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Case Details (Sorted by Vaccination Date)

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VAERS ID:311697 (history)  Vaccinated:2008-04-30
Age:0.2  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 1
Location:Michigan  Entered:2008-05-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: 2 hr NICU stay for resp distress
Diagnostic Lab Data: CBC-WBC 14.5. Labs and Diagnostics: CBC WNL. EEG WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B145AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF012AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC492710IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0019Y0PO 
Administered by: Private     Purchased by: Private
Symptoms: Apparent life threatening event, Cyanosis, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Hypotonia, Immunisation reaction, Pallor, Somnolence, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 6 hrs after vaccines given-pt had extreme pallor- circumoral cyanosis-extremely sleepy-poor feeding. Went to the ER. CBC normal EKG (-). 5/29/2008 MR received for DOS 4/30-5/01/2008 with DX: Acute Life Threatening Event s/p 1 month vaccinations. Infant found by parent in crib pale with circumoral cyanosis and limp. Lasted ~45". by arrival in ER infant was pink and smiling. W/U (-). Observed o/n with no further episodes.

VAERS ID:311707 (history)  Vaccinated:2008-04-30
Age:14.0  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 1
Location:California  Entered:2008-05-06, 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: tobramycin 0.3% eye drops-pres. 4/30/0
Current Illness: stye
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2552AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1268U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Eye movement disorder, Muscle twitching, Pallor, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: After patient received her 3 injections, she became pale and started slumping over. As mom and RN were helping her lay down they noticed her eyes deviating to the right and twitching of her mouth for no more than 15 seconds. She woke up right away and was appropriated. Vasovagal syncope.

VAERS ID:311738 (history)  Vaccinated:2008-04-30
Age:4.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-06, Days after onset: 5
Location:Tennessee  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NOT APPLICABLE
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2554AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR2106923SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0043X1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U1SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient was seen in Hospital Emergency Room 05/01/2008 for left leg swelling and rednes at injection site. Diagnosis was Acute Local Large Reaction. Reaction was at the site where Varicella was given.

VAERS ID:311752 (history)  Vaccinated:2008-04-30
Age:14.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 5
Location:Missouri  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sore throat - rapid strep screen negative and low threshold of risk for group A beta-hemolytic Streptococcus
Preexisting Conditions: Alleges allergic reaction to Pediazole, history of asthma and allergic rhinitis.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.196760IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.197741SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, Streptococcus identification test, Streptococcus identification test negative
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: rash at injection site -red, raised, 3 inches long by 2 inches wide at injection site on left upper arm.

VAERS ID:311772 (history)  Vaccinated:2008-04-30
Age:13.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Female  Submitted:2008-05-05, Days after onset: 4
Location:Massachusetts  Entered:2008-05-06, 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: Trazadone; Clonipin; Claritin; Miral
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B0163A IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1766U1SC 
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Inflammation
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness, inflammation of right arm, afebrile.

VAERS ID:311765 (history)  Vaccinated:2008-04-30
Age:0.4  Onset:2008-04-30, Days after vaccination: 0
Gender:Male  Submitted:2008-05-01, Days after onset: 1
Location:Michigan  Entered:2008-05-07, 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: Recurring wheezing & reactive airway disease
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B139AA IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF250AD IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC49918 IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1830U PO 
Administered by: Private     Purchased by: Public
Symptoms: Blepharospasm, Dyskinesia, Muscle twitching, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Patient had episode of unusual movements on day of vaccination. Movements involved brief twitching of arms and fluttering of eyelids. Duration only 15 seconds. Pt then noted to have fever temp 101.6. After this seemed unusually somnolent for 1 hour. After this returned to nl activity.

VAERS ID:311801 (history)  Vaccinated:2008-04-30
Age:12.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-01, Days after onset: 0
Location:New Mexico  Entered:2008-05-07, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B023AA0 RA
Administered by: Other     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 05/01/2008 10:30 AM student c/o "high fever", took temp 101 degrees. Called mother and she came to get him.

VAERS ID:311805 (history)  Vaccinated:2008-04-30
Age:0.2  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-07, Days after onset: 7
Location:Indiana  Entered:2008-05-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Pollen allergies
Diagnostic Lab Data: Bloodwork, CXR, Urine/stool samples - no results.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B136BB1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF294AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499200IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1620U0PO 
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Body temperature increased, Chest X-ray, Crying, Diarrhoea, Listless, Stool analysis, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Vomiting, persistent diarrhea started 4-30-08 at midnight. temp 101.4 degrees, Listless; High pitched crying. Pedialyte given. To ER on May 2. Vomiting, diarrhea ended May 3 at noon.

VAERS ID:311868 (history)  Vaccinated:2008-04-30
Age:25.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Female  Submitted:2008-05-02, Days after onset: 1
Location:North Carolina  Entered:2008-05-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: cough x 3 wks; URI; Sinus inflammation
Preexisting Conditions:
Diagnostic Lab Data: CBC
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Epistaxis, Full blood count, Hyperhidrosis, Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt has an area of redness and swelling the size of a 50 cent piece at injection site: c/o fever, chills and sweats onset 5/1/08. Also nose bleed. Fever on 5/1/08 102.9 now with intermittent fevers.

VAERS ID:311891 (history)  Vaccinated:2008-04-30
Age:25.0  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2008-05-08, Days after onset: 8
Location:Alabama  Entered:2008-05-08
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: None
CDC Split Type: AL0811
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 5/5/08 4:45 PM Pt. into clinic reported redness and swelling with tenderness to R.arm. Received Tdap in R.arm 4/30/08. Pt. states arm became swollen on 4/30/08. Pt. has been taking Tylenol. Arm is swollen, minimal redness to area. Advised to contiue Tylenol, Cold compression today followed by warm compression tomorrow. See MD if needed.

VAERS ID:311959 (history)  Vaccinated:2008-04-30
Age:5.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-05-02, Days after onset: 1
Location:Illinois  Entered:2008-05-09, 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: None
Current Illness: School Physical
Preexisting Conditions: Allergy to Amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ010093IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1170F1IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.117741IMRL
Administered by: Private     Purchased by: Other
Symptoms: Cellulitis, Injection site pain, Injection site urticaria, Injection site warmth
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Left upper thigh had hot wheal-like lesion at 8 cm diameter. C/O (L) leg pain. No fever. Dr Rx Cephalexin x 10 days - Dx: Cellulitis to leg.

VAERS ID:311988 (history)  Vaccinated:2008-04-30
Age:1.0  Onset:2008-05-08, Days after vaccination: 8
Gender:Female  Submitted:2008-05-09, Days after onset: 1
Location:Unknown  Entered:2008-05-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: "Allergy symptoms"
Preexisting Conditions: * 36wk gestation* Hx of eczema, allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB253BA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0746U0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC547633IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1506U0SCLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt presented with 25x30mm red, hot, raised area on lateral (L) thigh, noted yesterday morning, worsened today; no fever per mother. States pt has had a red "bump" at this site since receiving Varicella injection on 30 Apr 08; pt''s sister has had a similar delayed reaction to Varicella vaccine in the past. Mom states she was advised by a phone-advice nurse to place cold packs at the site, which may have contributed to the persistence of vaccine serum / irritation in the local tissue; pt was scratching the site throughout triage and screening today as well. Pt was diagnosed with cellulitis and placed on Cephalexin 250mg x 10 days.

VAERS ID:313485 (history)  Vaccinated:2008-04-30
Age:1.3  Onset:2008-05-21, Days after vaccination: 21
Gender:Female  Submitted:2008-05-27, Days after onset: 6
Location:Florida  Entered:2008-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol after vaccination
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF026AA3IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1800U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema multiforme, Pyrexia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Patient seen again on 5/21/08 with fever and an atypical varicella rash. Patient seen again on 5/23/2008 and diagnosed with fever and erythema multiforme minor most likely secondary to the varicella post vaccination. She has been afebrile since 5/23/2007 and rash is slowly resolving on a tapering dose of Prednisolone and hydroxyzine for symptomatic relief. No mucosal involvement. Lesions have scabbed over.

VAERS ID:314390 (history)  Vaccinated:2008-04-30
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Arkansas  Entered:2008-05-30
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
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURERMSD1758Y0IMRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERPMCC2899AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: none

VAERS ID:314729 (history)  Vaccinated:2008-04-30
Age:38.0  Onset:2008-05-03, Days after vaccination: 3
Gender:Female  Submitted:2008-05-27, Days after onset: 24
Location:New York  Entered:2008-06-03, 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:
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937BA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized swelling, treated with BENADRYL and hydrocortisone cream. Much improvement in 3days.

VAERS ID:314971 (history)  Vaccinated:2008-04-30
Age:46.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Female  Submitted:2008-06-04, Days after onset: 34
Location:Michigan  Entered:2008-06-04
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 reported
Preexisting Conditions: NKMA PT IS ASPLENIC
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1344U IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient complained of onset of Temp of 102 and nausea 24/hrs post injection. Noted localized redness and swelling at the injection site. (immunzation given 4/30/08 pm) Patient was seen by physician on 5/2/08 and was given course of antibiotics. 5/3/08 report per pt much improved. Redness and swelling down and temp @ 99''.

VAERS ID:314995 (history)  Vaccinated:2008-04-30
Age:10.0  Onset:2008-05-04, Days after vaccination: 4
Gender:Male  Submitted:2008-06-05, Days after onset: 32
Location:Pennsylvania  Entered:2008-06-05
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: autism
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1917U2SCLA
Administered by: Private     Purchased by: Public
Symptoms: Blister, Influenza like illness, Pyrexia, Rash erythematous, Rash maculo-papular, Rash pustular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 3-4 days after vaccine, developed fever and flu-like symptoms, then developed erythematous maculopapular rash. Had a few vesicles and pustules, no cellulitis

VAERS ID:315330 (history)  Vaccinated:2008-04-30
Age:6.0  Onset:2008-05-01, Days after vaccination: 1
Gender:Male  Submitted:2008-06-06, Days after onset: 36
Location:Pennsylvania  Entered:2008-06-06
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: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1784U SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Body temperature increased, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: swelling and redden 4x3 inches on (R) shoulder, mild tenderness. No fever on 5/26, from prev. day up to 101.5. No Rx, responed ice, Tylenol

VAERS ID:315643 (history)  Vaccinated:2008-04-30
Age:11.0  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 0
Location:Illinois  Entered:2008-06-09, Days after submission: 40
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2582AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Consciousness fluctuating, Dizziness, Dizziness postural, Head injury, Heart rate normal, Injection site oedema, Injection site pain, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Department of Health mass immunization clinic at elementary and high school to provide meningococcal vaccine in a large group setting. Patient received vaccination at 10:00 am was monitored in the same area for 20 minutes post vaccination. Patient went back to class. Teacher called school nurse up to room at 11:00 am. Stating child was light headed. School nurse immediately call 911 and brought child back to immunization area in stretcher/chair. VS: Pulse 68. Patient semi in and out of conscious. Ambulance arrive. Parent called by school nurse. School nurse escorted child in ambulance and transported to hospital. Pt same day transfered to another Hospital. 6/24/08-records received for DOS 4/30/08-C/O pain in right upper arm after vaccine. Dizziness when standing up after vaccine. Some weakness in legs. While at school pushed by another student and had mild bump on head no LOC. PE:WNL, upper extremity (R) at injection site mild edema, tenderness. Neuro exam WNL. Assessment:probably reaction to injection now fine

VAERS ID:389890 (history)  Vaccinated:2008-04-30
Age:61.0  Onset:2008-05-05, Days after vaccination: 5
Gender:Female  Submitted:0000-00-00
Location:Maryland  Entered:2008-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lymes Dx
Preexisting Conditions: Allergic rhinitis and childhood asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Rash erythematous, Rash pruritic, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 3 inch diameter itchy red warm erythematous rash resolved with Benadryl/triamcinolone 0.1%.

VAERS ID:343546 (history)  Vaccinated:2008-04-30
Age:0.5  Onset:2008-04-30, Days after vaccination: 0
Gender:Male  Submitted:2009-01-23, Days after onset: 268
Location:Connecticut  Entered:2009-04-03, Days after submission: 69
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: Environmental and food allergies. No known drug allergies. Had received DAPTACEL and PREVNAR on 18 April 2008 and later developed leg swelling and redness on the same day, as well as "full body tremors" two to three days later. No concomitant medication and no illness at the time of vaccination.
Diagnostic Lab Data:
CDC Split Type: 200900224
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURMF342A1UNUN
Administered by: Private     Purchased by: Other
Symptoms: Crying, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Initial report received on 20 January 2009 from a consumer, who is the patient''s parent. A 5 month old male patient, with a history of environmental and food allergies, received a second leg injection of ACT-HIB (lot number MF342AB, which is not a valid sanofi Pasteur lot number) on 30 April 2008. The patient had no concomitant medications and no illness at the time of vaccination. He had previously received a second right leg injection of DAPTACEL (lot number C2799AA) and a right leg injection of PREVNAR (other manufacturer, lot number not reported) on 18 April 2008 and had later developed leg redness and swelling and "full body tremors". After an unspecified amount of time on the day of ACT-HIB vaccination (30 April, 2008), the patient''s leg became extremely swollen and red at the injection site, lasting for two days. Also, the patient had inconsolable crying lasting two to three hours on the day of vaccination. No other information was provided. Case 2008-00223 was created to capture the events of leg swelling and redness and "full body tremors" which had occurred after the DAPTACEL and PREVNAR injections on 18 April 2008.

VAERS ID:314409 (history)  Vaccinated:2008-04-30
Age:0.3  Onset:2008-05-05, Days after vaccination: 5
Gender:Female  Submitted:2008-05-30, Days after onset: 25
Location:Foreign  Entered:2008-05-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound abdomen, 06May2008, ISunit
CDC Split Type: B0522202A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Enema administration, Intussusception, Malaise, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was in her weight and size according to her age and in good health. The subject''s did not have any medical history of intussusception. She had a twin sister who received ROTARIX the same day without developing any adverse event. On 30 April 2008 the subject received 1st dose of ROTARIX (oral) lot number not provided. On 5 May 2008, 5 days after vaccination with ROTARIX, the subject started to feeling unwell. On 06 May 2008 the subject was brought to hospital and intussusception was diagnosed after abdominal ultrasound. The subject did not have fever or diarrhea or bloody stools. The subject was hospitalised for 5 days and discharged completely recovered. The subject was treated with enema. The physician considered the events were almost certainly related to vaccination with ROTARIX. Further information was not expected and therefore this case has been closed.

VAERS ID:324110 (history)  Vaccinated:2008-04-30
Age:0.2  Onset:2008-04-30, Days after vaccination: 0
Gender:Male  Submitted:2008-09-03, Days after onset: 126
Location:Foreign  Entered:2008-09-04, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None provided
CDC Split Type: DEWYEG02083808
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 2-month-old male patient who experienced coma. The patient received the first dose on 30-Apr-2008. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced coma in the evening on 30-Apr-2008 after the first vaccination. The patient patient was reaminated by the emergency doctor. The patient is still in the rehab clinic at the time of this report. The outcome is unknown.

VAERS ID:333826 (history)  Vaccinated:2008-04-30
Age:0.2  Onset:2008-05-01, Days after vaccination: 1
Gender:Female  Submitted:2008-12-03, Days after onset: 216
Location:Foreign  Entered:2008-12-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811AUS00205
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA400A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA400A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA400A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA400A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH28592 IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0811U7PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling hot, Gaze palsy, Hypotonic-hyporesponsive episode, Irritability, Pallor, Poor sucking reflex, Somnolence, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ocular motility disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning an 8 week old female who on 30-APR-2008 was vaccinated with ROTATEQ (Batch # 0811U, Lot # 657657/0811U). Other suspect therapy included INFANRIX HEXA (Batch # A21CA400A) and PREVENAR (Batch # 28592). On 01-MAY-2008 the patient experienced feeling hot, hypotonic-hyporesponsive episode, irritability and somnolence and was hospitalised. It was described that the child initially was warm and irritable, slept 10 hours and was difficult to rouse, poor sucking, became pale, unresponsive and her eyes rolled back. At the time of reporting the agency on 02-JUN-2008, the patient had recovered from feeling hot, hypotonic-hyporesponsive episode, irritability and somnolence. The agency considered that feeling hot, hypotonic-hyporesponsive episode, irritability and somnolence were possibly related to therapy with ROTATEQ, INFANRIX HEXA and PREVENAR. The original reporting source was not provided. Additional information is not expected.

VAERS ID:341495 (history)  Vaccinated:2008-04-30
Age:17.0  Onset:2008-04-30, Days after vaccination: 0
Gender:Female  Submitted:2009-03-10, Days after onset: 314
Location:Foreign  Entered:2009-03-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Magnetic resonance imaging, 05?Oct08, diagnose was first inflammatory event of central nervous system; Magnetic resonance imaging, two new lesions without any gadolinium contrast uptake
CDC Split Type: WAES0903USA00870
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Central nervous system inflammation, Incorrect route of drug administration, Nuclear magnetic resonance imaging abnormal, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Information has been received from the health authorities (reference numbers LL20090063 and LL0900064) concerning a 17 year old female patient with no relevant medical history who on 07-FEB-2008 was vaccinated with the first dose of GARDASIL (lot number, site and route not reported). On 30-APR-2008, the patient received the second dose of GARDASIL (lot number and site not reported) via an inappropriate route i.e. subcutaneous route instead of intramuscular route. On 05-OCT-2008 the patient presented with right visual acuity decreased. After work-up (clinical examination, MRI, no lumbar puncture because the patient refused it) diagnosis was first inflammatory event of central nervous system (or clinically isolated syndrome). There was a 100 percent recuperation after a bolus of Solumedrol 3 g. There was hospitalization (unspecified dates). The patient was vaccinated with a third dose of GARDASIL (lot number, site and route not reported) on 10-OCT-2008. Evolution: 3 months control MRI showed 2 new lesions without any gadolinium contrast uptake. There was no diagnosis of multiple sclerosis in this case due to the absence of temporal dissemination. At time of reporting the patient had not recovered from inflammation of central nervous system. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination was "doubtful" (C1 S1 L1) according to the foreign method of assessment. Other business partner numbers included: E2009-01933. Additional information has been requested.

VAERS ID:344398 (history)  Vaccinated:2008-04-30
Age:17.0  Onset:2008-05-03, Days after vaccination: 3
Gender:Female  Submitted:2009-04-17, Days after onset: 349
Location:Foreign  Entered:2009-04-20, 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: Upper respiratory tract infection
Preexisting Conditions:
Diagnostic Lab Data: diagnostic laboratory test, 02Jul08, anti-proteasome antibody: positive; abdominal ultrasound, 02Jul08, mild splenomagaly; ultrasound, 02Jul08, total volume of thyroid gland above the normal range, unusual for HASHIMOTO''s thyroiditis; ultra
CDC Split Type: WAES0904USA02133
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1068U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Anti-thyroid antibody positive, Antibody test positive, Antinuclear antibody increased, Autoimmune thyroiditis, Biopsy muscle abnormal, C-reactive protein increased, Enterovirus serology test positive, Goitre, Haemoglobin decreased, Hypochromic anaemia, Malaise, Muscle spasms, Muscle swelling, Myositis, Oedema, Pain in extremity, Polymerase chain reaction, Pyrexia, Splenomegaly, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Ultrasound thyroid abnormal, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vasculitis (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a pharmacist. It was reported that a female patient (age not reported) was vaccinated with a dose of GARDASIL (lot # not reported) on an unspecified date. Subsequently, the patient developed lymphoma (date not reported). No further information on the outcome etc has not been made available at the time of reporting. Further information was requested. Follow up information received on 07-APR-2009. The hospital report, the reporting form and a doctor''s letter was provided. It was confirmed that the patient did not develop a lymphoma, this was reported by mistake by the pharmacist. It was reported that the 17 year old female patient was vaccinated IM with a first dose of GARDASIL (batch # NH06410, lot #1068U, injection site illegible) on 30-APR-2008. On 03-MAY-2008 to 31-MAY-2008 and on 03-JUN-2008 to 04-JUN-2008 the patient developed increasing gain and cramps of the calves on effort. Due to these symptoms she was hospitalized from 08-JUN-2008 until 10-JUN-2008. Vein thrombosis was excluded by a specialist. The patient was treated with ibuprofen. After discharged the complaints were persisting. On 20-JUN-2008 the patient was hospitalized again in a pediatric hospital. She had fever and CRP increase of 140 mg/l. Antibiotic therapy with cefuroxime, clindamycin and Vancomycin was initiated. Purulent myositis was suspected. MRI showed an enhancement of the calf muscles. Sonography showed edema of several calf muscle. As the antibiotic therapy was not sufficient enough the patient was transferred to another hospital to clarify by a muscle biopsy the suspicion of an autoimmunologic or vascular disease on 02-JUL-2008. At that time the patient complained of malaise, feeling swollen of the calves, appetite lost and weight loss (6kg) during the last 4 weeks. On 02-JUL-2008 CRP was increased (8.48 mg/dl), Hb was decreased 9.0 g/dl. Autoimmune diagnostic showed ANA slightly increased (1:160), thyreogolobulin and anti-TPO antibodies were increased (478U/ml and 2900U/ml). Serology for enteroviru

VAERS ID:377703 (history)  Vaccinated:2008-04-30
Age:15.0  Onset:2008-08-01, Days after vaccination: 93
Gender:Female  Submitted:2010-01-20, Days after onset: 537
Location:Foreign  Entered:2010-01-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Vasovagal reaction; Stomach ache
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1001USA01332
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1147U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Crohn's disease, Diarrhoea, Haematochezia, Reaction to previous exposure to any vaccine
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning adolescent female patient aged 15 or 16 year old who on 30-APR-2008 was vaccinated with the third dose of GARDASIL (batch number NH06740, lot number 1147U). In August 2008, i.e. four months after vaccination, the patient developed stomach ache. In September 2008, she also presented with repeated diarrhoeas. The patient was hospitalized. Blood was found in her stools. Different examinations were performed (no further specification). The diagnosis of Crohn''s disease was established. The patient was treated with PENTASA and corticosteroids. To be noted that after receiving the first dose of GARDASIL, she had experienced in December 2007 malaise, vertigo, nausea, lose of consciousness, cephalgia and hypotension at 10/6. She had been hospitalized. vagal malaise had been diagnosed. She had recovered on an unspecified date. Case linked with serious case E2010-00198 (same reporter, same patient, same product, but different dose and different reaction). The patient had received second dose of GARDASIL in December 2007 and had developed stomach ache which had been treated with SPASFON. At the time of reporting, the patient was doing better but pain still persisted.

VAERS ID:311411 (history)  Vaccinated:2008-05-01
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-01
Location:Michigan  Entered:2008-05-01
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.087402IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.125900IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.052700SCLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.138800PO 
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: NO ADVERSE EFFECTS AT PRESENT IMMUNIZATION GIVEN OUT OF RECOMENDED GUIDELINES (ROTAVIRUS)

VAERS ID:311439 (history)  Vaccinated:2008-05-01
Age:22.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 0
Location:Ohio  Entered:2008-05-01
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: Migraines, Endometriosis
Diagnostic Lab Data: None known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0073X0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: Temperature per patient 99.2 - patient took Tylenol. Weakness - no treatment done.

VAERS ID:311451 (history)  Vaccinated:2008-05-01
Age:10.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-05-02, Days after onset: 1
Location:Massachusetts  Entered:2008-05-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: ~Measles + Mumps + Rubella (no brand name)~2~5~In Patient
Other Medications:
Current Illness: none
Preexisting Conditions: reaction to MMR vaccine 5 yrs prior, PDD-NOS, cleft lip/palate
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1997U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Pain, Pharyngeal oedema, Rash macular
SMQs:, Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Pt given vaccine (Varivax) approx 5 min later c/o throat swelling, lip stinging, red blotchy rash noted on R arm where vaccine given. Administered Benadryl, epi. Sent pt to local ER via ambulance.

VAERS ID:311646 (history)  Vaccinated:2008-05-01
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-05
Location:Unknown  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After receiving injection pt. walked out of room and started feeling dizzy and passed out on the floor. Pt. eyes were open and pt. was alert. Pt states felt very lightheaded. Went into room and laid on the table s/p check. Pt. remained on table x 30 min. Discharged in stable condition.

VAERS ID:311731 (history)  Vaccinated:2008-05-01
Age:42.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Minnesota  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1743U4SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dry skin, Injection site urticaria, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient is an employee at the clinic, I do employee health at the clinic. For our policy, we have to have proof of immunization of 2 MMR''s along with other required immunizations. I noted she only had 1 MMR which was given elsewhere, so I did give her another to meet employee clinic policy. She said 1 day after injection, she got a 4 inch red raised welt at her injection site which went away in 2 days. She also said she developed on her lower abdomen a red raised itchy rash. She did see her Dr. in another clinic which diagnosed her abdomen rash as dry skin. She got Eucerin cream to use prn at home. She also mentioned that the rash is mild in the am, but gets worse in the pm. I did see the abdomen rash this am, and it was pink and welty looking. She said that the Doctor she seen did not feel that it was related to the vaccine. At the time, she states that she was remodeling her home and could have gotten exposed to something there.

VAERS ID:311744 (history)  Vaccinated:2008-05-01
Age:27.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:New York  Entered:2008-05-06
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA1IMRA
Administered by: Public     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Severe rash developing all over the patient body a day after the vaccination.

VAERS ID:311747 (history)  Vaccinated:2008-05-01
Age:19.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 4
Location:Michigan  Entered:2008-05-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acutane
Current Illness: None
Preexisting Conditions: Acne
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2604AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Dyspnoea, Injection site bruising, Injection site erythema, Injection site swelling, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: 5-2-08 Body Aches, 5-3-08 Fever, Body Aches & shortness of Breath took advil symptoms resolved by 5-4-08. Had developed increased Redness, swelling and brusing at the injection site (right deltoid) 5-2-2008. The patient called the family physician and he recommended taking benadrylx2.

VAERS ID:311846 (history)  Vaccinated:2008-05-01
Age:14.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-05-06, Days after onset: 5
Location:Florida  Entered:2008-05-08, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had a history of allergies to Augmentin and peaches, as well as seasonal allergies. He had no illness at the time of vaccination on 01 May 2008.
Diagnostic Lab Data:
CDC Split Type: 200801391
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2613AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash pruritic, Throat irritation, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a health care professional on 02 May 2008. A 14-year-old male patient with a medical history of allergies to Augmentin and peaches, as well as seasonal allergies, had received an intramuscular injection of Menactra, lot number U2613AA, on 01 May 2008 at 4:00 PM. 60 minutes later, the patient called the physician''s office to report symptoms of scratchy throat and an itchy rash on his abdomen. He also experienced wheezing, but his breathing was not labored. He was seen in the emergency room and was treated with IV steroids (unspecified). He was discharged to home with an Epi-Pen and prescriptions for prednisone and Zyrtec. The physician''s office followed up with the patient on 02 May 2008 and reported that he was doing well and had recovered from the events.

VAERS ID:311873 (history)  Vaccinated:2008-05-01
Age:4.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Female  Submitted:2008-05-05, Days after onset: 3
Location:California  Entered:2008-05-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: viral illness on 4/29/08
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2354CA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2523AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA047423IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1671U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: LD area red, swollen and warm. X3 days.

VAERS ID:311889 (history)  Vaccinated:2008-05-01
Age:4.0  Onset:2008-05-07, Days after vaccination: 6
Gender:Male  Submitted:2008-05-07, Days after onset: 0
Location:California  Entered:2008-05-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR 4 LA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR 3 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1 RA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L upper extremity swelling and redness, itching of the area.

VAERS ID:311895 (history)  Vaccinated:2008-05-01
Age:28.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Male  Submitted:2008-05-08, Days after onset: 6
Location:Wisconsin  Entered:2008-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN
Diagnostic Lab Data: Aerobic Culture: few staphylococcus coagulase negative, done at MC early am. Intraoperative cultures done no growth in 72 hours. BMP done 5/3/08 Chloride at 108 and high. BMP done 5/4/08, total CO2 at 21 and low, Ca+ 8.2 and low, CBC done 5/3/08 with WBC at 14.3 and high, neutrophils at 10.6 and high, monocytes at 1.2 and high, lymphs at 15 and low. CBC 5/4/08 wnl.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1744SCLA
Administered by: Military     Purchased by: Military
Symptoms: Bacterial culture negative, Blood calcium decreased, Blood chloride increased, Carbon dioxide decreased, Cellulitis, Debridement, Erythema, Full blood count, Induration, Lymphocyte morphology abnormal, Metabolic function test, Monocyte count increased, Neutrophil count increased, Soft tissue infection, Surgery, Swelling, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Malignant lymphomas (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad)
Write-up: Patient had Anthrax vaccination on 5/1/08 and developed increasing redness and welling. Was seen at MC ER on 5/3/08 and transferred to MC for definitive care. On exam, L upper extremity with very large cellulitic area extending across the deltoid, biceps and posterior left upper arm. Area of induration was present and appeared somewhat fluctuant anteriorly. This area measured 15 by 20cm. Diagnosed with L upper extremity deep soft tissue infection. Area was incised and debrided in the operating room and intraoperative cultures were taken. Hospital admission for IV Vancomycin treatment. Discharged on 5/4/08 with Vicodin and Clindamycin. Wound packing q day. Open wound to L upper arm measures 4.5 inches by 2 inches by 1.5 inches. 5/21/08-records received for DOS 5/3-5/6/08: DC DX: Cellulitis possible reaction to anthrax vaccine. Deep soft tissue infection, left upper extremity. Incision and debridement of left upper extremity soft tissue infection. PE: fluctuance and cellulitis, pain over injection site.

VAERS ID:312117 (history)  Vaccinated:2008-05-01
Age:39.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-05, Days after onset: 4
Location:South Carolina  Entered:2008-05-12, 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: Allergy serum .50cc SQ every week
Current Illness:
Preexisting Conditions: Allergic to tetracycline, cats, dust mites
Diagnostic Lab Data:
CDC Split Type: SC0805
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB526AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Temp 99.5-100.5 from 5/1/08 through 5/5/08

VAERS ID:312529 (history)  Vaccinated:2008-05-01
Age:11.0  Onset:2008-05-03, Days after vaccination: 2
Gender:Female  Submitted:2008-05-16, Days after onset: 13
Location:New Jersey  Entered:2008-05-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 21 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism
Preexisting Conditions: PMH: Hypocalcemia. Hypothyroidism
Diagnostic Lab Data: spinal tap 05/03/08 - Partially abnormal. Labs and Diagnostics: CSF cell count 322 with 232 RBCs. CSF Glucose 79. CSF protien 113.7. Repeat 5/13/08 with CSF cell count down to 13, glucose 62, protein 22.4. CSF cx (-). Brain MRI c/w meni
CDC Split Type: WAES0805USA01353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Angiogram, Blood thyroid stimulating hormone increased, Bruxism, C-reactive protein increased, CSF cell count abnormal, CSF culture negative, CSF glucose increased, CSF oligoclonal band absent, CSF protein increased, CSF virus no organisms observed, CSF white blood cell count increased, Complement factor C3 increased, Complement factor C4 increased, Computerised tomogram abnormal, Convulsion, Disorientation, Encephalitis, Encephalopathy, Epstein-Barr virus antibody positive, Faecal incontinence, Full blood count, Gaze palsy, Headache, Hyperreflexia, Hyporeflexia, Lumbar puncture abnormal, Malaise, Mental status changes, Muscle rigidity, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity, Pleocytosis, Red blood cells CSF positive, Scan brain, Thyroxine free decreased, Tremor, Unresponsive to stimuli, Vitamin D abnormal, White blood cell count increased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 11 year old female patient with hypothyroidism who on 01-MAY-2008 was vaccinated with a first dose of Gardasil. Concomitant therapy included SYNTHROID. On 03-MAY-2008 the patient experienced encephalopathy after receiving the first injection, was seen at the emergency room (ER). Subsequently she was hospitalized. Laboratory diagnostic test spinal tap was done. No further information was provided. The patient had not recovered. Additional information has been requested. 06/16/2008 MR received from CDC for DOS 5/6-27/2008 with D/C DX: Meningoencephalitis. Hypothyroidism. Hypocalcemia. Pt presented to local ER with c/o pain in the arms and legs, headache and then episodes of shaking of the arms and legs, stool incontinence and unresponsiveness and progressive changes in mental status. In local ER had witnessed episode of eye rolling and shaking of the arms and legs. Transfered to current facility for further w/u. CSF showed WBC pleocytosis. PE (+) for brisk DTRs on the L and difficult to elicit on the R. 10/6/2008 Additional records received from initial ER 5/3/08. Pt presented with disorientation and not feeling well since 5/2/08. Had Gardasil 5/1/08. In ER had several episodes of tremors, clenched teeth, rigid, downward going toes and clenched hands drawn to the chest. Transfered to above facility to r/o meningitis.

VAERS ID:312715 (history)  Vaccinated:2008-05-01
Age:17.0  Onset:2008-05-19, Days after vaccination: 18
Gender:Female  Submitted:2008-05-20, Days after onset: 1
Location:Louisiana  Entered:2008-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0004X1SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Patient was ~34-35 weeks pregnant at time of the immunization administration. No UPT was done prior to administration. Patient delivered an infant girl on 5/19/2008 at ~37 weeks EGA. No prenatal care received. Infant appears well at this time, but will report this immunization administration if adverse events were to occur at a later date.

VAERS ID:313033 (history)  Vaccinated:2008-05-01
Age:35.0  Onset:2008-05-05, Days after vaccination: 4
Gender:Female  Submitted:2008-05-22, Days after onset: 17
Location:Oregon  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL-CHLORTHALIDONE 50 MG-25 MG TAB 30 11 5/13/2008 5/13/2008 Sig: 1 tablet by mouth daily for high blood pressure DEPO-PROVERA 150 MG/ML IM SYRINGE administered 4/30/08 TRAZODONE 50 MG TAB
Current Illness: none
Preexisting Conditions: HTN
Diagnostic Lab Data: CT, MRI done 5/4 or 5/5. I do not have report to attach.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB096AA0IMGM
TDAP: TDAP (ADACEL)SANOFI PASTEURC2888AA IMGM
Administered by: Unknown     Purchased by: Unknown
Symptoms: Back pain, Balance disorder, Chest pain, Communication disorder, Computerised tomogram, Decreased appetite, Disturbance in attention, Dizziness, Essential hypertension, Headache, Hyperhidrosis, Hypoaesthesia, Laboratory test, Nausea, Neck pain, Nuclear magnetic resonance imaging
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Pt is a 35 year old female here for follow up of an acute headache. She has been having symptoms since 5/2/08. She was seen in the ER 5/4/08 with the headache after she woke up with diaphoresis, chest pain, dizziness, numbness in fingertips, and headache behind eyes. CT scan was done and was read as possible mild swelling and she was called back to the ER. Subsequent MRI with nonspecific changes.There was an initial plan to do an LP but with the MRI results and a shift change the plan change and she was sent home. She had trouble taking care of her son because of the headache and dizziness. She was seen again 5/10/08 in the ER, was given parenteral non narcotic and anti nausea medication. She continues to have headache in the face and behind her eyes as well as pain in the neck(spine) which radiates down to buttock, decreased appetite and nausea. She is no longer having vomiting. She does not feel as mentally sharp as she usual and actually recalls some problems talking/communicating when she was in the ER. EXAM: Pleasant, alert and oriented, very clear historian. BP 122/92 | Pulse 68 | Temp 98.1 | Wt 130 lbs (59.0kg) | SpO2 100% | LMP 04/15/2008 | Pain Score: 5-Worst Alert and oriented x 3. Ears and throat normal. Neck fully supple without nodes. Cranial nerves are normal. Fundi are poorly visualized. DTRs normal and symmetric. Babinski sign absent. Mental status normal. Minimally unsteady on Romberg with a non specific sway. FTN nl.Sensation intact to LT. Motor normal. ASSESSMENT/PLAN: 784.0 HEADACHE (primary encounter diagnosis): TC to ER.TC to Dr. for a phone consult who agrees that an LP is indicated to evaluate the headache. Dr. agrees that an LP is reasonable. Pt will return to the ER for an LP to evaluate for aseptic meningitis, etc. 642.03 ESSEN HYPERTEN-ANTEPART Plan: ATENOLOL-CHLORTHALIDONE 50 MG-25 MG TAB, DOSE INCREASED AS BP ON MY RECHECK WAS 150/100. COMPREHENSIVE METABOLIC PANEL

VAERS ID:313449 (history)  Vaccinated:2008-05-01
Age:17.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-20, Days after onset: 19
Location:North Carolina  Entered:2008-05-27, 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: Contact Dermatitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient passed out, approx, 5 mins. after injection.

VAERS ID:314750 (history)  Vaccinated:2008-05-01
Age:21.0  Onset:2008-05-06, Days after vaccination: 5
Gender:Female  Submitted:2008-05-21, Days after onset: 15
Location:Minnesota  Entered:2008-06-03, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall XP; Cleocin gel; Azelax Cream
Current Illness: None known
Preexisting Conditions:
Diagnostic Lab Data: WBC 11.7; Sed Rate 30; Uric Acid - neg; Blastomyces - neg; CRP 3.4; Lymes - neg; CCP - neg
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Blood uric acid normal, Borrelia burgdorferi serology negative, C-reactive protein increased, Injection site pain, Pain in extremity, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt stated she experienced some tenderness at injection site. Later in day after injection approximately 4 days after injection she c/o bilateral forearm and wrist pain and tenderness in (L) foot. Approximately 10 days after injection c/o pain in arms, wrists, ankles and knees. Pt was tx''d with Levaquin, Doxycycline, Lor-Tab, Toradol, and Prednisone with minimal relief. Urgent care visits x 2 ER x 2 and PCP x 1.

VAERS ID:314981 (history)  Vaccinated:2008-05-01
Age:50.0  Onset:2008-05-06, Days after vaccination: 5
Gender:Male  Submitted:2008-06-04, Days after onset: 29
Location:Washington  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic leukopenia & heart murmur. Allergies to: Hyrdrocodone, darvocet, tree,weed grass pollens
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR02842AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Dizziness, Headache, Pyrexia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Pt. contacted clinic on 05/06/08stating that at 0600 on 05/02/08 (day after Tdap) he experienced chiils, fever of 101, dizziness, headache, & feeling as if his throat was constricting. There was no local reaction noted by pt. & he did not seek medical treatment at the time. He reported feeling fine by the next day.***Pt. regularly receives allergy shots which were administerd in each arm at that appt.

VAERS ID:317086 (history)  Vaccinated:2008-05-01
Age:0.3  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-06-13, Days after onset: 43
Location:New Mexico  Entered:2008-06-16, 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: None
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA00873
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.13941PO 
Administered by: Other     Purchased by: Other
Symptoms: Accidental overdose, Constipation
SMQs:, Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 4 month old male with no pertinent medical history or drug allergies who on 01-MAY-2008 was vaccinated PO with a first and second dose of ROTATEQ (lot# 657987/1394U, 657987/1394U) on the same day. Concomitant vaccinations administered on that same day included a dose of ACTHIB, a dose of PEDIARIX and a dose of PREVNAR. On 02-MAY-2008 the patient experienced constipation. The patient''s mother contacted the office at the time of the event and the patient was scheduled to come into the office on 05-MAY-2008 to see the physician. No labs or diagnostic studies were performed. The outcome was unknown. There was no product quality complaint. No further information is available. Additional information has been requested.

VAERS ID:316397 (history)  Vaccinated:2008-05-01
Age:31.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-06-17, Days after onset: 47
Location:North Carolina  Entered:2008-06-17
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB526AA2IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224BA1IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0805 SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2568AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Pt received vaccines late afternoon, played sports in early evening, and during the night began to experience fever(102.9) and chills. These continued through the night and into the next day with fever breaking during the afternoon.

VAERS ID:316952 (history)  Vaccinated:2008-05-01
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2008-05-06
Location:Texas  Entered:2008-06-23, Days after submission: 48
Life Threatening? No
Died? Yes
   Date died: 2008-05-05
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZMAX
Current Illness: SINUSITUS
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B142AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF238AF0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08702B0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1231F0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)
Write-up: INFANT IN BED WITH PARENTS AT TIME OF DEATH. 6/30/08 Autopsy report states COD as SID, pt found unresponsive in bed w/parents.

VAERS ID:317698 (history)  Vaccinated:2008-05-01
Age:77.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-26, Days after onset: 56
Location:Unknown  Entered:2008-06-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory, 05?/??/08, negative for shingles
CDC Split Type: WAES0806USA03832
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Laboratory test, Pain, Rash generalised, Skin reaction, Varicella zoster serology negative
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a consumer concerning her 77 year old grandmother who about a month ago, was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included baby aspirin. The consumer reported that her grandmother experienced a severe skin reaction about one week after receiving ZOSTAVAX (Oka/Merck). Physician ruled out shingles. The patient had a rash all over including her abdomen, arms and legs. She was in extreme pain and was not able to work for a while. She was treated with unspecified antibiotics and creams. Lab diagnostics studies performed was reported as: negative for shingles. Patient had recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.

VAERS ID:320796 (history)  Vaccinated:2008-05-01
Age:30.0  Onset:2008-07-01, Days after vaccination: 61
Gender:Female  Submitted:2008-07-25, Days after onset: 24
Location:Texas  Entered:2008-07-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA. Not pregnant. No medical problems. I take a multivitamin but no other medications. I have one D&C when I was 25 years old and one LEEP done in April this year. No major surgeries.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.152112UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Inappropriate schedule of drug administration, Presyncope
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: I completed my series of the GARADASIL vaccines last month. I have no idea if I am having a side effect from the vaccine but over the last 3 weeks I have been having the occasional dizzy spells. I have never had an actual syncopal episode, just the near syncopal episodes. I am an ER nurse and am familiar with the fact that many people try to relate medical problems to sides effects of their medications. I know that many people have reported unusual symptoms after receiving GARDASIL so I thought I would mention my near syncopal episodes although they may not be related. I have never had any serious medical or health problems though. I did have a thorough lab work up back in January after I turned 30, and my lab work was perfect. I have not had any labs tests done since then.

VAERS ID:326480 (history)  Vaccinated:2008-05-01
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-14
Location:New York  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: MRI
CDC Split Type: WAES0807USA05764
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Headache, Loss of consciousness, Nuclear magnetic resonance imaging
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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a 16 year old female who in May 2008, complete her series of GARDASIL vaccine (yeast). In 2008, the patient experienced chest pain and she also had pressure in her head that caused blacking out. The patient had no problems when the series of GARDASIL vaccine (yeast) was completed. An MRI was performed (results not reported). At the time of this report, the patient was recovering. The patient sought medical attention. Additional information has been requested.

VAERS ID:326501 (history)  Vaccinated:2008-05-01
Age:  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 105
Location:Michigan  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00149
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, No reaction on previous exposure to drug
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a registered nurse concerning a female who on unspecified dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). In May 2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast), 0.5 mL, IM, and developed nausea. The patient sought medical attention at the office. At time of reporting, the patient had not recovered. Additional information has been requested.

VAERS ID:324178 (history)  Vaccinated:2008-05-01
Age:2.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-05-02, Days after onset: 1
Location:California  Entered:2008-09-04, Days after submission: 125
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC29518A3UNLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt vomited, pt felt fatigued.

VAERS ID:326783 (history)  Vaccinated:2008-05-01
Age:  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2008-09-15, Days after onset: 137
Location:Unknown  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA01390
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from a male who in May 2008, was inadvertently vaccinated with a dose of GARDASIL vaccine (yeast) instead of hepatitis B for the third dose. No adverse experiences reported. No further information is available.

VAERS ID:327102 (history)  Vaccinated:2008-05-01
Age:  Onset:2008-08-01, Days after vaccination: 92
Gender:Unknown  Submitted:2008-10-02, Days after onset: 62
Location:Arkansas  Entered:2008-10-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04511
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a patient who in May 2008, completed the series of GARDASIL (lot # was not available). In August 2008, the patient experienced seizures episodes. At the time of recovering, the patient was recovering from seizures episodes. Physician noted that the patient is blaming GARDASIL for her seizures. The patient sought medical attention with the physician. Telephone follow-up information was received from the nurse for the physician reporting that the physician not feel that the seizure was caused by GARDASIL. The patient was seen in the ER, but not hospitalized. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:329686 (history)  Vaccinated:2008-05-01
Age:14.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 166
Location:New York  Entered:2008-10-17, 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: ALLEGRA
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory, blood work which was negative.
CDC Split Type: WAES0809USA02124
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Blood test normal
SMQs:
Write-up: Information has been received from a consumer concerning her 14 year old daughter who had no pertinent medical history or allergies who in November 2007, was vaccinated with the first dose of GARDASIL and in May 2008, was vaccinated with the second dose of GARDASIL . Concomitant therapy included ALLEGRA. In June 2008, the mother reported that her daughter started losing her hair, where her hair was thinning and she had bald spots on the front of her head and in other specific areas. The mother''s patient also reported that the patient had seen her physician and was diagnosed with alopecia. It was reported that the physician did full blood work which were negative. The mother stated that her daughter looked like a man balding with hair plugs. It was reported that physician gave her a medicated shampoo, just in case of fungus on her scalp, which she was almost finished and she was starting to see some regrowth, but her hair was still thin. The mother also reported that in November 2007 the patient had stopped therapy with fexofenadine hydrochloride when she received her first dose of GARDASIL. The patient was also received routine vaccines (names and manufactures unspecified), before going back to school. The HPV vaccine series was discontinued (last dose May 2008). Additional information has been requested.

VAERS ID:329692 (history)  Vaccinated:2008-05-01
Age:24.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 166
Location:New York  Entered:2008-10-17, 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: Hormonal contraceptives
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA02136
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 24 year old female who in May 2008, was vaccinated with the third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, after vaccination the patient experienced generalized urticaria. As of 15-SEP-2008, generalized urticaria persisted. The patient sought medical attention. She was seen by the physician. Additional information has been requested.

VAERS ID:333328 (history)  Vaccinated:2008-05-01
Age:31.0  Onset:2008-05-15, Days after vaccination: 14
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:2008-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Omega-3
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: O&P, June 2008, per pvt md, results negative per client; CT ABD, June 2008, no significant results per client.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Abasia, Activities of daily living impaired, Computerised tomogram normal, Diarrhoea, Fatigue, Nausea, Oedema peripheral, Pain in extremity, Parasite stool test negative, Sensation of heaviness
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Client stated that s/s began 5/15/08 with swelling of R arm x 2 wks with soreness; nausea; tiredness; legs very heavy and unable to walk. Diarrhea x 7 wks beginning 5/15/08 (on antibiotics x2). Absent from work x 3 d in may after injection; was seen in a local ED for inability to ambulate in June 08

VAERS ID:336390 (history)  Vaccinated:2008-05-01
Age:18.0  Onset:2008-06-24, Days after vaccination: 54
Gender:Female  Submitted:2009-01-02, Days after onset: 192
Location:California  Entered:2009-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none PMH: frontal H/A. Low back pain x 1 yr.
Diagnostic Lab Data: ekg, eeg, cat scan, mri, blood tests. Labs and Diagnostics: EKG WNL. EEG WNL. Normal imaging studies. Brain MRI WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB281IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Amenorrhoea, Back pain, Blood test, Chills, Computerised tomogram, Dizziness, Ear pain, Electrocardiogram normal, Electroencephalogram normal, Headache, Immobile, Loss of consciousness, Malaise, Menstruation irregular, Migraine, Nausea, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia, Photophobia, Presyncope, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad)
Write-up: syncope or seizure still being determined,events started in june of 08, she has experienced over 100 syncope episodes since that time, a month or so after inoculation, co administered with Hep A, episodes began in june, again in august, september, weekly in november, december, has experienced immobility, nausea, irregular and missed periods, migraine like headaches, left ear pain, leg pain and tingling in hands and feet, lower back pain, to date she has been to the ER 7 times and had two hospital stays for issues of passing out from 3 minutes to over 30 minutes as she passes out repeatedly, no medical treatment other than rest up until this point, she is being admitted for further neurological understanding and a three day hospital evaluation. 2/4/09 Neurology consult received dated 12/22/08 for eval of episodic LOC. Pt initially began having lapses of consciousness in 6/2008 on vacation. Seen in ER and found to be dehydrated, possibly r/t alcohol consumption. Repeat attacks however were with good hydration status. 1 week after 1st episode pt was feeling ill and unable to walk/stand w/o having an episode. W/U (-). Pt may have weeks w/o episodes, but then begin with teeth chattering, then a "head rush", dizziness and the feeling of going to pass out. Holter monitor did not register any abnormalities during episodes. Episode in 8/2008, pt was unable to roused x 30 minutes. W/U (-). In 12/08 episode did not involve complete LOC but had bifrontal H/A with photophobia after. Some events involve hand shaking or whole body shaking. Pt to be admitted for further eval.D/C Summary received for DOS 1/5-8/2009 with D/C DX: Unexplained LOC. PE WNL. One mild event noted during admission with teeth chattering and tremulous movements of the upper extremities, L$gR. No LOC. No further events during admission.

VAERS ID:337032 (history)  Vaccinated:2008-05-01
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2009-01-09
Location:Tennessee  Entered:2009-01-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
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: WAES0901USA00354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNRA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Computerised tomogram, Nerve injury, Nuclear magnetic resonance imaging, Pain in extremity
SMQs:, Dementia (broad), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning an 18 year old female who in May 2008 was vaccinated with the third dose of GARDASIL and within 1 week experienced right arm pain (2008). The patient saw an unspecified neurologist who said there of the vaccine was nerve damage. Lab diagnostics performed included MRI and CAT scan. All 3 doses were given in the right arm. Unknown if the patient had any problems with the first or second dose. The patient sought medical attention by visiting the physician''s office. Nerve damage was considered to be disabling by the physician because the patient was on the golf team and was unable to participate. Additional information has been requested.

VAERS ID:338021 (history)  Vaccinated:2008-05-01
Age:1.1  Onset:2008-06-27, Days after vaccination: 57
Gender:Female  Submitted:2009-01-12, Days after onset: 199
Location:Unknown  Entered:2009-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Body temp, 6/27/2008, 102.7, F
CDC Split Type: WAES0807USA00576
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1353F SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Body temperature increased, Rash, Varicella
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 15 month old female child who on 01-MAY-2008 was vaccinated SQ with 0.5ml of PROQUAD (lot # 656164/1353F). Concomitant vaccinations included DTAP (unspecified) (+) tetanus toxoid (manufacturer unknown) and PREVNAR. Subsequently, on 27-JUN-2008 the patient developed a rash with 12-15 lesions on her face, scalp and back. It was noted that some of the lesions had blisters. The patient also had a temperature of 102.7 F. On 30-JUN-2008 the patient was seen in office by physician. There were no lab studies performed. The patient was diagnosed with chicken pox. The patient was treated with TYLENOL and BENADRYL as needed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:340650 (history)  Vaccinated:2008-05-01
Age:14.0  Onset:2008-05-22, Days after vaccination: 21
Gender:Female  Submitted:2009-02-13, Days after onset: 267
Location:Florida  Entered:2009-02-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA01221
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0152X2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Echocardiogram, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 14 year old female who on 01-MAY-2008 was vaccinated with the third dose of GARDASIL (lot # 0152X) and 3 weeks later (approximately 22-may-2008) was diagnosed with pericardial effusion. At the time of reporting the patient was not recovered. Lab diagnostics studies performed included echocardiogram.

VAERS ID:347779 (history)  Vaccinated:2008-05-01
Age:5.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 379
Location:Connecticut  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Eczema (outgrew)
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA03860
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise
SMQs:
Write-up: Information has been received from a physician concerning his 5 year old grandson with a history of eczema (outgrew) and no known allergies who in May 2008, was vaccinated with the first dose of VARIVAX vaccine (Oka). There was no concomitant medication. On an unspecified date the patient was not feeling well. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:347846 (history)  Vaccinated:2008-05-01
Age:45.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 379
Location:California  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroid
Current Illness: Thyroid disorder
Preexisting Conditions:
Diagnostic Lab Data: Biopsy 08/15/08 - fixed drug reaction
CDC Split Type: WAES0808USA03213
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Biopsy, Chapped lips, Cheilitis, Influenza like illness, Lip haemorrhage, Myalgia, Nasopharyngitis, Ocular hyperaemia, Oedema mouth, Pyrexia, Rash macular, Rash pruritic, Similar reaction on previous exposure to drug
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a male in his 40''s with a past medical history significant for a thyroid disorder treated with "thyroid hormone" since the age of 15 years old. There was no history of immuno compromise or drug allergies. There was no other concomitant medication. In May 2008, the patient was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed mild "flu-like symptoms" including cold symptoms and muscle acne. In June 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced mild "flu-like symptoms", rash described as purple patches (1/2-2 cm firm macules) on his face, arms, back, neck that were itchy, fever , a mouth felt inflamed and swollen without lesions, red/ chapped lips that bled when touched, redness around the eyes and joint pain. On approximately 11-Aug-2008, "last week", the patient experienced fever and redness around the eyeballs. On approximately 15-Aug-2008, "last Friday", the patient was seen by a dermatologist. Rash was biopsied with results showing "fixed drug reaction". The healthcare physician questioned possible HSP or vasculitis. The patient currently continued with the rash, although the rest of the symptoms had subsided. Additional information has been requested.

VAERS ID:349936 (history)  Vaccinated:2008-05-01
Age:1.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Male  Submitted:2009-05-29, Days after onset: 393
Location:California  Entered:2009-06-17, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Atopy; Hypersensitivity; Egg allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA01349
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Underdose, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an "approximately 12 or 13 month old" male child with egg allergy, "very allergic and atopic" who "approximately a month or two ago" was vaccinated SQ with a quarter dose (0.125ml) of a first dose of MMR II (Merck). Subsequently the patient broke out in hives. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient was treated with BENADRYL and recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:363352 (history)  Vaccinated:2008-05-01
Age:20.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2009-10-27, Days after onset: 544
Location:Ohio  Entered:2009-10-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA02801
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a Licensed Practical Nurse for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient who in May 2008, was vaccinated with the second dose of GARDASIL (dose, route and lot # unspecified). The nurse reported that the patient stated she became pregnant after receiving her second dose of GARDASIL and then had a miscarriage. The patient sought medical attention (office visit). Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.

VAERS ID:398116 (history)  Vaccinated:2008-05-01
Age:20.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 825
Location:Unknown  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 4/24/2008)
Preexisting Conditions:
Diagnostic Lab Data: Ultrasound, 09/09/08, normal; Apgar score, 01/21/09, 7/8; Apgar score, 01/21/09, 7 at 1 minute; Apgar score, 01/21/09, 8 at 5 minute
CDC Split Type: WAES0808USA02459
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Delivery, Drug exposure during pregnancy, Postpartum depression, Shoulder dystocia, Ultrasound scan normal
SMQs:, Depression (excl suicide and self injury) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 20 year old female with no medical history or drug allergies who was vaccinated with a dose of GARDASIL. There was no concomitant medication. The patient was pregnant 15 weeks and 6 days. No problems reported. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information was received concerning a female was vaccinated with the first dose of GARDASIL in May 2008. On 09-SEP-2008, ultrasound was performed and it was normal. Follow-up information on 01-JUL-2009 was received from a certified nurse-midwife who reported that on 21-JAN-2009, the patient delivered a female infant who weighed 6Lbs 14 Oz and had Apgar of 7 & 8 at 1 and 5 minutes respectively. The patient delivered vaginally and had a shoulder dystocia during delivery. The baby was fine and doing wonderfully. The patient developed a postpartum depression, but was currently in treatment and her depression was resolving. As of 01-JUL-2009, the outcome of shoulder dystocia was unknown. Additional information is not expected.

VAERS ID:398493 (history)  Vaccinated:2008-05-01
Age:17.0  Onset:2008-05-04, Days after vaccination: 3
Gender:Female  Submitted:2010-09-14, Days after onset: 863
Location:Unknown  Entered:2010-09-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: I had an EEG and a MRI performed on me. As well as being admitted to the emergency room. They both concluded that I do, in fact, have a seizure disorder. Nothing else in my medical history has contributed to the seizures.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging abnormal, Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: About a month after receiving the third and final dosage of the GARDASIL medication, I began having absent seizures. I have now been diagnosed with epilepsy. My neurologist says that it is, more than likely, going to stay with me for the rest of my life.

VAERS ID:414038 (history)  Vaccinated:2008-05-01
Age:84.0  Onset:2010-10-01, Days after vaccination: 883
Gender:Female  Submitted:2010-11-22, Days after onset: 52
Location:Florida  Entered:2011-01-05, Days after submission: 44
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease; Nerve damage
Preexisting Conditions: Hip replacement
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1011USA01534
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Foot operation, Herpes zoster, Limb operation, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from an 87 year old female patient, with Crohns disease, no drug reactions or allergies and a history of nerve damage to left leg after a hip replacement, who "approximately two to two and a half years ago" (in approximately May 2008), was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, expire date and route not reported). Concomitant therapy included "various" (unspecified medications). "A month ago" (on approximately 11-OCT-2010) the patient had shingles. The patient stated that the physician looked at them to determine that it was shingles. The patient had been using "SYCHOVIA ointment" (manufacturer unspecified) and "the medicine", but neither seemed to work. Additionally, the patient had very mild itching off and on, no pain, and something on the left side of her leg; but she had surgery on that part of the leg, she did not know if that is a result of that. It was not a very severe reaction. She thought she may have picked the shingles up at the hospital while she was having surgery on her left foot. It showed up while she was on rehabilitation at the hospital, right after the surgery. At the time of the report, the patient had not recovered; her condition had improved "very little". Additional information has been requested.

VAERS ID:429813 (history)  Vaccinated:2008-05-01
Age:72.0  Onset:2011-02-07, Days after vaccination: 1012
Gender:Male  Submitted:2011-07-19, Days after onset: 161
Location:Unknown  Entered:2011-08-03, Days after submission: 15
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: WAES1102USA00886
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a Medical assistant concerning a 75 year old male patient who in May 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). On 07-FEB-2011, the patient reported to the practice with shingles. Treatment included VALTREX 1 gram BID x7 days, LYRICA 75 mg TID and VICODIN prn for pain. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:430417 (history)  Vaccinated:2008-05-01
Age:74.0  Onset:2010-07-03, Days after vaccination: 793
Gender:Female  Submitted:2011-07-19, Days after onset: 381
Location:Colorado  Entered:2011-08-03, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sulfonamide allergy
Preexisting Conditions: Mastectomy; Breast reconstruction
Diagnostic Lab Data: None
CDC Split Type: WAES1007USA00670
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Herpes zoster, Oropharyngeal pain, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a 76 year old female with drug reaction to sulfa and a history of mastectomy and reconstructive surgery (in 1998) who in May 2008, was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included ADVAIR and blood pressure pills. On 03-JUL-2010 the patient broke out with shingles. The patient also reported a sore throat along with blisters and bumps all along her arm. Unspecified medical attention was sought and there was no laboratory test performed. Additional information has been requested.

VAERS ID:433621 (history)  Vaccinated:2008-05-01
Age:78.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2011-07-29, Days after onset: 1184
Location:Unknown  Entered:2011-08-04, 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: Hypertension; Arthritis; Cardiac valve leak; Hospitalisation; Penicillin allergy; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1105USA02150
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a registered dietician concerning a 78 year old female inpatient with hypertension, arthritis and leaky valve of heart, drug reaction/allergies to penicillin and naproxen who in May 2008, "3 years ago", was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) while in the hospital for an unrelated condition. Concomitant therapy included TOPROL XL TABLETS, DYAZIDE and PREMARIN. In May 2008, "3 years ago", the patient''s arm immediately became swollen, "it was very significant." She did not know how long the swelling lasted but denied any difficulty breathing. The patient was given cold packs only due to other medical problems at that time. On an unspecified date, the patient recovered from her arm immediately became swollen. The patient sought medical attention while an inpatient at the hospital. Additional information has been requested.

VAERS ID:443675 (history)  Vaccinated:2008-05-01
Age:30.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-22
Location:Pennsylvania  Entered:2011-11-28, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient denied any medical history or concomitant medications. She had no known allergies. The patient denied any illness at the time of vaccination. The patient may have possibly received hepatitis vaccine within 4 weeks prior to the ADACEL.
Diagnostic Lab Data: The patient had a blood test that was recently drawn for pertussis.
CDC Split Type: 201111279
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bordetella test positive, Cough, Decreased appetite, Fatigue, Pertussis, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad)
Write-up: Initial report received from a consumer on 16 November 2011. A 31-year-old female patient received an intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number not reported, on an unknown date in May 2008. The patient denied any medical history or concomitant medications. She had no known allergies. The patient denied any illness at the time of vaccination. The patient may have possibly received hepatitis vaccine within 4 weeks prior to the ADACEL. In August-September 2011, the patient developed persistent dry cough, fatigue, loss of appetite, and weight loss of eleven pounds. The patient was informed by a nurse that she had pertussis. This was following a blood test that recently was drawn. The patient had been ill for three months. The outcome was reported as not recovered. Documents held by sender: None.

VAERS ID:492095 (history)  Vaccinated:2008-05-01
Age:74.0  Onset:2013-04-03, Days after vaccination: 1798
Gender:Female  Submitted:2013-05-20, Days after onset: 47
Location:Colorado  Entered:2013-05-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CENTRUM SILVER, CALTRATE 600 PLUS VITAMIN D; ibuprofen; oxygen; ADVAIR; albuterol; gabapentin; LISINOPRIL; aspirin; TRUSOPT; HYDROCHLOROTHIAZIDE
Current Illness: Glaucoma; Emphysema; Chronic obstructive pulmonary diseae; Bronchitis chronic; Blood pressure abnormal
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA009548
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Disturbance in attention, Feeling abnormal, Herpes zoster, Influenza like illness, Joint swelling, Memory impairment, Oedema peripheral, Pain, Pruritus, Pyrexia
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This spontaneous report as received from a 79 year old female consumer (reporting on herself). The patient had current conditions including blood pressure issues, chronic bronchitis, chronic obstructive pulmonary disease (COPD) with emphysema and glaucoma. The patient did not have any drug reaction allergy. It was reported that about five years ago, approximately in May 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (1 dose, route unspecified). Concomitant therapy included minerals (unspecified), CENTRUM SILVER (OTC product), calcium carbonate, CALTRATE 600 PLUS VITAMIN D (OTC product), ibuprofen, oxygen, fluticasone propionate, ADVAIR, SPIRIVA, albuterol, gabapentin, lisinopril, baby aspirin (OTC product) self prescribed, hydrochlorothiazide HGTZ and TRUSOPT. On or about 03-APR-2013, the patient broke out with shingles. She said at first she felt as if she was getting the flu and this lasted a day or two. Finally she felt feverish and she went to bed and slept 19 hours straight and when she woke up she noticed blisters erupting on the left side of her face above her eyebrow. She said she went to the doctor about 4 days later. The patient described the having itching, painful blisters in the left side of her face and scalp and on around her left eye. She also said that since this occurred she had been having her feet swelling as well as her ankles. The patient also said that for the past few weeks she does not felt as "sharp" as she usually did. She claimed she was having a hard time focusing on what she was saying and seemed forgetful. The patient sought medical attention and was given acyclovir, NEURONTIN, ZADITOR, erythromycin, VICODEN and tramadol as a treatment for adverse events. Laboratory diagnostic studies were not performed recently. At the time of the report the flu symptoms were recovered, the shingles, swelling of ankles and feet were reported as recovering. The event hard time focusing on what she was saying and seemed forgetful were reported as not recovered. Additional information has been requested.

VAERS ID:504987 (history)  Vaccinated:2008-05-01
Age:0.5  Onset:2008-05-08, Days after vaccination: 7
Gender:Male  Submitted:2013-10-01, Days after onset: 1972
Location:Illinois  Entered:2013-10-01
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: diarrhea~DTaP (Daptacel)~2~0.58~Patient|Yeast diaper rash~DTaP (Daptacel)~2~0.58~Patient|colic symptoms~DTaP (Daptacel)~2~0.58~P
Other Medications: None, Tylenol as needed
Current Illness: Fever, cough and loose stools
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA1IMLL
HIBV: HIB (PROHIBIT)SANOFI PASTEURUF253AD1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03011PO 
PPV: PNEUMO (PNU-IMUNE)PFIZER/WYETHC547661IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0235U2PO 
Administered by: Unknown     Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Fever, rash, diarrhea.

VAERS ID:519901 (history)  Vaccinated:2008-05-01
Age:46.0  Onset:2008-06-02, Days after vaccination: 32
Gender:Female  Submitted:2014-01-20, Days after onset: 2058
Location:Unknown  Entered:2014-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 60 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Papnicolaou (PAP) smear (??JAN2007) results: Normal; Hormones (??JAN2007) results: Normal
CDC Split Type: WAES1401USA006967
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Infertility female, Limb injury, Liver operation, Muscle injury, Nerve injury, Post procedural complication, Spinal disorder, Stent placement
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Accidents and injuries (narrow), Fertility disorders (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This spontaneous report as received from a consumer refers to an approximately 46 year old female patient reporting on herself. In January 2007, a Papanicolaou (PAP) smear and hormones tests were done which resulted normal. In March 2008, a colposcopy and blood tests were done (results were not reported). In March 2008, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported) on doctor''s recommendation. In late May 2008, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On an unknown date in 2008, after receiving GARDASIL, the patient''s bilirubin became so elevated, that after a certain course of events she was admitted (from approximately May 2008 to July 2008) to the liver transplant ward in a hospital for 2 months. The patient had bilirubin levels measured from November 2007 until August 2012 (results unspecified). In May 2008, the patient signed a stent uninformed consent. On 02-JUN-2008, the patient had a stent placement. On 18-JUL-2008, the patient experienced liver surgery stent removal. The patient reported that her amended preadmission consent was misplaced. On an unknown date, the patient stated that a physician tried to get her to sign a care plan stating that she had ongoing drug, cigarette and alcohol abuse, as well as falsely claiming she had significant psychiatric problems (the patient refused: medico legal). On an unknown date, an in-vitro fertility (IVF) specialist, made light of the patient's fertility issue and egg saving. The patient did not save eggs prior to surgery with risk if death at age 46. On an unknown date in 2013, reported as 2013/2014, the patient experienced accumulative right side muscle and nerve damage post-surgery, spine twist and subsequent damage to right leg. The patient stated that it was a wonderful blessing that she did not die and that she would like to contribute to clinical trials to help perfect GARDASIL, as she had carefully put together reports, blood tests internationally over 20 years from eminent specialists. The outcome of liver surgery stent placement, liver surgery stent removal, damage to right leg, spine twist, accumulative right side muscle and nerve damage post-surgery, fertility issue and bilirubin became so elevated was unknown. Causality was not reported. Upon internal review, stent surgery and liver surgery stent removal were considered as medically significant events. Additional information has been requested.

VAERS ID:608629 (history)  Vaccinated:2008-05-01
Age:22.0  Onset:2009-08-01, Days after vaccination: 457
Gender:Female  Submitted:2015-11-10, Days after onset: 2292
Location:California  Entered:2015-11-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fatigue/headaches/flu like symptoms
Preexisting Conditions: N/A
Diagnostic Lab Data: Sleep study; MLST; Counseling
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1732SYRRA
Administered by: Military     Purchased by: Military
Symptoms: Amnesia, Arthralgia, Back pain, Confusional state, Disturbance in attention, Fatigue, Muscular weakness, Narcolepsy, Sleep study, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: Chronic Fatigue/Narcolepsy 6+ Years. Muscle weakness 6+ years. Memory loss/confusion 6+ years. Chronic joint and back pain 6+ years. Vision problems 5+ years. Trouble concentrating 6+ years.

VAERS ID:316161 (history)  Vaccinated:2008-05-01
Age:15.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-12, Days after onset: 42
Location:Foreign  Entered:2008-06-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement, ??May08, 90/50
CDC Split Type: WAES0806USA01182
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Concussion, Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health authority concerning a 15 year old female with no reported relevant medical history, who on an unspecified date in May 2008, was vaccinated with the first dose of GARDASIL, batch # not reported. Immediately after vaccine administration with GARDASIL, the patient had a syncope (described as severe by the reporter), due to syncope the patient fell ending up with a concussion. The patient was brought to hospital emergency room where she recovered. BP after syncope 90/50. It was reported that the patient recovered on the same day. Events were considered as medically relevant by the reporter. Case is closed. Other business partner numbers include E2008-05040. Additional information is not expected.

VAERS ID:316495 (history)  Vaccinated:2008-05-01
Age:  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 47
Location:Foreign  Entered:2008-06-18, 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: Anxiety
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA02356
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Incorrect route of drug administration, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a general practitioner concerning a female patient with anxiety, who in May 2008, was vaccinated subcutaneously with the first dose of GARDASIL. A few seconds after the vaccination, the patient experienced loss of consciousness and convulsive movements. The patient spontaneously recovered in a few minutes. It was specified that the patient was anxious because of the vaccination. The reporter considered loss of consciousness and convulsive movements to be other medically important events. Other business partners numbers include: E200805165. No further information is available.

VAERS ID:316498 (history)  Vaccinated:2008-05-01
Age:0.7  Onset:2008-05-01, Days after vaccination: 0
Gender:Unknown  Submitted:2008-06-16, Days after onset: 46
Location:Foreign  Entered:2008-06-18, 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: Unknown
Current Illness: Congenital anomaly
Preexisting Conditions: Premature baby
Diagnostic Lab Data: None Provided.
CDC Split Type: DEWYEG01676908
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via sales representative regarding an 8-month-old patient who experienced oxygen saturation decreased during night. The patient received the first dose in May-2008. The patient''s concurrent illness includes several congenital anomalies (not further specified) with a past history of being a premature baby (gestational week 36 plus three days). Concomitant medications were not reported. Due to several congenital anomalies the patient received the first dose of PREVENAR at the age of eight months. After vaccination the patient experienced oxygen saturation decreased during night in May-2008. The patient was hospitalised. The outcome was unknown. No additional information was available at the time of this report but has been requested.

VAERS ID:317932 (history)  Vaccinated:2008-05-01
Age:0.4  Onset:2008-06-01, Days after vaccination: 31
Gender:Male  Submitted:2008-06-30, Days after onset: 29
Location:Foreign  Entered:2008-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Platelet count, 1110?3/ul, 150 (low), 350 (high)
CDC Split Type: B0526158A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Ecchymosis, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad)
Write-up: This case was reported by a consumer and described the occurrence of thrombocytopenia in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). In May 2008 the subject received unspecified dose of ROTARIX (oral). In June 2008, 1 month after vaccination with ROTARIX, the subject developed ecchymosis. He was brought to hospital where the diagnosis was thrombocytopenia. Relevant test results included platelet count 11000. Intravenous immunoglobulin treatment was advised but the subject''s parents were reluctant to follow the physician''s advise. At the time of reporting the outcome of the events was unspecified.

VAERS ID:318412 (history)  Vaccinated:2008-05-01
Age:6.0  Onset:2008-05-29, Days after vaccination: 28
Gender:Male  Submitted:2008-07-07, Days after onset: 39
Location:Foreign  Entered:2008-07-07
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: B0527870A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSC14B063BG UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hypotension, Injection site induration, Pallor, Pulse abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority (Regulatory Authority # 923540232) and described the occurrence of filiform pulse in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). In May 2008 the subject received unspecified dose of INFANRIX (unknown, left arm). On 29 May 2008, less than one month after vaccination with Infanrix, the subject experienced filiform pulse, injection site induration, arterial hypotension and pallor. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX. No further information was expected as this was the only information the Regulatory Authority had, therefore this case has been closed.

VAERS ID:318503 (history)  Vaccinated:2008-05-01
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2008-07-07
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: ascorbic acid; vitamin d (unspecified)
Current Illness: Viral infection
Preexisting Conditions:
Diagnostic Lab Data: stool analysis, bacteriological analysis- negative (Salmonella, E.coli)
CDC Split Type: WAES0806POL00009
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Faeces discoloured, Haematochezia, Mucous stools, No reaction on previous exposure to drug, Stool analysis normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a mother of a 5 month old male with viral infection who in approximately April 2008, was vaccinated with first dose of ROTATEQ. Concomitant therapy included vitamin D (unspecified) and ascorbic acid. After first dose the vaccine no adverse experiences were observed. In approximately May 2008, the patient was vaccinated with second dose ROTATEQ. Four-five days after vaccination the patient experienced mucus in stool (green stools). After some time the patient experienced blood in stool. The symptoms lasted 4 weeks. Performed bacteriological stool test was negative (Salmonella, E. coli). The patient was treated with prebiotic and probiotic (LACIDO BABY). Subsequently, the patient recovered from blood in stool and mucus in stool. One doctor felt that mucus in stool and blood in stool were related to ROTATEQ and advised not to vaccinate the patient with third dose the vaccine. Other doctor felt that mucus in stool and blood in stool were not related to ROTATEQ and advised to vaccinate the patient with third dose the vaccine. The mother decided to administer the third dose the ROTATEQ. Upon internal review blood in stool was considered to be an Other Important Medical Event. Additional information has been requested.

VAERS ID:324116 (history)  Vaccinated:2008-05-01
Age:17.0  Onset:2008-06-01, Days after vaccination: 31
Gender:Female  Submitted:2008-09-03, Days after onset: 94
Location:Foreign  Entered:2008-09-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA05399
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anogenital warts
SMQs:
Write-up: Information has been received from a health authority (reference number ES-AGEMED-716903335) concerning a 17 year old female with no other relevant history who in May 2008 was vaccinated intramuscularly with a dose of GARDASIL (exact date, batch number and site of administration not reported). One month after in June 2008, the patient presented genital warts. Outcome was unknown. The case was considered medically relevant by the reporter. Presented genital warts was considered to be an other important medical event. Other business partner numbers included E2008-08048. No further information is available. Case is closed.

VAERS ID:325802 (history)  Vaccinated:2008-05-01
Age:58.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-23, Days after onset: 145
Location:Foreign  Entered:2008-09-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MA20081950
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER419011A UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF lymphocyte count abnormal, Convulsion, Headache, Meningitis viral
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Malignant lymphomas (broad)
Write-up: On 16 SEP 2008 we received via agency the following information: A 20-year-old female patient was vaccinated with rabies vaccine (batch number and manufacturer unknown) in May 2008. Patient also takes an oral contraceptive. After the vaccination (May 2008) the patient experienced headaches and later started to have seizures. 48 hours after the immunisation, the patient was seen by the neurologist and was diagnosed with a viral meningitis with a lymphocytic cerebrospinal fluid. It was reported that the viral meningitis with lymphocytic cerebrospinal fluid started on 29 MAY 2008. The patient recovered. There was no definitive evidence of encephalitis. The patient had some attacks which may have been epilepsy; the neurologist stated that it was hard to be definitive and they may have indeed been stress related. The neurologist and the infections disease team felt that the patient''s symptoms evolved too shortly after the rabies vaccination to strongly suggest a post-rabies encephalomyelitis. The patient is to be seen again in the clinic to monitor her progress. Seriousness criterion: medically significant. Causality: not related (viral meningitis is due to infectious agent not due to vaccination). Expectedness assessment according to label: The reported symptoms, except for headache, are not expected after vaccination with RABIPUR. On a case level, the case is considered not expect. No change in benefit-risk-ratio. No measures necessary. MHRA no. ADR 20310514. Company ref. no. C2008-04996.

VAERS ID:326517 (history)  Vaccinated:2008-05-01
Age:19.0  Onset:2008-06-29, Days after vaccination: 59
Gender:Female  Submitted:2008-09-29, Days after onset: 92
Location:Foreign  Entered:2008-09-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance imaging, 29Jun08, Comment: revealed lesion
CDC Split Type: WAES0809USA03950
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Central nervous system lesion, Facial palsy, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Information has been received from a health care professional concerning a 19 year old female who was vaccinated with the second dose of GARDASIL (route and lot number not reported) by the end of May-2008. On 29-Jun-2008 the patient presented with facial palsy. Symptoms were not observed by the reporter. MRI on 29-Jun-2008 revealed lesions. The specialist performed another MRI with contrast''s product (unspecified date) but there was no contrast uptake for lesions. The specialist evoqued past multiple sclerosis. A MRI was scheduled in Dec-2008. At time of reporting the outcome was not specified. She had received the first dose of GARDASIL in Mar-2008. Upon internal review, multiple sclerosis-like syndrome was determined to be other important medical events. Other business partner numbers included: E2008-08715. No further information is available.

VAERS ID:326808 (history)  Vaccinated:2008-05-01
Age:0.5  Onset:2008-08-12, Days after vaccination: 103
Gender:Male  Submitted:2008-10-01, Days after onset: 50
Location:Foreign  Entered:2008-10-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Abdominal ultrasound, 13?Aug08, intussusception, free liquid detected around spleen and left hemiabdomen; Abdominal ultrasound, 13?Aug08, Pseudo-kidney image starts half way from transverse up to sigmoid colon; Abdominal ultrasound, 13?Aug0
CDC Split Type: WAES0809USA04824
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Appendicectomy, Barium enema abnormal, Enema administration, Intussusception, Irritability, Oedema, Rectal haemorrhage, Ultrasound abdomen abnormal, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Information has been received from a health authority (reference number ES-AGEMED-823836232) regarding a 6 month old male who had been vaccinated with a dose (number in series not reported) of a ROTATEQ (batch number not reported), by oral route, between 05-2008 and 06-2008, exact date not reported. It is reported that the patient was hospital admitted on the 13-AUG-2008 due to abdominal pain and an irritability episode accompanied with continuous vomiting. These symptoms had started on the 12-AUG-2008, stop date not reported. A few hours after hospitalization, the patient presented with rectal hemorrhage. After performing an abdominal ultrasound the patient was diagnosed with an intussusception. According to the abdominal ultrasound, free liquid was detected around the spleen and the left hemiabdomen. Pseudo-kidney image starts half way from the transverse up to the sigmoid colon which presents liquid and a large oedema. Barium enema test revealed intussusception with frank rectal hemorrhage. Opaque enema was performed to unfold the head of proximal intussusception. The intussusception was visualized in the descendent colon and was unfolded unto the transverse colon area closest to the hepatic triangle. The exploration was stopped due to the free liquid and possible coil stress. The intussusception was reduced manually, an appendectomy was also performed. The patient recovered on 16-AUG-2008. No further information is given. Other business partner numbers included: E2008-08833.

VAERS ID:327490 (history)  Vaccinated:2008-05-01
Age:20.0  Onset:2008-06-01, Days after vaccination: 31
Gender:Female  Submitted:2008-10-07, Days after onset: 128
Location:Foreign  Entered:2008-10-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA00329
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Encephalitis viral, Epstein-Barr virus infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a health authority (reference no. PA20080269 and PA0800294) concerning a 20-year-old female patient with no known infections medical history who received an injection of GARDASIL in May-2008. 2 weeks later on 01-Jun-2008 the patient experienced viral encephalitis. On 06-Jun-2008 she was hospitalized for physical and equilibrium troubles in a febrile context. Diagnosis was Epstein Barr virus viral encephalitis. There was a progressive amelioration until regression of troubles in 2 months. The patient had recovered without any sequelae. Other business partner numbers included: E2008-09118. No additional information is available.

VAERS ID:330095 (history)  Vaccinated:2008-05-01
Age:  Onset:2008-05-08, Days after vaccination: 7
Gender:Female  Submitted:2008-10-24, Days after onset: 169
Location:Foreign  Entered:2008-10-27, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA03433
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a general practitioner concerning a female who in the first week of May 2008, was vaccinated with the third dose of GARDASIL (batch number not reported) via intramuscular. Seven days later, the patient experienced a mal epileptic status. On an unspecified date, the patient was hospitalized. At time of reporting the outcome was not specified. The patient had no concomitant treatment. Other business partner numbers include: E2008-09668 and E2008-05670. Additional information has been requested.

VAERS ID:330189 (history)  Vaccinated:2008-05-01
Age:21.0  Onset:2008-05-02, Days after vaccination: 1
Gender:Male  Submitted:2008-10-27, Days after onset: 178
Location:Foreign  Entered:2008-10-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0059119A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of facial paresis in a 21-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On an unknown date in May 2008 the subject received an unspecified dose of HAVRIX 1440 (1 ml, unknown). Approximately one day post vaccination with HAVRIX 1440, in the evening of the next day, on an unknown date in 2008, the subject experienced facial paresis. This case was assessed as medically serious by GSK criteria. The subject was examined ambulatory at a hospital. No diagnostic results were available. After about 3-4 days, on an unknown date in 2008, the event was resolved. The hospital physician (s) considered that the event was related to vaccination with HAVRIX 1440. Follow-up information has been requested.

VAERS ID:335735 (history)  Vaccinated:2008-05-01
Age:14.0  Onset:2008-10-01, Days after vaccination: 153
Gender:Female  Submitted:2008-12-19, Days after onset: 79
Location:Foreign  Entered:2008-12-19
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: Unknown
CDC Split Type: D0059940A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB104CF UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Anorexia, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a consumer and described the occurrence of abdominal pain in a 14-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). A physician or other health care professional has not verified this report. In May 2008 the subject received unspecified dose of TWINRIX ADULT (unknown route and application site). In October 2008, 5 months after vaccination with TWINRIX ADULT, the subject experienced nausea, lack of appetite and abdominal pain. The subject was hospitalised in December 2008 because of abdominal pain. At the time of reporting the events were unresolved. Follow-up information has been requested.

VAERS ID:337919 (history)  Vaccinated:2008-05-01
Age:37.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:2008-12-19
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: 200813434
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED10059429 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Eye swelling, Headache, Ocular hyperaemia, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypersensitivity (narrow)
Write-up: Report received from a non-health professional reporter on 02-MAY-2008. A 37-year-old female patient received FLUVAX (batch number B090620601, expiry: 01/09) for influenza immunisation on 01-MAY-2008. On 01-MAY-2008, after FLUVAX administration, the patient experienced swollen and feet and blood shot eyes. On 02-MAY-2008, the patient also developed puffy eyes and headache. The patient was unable to go to work on the morning of 02-MAY-2008. It is not known whether the patient received any treatment for the reaction. At the time of reporting, the reaction was ongoing.

VAERS ID:342587 (history)  Vaccinated:2008-05-01
Age:0.2  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2009-03-24, Days after onset: 327
Location:Foreign  Entered:2009-03-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: FRWYEG03348709
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Fatigue, Hypotonia, Pyrexia, Rash, Similar reaction on previous exposure to drug
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via regulatory authority regarding a 3-month-old female patient who experienced hypotonia, fever and cutaneous rash. The patient received the first dose in May-2008. The patient experienced hypotonia, fever and cutaneous rash in May-2008 after vaccination and was hospitalized. The patient recovered without sequelae. No additional information was available. She then received vaccines separately. On 24-Jan-2009, after the third dose of INFANRIX HEXA, the patient experienced again hypotonia and fever associated with fatigue and loss of appetite for one week. No further adverse event was reported after PREVENAR injections.

VAERS ID:342950 (history)  Vaccinated:2008-05-01
Age:20.0  Onset:2008-06-01, Days after vaccination: 31
Gender:Female  Submitted:2009-03-27, Days after onset: 299
Location:Foreign  Entered:2009-03-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA04405
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: No reaction on previous exposure to drug, Rash, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a gynaecologist concerning a 20 year old female patient who in April 2008, was vaccinated with her first dose of GARDASIL (lot number, site and route not reported) and was well tolerated. In May 2008, the patient received her second dose of GARDASIL (lot number, site and route not reported). Four weeks post the vaccination, the patient developed exanthem from which she recovered on an unknown date with remaining white spots. In Oct 2008, the patient was admitted to a dermatological clinic. At the time of reporting the patient still had the white spots. The reporter was informed about this event at the time of reporting. Up to now he had no hospital report. Other business partner number include: E2009-02386. Additional information has been requested.

VAERS ID:345449 (history)  Vaccinated:2008-05-01
Age:0.2  Onset:2008-05-31, Days after vaccination: 30
Gender:Male  Submitted:2009-05-01, Days after onset: 335
Location:Foreign  Entered:2009-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, May2008, intussuscept; Biopsy intestine, May2008, necrosis; Body temperature, May2008, 37.8deg C; Diagnostic ultrasound, May2008, intussuscept; Stool culture, May2008, negative
CDC Split Type: B0571230A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Biopsy intestine abnormal, Body temperature increased, Culture stool negative, Enema administration, Gastrointestinal necrosis, Haematochezia, Intestinal resection, Intussusception, Irritability, Lethargy, Mucous stools, Pallor, Pyrexia, Rotavirus test negative, Small intestinal haemorrhage, Surgery, Ultrasound abdomen abnormal, Virus serology test, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). This case was collected through a study occurring post Rotavirus vaccination. The subject had no history and no family history of intussusception. The subject had no previous significant illness/hospitalizations/operations. Feeding history: The subject currently fed formula. The subject had no concomitant medication. Concurrent vaccination included INFANRIX HEXA (GlaxoSmithKline) given on 1 May 2008; PREVENAR (non-GSK manufacturer) given on 1 May 2008. On 1 May 2008, the subject received 1st dose of ROTARIX (unknown route). Lot number not provided. On 31 May 2008, 30 days after vaccination with ROTARIX, the subject was admitted at hospital due to ileocolic intussusception. The subject experienced abdominal pain, vomiting, lethargy, pallor, fever (37.8 deg C), irritability and currant jelly stool (48 hours prior to diagnosis of intussusception). The subject was hospitalized. On 04 June 2008, stool sample was collected and was negative for Rotavirus and Adenovirus. The diagnosis of intussusception was made based on abdominal ultrasound exam and abdominal X-ray. The intussusception was localized in the ileocecal valve. Air enema was performed but did not reduce the intussusception. A surgery was performed with an intestine resection of 5 cm and a biopsy showed hemorrhages and necrosis of the small intestine. On 5 June 2008, the subject was discharged alive. At the time of reporting the outcome of the events was unspecified. No further information could be obtained due to the nature of the collaborative research trial under which the event report was reported; this case has therefore been closed.

VAERS ID:382945 (history)  Vaccinated:2008-05-01
Age:26.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2010-03-17, Days after onset: 685
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1003USA01209
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Dysarthria, Dysgraphia, Fall, Fatigue, Hemiplegia, Hypokinesia, Immune system disorder, Impaired work ability, Insomnia, Loss of consciousness, Malaise, Nausea, Nervous system disorder, Tremor, Visual acuity reduced
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from newspaper articles title via CSL as part of a business agreement concerning a 26 year old female who in May 2008, was vaccinated with the first dose of GARDASIL. Two weeks later, the patient lost her balance and fell. The patient noted that "at the time, she didn''t think anything of it. She just thought she was clumsy." In August 2008, the patient received the second dose of GARDASIL. About four weeks after that, all of the symptoms began. The patient lost some of her eyesight, started to feel nauseous, was extremely tired but couldn''t sleep. Then she became paralysed on the right side of her body. The patient couldn''t walk properly, lack of fine motor skills, and her ability to write went within a week. The patient reported "the whole thing was rapid and slow all the same time. It was like I had had a stroke." The patient sought the help of a neurologist. Between February and July 2009, the patient showed further declined, forcing her to give up her job. The patient noted that "Before all of this she was just so healthy." Since approximately September 2008 (18 months from the time of the article), the patient had been treated for multiple sclerosis and acute disseminated encephalomyelitis, neurological disorders caused by damage to the myelin sheath that covers nerves. It was reported that "the patient''s illness remained a mystery and she had not officially been diagnosed with either disease." At the time of article, the patient struggled with paralysis, lack of the fine motor skills, tremors, slurred speech, fatigue, sickness and a compromised immune system. The outcome for lost her balance, fell, lost some of her eyesight, feel nauseous, could not sleep, treated for multiple sclerosis not officially diagnosed, treated for acute disseminated encephalomyelitis not officially diagnosed, neurological disorders, lost ability to write was unknown. The patient also reported that she experienced "blackouts" (onset date, outcome not reported). Upon internal review, lost some of her eyesight, paralysed on the right side of her body and multiple sclerosis were determined to be other important medical events. No further information is available.

VAERS ID:434307 (history)  Vaccinated:2008-05-01
Age:  Onset:0000-00-00
Gender:Female  Submitted:2011-09-13
Location:Foreign  Entered:2011-09-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown medical history; It was unknown if the patient had received concomitant therapy
Diagnostic Lab Data: Electromyographical examination showed sensory-motor peripheral neuropathy affecting all four limbs, clear predominance of distal, motor and in lower limbs, with marked degeneration of sensory nerve fibers in the lower limbs and light (intrinsic hand muscles), mild to moderate (thighs muscles) and moderate to severe (leg muscles), and severe (intrinsic foot muscles) degeneration of motor nerve fibers. The lesional pattern was primarily demyelinating compatible with an inflammatory etiology (postvaccination acute polyradiculoneuritis).
CDC Split Type: 201108457
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Acute polyneuropathy, Akathisia, Demyelinating polyneuropathy, Diplegia, Electromyogram abnormal, Mobility decreased, Motor dysfunction, Nerve degeneration, Peripheral sensorimotor neuropathy, Post vaccination syndrome, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from a consumer in a foreign country on 05 September 2011 under the reference number BR-BT2011-3639. A female patient (age not reported), with unknown medical history, had received a dose of influenza vaccine (manufacturer unknown, batch number, route and site of administration unknown) on the first fortnight of May 2008 during a campaign of vaccination. The vaccination was performed by a company. A few days post-vaccination, the patient experienced some motor difficulties in upper and lower limbs, which led to the impossibility of movement (motor restlessness). Motor difficulties culminated in paralysis of her lower limbs and severe difficulties in the upper limbs. In the following months, she sought several medical experts in order to get the cause and cure of her disease, but on July 16th 2008 she was diagnosed with postvaccination inflammatory demyelinating polyneuropathy. The causal link was the connecting link between the vaccine given to the administrative behavior. Such link was proven through medical report obtained by the time the disease had manifested. Electromyographical examination showed sensory-motor peripheral neuropathy affecting all four limbs, clear predominance of distal, motor and in lower limbs, with marked degeneration of sensory nerve fibers in the lower limbs and light (intrinsic hand muscles), mild to moderate (thighs muscles) and moderate to severe (leg muscles), and severe (intrinsic foot muscles) degeneration of motor nerve fibers. The lesional pattern was primarily demyelinating compatible with an inflammatory etiology (postvaccination acute polyradiculoneuritis). The patient could not perform her everyday tasks. The patient was deprived of her movements, becoming dependent on others for all the tasks. She spent three years of her life on a wheelchair and with tiny movements of upper limbs. During this period of three years, the patient saw monthly psychiatry, physical therapy and medication. Thus, these were included as corrective treatments or actions taken, although no detailed description of procedures and/or drugs used are available. The patient had not recovered at the time of reporting.

VAERS ID:440336 (history)  Vaccinated:2008-05-01
Age:15.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2011-10-26, Days after onset: 1273
Location:Foreign  Entered:2011-10-27, 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: Specific allergy (drug); Chronic rhinitis; House dust mite allergy; Immune tolerance induction
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory test, 1280, anti-histones antibodies; Diagnostic laboratory test, anti-histones antibodies showed negative; DNA Ab immunoprecipitation, slightly positive; DNA Ab immunoprecipitation, 2; Serum ANA, 4096; Serum ANA, 1280; Serum alanine aminotransferase, 36 iu/l
CDC Split Type: WAES1110USA03270
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Antinuclear antibody, Arthralgia, Autoantibody negative, DNA antibody positive, Laboratory test normal, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Case received from the Health Authorities on 14-OCT-2011 under the reference number NY20110740. Case medically confirmed. A 15-year-old female patient had received the three doses of GARDASIL (dose, route and batch number not reported) from January 2008 to May 2008. Since September 2007, the patient was undergoing a house dust mites desensitization by house dust mites allergen (STALORAL), which was also reported as suspect. A few days after the third dose, she experienced arthralgia in hands associated with oedema. The symptoms increasingly worsened. In May and June 2008, desensitization was carried on. Initial immunological work-up for polyarthralgia showed antinuclear antibodies 4096, anti-histones antibodies 1280, anti-native DNA antibodies slightly positive. Follow-up immunological work-up (unspecified date) showed antinuclear antibodies 1280, anti-native DNA antibodies at 2 units and no anti-histones antibodies. In April 2011, the patient was seen in a specialized service for a check-up. Laboratory tests showed no inflammatory syndrome, ALAT at 36, and no other anomaly was found. Physical examination showed that the general and joint symptomatology regressed. Nothing was suggestive of an inflammatory rheumatism or an evolution systemic disease. At the time of reporting, the patient had recovered without sequelae. The patient had a medical history of chronic allergic rhinitis since she was 6 years old. She also was allergic to PRIMALAN. The Health Authorities added that the patient experienced a "possible polyarthralgia induced by GARDASIL". Case reported as serious by the Health Authorities with other medically important condition as criteria. The Health Authorities assessed the causal relationship between the reported reaction and vaccination with GARDASIL as possible and for STALORAL as doubtful according to the method of assessment. Other business partner numbers include E2011-06239.

VAERS ID:446598 (history)  Vaccinated:2008-05-01
Age:18.0  Onset:2008-11-08, Days after vaccination: 191
Gender:Female  Submitted:2011-12-30, Days after onset: 1147
Location:Foreign  Entered:2012-01-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asthma; Smoker
Preexisting Conditions:
Diagnostic Lab Data: head computed axial tomography, normal; computed axial tomography, angio CT-scan=normal; spinal tap, protein level of 0.22 g, normoglycorrhachia, PCR Epstein-Barr virus, cytomegalovirus, herpes simplex; ophthalmological exam, decreased visual acuity in the right eye at 4/10; magnetic resonance imaging, encephalic MRI=normal; optical coherence tomography, normal; electroencephalography, a few paroxysmal abnormalities; serum C-reactive protein, normal; serum antithyroglobulin antibody, negative; complete blood cell count, normal; erythrocyte sedimentation rate, normal
CDC Split Type: WAES1112USA03044
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiogram, Anti-thyroid antibody negative, C-reactive protein normal, CSF glucose normal, CSF protein, Computerised tomogram head normal, Computerised tomogram normal, Conversion disorder, Cranial nerve disorder, Cytomegalovirus test negative, Dysuria, Electroencephalogram abnormal, Epilepsy, Epstein-Barr virus antibody negative, Full blood count normal, Fundoscopy normal, Headache, Herpes simplex serology negative, Human herpes virus 6 serology negative, Hypoaesthesia, Lumbar puncture, Malaise, Micturition urgency, Motor dysfunction, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination abnormal, Optic neuritis, Optical coherence tomography, Pain, Paraplegia, Plasmapheresis, Polymerase chain reaction, Red blood cell sedimentation rate normal, Sensorimotor disorder, Tongue biting, VIIth nerve paralysis, Varicella virus test negative, Visual acuity reduced
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular infections (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case received from the Health Authorities on 21-Dec-2011 under the reference number BX20111241. Case medically confirmed. An 18-year-old female patient developed facial palsy a few months after she had received the first dose of GARDASIL (batch number not reported) via the intramuscular route in May 2008. She suddenly experienced pain in the right hemibody on 08-NOV-2008 and hypoesthesia of the right hemibody with cephalgia on 12-NOV-2008. The patient had a medical history of asthma treated only during asthmatic attacks and was a smoker (? packs/day). Physical examination showed right central face palsy. In December 2008 she developed sensorimotor impairment of the right hemibody. Laboratory tests showed normal complete blood count, erythrocyte sedimentation rate and CRP. Antithyroglobulin and thyroperoxidase antibodies were negative. Cerebral CT-scan, angio CT-scan and encephalic MRI were normal. Lumbar puncture showed a protein level of 0.22 g, normoglycorrhachia, PCR Epstein-Barr virus, cytomegalovirus, herpes simplex virus, HSV-6 and varicella zoster virus were negative in CSF. Ophthalmological examination showed decreased visual acuity in the right eye at 4/10. Fundus oculi and papillary Optical Coherence Tomography were normal. The patient received a 5g perfusion of SOLU-MEDROL. In conclusion, the patient was diagnosed with possible retrobulbar optic neuritis. She experienced an episode of multiple impairment of cranial nerves, especially on the right side (II, V, VII). Tumoral, inflammatory and infectious aetiologies were ruled out. In December 2008 sensorimotor impairment extended to the right hemibody. Improvement was noted after plasmapheresis. In January 2009 the impairment regressed but progressive neurological impairment occurred and spread to the left lower limb associated with urinary urgency and dysuria, which gradually aggravated, leading to a picture of paraplegia with discordances on physical examination. A new course of SOLU-MEDROL and plasmapheresis were instaured. The patient was hospitalised in reeducation from January to late March 2009. She was hospitalised in April 2009 following a malaise and an epileptic seizure was suspected. The work-up showed no aetiology. In June 2009 psychiatric follow-up was proposed and a diagnosis of conversion was suggested. Subsequently, on an unspecified date, she experienced a generalised epileptic seizure with tongue biting and a few paroxysmal abnormalities on EEG. The patient received treatment with levetiracetam. Anti-NMO antibodies in 2009 were negative. In March 2010 moderate motor deficit of the right upper and lower limbs persisted. The patient received the second dose of GARDASIL in August 2009 and the third dose in June 2011. According to the Health Authorities the patient had recovered from facial palsy, retrobulbar optic neuritis had resolved with sequelae and neurological disturbances were resolving. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment. Other business partner numbers include E2011-08325.

VAERS ID:487712 (history)  Vaccinated:2008-05-01
Age:53.0  Onset:2008-05-01, Days after vaccination: 0
Gender:Female  Submitted:2013-03-22, Days after onset: 1786
Location:Foreign  Entered:2013-03-25, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: After each vaccination since childhood, she had experienced allergic reactions. The patient had a medical history of pollen allergy and Quincke''s edema with an infectious context on unspecified dates. She had received a dose of DT POLIO (batch number not reported) uneventfully.
Diagnostic Lab Data:
CDC Split Type: E201302099
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Hypersensitivity, Oedema, Skin reaction, Skin test positive
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Case received from the Health Authorities on 14-Mar-2013 under the reference number LL20080251. Case medically confirmed. A 53-year-old female patient presented with allergic reactions shortly after she had received a dose of VACCIN TETANIQUE PASTEUR (batch number not reported) on an unspecified date, a dose of IMOVAX POLIO (batch number not reported) in May-2008 and a dose of BOOSTRIXTETRA (other manufacturer, batch number not reported) on an unspecified date. All these vaccines contained aluminum or polysorbate 80 or both together. After each vaccination since childhood, she had experienced allergic reactions which worsened with cutaneous and systemic manifestations in May-2008. The patient had received a first dose and shortly after, she had presented with cutaneous allergic reaction then she had received the following doses and cutaneous reaction spread and systemic signs appeared (oedema, difficulty in breathing...). She was given POLARAMINE as corrective treatment which was effective against cutaneous reactions but was no longer effective against systemic signs. Skin tests with aluminum and polysorbate were negative but revealed BOOSTRIXTETRA, poliomyelitis and tetanus vaccine allergy. To be noted that she had received a dose of DT POLIO (batch number not reported) uneventfully and she had a medical history of pollen allergy, Quincke''s oedema with an infectious context on unspecified dates. Symptoms completely regressed within a few hours and the patient recovered. The Health Authorities assessed the causal relationship between the reported reaction and VACCIN TETANIQUE PASTEUR vaccination as very likely (C3 S3 I4) according to the method of assessment. The Health Authorities assessed the causal relationship between the reported reaction and BOOSTRIXTETRA vaccination as very likely (C3 S3 I4) according to the method of assessment.

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