Days after onset: 3
Location:Michigan  Entered:2007-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to Ceclor Diagnosed with Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2233CA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0611U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Local reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large local reaction. 1 x 4 cm welt 5 x 7 cm redness at injetion site. Required additional doctor office visit. Treated with Benadryl as an allergic reaction

VAERS ID:284236 (history)  Vaccinated:2007-07-06
Age:29.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-10, Days after onset: 4
Location:Oklahoma  Entered:2007-07-10
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 (DAPTACEL)SANOFI PASTEURC2690AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Breast pain, Injection site bruising, Injection site erythema, Injection site nodule, Musculoskeletal pain, Nausea, Pain in extremity, Wrong drug administered
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)
Write-up: Left arm hurt immediately after vaccination. Later in day, soreness from elbow to top of Lft shoulder, under arm and side of Lft breast. Redness, bruise and knot @ injection site, "Feels like a ball in my armpit". Unable lay on left side or pick up her son. Nausea today.

VAERS ID:284238 (history)  Vaccinated:2007-07-06
Age:70.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-10, Days after onset: 4
Location:Michigan  Entered:2007-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Swollen, inflammed Rt Leg
Preexisting Conditions: HTN,DM 11,Pancreatitis, HLD
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD-165 IDLA
Administered by: Private     Purchased by: Private
Symptoms: Wrong technique in drug usage process
SMQs:, Medication errors (narrow)
Write-up: Td 0.1 ml given intradermally into left forearm --no reaction noted, arm rechecked 07/09/2007-no reaction noted , pt notified

VAERS ID:284277 (history)  Vaccinated:2007-07-06
Age:1.3  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-10, Days after onset: 3
Location:Iowa  Entered:2007-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC148018AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0148F0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0964F0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient has developed fine rash since receiving immunizations on 7/6/07. Fever (low grade) x 1 days.

VAERS ID:284383 (history)  Vaccinated:2007-07-06
Age:8.0  Onset:2007-07-09, Days after vaccination: 3
Gender:Female  Submitted:2007-07-11, Days after onset: 2
Location:Texas  Entered:2007-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB172BA1IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0175U1SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Cellulitis - warm, redness, swelling left posterior thigh Tx with 2 gram Rocephin IM injection and Clindamycin 75/5 15 ml TID x 10 days.

VAERS ID:284456 (history)  Vaccinated:2007-07-06
Age:1.1  Onset:2007-07-08, Days after vaccination: 2
Gender:Female  Submitted:2007-07-12, Days after onset: 4
Location:Rhode Island  Entered:2007-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Seizure~DTaP + HepB + IPV (Pediarix)~1~0~In Patient
Other Medications: AXID, KEPPRA, VITAMIN B6, NITROFURONTIN
Current Illness: None
Preexisting Conditions: Epilepsy, Vesico-ureteral reflux grade 2, GERD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0454U0SC 
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Convulsion, Viral pharyngitis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 2 Days after getting Varivax. Patient had first a brief seizure (20 seconds) and then a longer seizure (20 minutes). Was evaluated in ER - had temp 101 and viral pharyngitis.

VAERS ID:284632 (history)  Vaccinated:2007-07-06
Age:47.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-12, Days after onset: 5
Location:Montana  Entered:2007-07-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None stated
Preexisting Conditions: None stated
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB08AB0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Mother and daughter, both had Twinrix# 1 on 7/6/07. Next day, both had headache, nausea, diarrhea, achy muscles, slightly better by 7/10 but still achy with headache.

VAERS ID:284633 (history)  Vaccinated:2007-07-06
Age:21.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-12, Days after onset: 5
Location:Montana  Entered:2007-07-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None stated
Preexisting Conditions: None stated
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB0BAAB0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Diarrhoea, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Phone call 7/10/07 from patient''s mother - she and patient both had Twinrix #1 on 7/6/07. Next day both had headache, nausea, diarrhea, and achy muscles, slightly better by 7/10. (7/10/07 slightly better but still achy with headache).

VAERS ID:284721 (history)  Vaccinated:2007-07-06
Age:4.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-06, Days after onset: 0
Location:California  Entered:2007-07-16, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURAVBC2554AA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAVPSP200183SCLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.MSD0161U1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Small hive developed below area of injection of Proquad in about 5 min after injection. Benadryl given no respir sx in voice or swallowing lungs clear

VAERS ID:284747 (history)  Vaccinated:2007-07-06
Age:4.0  Onset:2007-07-13, Days after vaccination: 7
Gender:Female  Submitted:2007-07-16, Days after onset: 3
Location:Nevada  Entered:2007-07-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: Kinzie appears to have Chicken Pox. She is not running a fever or anything like that, just the sores on her arms, legs and torso. Not sure if she should go to the doctor or not, have called the advice nurse. Expect that calomine lotion and TLC will do best. Absence of fever indicates this is not too severe.

VAERS ID:284875 (history)  Vaccinated:2007-07-06
Age:17.0  Onset:2007-07-08, Days after vaccination: 2
Gender:Female  Submitted:2007-07-09, Days after onset: 1
Location:Pennsylvania  Entered:2007-07-17, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yas BCP
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Documented (-) antibody prior to vaccine
CDC Split Type:
Vaccination
Manufacturer
Lot
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Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1043F0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Antibody test negative, Erythema, Induration, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: erythema, edema, induration

VAERS ID:284947 (history)  Vaccinated:2007-07-06
Age:1.0  Onset:2007-07-09, Days after vaccination: 3
Gender:Male  Submitted:2007-07-17, Days after onset: 8
Location:Missouri  Entered:2007-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cefzil
Current Illness: Otitis Media in left ear
Preexisting Conditions: 8/27/07-records received-PMH:multiple otitis medias last one diagnosesd 6/26/07, hospitalized for croup and penumonia. -
Diagnostic Lab Data: CSF culture negative, blood culture negative, Enteroviral culture pending 8/27/07-records received-Lumbar puncture and blood culture done at outside hospital were negative. Viral culture respiratory:no virus isolated
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0542U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB26510K0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, CSF culture negative, Culture, Culture negative, Diarrhoea, Lethargy, Otitis media, Petechiae, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Petechial Rash and Fever. Given Ceftriaxone for possible meningococemia. 8/27/07-records received for DOS 7/15-7/17/07-DC DX: Petechial rash possible secondary to MMR vaccination reaction. presents with 5 day history of rash, fever, bilateral otitis media, diarrhea, lethargic on day of admission and temperature of 103.5. Patient had been chewing on hands more often.

VAERS ID:284970 (history)  Vaccinated:2007-07-06
Age:14.0  Onset:2007-07-16, Days after vaccination: 10
Gender:Female  Submitted:2007-07-17, Days after onset: 1
Location:California  Entered:2007-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC Herpes H2 Mono Aso Chem Sed Rate
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427E1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema multiforme, Full blood count, Haematocrit, Haemoglobin, Herpes simplex serology, Laboratory test, Mononucleosis heterophile test, Red blood cell sedimentation rate
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythema Multiforme 12 days post Gardasil vaccine. Eruptions started on 10 day post vaccine

VAERS ID:285173 (history)  Vaccinated:2007-07-06
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2007-07-09
Location:Illinois  Entered:2007-07-19, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: local~Varicella (Varivax)~1~2~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: drug allergy; RAD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
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Dose
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Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011BA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0455U1UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Local reaction, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: local reaction-4 cm swelling, redness, tenderness

VAERS ID:285203 (history)  Vaccinated:2007-07-06
Age:22.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-09, Days after onset: 2
Location:Michigan  Entered:2007-07-19, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Orthotricyclen, Zyrtec, Cortef
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2234AA0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local (faint) redness and induration 6.5 cm x 8cm. 4 days post vaccination.

VAERS ID:285219 (history)  Vaccinated:2007-07-06
Age:1.1  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-13, Days after onset: 7
Location:California  Entered:2007-07-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0100U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB0866D3IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness to left anterior thigh, measures 10.0 L x 7.5 W, warm to touch. No open areas. No blisters present. No discomfort upon assessment.

VAERS ID:285968 (history)  Vaccinated:2007-07-06
Age:25.0  Onset:2007-07-18, Days after vaccination: 12
Gender:Male  Submitted:2007-07-23, Days after onset: 5
Location:Alaska  Entered:2007-07-25, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
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SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760 LA
Administered by: Military     Purchased by: Military
Symptoms: Rash erythematous, Rash papular, Rash pustular, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received smallpox vaccination 7/06/07. 7/18/07 noted lesions on chest arms and back. 7/18-15 papules/pustules noted by Dr. (chest/back) 7/19 "small erythematous lesions <1cm in size, "Rt and left shoulder/chest. Felt well, educated by provider

VAERS ID:286021 (history)  Vaccinated:2007-07-06
Age:21.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-19, Days after onset: 12
Location:Arizona  Entered:2007-07-26, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB139AA1  
HPV4: HPV (GARDASIL)MERCK & CO. INC.0363U1  
Administered by: Military     Purchased by: Military
Symptoms: Cell death, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe shoulder pain lasting 2 weeks after shot. Doctor believes it may be cell death.

VAERS ID:286202 (history)  Vaccinated:2007-07-06
Age:1.3  Onset:2007-07-14, Days after vaccination: 8
Gender:Male  Submitted:2007-07-17, Days after onset: 3
Location:Arizona  Entered:2007-07-30, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin - 7-14 or 7-15.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: In E.R., CBC and BMP were normal.
CDC Split Type:
Vaccination
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HIBV: HIB (ACTHIB)SANOFI PASTEURUF101AB3 RL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0159U0 LL
Administered by: Private     Purchased by: Private
Symptoms: Febrile convulsion, Full blood count, Metabolic function test normal, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had mild fever 7-14-07. Not aware of fever on 7-15. Had seizure 7-15. Went to hospital ER diagnosed with "febrile seizure". Had normal C.B.C. and B.M.O. On 7-17, came to my office for follow up. Rash first noted then. Macular or flat spots especially on trunk, less on neck and extremities.

VAERS ID:286228 (history)  Vaccinated:2007-07-06
Age:32.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-30, Days after onset: 23
Location:New York  Entered:2007-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB412AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient developed itchy rash within 24 hours of receiving vaccine. Rash stared on arms and spread to face and stomach. No fever or other clinical symptoms

VAERS ID:286781 (history)  Vaccinated:2007-07-06
Age:0.2  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-08-03, Days after onset: 28
Location:New York  Entered:2007-08-03
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:
Diagnostic Lab Data: stool culture (-), Wright stain (+), guiaic (+)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B096CA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF921AA0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0237U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Culture stool negative, Flatulence, Melaena, Mucous stools, Occult blood positive, Screaming
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (broad)
Write-up: 7/6/07 3-4 hr after Rotateq developed "blood and curdling" screams and abdominal gas and farting. Dev. melena 7/30 with mucus -$g resolved after 24-48 hr.

VAERS ID:286773 (history)  Vaccinated:2007-07-06
Age:1.9  Onset:2007-07-19, Days after vaccination: 13
Gender:Female  Submitted:2007-08-05, Days after onset: 17
Location:California  Entered:2007-08-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Not recovered yet. Skin culture came back normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Culture negative, Pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: approxamately 2 weeks after a small rash appeard on her rear inner thigh. This rash didn''t look like much so I tried to self treat. By the end of the week it covered her whole thigh and dots were appearing on the fronts of her legs and elbows. Now it has been 2 weeks. she went to urgent care because it did not seem to be getting better. a culture showed nothing. 2days after that we went to the doctor again it was still getting worse the dots on her thighs had completely merged together and it was very itchy. Doctor saif looked Viral and said it would keep spreading until it went away. Now it seems that it isn''t getting any bigger but has yet to start going away. We put Dermoplast on it to keep the itching down and that seems to be working for pain.

VAERS ID:287116 (history)  Vaccinated:2007-07-06
Age:0.3  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-08-02, Days after onset: 27
Location:New Jersey  Entered:2007-08-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B092AA1UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF119AA1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845H1UNRL
Administered by: Private     Purchased by: Private
Symptoms: Flushing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt had flushing of leg where Prevnar and Hib were given. Within 5 mins there was a flat non pruritic lacey flush of about 5cm area. Within 15 min everything gone. Your officials called next day and left message and no one responded. Is this a known or serious reaction

VAERS ID:287304 (history)  Vaccinated:2007-07-06
Age:1.0  Onset:2007-08-01, Days after vaccination: 26
Gender:Male  Submitted:2007-08-02, Days after onset: 1
Location:New York  Entered:2007-08-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH82651083IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0370U0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pox-30 lesions

VAERS ID:288173 (history)  Vaccinated:2007-07-06
Age:21.0  Onset:2007-07-11, Days after vaccination: 5
Gender:Female  Submitted:2007-08-15, Days after onset: 35
Location:Tennessee  Entered:2007-08-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: 1. recently completed course of keflex for parotitis (Mumps IgM titers were negative, amitriptyline 25 mg QHS (IBS symptoms), seasonale (OCP)
Current Illness: had already recovered from episode of parotitis
Preexisting Conditions: history of idiopathic chronic urticaria 8/16/07- PMH: 1st episode of urticaria at 18months of age and several subsequent episodes but less frequent. Mild hives 2003. Chronic sinus infections. Frequent pharyngitis and has had up to 4 rounds of antibiotics per year. Parotitis times 2 this summer with negative mumps, IgM titers and poisitve IgG titers. Usually her episodes of angioe
Diagnostic Lab Data: Labs from the above hospitalization included CBC (WBC 12.8, hct 39.7, plt 281), BMP (Na 138, K 3.9, Cl 108, HCO3 26, BUN 8, Cr 0.7), LFT''s(essentially normal), ESR 16, and CRP 7.9, and UA (normal). Blood cultures normal x 2. 8/16/07-recor
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioedema, Arthralgia, Blood bicarbonate, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Full blood count, Haematocrit normal, Hypersensitivity, Idiopathic urticaria, Irritable bowel syndrome, Liver function test normal, Pain, Pharyngeal oedema, Pharyngitis, Platelet count normal, Red blood cell sedimentation rate increased, Red blood cell sedimentation rate normal, Serum sickness, Sinusitis, Urine analysis normal, Urticaria, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: developed serum sickness with arthralgias, urticaria, and angioedema of eyes and lips, high CRP during hospitalization (CRP = 7.9). Received Gardasil on 7/6/07, 5 days before her symptoms began. Hospitalization lasted 5 days for refractory pain from arthralgias. Did not have fever. Urticaria were refractory and lasted for several days after her hospitalization. Of potential confouding interest, she had also recently received keflex (finished a few days prior to when her symptoms began) 8/16/07-records received for DOS-8/9/07-clinic visit after hospitalization for uticaria, angioedema and pain secondary to arthralgias. 7/11/07-began having mild arthralgias in hands and feet followed by urticarial rash head to toe and angioedema of her eyes and lips. Sensation of throat swelling. Two days later after steroid treatment admitted to hospital with worsening arthralgias for pain control. Impression chronic idiopathic urticaria with angioedema. 8/22/07records received for DOS 7/13/07-7/17/07-DC DX: Allergic reaction. Episode 3 days ago of urticaria, extreme arthralgias accompanied by angioedema of face lip and tongue. Generalized itching was severe and generalized rash.

VAERS ID:288750 (history)  Vaccinated:2007-07-06
Age:15.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 39
Location:Pennsylvania  Entered:2007-08-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRILOSEC
Current Illness: Irritable bowel syndrome
Preexisting Conditions:
Diagnostic Lab Data: blood pressure 07/06/07 100/60; blood pressure 07/06/07 90/65
CDC Split Type: WAES0707USA01028
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 15 year old female with irritable bowel syndrome and with no history of drug reactions/allergies, who on 06-JUL-2007 was vaccinated with the first dose of Gardasil (0.5 ml). Concomitant vaccination on 06-JUL-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and MENACTRA. Other concomitant therapy included PRILOSEC. It was reported that within a few minutes the patient experienced sharp abdominal pain, and her blood pressure dropped from 100/60 to 90/65 and she felt faint. The patient remained in the office and lied down. It was reported that she felt better. Additional information has been requested.

VAERS ID:288875 (history)  Vaccinated:2007-07-06
Age:20.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 39
Location:Unknown  Entered:2007-08-16, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA01392
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Presyncope, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 20 year old female with allergy to pencillin, amoxicillin and sulfa, who on 08-MAY-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included unspecified "birth control" therapy. On 06-JUL-2007 the patient was vaccinated intramuscularly with a second dose of GARDASIL. "Almost immediately post vaccination the patient experienced extreme nausea, dizziness, and vomiting. Physician reported that the patient almost fainted twice. The patient was retained in the physician''s office for about three hours until the symptoms subsided. There was no product quality complaint. Additional information has been requested.

VAERS ID:289781 (history)  Vaccinated:2007-07-06
Age:  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 39
Location:Unknown  Entered:2007-08-16, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA04622
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dysgeusia, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a pharmacy technician concerning a female who on 06-JUL-2007 was vaccinated by injection with Gardasil, ("lot unavailable"). On 06-JUL-2007 the patient experienced a metallic taste in mouth, nausea, vomiting and taste remained for a few hours after receiving Gardasil. The patient sought unspecified medical attention. At the time of the report the patient had recovered. No additional information was provided. Additional information has been requested.

VAERS ID:288509 (history)  Vaccinated:2007-07-06
Age:23.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-07-30, Days after onset: 23
Location:Texas  Entered:2007-08-20, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB294AA1 LA
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling at injection site and down same arm. No treatment given by pharmacy.

VAERS ID:289862 (history)  Vaccinated:2007-07-06
Age:1.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Male  Submitted:2007-07-13, Days after onset: 6
Location:Arkansas  Entered:2007-09-05, Days after submission: 54
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec 1/2 tsp po qd
Current Illness: None known
Preexisting Conditions: Seasonal allergies, fluid on brain - dx''d - no procedures yet - only CT Scans
Diagnostic Lab Data: N/A
CDC Split Type: AR0727
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF101AA3IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0183U0SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB8689C3IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.044760SCRA
Administered by: Public     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: No fever. Child woke with "spots" on forehead (R) side and ant. neck and temple on 070707. More spots on 0712/07. Mother took child to doctor on 0712/07. TC from doctors office AM 0713/07 with above info. MD not sure if reaction from vaccines. TC to CDNS. Call mother to fill out VAERS and received more info. Mother state day 071307that spots have not increased. Denies any blisters$g denies any fever. Mother states spots are barely raised.

VAERS ID:290147 (history)  Vaccinated:2007-07-06
Age:59.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-07, Days after onset: 63
Location:Minnesota  Entered:2007-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB409AA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Dry eye, Eye pain, Headache, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccination given at 8:00 a.m. on 7/6/07;symptoms started at 10:30 p.m. 7/6/07.Vomiting, diarrhea, fever, headache and eyes were sore and dry

VAERS ID:290171 (history)  Vaccinated:2007-07-06
Age:71.0  Onset:2007-07-08, Days after vaccination: 2
Gender:Female  Submitted:2007-08-31, Days after onset: 54
Location:Ohio  Entered:2007-09-07, 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: Bactrim
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1704DA UNUN
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling and soreness developed 2-3 days after vaccination intense redness, "heat" and increased swelling began 3rd days thereafter. (see photo attached)

VAERS ID:291018 (history)  Vaccinated:2007-07-06
Age:14.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Male  Submitted:2007-07-16, Days after onset: 9
Location:Indiana  Entered:2007-09-10, Days after submission: 56
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200702529
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2171A0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Musculoskeletal stiffness, Neck pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: A 14-year-old male patient with no known history received a right deltoid intramuscular injection of Menactra (lot number U2171AA) on July 2007. On 07 July 2007 he developed left neck pain and stiffness, and treatment included Tylenol and Motrin. On 11 July 2007 he was evaluated by his physician and prescribed Motrin 600 mg and heat to the left side of the neck. Outcome was unknown.

VAERS ID:290869 (history)  Vaccinated:2007-07-06
Age:90.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-05, Days after onset: 60
Location:New York  Entered:2007-09-19, Days after submission: 14
Life Threatening? No
Died? Yes
   Date died: 2007-07-28
   Days after onset: 21
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synthroid, Metoprolol, Lisinopril, Digitek, Zoloft, Warfarin, B-12 supplement
Current Illness: None
Preexisting Conditions: Hypothyroid, Atrial Fib, CHF, high blood pressure PMH: depression, osteoporosis, mitral regurgitation, dysuria, hyponatremia, anemia, B12 deficiency.
Diagnostic Lab Data: Complete Blood Work, Blood Cultures, on heart monitor, CT scan of Brain (3x), EEG - all normal LABS: EKG revealed a-fib & bradycardia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Anaemia, Asthenia, Atrial fibrillation, Blood culture negative, Blood test normal, Bradycardia, Cardio-respiratory arrest, Computerised tomogram normal, Confusional state, Contusion, Death, Dysphagia, Electrocardiogram abnormal, Electroencephalogram normal, Facial palsy, Fall, Full blood count normal, Gait disturbance, Hypertension, Hypothyroidism, Incontinence, Lethargy, Memory impairment, Mental status changes, Mitral valve incompetence, Somnolence, Speech disorder, Staring, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypothyroidism (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: Shot (vaccine) given 7/6/07. 7/7/07 Somewhat not responding to conversation. 7/8/07 - Very sleepy, hard time answering questions, difficulty getting out of chair - as the next 20 days progressed, she experienced feeling of weakness, some facial droop, swallowing difficulties, unable to answer questions (stare, then a shrug [I don''t know]), confusion, incontinence, walk very slowly, occasional dragging of foot. Just before she died (approx 17 hours earlier), she described some things that she did at rehab. Her descriptions were rather odd - after she said them, she realized they sounded odd and stated she thought she must be going crazy - she knew something wasn''t right. She went from being able bodied, alert, communicative, capable person to unable to do simple personal tasks. An otherwise healthy person does not have a rapid change as this one without a reason. All tests run came back perfectly normal - 3 Cat scans showed nothing wrong. Blood work - that of a 50 year old. No evidence of stroke. Drs - both primary MD and Hospital staff said vaccine couldn''t have done it. Symptoms occurred w/in 24 hours of getting vaccine. 9/25/07 Received medical records & death certificate from pcp which reveals COD as cardio-respiratory arrest with atrial fibrillation, mitral regurgitation, HTN, hypothyroid, anemia as contributing factors. Medical records reveal patient in usual state of health & on Coumadin for a. fib when received zostavax on 7/6/07 but no lot # provided. Returned to pcp on 7/9/07 after a fall 7/8/07 & now w/trouble ambulating & speech & memory were slow. No hx of neuro problems & no current head injury, but w/bruising of right arm. Dx at that time: syncope. Admitted directly to hospital. Returned to pcp on 7/18 for hospital f/u. Receiving home health RN, PT/OT & was doing poorly w/dysphagia, lethargy/sleepiness & incontinence. Readmitted to hospital directly. 10/9/07 Reviewed hospital medical records which reveal patient experienced fall at AL facility, seen in pcp office & direct admitted to hospi

VAERS ID:294959 (history)  Vaccinated:2007-07-06
Age:60.0  Onset:2007-07-17, Days after vaccination: 11
Gender:Female  Submitted:2007-09-24, Days after onset: 69
Location:Virginia  Entered:2007-09-27, 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: Drug hypersensitivity
Preexisting Conditions: Chickenpox; Hives
Diagnostic Lab Data: skin biopsy 07/24/07 scab-inadequate [not a scab, but a tiny piece of "something"; skin biopsy 07/24/07 swab left shin-inadequate; skin biopsy 07/24/07 swab left ankle-negative; skin biopsy 07/24/07 VZV DNA was not amplified. B-globulin DNA was amplified, L ankle only.
CDC Split Type: WAES0707USA03119
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0740U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Beta globulin increased, Biopsy skin abnormal, Herpes zoster, Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician and a nurse practitioner concerning a 60 year old female with a history of childhood chickenpox and hives from DEMEROL who on 06-JUL-2007 was vaccinated SQ in her left arm with Zostavax (Oka/Merck) (lot #657767/0740U). There was no illness at the time of vaccination. Concomitant therapy included FLONASE, ZYRTEC, BENADRYL, vitamins (unspecified) and calcium (unspecified). On 17-JUL-2007 the patient developed a varicella-like rash on both arms and legs, worse at left posterior thigh and ankle. The patient was treated with cortisone cream and a gel for the itching. The patient had not had any recent exposure to chickenpox or shingles. On 24-JUL-2007, a specimen was taken from the lesion which were described as vesicles, papules and scabs (results not provided). At the time of this report, the patient had not recovered. There were no reported adverse events following prior vaccination. The patient was enrolled in the varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck VZV strain. Follow up information was received from a university associate research scientist, who reported the PCR results on the three specimens collected from the patient on 24 JUL 2007. The PCR results, received on 25 JUL 2007 at the lab, included the following: scab-inadequate (not a scab, but a tiny piece of "something"), swab left shin-inadequate, and swab left ankle-negative. VZV DNA was not amplified. B-globulin DNA was amplified, L ankle only. The reporter noted they were still working on CSF. Additional information had been requested. This is in follow-up to report(s) previously submitted on 9/24/2007. Follow up information was received from a medical assistant who reported on an undisclosed date the patient recovered. No further information is expected.

VAERS ID:295296 (history)  Vaccinated:2007-07-06
Age:7.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-24, Days after onset: 80
Location:Missouri  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA01096
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1406F SCUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a healthcare worker concerning a 7-year-old female who on 06-JUL-2007 was vaccinated subcutaneously with "one vial" of Zostavax (Oka/Merck) (lot# 654604/1406F) instead of Varivax. Medical attention was not sought. The outcome was not provided. No product quality complaint was involved. Additional information has been requested.

VAERS ID:295303 (history)  Vaccinated:2007-07-06
Age:85.0  Onset:2007-07-08, Days after vaccination: 2
Gender:Female  Submitted:2007-09-24, Days after onset: 78
Location:Minnesota  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hay fever; Drug hypersensitivity; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA01339
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from an 85 year old female with hay fever and allergies to rofecoxib (MSD) (WAES # 0707USA02086), ibuprofen and penicillin who on 06-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck). There was no concomitant medication. On 08-JUL-2007, the patient experienced redness and itching at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:296049 (history)  Vaccinated:2007-07-06
Age:  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-24, Days after onset: 80
Location:Unknown  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0708USA05569
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure, Eye burns, Eye disorder, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a female, who on 06-JUL-2007 was exposed to ZOSTAVAX. The patient, a caregiver for someone receiving ZOSTAVAX (WAES# 0707USA01060) lifted up the sleeve of the person being vaccinated. When giving the vaccination the tech pulled out the needle and the vaccination "flew" into her eye. She had to go to urgent care. She had a film over her eye for 3 days, she stated that could not see, it burned, and it "doesn''t make tears like it used to". She stated that "this was money out of her pocket" as she is the caregiver and not the patient. She felt that the costs she incurred were not her responsibility and what scared her is that "no one knew anything about side effects because it was supposed to be brand new." No further information is available.

VAERS ID:296754 (history)  Vaccinated:2007-07-06
Age:24.0  Onset:2007-08-06, Days after vaccination: 31
Gender:Female  Submitted:2007-10-08, Days after onset: 63
Location:Michigan  Entered:2007-10-12, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA00785
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a 24 year old female who on approximately 06-AUG-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. There were no concomitant medications. The patient stated that she might be pregnant. She has not been tested, but she is "showing symptom" of pregnancy. The patient reported that if she was pregnant," it happened within the past month". Additional information has been requested.

VAERS ID:299682 (history)  Vaccinated:2007-07-06
Age:18.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 131
Location:Michigan  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown None
Diagnostic Lab Data: Unknown None
CDC Split Type: WAES0710USA05072
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1208F0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning an 18 year old female with no pre-existing medical conditions or drug allergies who on 06-JUL-2007 at 1pm was vaccinated intramuscularly in the right arm with a first dose of GARDASIL (lot# 654741/1208F) and experienced syncope post vaccination. The patient was monitored in the office and fully recovered on 06-JUL-2007, no sequelae. On 25-SEP-2007, the patient was vaccinated (site and route not reported) with the second dose of GARDASIL (lot# not reported) and experienced no adverse event post vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. No additional information is expected.

VAERS ID:300967 (history)  Vaccinated:2007-07-06
Age:44.0  Onset:2007-07-07, Days after vaccination: 1
Gender:Male  Submitted:2007-12-19, Days after onset: 165
Location:New York  Entered:2007-12-26, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild eczema present
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA0  
Administered by: Other     Purchased by: Private
Symptoms: Dermatitis, Rash papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient had small patch of papulosquemous dermatitis in left parascapular area of skin over back. On 7/6/07 had Tdap vaccine and within days, localized dermatitis became wide spread over entire trunk persisting for weeks.

VAERS ID:301688 (history)  Vaccinated:2007-07-06
Age:57.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 168
Location:Ohio  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec; Premarin
Current Illness: Sinusitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: WAES0708USA05715
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0622F0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Burning sensation, Herpes zoster, Inappropriate schedule of drug administration, Incorrect route of drug administration, Pain, Rash pustular, Skin lesion, Stress
SMQs:, Peripheral neuropathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 57 year old female with no pertinent medical history and no known drug reactions/allergies who on 06-JUL-2007 at 10:45 AM was vaccinated IM with a first dose of Zostavax (Oka/Merck) (Lot#652965/0622F). Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and estrogens conjugated (PREMARIN). On 25-AUG-2007 the patient developed shingles. The outbreak was on her abdomen, side and back. She had pain, burning, and lesions in the area. The patient sought unspecified medical attention. As of 30-AUG-2007, the patient''s shingles persisted. Follow up information from the nurse indicated that the patient was seen on 30-AUG-2007 complaining of a rash for 5 days. The doctor observed 1 pustule or lesion on the front of the abdomen. No other lesions were seen. The patient also complained of increased stress. The physician prescribed alprazolam (XANAX), valacyclovir (VALTREX) and cephalexin (KEFLEX). The patient was instructed to follow up if the symptoms persisted. The diagnosis was infected lesion vs. shingles. The prescribed made covered both. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected.

VAERS ID:301254 (history)  Vaccinated:2007-07-06
Age:19.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-24
Location:New York  Entered:2007-12-31, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Per the reporter, the patient may possibly have had Epstein Barr at the time of vaccination.
Preexisting Conditions: History of mitral valve prolapse, "possibly" allergic to iodine.
Diagnostic Lab Data: Testing positive for Epstein-Barr virus. All other tests were negative.
CDC Split Type: 200704400
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Anorexia, Asthenia, Choreoathetosis, Diarrhoea, Dyspnoea, Epstein-Barr virus infection, Epstein-Barr virus test positive, Eye rolling, Insomnia, Lethargy, Loss of consciousness, Muscle twitching, Pharyngolaryngeal pain, Pollakiuria, Retching, Staring, Tachycardia, Tremor, Weight decreased
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), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (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), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".

VAERS ID:312852 (history)  Vaccinated:2007-07-06
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-14
Location:Pennsylvania  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804USA01532
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site induration, Injection site nodule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 13 year old female who on 06-JUL-2007 was vaccinated with the first dose of GARDASIL (lot# not provided). Subsequently the patient developed a firm nodule on her arm close to the injection site about half centimeter in size. Physician saw the nodule yesterday (03-Apr-2008) when patient visited the clinic. It was unknown when the patient developed the firm nodule. Medical attention was sought by visiting the physician. The patient''s outcome was unknown. Additional information has been requested.

VAERS ID:315178 (history)  Vaccinated:2007-07-06
Age:1.5  Onset:2007-07-06, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 315
Location:Ohio  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA01054
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1041F SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 18 month old male with no medical history or allergies who on 06-JUL-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 654525/1041F). Concomitant therapy included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 06-JUL-2007, after vaccination the patient developed redness and a welt like area at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:315183 (history)  Vaccinated:2007-07-06
Age:11.0  Onset:2007-07-08, Days after vaccination: 2
Gender:Male  Submitted:2008-05-16, Days after onset: 313
Location:Massachusetts  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dermatitis contact; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA01326
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528013AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0716U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Dermatitis contact, Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning an 11 year old 75 lb male with a sulfa allergy who on 06-JUL-2007 was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck) (lot.no 657650/0716U) and Menactra in the R arm and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the L deltoid. At the time of the vaccination, the patient had contact dermatitis described as an itchy rash on his trunk and extremities. He was treated with fluocinolone, cool compress, Benadryl, bacitracin and Calamine. On 09-JUL-2007, the patient was seen in follow up of the poison ivy on his face, ear, left finger and arm, R hand, back and under R arm. He also had a 1 1/2 inch circle of induration, redness and some slight tenderness 1 1/2 inches below the varicella injection site of his R arm, which occurred on 08-JUL-2007. The patient''s poison ivy and injection site induration, redness and tenderness persisted (in follow up, the outcome was reported as unknown). He was prescribed oral prednisone for the contact dermatitis but it was discontinued on 12-JUL-2007 due to behavioral side effects. Additional information is not expected.

VAERS ID:315367 (history)  Vaccinated:2007-07-06
Age:5.0  Onset:2007-07-20, Days after vaccination: 14
Gender:Female  Submitted:2008-05-16, Days after onset: 301
Location:Illinois  Entered:2008-05-23, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03739
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0182U1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0674U0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Blister, Pruritus, Scab, Varicella
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 5 year old white female with no pertinent medical history or drug allergies, who on 06-JUL-2007 at 15:10 was vaccinated at 15:10 with the first 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 653306/0674U) in the left thigh. Concomitant vaccination on that day at 15:10 included a second SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot# 656034/0182U) in the right thigh. There was no illness at the time of vaccination. On 20-JUL-2007 at 09:40 (also reported as 23-JUL-2007 at 10:00), the patient developed chicken pox breaking out in 8 to 10 areas characterized as itching, fluid-filled and starting to scab over. No medical attention was sought. No labs were performed. On 26-JUL-2007 the patient recovered. There was no product quality complaint. Follow-up information has been received from a registered nurse who indicated the pox were on the left leg at the injection site around the navel, and on the chest and face. On 01-AUG-2007 the patient recovered. Additional information has been requested.

VAERS ID:319573 (history)  Vaccinated:2007-07-06
Age:74.0  Onset:2008-05-08, Days after vaccination: 307
Gender:Female  Submitted:2008-06-24, Days after onset: 47
Location:Ohio  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin; ALLEGRA; FLONASE. METROGEL; minocycline
Current Illness:
Preexisting Conditions: Chickenpox
Diagnostic Lab Data: body temp 98.3
CDC Split Type: WAES0805USA02336
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0585U UNLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Body temperature, Chest pain, Herpes zoster, Pain
SMQs:, Severe cutaneous adverse reactions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Information has been received from a certified medical assistant concerning an approximately 75 year old female consumer who on 06-JUL-2007 was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and METROGEL. It was reported that in April 2008, the patient felt a shocking and burning pain under her left breast. The pain continued and developed into shingles lesions within two weeks. Unspecified medical attention was sought and it was unspecified if lab studies were performed. The patient was treated with NEURONTIN. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from the physician concerning this 75 year old female consumer with no known allergies and a history of chickenpox years ago who on 06-JUL-2007 was vaccinated in the left arm with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 657765/0585U). Concomitant therapy included ALLEGRA, aspirin, FLONASE, and minocycline. Subsequently, on 08-MAY-2008 the patient developed left sided chest pain and clusters of vesicles on the left side of her chest and back. The patient did not developed a rash at the site of injection or elsewhere within 42 days of vaccination. The patient''s temperature was 98.3. It was noted that there was no recent exposure to chickenpox or herpes zoster. The physician also reported that the patient''s treatment was changed from NEURONTIN to LYRICA. The patient recovered on an unspecified date. Additional information is not expected.

VAERS ID:322521 (history)  Vaccinated:2007-07-06
Age:13.0  Onset:0000-00-00
Gender:Unknown  Submitted:2008-07-30
Location:Virginia  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA04356
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: Initial and follow-up information has been received from a physician concerning a 13 year old female with multiple medical problems who on 06-JUL-2007 was vaccinated with PNEUMOVAX (lot # unknown) injection. On an unspecified date the patient developed cellulitis after the vaccine. The physician reported that the patient experienced symptoms 48 hours after the injection was given. Medical attention was sought. No further information was provided. At the time of reporting the patient had recovered. Follow-up information was received from the physician and stated that this is not a case of cellulitis. Additional information is not expected. This is one of two reports from the same source.

VAERS ID:325361 (history)  Vaccinated:2007-07-06
Age:6.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-24, Days after onset: 18
Location:Iowa  Entered:2008-09-17, Days after submission: 421
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: allergic rhinitis
Diagnostic Lab Data: CBC with diff (7/10/07): 173 plts; 5.2 WBC; Throat cx (-) 7/18/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0720U1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Cold compress therapy, Culture throat negative, Full blood count, Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction, Platelet count normal, Rash maculo-papular, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received vaccine 7/6/07- (R) thigh. Over subsequent 72 hr developed increasing redness, tenderness, warmth at injection site. Return of office visit 7/9/07. Site indurated, red and warm but without drainage. Impression-local tissue reaction without infection sent home on BENADRYL, cold compress. Return 7/18/07 with maculopapular rash over torso ext. vaccine site bruised, indurated.

VAERS ID:331437 (history)  Vaccinated:2007-07-06
Age:1.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Male  Submitted:2008-11-05, Days after onset: 488
Location:Georgia  Entered:2008-11-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: 07/07/2008 Urinary Porphyrins diagnosed remarkable mercury toxin effects on bodily physiology. 07/08/2008 Red Blood Cell Elements diagnosed potassium low, zinc low, selenium low, and lead high. 07/16/2008 Organic O.A.T. Test diagnosed elevated yeast/fungal metabolites.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS129AA0IMUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0406F2IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08691B3IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autism spectrum disorder, Blood lead increased, Blood potassium decreased, Blood selenium decreased, Blood zinc decreased, Communication disorder, Fungal infection, Pyrexia, Red blood cell abnormality, Regressive behaviour, Social avoidant behaviour, Unresponsive to stimuli, Urine mercury abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Ran a fever of 103 degrees for two days after the shot was administered, he was given childrens tylenol as directed by physician before and after the shot was given. After the shot was administered he lost communication skills (stopped talking), lost eye contact, withdrew from social contact and interactions with others (adults and children), did not respond to verbal prompts and commands. This occurred from the time the shot was given until present. He was diagnosed with Regressive Autisism Spectrum Disorder on April 4, 2008. On April 6, 2008 he began the g.f.c.f. diet. On June 25, 2008 we (his parents) took oatient to a D.A.N. doctor and the doctor did blood tests and urine tests. The results showed a high mercury and lead content. He is on supplements and vitamins to clean the toxins from his system along with other medications. 12/12/08-routine office visit records received-1/30-2/28/08-speech delay, C/O acting as if can not hear, not following directions. Fever 12/28/07. 1/29/2010 Autism.

VAERS ID:284705 (history)  Vaccinated:2007-07-06
Age:17.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-13, Days after onset: 7
Location:Foreign  Entered:2007-07-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Revaxis, Rudivax
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA01357
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug administration error, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 17 year old female who on 06-JUL-2007 was to receive a dose of MMR II. It was reported that the patient was late in her vaccination schedule and had received a booster dose of Revaxis in July 2007. The patient had also received a dose of Rudivax on an unreported date. On 06-JUL-2007 the physician only administered the solvent by error. Approximately 10 minutes later, the patient experienced a vasovagal syncope with a blood pressure at "6". There was no fall nor loss of consciousness. A few minutes later, her blood pressure was back to "10", which was her usual blood pressure. At the time of report the patient had recovered. The patient''s experience was considered to be an other important medical event by the reporter. Other business partners numbers include E2007-04390. No further information is available.

VAERS ID:286186 (history)  Vaccinated:2007-07-06
Age:25.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-07-27, Days after onset: 21
Location:Foreign  Entered:2007-07-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Electrocardiogram 06Jul07 Comment: Bradycardia
CDC Split Type: WAES707POL00019
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Convulsion, Electrocardiogram abnormal, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 25 year old female who on 06-JUL-2007 was vaccinated with Gardasil. On 06-JUL-2007 after administration of whole dose of Gardasil the patient experienced loss of consciousness, bradycardia and convulsion. Lost of consciousness and convulsion lasted several seconds. Bradycardia lasted about half an hour. Electrocardiogram performed on 06-JUL-2007 showed bradycardia. The reporter marked life threatening as unknown for lost of consciousness. Therapy with human papillomavirus vaccine was discontinued (the reporter decided not to administer in the future the second and the third dose of Gardasil). The patient recovered from loss of consciousness, bradycardia and convulsion. The reporter felt that loss of consciousness, bradycardia and convulsion were related to therapy with Gardasil. Upon internal review, convulsion was considered to be an other important medical event. Additional information is not expected.

VAERS ID:291176 (history)  Vaccinated:2007-07-06
Age:17.0  Onset:2007-07-11, Days after vaccination: 5
Gender:Male  Submitted:2007-09-24, Days after onset: 75
Location:Foreign  Entered:2007-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: FACIAL PARESIS
Diagnostic Lab Data: UNK
CDC Split Type: D0054627A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRL
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Dysgeusia, Facial paresis, Hypoaesthesia oral, Lumbar puncture normal
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a regulatory authority # DE-PEI-PEI2007007863) and described the occurrence of relapsing facial paresis in a 17-year-old male subject who was vaccinated with Engerix B adult, GlaxoSmithKline and Havrix 1440, GlaxoSmithKline. The subject''s medical history included facial paresis left-sided in approximately 1990 after vaccination with unspecified polio vaccine. The subject''s medical history included again facial paresis left-sided in approximately 2000 temporally associated after occurrence of Herpes zoster. Cranial computerized tomography and lumbar puncture were without pathologic findings. Both events were reversible. The subject had no adverse event following receipt of prior immunisation with Engerix B adult and Havrix 1440. On 06 July 2007 the subject received unspecified dose of Engerix B adult (intramuscular, unknown site of injection) and unspecified dose of Havrix 1440 (intramuscular, unknown site of injection). On 11 July 2007, 5 days after vaccination with Engerix B adult and Havrix 1440, the subject experienced left-sided numbness of tongue, parageusia and facial paresis. On 12 July 2007 at an ambulatory examination, paresis of peripheral seventh nerve left side of face including parageusia was diagnosed. Other neurological examinations were normal. An idiopathic facial paresis left-sided was suspected. This case was assessed as medically serious by GSK. The subject was treated with prednisolone (Decortin H), which was slowly discontinued (-20mg/d), and pantoprazole (Pantozol). If required the subject was treated with eye dressing using spherical calotte of Perspex. The subject maintained physiotherapy. Laboratory value of glucose and potassium was controlled ambulatory. On 30 July 2007 facial paresis was clearly improved, but not completely restored. At the time of reporting the outcome of the other events were unspecified. The reporting physician considered that the events were related to vaccination with Engerix B adult and Havrix 1440.

VAERS ID:291815 (history)  Vaccinated:2007-07-06
Age:16.0  Onset:2007-07-06, Days after vaccination: 0
Gender:Female  Submitted:2007-10-01, Days after onset: 87
Location:Foreign  Entered:2007-10-02, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Rhinitis allergic
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04287
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1466F0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myocarditis, Nausea, Pyrexia, Ventricular extrasystoles
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a hospital pediatrician concerning a 16 year old female with a history of allergic rhinitis who on 06-JUL-2007 was vaccinated IM into the upper arm with a first dose of Gardasil (Lot #1466F and batch #NF15720). The same day the patient experienced fever and complained about nausea and subsequently she recovered. On 31-JUL-07 ventricular extrasystoles were detected. She was admitted to the hospital where myocarditis was diagnosis. She was referred to ICU for 7 days. Treatment was started with magnesium and beta blockers. At the time of this report, her symptoms were ongoing. The hospital pediatrician considered myocarditis to be life-threatening. Other business partner numbers included E2007-06340. Additional information is not available.

VAERS ID:348697 (history)  Vaccinated:2007-07-06
Age:1.1  Onset:0000-00-00
Gender:Male  Submitted:2009-06-08
Location:Foreign  Entered:2009-06-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0575975A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CA730A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal behaviour, Autism, Developmental delay, Disturbance in attention, Disturbance in social behaviour, Faeces hard, Hair metal test abnormal, Malaise, Metal poisoning, Speech disorder, Unresponsive to stimuli, Urine analysis abnormal, Urine arsenic, Urine mercury abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Drug abuse and dependence (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer (subject''s father) and described the occurrence of autism in an18-month-old male subject who was vaccinated with PRIORIX (GlaxoSmithKline), ENGERIX B (GlaxoSmithKline), INFANRIX-IPV/HIB (GlaxoSmithKline), PREVENAR (non-GSK), NEISVAC-C, PENTAVAC (non-GSK), VARIVAX (non-GSK) and MENJUGATE. A physician or other health care professional has not verified this report. On 3 June 2006, the subject received unspecified dose of ENGERIX B (unknown route of administration). On 3 August 2006, the subject received unspecified dose of ENGERIX B (unknown route of administration), unspecified dose of PENTAVAC (unknown route of administration), unspecified dose of MENJUGATE (unknown route of administration) and unspecified dose of PREVENAR (unknown route of administration). On 3 October 2006, the subject received unspecified dose of INFANRIX-IPV/HIB (unknown route of administration) and unspecified dose of PREVENAR (unknown route of administration). On 7 December 2006, the subject received unspecified dose of ENGERIX B (unknown route of administration), unspecified dose of PREVENAR (unknown route of administration), unspecified dose of MENJUGATE (unknown route of administration) and unspecified dose of PENTAVAC (unknown route of administration). On 30 May 2007, the subject received unspecified dose of VARIVAX (unknown route of administration). On 6 July 2007, the subject received unspecified dose of PRIORIX (unknown route of administration). On 4 December 2007, the subject received unspecified dose of PREVENAR (unknown route of administration), unspecified dose of NEISVAC-C (unknown route of administration), and unspecified dose of PENTAVAC (unknown route of administration), On unspecified date, at an unspecified time after vaccination with ENGERIX B, INFANRIX-IPV/HIB, MENJUGATE, VEISVAC-C, PENTAVAC, PREVENAR, PRIORIX and VARIVAX, the subject experienced a generalized developmental disorder due to an intoxication of heavy metals, He experienced hair mercury abnormal, urine mercury abnormal and

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