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Found 551189 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:451667 (history)  Vaccinated:2012-03-07
Age:57.0  Onset:2012-03-07, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 5
Location:Massachusetts  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor 10mg
Current Illness: no
Preexisting Conditions: high cholesterol
Diagnostic Lab Data: None to date, although have asked patient to come in for lab testing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH1223 SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG048111IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH276AA0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Cataract, Decreased appetite, Malaise, Myalgia, Pyrexia, Visual acuity reduced
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (narrow), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Acute decrease in vision started hours after vaccine. Saw ophtho and reported this is just cataract (but he had never had symptoms from it before). They saw no evidence of neuritis/uveitis. Then 3 days later didn''t feel well. Day 4 - fever (102), myalgia, anorexia. Fever resolved by day 5 and myalgias and anorexia slowly improving (currently day 7). Patient has remained out of work this whole week.

VAERS ID:451988 (history)  Vaccinated:2012-03-07
Age:35.0  Onset:2012-03-08, Days after vaccination: 1
Gender:Female  Submitted:2012-03-09, Days after onset: 1
Location:Louisiana  Entered:2012-03-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: LA120303
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0SYRUN
TDAP: TDAP (ADACEL)SANOFI PASTEURU3979AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Tdap given (L) deltoid IM on 3/7/12 - pain & redness after a few hrs. 3/8/12 Redness & swelling extended downward to elbow - took ibuprofen. 3/9/12 Soreness today redness reduced to a round 3 x 3 cm reaction at injection site.

VAERS ID:452241 (history)  Vaccinated:2012-03-07
Age:65.0  Onset:2012-03-07, Days after vaccination: 0
Gender:Female  Submitted:2012-03-22, Days after onset: 14
Location:California  Entered:2012-03-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin, Motrin,
Current Illness: No
Preexisting Conditions: Hyperlidemia, Diverticulosis
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Other
Symptoms: Asthenia, Headache, Oral pain, Toothache
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Left side of mouth (teeth) started hurting....extremely painful, lasting for 45 mins. Weakness started after 30 mins. then headache came on lasting for 2 hours. Took 200 mg. Motrin. Teeth pain, weakness, were over in 1 hour, while the headache lasted about 2 hours.

VAERS ID:453894 (history)  Vaccinated:2012-03-07
Age:0.4  Onset:2012-03-09, Days after vaccination: 2
Gender:Male  Submitted:2012-04-17, Days after onset: 38
Location:Colorado  Entered:2012-04-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: R/T 100 degrees fever; No other sx. Teething?
Preexisting Conditions: None
Diagnostic Lab Data: PCR (+) nasal swab pertussis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300BA1UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH259AB1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH919741UNRL
Administered by: Public     Purchased by: Public
Symptoms: Bordetella test positive, Cough, Polymerase chain reaction
SMQs:, Anaphylactic reaction (broad)
Write-up: Tested PCR (+) via nasal swab for Pertussis. Onset of cough 3/9/2012. Pt. not hospitalized. Treated with Z-PACK x 5 days.

VAERS ID:451367 (history)  Vaccinated:2012-03-08
Age:1.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:Florida  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: loratadine
Current Illness: A URI
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.174AA3SYRRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1122AA0SYRLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF272913SYRLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1250AA0SYRRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vaccines were given on 3/8/12. On the morning of 3/9/12 mom noticed redness around injection site (left). Patient has brought to office & prescribed AUGMENTIN (600/5) 5 ml PO BID x 10 days.

VAERS ID:451398 (history)  Vaccinated:2012-03-08
Age:10.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:Virginia  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: irritable/depressed~Typhoid Vi Polysaccharide (no brand name)~1~8.17~Sibling|irritable/depressed~Yellow fever (no brand name)~1
Other Medications: Metadate CD 10 mg Singulair, 5 mg Zyrtec, 10 mg Fish Oil (as a vitamin supplement)
Current Illness: No.
Preexisting Conditions: ADHD Allergies: dogs, cats, dust, some pollen
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Confusional state, Diarrhoea, Disorientation, Hallucination, visual, Headache, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient became extremely disoriented and confused. Described visual hallucinations when he closed his eyes - swirling fragments of colored maps. Did not recognize our street when we were driving on it. Mild sweating. Headache. Nausea. Three bouts of diarrhea in a 4 hour period. Symptoms began to clear up at noon, and he seems himself again now (3:00 PM, same day).

VAERS ID:451399 (history)  Vaccinated:2012-03-08
Age:8.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-09, Days after onset: 0
Location:Virginia  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: confusion/disorientation~Typhoid Vi Polysaccharide (no brand name)~1~10.33~Sibling|confusion/disorientation~Yellow fever (no br
Other Medications: None.
Current Illness: No.
Preexisting Conditions: Peanut allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCRA
Administered by: Public     Purchased by: Other
Symptoms: Abnormal behaviour, Crying, Depression, Emotional disorder, Headache
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Child was suddenly and very uncharacteristically depressed, emotional and (in her words), "grumpy." She could not give a reason why she would suddenly start crying...Also reported having a bad headache. This behavior is *extremely* unusual in this child. Given how her brother and mother reacted at the same time, I thought it was worth reporting.

VAERS ID:451401 (history)  Vaccinated:2012-03-08
Age:38.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-09, Days after onset: 0
Location:Virginia  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamictal, 300 mg Advil, 400 mg
Current Illness: No.
Preexisting Conditions: Diagnosed depression.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER 1SCRA
Administered by: Public     Purchased by: Other
Symptoms: Depression, Fatigue, Headache, Malaise, Musculoskeletal stiffness, Nausea, Tearfulness
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Arthritis (broad)
Write-up: Depression/malaise. Woke up in tears. Burst into tears several times throughout the day for no reason. Really bad headache. Slight nausea. Extreme fatigue. Stiff neck. Still feeling like this now (3:00 PM).

VAERS ID:451429 (history)  Vaccinated:2012-03-08
Age:25.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-03-09, Days after onset: 1
Location:Connecticut  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTC Multivitamin
Current Illness: Per office note- no
Preexisting Conditions: Per office note - no
Diagnostic Lab Data: Patient seen in office today.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4304BA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache, Malaise, Nausea, Pain in extremity, Pyrexia, Tongue oedema, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Nausea; Vomiting; fever; chills; fatigue; malaise; arthralgias; arm soreness; Dizziness; Headache; Tongue edema.

VAERS ID:451430 (history)  Vaccinated:2012-03-08
Age:52.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-10, Days after onset: 1
Location:Alabama  Entered:2012-03-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~Influenza (Seasonal) (no brand name)~UN~0.00~Patient
Other Medications: Celebrex, Advair, Singulair, Xyzal, Synthroid, Dexilant
Current Illness: None
Preexisting Conditions: Allergies, IGA deficiency, asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever that rose throughout the day and into the night peaking at 102 degrees and resulting in violent chills and nausea, but no vomiting. Also experienced terrible muscle/joint soreness and weakness.

VAERS ID:451454 (history)  Vaccinated:2012-03-08
Age:4.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:Alaska  Entered:2012-03-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B136BB IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG1083 SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0518AA SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143AA SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Local reaction
SMQs:
Write-up: Large local reaction OTC cetirizine.

VAERS ID:451457 (history)  Vaccinated:2012-03-08
Age:72.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-10, Days after onset: 2
Location:Virginia  Entered:2012-03-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Diabetes; lung disease
Diagnostic Lab Data: Pt checked allergic to thimerosal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102601 SYRLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA SYRRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt stated the injection site got extremely red and swollen. It did not hurt - but pt got flu shot in opposite arm and did not have any reaction to that vaccine.

VAERS ID:451438 (history)  Vaccinated:2012-03-08
Age:21.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-11, Days after onset: 2
Location:Utah  Entered:2012-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH470AD IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB532AA IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4241AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1170AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Local reaction, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Had large local reaction to Pneumovax as well as fevers, rigors, myalgias present on 3/11/2012. Had hep A, influenza, Menactra same day other arm; had Adacel same day same arm.

VAERS ID:451443 (history)  Vaccinated:2012-03-08
Age:44.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 3
Location:Puerto Rico  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Relafen 500MG or Celebrex 200MG.
Current Illness:
Preexisting Conditions: Diagnosed with Rheumatoid Arthritis. Allergy to a high doses of aspirin.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER1113 21 1/120SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Headache, Pruritus, Rash, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Runny Nose, headache, joint pain, itching (skin rash in back, chest, face and arms). Every six hours used two Benadryl for the allergy and once a day Advil for the pain.

VAERS ID:451515 (history)  Vaccinated:2012-03-08
Age:12.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:New York  Entered:2012-03-12
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: Asthma
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Other
Symptoms: Chest pain, Cough, Decreased appetite, Dyspnoea, Fatigue, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Chest pain next day. Tired, decrease appetite 2 days later. Vomiting, cough, SOB 2 days later.

VAERS ID:451545 (history)  Vaccinated:2012-03-08
Age:45.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 3
Location:Massachusetts  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: had completed TST (JHP Pharm) has had previous tetanus vaccines - last 12 yrs prior but not Tdap
Current Illness: none
Preexisting Conditions: cat allergy
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4015AA0IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Dysgeusia, Erythema, Fatigue, Myalgia, Oropharyngeal pain, Pain, Pain in extremity, Papule, Rhinorrhoea, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Metallic taste in mouth lasted an hour, then bad sore throat, rhinorrhea, myalgias, fatigue and urticaria, few scattered red papules, lives alone, no one had similar sx, sx resolved 24-36 hours and then noted arm sore, was sl tired and achy but otherwise sx resolved.

VAERS ID:451565 (history)  Vaccinated:2012-03-08
Age:34.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 3
Location:Oregon  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OCELLA
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4305BA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Fatigue, Feeling abnormal, Injection site pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Tdap on 3/8/12 as part of her annual exam. A few hours after vaccine administered she began to feel "fuzzy" and was tired. On 3/9/12 she woke up & (L) axillary was swollen & painful. (L) deltoid was also painful. No rash or fever.

VAERS ID:451563 (history)  Vaccinated:2012-03-08
Age:22.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-12, Days after onset: 2
Location:Maryland  Entered:2012-03-13, 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: No meds
Current Illness: None specified
Preexisting Conditions: CECLOR, unknown reaction, child; PCN, rash
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1668AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG01810IMLA
Administered by: Military     Purchased by: Military
Symptoms: Rash papular
SMQs:
Write-up: Erythematous 1.5cm well circumscribed papules - trunk, posteriorly/anteriorly. Non-pruritic, non-painful. Given steroid cream (1%) and diphenhydramine.

VAERS ID:451614 (history)  Vaccinated:2012-03-08
Age:5.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-12, Days after onset: 2
Location:California  Entered:2012-03-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4022AA4IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1024AA1SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0935AA1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Diffuse swelling that is nontender, nonerythematous and no warmth on left upper arm.

VAERS ID:451635 (history)  Vaccinated:2012-03-08
Age:6.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 4
Location:Florida  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin
Current Illness: Animal Bite to face 3/4/12. Post exposure prophylaxis initiated 3/5/12.
Preexisting Conditions: Autism. Zantac, Reglan drug allergies.
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURE092121IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Mother reported on 3/12 that 45 minutes after 3/8 rabies vaccine, child c/o chest hurting. Resolved without intervention 3 hours later.

VAERS ID:451639 (history)  Vaccinated:2012-03-08
Age:23.0  Onset:2012-03-12, Days after vaccination: 4
Gender:Female  Submitted:2012-03-12, Days after onset: 0
Location:Nevada  Entered:2012-03-13, 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: "Blood pools in her eyes" congenital defect
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA628BA IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB538AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt has had intermittent intensity of numbness but still has from and normal strength in (R) deltoid where pt was given Hep A.

VAERS ID:451668 (history)  Vaccinated:2012-03-08
Age:0.9  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 3
Location:Illinois  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mother denies.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC415GAB IM 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916974 IM 
Administered by: Public     Purchased by: Public
Symptoms: Irritability, Pyrexia, Rash erythematous, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: The next morning when she woke up mom said she had a red rash to her forehead, cheeks, stomach and back. Had a low grade temp. of 99.8, and was fussy. Mom called ER and they told her to give her Benadryl and if it doesn''t get any better to bring her in to be seen. She took her in to ER that evening, and they told her it was a reaction to the vaccines she received the day before. She cont to give her Benadryl for 2-3 days and it went away.

VAERS ID:451700 (history)  Vaccinated:2012-03-08
Age:6.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 3
Location:Alabama  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Molluscum contagiosum
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4184BD UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA UNUN
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Reaction began Fri 9 March, redness & warmth at the site & increased over the weekend, painful to touch or move. Treated with BENADRYL & observed closely & continued to enlarge. Initiated antibiotics KEFLEX 250 mg/5ml to give 8.5 ml twice daily x 10 days.

VAERS ID:451721 (history)  Vaccinated:2012-03-08
Age:4.0  Onset:2012-03-10, Days after vaccination: 2
Gender:Female  Submitted:2012-03-14, Days after onset: 3
Location:North Carolina  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Environmental allergies
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171DA IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1189AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1004AA1SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227224IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1219AA1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Small area of erythema (2cm) to LUE - no induration.

VAERS ID:451751 (history)  Vaccinated:2012-03-08
Age:60.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-03-09, Days after onset: 1
Location:New York  Entered:2012-03-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COLACE 100mg PO
Current Illness: Cystoscopy and TURP
Preexisting Conditions:
Diagnostic Lab Data: Blood cultures; urine culture; temperature
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT492AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Blood culture, Computerised tomogram head, Culture urine, Mental status changes, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad)
Write-up: Fever 102.9 3-8-12 at 1400 (TYLENOL 650mg PO, IV antibiotics, IV fluids). Altered mental status (CT of brain). (Fever came down to 101.7 degrees then 98.2 at 1900; PO fluids encouraged; IV fluids - antibiotics initiated; mentation remains altered though pt appears to be improving).

VAERS ID:451859 (history)  Vaccinated:2012-03-08
Age:1.4  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 5
Location:Nevada  Entered:2012-03-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 103 degrees~DTaP + IPV + Hib (Pentacel)~1~0.50~Patient|fever of 103 degrees~Pneumo (no brand name)~1~0.50~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.AHBVC022CA2IMUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.1416AA0IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0871AA0SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1380AA0SCUN
Administered by: Public     Purchased by: Public
Symptoms: Pruritus, Rash generalised, Rash papular, Scab, Varicella post vaccine
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mom RTC 6 days after vaccination stating child started having whole body rash 3 hours after vaccination with itching. She gave child ibuprofen & BENADRYL. Child was seen by APN at clinic & diagnosed with breakthrough varicella per APN''s notes, with multiple red papulovesicular lesions - some with scabs on cheeks, arms & legs and mild on trunk & abdomen.

VAERS ID:451903 (history)  Vaccinated:2012-03-08
Age:4.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-03-15, Days after onset: 5
Location:Alabama  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA4IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4118BA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0190AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0695AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm, where vaccine was given was red and swollen, up into the shoulder area. Warmth, edema, and redness noted. Treatment: Applied cool compress to affected area. Instucted mom to give Tylenol/or ibuprofen. If no improvement, to see MD or ER immediately.

VAERS ID:451924 (history)  Vaccinated:2012-03-08
Age:69.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 6
Location:California  Entered:2012-03-15
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: HTN (hypertension)
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA603BB IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1418AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Erythema, Headache, Injection site haematoma, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient c/o severe swelling of (L) arm after receiving influenza vaccine on 3/8/12. She described it as red, sore & swollen for 5 days. Reports fever & headaches 2-3 days after receiving vaccine. Pt took anti inflammatory med to relieve pain & swelling. Today arm is not swollen, but severe bruising from deltoid to elbow. Able to move arm freely, no fever, & denies pain. Continue to feel weak.

VAERS ID:451994 (history)  Vaccinated:2012-03-08
Age:61.0  Onset:2012-03-10, Days after vaccination: 2
Gender:Female  Submitted:2012-03-11, Days after onset: 1
Location:Delaware  Entered:2012-03-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pravastatin; Atenolol; Triamt/Hctz
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1604AA0IMUN
Administered by: Other     Purchased by: Private
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient presented 3/11/12 with itching, red rash at injection site. (Dark red rash of 1.5", light red rash of 6" diameter). Counseled to use hydrocortisone & BENADRYL.

VAERS ID:452075 (history)  Vaccinated:2012-03-08
Age:5.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-03-16, Days after onset: 7
Location:Florida  Entered:2012-03-19, 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: The patient''s past medical history was not reported; however, the patient had allergies to "Termeric" (Turmeric) and dairy protein. The patient had no illness at time of vaccination, took no concomitant medications and had not received any vaccinations four weeks prior to date of vaccination.
Diagnostic Lab Data:
CDC Split Type: 201202702
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR 3UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR 0UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Body temperature increased, Cough, Eyelid oedema, Gastric disorder, Injection site erythema, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Initial report was received on 08 March 2012 from a consumer, who is also the patient''s parent. A 5-year-old male patient received an injection of dose one of IPOL, sanofi pasteur SA (lot number unknown, route and site not reported) and an injection of dose four or five of DAPTACEL, sanofi pasteur Ltd. (lot number unknown, route and site not reported) on 08 March 2012 at 11:30AM. The patient''s past medical history was not reported; however, the patient had allergies to "Termeric" (Turmeric) and dairy protein. The patient had no illness at the time of vaccination, took no concomitant medications and had not received any vaccinations four weeks prior to date of vaccination. On 08 March 2012 at 8:00PM, eight and one half hours after vaccination, the patient experienced a "stomach reaction", throat constriction, coughing, and temperature of 99.2 degrees Fahrenheit, puffy eyes and redness at injection site. The patient''s parent stated he gave his son BENADRYL and called the healthcare professional and would seek treatment as needed. The patient''s outcome was not recovered. Documents held by sender: None.

VAERS ID:452131 (history)  Vaccinated:2012-03-08
Age:68.0  Onset:2012-03-14, Days after vaccination: 6
Gender:Male  Submitted:2012-03-20, Days after onset: 6
Location:Virginia  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Humalog insulin, Lantus, losartan, actoplus metformin, lovastatin
Current Illness: none
Preexisting Conditions: Diabetes- insulin dependent
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Private     Purchased by: Other
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site rash, Sneezing
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Bump at Tdap injection site on right arm, hot red circle about 3 inches around, lasted 3 days, then diarrhea, then sneezing and constant cough.

VAERS ID:452930 (history)  Vaccinated:2012-03-08
Age:51.0  Onset:2012-03-15, Days after vaccination: 7
Gender:Female  Submitted:2012-04-03, Days after onset: 19
Location:Wisconsin  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid .112mcg , Aleve 1 tablet per day, Quinapril 20 mg
Current Illness: No.
Preexisting Conditions: Allergic to Sulfa and Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU43014BA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue, Hypertension, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad)
Write-up: Awoke with very high blood pressure, pounding heart rate. At times, my blood pressure was 145/97. This lasted for over 15 days. I visited Clinic twice within 3 weeks of vaccination. They denied it was connected to vaccine. I do not agree. Severity of symptoms has subsided 04/01/2012. Prior to this vaccination, my blood pressure has been controlled and kept normal for 20 years. I was fearful of stroke or heart attack. I was exhausted from my heart pounding. I will never take this vaccination again. Please ask medical people to take this more seriously.

VAERS ID:453376 (history)  Vaccinated:2012-03-08
Age:1.3  Onset:0000-00-00
Gender:Male  Submitted:2012-04-11
Location:West Virginia  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA0IMRL
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB5390A0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Patient received KINRIX in error. Should have received DTaP.

VAERS ID:454917 (history)  Vaccinated:2012-03-08
Age:38.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-02
Location:Missouri  Entered:2012-05-03, 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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201204505
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4008BA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a cluster of two patients who had received ADACEL, lot number C4008BA and experienced cellulitis. One patient is captured in this case and the other was captured in case number 2012-03108. A 38-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, sanofi pasteur Ltd., lot number C4008BA on 08 March 2012 and an unspecified amount of time later in March 2012 developed cellulitis at the injection site with swelling, redness and pain. The patient was evaluated in the emergency room (ER). No further information was available at the time of the report. The patient''s outcome was unknown. Documents held by sender: None.

VAERS ID:455396 (history)  Vaccinated:2012-03-08
Age:14.0  Onset:2012-03-11, Days after vaccination: 3
Gender:Male  Submitted:2012-05-11, Days after onset: 60
Location:New Jersey  Entered:2012-05-11
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: Penicillin, Vyvanse
Diagnostic Lab Data: Normal CBC, CMP, ESR, CRP, ferritin, celiac panel, AM cortisol, C3, C4, TSH, T4, RPR. Negative serology for Lyme, EBV, CMV. Parvovirus IgG-6. IgM-1.4.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMRA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Blood cortisol normal, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal, Complement factor C3, Complement factor C4, Cytomegalovirus test negative, Disturbance in attention, Dizziness, Epstein-Barr virus test negative, Fatigue, Full blood count normal, Gait disturbance, Joint stiffness, Laboratory test normal, Metabolic function test normal, Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Parvovirus B19 test positive, Red blood cell sedimentation rate normal, Serum ferritin normal, Thyroxine normal, Treponema test negative
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: On 3/11/12 he had pain radiating down his right arm (the arm in which he was vaccinated). The next day the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness, and difficultt concentrating. This lasted through early May, then resolved. He is now back to normal.

VAERS ID:455944 (history)  Vaccinated:2012-03-08
Age:0.5  Onset:2012-03-10, Days after vaccination: 2
Gender:Male  Submitted:2012-05-21, Days after onset: 71
Location:New Jersey  Entered:2012-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient was diagnosed with a mild ear infection and took amoxicillin for 7 days and stopped this medication one day prior to the reaction. He was previously on amoxicillin with no reaction.
Preexisting Conditions: Eczema
Diagnostic Lab Data: Blood test revealed that he was not allergic to Pears and he showed low probablity of other allergies as well.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMLG
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Agitation, Allergy test negative, Blood test normal, Eczema, Erythema, Pruritus, Rash, Rash erythematous, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: On 3/10/2012 patient got a rash around his mouth and face. He was itching his face. He became agitated. Our pediatrician recommended we give him Benadryl which decreased the rash and made him sleepy. Patient had eaten Pears for the second or third time when this happened - so pediatrician thought it may be pear related. On the morning of 3/11/2012 - patient had large red patches on both legs and diaper area. He had red dots on his trunk, neck and arm pits. He had a rash on his face. We took him to the ER and the rash responded to Benadryl and he was sent home. The rash came back and this time it looked like large red circles on his legs and diaper area and dots on face and trunk. We took to the ER again on 3/12/2012 because the rash would not go away. We were told it could be viral, a reaction to pears or amoxicillin. We felt dismissed everytime we asked if it was related to the vaccines he had on 3/8/2012. By 3/13/2012 - the large red circles were gone - but since then patient has suffered from bad Eczema on his face when prior to this it was only mild.

VAERS ID:456165 (history)  Vaccinated:2012-03-08
Age:68.0  Onset:2012-04-01, Days after vaccination: 24
Gender:Female  Submitted:2012-05-24, Days after onset: 53
Location:California  Entered:2012-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Wellbutrin, amlodipine, Coreg, Nexium, Seroquel, Ambien
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1160AA SCRA
Administered by: Other     Purchased by: Public
Symptoms: Anxiety, Arthralgia, Pain in extremity, Pruritus, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Rash on both forearms, under the skin, very itchy, with red bumps. Pain in both legs, upper thighs next to pelvis, knee pain, pain getting worse, high anxiety.

VAERS ID:457092 (history)  Vaccinated:2012-03-08
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2012-06-08
Location:Minnesota  Entered:2012-06-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR    
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site papule
SMQs:
Write-up: 4 mm flesh-colored papular lesion anterior proximal left thigh. Not currently vesicular on upper left thigh.

VAERS ID:457196 (history)  Vaccinated:2012-03-08
Age:33.0  Onset:2012-03-16, Days after vaccination: 8
Gender:Male  Submitted:2012-06-11, Days after onset: 87
Location:Puerto Rico  Entered:2012-06-11
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aspirin allergy
Preexisting Conditions: The subject was reported to have a medical history of falciform anemia.
Diagnostic Lab Data: UNK
CDC Split Type: A0980286A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA614BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Movement disorder, Multiple sclerosis
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by a healthcare professional via a sales representative and described the occurrence of difficulty moving arm in a 33-year-old male subject who was vaccinated with FLUARIX 2011-12 season (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and falciform anemia. Concurrent medical included COPAXONE. On 8 March 2012 at 09:34 the subject experienced unspecified dose of FLUARIX 2011-12 season in an unknown arm. On 16 March 2012, 8 days after vaccination with FLUARIX 2011-12 season, the subject experienced difficulty moving arms and legs and fatigue. It was reported that the symptoms mimicked the symptoms of multiple sclerosis. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events was unspecified. The lot number was reported as AFWA614BA from the reporter; however; however, based on GlaxoSmithKline sales data review, the lot number was corrected to AFLUA614BA.

VAERS ID:457900 (history)  Vaccinated:2012-03-08
Age:0.6  Onset:0000-00-00
Gender:Male  Submitted:2012-06-21
Location:Unknown  Entered:2012-06-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA02528
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR  UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1240AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection
SMQs:
Write-up: Information has been received from a physician''s office, concerning an 8 month old male patient who on 08-MAR-2012 was vaccinated with a dose of ROTATEQ (lot number 671576/01240AA) (route, site and dose not provided). Secondary suspect vaccine given on the same day included a dose of RECOMBIVAX HB (lot number, route, site and dose not provided). Concomitant vaccines given on the same day included a dose of PENTACEL and a dose of PREVNAR. It was reported that on an unspecified date the patient was hospitalized for rotavirus. The patient was treated with ZOFRAN and IV fluids. The patient was discharged on 04-MAY-2012. The patient had not been to the physician''s office for a follow up visit. At the time of the report, the patient had recovered. Additional information has been requested.

VAERS ID:462313 (history)  Vaccinated:2012-03-08
Age:2.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Male  Submitted:2012-04-18, Days after onset: 40
Location:Unknown  Entered:2012-08-17, Days after submission: 121
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: MEDI0015185
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK12207  UN
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 25-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 08-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.

VAERS ID:470530 (history)  Vaccinated:2012-03-08
Age:23.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-10-14, Days after onset: 219
Location:Unknown  Entered:2012-10-14
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:
CDC Split Type: WAES1210USA005454
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This spontaneous report as received from a nurse practitioner refers to a 23 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) intramuscularly on 08-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. After the injection that she was driving home and vomited for an hour straight. The outcome of vomited was reported as recovering. Additional information is not expected.

VAERS ID:487475 (history)  Vaccinated:2012-03-08
Age:2.0  Onset:0000-00-00
Gender:Unknown  Submitted:2013-02-28
Location:Unknown  Entered:2013-03-20, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0969863A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB518BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 24-month-old subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On 8 March 2012 the subject received unspecified dose of HAVRIX (details unknown). In March 2012, less than one week after vaccination with HAVRIX, the subject experienced swelling injection site and injection site redness. The subject had a "large swollen red area" at the injection site. At the time of reporting the outcome of the events was unspecified.

VAERS ID:506824 (history)  Vaccinated:2012-03-08
Age:42.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-10
Location:New York  Entered:2013-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Asthma; Hypertension
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1309USA013873
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1706AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report as received from a currently 43 year old female physician refers to herself with high blood pressure and asthma. On 08-MAR-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 672781/1706AA, expiration date 03-OCT-2013, dose, route not reported) for vaccination. Concomitant medication included TB test in separate site on 08-MAR-2012 with unspecified medications. On an unknown date the patient experienced injection site swollen, injection site red, injection site tender, injection site sore and flu-like symptoms with a low grade fever. There was no treatment given for the events. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as resolved 3 days later. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:452052 (history)  Vaccinated:2012-03-08
Age:2.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Unknown  Submitted:2012-03-15, Days after onset: 5
Location:Foreign  Entered:2012-03-19, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012065237
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Mycoplasma infection, Pyrexia, Tonsillitis
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow)
Write-up: This is a spontaneous report form a contactable physician via the Pfizer representative. A 2-year-old patient (gender unknown) received the first dose of PREVENAR on 08Mar2012. Relevant medical history and concomitant medications were not provided. On 09Mar2012 the patient developed a fever and was diagnosed with mycoplasma infection and tonsillitis in the hospital. The outcome of the events of fever, mycoplasma infection and tonsillitis was not recovered.

VAERS ID:452134 (history)  Vaccinated:2012-03-08
Age:20.0  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-03-19, Days after onset: 9
Location:Foreign  Entered:2012-03-20, 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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 11Mar2012, 40degC
CDC Split Type: D0074895A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Dizziness, Headache, Hypoaesthesia, Muscle spasms, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: This case was reported by a consumer and described the occurrence of a fainting fit in a 20-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 08 March 2012 the subject received the second dose of TWINRIX adult (1 ml, unknown). Approximately one day post vaccination with TWINRIX adult, on 09 March 2012, the subject experienced dizziness. Approximately two days post vaccination with TWINRIX adult, on 10 March 2012, the subject experienced numbness in ear, numbness of neck and headache. Approximately three days post vaccination with TWINRIX adult, on 11 March 2012, the subject experienced high fever of 40 degC and joint pain. The subject visited a hospital. After being for about 10 minutes in the waiting room of the hospital, on 11 March 2012, the subject experienced a fainting fit for about one minute. Additionally the subject experienced cramps in hands and feet. The subject was hospitalised for an unknown period of time. At the time of reporting the outcome of the events except fainting fit was unspecified. Follow-up information has been requested.

VAERS ID:452479 (history)  Vaccinated:2012-03-08
Age:0.2  Onset:0000-00-00
Gender:Male  Submitted:2012-03-26
Location:Foreign  Entered:2012-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Serum adenovirus Ab, positive; stool rotavirus RNA, positive; Rotavirus test
CDC Split Type: WAES1203USA02598
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adenovirus test positive, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case received from a healthcare professional, a peadiatrician, through a company representative, on 15-MAR-2012. Case medically confirmed. A two month-old male patient had received the first dose of ROTATEQ (batch number not reported) via oral route on 16-FEB-2012 and on 08-MAR-2012, the patient presented with vomiting and diarrhea. A rotavirus test was performed on an unspecified date and it was positive, typing was not been performed. He was diagnosed with gastroenteritis rotavirus on 10-MAR-2012. Also, the test was positive to adenovirus. The patient was hospitalized (start date: 12-MAR-2012, stop date: 15-MAR-2012). The patient received corrective treatment with auerotherapy. The patient recovered on 15-MAR-2012. According to the reporter, the picture has been mild. Other business partner numbers included E2012-01808. No further information reported.

VAERS ID:452747 (history)  Vaccinated:2012-03-08
Age:20.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-03-30, Days after onset: 21
Location:Foreign  Entered:2012-03-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatitis B
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0791631A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB913AC2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site cellulitis, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a nurse via regulatory authority (2012-010357) and described the occurrence of injection site cellulitis in a 20-year-old female subject who was vaccinated with ENGERIX B ADULT (GlaxoSmithKline). Concurrent medical conditions included hepatitis B. The subject received 1st dose of HBVAXPRO (Non GSK), on 04 October 2011 and 2nd dose of ENGERIX-B, on 15 November 2011. On 8 March 2012, the subject received 3rd dose of ENGERIX B ADULT (intramuscular, unknown injection site). On 8 March 2012, 4-5 hours after vaccination with ENGERIX B ADULT, the subject experienced injection site cellulitis and redness. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:452855 (history)  Vaccinated:2012-03-08
Age:49.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-04-02, Days after onset: 24
Location:Foreign  Entered:2012-04-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Previous allergies to dust mites; Previous allergy to grass seed; Previous allergy to crustaceans; Allergic to dust; Allergic to grass
Diagnostic Lab Data:
CDC Split Type: 2012031702
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090631502 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Feeling hot, Headache, Hyperhidrosis, Immediate post-injection reaction, Neck pain, Oropharyngeal pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This medically confirmed spontaneous report (initial receipt: 20-Mar-2012) concerns a 49 year old female patient with a medical history of allergies to dust, dust mites, grass, grass seed and crustaceans. She was well on the day of vaccination, had not have a severe reaction following any vaccine, did not suffer from any medical conditions or taking any medications, no history of Guillain-Barre syndrome or paralysis, not pregnant and had not been vaccinated against the flu in previous years. On 08-Mar-2012 at 14:00 the patient received one dose of FLUVAX (batch number: 090631502) intramuscularly in left upper arm for ''flu". The suspect drug was stored in cooled conditions (refrigerator, 2-8 degrees Celsius/35.6-46.4 degrees Fahrenheit). The storage temperature remained the same during storage at reporting site. Immediately (within 30 minutes) after receiving the injection the patient felt pain and sweating at the base of her neck. She became hot and itchy. She waited until 14:00 (as reported) to return to clinic. She complained of abdominal pain with sore throat and headache at based skull. The patient followed up with her nurse and doctor on the same day. Her BP (blood pressure) was 120/60 and 120/70. P (pulse) was 88 (strong). She was given oral cortisone and a referral to an allergy specialist. Following treatment with cortisone the symptoms abated immediately. The nurse called the patient the next day. She was no longer concerned. On 09-Mar-2012 the event outcome was recovered. Dechallenge, rechallenge and previous treatment with the suspect drug were not applicable. Follow up (28-Mar-2012): patient initials, suspect drug (storage condition, route of administration, one dose, indication for use, time of administration, site of administration), additional AE terms, reporter''s seriousness and causality assessment, event outcome, dechallenge, rechallenge, previous treatment with suspect drug, time to onset, event summary description, AE stop date, medical history, case upgraded to serious by company.

VAERS ID:454030 (history)  Vaccinated:2012-03-08
Age:47.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-04-19, Days after onset: 41
Location:Foreign  Entered:2012-04-19
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: Hypertension
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0075116A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB874CB0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Ear pain, Headache, Memory impairment, Meningism, Pain in extremity, Photophobia, Somnolence, Speech disorder, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of meningism in a 47-year-old female subject whow as vaccinated with ENGERIX B ADULT (GlaxoSmithKline). On 8 March 2012, the subject received the first dose of ENGERIX B ADULT (unknown). Since that time, the subject suffered from dizziness, headache and pain in the injection arm. At the time of reporting the events were unresolved. Written follow-up information received from the physician on 16 April 2012: Concurrent medical conditions included hypertension. Concurrent medications included Ramipril. On 8 March 2012, the subject received the first dose of ENGERIX B ADULT (intramuscular, unknown deltoid). On the same day of vaccination with ENGERIX B ADULT, the subject developed head pressure, otalgia, drowsiness, dizziness, vision disturbance, memory disturbance, meningism, photophobia, and speech disturbance. The subject was referred to hospital on 10 April 2012. This case was upgraded to serious in follow-up. The subject received unspecified treatment for initially suspected head-nose-throat disease, which was completed at the time of reporting, prior to referral to hospital. At the time of reporting the events were unresolved. The vaccination course with ENGERIX B ADULT was discontinued. The physician considered the events were probably related to vaccination with ENGERIX B ADULT.

VAERS ID:454260 (history)  Vaccinated:2012-03-08
Age:1.8  Onset:2012-03-09, Days after vaccination: 1
Gender:Female  Submitted:2012-04-20, Days after onset: 41
Location:Foreign  Entered:2012-04-24, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201203857
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC3546AE IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site extravasation, Injection site haematoma, Injection site pain, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Case received from the Health Authorities in a foreign country on 11 April 2012 under the reference number 2012/0103 (HA''s number PLURPLOCR20120323002). A 22-month-old female patient, with no reported medical history and concomitant therapy, had received an intramuscular dose of TRIPACEL (batch number C3564AE, site of administration not reported) on 08 March 2012. On 09 March 2012, the patient experienced 20cm infiltration at the injection site covering the shoulder joint, and pain and bruising at the injection site. The patient did not have fever, infiltration was not painful and oedema "much diminished". The patient was in good condition. The patient recovered on an unspecified date. The case was assessed as serious due to other medical important condition. The Health Authorities coded injection site infiltration, injection bruising and injection site pain.

VAERS ID:454350 (history)  Vaccinated:2012-03-08
Age:0.3  Onset:2012-03-11, Days after vaccination: 3
Gender:Female  Submitted:2012-04-25, Days after onset: 44
Location:Foreign  Entered:2012-04-25
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0797242A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA405CA0PO 
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Diarrhoea, Laboratory test normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of convulsion in a 12-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 8 March 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 11 March 2012, 3 days after vaccination with ROTARIX, the subject experienced convulsion and fever. Later, on the night, she experienced diarrhea. The subject was hospitalised. Test for meningitis and others showed no abnormality. After 2 days, the subject was discharged. At the time of reporting, the events were resolved. The physician considered thee vents were related to vaccination with ROTARIX.

VAERS ID:454638 (history)  Vaccinated:2012-03-08
Age:0.1  Onset:2012-03-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-04-27, Days after onset: 49
Location:Foreign  Entered:2012-04-30, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201204418
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG9952 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site oedema, Injection site reaction, Oedema, Pyrexia, Tearfulness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities through the local affiliate in a foreign country on 19 April 2012 under the reference number PL-URPL-OCR-20120402002 (local reference number 2012/0119). An 01-month-old patient (gender not specified), with no reported medical history, had received a subcutaneous dose of ACT-HIB, batch number G995-1, on 08 March 2012. On 08 March 2012, post-vaccination, the patient experienced a reaction at the injection site (3-5 cm in diameter). Tearfulness, body temperature up to 38 C as well as oedema were also reported. The patient was hospitalized for 3 days. The Health Authorities coded "injection site reaction", "tearfulness", "fever" and "injection site oedema". The patient recovered on an unspecified date. Documents held by sender: none.

VAERS ID:454778 (history)  Vaccinated:2012-03-08
Age:1.8  Onset:2012-03-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-04-26, Days after onset: 48
Location:Foreign  Entered:2012-05-01, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2012097203
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a spontaneous report from a foreign Health Authority. Regulatory authority report number N280/2012. A 22-months-old patient of an unspecified ethnicity and gender received PREVENAR 13 and PENTAXIM intramuscularly, in separate thighs respectively, on 08Mar2012 at DF. The patient medical history and concomitant medications were not reported. On 08Mar2012, after about 3 hours from vaccination, the patient experienced blisters on feet, swelling of feet and painful feet. All the events were assessed as medically significant. Suppository 250 mg hydrocortisonum was administered. The patient recovered from all the adverse events on unknown date. No follow-up attempts possible. No further information expected.

VAERS ID:456717 (history)  Vaccinated:2012-03-08
Age:0.1  Onset:2012-03-08, Days after vaccination: 0
Gender:Unknown  Submitted:2012-06-01, Days after onset: 84
Location:Foreign  Entered:2012-06-04, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201205615
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20911001A SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERUVA10012 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR9952 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities through the local affiliate on 29 May 2012 under the reference number PL-URPL-OCR-20120514002 (local reference number 2012/0163). An 01-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of ACT-HIB, batch number "9952-1", concomitantly with a subcutaneous dose of DTP vaccine (other manufacturer, batch number 20911001A) and an intramuscular dose of EUVAX B (other manufacturer, batch number UVA10012) on 08 March 2012. On 08 March 2012, post-vaccination, the patient experienced uncontrollable crying and screaming for more than 5 hours. There were no local reaction and fever. The patient''s events were reported by the mother at the time of the next vaccination. The Health Authorities coded "crying uncontrollable" and "screaming". The patient recovered in an unspecified date. This case was reported as serious, i.e. as a medically important condition. Documents held by sender: Not reported.

VAERS ID:462016 (history)  Vaccinated:2012-03-08
Age:1.3  Onset:2012-03-09, Days after vaccination: 1
Gender:Male  Submitted:2012-08-14, Days after onset: 157
Location:Foreign  Entered:2012-08-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood creatinine, 0.4 mg/dl; Blood glucose, 96 mg/dl; 09-MAR-2012, Blood pressure, 91/32 mmHg; 09-MAR-2012, Body temperature, 36.8 Centigrade; C-reactive protein, 24.5 mg/l; Haemoglobin, 12.4 g/dl; urine examination (unknown date during hospitalization): normal; leukocyte count (unknown date during hospitalization): 17200 cells/ul, with neutrophils 39.7%, lymphocytes 58.4%, monocytes 1.1% and eosinophils 0.5%; thrombocytes (unknown date during hospitalization): 321000 cells/ul; blood gas analysis (unknown date during hospitalization): pH 7.39, pCO2 36 mmHg, BE -3.4 mmol/l
CDC Split Type: 2012193251
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB238A3IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF651893IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Base excess decreased, Blood creatinine normal, Blood glucose normal, Blood pH normal, C-reactive protein increased, Eosinophil percentage decreased, Haemoglobin normal, Hypersensitivity, Lymphocyte percentage increased, Monocyte percentage decreased, Neutrophil percentage decreased, PCO2 normal, Platelet count normal, Pruritus, Rash, Urine analysis normal, Urticaria, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report received from the foreign Health Authority by a contactable physician. Regulatory Authority report number DE-PEI-PEI2012025666. A 15-month-old male patient of unknown race (9.8 kg weight, 79 cm height) received the fourth dose of PREVENAR 13 (lot n. F65189) intramuscularly at 0.5 ml, single on 08Mar2012 and the fourth dose of INFANRIX HEXA (Lot n. A21CB238A) intramuscularly, at 1 dose form (DF) single on 08Mar2012. The patient had been vaccinated together with his brother. Relevant medical history was not provided. Next day after vaccination, on 09Mar2012, the patient experienced urticaria, allergic reaction, exanthema and itching. The patient was hospitalized from 09Mar2012 to 11Mar2012. The patient developed an extensive urticarial exanthema. The patient''s physician was consulted. After administration of FENISTIL the exanthema was stable for a short period only and then further aggravated to a generalized state but no pulmonary symptoms. In hospital the patient then received prednisolone intravenously (once) and under continued FENISTIL treatment the patient''s general condition improved over 36 hours but not completely resolved. Patient was discharged to outpatient care on 11Mar2012. In the hospital, blood samples were taken and examinations were performed. Lab tests included: blood pressure at 91/32 mmHg on 09Mar2012; body temperature at 36.8 centigrade on 09Mar2012; urine examination (unknown date during hospitalization): normal; leukocyte count (unknown date during hospitalization): 17200 cells/ul, with neutrophils 39.7%, lymphocytes 58.4%, monocytes 1.1% and eosinophils 0.5%; haemoglobin (unknown date during hospitalization): 12.4 g/dl; thrombocytes (unknown date during hospitalization): 321000 cells/ul; creatinine (unknown date during hospitalization): 0.4 mg/dl. C-reactive protein (CRP) (unknown date during hospitalization): 24.5 mg/l; blood gas analysis (unknown date during hospitalization): pH 7.39, pCO2 36 mmHg, BE -3.4 mmol/l; blood sugar (unknown date during hospitalization): 96 mg/dl. The symptoms were improving, but the patient had not completely recovered at the date of reporting.

VAERS ID:524178 (history)  Vaccinated:2012-03-08
Age:13.0  Onset:2012-08-01, Days after vaccination: 146
Gender:Female  Submitted:2014-02-27, Days after onset: 575
Location:Foreign  Entered:2014-02-27
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: Albumin CSF increased, 21.1mg/dl; Cerebrospinal fluid protein, 36mg/dl; Neuropsychological test, See text; Single photon emission compute, Cerebral hypoper; Psychological examination revealed significant decline in language comprehension and working memory.
CDC Split Type: B0971121A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA156BA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Albumin CSF increased, Asthenia, CSF protein normal, Cerebral hypoperfusion, Cognitive disorder, Complex partial seizures, Dyslalia, Educational problem, Headache, Malaise, Memory impairment, Mental impairment, Neuropsychological test abnormal, Single photon emission computerised tomogram abnormal, Sleep disorder, Visual field defect
SMQs:, Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13001176) and described the occurrence of cerebration impaired in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st and 2nd doses of CERVARIX (GlaxoSmithKline) given on 1 September 2011 and 5 October 2011 respectively. On 8 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). In August 2012, 5 months after vaccination with CERVARIX, the subject''s academic performance was declined. In September 2012, 6 months after vaccination with CERVARIX, the subject had an episode of complex partial seizures starting with visual field defect. In April 2013, 13 months after vaccination with CERVARIX, the subject had headache every day. In November 2013, 20 months after vaccination with CERVARIX, the subject had general malaise. In January 2014, 22 months after vaccination with CERVARIX, the subject had weakness, dyslalia and sleep disorder. On an unspecified date, single-photon emission computed tomography (SPECT) revealed cerebral hypoperfusion, psychological examination showed significant decline in language comprehension and working memory and examination of cerebrospinal fluid showed increased protein (36 mg/dl) and albumin (21.1). The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified.

VAERS ID:451387 (history)  Vaccinated:2012-03-09
Age:5.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:Ohio  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0446AA2SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0944AA2SCLA
Administered by: Public     Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:
Write-up: MMR and VARIVAX given. The went into impact and found out child had received these vaccines on 3/8/12.

VAERS ID:451389 (history)  Vaccinated:2012-03-09
Age:9.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:New York  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0711AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Epistaxis, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Difficulty breathing, wheezing, bloody nose; gave albuterol back to back.

VAERS ID:451437 (history)  Vaccinated:2012-03-09
Age:1.1  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-03-11, Days after onset: 1
Location:North Carolina  Entered:2012-03-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild cold
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC. 0SYRRL
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLL
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 100.0 fever, rash at injection site the size of a dollar coin. The rash feels firm and warm.

VAERS ID:451440 (history)  Vaccinated:2012-03-09
Age:0.2  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 2
Location:Missouri  Entered:2012-03-12
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: Premature birth, one month early. Low birth weight.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 0IM 
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Decreased appetite, Emotional distress, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: BABY STARTED CRYING AT 1300, SCREAMING AT HIGH PITCH, FLAILING ARMS, INCONSOLABLE FOR 7 HOURS. GAVE TYLENOL BY WEIGHT, EVERY 4 HOURS. CONSTANT COMFORTING- ROCKING, ETC. BABY DID NOT EAT WELL UNTIL NEXT 12 HOURS AFTER IMMUNIZATIONS. DIDN''T REPORT TO DR. READ TODAY THAT CRYING MORE THAN 3 HOURS SHOULD BE REPORTED.

VAERS ID:451507 (history)  Vaccinated:2012-03-09
Age:35.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 2
Location:Washington  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LYRICA; MAXALT; Compazine; REGLAN; Gabapentin; AMBIEN; Lisinopril; TOPAMAX; Metformin; CIALIS; Vit C; ZYRTEC; Folic acid; Oxycodone; Carisoprodol; Ondansetron
Current Illness: None
Preexisting Conditions: Non-insulin diabetes; Hypertension; Obesity; Chronic low back pain with spinal stimulator
Diagnostic Lab Data: EKG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC018BA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Electrocardiogram, Hypersensitivity, Lip swelling, Migraine, Rash, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: EE states first noticed itchy rash legs on 3/9/12 several hours after Hepatitis B vaccine. Then developed mild lower lip swelling, vomiting up blood, migraine & rash/hives arms, face & legs. Went to ED where diagnosed with allergic reaction & given IV BENADRYL, IV SOLUMEDROL & po BENADRYL.

VAERS ID:451512 (history)  Vaccinated:2012-03-09
Age:63.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:Ohio  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Two blood pressure medications - Lisinopril Metoprol
Current Illness: No
Preexisting Conditions: Doctor and Nurse advised of numerous allergies/reactions to medications - seemed to want to ignore this. Had fallen and landed face first - needed stitches. Nurse scared my spouse with the lock jaw issue - husband talked me into it against my desires.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU3748BA0JETLA
Administered by: Public     Purchased by: Other
Symptoms: Dysphonia, Feeling abnormal, Feeling cold, Injection site erythema, Injection site haematoma, Injection site nodule, Injection site streaking, Injection site swelling, Insomnia, Peripheral coldness, Rash macular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Could not get warm. Raspy voice. Could not sleep that night. "Funny" feeling in arm - at 6:00 a.m. the next morning, red nodule at injection sight surrounded by very large bruise. Red lines radiating toward elbow area - swelling from top of shoulder to elbow - feeling as if one banged their elbow - funny feeling in hand - still minor on Monday, March 12. Arm was cold to touch with splotches.

VAERS ID:451516 (history)  Vaccinated:2012-03-09
Age:40.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:Ohio  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: trazodone, glyburide, tiotropium bromide, aspirin EC, Prilosec, Zocor, iloperidone, Lexapro,
Current Illness: schizoaffective disorder, suicidal ideations.
Preexisting Conditions: acetaminophen, codeine, naproxen, oxycodone
Diagnostic Lab Data: blood work,
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1489AA0SCRA
Administered by: Military     Purchased by: Other
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Rt upper arm red swollen, painful.

VAERS ID:451526 (history)  Vaccinated:2012-03-09
Age:20.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 2
Location:South Carolina  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU3748AA UNAR
Administered by: Unknown     Purchased by: Other
Symptoms: Dizziness, Pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Light head and very sore.

VAERS ID:451543 (history)  Vaccinated:2012-03-09
Age:25.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:New Jersey  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: mefloquine 250 1 per wk (already took 2 doses)
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD 0PO 
Administered by: Other     Purchased by: Private
Symptoms: Genital rash, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash on neck, torso and genital/leg area. Given prednisone, loratidine and betamethasone valerate oint.

VAERS ID:451558 (history)  Vaccinated:2012-03-09
Age:1.1  Onset:2012-03-10, Days after vaccination: 1
Gender:Male  Submitted:2012-03-13, Days after onset: 2
Location:Minnesota  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533BA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166173IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: By Sunday 3-11-12 patient had a 6 1/2 cm x 4 cm red, warm raised lump where injection was given. PCV-13 is what was given in that thigh that he reacted to (R thigh).

VAERS ID:451567 (history)  Vaccinated:2012-03-09
Age:9.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:Oklahoma  Entered:2012-03-13, 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: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Tenderness, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Pt stated she had a large welt on her arm, tenderness throughout entire body, decreased appetite & sluggishness & went to ER. Welt has gone down slightly.

VAERS ID:451611 (history)  Vaccinated:2012-03-09
Age:1.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 3
Location:Arizona  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Eczema
Diagnostic Lab Data: Rapid strep - re in new of fever/rash
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB54CA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1026AA0SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1246AA0SCUN
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash, Streptococcus test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Urticarial rash in less < 8 hrs after administration of MMR, varicella & Hep A vaccines, responding to antihistamines. No other allergies hygiene identified.

VAERS ID:451612 (history)  Vaccinated:2012-03-09
Age:4.0  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 2
Location:Kansas  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None, mother mentioned client has had swelling in hands/face in the past
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA0UNUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441AA1UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1405AA1UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0972AA1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 03/10/2012 mild other mother reports injection site was hot/swollen with a hard spot 2.5 inches in diameter.

VAERS ID:451649 (history)  Vaccinated:2012-03-09
Age:5.0  Onset:0000-00-00
Gender:Male  Submitted:2012-03-12
Location:Nevada  Entered:2012-03-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196CA UNRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH455AD2UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient was seen in our office due to right deltoid red, swollen. Patient was rx KEFLEX 250mg, twice a day for 10 days.

VAERS ID:451666 (history)  Vaccinated:2012-03-09
Age:17.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 3
Location:South Carolina  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: denies any meds
Current Illness: denied by client
Preexisting Conditions: denied by client
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3838AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Injection site swelling, Injection site warmth, Neck pain, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Client reports soreness began 3-9-12. Next day noted "some" swelling. Now c/o R arm at site of injection with 3 inch diameter swelling and c/o "hot" to touch . Also states had neck pain and headache over the weekend after vaccines received. Denies any hives or Resp distress at any time after vaccines. States has "normal" temperature now and denies any drainage at site. Advised client to see his private MD or urgent care facility to assess above area and C/o of headache and neck pain.

VAERS ID:451762 (history)  Vaccinated:2012-03-09
Age:0.8  Onset:2012-03-10, Days after vaccination: 1
Gender:Male  Submitted:2012-03-13, Days after onset: 2
Location:California  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4074AA2UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4230AA1UNLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1481AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172421UNRL
Administered by: Public     Purchased by: Public
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient received PENTACEL, PREVNAR 13, hepatitis B vaccine, flu vaccine on 3/9/12 in am. After about 12-15 hours, pt developed fever 1-3.5 and generalized seizures for about 2 mins. brought to ER, diagnosed w/ febrile seizure, possible side affect of vaccines; discharged home in few hours; no further seizures since then.

VAERS ID:451777 (history)  Vaccinated:2012-03-09
Age:1.5  Onset:2012-03-14, Days after vaccination: 5
Gender:Female  Submitted:2012-03-14, Days after onset: 0
Location:Michigan  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC1413146AA4IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB534AA0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria that started at injection site, and spread throughout body, 5 days after immunization.

VAERS ID:451811 (history)  Vaccinated:2012-03-09
Age:60.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 4
Location:Minnesota  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D aspirin calcium red yeast rice
Current Illness: none
Preexisting Conditions: hyperlipidemia, CAD, osteopenia, hx breast cancer. allergies to tetracycline, ranitidine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1601AA0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Headache, Hyperaesthesia, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Diffuse headache, tremulousness, fatigue, skin hyperalgesia, nausea.

VAERS ID:451874 (history)  Vaccinated:2012-03-09
Age:11.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 5
Location:California  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: Slight cough
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1524AA IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3906AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4034AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Fatigue, Hand-foot-and-mouth disease, Pyrexia, Rash, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Received shots 3/9/12 and 1 1/2 hours later, pt developed 104 fever, achy joints & was sleepy x2 days but still tired. Had slight cough before shots & still has it. Fever gone. On 3/14/12 broke out with rash on hands - Dx Hand Foot Mouth.

VAERS ID:451986 (history)  Vaccinated:2012-03-09
Age:0.2  Onset:2012-03-12, Days after vaccination: 3
Gender:Female  Submitted:2012-03-12, Days after onset: 0
Location:Nebraska  Entered:2012-03-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Mild gastroesophageal reflux
Diagnostic Lab Data: Hemoccult
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4075AA0IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1259AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF309220IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB213A0PO 
Administered by: Private     Purchased by: Public
Symptoms: Decreased appetite, Haematochezia, Irritability, Occult blood
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Following vaccine administration, patient was noted to be fussier than normal, not eating as well; 3 days later, mom noticed a small amount of blood in a soft stool. No fevers/URI symptoms/constipation. Tx: Avoidance of dairy/soy in mom''s diet (breastfeeding)/NUTRAMIGEN supplementation. Monitoring further bloody stools/abdomen changes.

VAERS ID:451987 (history)  Vaccinated:2012-03-09
Age:10.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-09, Days after onset: 0
Location:New York  Entered:2012-03-16, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB539CA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4033A0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B062AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1206AA1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Chills, Dizziness, Pain, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)
Write-up: 10 mins after BOOSTRIX, MENACTRA, Hep A, Varicella vaccines - felt dizzy & fainted (vasovagal syncope). Recovered 1-2 mins. 2 hours later came back in office w/ chills & shooting pain legs = gave MOTRIN, slowly recovered 30 mins - 1 hour.

VAERS ID:452110 (history)  Vaccinated:2012-03-09
Age:1.3  Onset:2012-03-18, Days after vaccination: 9
Gender:Male  Submitted:2012-03-19, Days after onset: 1
Location:Arizona  Entered:2012-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B146993IM 
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4230AA1IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0597AA0SC 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143990SC 
Administered by: Private     Purchased by: Public
Symptoms: Irritability, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Mom calls today 03-19-2012 @ 11 am. States child has rash on face and upper torso and on her back. Fever of 101-102. Very fussy.

VAERS ID:452184 (history)  Vaccinated:2012-03-09
Age:1.0  Onset:2012-03-18, Days after vaccination: 9
Gender:Male  Submitted:2012-03-20, Days after onset: 2
Location:Ohio  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: No tests done. At this time (2 days after onset) child is still covered in rash from head to buttocks.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLG
Administered by: Unknown     Purchased by: Private
Symptoms: Pyrexia, Rash, Rash morbilliform
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Child first got a low grade fever for about 1 day, followed by a rash (measles-like spots) that began on his face and eventually spread down his neck and torso. Dr. seemed unconcerned by the side-effect and we are currently monitoring the rash.

VAERS ID:452230 (history)  Vaccinated:2012-03-09
Age:0.4  Onset:2012-03-12, Days after vaccination: 3
Gender:Male  Submitted:2012-03-21, Days after onset: 9
Location:Michigan  Entered:2012-03-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: X-ray
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4158AB1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1512AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Haematochezia, X-ray
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Bloody stools / diarrhea shortly past immns.

VAERS ID:452261 (history)  Vaccinated:2012-03-09
Age:0.5  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-03-09, Days after onset: 0
Location:Rhode Island  Entered:2012-03-22, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315BA UNRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4217AA UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF24141 UNLL
Administered by: Public     Purchased by: Public
Symptoms: Breath holding, Crying, Pallor
SMQs:, Acute central respiratory depression (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)
Write-up: Patient received the following shots (PEDIARIX, PREVNAR #13, Influenza). Cried out on the 1st and 2nd then held his breath for a few seconds on the 3rd (Flu) shot. Skin turn slightly pale. Pt mom said this had happened before when pt was hit with a toy. Treatment - pulse ox checked -$g 99-100%; Dr. called in to assess pt. which resulted in longer hospitalization.

VAERS ID:452273 (history)  Vaccinated:2012-03-09
Age:28.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 4
Location:Massachusetts  Entered:2012-03-22, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Asthma; Prediabetes; allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG1130 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: 1/2 hr after receiving typhoid vaccine pt developed asthma exacerbation.

VAERS ID:452373 (history)  Vaccinated:2012-03-09
Age:47.0  Onset:2012-03-17, Days after vaccination: 8
Gender:Female  Submitted:2012-03-23, Days after onset: 6
Location:Texas  Entered:2012-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diovan, Ibuprofen
Current Illness:
Preexisting Conditions: Hypertension, hyperparathyroidism
Diagnostic Lab Data: UA with trace occult blood, RBCs, and trace ketones Strep test negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC090CA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0820AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1026AA0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Blood urine present, Cough, Headache, Joint stiffness, Lymphadenopathy, Myalgia, Oropharyngeal pain, Rash pruritic, Red blood cells urine, Streptococcus test negative, Urine ketone body present
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Symptoms started wtih headache, neck lymphadenopathy. By 03/21/2012 progressed to diffuse myalgia, stiff joints, sore throat, and diffuse pruritic rash on face and trunk. Rash spread to extremities on 03/22/2012 and cough started on 03/23/2012.

VAERS ID:452432 (history)  Vaccinated:2012-03-09
Age:20.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-26, Days after onset: 16
Location:California  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0841AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: System was down; unable access record. According to Yellow shot card patient provided. #1 HPV given 12-21-2011. No other doses shown. Administered #2 03-09-2012. Later in day when clerk entered information which was now up it showed that she had #1 on 07-09-2009, so the 12-20-2011 dose was actually #2, which would make #3 due 03-21-2012. This made on 03-12-2012 twelve days early. We need to repeat #3.

VAERS ID:452439 (history)  Vaccinated:2012-03-09
Age:55.0  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-03-26, Days after onset: 15
Location:Tennessee  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LORTAB; unknown
Current Illness: Allergy to molds; dust allergy (unspecified)
Preexisting Conditions: The subject reported that she had a history of allergy to dust and mold, but refused to provide additional history as she felt that information was private. It was reported that the subject was seen in an urgent care facility for a cut to her finger prior to receiving BOOSTRIX.
Diagnostic Lab Data: UNK
CDC Split Type: A0970737A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Erythema, Incorrect dose administered, Induration, Infection, Mass, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer and described the occurrence of cellulitis of upper arm in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect vaccine included Tetanus vaccine and influenza virus vaccine (unspecified) given in November 2011. These vaccinations resulted in arm soreness which began on unknown dates in November 2011. The subject reported that her usual treatment with TYLENOL and Alcohol resolved the arm soreness following unspecified influenza virus vaccination. The outcome of arm soreness following the Tetanus vaccination was not specifically reported. No further details were provided regarding these events. Concurrent medical conditions included allergy to molds and dust allergy (unspecified). Concurrent medications included LORTAB and other unknown concurrent medications (not reported as the subject felt this information was private). On the night of 9 March 2012 the subject received a dose of BOOSTRIX in the left arm following a cut to the finger. This was an extra dose of vaccine administered as the subject received a Tetanus vaccination in November 2011. On 10 March 2012, 1 day after vaccination with BOOSTRIX, the subject noticed a hard knot on her arm (upper arm knot), swelling (swelling of upper arm), redness (upper arm red) and upper arm pain that were from her shoulder almost down to her elbow. She used pain medication (Pain medication unspecified) and Alcohol for relief. Two days later, on 12 March 2012, the swelling and redness were reported to be worse. The subject reported that she was at a health facility when a billing associate saw her arm and voiced concern. A "medical person" at the facility viewed the arm and informed the subject she had had a reaction to "the vaccination." The subject then went back to the facility where she received the BOOSTRIX vaccination and was prescribed CEPHALEXIN after being told that she had an infection in her arm called cellulitis (cellulitis of upper arm). The subject was encouraged to follow-up with her primary care physician and to discuss the potential ingredients in BOOSTRIX for possible reactions to future vaccines. No additional information is expected as the subject refused follow-up with her physician. She stated that, "that''s her private information."

VAERS ID:452600 (history)  Vaccinated:2012-03-09
Age:1.0  Onset:2012-03-13, Days after vaccination: 4
Gender:Male  Submitted:2012-03-28, Days after onset: 15
Location:California  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: mom had given Tylenol x 1 on 03/08/12
Current Illness: Mom reported a tactile temperature the day prior to the appointment x 1 which had resolved. Pt had no other symptoms.
Preexisting Conditions: none
Diagnostic Lab Data: blood, urine cultures, xray, PPD all negative from hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB522AA0 LA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0597AA0 RA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF227203 LL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1143AA0 LA
Administered by: Public     Purchased by: Public
Symptoms: Blood culture negative, Culture urine negative, Pyrexia, Rhinorrhoea, Tuberculin test negative, X-ray normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Pt came to clinic with temp 104.5, mild runny nose and no other symptoms, exam was WNL and fever attributed to vaccines. Pt went to ED 3/14 again with high fever and was admitted for 10 days with intermittent high fever, no other symptoms, extensive work up for infection was negative. Vitals were always stable and pt appeared clinically well except for high fevers.

VAERS ID:452635 (history)  Vaccinated:2012-03-09
Age:67.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 2
Location:North Carolina  Entered:2012-03-29, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1256AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Rash, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient called the day after injection, 3/10/12, and stated she had rash on face & neck that was red & itching continuously. Advised the patient to take BENADRYL and keep a close eye on rash. Advised that if symptoms didn''t improve to see a doctor. Followed up on 3/11/12. Symptoms had improved, no itching, still slightly red.

VAERS ID:452797 (history)  Vaccinated:2012-03-09
Age:4.0  Onset:2012-03-12, Days after vaccination: 3
Gender:Female  Submitted:2012-04-02, Days after onset: 21
Location:Wisconsin  Entered:2012-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clarinex prn
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B196BA0IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1365Z0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3X3 area of redness and warmth to area pt received Kinrix vaccine.

VAERS ID:452970 (history)  Vaccinated:2012-03-09
Age:19.0  Onset:2012-03-12, Days after vaccination: 3
Gender:Female  Submitted:2012-04-03, Days after onset: 22
Location:Washington  Entered:2012-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 3/22/12: facial lesion PCR positive for non-variola orthopox
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
Administered by: Military     Purchased by: Military
Symptoms: Orthopoxvirus test positive, Polymerase chain reaction, Scab, Secondary transmission, Skin lesion
SMQs:
Write-up: 19 yo health female who had intimate contact with friend, primary vaccinee (vaccination date of 3/2/12) on 3/9/12. Friend''s vaccination site was not covered and he was wearing short sleeve during intimate contact. On 3/13/12 she noted 5 facial lesions (left and right cheek and chin) which were originally treated with KEFLEX and then BACTRIM. Lesions tested positive for non-variola orthopox (per LRN) 3/22/12. As of 4/2/12 lesions are scabbed.

VAERS ID:454662 (history)  Vaccinated:2012-03-09
Age:42.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-30, Days after onset: 51
Location:Kentucky  Entered:2012-04-30
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:
Preexisting Conditions: MR; Intermittent explosive disorder; Psychiatric disorder, NOS; Seizure disorder; DM; HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC004AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4023AA0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Condition aggravated, 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: On 3-9-12, at 12:40 pm, Tdap & Hepatitis B vaccines were administered. At 3:13pm, patient experienced a seizure in excess of 6 minutes, (7 min). Our client was transferred to local hospital where he stayed 5 days. He does have a seizure disorder & experienced another seizure on 3-10-12 & one more on 3-11-12. His seizure meds were adjusted & he was released from hospital back to our facility. Our P & T committee reviewed this case as a possible ADR from the vaccines (most probably Tdap).

VAERS ID:455890 (history)  Vaccinated:2012-03-09
Age:10.0  Onset:2012-05-21, Days after vaccination: 73
Gender:Female  Submitted:2012-05-21, Days after onset: 0
Location:New York  Entered:2012-05-21
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hashimoto''s thyroiditis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1317AA2IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Abnormal behaviour, Activities of daily living impaired, Educational problem, Memory impairment
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Mother called office states within days of receiving 3rd dose of GARDASIL pt started to have behavior changes ie pt. went from being an honor student to failing all classes, having memory problems. Doesn''t remember to rinse shampoo from hair, puts on socks inside out, drawing on toys etc.

VAERS ID:456282 (history)  Vaccinated:2012-03-09
Age:67.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-05-17, Days after onset: 68
Location:Idaho  Entered:2012-05-24, 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: Routine vaccination
Preexisting Conditions: ASA; CIPRO; Penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA1UNLL
Administered by: Other     Purchased by: Other
Symptoms: Erythema multiforme, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash & erythema multiform.

VAERS ID:462312 (history)  Vaccinated:2012-03-09
Age:3.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-16, Days after onset: 37
Location:Unknown  Entered:2012-08-17, Days after submission: 123
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: MEDI0015186
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK12207  UN
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 36-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.

VAERS ID:462743 (history)  Vaccinated:2012-03-09
Age:5.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-17, Days after onset: 38
Location:Unknown  Entered:2012-08-17, Days after submission: 122
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: MEDI0015158
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK2207 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. FLUMIST was given intra-nasally for flu prevention. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.

VAERS ID:462770 (history)  Vaccinated:2012-03-09
Age:9.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-16, Days after onset: 37
Location:Unknown  Entered:2012-08-17, Days after submission: 123
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: MEDI0015189
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK1227 IN 
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither the patient''s past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012 and incorporated into the narrative: No late occurring adverse event.

VAERS ID:462795 (history)  Vaccinated:2012-03-09
Age:8.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-16, Days after onset: 37
Location:Unknown  Entered:2012-08-17, Days after submission: 123
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: MEDI0015188
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK12207 IN 
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an eight-year-old female. Neither the patient''s past medical history nor the concomitant medications were reported. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 18-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.

VAERS ID:462840 (history)  Vaccinated:2012-03-09
Age:15.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-16, Days after onset: 37
Location:Unknown  Entered:2012-08-17, Days after submission: 123
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: MEDI0015191
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK12207 IN 
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 15-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.

VAERS ID:470827 (history)  Vaccinated:2012-03-09
Age:77.0  Onset:2012-03-15, Days after vaccination: 6
Gender:Female  Submitted:2012-09-26, Days after onset: 195
Location:Unknown  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; Atorvastatin calcium
Current Illness: Drug hypersensitivity; Hypertension
Preexisting Conditions: --/--/2002, Myocardial infarction; Penicillin (unspecified), Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA007496
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Echocardiogram, Pruritus, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a 77 years old female patient refers to herself (140 lbs, 62 inch) with high blood pressure, allergy to penicillin and allergy to LIPITOR. The patient''s medical history included heart attack in 2002. The patient was vaccinated under the skin of the left arm with a dose of ZOSTAVAX (lot # not reported) on 09-MAR-2012. Concomitant medications included LIPITOR, generic atorvastatin calcium and unspecified blood pressure medicine. It was reported that after the patient got ZOSTAVAX on 15-MAR-2012 she had had an incident of burning and itching all around her neck. The patient also stated that she had gotten an ultrasound this same time (in March of 2012) that produced a horrible burn around her neck. However she said this came and gone. She said she also took LIPITOR and stopped taking it for 3 days and the pain and itching stopped. She took the LIPITOR again this Sunday and today she had the itching and burning had come back. She called her cardiologist today and he advised her to discontinue the LIPITOR. She said she had been using LIPITOR for about a year, but switch to the generic version (atorvastatin Calcium) in 13-MAR-2012. Unspecified treatment was given for the adverse events. On 11-SEP-2012 echocardiogram was performed and the result was not reported. The patient was not pregnant. The outcome of the adverse events was unknown. Additional information is not expected.

VAERS ID:487476 (history)  Vaccinated:2012-03-09
Age:3.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2013-02-28, Days after onset: 356
Location:Nevada  Entered:2013-03-20, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown; Nutritional supplement
Current Illness: Celiac symptoms NOS; Flour sensitivity; Sensitive to chemicals
Preexisting Conditions: The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient''s mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole for reflux during 3rd trimester. Grandmother reports patient''s mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn''t have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted by another family. The patient had a reaction to MIRALAX, for his constipation, previously. Grandmother states it was due to the pol
Diagnostic Lab Data: Body temperature, 2012, 105degrees; Body temperature, 15Mar2012, 104degrees; Body temperature, 16Mar2012, 99.8degrees; Pulse rate, 16Mar2012, 112; Respiratory rate, 16Mar2012, 20
CDC Split Type: A0970857C
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB522AA1UNLG
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Abnormal behaviour, Activities of daily living impaired, Autism, Crying, Decreased appetite, Erythema, Irritability, Lethargy, Pyrexia, Rash, Sensory integrative dysfunction, Sleep disorder, Speech disorder, Staring, Streptococcus test, Streptococcus test negative, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer (subject''s grandmother) and described the occurrence of low grade fever in a 3-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject''s medical history included constipation, drug reaction and thrush. Concurrent medical conditions included celiac symptoms nos, flour sensitivity and sensitive to chemicals. Historic vaccination included Hib; manufacturer unspecified; unknown given on 16 December 2008; DTaP; manufacturer unspecified; unknown given on 16 December 2008; DTaP-polio-Hib (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; Hep A; manufacturer unspecified; unknown given on 23 March 2010; live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 16 December 2008; MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; IPV (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010. Concurrent medications included unknown (suppository). On 9 March 2012 the subject received 2nd dose of HAVRIX (unknown route, unknown thigh). On 9 March 2012, less than one day after vaccination with HAVRIX, the subject experienced low grade fever and not eating properly. On 13 March 2012, 4 days after vaccination with HAVRIX, the subject experienced. On 14 March 2012, 5 days after vaccination with HAVRIX, the subject experienced cranky, acting out ("acting out by throwing rocks and toys"), stares "off" and blank appearance. On 15 March 2012, 6 days after vaccination with HAVRIX, the subject experienced gastric problem ("holding his stomach"), crying, decreased speech, lethargy, sleep (nos) and reluctant to attend school. The subject did not have a bowel movement on 14 March 2012. The grandmother has not contacted the subject''s physician and has not treated the fever. She has provided suppositories, given prunes, soup and mangos for the constipation. The subject receives suppositories for constipation, but the constipation was worse on 14 March 2012 than previously. The grandmother reported that the subject has history of "doesn''t detoxify". The grandmother is the subject''s caregiver. At the time of reporting the events were unresolved. Prior to these vaccinations, the subject was vaccinated with DTaP on 16 December 2008 and experienced some of the same events plus some different events. See case A0970857A for details. On 23 March 2010, the subject was vaccinated with DTaP/IPV/HIB combination vaccine and experienced some of the same events plus different events. See case A0970857B for details. Follow-up information was received on 27 April 2012 via consumer (subject''s grandmother) who provided the subject''s immunization record. It was clarified that 3-year-old male subject''s historic vaccinations included DTaP-polio-Hib (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008, 20 March 2009, 10 July 2009 and 23 March 2010; Hep A; manufacturer unspecified; unknown given on 23 March 2010; Hep B; GlaxoSmithKline; unknown; unknown given on 16 October 2008, 16 December 2008 and 10 July 2009; influenza virus vaccine; manufacturer unspecified; unknown, unknown given on 10 September 2009; live attenuated human rotavirus vaccine; GlaxoSmithKline; unknown given on 20 March 2009; MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008, 20 March 2009, 10 July 2009 and 23 March 2010; rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008 and 10 July 2009; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown given on 23 March 2010. Concurrent medications included unknown (suppository) and Probiotics. It was reported tha

VAERS ID:520191 (history)  Vaccinated:2012-03-09
Age:  Onset:2012-03-09, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-22, Days after onset: 684
Location:Unknown  Entered:2014-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA008564
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1605AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 09-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.

VAERS ID:563993 (history)  Vaccinated:2012-03-09
Age:4.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2015-02-05, Days after onset: 1063
Location:California  Entered:2015-02-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 2 ER Visit/Hospitalization - Severe vomiting, listless, slight rash on chest~Measles + Mumps + Rubella (MMR II)~1~1.08~Patient|2
Other Medications: None given at time of vaccination
Current Illness: None
Preexisting Conditions: PDD NOS/Autism
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4006AA4UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0870AA1UNUN
Administered by: Unknown     Purchased by: Other
Symptoms: Asthenia, Constipation, Cough, Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia, Retching
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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: Decrease Energy and appetite, redness and swelling at injection site, persistent cough, dry heaving, constipation, fever.

VAERS ID:620230 (history)  Vaccinated:2012-03-09
Age:53.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-06-01, Days after onset: 83
Location:Pennsylvania  Entered:2015-09-22, Days after submission: 1208
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012073061
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF588044 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dyspepsia
SMQs:, Gastrointestinal nonspecific dysfunction (narrow)
Write-up: This is a spontaneous report from a contactable nurse . A 53-year-old female patient received a dose of PREVNAR13, 0.5 ml single dose intramuscularly in left deltoid on 09MAR2012. Medical history and concomitant medications were unknown. On 09MAR2012 she experienced stomach burning. Relevant lab data was unknown. No treatment was required for the stomach burning. At the time of the report she had not recovered from the stomach burning. Follow-up (06APR2012): New information received from a contactable nurse includes: suspect product data and treatment received. Follow-up (23APR2012) Follow-up attempts completed. No further information expected.

VAERS ID:620906 (history)  Vaccinated:2012-03-09
Age:60.0  Onset:2012-03-16, Days after vaccination: 7
Gender:Male  Submitted:2012-06-01, Days after onset: 77
Location:Pennsylvania  Entered:2015-09-22, Days after submission: 1208
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012073107
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable nurse. This nurse reported similar events for three patients. This is the third of three reports. A 60-year-old male patient received the first dose of PREVNAR 13 (Lot Number F8804) intramuscularly, in the left deltoid on 09Mar2012. Relevant medical history, concomitant medications, and past product history were unknown. On 16Mar2012, following administration of the vaccination, the patient developed a red raised rash at the site of the injection. Treatment was not required for the event. The outcome of the event was unknown. Follow-up (06Apr2012): New information reported from a contactable nurse includes: Lot Number, patient information, and treatment details. Follow-up (26APR2012) Follow-up attempts completed. No further information expected.

VAERS ID:620907 (history)  Vaccinated:2012-03-09
Age:52.0  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-06-01, Days after onset: 82
Location:Pennsylvania  Entered:2015-09-22, Days after submission: 1208
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012073114
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF88044 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report from a contactable nurse. This nurse, a Pfizer internal colleague, reported events on three patients. This is the second of three reports. A 52-year-old female patient received a dose of PREVNAR 13 intramuscularly in the left deltoid of pneumococcal infection on 09Mar2012. No other vaccines administered on same day. Relevant medical history and concomitant medications were unknown. On 10Mar2012, the patient experienced red raised rash a six inch in diameter at the site of injection. Relevant lab data was unknown. No treatment required. The outcome of the event is ongoing as on 06Apr2012. Follow-up (06Apr2012): New information received from the same contactable nurse includes: reaction data. Follow-up (27APR2012) Follow-up attempts completed. No further information expected.

VAERS ID:602533 (history)  Vaccinated:2012-03-09
Age:  Onset:0000-00-00
Gender:Female  Submitted:2015-10-06
Location:Unknown  Entered:2015-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Hypersensitivity
Preexisting Conditions: Drug Reaction, Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1510USA002041
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient''s concurrent condition included multiple reactions to medications. On 09-MAR-2012, the patient was vaccinated with ZOSTAVAX vial at the pharmacy (lot number, dose, site and route of administration not reported). In March 2012 (reported as one week later), the patient developed zoster like rash and the patient was prescribed with VALTREX for approximately 3 months. The outcome of zoster like rash was unknown. The causality of zoster like rash with ZOSTAVAX was not reported. No further information was provided. No product quality complaint (PQC) was filed. This is one of the two reports of the same reporter. Additional information has been requested.

VAERS ID:452221 (history)  Vaccinated:2012-03-09
Age:  Onset:2012-03-14, Days after vaccination: 5
Gender:Unknown  Submitted:2012-03-21, Days after onset: 7
Location:Foreign  Entered:2012-03-21
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: UNK
CDC Split Type: D0074942A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician''s assistant via a sales representative and described the occurrence of severe exanthema in an infant subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 09 march 2012 the subject received an unspecified dose of ROTARIX (oral). Approximately five days post vaccination with ROTARIX, on 14 March 2012, the subject experienced severe exanthema at the arms, the feet and the face as well as severe swelling at dorsum of foot both sides. On 14 March 2012 the subject was hospitalised for three days. On 16 March 2012 the subject was discharged from hospital. At the time of initial reporting, on 19 March 2012, the outcome of the events was unspecified. Note: In initial report source data all dates were given as 2011 including date of first information received. Therefore an error in data reporting was considered and all data have been entered as 2012. Follow-up information was received on 21 March 2012 by phone from the sales representative. The sales representative confirmed that 2012 was the correct year for date of vaccination, date of occurrence of the event and date of hospitalisation. Follow-up information has been requested.

VAERS ID:452540 (history)  Vaccinated:2012-03-09
Age:0.1  Onset:2012-03-14, Days after vaccination: 5
Gender:Female  Submitted:2012-03-27, Days after onset: 13
Location:Foreign  Entered:2012-03-28, 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: Unknown
Diagnostic Lab Data: Electroencephalography, No epileptic potential; Stool analysis, Positive for Rotavirus, stool frequency was normal, stool was soft
CDC Split Type: WAES1203USA02597
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Convulsion, Drug administered to patient of inappropriate age, Electroencephalogram normal, Pallor, Rotavirus test positive, Stool analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case of misuse received from a healthcare professional on 16-MAR-2012. The case was medically confirmed. Case of misuse because the patient had received the first dose before the age of 6 weeks. A one month-old female patient received dose 1 of rotavirus (dose, route and lot # reported) orally. O 09-MAR-2012, five days later, on 14-MAR-2012, the patient presented with vomiting and was hospitalized. The next day, on 15-MAR-2012, the patient experienced a convulsion (which was observed by a physician). Afterwards the patient was pale and had asthenia but no fever was observed. An electroencephalogram (EEG) showed no epileptic potential. At an unspecified date a stool test was positive for rotavirus. Stool frequency was normal, stool was soft. At the time of the report the patient had recovered, but was still in hospital. The reporter considered a temporal relationship between the vaccination and the events. Other business partner numbers included: E2012-01830. No further information is available.

VAERS ID:453106 (history)  Vaccinated:2012-03-09
Age:6.0  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-04-05, Days after onset: 25
Location:Foreign  Entered:2012-04-06, 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: None reported.
Diagnostic Lab Data:
CDC Split Type: E201202044
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Case received from the Health Authorities (reported to them by a physician) in a foreign country on 26-MAR-2012 under the reference number: ES-AGEMED-510464337. Case medically confirmed. A 6 year-old female patient had received a dose of TRIAXIS (batch number not reported) via intramuscular (site of administration not reported) on 09-MAR-2012, and 24 hours later, on 10-MAR-2012, the patient presented with vaccination site pain, vaccination site induration, vaccination site warmth and injection site erythema in the left arm, of approximately 10 cm in diameter. The patient received corrective treatment with local cold and antiinflamatory (product name not reported, dose not reported, start and stop dates not reported). The patient improved, but induration, warmth and erythema persisted 5 days after onset. Case reported as serious by the Health Authorities with other medically important condition as criteria. No further information reported.

VAERS ID:453174 (history)  Vaccinated:2012-03-09
Age:0.4  Onset:2012-03-16, Days after vaccination: 7
Gender:Female  Submitted:2012-04-06, Days after onset: 21
Location:Foreign  Entered:2012-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0792733A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA414AA1PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Faeces pale, Gastroenteritis rotavirus
SMQs:, Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of rotavirus diarrhea in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included 1st dose of ROTARIX (GlaxoSmithKline; oral) given on 30 January 2012. On 9 March 2012, the subject received 2nd dose of ROTARIX (1.5 ml, oral). On 16 March 2012, 7 days after vaccination with 2nd dose of ROTARIX, the subject experienced loose stools which persisted. On 29 March 2012, the subject presented with faeces pale, which made the physician recall a stool condition observed sometimes in rotavirus infection. She visited the reporting physician''s hospital for the above-mentioned event. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:453259 (history)  Vaccinated:2012-03-09
Age:19.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-09, Days after onset: 30
Location:Foreign  Entered:2012-04-10, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA00525
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Feeling of body temperature change, Headache, Induration, Local reaction, Malaise, Swelling, Ultrasound scan, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (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), Hypersensitivity (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 19 year old female patient who on 09-MAR-2012, was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose and route not reported). The patient was concomitantly vaccinated with a dose of BOOSTRIX intramuscular and a dose of influenza virus split virion 3v vaccine inactivated (MSD). The patient went to general practitioner (GP) for vaccine and in the evening developed headache and felt hot and cold. No recorded increase of temperature. Next morning, the patient developed increased local reaction, red swollen and hard, increase in temperature, vomiting and generally feeling unwell. The patient went to GP who referred her to emergency department. On 12-MAR-2012, the patient was still in hospital. IV anti''s lincomycin, three times a day (tds) and benzyl penicillin, four times a day (qid) were given. Ultrasound for collection was performed. Theatre for drainage of collection - dry. At the time of the report, the patient''s outcome was unknown. The causality was assessed as possible by agency. The original reporting source was not provided. Additional information is not expected.

VAERS ID:453471 (history)  Vaccinated:2012-03-09
Age:0.3  Onset:2012-03-09, Days after vaccination: 0
Gender:Male  Submitted:2012-04-09, Days after onset: 30
Location:Foreign  Entered:2012-04-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2012083653
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21C323SA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF610191IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0994AA2PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Local reaction, Neurological examination normal, Restlessness, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: This is a spontaneous report downloaded from the web-portal of a foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2012009622. A 3-month-old male received a second dose of PREVENAR (lot number F61019), intramuscularly in the thigh, mediolateral left; a third dose of ROTATEQ (lot number 0994AA), orally and a second dose of INFANRIX HEXA (lot number A21C323SA) intramuscularly in the thigh mediolateral right, all administered on 09Mar2012. The patient had previously received first doses of PREVENAR and INFANRIX HEXA on 03Feb2012, and first and second doses of ROTATEQ on 06Jan2012 (first dose) and 03Feb2012 (second dose). No vaccine complications occurred at previous vaccinations. Relevant medical history and concomitant medications were not provided. On 09Mar2012, in the evening, the patient presented with restlessness, high-pitched crying, weeping and vomiting. The events resolved within three days and the patient was considered recovered from all events on 11Mar2012. It was additionally noted during an examination and consultation on 12Mar2012, slight local reactions with infiltrations/swelling (not further specified), with an unknown outcome and an oriented neurological examination was without any pathological findings. No follow-up attempts needed, follow-up automatically provided by PEI.

VAERS ID:453669 (history)  Vaccinated:2012-03-09
Age:19.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-04-12, Days after onset: 33
Location:Foreign  Entered:2012-04-13, 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:
CDC Split Type: 2012031869
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  SYRUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SYRUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Feeling of body temperature change, Headache, Induration, Injection site cellulitis, Local reaction, Malaise, Swelling, Ultrasound scan, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (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), Hypersensitivity (broad)
Write-up: This health authority report (initial receipt 03-Apr-2012) concerns a 19 year old female patient. On 09-Mar-2012, the patient received one dose of FLUVAX injection (batch unspecified). On the same day the patient also received one dose of BOOSTRIX injection via intramuscular route, and one dose of PNEUMOVAX 23 injection. The patient went to the GP (general practitioner) for the vaccine and in the evening developed headache and felt hot and cold. There was no recorded increase in temp (temperature). The next morning, the patient had increased local reaction which was red, swollen and hard, increase in temp (temperature), vomiting and was generally feeling unwell. The patient went to the GP who referred her to the emergency department. The patient developed cellulitis at injection site. The patient was still in hospital on 12-Mar-2012. The patient was treated with IV (intravenous) anti''s (antibiotics) lincomycin tds (three times daily) and Benzyl penicillin qid (four times daily). Ultrasound for ?collection was performed. Theatre for drainage of collection was dry. The event outcome was unknown. Reporter''s comments: On 03-Apr-2012, the reporter considered events serious due to hospitalisation and possible in relation to the suspect drugs.

VAERS ID:455686 (history)  Vaccinated:2012-03-09
Age:6.0  Onset:2012-03-14, Days after vaccination: 5
Gender:Female  Submitted:2012-05-16, Days after onset: 63
Location:Foreign  Entered:2012-05-16
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: B0800784A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B174AK UNLA
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSA69CC660A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via regulatory authority (# 2012-011277) and described the occurrence of injection site redness in a 6-year-old female subject who was vaccinated with PRIORIX (GlaxoSmithKline) and INFANRIX-POLIO. On 9 March 2012, the subject received an unspecified dose of PRIORIX (intramuscular, administration site unknown) and an unspecified dose of INFANRIX-POLIO (route unknown, left arm). On 14 March 2012, 5 days after vaccination with INFANRIX-POLIO and PRIORIX, the subject experienced injection site redness and injection site induration (coarse red lumpy rash developed on the front and back of the trunk) and the left arm where INFANRIX-POLIO was administered became red and angry looking (rash erythematous aggravated). The regulatory authority reported that the events were clinically significant (or requiring intervention). No corrective treatment was administered. After 3 days, the events were resolved.

VAERS ID:455880 (history)  Vaccinated:2012-03-09
Age:33.0  Onset:2012-03-11, Days after vaccination: 2
Gender:Male  Submitted:2012-05-18, Days after onset: 67
Location:Foreign  Entered:2012-05-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None reported.
Diagnostic Lab Data: Red blood cell sedimentation rate (ESR) of 22 no unit reported, no normal range reported; C-reactive protein of 80 no unit reported, no normal range reported; Rheumatoid factor negative; antinuclear factor negative; angiotensin-converting enzyme negative; antistreptolysin-o-titre negative; chest x-ray showed no bilateral hilar lymphadenopathy; mild lymphopenia at 0.96x10^9/l; ESR normalising at 12 no unit reported, no normal range reported
CDC Split Type: E201203126
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURH0317 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiotensin converting enzyme decreased, Antinuclear antibody negative, Arthritis, C-reactive protein increased, Chest X-ray normal, Erythema, Joint swelling, Lymphopenia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Streptococcus test, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was received from the health authority on 10-May-2012. GB-MHRA-ADR 21630091. This case is medically confirmed. A 33 year old male patient who was taking concomitant omeprazole for an unknown indication received an injection of TYPHIM VI (batch number H0317-3), 0.5mls, IM, site not reported, on 09-Mar-2012. On 11-Mar-2012, two days post vaccination, the patient experienced acute arthritis of ankles with erythema. The reporter stated that it was reminiscent of those typical of acute sarcoidosis. The ankles were swollen and red within two days of vaccination. There was also involvement of the wrists and, to a lesser extent, the elbows, knees and shoulders without erythema or swelling. There was no small joint involvement and no erythema nodosum. The patient had a raised red blood cell sedimentation rate (ESR) of 22 (no unit reported, no normal range reported) and c-reactive protein of 80 (no unit reported, no normal range reported). Rheumatoid factor, antinuclear factor, angiotensin-converting enzyme and antistreptolysin-o-titre were all negative. A chest x-ray showed no bilateral hilar lymphadenopathy. The patient had mild lymphopenia at 0.96x10^9/l. The patient was treated with non-steroidal anti-inflammatory drugs and was improving after four weeks with his ESR normalising at 12. At the time of reporting the patient was recovering from all the events. The events were considered to be medically significant.

VAERS ID:456952 (history)  Vaccinated:2012-03-09
Age:12.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-06-06, Days after onset: 88
Location:Foreign  Entered:2012-06-07, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA00070
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1535Z0IMUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.NN124500IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Fatigue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail form (Local Reference Number AUS/12/107, OPR Number: 298725) concerning a 12 year old female patient who on 09-MAR-2012 was vaccinated with the first dose of GARDASIL (Lot number NN12450, Batch number G005535), intramuscularly, 1 dose, 1 time. Also vaccinated with the first dose of RECOMBIVAX HB (Lot number 1535Z, Batch number NP27800), intramuscularly, 1 dose, 1 time. On 09-MAR-2012, the patient experienced dyspnea, fatigue and syncope, and was hospitalized. At the time of the report the outcome was unknown. The reporter felt that syncope, dyspnea and fatigue were possibly related to therapy with GARDASIL. The agency felt that dyspnea, fatigue and syncope, were possibly related to therapy with GARDASIL and RECOMBIVAX HB. The original reporting source was not provided. No further information is available.

VAERS ID:457193 (history)  Vaccinated:2012-03-09
Age:47.0  Onset:2012-03-10, Days after vaccination: 1
Gender:Female  Submitted:2012-06-11, Days after onset: 92
Location:Foreign  Entered:2012-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to cat hair; Allergic rhinitis; Wasp''s sting allergy
Preexisting Conditions: Urticaria
Diagnostic Lab Data: IgE, 2012, 36.6IU/ml; Examinations: Wasp IgE "at the moment" 36.6 IU/ml; Total IgE on 7 December 2005 1202 IU/ml
CDC Split Type: D0075871A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bedridden, Blood immunoglobulin E, Cardiovascular disorder, Chills, Erythema, Lichen planus, Lichenoid keratosis, Oral discomfort, Oral disorder, Pain in extremity, Paraesthesia, Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of lichen ruber in a 47-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject''s medical history included urticaria in childhood. Concurrent medical conditions included allergic reaction to cat hair, allergic rhinitis and wasp''s sting allergy starting on 29 January 2009. Concurrent medications included wasp hyposensitization therapy received on 21 February 2012. On 9 March 2012 the subject received 3rd dose of TWINRIX (unknown route and application site). On 10 March 2012, 24 hours after vaccination with TWINRIX, the subject experienced chills. On 10 or 11 March 2012, the subject experienced circulation disorder and limb pain. The subject was bedridden for 2 days over the weekend. On 12 March 2012 the subject was working again. On 15 March 2012, the subject experienced lip burning, tingling, erythema for 2 weeks and stomatitis with white coat. The subject visited the dermatologist. On 20 March 2012 lichen ruber with mucosa affection was diagnosed. This case was assessed as medically serious by GSK. The subject was treated with unknown gel, XUSAL and FENISTIL. It was reported the wasp IgE was "increased unusually" (36.6 IU/ml). On the end of March 2012 the subject experienced lichenoid efflorescences on bends, neck and axilla for over 4 weeks. At the time of reporting, on 25 May 2012, the overall events were unresolved. The physician considered the subject was "temporarily severely impaired". The physician considered the events were related to vaccination with TWINRIX.

VAERS ID:457658 (history)  Vaccinated:2012-03-09
Age:11.1  Onset:2012-03-15, Days after vaccination: 6
Gender:Male  Submitted:2012-06-18, Days after onset: 95
Location:Foreign  Entered:2012-06-19, 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: Mild nasal discharge before vaccination. No concomitant therapy. The patient''s body temperature was 37.1 degrees C before vaccination
Diagnostic Lab Data: Not reported
CDC Split Type: 201205881
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURG13940SCLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH11C03A0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Breath holding, Convulsion, Crying, Muscle rigidity, Pallor, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow)
Write-up: Case received from the Health Authorities through the local affiliate on 05 June 2012 under the reference number HIB-379 (local reference number A201200158). A 13-month-old male patient, with a reported medical history, had received his 1st subcutaneous dose of ACT-HIB, batch number G1394, in the left upper arm, concomitantly with his 1st subcutaneous dose of PREVENAR (other manufacturer, batch number 11C03A) in the right upper arm and his 1st subcutaneous dose of MR vaccine (other manufacturer, batch number MR170), on 09 March 2012, at 10:00 am. The patient had a medical history of mild nasal discharge before vaccination. He had had no concomitant therapy. The patient''s body temperature was 37.1 degrees C before vaccination. On 15 March 2012, at 07:05pm, the patient presented with facial pallor and limbs rigidity after a strong crying. He was seen in a different hospital than the reporting physician''s. The patient developed fever at 37.9 degrees C. The suspected symptoms of febrile convulsion "were diagnosed with breath-holding spells". The patient had developed similar symptoms several times except for fever (dates not specified). However, he had not presented with similar convulsions since the last one he presented with in early April. The convulsions which occurred after the second one were suspected to be breath-holding spells. On 04 June 2012, the patient was seen in the reporting physician''s hospital to receive his 2nd dose of PREVENAR. The outcome was recovered on 04 June 2012. "This case was not serious. A causal relationship between the vaccines and the events was not described. Breath-holding spells were suspected of being related to the event". Upon internal review, this case was assessed as serious, i.e. as a medically important condition. Documents held by sender: None.

VAERS ID:458015 (history)  Vaccinated:2012-03-09
Age:12.0  Onset:2012-03-13, Days after vaccination: 4
Gender:Female  Submitted:2012-06-25, Days after onset: 104
Location:Foreign  Entered:2012-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 26Mar2012, 411U/l; Aspartate aminotransferase, 26Mar2012, 137U/l
CDC Split Type: B0809256A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gastrointestinal pain, Hepatic function abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician via regulatory authority (NL-LRB-137840) and described the occurrence of decreased liver function in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included rheumatoid arthritis. Concurrent medications included methotrexate, omeprazole, ZOFRAN and CELEBREX. On 9 March 2012, the subject received 1st dose of CERVARIX (intramuscular, administration site unknown, batch number not provided). On 13 March 2012, 4 days after vaccination with CERVARIX, the subject experienced gastrointestinal pain. On 26 March 2012, 17 days after vaccination with CERVARIX, the subject experienced decreased liver function (alanine aminotransferase; 411 U/l and aspartate aminotransferase: 137 U/l). This case was assessed as medically serious by GSK. Methotrexate was stopped and a week after, her liver functions were normalised. It was stopped until the 2nd vaccination with CERVARIX and after this, methotrexate was slowly started again. After the 2nd dose, there were no complaints. At the time of reporting, the events were resolved.

VAERS ID:460923 (history)  Vaccinated:2012-03-09
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-02
Location:Foreign  Entered:2012-08-02
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: Incorrect route of drug administration
Diagnostic Lab Data: Examinations were performed with the following results on 27-Mar-2012: hemogram normal, Ultrasonography: supra centimeter carotid-jugular and submandibular bilateral ganglia (echogenic center and reactive aspect) measuring between 11 and 16 mm. On 27-Jun-2012, in the left supraclavicular fossa lump - 20 mm (between ganglion and lipoma), nodular image of 5.4 mm (favouring small ganglion with non specific characteristic).
CDC Split Type: WAES1208PRT000709
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.G0082221SCUN
Administered by: Other     Purchased by: Other
Symptoms: Full blood count normal, Incorrect route of drug administration, Lymph node pain, Lymphadenopathy, Mass, Synovial cyst, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: Case of misuse received from the Health Authorities (which received it from a physician) on 27-Jul-2012 under the reference number L201207-582 via the local site Sanofi Pasteur MSD. Case medically confirmed. A 14-year-old patient had received the first and second doses of GARDASIL (batch number G008222) via subcutaneous route - instead of intramuscular as recommended - on 10-Jan-2012 and 09-Mar-2012. A few days after the second injection in Mar-2012, the patient developed cervical lymphadenopathies, painful to palpation, with no other symptoms. The event lasted 3 months. It was unknown if the suspected drug was suspended due to the AE. There was no suspicion of drug interaction. The same drug was not reintroduced. There was no known previous reactions to the same drug or other drugs and allergies were denied. She had received the first dose uneventfully. The adverse event monitoring was performed with ultrasound to soft tissue. Examinations were performed with the following results on 27-Mar-2012: hemogram normal, Ultrasonography: supra centimeter carotid-jugular and submandibular bilateral ganglia (echogenic center and reactive aspect) measuring between 11 and 16 mm. On 27-Jun-2012, in the left supraclavicular fossa lump - 20 mm (between ganglion and lipoma), nodular image of 5.4 mm (favouring small ganglion with non specific characteristic). There was no specific treatment of the reaction. There are no known clinical history. At the time of reporting the patient had recovered.

VAERS ID:467717 (history)  Vaccinated:2012-03-09
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-04
Location:Foreign  Entered:2012-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210DEU002623
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Adnexa uteri pain, Chest pain, Fatigue, Headache, Nasopharyngitis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Case was received from the Health Authorities in a foreign country on 27-Sep-2012 (reference number PEI2012039395). Case is medically confirmed. Case is linked with case E2012-06375 (same patient, same product, same reporter). A 15-year-old female patient (weight: 80 kg, height: 166 cm) with no relevant medical history reported, had received the first dose of GARDASIL (lot no. , route and site of administration not reported) on 09-Mar-2012. Two to three days pv (at the age of 16), the patient experienced ovarian pain and thoracic pain. The patient developed severe headache lasting for about ten days and tiredness (onset not reported). She also experienced a cold for three times (onset not reported). At the time of reporting the patient had recovered. According to the reporter the reaction was related to the vaccination. This case was considered serious by the HA. CASE IS CLOSED.

VAERS ID:476429 (history)  Vaccinated:2012-03-09
Age:66.0  Onset:2012-03-09, Days after vaccination: 0
Gender:Female  Submitted:2012-12-04, Days after onset: 270
Location:Foreign  Entered:2012-12-04
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: Thyroxine sodium; Cetirizine hydrochloride
Current Illness: Hypothyroidism
Preexisting Conditions: Vision Loss
Diagnostic Lab Data: Neurological examination, 22May2012, reduced sensibil; Nuclear magnetic resonance ima, 08Jun2012, see text; Nuclear magnetic resonance ima, 08Jun2012, negative
CDC Split Type: B0848249A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB505AB UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39B033BB UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B033BB UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERE5416 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Areflexia, Hypoaesthesia, Hypoaesthesia oral, Listless, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia, Spinal osteoarthritis
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician via a regulatory authority (NO-NOMAADVRE-FHI-2012-15075) and described the occurrence of numbness toe in a 66-year0old female subject whow as vaccinated with HAVRIX (GlaxoSmithKline), BOOSTRIX-POLIO and STAMARIL (non-gsk). The subject''s medical history included vision loss in right eye in 2007 for 5 days. Concurrent medical conditions included hypothyroidism. Concurrent medications included LEVAXIN and CETIRIZIN. On 9 March 2012, the subject received an unspecified dose of HAVRIX (parenteral, administration site unknown), an unspecified dose of BOOSTRIX-POLIO (parenteral, administration site unknown) and an unspecified dose of STAMARIL (parenteral, unknown). on 9 March 2012, 12 hours after vaccination with HAVRIX, BOOSTRIX-POLIO and STAMARIL, the subject experienced numbness toe and pain in toes. She travelled to a foreign land. ON 21 May 2012, 73 days after vaccination with HAVRIX, BOOSTRIX-POLIO and STAMARIL, the subject experienced numbness in both legs, arms, lip and tongue when she woke up. On 22 May 2012, 74 days after vaccination with HAVRIX, BOOSTRIX-POLIO and STAMARIL, the subject experienced listlessness. She had slight reduced sensibility on the left side of face (neurological examination). No loss of strength. She had slight reduced sensibility in right lower limb and upper extremity. No provoked reflex in ankles bilateral. She was troubled with pricking, tingling and numbness in lower limbs. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). On 8 June 2012, 91 days after vaccination with HAVRIX, BOOSTRIX-POLIO and STAMARIL, the subject experienced increasing numbness in all 4 extremities. Due to this, a magnetic resonance imaging was performed with question of demyelination. The results of MRI total medulla showed degenerative changes cervical. The MRI of brain was negative. At the time of reporting, the events were improved. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX, BOOSTRIX-POLIO and STAMARIL.

VAERS ID:497910 (history)  Vaccinated:2012-03-09
Age:13.0  Onset:2012-03-11, Days after vaccination: 2
Gender:Female  Submitted:2013-07-29, Days after onset: 504
Location:Foreign  Entered:2013-07-29
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: Fero-gradumet
Current Illness: Iron Deficiency Anemia
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0911175A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Asthma, Colitis ulcerative, Condition aggravated, Dyspnoea exertional, Haematochezia, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician via a regulatory authority (V13000466) and described the occurrence of ulcerative colitis in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included iron deficiency anemia. Historic medications included Ferromia. Concurrent medications included Fero-gradumet. Subject''s body temperature before the vaccination was 35.5 Deg. C. On 9 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown injection site). On 10 March 2012, the subject had queasy and difficulty in orally receiving his treatment for iron deficiency anaemia: Ferromia tablet. Accordingly, the medication was switched to Fero-Gradumet. On 11 March 2012, 2 days after vaccination with CERVARIX, the subject experienced exertional dyspnea and asthma-like attack during the club activity, for which she received inhalation treatment at hospital. The symptom improved. On 31 March 2012, 22 days after vaccination with CERVARIX, the subject experienced bloody stools. On 23 April 2012, 45 days after with CERVARIX, the subject was admitted to the hospital for aggravated anaemia. On 09 May 2012, the subject was hospitalised for suspected ulcerative colitis. A diagnosis of ulcerative colitis was made, for which she received treatment. On 25 June 2012, the subject was discharged from the hospital. On 16 July 2013, the exertional dyspnea, bloody stools improved. At the time of reporting the outcome of aggravated anaemia was unspecified and the outcome of ulcerative colitis was unresolved.

VAERS ID:507850 (history)  Vaccinated:2012-03-09
Age:  Onset:2012-05-01, Days after vaccination: 53
Gender:Female  Submitted:2013-10-14, Days after onset: 531
Location:Foreign  Entered:2013-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 2012, see text; No findings suggestive of collagen disorder were noted following the blood tests performed.
CDC Split Type: B0929715A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA161AA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Blood test normal, Fibromyalgia, Pain
SMQs:, Dementia (broad)
Write-up: This case was reported by a physician via a regulatory authority (# V13000691) and described the occurrence of fibromyalgia in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included CERVARIX; GlaxoSmithKline; intramuscular given on 11 August 2011 and 26 September 2011. On 9 March 2012, the subject received 3rd dose of CERVARIX (intramuscular; unknown injection site). In May 2012, 2 months after vaccination with CERVARIX, the subject experienced pain in both hands and both elbow joints and pain in spine. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 23 May 2012, the subject visited hospital where a treatment including local rest and fixation and administration of Non-steroidal anti-inflammatory drug were recommended. The treatment showed no efficacy. Furthermore, the area affected by the pain was gradually extended to the both shoulders, the back, the knee joints and the ankles. The subject temporarily had difficulty in attending school. Fibromyalgia was diagnosed. Based on the results of blood tests, no findings suggestive of collagen disorder were noted. At the time of this report, the subject was under treatment with oral medication. As the cause of the events was unknown, the subject had been receiving treatment for fibromyalgia. However, no improvement in the pain was noted. At the time of reporting the events were unresolved. As the pain had been intense and interfering with the subject''s daily activities, the subject dropped out of high school. The subject was considered to have severe symptoms. The regulatory authority reported that the events were related to vaccination with CERVARIX.

VAERS ID:451546 (history)  Vaccinated:2012-03-10
Age:17.0  Onset:2012-03-11, Days after vaccination: 1
Gender:Female  Submitted:2012-03-12, Days after onset: 0
Location:Texas  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown cholesterol med
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None at this time
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4098AB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Grandmother/legal guardian called clinic 3/12/12 approx 1:30pm. Stated the patient c/o dizziness since last evening. Denies sinus, inner ear or other symptoms. Denies new food, medication, drug or alcohol usage. Bp per grandmother is 101/59 and respirations normal. Instructed to call personal physican for appt or advice and informed that she could take Benadryl 1 dose tonight at bedtime with MD okay and that VAERS would be done and to expect contact. Informed that unlikely it is related to vaccine at this late time post vaccination but, to stay in touch.

VAERS ID:451816 (history)  Vaccinated:2012-03-10
Age:51.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Illinois  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM; glimepiride; CYMBALTA; ACTOS; JANUVIA; LIPITOR; lisinopril
Current Illness: None
Preexisting Conditions: Diabetes; Hypertension; Hypercholesterolemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1607AA0SCLA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm, Upper extremity mass
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt. received vaccine on 3/10/12 and presented to pharmacy on 3/16/12 that her arm was red, swollen, hot to touch, & had a lump. Pt. contacted MD & he said must be a side effect & to use warm compress.

VAERS ID:454979 (history)  Vaccinated:2012-03-10
Age:14.0  Onset:2012-03-10, Days after vaccination: 0
Gender:Male  Submitted:2012-05-04, Days after onset: 54
Location:Unknown  Entered:2012-05-04
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:
CDC Split Type: PHEH2012US008954
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM11041 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Case number PHEH2012US008954 is an initial spontaneous report received from a nurse on 25 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. He was vaccinated with MENVEO (batch number: M11041) intramuscularly on to unspecified site on 10 Mar 2012. It was reported that the patient subsequently experienced a seizure. He experienced a fainting episode with tonic-clonic movements within minutes after vaccination and was better within 10 minutes. The causality was not provided. No further information was available.

VAERS ID:570154 (history)  Vaccinated:2012-03-10
Age:1.5  Onset:2012-03-11, Days after vaccination: 1
Gender:Male  Submitted:2015-03-16, Days after onset: 1099
Location:Texas  Entered:2015-03-16
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: Localized reaction to vaccination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSDR2940UNRA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUI190AC1UNLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.K0107970UNRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Localized redness, swelling and induration on the right arm.

VAERS ID:452435 (history)  Vaccinated:2012-03-10
Age:  Onset:2012-03-17, Days after vaccination: 7
Gender:Unknown  Submitted:2012-03-23, Days after onset: 6
Location:Foreign  Entered:2012-03-26, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA02142
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: Information has been received from a pediatrician (local reference number MYS/M12/0021) concerning a patient, who on approximately 10-MAR-2012 ("about a week ago from Saturday of 17-MAR-2012"), was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). It was reported that, on 17-MAR-2012, the baby was found to have intussusception and was referred to the government hospital on an unspecified date. At the time of the report, the patient''s outcome was unknown. No further information is available.

VAERS ID:452721 (history)  Vaccinated:2012-03-10
Age:40.0  Onset:2012-03-10, Days after vaccination: 0
Gender:Female  Submitted:2012-03-29, Days after onset: 18
Location:Foreign  Entered:2012-03-30, 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:
Current Illness:
Preexisting Conditions: The patient had a medical history of allergy to dipyrone and insect bites in childhood. She had also a history of vagal syncope treated for 2 years with midodorine.
Diagnostic Lab Data: Culture was negative at 24 hours. Blood cell counts and C-reactive protein were negative.
CDC Split Type: 201203166
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3619AD UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein normal, Culture negative, Erythema, Full blood count normal, Nodule, Oedema, Pain, Papule, Secretion discharge, Type III immune complex mediated reaction, Vaccination site erythema, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Case received from a Healthcare Professional in a foreign country on 21 March 2012 under the reference number CO2012010. A 40-year-old female patient, with a medical history of allergy to dipyrone and vagal syncope treated for 2 years with midodorine, had received her booster dose of ADACEL (batch number C3619AD, route and site of administration not reported) on 10 March 2012. The patient had a medical history of allergy to dipyrone and insect bites in childhood. She had also a history of vagal syncope treated for 2 years with midodorine. On 10 March 2012, the patient experienced local pain worsening for 72 hours. 5 days post-vaccination, she had erythema, pain and oedema. 6 days post-vaccination, she experienced increased erythema at the vaccination site and papule in the hypothenar area of the left hand which extended within 12 hours on the palm of the hand with the appearance of a phlyctenula of serous fluid content and burning pain. The patient was hospitalized (dates of hospitalization not reported). The lesion on hand was treated with BACTRIM since 16 March 2012. The lesion progressed to large phlyctenula that drained a serous fluid. Culture was negative at 24 hours. Blood cell counts and C-reactive protein were negative. The patient was afebrile and there were no signs of systemic inflammatory response. Erythema turned violet involving the back of the hand. Vasculitis was diagnosed and complement test was ordered. Type III hypersensitivity reaction was also considered. The patient''s outcome was unknown. List of documents held by sender: pictures of the lesion.

VAERS ID:518167 (history)  Vaccinated:2012-03-10
Age:13.0  Onset:2013-05-01, Days after vaccination: 417
Gender:Female  Submitted:2013-12-30, Days after onset: 243
Location:Foreign  Entered:2013-12-30
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: Body temperature, 10Sep2011, 36.5 Deg. C; Body temperature, 15Oct2011, 36.4 Deg. C; Body temperature, 10Mar2012, 36.0 Deg. C
CDC Split Type: B0954653A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA150BA2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Body temperature decreased, Dysstasia, Gait disturbance, Headache, Hyperventilation, Muscle spasms, Muscular weakness, Neuropathy peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a physician via regulatory authority (# V13001029) and described the occurrence of peripheral neuropathy in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccinations included 1st and 2nd doses of CERVARIX (GlaxoSmithKline; intramuscular, unknown site of injection) given on 10 September 2011 and 15 October 2011 respectively. On 10 March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown site of injection). In May 2013, 14 months after vaccination with CERVARIX, the subject experienced cramps in hand and hyperpnoea. In July 2013, the subject experienced weakness of lower extremities, headache and difficulty in standing and walking. In October 2013, cramps in left foot developed. In December 2013, the subject experienced back pain. The subject also developed peripheral neuropathy. In January 2014, the subject had scheduled a visit to centre for pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The regulatory authority reported that the events were related to vaccination with CERVARIX.

VAERS ID:528190 (history)  Vaccinated:2012-03-10
Age:20.0  Onset:2012-03-12, Days after vaccination: 2
Gender:Female  Submitted:2014-04-11, Days after onset: 760
Location:Foreign  Entered:2014-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Endoscopy, Mild inflammation; Ultrasound abdomen, Normal
CDC Split Type: B0983030A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal distension, Constipation, Diarrhoea, Endoscopy abnormal, Gastrointestinal inflammation, Irritable bowel syndrome, Malaise, Muscle spasms, Ultrasound abdomen normal
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by the regulatory authority (# GB-MHRA-EYC 00109800) and described the occurrence of diarrhea in a 20-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included LOESTRIN. On 10 March 2012 the subject received 1st dose of TWINRIX. On 12 March 2012, 2 days after vaccination with TWINRIX, the subject experienced diarrhea, constipation, gastrointestinal discomfort, bloating, cramp, sickness and irritable bowel syndrome. An endoscopy on an unspecified date showed gastrointestinal inflammation. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. Verbatim Text: The initial injection coincided with gastrointestinal issues including diarrhoea for around a year which subsided but still on-going when a booster injection was performed. Gastrointestinal discomfort including diarrhoea and constipation, bloating, cramps and sickness which was ongoing and extremely upsetting for around 1 year until the point of booster injection. Whilst the symptoms have not gone completely they strangely subsided when the booster injection occurred, leading me to suspect the injection. It has been diagnosed as irritable bowel syndrome however it seems very coincidental that the symptoms coincided with the injections. I had no past issues which are bowel related. Endoscopy showed mild inflammation but nothing to be concerned about. Lower abdomen ultrasound proved okay. Selective serotonin re-uptake inhibitors didn''t help, nor did peppermint capsules or domperidone.

VAERS ID:451439 (history)  Vaccinated:2012-03-11
Age:47.0  Onset:2012-03-11, Days after vaccination: 0
Gender:Male  Submitted:2012-03-11, Days after onset: 0
Location:Unknown  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline 100 mg for malaria prophylaxis
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Military     Purchased by: Military
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea at 7:30, two bouts of emesis at 07:55 AM.

VAERS ID:451506 (history)  Vaccinated:2012-03-11
Age:86.0  Onset:2012-03-12, Days after vaccination: 1
Gender:Female  Submitted:2012-03-12, Days after onset: 0
Location:Oregon  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: DVT right popliteal
Preexisting Conditions: Allergic to Codeine and Procaine; Hx DVT; HPTN; CHF; CAD; DM
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0813AA1UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4305AA UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left upper arm and shoulder swelling with warmth and redness. Tender to touch.

VAERS ID:451673 (history)  Vaccinated:2012-03-11
Age:37.0  Onset:2012-03-12, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:Indiana  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Numerous pain meds (Fentanyl patch)
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B05AA IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Lethargy, Oedema peripheral, Pyrexia, Spinal myelogram, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, swelling, fever, tenderness (R) arm. Lethargic. Had myelogram on 3-12-12 AM.

VAERS ID:451906 (history)  Vaccinated:2012-03-11
Age:0.2  Onset:2012-03-11, Days after vaccination: 0
Gender:Male  Submitted:2012-03-15, Days after onset: 3
Location:North Carolina  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ferrous Sulfate, BioGaia, Vitamin D
Current Illness: none
Preexisting Conditions: Anemia
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B315BA0IMLG
Administered by: Public     Purchased by: Other
Symptoms: Apnoea, Procalcitonin
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)
Write-up: Patient experienced events of apnea for a period of 6 to 8 hours after 2:00 pm. Patient''s procalcitonin was 1.13 at 3:37 pm on 3/11/2012.

VAERS ID:451919 (history)  Vaccinated:2012-03-11
Age:61.0  Onset:2012-03-11, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 3
Location:Nevada  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN; Tetracycline; Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1265AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Allergy symptoms, swelling, pain and redness at injection site, patient has also developed beginning of rash on other arm, she has had a low grade fever since injection.

VAERS ID:452034 (history)  Vaccinated:2012-03-11
Age:23.0  Onset:2012-03-17, Days after vaccination: 6
Gender:Male  Submitted:2012-03-18, Days after onset: 1
Location:Oregon  Entered:2012-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: No
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME)SANOFI PASTEURU3989AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: SIGNS AND SYMPTOMS INCLUDE 3 INCH RASH ON ABDOMEN AT THE UMBILICUs 6 days post immunization.

VAERS ID:467070 (history)  Vaccinated:2012-03-11
Age:60.0  Onset:2012-03-12, Days after vaccination: 1
Gender:Female  Submitted:2012-09-14, Days after onset: 186
Location:California  Entered:2012-09-29, 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: Diabetes Mellitus
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH747AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Faecal volume decreased, Frequent bowel movements, Urinary tract infection
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Dizziness, urinary tract infection, little & frequent bowel movement.

VAERS ID:619386 (history)  Vaccinated:2012-03-11
Age:0.0  Onset:2012-03-25, Days after vaccination: 14
Gender:Female  Submitted:2016-01-17, Days after onset: 1393
Location:New York  Entered:2016-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Eczema, Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Severe eczema started on face and "spread" through the entire body. Red itch rash.

VAERS ID:451509 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 0
Location:Michigan  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3851AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4009AA4IMRA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria rash on chest and arms. Pt given BENADRYL 250 mg PO x 1.

VAERS ID:451626 (history)  Vaccinated:2012-03-12
Age:26.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-12, Days after onset: 0
Location:Texas  Entered:2012-03-13, 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: SUBOXONE
Current Illness: No
Preexisting Conditions: No allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3486AA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Feeling hot
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Shot administered at 3:50, patient said he felt lightheaded then he laid on floor & complained that he was hot then complained of difficulty breathing. Call 911 & gave EPIPEN shot at 3:55. A few minutes later & he said he was breathing OK & had him lay there for awhile then sat up & EMS arrived. He refused to go to ER.

VAERS ID:451631 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:Virginia  Entered:2012-03-13
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
HEPA: HEP A (VAQTA)MERCK & CO. INC.1586AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4096AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3899AA0IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Convulsion, Loss of consciousness, Presyncope
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: Upon completion of vaccine administration, patient passed out into arms of medical assistant. Patient was assisted into supine position on bed where she seemed to convulse for 1-2 seconds. Patient slowly became more alert and oriented within 1-2 minutes of presumed vasovagal reaction. Patient remained in office and monitored for approximately 15 more minutes at which time the doctor examined her and cleared her to leave.

VAERS ID:451670 (history)  Vaccinated:2012-03-12
Age:1.2  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 0
Location:Florida  Entered:2012-03-13
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: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4196AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH172AA3IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1007AA0SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166173IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1206AA0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized redness to injection site right upper arm with low grade fever up to 100.4.

VAERS ID:451699 (history)  Vaccinated:2012-03-12
Age:63.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:North Carolina  Entered:2012-03-13
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: Breast cancer
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Soreness at injection site.

VAERS ID:451714 (history)  Vaccinated:2012-03-12
Age:0.3  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:Florida  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Skin sensitivity to locally applied lotions
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323A1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH522AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH4169791IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1347AA1PO 
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticarial lesions noted on legs, feet and one on face by parents and MA within 2 minutes of all vaccines. Pt observed and no new lesions noted after 15 minutes.

VAERS ID:451736 (history)  Vaccinated:2012-03-12
Age:4.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-14, Days after onset: 1
Location:Maryland  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: no- had just finished 4 year well child check up
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B164AA1IMRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1413Z1IMLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Complaints of pains in legs where vaccine was administered. Woke in the morning with fever that lasted for about 14 hours.

VAERS ID:451738 (history)  Vaccinated:2012-03-12
Age:5.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-14, Days after onset: 1
Location:Georgia  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3 LL
Administered by: Private     Purchased by: Other
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: A purple welt several inches in area at the injection site was discovered by my wife last night -- actual onset may have been earlier. Area was swollen and tender/sore. This morning (3/14), the color had changed to red.

VAERS ID:451740 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-14, Days after onset: 1
Location:Texas  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Feeling hot, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: REDNESS, SWELLING, PAIN, WARMTH.

VAERS ID:451787 (history)  Vaccinated:2012-03-12
Age:54.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:North Carolina  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Headache, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: About 8pm on 3-12-12, began to have chills and a headache. She also began to have soreness at injection site that began about 12pm on 3-12-12. On the morning of 3-13-12 she woke up feeling weak with headache. Chills ended during the night.

VAERS ID:451788 (history)  Vaccinated:2012-03-12
Age:58.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 1
Location:North Carolina  Entered:2012-03-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Soreness at injection site.

VAERS ID:451806 (history)  Vaccinated:2012-03-12
Age:3.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-14, Days after onset: 1
Location:Washington  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: Vitiligo
Diagnostic Lab Data:
CDC Split Type: C3978AA
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3978AA0IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB492BA0IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Lcalized vaccine reaction, redness, swelling R thigh at injection site, low grade fever, transient.

VAERS ID:451807 (history)  Vaccinated:2012-03-12
Age:64.0  Onset:2012-03-14, Days after vaccination: 2
Gender:Female  Submitted:2012-03-14, Days after onset: 0
Location:Nebraska  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Naprosyn Oxycontin prn
Current Illness: none
Preexisting Conditions: Hx Asthma Mild, No Allergies,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU4308AA0IMLA
Administered by: Public     Purchased by: Private
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: Warm to touch, redness and swelling at injection site and just below site. Size approx 10 cm by 8 cm.

VAERS ID:451817 (history)  Vaccinated:2012-03-12
Age:15.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-14, Days after onset: 1
Location:North Carolina  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM101300IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 10mm induration at injection site.

VAERS ID:451818 (history)  Vaccinated:2012-03-12
Age:66.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-14, Days after onset: 1
Location:Ohio  Entered:2012-03-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Simvastatin
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0660AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient had a fever, swelling, redness at injection site as well as swelling in forearm. Patient took BENADRYL 50mg x 2 doses 6 hours apart and felt much better. Sxs were 12 hours after administration.

VAERS ID:451871 (history)  Vaccinated:2012-03-12
Age:4.0  Onset:2012-03-14, Days after vaccination: 2
Gender:Male  Submitted:2012-03-15, Days after onset: 1
Location:Maryland  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B121BB4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG11453SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0852AA1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1224AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Starting on 3/14/2012 child developed rash affecting entire body. Child states rash did itch and parents noted he was scratching. Rash is red, raised bumps, no pustules noted.

VAERS ID:451882 (history)  Vaccinated:2012-03-12
Age:57.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-14, Days after onset: 2
Location:North Carolina  Entered:2012-03-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; COREG; SYNTHROID; Lisinopril; NASONEX
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Headache, Injection site pain, Injection site swelling
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Soreness at injection site (started 3-13-12 at 2pm), weakness, severe headache & chills. Swelling (minor) at injection site.

VAERS ID:451883 (history)  Vaccinated:2012-03-12
Age:60.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-15, Days after onset: 3
Location:North Carolina  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan; TRICOR
Current Illness: None
Preexisting Conditions: High blood pressure; High cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site haematoma, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: Bruising and soreness at injection site.

VAERS ID:451884 (history)  Vaccinated:2012-03-12
Age:59.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-15, Days after onset: 3
Location:North Carolina  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMRA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Fatigue, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Soreness at injection site, fatigue, chills, body aches. Symptoms relieved by 4:30pm on 3-12-12.

VAERS ID:451896 (history)  Vaccinated:2012-03-12
Age:4.0  Onset:2012-03-14, Days after vaccination: 2
Gender:Male  Submitted:2012-03-15, Days after onset: 1
Location:California  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; PROAIR
Current Illness: None
Preexisting Conditions: H/O Rt. hydrocele. Mom states no Rt. scrotal swelling.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA0IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB541AA1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1293AA1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Eye swelling, Rash erythematous, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Red bumps under eyes then swelling, 2 days after vaccines. Vomited once - 3 days after.

VAERS ID:451904 (history)  Vaccinated:2012-03-12
Age:54.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-15, Days after onset: 2
Location:Massachusetts  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 0.137 mcg PO QD
Current Illness: No
Preexisting Conditions: Hypothyroidism Celiac Sprue No known allergies Meds: Synthroid 0.137 mcg PO QD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Nausea, Pyrexia, Rash macular, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Developed nausea, projectile vomiting, low grade fever and next morning developed red macular rash to neck, anterior and posterior trunk and bil upper thighs. Nausea, vomiting and fever resolved in 24 hours; rash still present on 3/15/12.

VAERS ID:451914 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-15, Days after onset: 2
Location:Washington  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Eye cyst and warts only
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1261AA IM 
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient recieved HPV vaccine on 3/12/12. The following day the area became red and tender. The redness continued to increase. Was seen by PCP on 3/15/12.

VAERS ID:451920 (history)  Vaccinated:2012-03-12
Age:64.0  Onset:2012-03-15, Days after vaccination: 3
Gender:Female  Submitted:2012-03-15, Days after onset: 0
Location:California  Entered:2012-03-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hx of Diabetes Mellitus
Preexisting Conditions: Diabetes Mellitus
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1599AA1SCLA
Administered by: Military     Purchased by: Military
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: Swelling, redness, feels warm to touch at the injection site early sign of cellulitis. Treated with dicloxacillin 250 mg by Dr.

VAERS ID:452019 (history)  Vaccinated:2012-03-12
Age:49.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-16, Days after onset: 4
Location:California  Entered:2012-03-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None that 24 hour period.
Current Illness: No
Preexisting Conditions: Allergies to most Antibiotics, mango, peanuts, squash
Diagnostic Lab Data: Tested for WBC and DVT''s in the ER on 3/15/2012 - negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1072AA IMUN
Administered by: Private     Purchased by: Public
Symptoms: Deep vein thrombosis, Erythema, Injection site swelling, Pharyngeal oedema, Rash, Swelling, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal allergic conditions (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Started with a mild facial rash & a little throat swelling. Over next two days my arm swelled at injection sight, then increased to swelling of the neck, back and most of the upper arm with redness, heat and extreme pain.

VAERS ID:452038 (history)  Vaccinated:2012-03-12
Age:0.3  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:Louisiana  Entered:2012-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EEG ordered, not yet done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3999AA1UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172431UNLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB208AA1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Breath holding, Chills, Cyanosis, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)
Write-up: Had breath holding spell, face turned blue and she had some shivering and tremors.

VAERS ID:452024 (history)  Vaccinated:2012-03-12
Age:0.2  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-17, Days after onset: 5
Location:Georgia  Entered:2012-03-17
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: Diarrhea onset on same day of vaccine administration.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4045AA IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB982BB IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916978 IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1653Z PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea onset same day of vaccine administration.

VAERS ID:452079 (history)  Vaccinated:2012-03-12
Age:23.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-13, Days after onset: 1
Location:Iowa  Entered:2012-03-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: No.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB208AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Diarrhoea, Muscular weakness, Pruritus generalised, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Had mild fever at 8 pm. Felt weakness in all four limbs. Was itching "all over". Took Acetaminophen last night. On 3/13/12 has diarrhea, no fever, only itching occasionally on his chest. No problems at injection site according to patient. Planning to refuse future doses in the series.

VAERS ID:452085 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 1
Location:California  Entered:2012-03-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CT scan of head
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1359AA2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram head, Fall, Gaze palsy, Haematoma, Head injury, Headache, Muscle twitching, Musculoskeletal stiffness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: 5 min. after the injection, pt. got up to get water. Started twitching, stiff, some rolling of eyes & fainted. Fell & hit her head on the floor. No incontinence. Came to in a few min. 2" x 3" hematoma. Headache & vomiting.

VAERS ID:452087 (history)  Vaccinated:2012-03-12
Age:36.0  Onset:2012-03-19, Days after vaccination: 7
Gender:Female  Submitted:2012-03-19, Days after onset: 0
Location:Georgia  Entered:2012-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAAHBB223DA0UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1121AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B072DA UNLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Edema noted to (L) deltoid no redness noted. Instructed pt to apply cool and warm compresses.

VAERS ID:452114 (history)  Vaccinated:2012-03-12
Age:65.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-13, Days after onset: 0
Location:South Carolina  Entered:2012-03-19, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA SCRA
Administered by: Other     Purchased by: Unknown
Symptoms: Cellulitis, Injection site reaction, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient received ZOSTAVAX Inj. on 3-12-12 and called on 3-13-12 stating round red rash appeared on arm at injection site. 3-14-12, pt. came back into pharm with antibiotic for cellulitis.

VAERS ID:452120 (history)  Vaccinated:2012-03-12
Age:14.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-18, Days after onset: 5
Location:California  Entered:2012-03-19, 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.U963AA0IMLL
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B070BA5IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0816AA2SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis
SMQs:
Write-up: On 03/14/12: Left post deltoid area 4 cm x 5 cm cellulitis rt Varicella vaccine site. Tx (1) SEPTRA DS 1 tab po BID x 10 day (2) BENADRYL 25 mg 1 tab po QID.

VAERS ID:452186 (history)  Vaccinated:2012-03-12
Age:53.0  Onset:2012-03-17, Days after vaccination: 5
Gender:Male  Submitted:2012-03-20, Days after onset: 3
Location:North Carolina  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENECAR; HCT; Lisinopril; VERAPAMIL; PROTONIX; LIPITOR; ULORIC; ENBREL
Current Illness:
Preexisting Conditions: Gout; HBP; High cholesterol; Reflux; Psoriasis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF880440IMLA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Fatigue and mild headache, mild dizziness and nausea.

VAERS ID:452187 (history)  Vaccinated:2012-03-12
Age:5.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-20, Days after onset: 7
Location:Wisconsin  Entered:2012-03-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B1404IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10682IMRL
Administered by: Private     Purchased by: Private
Symptoms: Discomfort, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient received vaccines on 3/12/2012. Mom called the following morning to report hives. Doctor recommended BENADRYL for itching and TYLENOL for discomfort. Told to call if symptoms worsened.

VAERS ID:452198 (history)  Vaccinated:2012-03-12
Age:14.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-19, Days after onset: 6
Location:South Carolina  Entered:2012-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Medication allergies CEFZIL/cephalosporins
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Myalgia, Neck pain, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Received GARDASIL #1 vaccine on Mon. 3-12-12. Patient began on following Tues. night with hand tremors at rest which con''t into Wed. & Thurs. No tremors today on Fri. March 16th. Patient also complains of sore neck & back muscles. No treatment.

VAERS ID:452243 (history)  Vaccinated:2012-03-12
Age:22.0  Onset:2012-03-14, Days after vaccination: 2
Gender:Female  Submitted:2012-03-19, Days after onset: 5
Location:Florida  Entered:2012-03-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: ZOFRAN - Allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC034AA0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1119A SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR04308BA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1218AA SCLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pain & edema to left upper ext. (applied cool compresses to area. Headache. Was prescribed Prednisone at Urgent Care.

VAERS ID:452284 (history)  Vaccinated:2012-03-12
Age:0.3  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-22, Days after onset: 9
Location:Missouri  Entered:2012-03-22
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: MO201204
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4131AA0IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBUC022EA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHF241410IMRL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Urticaria on trunk, limbs, face and hand. Low grade fever. FNP treated with Benadryl injection.

VAERS ID:452303 (history)  Vaccinated:2012-03-12
Age:39.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-22, Days after onset: 9
Location:Michigan  Entered:2012-03-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU3957DA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Headache, Mobility decreased, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Severe pain in arm, limited movement of arm, nausea, chills, headache.

VAERS ID:452349 (history)  Vaccinated:2012-03-12
Age:50.0  Onset:2012-03-14, Days after vaccination: 2
Gender:Female  Submitted:2012-03-17, Days after onset: 3
Location:Alaska  Entered:2012-03-23, 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:
Preexisting Conditions: Primary Biliary Cirrhosis
Diagnostic Lab Data: UA; CBC
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0620AA0SCUN
Administered by: Other     Purchased by: Unknown
Symptoms: Arthralgia, Full blood count, Lip blister, Malaise, Myalgia, Oral mucosal blistering, Pyrexia, Swelling face, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever (over 103 degrees) facial swelling, blisters in mouth and on lips, muscle & joint aches (severe), malaise.

VAERS ID:452370 (history)  Vaccinated:2012-03-12
Age:1.3  Onset:2012-03-20, Days after vaccination: 8
Gender:Female  Submitted:2012-03-23, Days after onset: 3
Location:Pennsylvania  Entered:2012-03-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mylicon Infant Gas Drops in the evening before bed.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDLL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDLL
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Where the injection site was (left thigh) it was red/raised and was sore to the touch. On 3-21-12 I noticed some red spots on face and chest. She had a fever in the evening that lasted on and off through 3-22-12. Called the doctors office on 3-22-12 who instructed to continue to give Motrin (every 8 hours) and Tylenol (every 4 hours) for the fever and use an cold wash cloth for the swelling. Today 3-23-12 I have noticed the rash starting to disappear, the fever to be gone and the redness on her leg starting to go away.

VAERS ID:452386 (history)  Vaccinated:2012-03-12
Age:1.8  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-03-25, Days after onset: 13
Location:California  Entered:2012-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: tantrum~ ()~~1.75~Patient|unusual hot rash~ ()~~1.75~Patient|vomiting~ ()~~1.75~Patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Abnormal behaviour, Aggression, Crying, Emotional distress, Screaming
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad)
Write-up: For over an hour he was screaming, yelling, crying and very upset. He can talk and I can understand him, and I have never seen him so upset. He tried to push me and every toy I tried to distract him with he threw it away. I''m extremely alarmed because I know him well and this is absolutely not normal behavior for him as his normal tantrums are short and infrequent.

VAERS ID:452398 (history)  Vaccinated:2012-03-12
Age:0.2  Onset:2012-03-19, Days after vaccination: 7
Gender:Male  Submitted:0000-00-00
Location:Maryland  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Terminal ileum & cecum resection with end to end anastomosis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B305BA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH317AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9165990IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB207A0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Intestinal anastomosis, Intussusception, Septic shock, Small intestinal resection
SMQs:, Agranulocytosis (broad), Toxic-septic shock conditions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow)
Write-up: Child presented with intussusception & septic shock on 3/19/12.

VAERS ID:452415 (history)  Vaccinated:2012-03-12
Age:76.0  Onset:2012-03-15, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:2012-03-26
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Private
Symptoms: Headache, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient recently had shingles & presented w/similar, but less severe symptoms; including headache & swollen left side of face.

VAERS ID:452462 (history)  Vaccinated:2012-03-12
Age:35.0  Onset:2012-03-23, Days after vaccination: 11
Gender:Male  Submitted:2012-03-26, Days after onset: 3
Location:North Carolina  Entered:2012-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
Administered by: Military     Purchased by: Military
Symptoms: Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient''s spouse noted red raised bumps on patient''s torso this morning when he got up.

VAERS ID:452528 (history)  Vaccinated:2012-03-12
Age:1.1  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-27, Days after onset: 14
Location:Illinois  Entered:2012-03-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1978AA0SCLL
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Local swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt mom states pt developed a localized area of swelling and redness that was still present when pt was brought in for evaluation on 03/22/2012.

VAERS ID:452552 (history)  Vaccinated:2012-03-12
Age:0.2  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-19, Days after onset: 6
Location:California  Entered:2012-03-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL infant drops
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4155AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172420IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0039A30PO 
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Irritability, Joint swelling, Oedema peripheral, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: 24-48 hrs after injection swelling & erythema (R) hand & both elbows. Wheals & urticaria. Fussiness about 24-48 hrs after injection.

VAERS ID:452590 (history)  Vaccinated:2012-03-12
Age:51.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Male  Submitted:2012-03-22, Days after onset: 9
Location:Indiana  Entered:2012-03-28, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB208AA2IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Pruritus, Rash erythematous
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red rash changing to blisters w/i 24 hour of vaccine administration started on back of neck, (L) side of neck, then (B) arms below elbows only. Takes a couple of weeks to resolve, (+) itching. Occured after 1st & 2nd doses of TWINRIX, but didn''t report it. Increased rxn after each shot. Has used hydrocortisone prior. Prednisone 5d now.

VAERS ID:452591 (history)  Vaccinated:2012-03-12
Age:  Onset:2012-03-13, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:Florida  Entered:2012-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: GERD
Diagnostic Lab Data: Adverse reaction to varicella
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF120553IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash generalised, Rash papular, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red papular rash scatter all over body 3-13-12.

VAERS ID:452639 (history)  Vaccinated:2012-03-12
Age:15.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-21, Days after onset: 9
Location:Ohio  Entered:2012-03-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TB test
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: Pt. was seen at ER
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Concussion, Fall, Head injury, Loss of consciousness, Neck pain, Syncope, Visual impairment
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), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: Patient had syncopal episode in lobby striking her head on floor & had brief LOC. Transferred to ER per EMS due to neck pain/visual disturb. Evaluated & released to home & diagn. with mild concussion. Episode occurred 10 min. after injection.

VAERS ID:452915 (history)  Vaccinated:2012-03-12
Age:4.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-03-23, Days after onset: 10
Location:Montana  Entered:2012-04-03, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184B UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1404AA1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, fatigue.

VAERS ID:452944 (history)  Vaccinated:2012-03-12
Age:1.1  Onset:2012-03-22, Days after vaccination: 10
Gender:Female  Submitted:2012-03-27, Days after onset: 5
Location:Indiana  Entered:2012-04-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1296AA0SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9181733IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1220AA0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash developed 10 days after vaccine and was a possible amoxicillin allergy. Then 14 days after the vaccine a bright red confluent rash developed only on the arms & legs with some spots distally on hands & ankles (+) itch. BENADRYL prn.

VAERS ID:452945 (history)  Vaccinated:2012-03-12
Age:63.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-03-27, Days after onset: 15
Location:Virginia  Entered:2012-04-04, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA; NEXIUM; XALATAN; Amlodipine; FLONASE; PRAVACHOL; Reguloid; MARINOL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1502AA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B073BA0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 3/13/2012: Patient presented to clinic. States she received dtap & pneumococcal 3/12/12 approx 1530. At 2230 broke out in generalized hives. Patient has strong hx of urticaria. Sees allergist for this. Took BENADRYL & hives went away. Needed lab work but lab would not do until cleared by provider. Uncertain if immunizations reaction. Same pt has history of urticaria.

VAERS ID:453060 (history)  Vaccinated:2012-03-12
Age:0.2  Onset:2012-03-23, Days after vaccination: 11
Gender:Female  Submitted:2012-03-30, Days after onset: 7
Location:California  Entered:2012-04-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia
Preexisting Conditions: Alloimmune hemolytic anemia transfused in utero 34 wk. S/P PDA closed.
Diagnostic Lab Data: Stool guaiac; hemogram
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B149E0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR412230SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9181720IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1543AA0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Blood test, Haematochezia, Occult blood
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Blood in stool for about 1 week after ROTATEQ given. Now resolved.

VAERS ID:453168 (history)  Vaccinated:2012-03-12
Age:23.0  Onset:2012-04-05, Days after vaccination: 24
Gender:Male  Submitted:2012-04-09, Days after onset: 4
Location:Unknown  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient is on No current Medications
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONS 0IMRA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR 0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Rash to right upper chest, axilla, upper arm, and back - vesicular rash. Does not follow any dermatone and is non-painful. Vaccine administered to left arm and site is healing well.

VAERS ID:453199 (history)  Vaccinated:2012-03-12
Age:32.0  Onset:2012-03-24, Days after vaccination: 12
Gender:Male  Submitted:2012-04-09, Days after onset: 16
Location:Kansas  Entered:2012-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prescribed : azithromycin and prednisone previous: multivitamins, glucosamine
Current Illness: Cold and cough
Preexisting Conditions: Pollen Allergies, possible amoxycillin allergy
Diagnostic Lab Data: Shingles blood test under way. Chest xrays, EKG.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSUNKNOWN SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Chest X-ray, Dry eye, Electrocardiogram, Eye swelling, Lacrimation increased, Ocular hyperaemia, Pain, Pulmonary oedema, Tinnitus, VIIth nerve paralysis, Vision blurred
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow)
Write-up: Bells Palsy, Left side of face paralysed, tearing in left eye. Drop / fluctuations in blood pressure. Fluid in lungs. Pain under ears. Higher sound in left ear. Drumming sound when yawning. Red swollen dry left eye. Dual blurred vision.

VAERS ID:453344 (history)  Vaccinated:2012-03-12
Age:1.5  Onset:0000-00-00
Gender:Female  Submitted:2012-04-11
Location:West Virginia  Entered:2012-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B184AA0IMLL
Administered by: Private     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Patient was given KINRIX in error. Should have received DTaP. No adverse events reported.

VAERS ID:456178 (history)  Vaccinated:2012-03-12
Age:0.2  Onset:2012-03-12, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 73
Location:New Mexico  Entered:2012-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4024AA0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Dyskinesia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: Vaccines given approximately 1400 3-12-12 - over following 6-8 hours infant had low grade fever and jerky movements of upper arms. Resolution & no residual problems.

VAERS ID:456393 (history)  Vaccinated:2012-03-12
Age:4.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-05-21, Days after onset: 69
Location:California  Entered:2012-05-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B187AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0853AA SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1059AA SCRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling & erythema of 1 cm at (R) upper arm.

VAERS ID:457329 (history)  Vaccinated:2012-03-12
Age:  Onset:2012-03-22, Days after vaccination: 10
Gender:Unknown  Submitted:2012-06-08, Days after onset: 78
Location:Virginia  Entered:2012-06-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201205887
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Pericardial disease
SMQs:
Write-up: This study case was received from the investigator on 04 June 2012. A subject received the following vaccinations on 12 March 2012: an injection of ACAM2000 (lot number not reported), TYPHIM Vi (lot number not reported) and anthrax (manufacturer not reported). On 22 March 2012, the subject was diagnosed with unspecified disease of pericardium. Medical history was not reported. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance study. Documents held by sender: None.

VAERS ID:459420 (history)  Vaccinated:2012-03-12
Age:59.0  Onset:2012-03-13, Days after vaccination: 1
Gender:Female  Submitted:2012-07-09, Days after onset: 118
Location:Missouri  Entered:2012-07-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1269AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: States arm was a bit red & itchy day of injection following AM. Said while upper arm was red & painful and felt like it was on fire for about 1 week. Redness did not subside & 3 weeks. She did not seek medical attention for this.

VAERS ID:460872 (history)  Vaccinated:2012-03-12
Age:15.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-08-02, Days after onset: 143
Location:Unknown  Entered:2012-08-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1207USA012221
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1537AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Concussion, Fall, Head injury, Loss of consciousness, Neck pain, Syncope, Visual impairment
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), Accidents and injuries (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no known pertinent medical history or previous illness was vaccinated intramuscular into the left arm with first dose of GARDASIL (lot # 671994/1537AA) on 12-MAR-2012. A tuberculin (TB) test was performed. The patient experienced concussion, fall, head injury, loss of consciousness, neck pain, syncope and visual impairment on 12-MAR-2012. Patient had syncopal episode in lobby striking her head on floor and had brief LOC (lever of consciousness). She was transferred to ER (emergency room) due to neck pain/visual disturb. The patient was evaluated and released to home and diagnosed with mild concussion. Episode occurred 10 minutes after injection. The listing indicated that one or more of the events required ER visit but were not serious. Upon internal review, loss of consciousness was considered to be a medically significant event. No further information is available. The original reporting source was not provided.

VAERS ID:461866 (history)  Vaccinated:2012-03-12
Age:11.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-08-02, Days after onset: 143
Location:Unknown  Entered:2012-08-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Computerised tomogram head
CDC Split Type: WAES1207USA012206
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1359AA2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram head, Fall, Gaze palsy, Haematoma, Head injury, Headache, Muscle twitching, Musculoskeletal stiffness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (671463/1359AA) dose 3 GARDASIL on 12-MAR-2012. There was no concomitant medication. 5 minutes after the injection, patient got up to get water. She started twitching, stiff, some rolling of eyes and fainted. Patient fell and hit her head on the floor. No incontinence. Patient came to in a few min. 2" x 3" hematoma was noticed. Patient had headache and vomiting. CT scan of head was performed, result not provided. The patient visited emergency room. The status of the patient was unknown. The report was considered to be non serious. The original reporting source was not provided. Additional information is not expected.

VAERS ID:461793 (history)  Vaccinated:2012-03-12
Age:48.0  Onset:2012-06-30, Days after vaccination: 110
Gender:Female  Submitted:2012-08-13, Days after onset: 44
Location:Illinois  Entered:2012-08-13
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 25 days
    Extended hospital stay? Yes
Previous Vaccinations: Leukemia (AML)~Tdap (no brand name)~1~48.75~Patient|Leukemia (AML)~Typhoid Vi Polysaccharide (no brand name)~1~48.75~Patient|Le
Other Medications: Hydrchlorothiazide, Vitamin D
Current Illness: No
Preexisting Conditions: Drug allergies: Penicillin, Tetracycline Medical conditions: mild hypertension
Diagnostic Lab Data: Reporting as leukemia diagnosis very coincidental after receiving vaccines for Typhoid, Encephalitis and dTap. Did not know who else to report to. Not looking for compensation, but want to make sure it''s documented. Treatment not concluded.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV10J64E0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528076BA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG114010IMRA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Acute myeloid leukaemia, Blood test normal, Headache, Hyperhidrosis
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Malignant tumours (narrow)
Write-up: Headaches, sweats, right upper quadrant pain/ultimately diagnosed with leukemia (AML). Blood tests done during time of vaccination all normal.

VAERS ID:462568 (history)  Vaccinated:2012-03-12
Age:2.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-04-17, Days after onset: 36
Location:Unknown  Entered:2012-08-17, Days after submission: 122
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: MEDI0015156
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK2207 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 27-month-old female. Neither the patient''s past medical history nor the concomitant medications were reported. FLUMIST was given intranasally. The product expired on 04-Mar-2012. On 12-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune''s FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.

VAERS ID:462597 (history)  Vaccinated:2012-03-12
Age:2.0  Onset:2012-03-12, Days after vaccination: 0
Gender:Female  Submitted:2012-04-17, Days after onset: 36
Location:Unknown  Entered:2012-08-17, Days after submission: 122
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: MEDI0015154
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, IN