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Case Details (Sorted by Vaccination Date)

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VAERS ID:290790 (history)  Vaccinated:2007-09-17
Age:70.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2007-09-18, Days after onset: 1
Location:California  Entered:2007-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hypertension
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS792411IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0038U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left deltoid with swelling, redness, hot. Pt c/o pain to site Rx Keflex 500 mg QID x 7 days.

VAERS ID:290901 (history)  Vaccinated:2007-09-17
Age:4.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Female  Submitted:2007-09-19, Days after onset: 1
Location:Florida  Entered:2007-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2765AA IM 
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273 IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0459Y IM 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: SWELLING, HIVES AND REDNESS AT SITE OF INJECTION, EXTENDING TO SHOULDER AND BACK.

VAERS ID:290903 (history)  Vaccinated:2007-09-17
Age:0.2  Onset:2007-09-18, Days after vaccination: 1
Gender:Female  Submitted:2007-09-19, Days after onset: 1
Location:Kansas  Entered:2007-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations: None~ ()~~0~In Patient|None~ ()~~0~In Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC, blood culture, lumbar puncture LABS: WBC 22,000, segs 51% (H), lumphs 36% (H), neutros 13 (H), lymphs 7.9 (H). Alk Phosphatase 363 (H). CSF. Blood, urine & CSF cultures neg.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA0IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0016U0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10090IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB26510F0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0968U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Apparent life threatening event, Blood alkaline phosphatase increased, Blood culture, Blood culture negative, CSF culture negative, Crying, Culture urine negative, Cyanosis, Full blood count, Hypotonia, Infantile apnoeic attack, Leukocytosis, Lumbar puncture, Lymphocyte count increased, Neutrophil count increased, Neutrophil percentage increased, Pyrexia, Respiratory arrest, Resuscitation, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow)
Write-up: ALTE- Mother checked on child while napping, and noted the infant was blue and not breathing. Mother provided CPR and EMS was contacted. Child resumed spontaneous respirations and was crying. Child was admitted to the hospital for monitoring. A fever had been noted on the day of admission with maximum temp 103.6 axillary. A septic workup was initiated due to the fever, despite knowledge of recent vaccinations. 9/25/07 Vax record reviewed which confirms RO dose & lot # as reported. 11/13/07 Reviewed hospital medical records which reveal patient experienced fever, cyanosis, limpness & apnea. Parent initiated CPR & patient responded. Transported by EMS to hospital. Admitted 9/18-9/20/2007. LP done & started IV antibiotics. No further episodes in hospital. D/C to home on apnea monitor. FINAL DX: acute life threatening event w/fever; apnea of newborn; status was cardiorespiratory; anemia, phpysiologic; & leukocytosis.

VAERS ID:290906 (history)  Vaccinated:2007-09-17
Age:28.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-09-19, Days after onset: 1
Location:South Carolina  Entered:2007-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: Stool studies pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1113SC 
Administered by: Military     Purchased by: Military
Symptoms: Diarrhoea, Nausea, Stool analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: ~NEW PATIENT COMPLAINT: diarrhea-- ~ONSET OF SYMPTOMS: approx 7 weeks ~QUALITY SYMPTOMS: Pure water, No blood, normal 3-5x/day, yesterday q30-45 min, none today yet ~MODIFYING FACTORS: No relief with immodium, took atropine pills -left over from ER visit 1 yr ago-some slowing ~TRIGGERS : ? anthrax shot ~SEVERITY: ? improved today ~ASSOC SX: Nausea yesterday-now resolved, Vomited once yesterday also, No abd pain, no fever, no wgt loss, no night sweat. ~MISC HPI: PCS next Tuesday, Got Smallpox, thyphoid , anthrax--7 week ago--developed diarrhea- for 2 week then resolved for few days prior to second anthrax on 8/14- then diarhea x 2 weeks then resolved, then got 3rd anthrax shot on 9/17 and developed diarrhea next day. No recent travel, No sick contacts, No recent abx.

VAERS ID:290916 (history)  Vaccinated:2007-09-17
Age:17.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2007-09-19, Days after onset: 2
Location:Massachusetts  Entered:2007-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic rhinitis, Acne
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2758AA0IMLA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER1061W0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain, Dyspnoea, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Patient experienced throat swelling, difficulty breathing and chest pain on inspiration just after leaving the office where she had received Gardasil and Adacel. Symptoms gradually resolved over 48 hours. She did not pursue any medical treatment until 48hrs later and did not take any medications.

VAERS ID:291354 (history)  Vaccinated:2007-09-17
Age:9.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Female  Submitted:2007-09-21, Days after onset: 3
Location:Ohio  Entered:2007-09-25, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1096U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature, Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9/18/07 Morning after injection noticed redness and swelling, temperature later that day drainage noted from site increase redness and swelling the next day 9-19-07 seen in office 9-19-07 at 16:30p - area of induration and erythema 3'' x 4" - cellulitis - Rx with Keflex. Received Varivax #2 afternoon of 9-17-07 in left arm. Rechecked 9/21/07 decrease Rx.

VAERS ID:291423 (history)  Vaccinated:2007-09-17
Age:4.0  Onset:2007-09-19, Days after vaccination: 2
Gender:Male  Submitted:2007-09-26, Days after onset: 7
Location:Michigan  Entered:2007-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: Yes patient did come back into the office two days later and saw Dr.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2655AA4IMRA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURZ05273IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1031F1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site infection, Injection site scab, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient was given Dtap,Ipv and MMR in his right arm. The Dtap was given first IM in his upper deltoid and the Ipv was given 1 inch below that and the MMR was given sub q in the back fatty part of his right arm. The shots were given on Monday September 17, 2007 and his arm started getting red and swollen on Wednesday and his right arm where the Dtap was given was crusted over with what looked like two open chicken pox bumps that had pus in them and looked like they were infected.

VAERS ID:291429 (history)  Vaccinated:2007-09-17
Age:6.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-09-26, Days after onset: 8
Location:Wisconsin  Entered:2007-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B044AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0451U SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Inflammation, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Day after vaccines patient''s mom complained that child had right arm pain, inflamation, and redness.

VAERS ID:291496 (history)  Vaccinated:2007-09-17
Age:4.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-09-22, Days after onset: 4
Location:Pennsylvania  Entered:2007-09-27, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Abnormal liver function test
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERAC14B056CA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA010923SCLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0774U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Eye rolling, Febrile convulsion, Loss of consciousness, Pyrexia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: He developed fever within 24 hrs after immunization T max 102. Mother started him on Tylenol. He had an episode of shaking of his arm and eyes were rolling lasted for approx 1 minute. Loss of consciousness. He was taken to ED with Dx Febrile seizure

VAERS ID:291506 (history)  Vaccinated:2007-09-17
Age:1.2  Onset:2007-09-20, Days after vaccination: 3
Gender:Male  Submitted:2007-09-28, Days after onset: 8
Location:New York  Entered:2007-09-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B1246AA2IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.2067U2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB36258D2IMRL
Administered by: Private     Purchased by: Private
Symptoms: Induration, Mass, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left thigh minimal tender arm non indurated mass.

VAERS ID:291704 (history)  Vaccinated:2007-09-17
Age:5.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2007-10-01, Days after onset: 14
Location:Colorado  Entered:2007-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: neoral, cellecept, enalapril, aspirin, zithromax
Current Illness: no acute illness
Preexisting Conditions: hypoplastic left heart s/p transplant, polysplenia syndrome, malrotation s/p repair. PMH: Hypoplastic L Heart Syndrome s/p heart transplant & thymectomy (8/02). 2 episodes of rejection. Polysplenia Syndrome. Interrupted IVC with azygous continuation. Coarct of Aorta-repaired 2/03. Allergic Colitis. Circumcision. Nickel dermatitis. ? eczema. Physiologic anisocoria R$gL. Nigh
Diagnostic Lab Data: Labs and Diagnostics: X-ray LLE WNL.. MRI with abnormal signal in the L vastus intermedius, biceps femoris, and SubQ tissue. No osteomyelitis or abscess noted. Sed rate 74. CRP 11.5, down to 2.4 on 9/22/07. CK 7. Blood culture (+) fo
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2605AA   
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2443AA   
HEPA: HEP A (VAQTA)MERCK & CO. INC.0304U   
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERZ0547   
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0002F   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Blood creatine phosphokinase, Blood culture positive, C-reactive protein increased, Diarrhoea, Full blood count, Haematocrit decreased, Haemoglobin decreased, Hyperkalaemia, Incontinence, Infection in an immunocompromised host, Inflammation, Injection site streaking, Mobility decreased, Movement disorder, Myositis, Nuclear magnetic resonance imaging abnormal, Oral intake reduced, Pain in extremity, Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased, Tenderness, White blood cell count decreased, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Note: patient immunocompromised s/p heart transplant. Developed inflammation/?myositis in both legs; refused to move them. Admitted, given iv antibiotics x48 hours, then oral abx. Recovered uneventfully. 10/15/2007 MR received from PCP. Vax record included and lot numbers updated in VAERS database. Pt in for WCC and vax on 9/17/2007. Seen again 9/19/07 for fever, decreased po intake, diarrhea, and "won''t move body since 9/17/07". (+) bladder incontinence because of refusal to get up. PE (+) for refusal to move and generalized tenderness of the lower extremities. Admited to hospital for presumed myositis. 01/14/2008 MR received for DOS 9/19-22/2007 with D/C DX: Myositis. Child presented for direct admit for c/o fever, pain and refusal to walk. PE (+) for tenderness from the L hip to knee. Red streaking noted on 9/20/07. Txd with abx with good result. Pt became hyperkalemic during admit with EKG changes which resolved with IVF changes and kayexolate. D/C on po abx.

VAERS ID:291756 (history)  Vaccinated:2007-09-17
Age:9.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-09-25, Days after onset: 7
Location:North Dakota  Entered:2007-10-01, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: 0712
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER0494U IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0609U SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pt developed erythema and induration to (R) thigh - 2.5 cm. Minimal warmth, some tenderness.

VAERS ID:291861 (history)  Vaccinated:2007-09-17
Age:0.4  Onset:2007-09-30, Days after vaccination: 13
Gender:Male  Submitted:2007-10-02, Days after onset: 2
Location:Tennessee  Entered:2007-10-02
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: KUB, CT abdomen, Air enema 10/15/07-records received-10/15/07-records received for DOS 10/1/07-DX Intussusception. Presented to ED with vomiting and bloody stools last 2 days. Onset abrupt. Exploratory laparotomy with reduction of intussusception and incidental appendectomy. Therapeutic enema with air contrast unsuccessful in reduction of intussusception beyond the level of ileocecal. KUB, CT scan, air enema
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0876U1UNUN
Administered by: Public     Purchased by: Public
Symptoms: Appendicectomy, Computerised tomogram, Enema administration, Haematochezia, Intussusception, Laparotomy, Urinary system X-ray, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)
Write-up: Intussusception 10/15/07-records received for DOS 10/1/07-DX Intussusception. Presented to ED with vomiting and bloody stools last 2 days. Onset abrupt. Exploratory laparotomy with reduction of intussusception and incidental appendectomy. Therapeutic enema with air contrast unsuccessful in reduction of intussusception beyond the level of ileocecal. Follow-up Information 02-OCT-2007: Intussusception treated with surgery

VAERS ID:291871 (history)  Vaccinated:2007-09-17
Age:80.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-10-02, Days after onset: 14
Location:Alabama  Entered:2007-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ambien, Flomax, Lorazapam, Neurontin, Protonix, Zostrix HP
Current Illness: Sciatica, Constipation, Edema
Preexisting Conditions: Lasix, Tramadol Cardiovascular Disease, Malignant neoplasm of Prostate, Spondylosis, Sciatica.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0886U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Shingles outbreak. Chest/abdomen

VAERS ID:291987 (history)  Vaccinated:2007-09-17
Age:1.1  Onset:2007-10-03, Days after vaccination: 16
Gender:Male  Submitted:2007-10-03, Days after onset: 0
Location:California  Entered:2007-10-03
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 - observation
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS21B129AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAVB184BA0IMRA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0256U3IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0911U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow)
Write-up: Mild maculopapular rash to chest, face both legs and feet 2 wks after MMRV given.

VAERS ID:292268 (history)  Vaccinated:2007-09-17
Age:59.0  Onset:2007-09-20, Days after vaccination: 3
Gender:Female  Submitted:2007-09-27, Days after onset: 7
Location:Michigan  Entered:2007-10-05, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy: Azithromycin/"Similar Rx to Flu Shot"
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2730AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Injection site pain, Lymphadenopathy, Musculoskeletal pain, Pharyngolaryngeal pain, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Localized Pain ((L) Deltoid), Redness, Swelling, Shoulder Pain, Cellulitis Axillary Adenopathy, Sore Throat Keflex 500 mg once po QID/Day

VAERS ID:292654 (history)  Vaccinated:2007-09-17
Age:0.5  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2007-10-02, Days after onset: 15
Location:Utah  Entered:2007-10-10, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~DTaP (no brand name)~1~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2651AA1 RL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF207AA1 RL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ087221 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5401SK1 LL
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad)
Write-up: Fever $g 102 x 5-7 days irritability, rhinorrhea same sx after 2 month and 4 month shots.

VAERS ID:298628 (history)  Vaccinated:2007-09-17
Age:23.0  Onset:2007-09-21, Days after vaccination: 4
Gender:Female  Submitted:2007-10-12, Days after onset: 21
Location:New York  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03955
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Rash generalised, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of Gardasil (Lot # 0530U). There was no concomitant medication. On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 23 year old female who on 17-SEP-2007 was vaccinated with a third dose of GARDASIL (Lot # 0530U) intramuscularly in the right arm. There was no concomitant medication. On 20-SEP-2007 the patient developed raised colorless macules over her arms and chest for three days. The patient recovered from this adverse event. On 21-SEP-2007 the patient developed a rash and had itchiness over her body. Unspecified medical attention was sought. The patient''s outcome was unknown. Additional information has been requested.

VAERS ID:298762 (history)  Vaccinated:2007-09-17
Age:10.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2007-10-12, Days after onset: 25
Location:California  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: No reaction on previous exposure to vaccine
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA04594
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a consumer concerning her 10 year old daughter who in March 2007 was vaccinated with the first dose of Gardasil with no reaction, and who on 17-SEP-2007 was vaccinated IM with the second dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. On 17-SEP-2007 following the vaccination, her daughter experienced pain at the site of injection. She recovered later on the same day. Additional information has been requested.

VAERS ID:297350 (history)  Vaccinated:2007-09-17
Age:7.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2007-09-27, Days after onset: 10
Location:Pennsylvania  Entered:2007-11-19, Days after submission: 53
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: 10/27/05~Measles + Mumps + Rubella (no brand name)~2~5~In Patient
Other Medications:
Current Illness: none
Preexisting Conditions: Previous reaction to DTap and MMR/ h/o hypospadias
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0036F1IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1009U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Lip swelling, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Lip swelling/hives/wheezing; Rx Epinephrine(1:1000) 0.2ml IM; Zyrtec 10mg po x1./ Recovered <30

VAERS ID:297369 (history)  Vaccinated:2007-09-17
Age:1.1  Onset:2007-09-21, Days after vaccination: 4
Gender:Female  Submitted:2007-11-20, Days after onset: 60
Location:Washington  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none per mom
Preexisting Conditions: None per mom
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PROHIBIT)SANOFI PASTEURUE923AA3IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08666D3IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0580U0PO 
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Received first dose RotaTeq on 09-17-2007. Very early morning 09-21 Child started getting sick, vomitted and by morning mom noted fever, which eventually got as high as 101. Diarrhea, fever and vomitting (a total of 4 times thru the entire course of the illness) were noted thru 09-23, gone by 09-24. Symptoms never progressed to where mom couldnt handle them at home. There are 3 other children at home, none of them became ill.

VAERS ID:301878 (history)  Vaccinated:2007-09-17
Age:5.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2007-12-21, Days after onset: 95
Location:South Dakota  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA02484
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1476F SCUN
Administered by: Public     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from a licensed practical nurse (LPN) concerning a 5 and 3/4-year-old male who on 17-SEP-2007 was vaccinated with a subcutaneous dose of 0.65 milliliters of Zostavax (Oka/Merck) instead of Varivax. Subsequently, the patient did not experience any known symptoms. It was unspecified if medical attention was sought. It was reported that this was not product confusion but a medical error. No product quality complaint was involved. Follow-up information from the LPN indicates that the patient''s mother reported that the patient was doing fine and had not experienced any problems with the vaccine. The lot number for the Zostavax (Oka/Merck) administered was 656412/1476F. The LPN reported that the clinic does not routinely have Zostavax (Oka/Merck) in stock but will order it when a patient requests it. Both vaccines were maintained in the same freezer on the same shelf. The Zostavax (Oka/Merck) vaccine was for a patient in a satellite office and the nurse thought it had already been sent to the other office. The nurse grabbed the Zostavax (Oka/Merck) vaccine by mistake since it was in a single-dose baggie on top of the note card that said Varivax. There was also a note in the freezer in the same area to save 2 Varivax doses for 2 specific patients. The LPN indicated that it was a medical mistake. The clinic is now going to separate the Varivax from the Zostavax (Oka/Merck) vaccine in the freezer by putting them in 2 different containers on two different shelves. They are also going to clearly label them. Additional information is not expected.

VAERS ID:302061 (history)  Vaccinated:2007-09-17
Age:60.0  Onset:2007-09-22, Days after vaccination: 5
Gender:Female  Submitted:2007-12-21, Days after onset: 90
Location:Kentucky  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; NEURONTIN; HYZAAR; LEVOXINE; RELAFEN
Current Illness:
Preexisting Conditions: cholesterol levels raised
Diagnostic Lab Data: Herpes simplex virus 09/24/07 - positive; VZV strain 09/24/07 not; body temp 09/22/07 98.4
CDC Split Type: WAES0710USA00047
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0885U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature, Herpes simplex, Herpes simplex serology positive, Pruritus, Rash, Rash pruritic, Rash vesicular, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 60 year old female with hypertension, hypothyroidism, elevated cholesterol, allergies to penicillin and diphenhydramine (BENADRYL) with a childhood history of chicken pox, who on 17-SEP-2007, received a dose in her left arm of zoster vaccine live (Oka/Merck) (lot# 685083/0855U). Concurrent medications included: atorvastatin calcium (LIPITOR), gabapentin (NEUROTIN), hydrochlorothiazide (+) losartan potassium (MSD), levothyroxine sodium (LEVOXINE), and nabumetone (RELAFEN). One week post vaccination on 22-SEP-2002, the patient developed less than or equal to 5 patchy lesions of a vesculiar puritic rash described as a disseminated zoster like rash on her neck, right arm and hand, left wrist and abdomen. She complained of significant itching. Her maximum temperature was 98.4 degrees. She was seen by her physician, who believe it was zoster. The patient was kept home from work due to transmission concerns. On 24-SEP-2007, a culture for herpes viral screen was obtained and sent it to a local lab. The lab results reported on 30-SEP-2007, were positive for herpes simplex and not zoster. At the time of the report the patient was recovering. No product quality complaint was reported. No further information was available. Additional information has been requested.

VAERS ID:302311 (history)  Vaccinated:2007-09-17
Age:  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-12-21, Days after onset: 94
Location:Unknown  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00026
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer reporting on her male husband who on 17-SEP-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 18-SEP-2007 ("the next day") the patient "broke out with a bad rash and has been having outbreaks ever since". The patient sought medical attention via an office visit. At the time of the report the patient''s status was not recovered. Additional information has been requested.

VAERS ID:303671 (history)  Vaccinated:2007-09-17
Age:16.0  Onset:2007-09-19, Days after vaccination: 2
Gender:Female  Submitted:2008-01-15, Days after onset: 118
Location:Unknown  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Papanicolaou smear abnormal; biopsy cervix
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA03752
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner, concerning a 16 year old female patient with no known allergies and a history of an abnormal Papanicolaou (Pap) smear and a cervical biopsy, who on 17-SEP-2007 was vaccinated IM, with a dose, 0.5 ml, of Gardasil (lot #658558/1061U). There was no concomitant medication. On 19-SEP-2007, 48 hours after vaccination, the patient developed hives. The patient''s mother contacted the physician, but no treatment was required and the hives subsequently resolved (duration not specified). Additional information has been requested.

VAERS ID:313672 (history)  Vaccinated:2007-09-17
Age:9.0  Onset:0000-00-00
Gender:Unknown  Submitted:2008-05-16
Location:Texas  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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04065
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.658291/1100U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a licensed visiting nurse concerning a patient who on 17-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658291/1100U) who experienced redness and induration at the injection site following vaccination. At the time of the report the patient''s status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:313976 (history)  Vaccinated:2007-09-17
Age:5.0  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 242
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: sodium fluoride
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02558
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.658373/1116U1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 5 year old female with no known medical history who on 26-May-2003 was vaccinated with a first dose and 17-Sep-2007 was vaccinated SQ with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). The patient experienced red and inflamed area at the injection site immediately after the vaccination. Medical attention was sought. The patient was recovered. No product quality complaint was involved. This is one of multiple reports of the same source. Additional information has been requested.

VAERS ID:321950 (history)  Vaccinated:2007-09-17
Age:0.3  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2008-07-30, Days after onset: 317
Location:California  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Poliovirus vaccine inactivated
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA02500
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2651AA UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF160AA UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0200U UNRL
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Initial and follow-up information has been received from a physician concerning a 4 month old male who on 17-SEP-2007 was vaccinated in the right thigh with a dose of PNEUMOVAX (Lot # 656233/0200U). Concomitant vaccination on the same day included PREVNAR. Other concomitant vaccination included ACTHIB (Lot #UF160AA). Other concomitant therapies included DTPA (unspecified) (Lot #C2651AA) and tetanus toxoid and poliovirus vaccine and poliovirus vaccine inactivated (unspecified) (Lot #20547-2). The physician also called Poison Control. The baby waited in the office for 2 hours and no adverse symptoms were noted. At the time of the report the patient''s outcome was unknown. On 26-SEP-2007 the physician reported that the boy was doing well and he had been calling daily to follow-up. He also reported that the nurse had mistakenly given the child PNEUMOVAX instead of PREVNAR. He reported that both vaccines were stored in the same refrigerator; however, they are clearly labeled and located on different shelves. Additional information has been requested.

VAERS ID:322342 (history)  Vaccinated:2007-09-17
Age:39.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Female  Submitted:2008-08-13, Days after onset: 330
Location:California  Entered:2008-08-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICSRNCHI412011A12IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site pain, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Intense pain at injection site and entire left arm which became stiff and painful to move. Exercise exacerbated symptoms, which last on and off six months. Symptoms would onset suddenly and last a few hours. Patient never sought treatment.

VAERS ID:332906 (history)  Vaccinated:2007-09-17
Age:15.0  Onset:2008-08-17, Days after vaccination: 335
Gender:Female  Submitted:2008-11-20, Days after onset: 95
Location:Georgia  Entered:2008-11-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hodgkins Lymphoma~HPV (Gardasil)~3~16~In Patient
Other Medications: Seasonique - Oral Contraceptive
Current Illness: none
Preexisting Conditions: allergy to PCN 1/30/09-records received-PMH:adopted, limited family history. Hemorrhoids/constipation.
Diagnostic Lab Data: Core Biopsy - August 11, 2008 1/20/09-records received-8/7/08-CT neck multiple enlarged lymph nodes in right neck. Abdominal and pelvis scan right supraclavicular right axillary mediastinal adenopathy. Small right pleural effusion.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0181U2UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy, Chemotherapy, Chest discomfort, Cough, Dermatitis contact, Dysmenorrhoea, Eczema, Haematochezia, Hodgkin's disease, Lymphadenopathy, Mediastinal mass, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pleural effusion, Rhinorrhoea, Sinus congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Malignant tumours (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Patient dx''d with Hodgkins Lymphoma following the vaccine 1/20/09-records received for DOS 9/13/08-Hodgkin''s Disease, nodular sclerosis of intrathoracic lymph nodes. Office notes for GYN visit 3/5/06 C/O left calf cramping. Subsequent visit 11/13/06 received first Gardasil vaccine C/O heavy and cramping periods. 8/5/08-sports physical exam enlarged group of cervical lymph nodes. Contact dermatitis and other eczema on visit 7/30/07. 1/8/08 C/O shoulder pain for 4 weeks. 2/14/08 presented with cough, chest tight, sinus congestion, hoarseness, runny nose, sore throat. 3/26/08 blood in BMs times 1 month. 4/22/08-insidious onset cervical pain referred to shoulder. 1/30/09-records received oncology records indicate date of diagnosis 8/20/08 Hodgkin''s after routine physical exam 8/5/08 when large right cervical lymphnode discovered. Receiving chemotherapy.

VAERS ID:483680 (history)  Vaccinated:2007-09-17
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2013-02-06
Location:Unknown  Entered:2013-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302USA001195
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0886U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) ZOSTAVAX on 17-SEP-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.

VAERS ID:487161 (history)  Vaccinated:2007-09-17
Age:81.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2013-03-18, Days after onset: 2008
Location:Alabama  Entered:2013-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMBIEN; FLOMAX; Lorazepam; NEURONTIN; PROTONIX; ZOSTRIX
Current Illness: Sciatica; Constipation; Edema; Spinal osteoarthritis; Prostate cancer; Cardiovascular disorder; Drug hypersensitivity
Preexisting Conditions: Tramadol hydrochloride, Cardiovascular disorder; LASIX, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1303USA005887
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0886U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Refers to an 81 year old male with sciatica, constipation and edema at the time of vaccination. The pre-existing conditions included Lasix allergy, tramadol, cardiovascular disease, malignant neoplasm of prostate, spondylosis and sciatica. On 17-SEP-2007 at 14:10, the patient was vaccinated with the first dose of ZOSTAVAX (lot # 0886U; exp. date: unknown) subcutaneously in the right arm. Concomitant therapies included AMBIEN, FLOMAX (MORNIFLUMATE), LORAZEPAM, NEURONTIN, PROTONIX and ZOSTRIX. On 18-SEP-2007 at 09:15, the patient developed shingles outbreak on chest/abdomen. At the time of reporting, the patient''s outcome was unknown. Additional information is not expected.

VAERS ID:539050 (history)  Vaccinated:2007-09-17
Age:8.0  Onset:2014-07-15, Days after vaccination: 2493
Gender:Male  Submitted:2014-08-06, Days after onset: 22
Location:Unknown  Entered:2014-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: Dermatitis, contact; Blister; Herpes zoster; Product used for unknown indication
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1407USA007703
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Dermatitis contact, Erythema, Herpes zoster, Polymerase chain reaction, Swelling, Varicella virus test negative
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a Registered Nurse and refers to an 8 year old male child. On 18-SEP-2007 the patient ws vaccinated with (Oka/Merck) VARIVAX. On 07-JUL-2014, the patient was diagnosed with Contact Dermatitis and given Triamcinolone. On 08-JUL-2014 the patient developed "red streaking and swelling on the left mid back", AUGMENTION was started on 08-JUL-2014, "a PCR test was performed which was Negative for VZV". On 09-JUL-2014, vesicles developed on the left mid back. On 15-JUL-2014, the patient ws seen by an unspecified Dermatologist who diagnosed the patient with Shingles. Acyclovir was started on 16-JULY-2014. The patient has not recovered. All listed data confirmed by the reporter, no further information was provided. Outcome is patient has not recovered. Additional information is not expected.

VAERS ID:566320 (history)  Vaccinated:2007-09-17
Age:12.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Female  Submitted:2014-04-17, Days after onset: 2403
Location:Pennsylvania  Entered:2015-01-28, Days after submission: 286
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2013SA115977
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial report received on 07-NOVEMBER-2013 from a pharmacist. A 12-year-old female patient whose medical history and concomitant medications were not reported, received a dose of ADACEL via intramuscular route (site of administration not reported) on 17-SEPTEMBER 2007. On 18-SEPTEMBER 2007, after vaccination the patient experienced redness, swelling and tenderness at the injection site. Corrective treatment was not reported. At the time of this report the outcome of the event was resolved. List of documents held by sender: none.

VAERS ID:292241 (history)  Vaccinated:2007-09-17
Age:0.2  Onset:2007-09-24, Days after vaccination: 7
Gender:Male  Submitted:2007-10-04, Days after onset: 10
Location:Foreign  Entered:2007-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: (composition unspecified) 21Sep07 - 24Sep07, amodiaquin 21Sep07 - 23Sep07, dextrose (+) electrolytes (unspecified) 21Sep07 - 24Sep07
Current Illness: Malaria; Gastroenteritis
Preexisting Conditions:
Diagnostic Lab Data: body temp 24Sep07 36.5 degrees Celsius, WBC count 25Sep07 14.7 x 10^3 cells/uL 4.5-10.5, hemoglobin 25Sep07 33.6 gm/dL 9.0-15.6, lymphocyte count 25Sep07 40.5 percent 20.5-51, blood Plasmodium species observation 25Sep07 negative, blood gra
CDC Split Type: WAES0709USC00090
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, Body temperature decreased, CSF granulocyte count normal, Condition aggravated, Dehydration, Diarrhoea, Eyes sunken, Fluid intake reduced, Fluid replacement, Fontanelle depressed, Gastroenteritis, Granulocyte count, Haemoglobin increased, Lymphocyte count normal, Malaria antibody test, Mean cell volume normal, Skin turgor decreased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from an investigator concerning a 9-week-old male with malaria and gastroenteritis who entered a study, title as stated above. On 17-SEP-2007, the patient was vaccinated with the first dose of blinded therapy. Concomitant therapy included amodiaquin, dextrose (+) electrolytes (unspecified) (oral rehydration solution) and "Entamax". On 21-SEP-2007, the patient presented to the hospital four days post dose one of blinded therapy with a two-day history of diarrhoea and vomiting. The patient was not dehydrated and was allowed home on oral fluids. Three days later, on 24-SEP-2007, the infant presented to the hospital again and was admitted with complaints that the diarrhoea had worsened. The diarrhoea occurred seven times and the vomiting occurred three times within 24 hours. On examination, the patient was sick looking, drinking poorly, had a sunken anterior fontanelle, sunken eyes, and reduced skin turgor. His temperature was 36.5 degrees Celsius, respiratory rate was 34 beats per minute, and pulse rate was 128 beats per minute. Laboratory results were pending for a malaria blood film and total blood count. A diagnosis of acute gastroenteritis with severe dehydration was made. Intravenous fluids were initiated. At the time of this report, the patient''s hydration status had improved. He was no longer vomiting but still had diarrhoea, and the acute gastroenteritis was considered recovering. The reporting investigator felt that acute gastroenteritis was of severe intensity and was related to study therapy. Additional information was received on 28-SEP-2007 from the investigator. On 25-SEP-2007, laboratory results revealed a negative blood film for malaria, a white blood cell count of 14.7 x 10^3 cells/uL, lymphocyte count was 40.5%, granulocyte count was 51.5%, hemoglobin was 13.6 gm/dL, and mean corpuscular volume (MCV) was 93%. On 26-SEP-2007, the patient was discharged from the hospital. On 27-SEP-2007, the diarrhoea and vomiting stopped and the acute gastroenteritis resolved. The repor

VAERS ID:292252 (history)  Vaccinated:2007-09-17
Age:0.3  Onset:2007-09-17, Days after vaccination: 0
Gender:Unknown  Submitted:2007-10-04, Days after onset: 17
Location:Foreign  Entered:2007-10-05, 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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: GRWYE366325SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Immediate post-injection reaction, Restlessness, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was assessed as serious. Information regarding Prevenar was received from a healthcare professional regarding a 3-month-old patient who experienced cyanosis of legs, restlessness and tachycardia. The patient received a dose on 17-Sep-2007. The patient (infant, 3-month-old) experienced cyanosis of legs, restlessness and tachycardia on 17-Sep-2007. The pediatrician reported that immediately after the administration of the vaccine the patient had experienced cyanosis of the legs and after that experienced also tachycardia and restlessness. Within half an hour the symptoms abated but the doctor decided to take care of the patient for another two hours so she would be definite that the infant had completely recovered. Additional information is that the patient didn''t have any symptom since then.

VAERS ID:292585 (history)  Vaccinated:2007-09-17
Age:1.8  Onset:2007-09-17, Days after vaccination: 0
Gender:Male  Submitted:2007-10-10, Days after onset: 23
Location:Foreign  Entered:2007-10-10
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0054760A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA316C UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA316C UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA316C UNUN
Administered by: Other     Purchased by: Other
Symptoms: Electroencephalogram, Febrile convulsion, Laboratory test, No reaction on previous exposure to drug
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of two febrile convulsions in 21-month-old male subject who was vaccinated with Infanrix-IPV+Hib (GlaxoSmithKline) for prophylaxis. Previous vaccinations with the first two doses of Infanrix-IPV+Hib, given on 17 March 2006 and 16 May 2006, were well tolerated. On 17 September 2007 the subject received the third dose of Infanrix-IPV+Hib (0.5 ml, unknown, left thigh). Less than one day post vaccination with Infanrix-IPV+Hib, on 17 September 2007, the subject experienced two febrile convulsions. On 17 September 2007 at around 18:35, the subject experienced the first febrile convulsion for about 10 minutes. On 17 September 2007 at around 20:00, the subject experienced the second febrile convulsion for about 10 seconds. The subject was hospitalised for a unknown period of time. The event was confirmed by laboratory examinations and electroencephalogram (EEG). Meningitis was excluded by differential diagnosis. The event did not recur without timely relation to vaccination with Infanrix-IPV+Hib. At the time of reporting the event was considered to be unresolved. The vaccination course with Infanrix-IPV+Hib was discontinued. No further information will be available.

VAERS ID:296206 (history)  Vaccinated:2007-09-17
Age:0.2  Onset:2007-11-02, Days after vaccination: 46
Gender:Female  Submitted:2007-11-08, Days after onset: 6
Location:Foreign  Entered:2007-11-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: nystatin 18Oct07 - 26Oct07; sulfamethoxale/trimethoprim 27Sep07 - Unk; vitamins (unspecified) 27Sep07 - Unk
Current Illness: Oral candidiasis; Opportunistic infection prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: body temp 02Nov07 36.1 degrees Celsius; respiratory rate measurement 02Nov07 56 breaths/minute
CDC Split Type: WAES0711USC00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature, Cough, Diarrhoea, Diet refusal, Eyes sunken, Fontanelle depressed, Gastroenteritis, Intercostal retraction, Malaise, Oral intake reduced, Pneumonia, Pyrexia, Respiratory rate increased, Skin turgor decreased, Tachypnoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad)
Write-up: Information has been received from an investigator concerning a 10-week-old female with oral candidiasis who entered a study. Concomitant therapy included multivitamin, sulfamethoxazole/trimethoprim, and nystatin. On 02-NOV-2007, the patient was admitted to the hospital with a 7 day history of diarrhoea, a 4 day history of cough and fever, and a 3 day history of vomiting. Diarrhoea had occurred 8 times in the preceding 24 hours while the vomiting had occurred 6 times in the preceding 24 hours. The patient was ill-appearing and drinking poorly. On examination, she had sunken eyes, a sunken anterior fontanelle, reduced skin turgor, tachypnea with a respiratory rate of 56 breaths/minute, and had chest retractions. Her temperature was 36.1 degrees Celsius. The patient was diagnosed with gastroenteritis and pneumonia. Treatment included intravenous (IV) fluids and IV penicillin. At the time of this report, acute gastroenteritis and pneumonia were unresolved. The investigator felt that acute gastroenteritis was possibly related to study therapy while pneumonia was not. Both events were of severe intensity. Additional information has been requested regarding SAE stop dates and outcomes, the patient''s date of hospital discharge, laboratory results, chest X-ray results, and action taken with study therapy.

VAERS ID:296823 (history)  Vaccinated:2007-09-17
Age:30.0  Onset:2007-09-22, Days after vaccination: 5
Gender:Female  Submitted:2007-11-13, Days after onset: 52
Location:Foreign  Entered:2007-11-15, Days after submission: 2
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:
Preexisting Conditions: Voltaren was used over time to treat psoratic arthritis. The patient was previously vaccinated on 07-Sep-2007 with Engerix-B (GSK), Typhoid vaccine (MFR UNK) and Mencevax ACWY. No adverse effect is reported.
Diagnostic Lab Data:
CDC Split Type: E200707666
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEUR  UNUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Oedema peripheral, Pain in extremity, Pruritus, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Initial case was reported as serious on 31-Oct-2007 by foreign Health Authority. It was reported that a 30-year-old female patient received an injection of Rabies Imovax, batch number, and site of administration not reported), Stamaril, batch number and site of administration not reported) and DTaP (manufacturer unknown) on 17-Sep-2007. On 22-Sep-2007 the patient developed oedema in legs and generalized urticaria. On 23-Sep-2007 she had pain in the foot and on 24-Sep-2007 she had itching and dyspnoea (no clinical findings to confirm it). The patient was hospitalized on unspecified date. The patient was treated with Prednosilone, antihistamines and Ventoline inhalations. The reporter thinks that when the urticarial rash begins 5 days after the vaccination, the vaccination could almost certainly be excluded as cause. The medical history of patient included vaccination with Engerix-B, Typhoid vaccine (MFR UNK) and Mencevax ACWY on 7-Sep-2007. No adverse effect is reported. Voltaren which was used over time for psoriatic arthritis (unknown debut and dosage) was stopped at the day of admission. No further information is available. The outcome is not reported. The case is closed.

VAERS ID:297072 (history)  Vaccinated:2007-09-17
Age:55.0  Onset:2007-09-18, Days after vaccination: 1
Gender:Male  Submitted:2007-11-16, Days after onset: 59
Location:Foreign  Entered:2007-11-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0495448A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHBVB305AN IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bone pain
SMQs:, Osteonecrosis (broad)
Write-up: This case was reported by a regulatory authority (Regulatory Agency # GB-RA-ADR 20183519) and described the occurrence of bone pain in a 55-year-old male subject who was vaccinated with (Hepatitis B vaccine) for prophylaxis. Concurrent medications included mefloquine. On 17 September 2007 and 15 October the subject received unspecified dose of Hepatitis B vaccine (1 ml, intramuscular). On 18 September 2007, one day after vaccination with Hepatitis B vaccine, the subject experienced bone pain. The regulatory authority reported that the event was disabling and clinically significant (or requiring intervention). At the time of reporting the event was unresolved. RA Verbatim text: Pectoral girdle pain. Treated by analgesics. 1st Injection pain lasted for five weeks. Medically significant: Off work for a while.

VAERS ID:299786 (history)  Vaccinated:2007-09-17
Age:0.4  Onset:2007-12-07, Days after vaccination: 81
Gender:Female  Submitted:2007-12-13, Days after onset: 6
Location:Foreign  Entered:2007-12-14, 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: Metronidazole; sulfamethoxazole/trimethoprim
Current Illness: Abdominal discomfort; HIV infection
Preexisting Conditions:
Diagnostic Lab Data: WBC count 07Dec07 22.4 x 10^3 cells/uL 4.5-10.5; body temp 07Dec07 38.2 degrees Celsius; hemoglobin 07Dec07 13.5 gm/dL 9.0-15.5; lymphocyte count 07Dec07 34.9 percent 20.5-51; blood granulocyte count 07Dec07 53.1 percent 42.4-75.2; blood Plasmodium malariae observation 07Dec07 negative; total heartbeat count 07Dec07 110 beats/minute; mean corpuscular volume 07Dec07 73.8 fl 80.0-99.9; respiratory rate measurement 07Dec07 52 breaths/minute; mean corpuscular hemoglobin 07Dec07 24.5 pg 27.0-31.0
CDC Split Type: WAES0712USC00031
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Diarrhoea, Diet refusal, Eyes sunken, Fontanelle depressed, Gastroenteritis, Granulocyte count, Haemoglobin normal, Heart rate increased, Lymphocyte count normal, Mean cell haemoglobin, Mean cell volume normal, Mucosal dryness, Pyrexia, Respiratory rate increased, Skin warm, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from an investigator concerning a 19-week-old female with abdominal discomfort and HIV infection who entered a study, title as stated above. On 17-SEP-2007, 19-OCT-2007, and 23-NOV-2007, the patient was vaccinated with the first, second, and third dose of blinded therapy. Concomitant therapy included Cotrimoxazole (sulfamethoxazole/trimethoprim), metronidazole, and multivitamins. On 07-DEC-2007, the patient presented to the hospital with a three day history of diarrhoea and hotness of the body. The diarrhoea was watery and non-bloody with a maximum of six hours occurring in the previous 24 hours. No incidence of vomiting was noted. The patient was febrile with a temperature of 38.2 degrees Celsius, pulse rate 110 beats/minute, and respiratory rate 52 breaths/minute. On examination, she was sick looking with sunken anterior fontanelle, sunken eyes, and dry mucous membranes. She had no tears and was unable to drink. Laboratory results revealed white blood cell count 22.4 x 10^3 cells/uL, and negative malaria blood smear. The patient was diagnosed with acute gastroenteritis and was treated with intravenous fluids. At the time of this report, the event of acute gastroenteritis was ongoing. The reporting investigator felt that acute gastroenteritis was of severe intensity and related to study therapy. Additional information has been requested from the site regarding SAE stop date, final outcome, and date of hospital discharge.

VAERS ID:307890 (history)  Vaccinated:2007-09-17
Age:14.0  Onset:2007-11-07, Days after vaccination: 51
Gender:Female  Submitted:2008-03-21, Days after onset: 134
Location:Foreign  Entered:2008-03-24, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Febrile convulsion
Diagnostic Lab Data: magnetic resonance imaging, 07Nov07, normal, cranial; ultrasound, 07Nov07, normal, duplex sonography (extracranial and transcranial); electroencephalography, 07Nov07, showed slight disorder centroparietal right with epileptic signs
CDC Split Type: WAES0803USA03172
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electroencephalogram abnormal, Feeling of body temperature change, Hypoaesthesia, Injected limb mobility decreased, Nuclear magnetic resonance imaging normal, Partial seizures, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a physician concerning a 14 year old female patient with a history of febrile convulsion within the first year of childhood who on 17-SEP-2007 was vaccinated with the first dose of Gardasil (Lot #1537F, Batch #NF37120), IM into the left arm. Concomitant medication was not reported. On 07-NOV-2007, the patient experienced suddenly a feeling of warmth and coldness in the left arm, the arm also felt numb and later on she was not able to move her arm anymore. The patient was admitted to the hospital on the same day for diagnostics. Cranial magnetic resonance imaging (MRI), duplex sonography (extracranial and transcranial) were normal. Electroencephalography (EEG) showed a slight disorder centroparietal right with epileptic signs. Diagnosis of cryptogenic focal epilepsy was established. No treatment was given as it was the first attack. The patient recovered completely within 2 hours. The patient was discharged from the hospital on 09-NOV-2007. On 12-NOV-2007, the patient was vaccinated with the second dose of Gardasil (Lot #0354U, Batch #NF58550) which was well tolerated. On 10-JAN-2008, the patient was seen in the outpatient department of a hospital for epilepsy. The physician reported that a final diagnosis of epilepsy can not be established as the symptoms were uncommon. The further course had to be awaited before establishing this diagnosis as possible differential diagnosis of psychogenic disorder was discussed. Other business partner numbers included E2008-02293. Additional information is not expected.

VAERS ID:378732 (history)  Vaccinated:2007-09-17
Age:  Onset:2007-09-17, Days after vaccination: 0
Gender:Female  Submitted:2010-01-28, Days after onset: 864
Location:Foreign  Entered:2010-01-28
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: B0628155A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Mobility decreased, Pain in extremity, Rheumatoid arthritis
SMQs:, Systemic lupus erythematosus (broad), Parkinson-like events (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a lawyer via GSK legal department and described the occurrence of forearm pain in a female subject of unspecified age who was vaccinated with ENGERIX B adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. Subject medical history was unspecified. On 17 September 2007, the subject received a dose of ENGERIX B adult (unknown batch number, route and injection site). The same day, in the evening, the subject experienced pain in her left forearm. On 18 September 2007, the subject experienced painful decreased mobility in the left shoulder then in right shoulder. In the following days decreased mobility involved four limbs. On 20 and 25 September 2007, the subject was diagnosed with an arthritis flare up by a physician; she was treated with an anti-inflammatory drug. On 15 October 2007, clinical condition worsened, corticosteroid treatment was prescribed by her physician. After several investigations, on 14 March 2008, a diagnosis of rheumatoid polyarthritis was made. Clinical course was favorable with corticosteroid treatment. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was improved. According to the subject''s lawyer, chronology was very suggestive of a causal relationship between vaccination with ENGERIX B adult and the events.

VAERS ID:412398 (history)  Vaccinated:2007-09-17
Age:57.0  Onset:2010-10-14, Days after vaccination: 1123
Gender:Male  Submitted:2010-12-07, Days after onset: 54
Location:Foreign  Entered:2010-12-10, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ALCOHOL USE; NON SMOKER
Preexisting Conditions: The subject used 60 units of alcohol per week.
Diagnostic Lab Data: Hepatitis B antibody, 14Oct2010, negative; Hepatitis B surface antigen, 14Oct2010, not detected
CDC Split Type: B0683425A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB388DB3UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antigen negative, Inappropriate schedule of drug administration, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2007 the subject received a primary course of ENGERIX B following the accelerated schedule 0, 7, 21 days and 12 months schedule but was deviated from the licensed schedule slightly, with the second dose at day 10, the third dose 2 weeks later and the fourth dose more than a year after the first dose. The subject was tested for markers of current and past infection which was negative (not responding to therapy). On the 8th November 2010 a nurse reported that a male patient was started on a course of ENGERIX B following the accelerated a primary course of ENGERIX B in 2007 but was deviated from the licensed schedule slightly, with the second dose at day 10, the third dose 2 weeks later and the fourth dose more than a year after the first dose. The patient had been tested for markers of current or past infection which were negative. There was no further information available at the time of reporting. Follow-up information received on 1 December 2010: The subject was a non-smoker and alcohol user (60 units per week). On 17 September 2007, 27 September 2007, 11 October 2007 and 24 March 2009 the subject received 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (20 mcg) in the left deltoid, except for the first dose which was received in right deltoid. The subject was tested for hepatitis B surface antigen on 14 October 2010 and the test result was ''not detected''. The healthcare professional considered the event was life threatening. The reporter considered the event may have been associated with ''deviation from license schedule'' (lack of efficacy and erroneous administration).

VAERS ID:451220 (history)  Vaccinated:2007-09-17
Age:25.0  Onset:2012-01-10, Days after vaccination: 1576
Gender:Female  Submitted:2012-03-06, Days after onset: 56
Location:Foreign  Entered:2012-03-07, 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: Cervical smear, ??Aug10, Showed PAP I; Cervical smear, 10Jan12, PAP IVa; Diagnostic pathological examination, 06Feb12, Hystology of the portio showed a small area of squamous epithelial carcinoma; Deoxyribonucleic acid analysis, 13Jan12, Cytometry: Severe cervical lesion of prospective malign potency; Cervix HPV DNA assay, 20Jan12, Positive for type 16
CDC Split Type: WAES1203USA00162
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0233U0IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical conisation, Cervix carcinoma stage 0, Cervix disorder, Flow cytometry, Histology abnormal, Human papilloma virus test positive, Papilloma viral infection, Pathology test, Smear cervix abnormal
SMQs:, Malignant tumours (narrow), Uterine and fallopian tube malignant tumours (narrow)
Write-up: This case was received from a Health Care Professional (nurse, mother of the patient) on 24-FEB-2012. The case was medically confirmed. A 25 year old female patient received dose 3 of GARDASIL (batch number: NF58540, lot number: 0253U) IM into the upper arm on 20-MAR-2008. In August 2010, the last smear test showed PAP I. Several reports on findings were made available. On 10-JAN-2012, a portio and cervical smear test showed suspicion of severe cervical lesion with cervical crypt involvement. The result was classified as PAP IVa. On 13-JAN-2012, a DNA cytometry showed severe cervical lesion of prospective malign potency with DNA-polyploidy (assessed as being possibly caused by HPV-infection) and formation of a DNA-aneuploid stem line. A conisation was recommended. On 20-JAN-2012, a hybridisation of the smear test was positive for "high risk" HPV-types, a molecular biological test showed positive HPV-type 16. On 06-FEB-2012, the patient underwent conisation and histology of the portio showed a small area of squamous epithelial carcinoma in situ with no infiltrative growth. The lesion was removed within healthy tissue. The patient had received dose 1 of GARDASIL (batch number: NF46740; lot number: 0233U) IM into the upper arm on 17-SEP-2007 and dose 2 (batch number: NG01520; lot number: 1536F) IM into the upper arm on 21-NOV-2007 - toleration was not reported. The patient had first sexual contact with intercourse in 2001. File closed. Carcinoma in situ of cervix and Papanicolaou smear abnormal, class IV A were considered as other important medical events by the reporter. Other business partner number included: E2012-01370. No further information is available.

VAERS ID:291206 (history)  Vaccinated:2007-09-18
Age:47.0  Onset:2007-09-21, Days after vaccination: 3
Gender:Female  Submitted:2007-09-24, Days after onset: 3
Location:Michigan  Entered:2007-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Lymphadenopathy, Musculoskeletal stiffness, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: two days after I got the shot my arm swelled up. Ihad swollen lymph glands and body chills and fever and stiff neck

VAERS ID:291308 (history)  Vaccinated:2007-09-18
Age:17.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Female  Submitted:2007-09-20, Days after onset: 0
Location:Ohio  Entered:2007-09-25, 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: Sulfa
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2402AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2824AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dyskinesia, Fatigue, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Tired, achy, (R) leg jerking.

VAERS ID:291317 (history)  Vaccinated:2007-09-18
Age:17.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Female  Submitted:2007-09-20, Days after onset: 0
Location:Colorado  Entered:2007-09-25, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1001U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site red and tender and swollen, afebrile.

VAERS ID:291330 (history)  Vaccinated:2007-09-18
Age:0.3  Onset:2007-09-20, Days after vaccination: 2
Gender:Female  Submitted:2007-09-19, Days after onset: 1
Location:Texas  Entered:2007-09-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Exanthem - rash
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2290AB1UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF113AA1UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ02401UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845E1UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0242U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Rash, Unevaluable event
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: None

VAERS ID:291339 (history)  Vaccinated:2007-09-18
Age:1.3  Onset:2007-09-18, Days after vaccination: 0
Gender:Male  Submitted:2007-09-25, Days after onset: 7
Location:Wisconsin  Entered:2007-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU2070BA/UF105AB3IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Lethargy, Oedema peripheral, Penile oedema, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 2 hours after receiving the vaccine dtap/hib ( trihibit) the child had hives/swelling of left leg, facial swelling, penis edema, lethargy and temp of 100.

VAERS ID:291355 (history)  Vaccinated:2007-09-18
Age:4.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2007-09-30, Days after onset: 11
Location:Virginia  Entered:2007-09-25, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA4 RL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10094 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0418UF1 LL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1100U1 LL
Administered by: Private     Purchased by: Public
Symptoms: Blister, Injection site swelling
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized swelling at vaccine site with superimposed 1cm blister tx with Bactroban.

VAERS ID:291361 (history)  Vaccinated:2007-09-18
Age:  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2007-09-20, Days after onset: 1
Location:California  Entered:2007-09-25, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B035AA4 RA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0254U3 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1217F1 LA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1173U1 RA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red and swollen right arm - hurts

VAERS ID:291362 (history)  Vaccinated:2007-09-18
Age:1.1  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-19, Days after onset: 0
Location:Mississippi  Entered:2007-09-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest X-ray, CBC showed "slightly increase WBC"
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0527U0SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1120U0SC 
Administered by: Private     Purchased by: Private
Symptoms: Chest X-ray, Cough, Full blood count, Pyrexia, Restlessness, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Onset of mild cough before giving to bed. Increase in cough, ? wheezing, restless asleep low grade fever early a.m. received Rocephin IM and Z-pak.

VAERS ID:291419 (history)  Vaccinated:2007-09-18
Age:4.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Male  Submitted:2007-09-26, Days after onset: 6
Location:Florida  Entered:2007-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA3IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAO1113IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.042441SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.109SU1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site induration, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Localized swelling, redness, induration at site of DTAP shot on LL

VAERS ID:291430 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-19, Days after onset: 0
Location:Mississippi  Entered:2007-09-26, 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: eCZEMA
Preexisting Conditions: NONE
Diagnostic Lab Data: n/a
CDC Split Type: MS07026
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B110930IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0077U0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845E0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.076940PO 
Administered by: Public     Purchased by: Public
Symptoms: Condition aggravated, Eczema, Injection site vesicles, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Baby presented to health department 9/19/07 with multiple blisters on uper half of r thigh. Taken to pediatrician and told that local reactio to shot due to severe eczema. Fever 100.1. No sob. Baby is active and playful. Mom was given 1% hydrolcortison to apply to eczema-not blistered area BID.

VAERS ID:291440 (history)  Vaccinated:2007-09-18
Age:68.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2007-09-21, Days after onset: 2
Location:Washington  Entered:2007-09-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1005F SCLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1957AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) arm swelling 1st & with increasing redness over 3 days Treated with antibiotics for possible cellulitis 9/21/07

VAERS ID:291510 (history)  Vaccinated:2007-09-18
Age:1.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-27, Days after onset: 8
Location:California  Entered:2007-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: Patient came in to office with complaint by parent of ataxia when crawling. Happened after receiving immunizations. Observe and will be following up in 1 week to readdress.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 3IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Ataxia, Crying, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Patient came into the office with complaint of loss of balance when crawling (ataxia) since administration of immunizations approx 1 week ago. waking at night more often crying. emesis x1 last PM.

VAERS ID:291586 (history)  Vaccinated:2007-09-18
Age:83.0  Onset:0000-00-00
Gender:Female  Submitted:2007-09-25
Location:Oregon  Entered:2007-09-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA0IM 
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse reaction, Wrong drug administered
SMQs:
Write-up: Adacel (Tdap) given to client over age 64 no adverse effects known.

VAERS ID:291618 (history)  Vaccinated:2007-09-18
Age:76.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Male  Submitted:2007-09-27, Days after onset: 7
Location:New York  Entered:2007-09-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: same~Influenza (no brand name)~~71~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Barrett''s cough
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Cough, Pyrexia, Similar reaction on previous exposure to drug, Throat tightness, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad)
Write-up: Fever 102, shaking chills, throat clogged, cough 48 hour after vaccine (occurred after flu shot years ago).

VAERS ID:291621 (history)  Vaccinated:2007-09-18
Age:56.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2007-09-20, Days after onset: 1
Location:Maine  Entered:2007-09-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Obesity, dyslipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0803A0 LA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Erythema, Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Generalized body aches, fever, chills with erythema, edema and warmth at injection site within 24 hours of injection.

VAERS ID:291632 (history)  Vaccinated:2007-09-18
Age:4.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-20, Days after onset: 1
Location:Kentucky  Entered:2007-09-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA4 LA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10693 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0414U1 RA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Mass
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Egg sized reddened hardened knot to left deltoid area.

VAERS ID:291636 (history)  Vaccinated:2007-09-18
Age:7.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-20, Days after onset: 1
Location:South Carolina  Entered:2007-09-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Well care
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1071U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: See picture

VAERS ID:291640 (history)  Vaccinated:2007-09-18
Age:1.4  Onset:2007-09-22, Days after vaccination: 4
Gender:Male  Submitted:2007-09-23, Days after onset: 1
Location:Massachusetts  Entered:2007-09-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2156BA3IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF144AA3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1169F0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient received DTaP, Hib and MMR on 9/18/07; mom noticed rash on 9/22/07 at approximately 730pm - Head to toe.

VAERS ID:291669 (history)  Vaccinated:2007-09-18
Age:13.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Male  Submitted:2007-09-24, Days after onset: 4
Location:Massachusetts  Entered:2007-09-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to Penicillin, Cephalosporins and bee stings
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2393BA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypersensitivity, Petechiae
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: Patient woke up with a purple petechial rash on his left lower arm approximately 24 hours after receiving Menactra vaccine in his left upper arm - seen by dermatologist who thought it hypersensitivity reaction.

VAERS ID:291699 (history)  Vaccinated:2007-09-18
Age:26.0  Onset:2007-09-25, Days after vaccination: 7
Gender:Male  Submitted:2007-10-01, Days after onset: 6
Location:North Carolina  Entered:2007-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No medical conditions; NKDA; No birth defects
Diagnostic Lab Data: Lumbar puncture-9/27/2007: Negative; Normal CSF Glucose; Normal Protein; 1 WBC; Normal CT Scan of the brain; MRI W/O findings consistent of ADEM or Encephalitis. 6/26/08-records received-Labs WNL, CSF negative, blood culutre negative. MRI brain suggestive of vermian hypoplasia with mega cisterna magna. CT head developmental variant partially hypoplastic cerebellar vermis mega cisterna magna.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200760ID 
Administered by: Military     Purchased by: Military
Symptoms: CSF glucose normal, CSF protein normal, Chills, Confusional state, Decreased appetite, Disturbance in attention, Erythema, Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Lumbar puncture normal, Malaise, Nuclear magnetic resonance imaging brain normal, Pyrexia, Scan brain, Swelling, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: Description: feeling general malaise over the weekend and into the following week, pain, redness at inoculation site. Decreased mental clarity noted by fellow service members. Flu-like symptoms < 96 hours Start: 09/22/2007 Confused Start: 09/27/2007 Comment: decrease in mental clarity Erythema Start: 09/25/2007 Swelling Start: 09/25/2007 Pain Start: 09/25/2007 Comment: at inoculation site. 6/26/08-records received for DOS 9/27-9/28/08-DC DX: Vaccine Reaction non specific. Presented with fever and confusion, mental acuity slower, malaise, decreased appetite and fatigue over past 1-2 days. Fever and chills.

VAERS ID:291915 (history)  Vaccinated:2007-09-18
Age:42.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-09-25, Days after onset: 7
Location:Louisiana  Entered:2007-10-02, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0203U0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Dyspnoea, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Fever 102 1st day itching from scalp to toes 1st day - (1/2 of the day) fever 99 and next 2 days no energy for 1st 4 days after vaccine. Felt like she couldn''t get a good breath.

VAERS ID:292230 (history)  Vaccinated:2007-09-18
Age:5.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-28, Days after onset: 9
Location:Pennsylvania  Entered:2007-10-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA2IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0570U0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02732SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0527U1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1100U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling of right thigh x 24 hrs. Also with fever on day 2 after vaccination. 3 inch size area of erythema and induration right anterolateral thigh, tender, warm to the touch. Treated with an antibiotic for probable cellulitis

VAERS ID:292284 (history)  Vaccinated:2007-09-18
Age:51.0  Onset:2007-10-01, Days after vaccination: 13
Gender:Female  Submitted:2007-10-02, Days after onset: 1
Location:Pennsylvania  Entered:2007-10-05, 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: PRILOSEC
Current Illness: None
Preexisting Conditions: ALLERGIC TO ERYTHROMYCIN
Diagnostic Lab Data: MMR Vax given due to negative Rubella titer 9/4/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1324F0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Rash, Rubella antibody negative
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received MMR vaccine September 18, 2007. Noted rash on anterior and posterior trunk, mildly itchy. Seen by Employee Health Physician October 2, 2007.

VAERS ID:292285 (history)  Vaccinated:2007-09-18
Age:1.0  Onset:2007-09-26, Days after vaccination: 8
Gender:Female  Submitted:2007-10-02, Days after onset: 6
Location:North Carolina  Entered:2007-10-05, 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: FLOVENT, ATARAX
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0799U0 LL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1410F0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1121U0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Blister, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 3 X 1cm area of redness with small vesicles on left thigh (treated with Benadryl).

VAERS ID:292286 (history)  Vaccinated:2007-09-18
Age:1.0  Onset:2007-09-27, Days after vaccination: 9
Gender:Male  Submitted:2007-10-02, Days after onset: 5
Location:North Carolina  Entered:2007-10-05, 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: ATARAX
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0799U0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1410F0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1121U0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Blister, Erythema
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 2 x 1cm area of redness with small vesicles on left thigh (treated with Benadryl)

VAERS ID:292437 (history)  Vaccinated:2007-09-18
Age:39.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Male  Submitted:2007-10-08, Days after onset: 20
Location:Oklahoma  Entered:2007-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB449AA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash, Reaction to preservatives
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash and itching began approximately 2 hours after vaccine administration. It spread to entire body within 3 days. Patient was seen in Hospital emergency room with diagnosis of vaccine reaction on 9/21/07. He received diphenhydramine 50mg, rantidine 50mg, promethazine 50mg, methyl sod suc 125mg. He was discharged with RX for hydroxyzine 25mg, Prednisone 40mg, Zantac 150mg.

VAERS ID:292538 (history)  Vaccinated:2007-09-18
Age:17.0  Onset:2007-09-23, Days after vaccination: 5
Gender:Female  Submitted:2007-10-09, Days after onset: 16
Location:Texas  Entered:2007-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: none prior~ ()~NULL~~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: mild GE reflux
Diagnostic Lab Data: MRI, CT HEAD, EEG, 48 HOUR AMBULATORY EEG, BLOOD TESTS
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Amnesia, Blood test, Computerised tomogram, Confusional state, Convulsion, Electroencephalogram, Hyperhidrosis, Nuclear magnetic resonance imaging, Presyncope, Somnolence, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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)
Write-up: 3 events: #1 ~10 days afer Gardasil injection #1 on 7/26/07,, pt awoke with nearly complete amnesia of events of the day before and confusion as to her whereabouts lasting ~ 1 hour; was somnolent , fell asleep, improved within a few hours after awakening. No history of any such episode previously. Event #2- 5 minutes after receiving Gardasil injection #2 on 9/18/07, patient became faint, diaphoretic and nearly lost consciousness. Quickly recovered. No prior history of such reaction to vaccinations. EVENT #3 - ~ 5 DAYS AFTER SECOND GARDASIL VACCINATION ON 9/18/07, PATIENT EXPERIENCED A GENERALIZED SEIZURE, NEW ONSET. FULL EVALUATION IN ER REVEALED NO OTHER ABNORMALITIES. RESULTS OF 48 HOUR AMBULATORY EEG MONITOR ARE PENDING. SHE HAS BEEN RECIEVING AED, TOPAMAX, AT LOW DOSE WITHOUT RECURRENCE OF SEIZURES.

VAERS ID:298576 (history)  Vaccinated:2007-09-18
Age:25.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-10-12, Days after onset: 24
Location:Unknown  Entered:2007-10-15, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03391
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0181U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information and f/u has been received from a registered nurse concerning a 25 year old female with no known allergies or reported medical conditions who on 18-SEP-2007 was vaccinated IM into the right deltoid with a first dose of Gardasil (Lot # 656371/0181U). Concomitant therapy included MENACTRA intramuscular in the left deltoid. On 18-SEP-2007 shortly after receiving the first vaccination of Gardasil the patient felt lightheaded, and fainted. It was reported that she lost consciousness for five - ten seconds and revived on her own. The patient was laid down on the floor and given soda and cold compresses. A full recovery was made within 20 minutes. The nurse followed up with a phone call on 19-SEP-2007 to her family and she was reported to be fine. Unspecified medical attention was sought. No additional information is expected.

VAERS ID:298640 (history)  Vaccinated:2007-09-18
Age:23.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-10-12, Days after onset: 24
Location:Pennsylvania  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: blood pressure, 09/18/07, 112/7; blood pressure, 09/18/07, 102/7; total heartbeat count, 09/18/07, 80
CDC Split Type: WAES0709USA04271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0742U0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Blood pressure decreased, Dizziness, Headache, Heart rate
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and no illness at the time of being vaccinated. On 18-SEP-2007, the patient was vaccinated with a first dose of Gardasil (lot # 654539/0742U) IM in the left deltoid. There was no concomitant medication. On 18-SEP-2007, 5 minutes after being vaccinated, the patient experienced dizziness and she needed to lie down. Her blood pressure was 112/76 after 20 minutes blood pressure was 102/78, pulse 80 and her dizziness resolved. She experienced a slight headache. On 18-SEP-2007, the patient recovered from the dizziness and slight headache. No additional information is expected.

VAERS ID:293281 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2007-09-18, Days after vaccination: 0
Gender:Male  Submitted:2007-10-09, Days after onset: 21
Location:Michigan  Entered:2007-10-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: CAFFEINE, MULTIVITAMIN
Current Illness: Mildly decreased ANC
Preexisting Conditions: Prematurity former 27 wk
Diagnostic Lab Data: Abdominal XR 9/21/07 - several mildly dilated loops of bowel; Ultrasound negative x 2 intussusception 10/17/07-Abdominal US no intusssusception mass is identified. Abdominal XR-no free intraperitoneal air, penumatosis or portal gas. Severa
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2765AA0IMLL
HEP: HEP B (FOREIGN)MERCK & CO. INC.0005U0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF218AB0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08690C0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0972U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Abdominal X-ray, Bowel movement irregularity, Decreased appetite, Haematochezia, Ileus, Irritability, Occult blood positive, Ultrasound scan normal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: Patient received immunizations on 9/18/07. 9/18/07 in evening has increase fussiness/emesis, 9/19/07 - was stooling normally with, intermittent emesis. Stool at 9/20/07, then no stool x 24 hours, then smell heme +, not grossly bloody stools. Admitted 9/21/07 with ileus, NBNB emesis, (see attached). 10/17/07-discharge summary included with report for DOS 9/21-9/23/07- DC DX: Possible viral GI infection. Two day history of poor po intake and vomiting as well as 1 day history of decreased stooling. Premature 27 weeks. Stool positive for trace occult blood. Previous hospitalization 9/14/07 with DX ALTE related to choking on medication. Mutlichannel study showed mild immature respiratory pattern with periodic breathing. 10/17/07-vac rec received no changes required.

VAERS ID:293367 (history)  Vaccinated:2007-09-18
Age:72.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-09-19, Days after onset: 1
Location:North Carolina  Entered:2007-10-16, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multiple meds for chronic disease
Current Illness: None except chronic
Preexisting Conditions: Multiple chronic diseases
Diagnostic Lab Data: None
CDC Split Type: NC07105
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0555U IMRA
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU2982AA5IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: 9/18/07 Pneumovax given (R) arm Td given (L) arm - (R) arm with 10 cm x 10 cm red, warm, tender, edematous resolved after 2 wks. Treated with Triamcinolone BID, Zyrtec 10 mg and Benadryl.

VAERS ID:293370 (history)  Vaccinated:2007-09-18
Age:45.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-09-20, Days after onset: 2
Location:Virginia  Entered:2007-10-16, Days after submission: 26
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 at this time
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0041U2IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 2.5 inc area of swelling and redness. Tx ice x 30 min Benadryl 25mg tb x 2. Observation x 1.5 hrs. Follow up next morning.

VAERS ID:295672 (history)  Vaccinated:2007-09-18
Age:10.0  Onset:2007-10-30, Days after vaccination: 42
Gender:Female  Submitted:2007-11-06, Days after onset: 7
Location:North Dakota  Entered:2007-11-06
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1093U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Pyrexia, Rash, Swelling face, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: puffy face; tender/itchy skin and rash to face, anterior arms; low grade fever; Treated with benedryl

VAERS ID:299712 (history)  Vaccinated:2007-09-18
Age:18.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2007-11-14, Days after onset: 57
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00815
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.658558/1061U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a Certified Registered Nurse Practitioner (CRNP) concerning an 18 year old female who on 18-SEP-2007 was vaccinated with GARDASIL vaccine (yeast) IM in her left deltoid (lot number 1061U). The patient received her injection on 18-SEP-2007 at 10:59 am. The patient called at 5:39 pm and stated the injection site itched, bumps appeared going down her arm that itched, she had swelling and pain at the injection site and she ran a slight fever. The patient took diphenhydramine hydrochloride (Benadryl) 50 mg po and the symptoms resolved (2007, exact date not reported). Additional information is not expected.

VAERS ID:298501 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2007-11-19, Days after vaccination: 62
Gender:Female  Submitted:2007-12-03, Days after onset: 14
Location:Ohio  Entered:2007-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations: extreme crying, high pitched crying~DTaP + HepB + IPV (Pediarix)~1~0.20~Sibling
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: x-rays, CT scans, surgery 1/9/08-records received-CT abnormal. Barium enema unsuccessful attempt at reduction of intussusception at approximately the level of the distal ascending colon near the level of hepatic flexure.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSPAC21B097AB0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF108AA0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0875U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Barium enema abnormal, Computerised tomogram abnormal, Haematochezia, Intussusception, Laparoscopy, Mucous stools, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)
Write-up: 11/19/07 began with abd. pain and vomiting. taken to ER in Findlay in evening, discharged to home when vomiting ceased. symptoms continued that week and febrile suppositories given. on 11/24/07 taken to PCACC and xray, CT scan done. transferred to Hospital and had surgery for intusseption. 1/9/08-records received for DOS 11/24-11/28/07. DC DX: Intussusception. Laproscopic reduction of ileocolonic intussusception. Five days prior to admission developed abdominal pain and emesis. Bowel movement present with bloody mucus 2-3 days prior to admission.

VAERS ID:299667 (history)  Vaccinated:2007-09-18
Age:0.4  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2007-12-13, Days after onset: 85
Location:Iowa  Entered:2007-12-13
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 noted
Preexisting Conditions: NKDA
Diagnostic Lab Data: Itchy red raised rash. On 11-29-07 doctor ordered to hold further immunizations for now.
CDC Split Type: IA07016
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B127AA1UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0064U1UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700D1UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0667U1PO 
Administered by: Public     Purchased by: Other
Symptoms: Rash papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Baby developed an unusual rash after 2nd set of shots. Rash developed in the 24 hrs after immunizations. A red raised rash was noted locally on 9-19-07. Baby put on an antibiotic. The rash worsened on 12-3-07.

VAERS ID:301653 (history)  Vaccinated:2007-09-18
Age:27.0  Onset:2007-09-20, Days after vaccination: 2
Gender:Female  Submitted:2007-11-16, Days after onset: 57
Location:Nebraska  Entered:2007-12-26, Days after submission: 40
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: She was on no other medications.
Current Illness: The patient had no illness at the time of vaccination.
Preexisting Conditions: The patient had no past medical history, no known allergies.
Diagnostic Lab Data: None
CDC Split Type: 200703341
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825A0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction, Injection site warmth, No reaction on previous exposure to drug, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Initial report received from a health care provider on 03 October 2007. A 27-year-old female patient had received a right deltoid intramuscular injection of Adacel, lot number C2825AA on 18 September 2007 and two days later, she developed redness, pain, warmth and hardness 6 cm x 7 cm around the injection site. On 23 September 2007, the skin at the affected area peeled like a sunburn. Corrective treatment included Tylenol, ice packs and a topical steroid. The symptoms subsided however the reporter stated that "a 1 cm and a 2 cm knot" were present under the skin at the affected area. The patient had not received any other vaccines during the four weeks prior to the receipt of Adacel. The patient had not experienced any adverse reaction after receipt of a tetanus and diphtheria booster dose in 1998. The patient had not recovered from the event and no further information was provided. Follow-up information received on 15 November 2007 from a health care professional. The redness, warmth, and pain resolved on 03 October 2007. One of the knots had resolved, and one knot of approximately five mm in size remained. Treatment included ice packs and topical Desonate. At the time of this report, all events had resolved except for one small knot at the injection area.

VAERS ID:313636 (history)  Vaccinated:2007-09-18
Age:7.0  Onset:2008-01-30, Days after vaccination: 134
Gender:Male  Submitted:2008-05-16, Days after onset: 106
Location:Pennsylvania  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: Peanut allergy
Preexisting Conditions: Asthma
Diagnostic Lab Data: diagnostic laboratory - 03/05/2008 - culture of lesions
CDC Split Type: WAES0803USA00888
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.658184/1094U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Culture, Rash vesicular, Varicella
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 7 year old male with peanut allergy and a history of mild asthma who was vaccinated with 0.5 ml subcutaneous doses of varicella virus vaccine live (Oka/Merck) on 07-FEB-2001 and 18-SEP-2007 (Lot# 658184/1094U). There was no concomitant medication. "About 3 weeks ago", on approximately 30-JAN-2008, symptoms of a rash began and two days ago, on 03-MAR-2008, a second rash developed. The rash was determined to be chickenpox. Rashes were described as vesicular and pustular lesions. At the time of the report the patient was seen in the office. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008. Additional information is not expected.

VAERS ID:313646 (history)  Vaccinated:2007-09-18
Age:16.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2008-05-16, Days after onset: 240
Location:Ohio  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA03732
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.658197/0853U1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Initial and follow up information has been received from a licensed practical nurse concerning a 16 year old female with a penicillin allergy and no pertinent medical history who on 22-APR-1996 was vaccinated SC in the left triceps with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck). On 18-SEP-2007 the patient received SC in the left arm a second booster dose of varicella virus vaccine live (Oka/Merck) (Lot#658197/0853U). Concomitant vaccines included a second dose of MSD vaccine (yeast) (Lot#658560/1062U) given in the right arm, and a dose of MENACTRA vaccine (dip toxoid) (Lot#U2402AAA) also given in the left arm. On 19-SEP-2007 the patient developed a swollen and red arm. The nurse told the mother to apply a warm compress, look for any red lines, or fever, and to let the office know if the patient''s arm did not improve. No lab studies were performed. On 20-SEP-2007 the mother called and said the arm was worse. The nurse instructed her to continue with the warm compresses. The nurse made a follow up call to the mother on 21-SEP-2007 and the arm continued to be reddened, but the swelling was less. 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:322104 (history)  Vaccinated:2007-09-18
Age:76.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Male  Submitted:2008-07-30, Days after onset: 316
Location:Florida  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: Thyroid disorder
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03448
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0962U IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Initial and follow up information has been received from a healthcare professional concerning a 76 year old male patient with no known drug allergies and a thyroid disorder, who on 18-SEP-2007, at 10:00 am, was vaccinated IM in the left deltoid, with a dose, 0.5 ml, of PNEUMOVAX (lot #658075/0962U). Later that day, he developed swelling and redness of his whole left arm, as well as a fever (value not specified). On 19-SEP-2007 ("the next morning"), the reaction had moved up and down the whole upper arm. On 20-SEP-2007, he visited the physician and was treated with BENADRYL, an injection of KENALOG, and an injection of ROCEPHIN. At the time of this report, the patient had recovered from the events (duration not specified). The HCP requested that a lot check be performed. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the research center and was released. Additional information is not expected.

VAERS ID:323373 (history)  Vaccinated:2007-09-18
Age:  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 316
Location:Maryland  Entered:2008-08-06, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA03272
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0061U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Pain in extremity, Wrong drug administered
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial and follow up information has been received from an RN and a practice manager concerning a female patient between the ages of 35-50 who on 18-SEP-2007 was inadvertently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U; instead of the flu vaccine. On 18-SEP-2007, the flu vaccine was to be given to elementary school teachers and their spouses. Due to human error (not product confusion), pneumococcal 23v polysaccharide vaccine, lot #655765/0061, was brought to the school and administered instead of the flu vaccine. The patient had pain down her entire arm (unspecified), which "settled in the wrist." Medical attention was sought. As of 21-SEP-2007, the patient "was ok." The nurse also reported on additional patients who received pneumococcal 23v polysaccharide vaccine, lot #655765/0061U, instead of flu vaccine; some of whom developed adverse reactions. The practice manager stated "is there anything wrong with this lot?" and a lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.

VAERS ID:329487 (history)  Vaccinated:2007-09-18
Age:4.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-09-26, Days after onset: 7
Location:New York  Entered:2008-10-21, Days after submission: 391
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient
Other Medications:
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ0548 SCRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.06S0U SCLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness and swelling of R upper arm. Warmth to touch noted mother also reports Pt had stomach pains. Pt was taken to ER on 9/19/2007. BENADRYL and AMOXICILLIN Q6 hour X 7 days were prescribed.

VAERS ID:338200 (history)  Vaccinated:2007-09-18
Age:  Onset:2007-09-18, Days after vaccination: 0
Gender:Unknown  Submitted:2009-01-12, Days after onset: 482
Location:Texas  Entered:2009-01-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject was born to a hepatitis B surface antigen negative mother. A second case was also reported see A0696035A. Two other cases were reported in September 2007, see A0682770A and A0682772A.
Diagnostic Lab Data: UNK
CDC Split Type: A0696084A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 0UNRL
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B surface antigen positive
SMQs:, Liver infections (narrow)
Write-up: On 18 September 2007 the subject received a birth dose of ENGERIX B (10 mcg, unknown). On September 2007, same day as the vaccination with ENGERIX B the subject tested positive for hepatitis B surface antigen. The subject was born to a hepatitis B surface antigen negative mother. Two vaccination dates were provided for ENGERIX B administration dates, 18 September 2007 and 19 September 2007. The laboratory report stated the hepatitis B surface antigen detection was performed on 18 September. No other information was provided. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. (GlaxoSmithKline).

VAERS ID:291929 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-10-02, Days after onset: 13
Location:Foreign  Entered:2007-10-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Blood Electrolytes 19-Sep-2007 normal, C-reactive protein 19-Sep-2007 normal, Chest X-ray 19-Sep-2007 normal, Electrocardiogram 19-Sep-2007 normal, Full blood count 19-Sep-2007 normal
CDC Split Type: FRWYE352321SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood electrolytes normal, C-reactive protein normal, Chest X-ray normal, Electrocardiogram normal, Erythema, Full blood count normal, Hypotonia, Loss of consciousness, Pallor, Staring, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional regarding an 8-week-old male patient who became pale on the body and red on the face, hypotonic and lost contact for a few minutes. The patient received the first dose on 18-Sep-2007. The patient was born at full term and had no relevant medical history. Concomitant medications were not reported. On 19-Sep-2007 at 12:00, i.e. 20 hours after immunisation, whereas the patient was bringing out of the bath, he became pale on the body and red on the face, hypotonic "like a rag doll" and lost contact with staring eyes but without abnormal movements. The patient recovered within a few minutes. He was hospitalized at 13:30. Investigations performed returned all normal results (see details in test results section). An EEG and a holter were scheduled. The events did not recur during the hospitalization. The patient''s discharge was scheduled on 20-Sep-2007. On 19-Sep-2007 test results were: full blood count (results: normal); blood electrolytes (results: normal); electrocardiogram (results: normal); chest X-ray (results: normal); and c-reactive protein (results: normal). No additional information was available at the time of this report.

VAERS ID:298179 (history)  Vaccinated:2007-09-18
Age:1.3  Onset:2007-09-19, Days after vaccination: 1
Gender:Male  Submitted:2007-11-27, Days after onset: 69
Location:Foreign  Entered:2007-11-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: AUWYEG00646607
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH18234 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Irritability, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 4-month-old male patient who experienced anorexia, facial rash and irritability. The patient received a dose on 18-Sep-2007. The patient experienced anorexia and facial rash on 19-Sep-2006 and irritability on 19-Sep-2007. The patient received Prevenar, Comvax and Infanrix-IPV on the 18-Sept-2006 and experienced anorexia, irritability and facial rash. The patient was admitted in the hospital and treated with hydration via IVT. The patient had recovered. The agency assessed causality as possible. No additional information was available at the time of this report.

VAERS ID:298270 (history)  Vaccinated:2007-09-18
Age:  Onset:2007-10-31, Days after vaccination: 43
Gender:Female  Submitted:2007-11-29, Days after onset: 29
Location:Foreign  Entered:2007-11-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04887
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Skin lesion, Vascular purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow)
Write-up: Information has been received from a female patient who on 18-SEP-2007 was vaccinated with Gardasil (lot number was not reported). Route and site of administration were not reported. On 17-NOV-2007, approximately 2 months after vaccination, the patient developed a few unspecified lesions, with subsequent aggravation. She was hospitalized and the diagnosis of vascular purpura was confirmed. The outcome was not reported. Follow-up information was received from a healthcare professional indicating that the patient''s lesions appeared one and a half months after vaccination (previously reported as 2 months). Work-up and cutaneous biopsy were planned to be performed at the hospital. At the time of reporting, the patient had not recovered. No further information is available. Other business partner numbers include E2007-08632.

VAERS ID:301150 (history)  Vaccinated:2007-09-18
Age:0.1  Onset:2007-09-18, Days after vaccination: 0
Gender:Unknown  Submitted:2007-12-26, Days after onset: 99
Location:Foreign  Entered:2007-12-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200704337
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906003D SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Crying, Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: Initial report received from health authorities in foreign country on 14 December 2007 under the reference number: PLURPLOCR20071128006. A 1-month-old patient of unspecified gender and medical history started inconsolable crying, became anxious, developed foot edema and redness of legs (primary source reaction: redness of feet, mother reported) on 18 September 2007, the day she/he received Act-Hib, DTP and EUVAX B (2 doses). The patient was hospitalised at an unspecified time and he/she recovered within an unspecified time frame.

VAERS ID:307254 (history)  Vaccinated:2007-09-18
Age:78.0  Onset:2007-09-19, Days after vaccination: 1
Gender:Female  Submitted:2008-03-17, Days after onset: 180
Location:Foreign  Entered:2008-03-18, 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: Hypertension; Hypercholesterolaemia
Preexisting Conditions:
Diagnostic Lab Data: ophthalmoscopy, hypertensive fundus with cotton wool focus; intraocular pressure was normal
CDC Split Type: WAES0803USA01980
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERM07A IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0394F IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blindness unilateral, Fundoscopy abnormal, Intraocular pressure test normal, Ophthalmological examination abnormal, Pruritus, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (narrow), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Hypersensitivity (broad)
Write-up: Information has been received from an agency concerning a 78 year old female with hypertension and hypercholesterolaemia who on 18-SEP-2007, was vaccinated IM with a dose of Pneumovax 23 (Lot# 654980/0394F; Batch# NE27420). Concomitant suspect therapy included a dose of INFLUVAC (Lot# M07A) vaccinated IM. On 19-SEP-2007, the patient experienced a sudden loss of vision in right eye and complained about pruritis. A Funduscopy revealed a hypertensive fundus with cotton wool focus. Her intraocular pressure was reported as normal. Since 30-OCT-2007, she felt well again. Her vision returned step by step but she still complained about temporary blurred vision. At the time of this report, the consumer recovered with sequelae. Loss of vision and pruritis were considered to be disabling and other important medical events. Other business partner numbers include: E200801990 and PEI2008001055. Additional information is not expected. The file is closed.

VAERS ID:313773 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2008-05-21, Days after vaccination: 246
Gender:Female  Submitted:2008-05-28, Days after onset: 7
Location:Foreign  Entered:2008-05-28
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0522130A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of rotavirus infection in a 11-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 18 September 2007 and 3 November 2007, the subject received 1st dose and 2nd dose of ROTARIX (oral), lots number not provided. On 21 May 2008, 8 months after 1st dose of ROTARIX and 6 months after 2nd dose of ROTARIX, the subject experienced rotavirus infection. This was regarded by GSK as a vaccination failure. The subject was hospitalised. At the time of reporting the events were unresolved. The case is associated to case B0522129A (subject''s twin) who also developed rotavirus infection at the same time. Additional information have been requested.

VAERS ID:313775 (history)  Vaccinated:2007-09-18
Age:0.2  Onset:2008-05-21, Days after vaccination: 246
Gender:Male  Submitted:2008-05-28, Days after onset: 7
Location:Foreign  Entered:2008-05-28
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0522129A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of rotavirus infection in a 11-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 18 September 2007 and 3 November 2007, the subject received 1st dose and 2nd dose of ROTARIX (oral), lot numbers not provided. On 21 May 2008, 8 months after 1st dose of ROTARIX and 6 months after 2nd dose of ROTARIX, the subject experienced rotavirus infection. This was regarded by GSK as vaccination failure. The subject was hospitalised. At the time of reporting the events were unresolved. The case is associated to case B0522130A (subject''s twin) who also developed rotavirus infection at the same time. Additional information have been requested.

VAERS ID:318492 (history)  Vaccinated:2007-09-18
Age:14.0  Onset:2007-12-11, Days after vaccination: 84
Gender:Female  Submitted:2008-07-07, Days after onset: 208
Location:Foreign  Entered:2008-07-08, 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: Serum cholesterol, 212 mg/dL
CDC Split Type: WAES0806USA08659
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood cholesterol increased, Deafness transitory, Dizziness, Headache, No reaction on previous exposure to drug, Tinnitus
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Lipodystrophy (broad)
Write-up: Information has been received from a health authority concerning a 14 year old female who was vaccinated with a first dose of GARDASIL (lot # not reported) on 18-SEP-2007. No adverse effects occurred. The patient was vaccinated with a second dose of GARDASIL (lot # not reported) on 27-NOV-2007. Two weeks post vaccination she developed headache and dizziness for 4 weeks. On 18-MAR-2008, the patient was vaccinated with the third dose of GARDASIL (lot # not reported). Two weeks post vaccination, the patient developed deafness for 1 day with subsequent tinnitus of the left ear for 3 weeks. The patient''s cholesterol was 212 mg/dL (date not reported). The patient was recovered at the time of reporting. It was reported that the deafness, tinnitus, headache and dizziness were other medically important events. Case closed. Other business partner numbers included: E2008-05825 and PEI2008008353. No further information is available.

VAERS ID:323267 (history)  Vaccinated:2007-09-18
Age:23.0  Onset:2008-06-10, Days after vaccination: 266
Gender:Female  Submitted:2008-08-25, Days after onset: 76
Location:Foreign  Entered:2008-08-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Myopia; Astigmatism
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 24Jun08, attached retina and secondary bleeding of vitreous body
CDC Split Type: WAES0808USA03452
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1113U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oedema, Retinal detachment, Ultrasound scan abnormal, Vitrectomy, Vitreous haemorrhage
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Accidents and injuries (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Retinal disorders (narrow)
Write-up: Information has been received from a health authority (HA ref No PEI2008012082) concerning a 23 year old female with myopia and astigmatism, who on 18-SEP-2007, was vaccinated with the first dose of GARDASIL, on 20-NOV-2007 was vaccinated with the second dose of GARDASIL and on 09-JUN-2008, was vaccinated with a third dose of GARDASIL (lot# 1113U batch# NH04240) i.m., into the left upper arm. On 10-JUN-2008, the patient experienced left retinal detachment with fissure of ora serrata. On 13-JUN-2008, the patient was hospitalized at an ophthalmic clinic where she underwent surgery (pars-plana-vitrectomy) on 16-JUN-2008. The retina was attached without complications. Postoperatively, secondary bleeding of vitreous body occurred. On 24-JUN-2008, the patient was discharged with the following results: ultrasound showed attached retina and secondary bleeding of vitreous body. Further examination on 01-AUG-2008 showed attached retina and rest edema. At the time of reporting the patient had not yet completely recovered. The previous two vaccinations with GARDASIL were well tolerated. Other business partner numbers included E2008-07746. No further information is available.

VAERS ID:338235 (history)  Vaccinated:2007-09-18
Age:17.0  Onset:2008-08-26, Days after vaccination: 343
Gender:Female  Submitted:2009-01-23, Days after onset: 150
Location:Foreign  Entered:2009-01-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Diagnostic Lab Data: brain biopsy, 26Aug08, reactive astrocytic gliosis; cerebrospinal fluid culture, increased number of cells
CDC Split Type: WAES0901USA02687
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy brain abnormal, CSF cell count increased, Cognitive disorder, Convulsion, Emotional disorder, Gliosis, Mental disorder due to a general medical condition, Psychotic disorder, Vasculitis cerebral
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from the foreign Health Authorities (Reference no.: PEI2008021098), concerning a 17 year old female patient, who on 18-SEP-2007, was vaccinated with the first dose of GARDASIL (toleration was not reported); on 20-NOV-2007, was vaccinated with the second dose of GARDASIL (toleration not reported) and on 11-MAR-2008, was vaccinated with third dose of GARDASIL, intramuscularly (Lot # and injection site not reported). Starting mid-Jun-2008, the patient developed cerebral vasculitis with acute psychotic symptoms and seizures. Cerebral biopsy, performed on 26-AUG-2008, revealed astrocytic gliosis. Lab finding showed increased number of cells in cerebrospinal fluid (=CSF). Despite of therapies with cortisone, neuroleptics and antiepileptics, the patient only improved slowly from the severe organic brain syndrome with slowdown, cognitive disorders and emotional symptoms. The cause of cerebral vasculitis remained unexplained. The patient had not recovered. Other business partner numbers included (E2009-00275). No further information is available.

VAERS ID:352105 (history)  Vaccinated:2007-09-18
Age:0.9  Onset:2008-04-28, Days after vaccination: 223
Gender:Female  Submitted:2009-07-22, Days after onset: 450
Location:Foreign  Entered:2009-07-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Stool rotavirus antigen positi, Apr2008, positive
CDC Split Type: D0062356A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 2PO 
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection, Rotavirus test positive
SMQs:
Write-up: This case was reported by a public health agency and described the occurrence of Rotavirus infection in an 11-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unknown date in 2007 the subject received the first dose of ROTARIX (0.5 ml, oral). On an unknown date in 2007 the subject received the second dose of ROTARIX (0.5 ml, oral). on 18 September 2007 the subject received the third dose of ROTARIX (0.5 ml, oral). Less than one year post vaccination with the first and second dose of ROTARIX and approximately seven months post vaccination with the third dose of ROTARIX, on 28 April 2008, the subject experienced Rotavirus infection. Stool Rotavirus antigen was tested positive. The subject has received complete vaccination with three doses of ROTARIX. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the event was unspecified. No further information will be available.

VAERS ID:382946 (history)  Vaccinated:2007-09-18
Age:16.0  Onset:2007-09-18, Days after vaccination: 0
Gender:Female  Submitted:2010-03-17, Days after onset: 911
Location:Foreign  Entered:2010-03-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Head computed axial tomography, 18?Sep07, unremarkable; electroencephalography, 18?Sep07, markedly abnormal demonstrating frequent epileptiform discharges; magnetic resonance imaging, 18?sep07, unremarkable
CDC Split Type: WAES1003USA01459
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Confusional state, Convulsion, Disorientation, Electroencephalogram abnormal, Epilepsy, Fatigue, Headache, Nuclear magnetic resonance imaging normal, Pain in extremity, Partial seizures, Somnolence, Tongue biting, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information was obtained on request by the company from the agency via a public case details form concerning a 16 year old female patient who on 18-SEP-2007 was vaccinated intramuscularly with a dose of GARDASIL (lot not reported). On 18-SEP-2007 the patient developed convulsion and was hospitalized. It was reported that the patient fell asleep on the school bus as she felt a little tired and recalled awakening approximately two hours later being in the back of an ambulance and taken to hospital to the ED. She was apparently disoriented and did not know her name and gave the wrong name and also did not know her parents'' names. Apparently she was sitting on the back seat of the bus disoriented and that she had three to four convulsions. She was confused, had a bad headache and vomited twice. She had bitten her tongue, had not been incontinent and the following day her arms and legs were really sore and she slept a lot. CT scan of head was unremarkable and EEG was markedly abnormal demonstrating frequent epileptiform discharges which occurred intermittently in the left frontal region. They were much more marked during sleep and were associated with continual focal low amplitude slowing. It was suspected that the patient had a focal seizure which secondarily generalized a number of times on the bus. Considering it all occurred within the one 24 hours period we called this a single event even though it was apparent that she had a cluster of seizures. The patient was observed in hospital emergency and later she discharged. Subsequent MRI was "unremarkable" and no further seizures within the following 3 months. The patient had been reviewed by a neurologist for 2 times and she was not prescribed anticonvulsants. At the time of this report, the patient had recovered from convulsion. The reporter felt that convulsion was possibly related to therapy with GARDASIL. The original reporting source was not provided. No further information is available.

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