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Found 500157 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:464889 (history)  Vaccinated:2012-09-12
Age:2.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-12, Days after onset: 0
Location:Indiana  Entered:2012-09-12
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 yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Private     Purchased by: Other
Symptoms: Incorrect dose administered
SMQs:
Write-up: 12/08/2011 He received his first of two Hepatitis A vaccines at the Health Department. 06/18/2012 he received his second of two Hepatitis A vaccines at the Health Department. Today, 09/12/2012, less than three months from his last of two Hepatitis A vaccines, he received a third (and unnecessary) Hepatitis A vaccine at the pediatrician''s office. The staff at the office should have asked to see his Official Immunization Record before giving him any vaccines. He never should have received this third Hepatitis A vaccine. The staff were negligent.

VAERS ID:464946 (history)  Vaccinated:2012-09-12
Age:38.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-12, Days after onset: 0
Location:New York  Entered:2012-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH718AB1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cough, Malaise
SMQs:, Anaphylactic reaction (broad)
Write-up: Patients husbands described coughing, ill feeling while driving received some antihistamines and breathing treatments. Patient got worse at MD''s office. Epi administered ambulance called. Symptoms resolved at ER.

VAERS ID:464947 (history)  Vaccinated:2012-09-12
Age:77.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-12
Location:Washington  Entered:2012-09-12
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204901 IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Chest discomfort, Choking, Cough, Insomnia, Muscle spasms, Muscular weakness, Palpitations, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: 9/10/12 - Tightness in chest (not short of breath) BENADRYL given by pt''s wife. No swelling, some choking; Difficulty sleeping at nights 9/10-9/11 heart racing, coughing slight tremor. 9/11 Cramps in legs, weakness in arms & legs, right arm.

VAERS ID:464965 (history)  Vaccinated:2012-09-12
Age:53.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-13, Days after onset: 0
Location:Virginia  Entered:2012-09-13
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: Severe sulfite sensitivity.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Pain, Sinus congestion, Skin disorder, Swelling, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Sinus congestion (couldn''t breath through nose), bad headache and achy, vomiting, swelling, feels like chemicals coming from my skin.

VAERS ID:464996 (history)  Vaccinated:2012-09-12
Age:4.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-12, Days after onset: 0
Location:Maryland  Entered:2012-09-13, 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: NKDA; H/O Cleft palate/lip repair
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213AA0IMRA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21390IN 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0367AE1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065311SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cough, Face oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, facial edema, coughing. Pulse Ox 94%, BP 103/62. Pt. given BENADRYL in office and observed for 1 hour. Facial edema, cough, hives improved. Pulse Ox 98%, BP 92/58.

VAERS ID:465043 (history)  Vaccinated:2012-09-12
Age:66.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-13, Days after onset: 1
Location:Nevada  Entered:2012-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA UNLA
Administered by: Other     Purchased by: Public
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: None stated.

VAERS ID:465047 (history)  Vaccinated:2012-09-12
Age:16.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-12, Days after onset: 0
Location:Indiana  Entered:2012-09-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pt had seizure activity 3 yrs ago.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0101AE1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074CA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Burning sensation, Convulsion, Dizziness, Fatigue, Gaze palsy, Headache
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt c/o HPV burning, 5 min later c/o feeling light headed pt sat down and seized up, eyes rolled back in head x 45 sec. Pt then reported feeling tired/headache, but over all, pt had Tdap in the past no problem.

VAERS ID:465052 (history)  Vaccinated:2012-09-12
Age:4.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-13, Days after onset: 1
Location:Alabama  Entered:2012-09-13
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
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B213BA4IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH745AA IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0679AE1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0109571SCLL
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticarial reaction greater on arms, trunk & buttocks - sparse on legs & face.

VAERS ID:465053 (history)  Vaccinated:2012-09-12
Age:70.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 1
Location:Louisiana  Entered:2012-09-13
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: Lipid disease; DM; AR; Parkinson
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA730AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Flu vaccine given 9-12-12 - redness to injection site Lt. deltoid - redness around neck & under chin.

VAERS ID:465071 (history)  Vaccinated:2012-09-12
Age:22.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-14, Days after onset: 1
Location:Mississippi  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bedbug bites still healing at time of vaccination.
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21090IN 
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Lip swelling, Oedema peripheral, Rash pruritic
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Itchy rash, lips swelling, fingers and hands swelling, chest heaviness. Symptoms started 12 after vaccination and continued for 12 hours.

VAERS ID:465079 (history)  Vaccinated:2012-09-12
Age:79.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-13, Days after onset: 0
Location:Tennessee  Entered:2012-09-14, 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: Palpitations; ASCBD; Memory loss; Renal insufficiency; Abdominal aortic aneurysm; TIA''s
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMAR
Administered by: Other     Purchased by: Other
Symptoms: Dysarthria, Guillain-Barre syndrome, Mobility decreased, Vertigo
SMQs:, Peripheral neuropathy (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (narrow)
Write-up: Patient was up about 2 AM with slurred speech, head spinning & around 6 AM pt could not move from waist down. She was taken to ER & admitted to hospital & given fluids. Patient was told that the symptoms are consistent with Guillain-Barre.

VAERS ID:465125 (history)  Vaccinated:2012-09-12
Age:82.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 2
Location:California  Entered:2012-09-14
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: Ceclor; Wellburton; Contrast dye
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Chills, fever, vomiting.

VAERS ID:465129 (history)  Vaccinated:2012-09-12
Age:0.3  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 2
Location:Pennsylvania  Entered:2012-09-14
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  SYRLL
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Diarrhoea, Flatulence, Injection site erythema, Injection site swelling, Insomnia, Irritability, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Swelling and redness at injection site, high fever, extreme irritability, non-stop crying, diarrhea, vomiting, excessive gas, unable to sleep.

VAERS ID:465198 (history)  Vaccinated:2012-09-12
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-14
Location:Kentucky  Entered:2012-09-14
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4259AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC2B081BA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H010854 SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness at vaccine site 2.5 inches in diameter hard, warm to touch, reaction is to varicella vaccine.

VAERS ID:465250 (history)  Vaccinated:2012-09-12
Age:1.4  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-14, Days after onset: 1
Location:New York  Entered:2012-09-14
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 (DAPTACEL)SANOFI PASTEURC4127AA3IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH405AC3IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9.5 x 6.5 erythematous, swollen & warm on (L) thigh.

VAERS ID:465154 (history)  Vaccinated:2012-09-12
Age:12.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-16, Days after onset: 3
Location:Maryland  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No; one-day vomiting illness 1 week prior to vaccination
Preexisting Conditions: Cat allergy; Exercise-induced asthma
Diagnostic Lab Data: None given
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDLA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus, Rash erythematous, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Small red spots on day 1, progressing on day 2 to 200+ target lesions on arms, legs, hands, soles. Severe itching over several days. Oral and topical antihistamines given. Considering prednisone.

VAERS ID:465174 (history)  Vaccinated:2012-09-12
Age:73.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-16, Days after onset: 4
Location:Washington  Entered:2012-09-16
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: Hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4492BA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Intense pain and redness at injection site. Beginning shortly after injection and continuing through reported date to us of 09/14/2012.

VAERS ID:465327 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-16, Days after onset: 4
Location:Utah  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Recovering from sinusitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204104 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B066AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site cellulitis
SMQs:
Write-up: Patient''s husband (a physician) diagnosed cellulitis in the right shoulder after vaccination.

VAERS ID:465337 (history)  Vaccinated:2012-09-12
Age:38.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-14, Days after onset: 1
Location:California  Entered:2012-09-17, 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: H/O smoking; DM Type 2
Preexisting Conditions: DM; Hyperlipidemia
Diagnostic Lab Data: Pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AE0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4149AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal discomfort, Arthralgia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Fever 106.7 degrees F starting one day after Tdap & PNEUMOVAX. Abdominal discomfort, body aches, joint pain.

VAERS ID:465371 (history)  Vaccinated:2012-09-12
Age:10.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Nevada  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2108 IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0131AE IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081BA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1907AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Oedema peripheral, Pain, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: 9/14/12 Rash, swelling on (L) arm, c/o of chills and body aches. Temp - 98.4 F on visit.

VAERS ID:465378 (history)  Vaccinated:2012-09-12
Age:35.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-12
Location:Pennsylvania  Entered:2012-09-17, 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: Nausea; Abd pain
Preexisting Conditions: None
Diagnostic Lab Data: Blood sugar 213
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH732AA1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood glucose increased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Syncope and collapse.

VAERS ID:465405 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Virginia  Entered:2012-09-17
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4493AA IMLL
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H009826 IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, warm to the touch - starting about 3 fingers from injection site middle of arm rotating to inner arm. Patient has never had a reaction to Flu

VAERS ID:465430 (history)  Vaccinated:2012-09-12
Age:0.4  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Indiana  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B344AA1UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH573AA1UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182461UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0207AE1PO 
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: Swelling with redness and swelling of right thigh. No purulent discharge was seen in emergency room and given KEFLEX. 4 days after area woke better. No fever, no systemic effects.

VAERS ID:465436 (history)  Vaccinated:2012-09-12
Age:69.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Iowa  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4497AA0UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1314AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Erythema, Hyperhidrosis, Nausea, Oedema peripheral, Pain, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm is swollen, red, warm to touch pt had sweating, chills, nausea and ached all over.

VAERS ID:465454 (history)  Vaccinated:2012-09-12
Age:51.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 1
Location:California  Entered:2012-09-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported - pt report not sick
Preexisting Conditions: Asthma; Diabetes; HBP; Smoker
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12047011IMLA
Administered by: Other     Purchased by: Public
Symptoms: Blood pressure increased, Chest pain, Condition aggravated, Dyspnoea, Hyperhidrosis, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad)
Write-up: approx 10 min after FLUVIRIN dose pt c/o heart palpitation, diaphoresis, chest pain, difficulty breathing. Called 911, had pt sit down and try to relax. EMT arrived within 5-10 min. Pt claims she felt better but EMT evaluation concluded pt needed to be transported to the hospital. EMT Reported increased BP.

VAERS ID:465456 (history)  Vaccinated:2012-09-12
Age:67.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:California  Entered:2012-09-17
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: Allergy only to tetanus
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489A1IMRA
Administered by: Unknown     Purchased by: Private
Symptoms: Dyspnoea, Erythema, Inflammation, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: FLUZONE HD administered 9/12/12 3pm. At 2 am patient had difficulty breathing. Right arm was red, inflamed and itching at 9/14/12 4:15 pm (2 days later) when she came in. No breathing problem.

VAERS ID:469314 (history)  Vaccinated:2012-09-12
Age:53.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 5
Location:Texas  Entered:2012-09-17
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: WAES1209USA006950
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP59207 UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was intramuscularly vaccinated with a dose of 0. 5ml PNEUMOVAX23 (lot # 669579/0595AA) on 12-SEP-2012. The patient was not experiencing any known symptoms. It was unspecified whether the patient had sought medical attention or not. The outcome was unknown. This is one of several reports received from same source. Additional information has been requested.

VAERS ID:465410 (history)  Vaccinated:2012-09-12
Age:61.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 6
Location:Connecticut  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Not sure. Thought I might have a bladder infection but test was negative. I came in for an antibiotic but was offered the heavily advertised vaccination since I was there.
Preexisting Conditions: Allergies to Keflex and Levaquin; Hay fever; Tobacco; Shellfish
Diagnostic Lab Data: Had tests for UTI, various bloodwork, Lyme, EKG (showed some change from previous).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0SYRLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal discomfort, Asthenia, Blood test, Borrelia test, Cardiac disorder, Chills, Cough, Dehydration, Diarrhoea, Dysphagia, Dyspnoea, Electrocardiogram abnormal, Fatigue, Oropharyngeal pain, Peripheral coldness, Pyrexia, Thirst, Urine analysis normal
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)
Write-up: Fatigue, thirst. Went to bed. Woke up couple hours later and had throat pain, trouble swallowing. Next day, weakness, fatigue, dehydration, diarrhea, chills, sllght fever, upset stomach, cold feet, heart laboring, slight labor in breathing with slight cough.

VAERS ID:465444 (history)  Vaccinated:2012-09-12
Age:22.0  Onset:2012-09-17, Days after vaccination: 5
Gender:Male  Submitted:2012-09-18, Days after onset: 1
Location:South Carolina  Entered:2012-09-18
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: Naproxen 500mg BID x 10 days
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21091IN 
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: Left shoulder started hurting while laying down.

VAERS ID:465472 (history)  Vaccinated:2012-09-12
Age:66.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-18, Days after onset: 5
Location:California  Entered:2012-09-18
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
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA727AB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: 9/12/12 - Immunization given in afternoon. 9/13/12 - Sore arm, feeling "tired". 9/14/12 Feeling tired, achy, headache, fever to 101 degrees. 9/15/12 - Feeling tired, achy, headache, fever to 101 degrees. 9/16/12 - Fever down to 99-100 degrees.

VAERS ID:465476 (history)  Vaccinated:2012-09-12
Age:3.0  Onset:2012-09-17, Days after vaccination: 5
Gender:Female  Submitted:2012-09-18, Days after onset: 1
Location:Georgia  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B323BA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB586CA0IMRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF561780IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Rash erythematous, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt. woke on 9-17-12 with a red rash over body. No pain, fever or swelling. Dr. prescribed BENADRYL.

VAERS ID:465598 (history)  Vaccinated:2012-09-12
Age:62.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-19, Days after onset: 6
Location:Illinois  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMLA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Back pain, Dizziness, Eye movement disorder, Eye pain, Headache, Nausea, Sensation of pressure, Spinal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Arthritis (broad)
Write-up: Pressure, pain in brain, top of skull radiating to eyes and down spine to lower back. Went away 9/16/2012. 9/17/2012 woke with severe dizziness, eyes darting back and forth, nausea and vomiting. Severe dizziness subsided 9/18/2012 but still weakness and slight dizziness 2 days later.

VAERS ID:465603 (history)  Vaccinated:2012-09-12
Age:2.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-19, Days after onset: 6
Location:Texas  Entered:2012-09-19
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: The patient was getting a breathing treatment with Albuterol Sulfate through Nebulizer until March/April 2012.
Current Illness: None
Preexisting Conditions: Wheezing History
Diagnostic Lab Data: Asthma Attack; Oxygen level: 93
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21930IN 
Administered by: Unknown     Purchased by: Private
Symptoms: Asthma, Body temperature increased, Cough, Immune system disorder, Respiration abnormal, Respiratory tract congestion, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: The Flu Vaccine (Flumist) was administered to the patient by his X-pediatrician and his Brother''s current pediatrician on Wednesday, September 12, 2012 at around 3:45 PM. On the morning of Thursday, September 13, 2012, we noticed that he was coughing. On Thursday night the coughing was bad and the patient also had Temperature (about 100 deg F). On Friday, September 14 the cough was worse and we got an appointment with the nurse practitioner at his pediatrician''s office. Upon examination, his Lungs, ears and throat were clear. We did not even think about the FluMist and did not remember to mention the same to the nurse. Nurse prescribed the patient with Mucinex for cough and Tylenol for temperature. We did not see any improvements all Saturday. Upon talking with some friends and neighbors on Saturday night, we realized that this might be an immune reaction due to the Flumist. The condition was getting worse and we rushed him to Urgent Care around 10:00Am on Sunday morning. We did mention about the Flumist to the pediatrician. Dr. diagnosed it as an Asthma attack and asked to start the breathing treatment immediately. We started treating him with Albuterol Sulfate through nebulizer (inhaler). On Monday, September 17, 2012 we took him back to see his current pediatrician and she confirmed the Asthma attack and the immune reaction due to Flumist since he has a Wheezing history. She asked us to treat him with the mixture of Albuterol sulfate and Budesonide (Pulmicort) through nebulizer. She also mentioned that if the condition does not improve then we will have to give him Oral Steroids else it will lead to pnuemonia. On late Tuesday night, we noticed that he was breathing very heavily, had Chest congestion and also had temperature (about 100 deg F). We visited his pediatrician again on Wednesday (September 19, 2012) morning at about 8:45 AM. She administered Steroids orally and levalbuterol tartrate (Xopenex) through nebulizer in her Clinic. She asked to increase the breathing treatment frequency to every 2 hours and continue with Albuterol sulfate through nebulizer.

VAERS ID:465631 (history)  Vaccinated:2012-09-12
Age:35.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-19, Days after onset: 7
Location:Kansas  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known to this reporter.
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP583060IMRA
Administered by: Public     Purchased by: Private
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Reported by the employee, "Received flu shot at around 1130 on Wednesday, 09/12/12. Woke up around 2330 with generalized severe urticaria. Called and spoke with Pharmacist and Dr who both offered to either see me in the ED as a patient or to call in scripts for allergic reaction. I chose to have scripts called in. I took the prescrbied meds and the itching subsequently resolved over the next couple days."

VAERS ID:465667 (history)  Vaccinated:2012-09-12
Age:62.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 2
Location:Michigan  Entered:2012-09-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fever; Rash
Preexisting Conditions: RLS; S/P A-fib; HTN; Hyperlipidemia; Hyperglycemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0106610IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B077BA0IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0110500SCRA
Administered by: Private     Purchased by: Private
Symptoms: Nodule, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever 102. Body aches rash on arm with knot.

VAERS ID:468624 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-19, Days after onset: 7
Location:Oregon  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA007633
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:
Write-up: This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 12-SEP-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported) that could not have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.

VAERS ID:469844 (history)  Vaccinated:2012-09-12
Age:60.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-19
Location:Unknown  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Blood cholesterol increased; Diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA005406
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This spontaneous report as received from a 60 years old female reporting on herself with no allergies, diabetes, high cholesterol and high blood pressure. The patient was vaccinated with dose 1 ZOSTAVAX (dose, route and lot # not reported) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included: SYNTHROID and LIPITOR. On an unknown date the patient bled after getting the ZOSTAVAX. No treatment information was reported. The outcome of patient bled was unknown. The relatedness for patient bled after getting the ZOSTAVAX was unknown for ZOSTAVAX. Additional information is not expected.

VAERS ID:465654 (history)  Vaccinated:2012-09-12
Age:49.0  Onset:2012-09-18, Days after vaccination: 6
Gender:Female  Submitted:2012-09-20, Days after onset: 2
Location:Massachusetts  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC4170AA0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:465776 (history)  Vaccinated:2012-09-12
Age:57.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 7
Location:Washington  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: HOLMES-ADIE SYNDROME; DYSAUTONOMIA; HTN; GERD; HYPOTHYROIDISM; DEPRESSION
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUNK5IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: INJECTION SITE WAS INDURATED (APPROXIMATELY SIZE OF A QUARTER, WITH SURROUNDING REDNESS EXTENDING ONFULL DELTOID REGION AND UNDER ARM, TENDERNESS, BRUISED SENSATION.

VAERS ID:465803 (history)  Vaccinated:2012-09-12
Age:54.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 7
Location:Washington  Entered:2012-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma; Bronchitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1222040IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0563AE0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site pruritus, 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: Injection about 1:00 pm, next morning woke with HA, fever of 102 and site of injection was swollen, red & itchy. When pt came to pharmacy 3 days after shot the red area was about 6 inches diameter. Pt still had HA. Didn''t feel well but was unsure if had a fever still. Slowly, swelling is decreasing.

VAERS ID:468779 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-20, Days after onset: 8
Location:Florida  Entered:2012-09-20
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: WAES1209USA005643
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a medical assistant refers to a patient who was vaccinated with the first dose of GARDASIL on an unspecified day in 2008 "about 4 years old", and was to receive the second dose of GARDASIL on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. There was no adverse event reported. It was unknown if the patient sought medical attention. At the time of report, the patient''s status was unknown. Additional information is not expected.

VAERS ID:465828 (history)  Vaccinated:2012-09-12
Age:1.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Kentucky  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: No
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0412AB0SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9182463IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0362AE0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Immediate post-injection reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Received VARIVAX right arm. Immediately had a distinct hive (s) pt had no respiratory distress. Pt given BENADRYL.

VAERS ID:465878 (history)  Vaccinated:2012-09-12
Age:52.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 9
Location:New Jersey  Entered:2012-09-21
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH734AB IMRA
Administered by: Public     Purchased by: Public
Symptoms: Fatigue, Malaise, Pain, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Very achy, fatigue, malaise, scratchy throat lasted about 12 hours.

VAERS ID:470410 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-21, Days after onset: 9
Location:Ohio  Entered:2012-09-21
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: WAES1209USA005984
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0617AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 12-SEP-2012, the patient was vaccinated with expired ZOSTAVAX of lot number 670616/0617AA. Expiry date was provided as 26-JUL-2012. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.

VAERS ID:466089 (history)  Vaccinated:2012-09-12
Age:10.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Male  Submitted:2012-09-18, Days after onset: 4
Location:Indiana  Entered:2012-09-24, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Exam by Dr.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH21070IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0126420IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash around injection site.

VAERS ID:466101 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-23, Days after onset: 11
Location:Illinois  Entered:2012-09-24, 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: Lt lateral epicondylitis
Preexisting Conditions: HTN; Hyperlip; GERD; PVCs; Vit B def; Sleep Apnea
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC5B094AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypoaesthesia, Joint swelling, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: (R) forearm pain 9/18/2012. (R) Wrist swelling and numbness. Itching.

VAERS ID:466108 (history)  Vaccinated:2012-09-12
Age:11.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Male  Submitted:2012-09-19, Days after onset: 5
Location:Georgia  Entered:2012-09-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOVENT; VENTOLIN HFA; Fluticasone nasal spray; Loratadine syrup
Current Illness: Asthma
Preexisting Conditions: Asthma; Depression; Anxiety
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AD3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB515AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Back pain, Dizziness, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Received influenza and Hep A vaccine 9/12/2012. Client was fine that day. 9/14/2012 900 pm complained of back pain severe - took TYLENOL - better L - eased up - still hurt Sat morning 9/15/2012 - complained of backache upper (L) quadrant started feeling dizzy 100 pm vomited 9/17 and 9/18 headache nausea and dizziness comes and goes.

VAERS ID:466192 (history)  Vaccinated:2012-09-12
Age:5.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 5
Location:Ohio  Entered:2012-09-24, 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: None known
Preexisting Conditions: None known
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4211AA3IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13053IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0852AA0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0077000SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Five minutes after shots administered, client fainted at reception desk. He did not sustain any.

VAERS ID:466257 (history)  Vaccinated:2012-09-12
Age:72.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-09-19, Days after onset: 6
Location:Ohio  Entered:2012-09-24, 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: None
Preexisting Conditions: DM; HTN; Increased cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA697BA IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Eructation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Burning pain in chest one day after receiving flu vaccine; located in substernal area; belching.

VAERS ID:466167 (history)  Vaccinated:2012-09-12
Age:1.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2012-09-25, Days after onset: 11
Location:California  Entered:2012-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None, did not bring in for evaluation.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 3UNUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Dyskinesia, Fall, Muscle spasms
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)
Write-up: At least 3 episodes of lower extremity spasms, one episode of spasmodic body movement resulting in falling over backwards from a sitting position. Afebrile at the time but was premedicated with Tylenol due to history of fevers after vaccines.

VAERS ID:466286 (history)  Vaccinated:2012-09-12
Age:17.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 5
Location:Connecticut  Entered:2012-09-25, 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: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ20240IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Nasal discomfort, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Burning inside nose x 24 h after nasal vaccine. Nausea, vomiting x 24 h after vaccine.

VAERS ID:466454 (history)  Vaccinated:2012-09-12
Age:52.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2012-09-26, Days after onset: 12
Location:Colorado  Entered:2012-09-26
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: HTN, High cholesterol
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4393BA IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Bone pain, Injection site induration, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Osteonecrosis (broad)
Write-up: Pain and hard lump at site of injection, 1 week later pain across shoulder girdle.

VAERS ID:466524 (history)  Vaccinated:2012-09-12
Age:66.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Arizona  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204901 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.12411IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Body temperature increased, Pain, Skin reaction, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: Temp 100. 5x3 area warm to touch, sore, very red, welted area.

VAERS ID:469609 (history)  Vaccinated:2012-09-12
Age:14.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Georgia  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: No other medications
Current Illness: Drug hypersensitivity, drug allergy to AUGMENTIN
Preexisting Conditions: 2010, Syncope; 2008, Anaemia; AUGMENTIN, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA008246
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0113501IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This spontaneous report as received from a registered nurse refers to a 14 years old female patient with drug allergy to AUGMENTIN. The patient''s medical history included anemia in 2008 and "passing out" seen by cardiologist in 2010. The patient was vaccinated with the first and second dose of GARDASIL (lot number reported as h011350, EXP 21-FEB-2015) intramuscular 0.5 ml respectively on 12-JUL-2012 and 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-SEP-2012 the patient complained of nausea, vomiting, and severe stomach pain. The patient had sought medical attention via got to urgent care clinic. No treatment was given for the adverse event. There were no laboratory diagnostics studies performed. The outcome of severe stomach pain, vomiting and nausea was unknown. Additional information has been requested.

VAERS ID:466655 (history)  Vaccinated:2012-09-12
Age:78.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-09-27
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH716AA UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Injection site discolouration
SMQs:, Hypersensitivity (narrow)
Write-up: Insert needle right below shoulder. Black and blue mark - size 2 1/2 inches in diameter yellowing out. Purple mark was immediate.

VAERS ID:466736 (history)  Vaccinated:2012-09-12
Age:45.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Male  Submitted:2012-09-27, Days after onset: 13
Location:Illinois  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Crestor, Norco PRN, Ambien PRN, Metropolol, Lisinopril
Current Illness: NO
Preexisting Conditions: High Cholesterol, High Blood Pressure
Diagnostic Lab Data: Blood test, MRI brain, MRI Cervical Spine, physical examination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12047010IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.HOE98260IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080CA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Burning sensation, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Headache on top R-side, Two days after same pain above L-ankle radiating to the knee. Day after numbness, tingling, and burning sensation on entire left side of the body and got worst.

VAERS ID:471052 (history)  Vaccinated:2012-09-12
Age:39.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Male  Submitted:2012-09-27, Days after onset: 13
Location:Unknown  Entered:2012-09-27
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: WAES1209USA007434
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H013581 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician via a company representative concerning a 39 year old male who on 12-SEP-2012 was vaccinated with a dose of PNEUMOVAX 23 (lot#HOL3581, exp date not provided). On 14-SEP-2012 the patient experienced swelling of the arm, itching, and chills from receiving PNEUMOVAX 23. The patient was seen by the physician and treated with BENADRYL. At the time of report, it was unknown if the patient had recovered. A lot check has been requested by the reporting physician. Additional information has been requested.

VAERS ID:466804 (history)  Vaccinated:2012-09-12
Age:15.0  Onset:2012-09-15, Days after vaccination: 3
Gender:Female  Submitted:2012-09-28, Days after onset: 13
Location:Alabama  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vyvanse 40 mg Melatonin Ibuprofen when needed Generic allergy medication when needed
Current Illness: None...a little congested
Preexisting Conditions: Ceclor/cephaclor......cats....seasonal allergies ADHD
Diagnostic Lab Data: EEG- normal EKG-normal Cat scan-normal Blood tests- normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.H0126421IMAR
HPV4: HPV (GARDASIL)MERCK & CO. INC.0630AE0IMAR
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Blood test normal, Catatonia, Cautery to nose, Computerised tomogram normal, Diplopia, Dizziness, Electrocardiogram normal, Electroencephalogram normal, Epistaxis, Erythema, Fatigue, Feeling abnormal, Heart rate increased, Heart rate irregular, Hypertension, Hypoaesthesia, Loss of consciousness, Seizure like phenomena
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: Nosebleeds, weakness, fatigue, high blood pressure, rapid heartbeat, fluctuating heartbeat to the extremes, "seizure like" episodes, dizziness, passing out, zoning out, catatonic state, numbness in legs and feet, double vision. Several ER visits and doctor visits. Tests come back ok with no explanation. Had nose cauterized. Didn''t work. Blood pressure stayed elevated. This went on from 9/15/12 thru 9/26/12. Stayed in hospital for two days trying to figure out what was wrong. We are going back to doctor Monday, October 1,2012.Also...her chest and face would turn beet red before some episodes.

VAERS ID:466837 (history)  Vaccinated:2012-09-12
Age:58.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-28, Days after onset: 16
Location:Alabama  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: On 9/14, patient''s arm is red, warm to touch and hurts to move it. On 9/27, patient told us her symptoms have resolved and she is fine now.

VAERS ID:466854 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2012-09-28, Days after onset: 14
Location:Indiana  Entered:2012-09-28
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203801 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Injection site haematoma, Injection site nodule, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Rt. arm red, hot, edematous, painful. Went to PCP, placed on oral and topical antibiotics x 10 days. Symptoms resolving after 9 days, has bruised area and knot in area now.

VAERS ID:466987 (history)  Vaccinated:2012-09-12
Age:60.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Male  Submitted:2012-10-01, Days after onset: 17
Location:North Dakota  Entered:2012-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none
Preexisting Conditions: unknown
Diagnostic Lab Data: none known
CDC Split Type: ND1220
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1600AA0SCRA
Administered by: Other     Purchased by: Other
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: Patient presented to pharmacy on 09/15/2012 with red, swollen, warm to touch bump at site of injection. He was told to apply ice and take diphenhydramine and call MD or pharmacist if it wasn''t better in a few days.

VAERS ID:467254 (history)  Vaccinated:2012-09-12
Age:39.0  Onset:2012-09-19, Days after vaccination: 7
Gender:Female  Submitted:2012-10-02, Days after onset: 13
Location:North Carolina  Entered:2012-10-02
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: Not recovered yet, still on antibiotics and steroids as well as inhalers. Out of 5 doctor visits in 11 days, no one did a flu swab or chest x-ray though the doctor seen on 9/21/12 told me she thought I had the flu.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUH718AA0IDLA
Administered by: Public     Purchased by: Other
Symptoms: Body temperature decreased, Body temperature fluctuation, Breath sounds abnormal, Bronchitis, Chills, Cough, Fatigue, Feeling cold, Hot flush, Myalgia, Oropharyngeal pain, Oxygen saturation decreased, Pyrexia, Respiratory tract congestion, Sinus congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad)
Write-up: Hot flashes and fevers alternating with cold and shivers and low temperatures. Progressed on 9/20/12 to sore throat, fatigue, muscle aches. Progresed on 9/21/12 to head and chest congestion, severe cough, rattling in chest. 9/26/12 Continued symptoms with worsening breathing issues, chest rattle, cough, fluctuating temperatures, etc. Progressed to low oxygen sats (92%) severe bronchitis, etc. on 9/29/12.

VAERS ID:467304 (history)  Vaccinated:2012-09-12
Age:67.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-09-14, Days after onset: 2
Location:Hawaii  Entered:2012-10-02, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0709AE0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Erythema, Feeling hot, Injection site oedema, Injection site swelling, Malaise, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Fever/chill/malaise overnight (8hrs) onset 2-3 hrs post vaccine. Swelling (edema) in deltoid region on arm vaccinated (R) onset 2-3 hrs post vaccine. Redness/ heat in arm vaccinated (R) onset 2-3 hrs post vaccine. pain upon movement pt report 7 out of 10 dissipated overnight.

VAERS ID:467314 (history)  Vaccinated:2012-09-12
Age:81.0  Onset:2012-09-24, Days after vaccination: 12
Gender:Female  Submitted:2012-09-24, Days after onset: 0
Location:North Carolina  Entered:2012-10-02, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12039011IMUN
Administered by: Other     Purchased by: Public
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received vaccination on 9/12/12 and called on 9/24/12 with a swollen hand. She was told it might not be the shot. Try BENADRYL & see her Dr.

VAERS ID:467320 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-27, Days after onset: 15
Location:Pennsylvania  Entered:2012-10-02, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH721AD IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0491AE0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site pain, Injection site warmth, Mobility decreased, Pain
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient states by 3:00 P site was warm and tender. By bedtime she couldn''t lift her arm at all and had 10/10 pain. Took TYLENOL with min. relief. Made follow up appt but cancelled - pain lessened by mid morning. Still exp. some sharp/shooting pains once in a while.

VAERS ID:467325 (history)  Vaccinated:2012-09-12
Age:64.0  Onset:2012-09-17, Days after vaccination: 5
Gender:Male  Submitted:2012-09-27, Days after onset: 10
Location:New York  Entered:2012-10-02, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0114310SCLA
Administered by: Private     Purchased by: Private
Symptoms: Rash pruritic, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received ZOSTAVAX 9/12/12. Seen again in office 9/21 c/o itchy rash (vesicular) on arms, abdomen and fingers. No fever. Treatment was to monitor. Returns on 9/27/12 with Varicella like rash on abd, arms, legs. Treated with BENADRYL and TIAMVIR.

VAERS ID:467469 (history)  Vaccinated:2012-09-12
Age:57.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-03, Days after onset: 21
Location:California  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA695BA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Injection site haematoma, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient states unable to lift left arm on the day of the injection. Also, noticed to feel limited range of motion. Injection site was swollen and hot for 2 days. Noticed large bruising of left upper arm.

VAERS ID:467501 (history)  Vaccinated:2012-09-12
Age:63.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-03, Days after onset: 21
Location:Michigan  Entered:2012-10-03
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: Kidney transplant patient
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH713AB IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Contusion, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Arm swollen, pain, bruising/black area on hand (left).

VAERS ID:472450 (history)  Vaccinated:2012-09-12
Age:9.0  Onset:2012-09-15, Days after vaccination: 3
Gender:Male  Submitted:2012-10-03, Days after onset: 18
Location:West Virginia  Entered:2012-10-03
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: 09/--/2012, laboratory test, results not reported; 09/--/2012, laboratory test, results not reported
CDC Split Type: WAES1209USA010293
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test, Blood test, Decreased appetite, Dizziness, Headache, Laboratory test, Pyrexia, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information was received from a patient''s mother regarding her 9 years old son who on 12SEP2012, was vaccinated with his first dose of GARDASIL, 0.5ml intramuscularly. It was reported that 3 days after receiving GARDASIL, he experienced dizziness, headaches, fever, and vomiting. The patient has also had loss of appetite and has lost 8 pounds. The patient had been to physician''s office five times and had also gone to hospital emergency room and was given ZOLFRAN and sent home. It was reported the patient has had extensive blood work and blue titer test meningitis (results not reported). At the time of this report it was noted that the patient has not recovered. Additional information has been requested.

VAERS ID:467511 (history)  Vaccinated:2012-09-12
Age:25.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2012-09-19, Days after onset: 5
Location:New Mexico  Entered:2012-10-04, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Latex
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701A IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Full body rash occurring 2 to 4 days after injection. Patient did no treat & clearing on its own.

VAERS ID:472644 (history)  Vaccinated:2012-09-12
Age:60.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-04, Days after onset: 22
Location:Unknown  Entered:2012-10-04
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: WAES1209USA005861
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0598AE0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site haematoma, Injection site haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: This spontaneous report was received from a pharmacist refers to a 60 years old female patient. On 12-SEP-2012, the patient was vaccinated subcutaneously with dose 1, 0.65 ml ZOSTAVAX lot # (972930/0598AE). No concomitant medications were reported. On 12-SEP-2012, the patient experienced significant bleeding and bruising at the injection site. The bleeding lasted a few seconds and the bruising was "quarter sized". No treatment information was reported. The outcome of significant bleeding and bruising at the injection site was unknown. The relatedness for significant bleeding and bruising at the injection site was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:468035 (history)  Vaccinated:2012-09-12
Age:51.0  Onset:2012-10-02, Days after vaccination: 20
Gender:Male  Submitted:2012-10-06, Days after onset: 4
Location:North Carolina  Entered:2012-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Sinus infection~ ()~~51.58~Patient
Other Medications: Levoxyl .88; Lipitor 20; Fish oil; Zyrtec
Current Illness: None
Preexisting Conditions: Seasonal allergies; High cholesterol; Hypothyroid
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0467AE0SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Acne, Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pimples, redness, itching.

VAERS ID:468123 (history)  Vaccinated:2012-09-12
Age:54.0  Onset:2012-09-27, Days after vaccination: 15
Gender:Female  Submitted:2012-10-08, Days after onset: 11
Location:Pennsylvania  Entered:2012-10-08
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER06449211A IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4170AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Neck pain
SMQs:, Arthritis (broad)
Write-up: Patient reported neck pain after receiving influenza vaccine.

VAERS ID:468343 (history)  Vaccinated:2012-09-12
Age:65.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-10-08, Days after onset: 26
Location:Colorado  Entered:2012-10-08
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203901 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMLA
Administered by: Public     Purchased by: Other
Symptoms: Axillary pain, Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pain in left arm pit beginning the night of the vaccine. The following day, red streaks noted from left shoulder to the center of chest. Streaks lasted 2-2 1/2 weeks.

VAERS ID:468468 (history)  Vaccinated:2012-09-12
Age:20.0  Onset:2012-09-22, Days after vaccination: 10
Gender:Male  Submitted:2012-10-01, Days after onset: 9
Location:Oregon  Entered:2012-10-09, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Labs; EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4152AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Electroencephalogram, Fall, Laboratory test, Loss of consciousness, Muscle twitching, Tremor
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), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt received ADACEL on 9/12/12. On 9/22/12 pt had seizure - where he fell to floor & had diffuse body shaking/twitching. Pt "out" x 4 minutes. Transported to ER, labs & EEG done. Pt given IV fluids, placed on Abx & antiseizure med.

VAERS ID:468687 (history)  Vaccinated:2012-09-12
Age:66.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-10-04, Days after onset: 21
Location:Iowa  Entered:2012-10-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1230231UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0653AE1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling redness right arm. Acetaminophen 650 MG QID.

VAERS ID:468814 (history)  Vaccinated:2012-09-12
Age:43.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-10-10, Days after onset: 27
Location:Massachusetts  Entered:2012-10-10
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: Chronic migraines. Allergies to PCN, Codeine, Vicodin, Methadone, Motrin.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA734AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Onset noticed about 8 am on 9/13/12. On 9/14/12 reported pain in left upper arm 4 on a scale of 10. Worse when lifting. Area red, puffy, itchy, warm to touch. Denied fever. Area of inflammation marked. 11cm top to bottom x 7cm wide. Dr. aware. Monitor and use warm / cold compress. Completely resolved by 9/19/12.

VAERS ID:468889 (history)  Vaccinated:2012-09-12
Age:0.2  Onset:2012-09-16, Days after vaccination: 4
Gender:Male  Submitted:2012-10-10, Days after onset: 24
Location:Oregon  Entered:2012-10-10
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: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 0UNLL
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site reaction, Rash, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Rash/hives developed on both twins; location included front chest & back; there was also a group of red bumps surrounding near the injection site on thigh.

VAERS ID:470035 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-10, Days after onset: 28
Location:Unknown  Entered:2012-10-10
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:
CDC Split Type: WAES1210USA001475
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Information was received from a registered nurse concerning a patient who was vaccinated with GARDASIL. The patient was vaccinated with the first dose of GARDASIL on 05JUN2012, vaccinated with the second dose of GARDASIL on 02AUG2012 and was vaccinated with the third dose of GARDASIL. No adverse event reported. Additional information not expected.

VAERS ID:470041 (history)  Vaccinated:2012-09-12
Age:0.2  Onset:2012-09-16, Days after vaccination: 4
Gender:Male  Submitted:2012-10-10, Days after onset: 24
Location:Oregon  Entered:2012-10-10
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 0UNLL
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Rash/hives developed on both twins; location included front chest & back; there was also a group of red bumps surrounding near the injection site on thigh.

VAERS ID:469131 (history)  Vaccinated:2012-09-12
Age:48.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-11, Days after onset: 29
Location:Texas  Entered:2012-10-11
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
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS0294AE IMRA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Haemorrhage, Insomnia, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: First night couldn''t breathe and she took benadryl. Saturday left arm was itching and pain in right arm. Blood spot appeared on right arm. Had stomach cramps, called ER. Was told to medicate for symptoms she was having. Can''t sleep but is tired.

VAERS ID:469427 (history)  Vaccinated:2012-09-12
Age:63.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-10-13, Days after onset: 30
Location:Texas  Entered:2012-10-13
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.0567AE SCRA
Administered by: Public     Purchased by: Public
Symptoms: Burning sensation, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: 24 hrs after getting shingles vaccine, a 1"x 2" rash developed and after 48 hrs, it''s burning. Advised by nurse to try ice, Benadryl and ibuprofen or Tylenol.

VAERS ID:470181 (history)  Vaccinated:2012-09-12
Age:66.0  Onset:2012-09-21, Days after vaccination: 9
Gender:Male  Submitted:2012-10-10, Days after onset: 19
Location:Florida  Entered:2012-10-16, 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: Penicillin allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H012577 UNUN
Administered by: Other     Purchased by: Private
Symptoms: Varicella
SMQs:
Write-up: Developed chicken pox about 2 weeks after vaccination. I had contacted chicken pox previously when I was 32 years of age. Treated with Avoclyr by personal physician.

VAERS ID:470291 (history)  Vaccinated:2012-09-12
Age:46.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2012-10-18, Days after onset: 36
Location:Arizona  Entered:2012-10-18
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: will be going to see doctor for hives / rash
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, itching all over body. The hives / rash outbreaks are still occurring from 09-12-2012 to date 10-18-2012.

VAERS ID:471224 (history)  Vaccinated:2012-09-12
Age:72.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-21, Days after onset: 8
Location:Kansas  Entered:2012-10-22, Days after submission: 31
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: Diabetes; High cholesterol; High blood pressure; Penicillin allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B065AA0UNRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Public     Purchased by: Private
Symptoms: Axillary pain, Chills, Contusion, Erythema, Mass, Pruritus
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (broad)
Write-up: 9/13/2012 The next morning huge lump goose egg size, red and itched like crazy, arm pit hurt. There is a bruise there now, no lump. 48 hours after shot, had a severe case of chills, but then the next day felt fine.

VAERS ID:471364 (history)  Vaccinated:2012-09-12
Age:56.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-16, Days after onset: 34
Location:Oregon  Entered:2012-10-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lovastatin; Topiramate; DETROL
Current Illness: No
Preexisting Conditions: Seizures; Cholesterol; Bladder control
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204301 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Stiffness and pain in arm - difficulty w/ movement especially in morning. Pain all day. Limited mobility with left arm where shot was administered.

VAERS ID:476250 (history)  Vaccinated:2012-09-12
Age:75.0  Onset:0000-00-00
Gender:Unknown  Submitted:2012-10-24
Location:Texas  Entered:2012-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Codeine, Hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1209USA010433
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site swelling, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a licensed Vocational nurse refers to a 75 years old patient with codeine allergy. The patient was vaccinated with ZOSTAVAX (dose, route and frequency unknown) (lot number reported as #0071AE and expiry date reported as 03-APR-2013) (expiry date also reported as 03-APR-2020) on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in September 2012 the patient experienced redness and soreness and the injection area became swollen about the size of an egg. The patient took BENADRYL as treatment. Medical attention has been sought by office visit. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of the several reports received from the same reporter. Additional information has been requested.

VAERS ID:471406 (history)  Vaccinated:2012-09-12
Age:57.0  Onset:2012-09-24, Days after vaccination: 12
Gender:Female  Submitted:2012-10-25, Days after onset: 31
Location:Arizona  Entered:2012-10-25
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
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITEDP58406 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Patient said the site became extremely red, hard and hot. RPh advised patient to apply a topical Benadryl and take ibuprofen. It cleared up by the end of the day.

VAERS ID:473209 (history)  Vaccinated:2012-09-12
Age:20.0  Onset:2012-09-17, Days after vaccination: 5
Gender:Male  Submitted:2012-09-20, Days after onset: 3
Location:South Carolina  Entered:2012-11-02, Days after submission: 43
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV3100UNLA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AJ21093IN 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG15410UNRA
Administered by: Military     Purchased by: Military
Symptoms: Mass, Pain
SMQs:
Write-up: Pt felt pain and lump on collarbone on 17 Sep 12.

VAERS ID:472834 (history)  Vaccinated:2012-09-12
Age:11.0  Onset:2012-09-20, Days after vaccination: 8
Gender:Female  Submitted:2012-11-04, Days after onset: 45
Location:Illinois  Entered:2012-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRLA
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0SYRLA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Severe stomach pain.

VAERS ID:473439 (history)  Vaccinated:2012-09-12
Age:25.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2012-11-07, Days after onset: 54
Location:North Carolina  Entered:2012-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 36 wk preemie
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B085AA1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm swollen, painful, red, difficulty raising arm up 2 days after vaccine, fevers 2 days later, oral antibiotics x 3 days no better.

VAERS ID:474987 (history)  Vaccinated:2012-09-12
Age:15.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-11-20, Days after onset: 69
Location:New York  Entered:2012-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3927AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1210AA1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Asthma, Cough, Dizziness, Dyspnoea, Headache, Oropharyngeal pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: 9/12/12 started coughing; 9/13/12 runny nose and sore throat; 9/14/12 chills, no fever; 9/16/12 @ 5PM difficulty breathing, dizzy, headache; 9/17/12 seen by MD, put on prednisone, nebulizer, ventalin inhaler-MD diagnosed asthma; 9/18/12 taken to ED, given nebulizer treatments and prednisone injection; 9/20/12 brought to ED- given penicillin and cough medication.

VAERS ID:477129 (history)  Vaccinated:2012-09-12
Age:0.4  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-12-07, Days after onset: 85
Location:Michigan  Entered:2012-12-07
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: Developmental delay, possible vision abnormality, in-utero exposure to maternal drugs
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300AA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1823AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172451IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1808AA1PO 
Administered by: Private     Purchased by: Public
Symptoms: Emotional distress, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Fever, extreme irritability, unconsolable for 6 hours.

VAERS ID:480380 (history)  Vaccinated:2012-09-12
Age:52.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2013-01-02, Days after onset: 112
Location:North Carolina  Entered:2013-01-07, 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: Calcium; Aspirin
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Not reported
CDC Split Type: 201209027
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH731AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Initial report received from a healthcare professional on 25 September 2012. A 52-year-old female patient, whose medical history and concomitant medications were unknown, received a dose of FLUZONE (lot number: UH731AB) intramuscularly in the left arm on 12 September 2012. On 12 September 2012, the patient developed soreness that was radiating down her left arm since the vaccine given. Corrective medications and laboratory investigations were not reported. At the time of this report, the outcome of the event was unknown. Follow-up information was received from a healthcare professional on 26 December 2012. Based upon the new information, this case has been upgraded to serious. Treatment included diclofenac 75mg twice daily and cyclobenzaprine 10mg at bedtime. As of 21 December 2012, the issue was still not resolved. The patient stated it aches like a toothache all the time. Concomitant medications included calcium and aspirin. Outcome was not recovered. List of documents held by sender: none.

VAERS ID:480710 (history)  Vaccinated:2012-09-12
Age:81.0  Onset:2012-10-01, Days after vaccination: 19
Gender:Male  Submitted:2013-01-08, Days after onset: 99
Location:Unknown  Entered:2013-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Blood glucose abnormal
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1301USA000298
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a consumer''s daughter refers to an 81 years old male patient with blood sugar issues and no drug reactions or allergies. On 12-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot number not provided) one time, subcutaneously. No other co-suspects were reported. Concomitant medications included several medications not provided. In October 2012, the patient contracted shingles after receiving ZOSTAVAX vaccine. The patient sought unspecified medical attention and received unspecified treatment. At the time of the report, the outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.

VAERS ID:481377 (history)  Vaccinated:2012-09-12
Age:56.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2013-01-15, Days after onset: 125
Location:Pennsylvania  Entered:2013-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxybutynin
Current Illness:
Preexisting Conditions: Hep C
Diagnostic Lab Data: See attached documents (also had an MRI which was negative for rotator cuff tear)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203901 SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Nuclear magnetic resonance imaging normal, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: After receiving Flu shot within 20 minutes pain shot down my arm into my fingers woke up next morning w/ excruciating pain at injection site (deltoid not muscle).

VAERS ID:481704 (history)  Vaccinated:2012-09-12
Age:32.0  Onset:2012-10-24, Days after vaccination: 42
Gender:Female  Submitted:2013-01-17, Days after onset: 85
Location:New Mexico  Entered:2013-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; Anxiety
Diagnostic Lab Data: MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA735BA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Myelitis transverse, Nuclear magnetic resonance imaging
SMQs:, Demyelination (narrow)
Write-up: Pt has been dx with transverse myelitis.

VAERS ID:482775 (history)  Vaccinated:2012-09-12
Age:49.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2013-01-28, Days after onset: 138
Location:California  Entered:2013-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN, CYTOMEL, LOVASTATIN
Current Illness: PATIENT HAS A LARGE MASS AT THE SITE OF INJECTION. PATIENT HAS SEEN PHYSICIAN AND WAS ADVISED TO FILE A REPORT. IT HAS BEEN 6 MONTHS AND HAS NOT SUBSIDED. THERE IS NO PAIN OR DISCHARGE REPORTED AT THE SITE. IT IS NOT HOT TO THE TOUCH OR GIVES ANY DISCOMFORT.
Preexisting Conditions: HYPOTHYROIDISM, DIABETES MELLITUS TYPE 2, DYSLIPIDEMIA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEUR12046011SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site mass, Mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: LARGE MASS DEVELOPED AND HAS SOLIDIFIED. STILL EXISTS 6 MONTHS LATER.

VAERS ID:483603 (history)  Vaccinated:2012-09-12
Age:60.0  Onset:2012-09-24, Days after vaccination: 12
Gender:Female  Submitted:2013-02-06, Days after onset: 135
Location:New Jersey  Entered:2013-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins, OTC Prevacid
Current Illness: None
Preexisting Conditions: Allergic to PCN
Diagnostic Lab Data: MRI
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS124801 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Ear infection viral, Hearing aid user, Nuclear magnetic resonance imaging, Tinnitus
SMQs:, Hearing impairment (narrow)
Write-up: Began to have buzzing and ringing in right ear. Few days later saw Dr. who said it was probably a viral infection in ear. Wants to rule out relation to flu shot. Saw ENT, MRI done. Now wears hearing aid. Was given PO Steroids with no improvement.

VAERS ID:483650 (history)  Vaccinated:2012-09-12
Age:28.0  Onset:2012-09-15, Days after vaccination: 3
Gender:Female  Submitted:2013-02-07, Days after onset: 145
Location:North Dakota  Entered:2013-02-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH717AC IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC046AA IMRA
Administered by: Public     Purchased by: Private
Symptoms: Asthenia, Cardiac disorder, Dizziness, Dyspnoea, Lacrimation increased
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Lacrimal disorders (narrow)
Write-up: Relates started with watering eyes for 2 weeks then into shortness of breath and ended up with heart issues, weakness, dizziness and hospitalization.

VAERS ID:484150 (history)  Vaccinated:2012-09-12
Age:11.0  Onset:2012-10-01, Days after vaccination: 19
Gender:Female  Submitted:2013-02-12, Days after onset: 134
Location:Virginia  Entered:2013-02-12
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: UNKNOWN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: COMPLAINED OF PAIN AND TINGLING IN LEFT ARM POST FLU SHOT. SYMPTOMS DID NOT BEGIN UNTIL SEVERAL DAYS TO A WEEK AFTER SHE RECEIVED THE SHOT.

VAERS ID:491337 (history)  Vaccinated:2012-09-12
Age:46.0  Onset:2012-09-16, Days after vaccination: 4
Gender:Male  Submitted:2012-10-05, Days after onset: 19
Location:Massachusetts  Entered:2013-05-10, Days after submission: 217
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin equine antirabies
Current Illness:
Preexisting Conditions: Medical history included hypertension. Ongoing illness at the time of vaccination included bat bite on left side of the collarbone. Concomitant medications not reported. Patient had first dose of RABAVERT on29 Aug 2012 in the left arm, IMOVAX first dose on 5 Sep 2012 in the left arm as a postexposure immunization.
Diagnostic Lab Data: On an unspecified date the blood work was done which showed WBC and lymphocytes were elevated.
CDC Split Type: 201208911
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIE-VAX)SANOFI PASTEUR 1IMLA
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Decreased appetite, Lymphocyte count increased, Malaise, Night sweats, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Initial information received from a consumer on 21 September 2012. A 46-year-old male patient received IMOVAX Rabies (batch number: not reported) intramuscularly in the left arm on 05 September 2012. On 12 September 2012, the patient received next dose of IMOVAX rabies intramuscularly in the left arm (batch number: not reported). He had also received RABAVERT (other manufacturer vaccine, intramuscular in the left arm, batch number: not reported), Tetanus (other MFR, intramuscular in the right arm, Batch number: not reported), RIG (other MFR, intramuscular in the gluteus and arm, batch number not reported) on 29 August 2012. On 01 September 2012, the patient received second dose of RABAVERT intramuscularly in the right arm. Medical history included hypertension. Ongoing illness at the time of vaccination included bat bite on left side of the collarbone. Concomitant medications not reported. On 16 September 2012, after completion of post exposure series the patient had fever 99-101, decreased appetite, night sweats and general malaise. On an unspecified date WBC and lymphocytes were elevated and blood work was done. Treatment medications were not reported. At the time of this report, the events were continued. Documents held by sender: none.

VAERS ID:496543 (history)  Vaccinated:2012-09-12
Age:64.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2013-05-13, Days after onset: 242
Location:Illinois  Entered:2013-07-12, Days after submission: 60
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEXAPRO; Fexofenadine hydrochloride; Fluticasone propionate
Current Illness: Anxiety; Arthritis; Seasonal allergy
Preexisting Conditions: There were no concomitant vaccinations given on the same date. It was reported that the subject had not previously received any flu vaccines. There were no known advese events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0995186A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA691AA0SYRLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site cellulitis in a 64-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included anxiety, arthritis and seasonal allergy. Concurrent medications included LEXAPRO, ALLEGRA and FLONASE. It was reported that the subject had not previously received any flu shots and there were no known adverse events following previous vaccinations. On 12 September 2012, the subject received dose of FLUARIX (.5 ml, details unknown, left deltoid). No other vaccines were administered on this same date. On 13 September 2012, 1 day after vaccination with FLUARIX, the subject experienced left shoulder warm, hot and painful above the injection site, "previous vaccination site was red" and bruise injection site. On 14 September 2012, 2 days after vaccination with FLUARIX, the subject experienced injection site cellulitis. This case was assessed as medically serious by GSK. The subject''s primary care physician diagnosed her with cellulitis and prescribed antibiotics and ZYRTEC to treat it. The subject required medical attention at the doctor''s office. The left shoulder warm, hot and painful above the injection site, "previous vaccination site was red", and injection site cellulitis resolved on 17 September 2012. At the time of reporting the bruise injection site was improved.

VAERS ID:498090 (history)  Vaccinated:2012-09-12
Age:72.0  Onset:2012-10-21, Days after vaccination: 39
Gender:Male  Submitted:2013-07-31, Days after onset: 283
Location:Oklahoma  Entered:2013-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1307USA016785
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report was received from a physician refers to an approximately 72 year old male patient with no pertinent medical history and no drug reactions/allergies. On 21-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported). Approximately on 21-OCT-2012 (reported as about 30 days after receiving ZOSTAVAX the patient experienced hives. The hives reappeared at times and have not ever fully gone away. The event did not resolve at the time of the report. The patient was given ranitidine 150 milligram (mg) once daily, fexofenadine hydrochloride (reported as fexofenadine) 180 mg once daily and hydroxyzine 25 mg as treatment for the event. Laboratory diagnostic studies were not performed. The patient saw the physician and sought medical attention. Causality was not reported. Additional information has been requested.

VAERS ID:501853 (history)  Vaccinated:2012-09-12
Age:54.0  Onset:2012-09-21, Days after vaccination: 9
Gender:Female  Submitted:2013-09-09, Days after onset: 353
Location:Minnesota  Entered:2013-09-09
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad)
Write-up: Unable to raise arm, very painful (hadn''t hurt at time of injection), decreased ROM--deltoid muscle. Symptoms gradually improved over one week''s time.

VAERS ID:502236 (history)  Vaccinated:2012-09-12
Age:29.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2013-09-10, Days after onset: 363
Location:South Carolina  Entered:2013-09-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RHOGAM
Current Illness:
Preexisting Conditions: Maternal history included one previous pregnancy resulting in twin births.
Diagnostic Lab Data: Not reported.
CDC Split Type: 201208582
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4384AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Exposure during pregnancy, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial report received from a healthcare professional on 12 September 2012. A 29-year-old pregnant female patient had received an intramuscular (IM) first dose of ADACEL vaccine in left deltoid (lot number U4384AA) on 12 September 2012. The date of the patient Last Menstrual Period was 17 February 2012. Estimated Date of Delivery was reported as 23 November 2012. It was reported that the patient did not experienced any adverse event. The patient''s obstetrical history, current medical history, and concomitant medication were not provided. The outcome was reported as unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded to serious. The patient experienced a relevant illness of thrombocytopenia during pregnancy/ongoing. Maternal history included one previous pregnancy resulting in twin births. In addition to ADACEL, medications used during pregnancy included AFLURIA and RHOGAM. The patient delivered a normal infant on 19 November 2012. Outcome for the event of thrombocytopenia was not reported. Documents held by sender: None.

VAERS ID:503003 (history)  Vaccinated:2012-09-12
Age:52.0  Onset:2012-09-21, Days after vaccination: 9
Gender:Female  Submitted:2013-09-18, Days after onset: 362
Location:Colorado  Entered:2013-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ, PROTONIX, ZOCOR
Current Illness: NONE
Preexisting Conditions: HBP
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4483ASA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Cough, Headache, Pyrexia, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: HEADACHE, FEVER (101.8 X 7DAYS), COUGH (2 MONTHS), CHEST CONGESTION (2 MONTHS).

VAERS ID:508121 (history)  Vaccinated:2012-09-12
Age:64.0  Onset:2012-09-14, Days after vaccination: 2
Gender:Female  Submitted:2013-10-14, Days after onset: 395
Location:Unknown  Entered:2013-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium (unspecified) (+) vitamin D (unspecified)
Current Illness: Unknown
Preexisting Conditions: Perdium fiber; Drug Reaction: Drug hypersensitivity, Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1310USA001018
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0468AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a physician via company representative refers to a 64 year old patient with Perdiem (reported as percadiem) allergy. No medical history was reported. On 12-SEP-2012, the patient was vaccinated with ZOSTAVAX (0468AE, expiry: 04-APR-2013), 0.65 ml, subcutaneously. Concomitant therapies included calcium (unspecified), vitamin D (unspecified). On 14-SEP-2012, the patient experienced redness and swelling at the injections site that was possibly cellulitis after receiving ZOSTAVAX. Patient received treatment with Augmentin. Patient sought medical attention: spoke with an unspecified physician. No laboratory tests were performed. The reporter verified that this adverse experience took place last year, but the physician just learned of it recently. The outcome of redness and swelling at the injections site that was possibly cellulitis was reported as recovered on an unspecified date. Additional information has been requested.

VAERS ID:524408 (history)  Vaccinated:2012-09-12
Age:35.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:Pennsylvania  Entered:2014-03-03
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH711AA0UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age
SMQs:
Write-up: None stated.

VAERS ID:525178 (history)  Vaccinated:2012-09-12
Age:68.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2014-03-07, Days after onset: 540
Location:Unknown  Entered:2014-03-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity; Gastrooesophageal reflux disease, unspecified acid reflux medication; Hypertension; Diabetes mellitus; Incontinence, unspecified incontinence medication
Preexisting Conditions: Penicillin: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: WAES1403USA002414
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Pain, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with incontinence, acid reflux, diabetes, high blood pressure and gastroesophageal reflux disease (GERD). The patient had drug reactions/allergies with penicillin. On 12-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX for shingles prevention (lot#, expiry date, route, dose and strength not reported. The patient presented with shingles the following day, on 13-SEP-2012. The patient stated that the evening of 13-SEP-2012 she experienced tingling on her neck and itchiness around her neck, head and eyes. She also experienced unspecified pain. The patient visited an unspecified emergency room on 13-SEP-2012. The patient was not admitted to the hospital. The patient was diagnosed with shingles on 13-SEP-2012. She was prescribed VALCYCLOVIR by a physician, to treat the shingles. The patient was fully recovered on an unspecified date. Additional information has been requested.

VAERS ID:530799 (history)  Vaccinated:2012-09-12
Age:69.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:Florida  Entered:2014-05-13
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR114490AA UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0255AE UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Chills, Injection site inflammation, Injection site rash, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 1 hour after receiving vaccination(s) patient experienced chills, fever, body aches, inflammation and rash at injection site to her left arm. This was reported 9-14-2012 patient felt better, however inflammation and rash still present. Patient was advised to take BENADRYL and Ibu.

VAERS ID:548899 (history)  Vaccinated:2012-09-12
Age:34.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2014-10-08, Days after onset: 756
Location:Connecticut  Entered:2014-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cyanocobalamin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410USA001618
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a medical assistant or nurse via a company representative refers to a 34 year old female patient. On 12-SEP-2012 the patient was vaccinated with PNEUMOVAX 23 subcutaneous (dose and lot# were not reported). Concomitant therapies included B-12 injection that was injected on the patient''s right arm. On 12-SEP-2012, within 24 hours after the patient was vaccinated, she experienced significant pain, redness and swelling that included a rash (extended through most of her left arm) at the injection site of PNEUMOVAX 23. On unknown date the patient also experienced fever of 101 F that lasted for three days. Patient took TYLENOL and ALEVE on her own on unknown date. There were not laboratory studies performed. Patient did not seek medical attention; however a call was made to physician to inquired about the adverse events. The outcome of the events was unknown. Additional information is not expected due to the physician did not want to be contacted.

VAERS ID:563970 (history)  Vaccinated:2012-09-12
Age:20.0  Onset:2012-10-05, Days after vaccination: 23
Gender:Male  Submitted:2015-02-05, Days after onset: 853
Location:Arizona  Entered:2015-02-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: No illness.
Preexisting Conditions:
Diagnostic Lab Data: After detoxing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMLA
TTOX: TETANUS TOXOID (TEVAX)GLAXOSMITHKLINE BIOLOGICALS 2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Lymphadenopathy, Malaise, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad)
Write-up: Started getting general ill feeling, losing weight, within two months lost 20 lbs, lymphnodes swelled everywhere.

VAERS ID:466177 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-09-25, Days after onset: 13
Location:Foreign  Entered:2012-09-25
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209HKG006232
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: This spontaneous report was received from a female company representative of unknown age (also the patient) (local reference number: HKG-12-0096) regarding herself. On 12-SEP-2012, the patient was vaccinated with the 1st dose of GARDASIL (lot number, dose and route of administration unspecified). No Concomitant medications were reported. On 12-SEP-2012, after vaccination, she experienced dizzy, numb of right hand, right leg, mouth and brain. On an unknown date, she was hospitalized (query pending). The outcome of dizzy, numb of right hand, right leg, mouth and brain was unknown. The relatedness for dizzy, numb of right hand, right leg, mouth and brain was unknown for GARDASIL. Additional information has been requested.

VAERS ID:466748 (history)  Vaccinated:2012-09-12
Age:29.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Female  Submitted:2012-09-27, Days after onset: 14
Location:Foreign  Entered:2012-09-27
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: UNK
CDC Split Type: B0832871A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERAC37B088AC UNAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site abscess, Injection site cellulitis, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This prospective pregnancy case was reported by a nurse and described the occurrence of injection site cellulitis in a 29-year-old female subject who was vaccinated with REFORTRIX (GlaxoSmithKline. On 12 September 2012, the subject received an unspecified dose of REFORTRIX (route unknown, unknown deltoid). The last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine during unknown trimester. On 13 September 2012, 1 day after vaccination with REFORTRIX, the subject experienced injection site cellulitis, injection site abscess, injection site redness. This case was assessed as medically serious by GSK. At the time of reporting, the events were unresolved. The pregnancy was ongoing. The physician considered the events were almost certainly related to vaccination with REFORTRIX. This case is 1 of the 4 cases reported by the same reporter.

VAERS ID:467294 (history)  Vaccinated:2012-09-12
Age:0.4  Onset:2012-09-17, Days after vaccination: 5
Gender:Male  Submitted:2012-10-02, Days after onset: 15
Location:Foreign  Entered:2012-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 09/17/2012, Amylase, 16 U/L; 09/18/2012, Amylase; 09/17/2012, Basophil count, 79%; 09/17/2012, Blood bilirubin, 0.2 mg/dL; 09/18/2012, Blood bilirubin; 09/17/2012, Blood glucose, 123 mg/dL; 09/18/2012, Blood glucose; 09/17/2012, Blood thyroid stimulating hormone, 0.191 IU/ml; 09/18/2012, Blood thyroid stimulating hormone; 09/17/2012, Body temperature; 09/17/2012, Haematocrit, 35.8%; 09/17/2012, Haemoglobin, 12.3 g/dL; 09/17/2012, Laboratory test, 1.16 ng/dL; 09/17/2012, Laboratory test, 1%; 09/17/2012, Laboratory test, 79%; 09/17/2012, Laboratory test, 3.83 pg/ml; 09/18/2012, Laboratory test, Positive; 09/18/2012, Laboratory test, %, haemoglobin in stool test; 09/18/2012, Laboratory test, %; 09/18/2012, Laboratory test; 09/18/2012, Laborato
CDC Split Type: WAES1209JPN010522
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amylase normal, Basophil percentage, Blood bilirubin decreased, Blood glucose increased, Blood thyroid stimulating hormone decreased, Body temperature decreased, Diarrhoea, Faeces discoloured, Haematocrit normal, Haemoglobin normal, Irritability, Laboratory test normal, Lethargy, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume, Monocyte percentage, Mood altered, Neutrophil percentage increased, Occult blood positive, Pallor, Peripheral coldness, Platelet count normal, Poor sucking reflex, Protein total normal, Red blood cell count normal, Rotavirus test positive, Thyroxine free increased, Tri-iodothyronine free increased, Viral test positive, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 20 week old male patient. The patient had no primary disease, concurrent conditions, past medical history or allergy. The patient had no abnormality at birth. On 12-SEP-2012, the patient was vaccinated with the first dose of ROTATEQ, Oral (dose and lot number not reported) at clinic B. Information on concomitant medication not provided. On 16-SEP-2012 at midnight, it was noticed that the patient''s complexion was pale and his hands and feet were cold and low feeling of body temperature. Body temperature was not measured. He was in bad mood and cranky. On 17-SEP-2012, at about 7 am, the patient was sucking milk but the sucking strength was poor and subsequently developed vomiting. His complexion was pale. Body temperature was 36.1 degrees C. He was taken to the emergency outpatient department of hospital A because of no liveliness. Blood test showed no abnormality and the patient went back home after receiving treatment only with rehydration therapy. WBC 6730 / ul, RBC 4,800,000/ ul, Hb 12.3g I dl, HCT 35.8%, MCV 74.6 fl. MCH 25.6 pg, MCHC 34.4%, PL T 321 0000/ ul, Seg 79.0%, Baso 0.5%, Lymph 15.0%, Mono 4.5%, A-ly 1.0%, total protein 6.2 g/dl, total bilirutin 0.2 mg/ dl, blood sugar 123 mg/ dl, amylase 16 U/L, TSH 0.191 uiU / mL (low), FT3 3.83 pg/ ml, FT41.16ng/ dl. Black diarrheal stools were seen once at nighttime. There was no vomiting. On 18-SEP-2012, the patient returned to hospital. His complexion was slightly poor and therewas not much liveliness. He was reportedly sucking milk poorly too. During the examination, large amount of black diarrheal stools was observed and because the surgical illness of the upper gastrointestinal tract was suspected with positive for hemoglobin in the stool, the patient was transferred to hospital C for detailed examination and treatment. A checking for infection was requested at the time of hospital transfer and examination for rotavirus antigen in stool was performed, which revealed positive for rotavirus antigen in stool. After presenting to the emergency outpatient department of hospital C, the patient was placed under follow-up observation on an outpatient basics. At the time of this report, the outcome of" complexion is pale", "hands and feet are cold", vomiting and black diarrhea stools was unknown. Event though it was black stools, it was asked if it could be considered as invagination of intestine. The reporting physician considered that the black diarrhea stools was serious (as other important medical event), and did not assess the seriousness of" complexion is pale", "hands and feet are cold" and vomiting. The reporting physician felt that black diarrhea stools was definitely related to live attenuated pentavalen rotavirus vaccine and judged that other factor was unknown. The reporting physician did not assess the causal relationship of" complexion is pale", "hands and feet are cold" and vomiting to ROTATEQ, Oral. Additional information has been requested.

VAERS ID:470287 (history)  Vaccinated:2012-09-12
Age:  Onset:2012-09-15, Days after vaccination: 3
Gender:Male  Submitted:2012-10-18, Days after onset: 33
Location:Foreign  Entered:2012-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Malt lymphoma
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0837088A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC099BB2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Vertigo
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: This case was reported by a health professional via a regulatory authority (# 2012-03343) and described the occurrence of vertigo in a 46-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included malt lymphoma diagnosed in 2011. The subject was treated for this. On 12 September 2012, the subject received 3rd dose of ENGERIX B adult (1 ml, intramuscular, unknown injection site). On 15 September 2012, 3 days after vaccination with ENGERIX B adult, the subject experienced vertigo, chills, abdominal pain and stomach cramps. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 20 September 2012, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ENGERIX B adult.

VAERS ID:471108 (history)  Vaccinated:2012-09-12
Age:0.2  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-10-23, Days after onset: 41
Location:Foreign  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Birth Twin; Premature Baby
Preexisting Conditions:
Diagnostic Lab Data: Blood test, 17Sep2012, See text; Body temperature, 12Sep2012, 39.2Deg. C.; Body temperature, 17Sep2012, 38.2 Deg. C.; Body temperature, 39.9 Deg. C.; Urine culture, 17Sep2012, Normal
CDC Split Type: B0839401A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B201AO0IMUN
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSA21CB206A0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Culture urine negative, Hypersomnia, Incorrect dose administered, Malaise, Monocyte count normal, Platelet count normal, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a consumer via a regulatory authority (NL-LRB-143658) and described the occurrence of possible viral infection in a 2-month-old female subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline) and INFANRIX HEXA. The subject was one of a twin and was dysmaturely born. Concomitant medication was not reported. The subject had no known medical history nor known past drug therapy. On 12 September 2012, the subject received 1st dose of INFANRIX-IPV (intramuscular, unknown injection site). The subject accidentally also received 1st dose of INFANRIX HEXA (intramuscularly, unknown injection site). On 12 September 2012, within hours of vaccination with INFANRIX HEXA and INFANRIX-IPV, the subject experienced fever at 39.2 Deg. C., she slept a lot and felt unwell. On 13 September 2012, 1 days after vaccination with INFANRIX HEXA and INFANRIX-IPV, the fever was resolved. On 17 September 2012, 5 days after vaccination with INFANRIX HEXA and INFANRIX-IPV, subject experienced a new episode of fever at 38.2 Deg. C. Blood tests were performed and showed no infection parameters, no thrombocytose, no monocytose. A possible viral infection was mentioned. Urine tests showed no abnormalities. On an unspecified date, the subject experienced pyrexia at 39.9 Deg. C. The subject was hospitalised for one night. At the time of reporting, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with INFANRIX-IPV and INFANRIX HEXA and the paediatrician considered that a viral infection was the most likely cause for the illness. No further information was expected. Case was closed.

VAERS ID:472364 (history)  Vaccinated:2012-09-12
Age:34.0  Onset:2012-10-04, Days after vaccination: 22
Gender:Male  Submitted:2012-10-29, Days after onset: 25
Location:Foreign  Entered:2012-10-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No history of acute or chronic illness, no surgical disorder, no history of hypertension, etc...No significant history of adverse event to a vaccine or a drug.
Diagnostic Lab Data: Widal test: Salmonella typhi O- 1:160, H -1:160, salmonella paratyphi negative; Dengue: IgM, IgG, NSI antigen all negative; PSMP: negative; CBC within normal limits
CDC Split Type: 201209846
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURJ0039 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Full blood count normal, Nasopharyngitis, Pain, Pyrexia, Salmonella test positive, Smear site unspecified normal, Typhoid fever, Vaccination failure, Viral test negative
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Case received from a consumer in a foreign country on 17 October 2012. This batch number J0039-1 was identified as at-risk of an antigen content below specifications. Voluntary batch recall in Sept 2012. A 34 year-old male patient, with no relevant medical history and no concomitant therapy, had received a dose of TYPHIM VI (batch number J00039-1) via intramuscular route in the right arm on 12 September 2012. The patient was asymptomatic during vaccination (no history of chronic and acute illness). On an unspecified date post vaccination, he experienced local mild pain for 15 minutes. Around 04 October 2012, he developed fever, cough, and cold and was given symptomatic treatment. Widal illness was assumed. The patient failed to respond adequately. Complementary investigations were performed and the patient was found to be Widal positive (Salmonella typhi 0 -1:160, H- 1:160, salmonella paratyphi negative) on 09 October 2012. Management was done accordingly, once diagnosis of typhoid was done. Treatment included capsule of AUGMENTIN for 9 days, oral MEFTAL FORTE for 5 days and oral cetirizine for 5 days. No complications with this treatment were reported. At the time of the report, the patient was recovering. The case was assessed as serious due to other important medical condition. Vaccination failure.

VAERS ID:472527 (history)  Vaccinated:2012-09-12
Age:25.0  Onset:2012-10-08, Days after vaccination: 26
Gender:Female  Submitted:2012-11-01, Days after onset: 24
Location:Foreign  Entered:2012-11-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness: Unknown
Preexisting Conditions: Pregnancy
Diagnostic Lab Data:
CDC Split Type: WAES1210GBR014459
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blighted ovum, Exposure during pregnancy, Haemorrhage, Pain, Ultrasound antenatal screen abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This pregnancy case was received from the Health Protection Agency in a foreign country on 25-Oct-2012. HPA REF 564. This case is medically confirmed. A 25-year-old female patient received a second dose of MMR II (manufacturer and batch number not reported), route and site not reported, on 12-Sep-2012. The patient was pregnant at the time of vaccination. Her LMP was 26-Aug-2012 and her EDD was 02-Jun-2013. The patient did not experience any adverse effect following vaccination. The patient received the first dose of MMR II (manufacturer and batch number not reported) on 01-Jan-1990. The patient''s vaccination history stated that she was suspectible to MMR II for vaccination as the patient was a health care professional. The patient was taking concomitant folic acid 400mcg for the pregnancy. The patient had no previous pregnancy. On 08-Oct-2012, 26 days post vaccination, the patient had an ultrasound scan due to slight pain and bleeding which showed intrauterine pregnancy uncertain viability. The ultrasound was to be repeated after 10 days. The patient outcome was not reported. Upon internal review the events were considered to be medically significant.

VAERS ID:474774 (history)  Vaccinated:2012-09-12
Age:9.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-11-16, Days after onset: 65
Location:Foreign  Entered:2012-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Salmonellosis; Tonsillectomy; Adenoidectomy
Diagnostic Lab Data:
CDC Split Type: WAES1211FRA006894
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis viral, Hepatocellular injury, Liver function test
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow)
Write-up: Case received from a pharmacist in a foreign country on 14-Nov-2012. Case medically confirmed. A 9-year-old female patient born in 2003 developed hepatic cytolisis after receiving a dose of MMRVAXPRO (batch number not reported, number in series unknown) on 12-Sep-2012. She experienced the first symptoms in the hours following vaccination on 12-Sep-2012 and she was hospitalised the following day. At the time of reporting, viral hepatitis was suspected but no causative agent had been identified. The patient was discharged on 23-Sep-2012. The reporting pharmacist specified that she saw the patient''s mother again and was told that the patient was feeling better and would have repeat liver function tests. It is worth noting that the patient had a medical history of salmonellosis in 2009. She had undergone adenoidectomy and tonsillectomy in 2009. At the time of reporting she was recovering. According to the reporter, the physician did not mention any causal relationship with vaccination in the hospital report.

VAERS ID:474814 (history)  Vaccinated:2012-09-12
Age:7.0  Onset:2012-09-13, Days after vaccination: 1
Gender:Male  Submitted:2012-11-16, Days after onset: 64
Location:Foreign  Entered:2012-11-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant patient''s medical history.
Diagnostic Lab Data:
CDC Split Type: E201208572
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3811AJ IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Cellulitis, Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, 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: Case was received from the Health Authorities in a foreign country on 08-Nov-2012 (reference number PEI2012056090). Case is medically confirmed. A 7-year-old male patient received a dose of COVAXIS (lot-no. C3811AJ) IM on 12-Sep-2012. One day later, on 13-Sep-2012, he presented with itching, swelling and redness at the left shoulder and upper arm. A phlegmone was diagnosed. He was hospitalised on an unspecified date and treated with CEFUROXIME IV. Duration was reported to be 5 to 7 days. Outcome was not reported. A blood sample was taken on an unspecified date and revealed CRP of 40 mg/l (reference range not reported). CASE IS CLOSED.

VAERS ID:475205 (history)  Vaccinated:2012-09-12
Age:13.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-11-21, Days after onset: 70
Location:Foreign  Entered:2012-11-21
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: WAES1211GBR008290
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H008041 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotension, Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was received from the health authority in a foreign country on 14-Nov-2012. GB-MHRA-ADR 21911904. This case is medically confirmed. A 13-year-old female patient, with no reported medical history or concomitant medication, received an injection of GARDASIL (batch no. H008041, dose and site of administration not reported) intramuscularly on 12-Sep-2012 and, immediately after the vaccination, she fainted. She also had a low blood pressure. She went home from school accompanied by a parent. At the time of reporting the patient had not recovered. The agency considered this case to be serious as an other medically important condition.

VAERS ID:475209 (history)  Vaccinated:2012-09-12
Age:12.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-11-22, Days after onset: 71
Location:Foreign  Entered:2012-11-22
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: 09/12/2012, Blood pressure, 90/50; 09/12/2012, Blood pressure, 110/65; 09/12/2012, Heart rate, 65; 09/12/2012, Heart rate, 68
CDC Split Type: WAEs1211GBR008193
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H008041 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: This case was received from the health authority in a foreign country on 14-Nov-2012. GB-MHRA-ADR 21911903. This case is medically confirmed. A 12 year old female patient received an injection of GARDASIL (batch number H008041, site of administration not reported) intramuscularly, 0.5 mL, on 12-Sep-2012. On the same day, the patient felt faint. Her blood pressure readings at 10:20am and 10:28am were 90/50 and 110/65 respectively. Her pulse readings at 10:20am and 10:28am were 65 and 68 respectively. She was sent home with her parent. At the time of reporting, the patient was not recovered. The agency considered this case to be serious as an other medically important condition.

VAERS ID:475435 (history)  Vaccinated:2012-09-12
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2012-11-23
Location:Foreign  Entered:2012-11-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Flu
Diagnostic Lab Data: Lumbar puncture (date unknown): confirmed viral meningitis
CDC Split Type: 2012290583
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lumbar puncture abnormal, Meningitis viral, Pyrexia, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad)
Write-up: This is a spontaneous report from a study. A contactable nurse reported that a 2-months-old female patient received the first dose of PREVENAR 13, intramuscular on 12Sep2012 at 0.5 ml, single. Medical history included flu (baby got flu from other family members which lead to viral meningitis as explained by the pediatrician to the mother of the baby). Concomitant medication included the first dose of INFANRIX HEXA intramuscularly, the first dose of oral ROTARIX and the first dose of POLIO SABIN (ORAL), all administered on 12Sep2012 at unknown dose. The patient became ill with fever on 24Sep2012. The patient experienced viral meningitis and urinary tract infection on unknown date in 2012 and was admitted to the ward (hospital) for 5 days. Therapeutic measures were taken as a result of viral meningitis and urinary tract infection. Lab data included lumbar puncture (LP) performed in the hospital (date not specified) that confirmed viral meningitis. The patient recovered from viral meningitis and urinary tract infection on 29Sep2012. The outcome of fever was unknown at the time of this report. The patient received the second dose of INFANRIX HEXA intramuscularly on 10Oct2012.

VAERS ID:478892 (history)  Vaccinated:2012-09-12
Age:0.5  Onset:2012-09-12, Days after vaccination: 0
Gender:Unknown  Submitted:2012-12-19, Days after onset: 98
Location:Foreign  Entered:2012-12-20, 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: Similar symptoms appeared a few times for 2-3 days post-vaccination.
Diagnostic Lab Data: Not reported
CDC Split Type: 201211924
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20910001C SCRA
HIBV: HIB (ACTHIB)SANOFI PASTEURG9965 IMRL
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURGO120 IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Case received from the Health Authorities on 11 December 2012 under the reference number PL-URPL-N1393/2012. A 06-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of ACT-HIB, batch number G9965-1, in the right thigh, concomitantly with a subcutaneous dose of "PIX360326" [interpreted as DTP vaccine] (other manufacturer, batch number 20910001C) in the right arm and an intramuscular dose of IMOVAX POLIO (batch number "GO120") in the left thigh, on 12 September 2012. On 12 September 2012, 2 hour post-vaccination, the patient experienced pallor and flaccidity for a few minutes. "Similar symptoms appeared a few times for 2-3 days post-vaccination". On 14 September 2012, 48 hours post-vaccination, the patient developed uncontrollable crying which lasted for more than 3 hours. The Health Authorities coded "hypotonic-hyporesponsive episode" and "inconsolable crying". The patient recovered. This case was reported as serious, i.e. as a medically important condition. Reporter''s comment: "The child was referred for consultation in the outpatient vaccination clinic for children at high-risk". Sender''s comment: "IVP is produced by Sanofi Pasteur so it is probably IMOVAX POLIO. Hypotonic-hyporesponsive episode is known and expected reaction after DTP vaccine (unexpected for ACT-HIB and IMOVAX POLIO), could appear after many vaccines. Crying is expected reaction after DTP and ACT-HIB, unexpected for IMOVAX POLIO". Documents held by sender: none.

VAERS ID:479262 (history)  Vaccinated:2012-09-12
Age:12.0  Onset:2012-09-12, Days after vaccination: 0
Gender:Female  Submitted:2012-12-26, Days after onset: 105
Location:Foreign  Entered:2012-12-26
Life Threatening? Yes
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: --/--/2012, Pneumonia, The patient had a pneumonia earlier in the year.
Diagnostic Lab Data:
CDC Split Type: WAES1212GBR009143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Headache
SMQs:, Anaphylactic reaction (broad)
Write-up: This case was received from the health authority on 11-Dec-2012. GB-MHRA-ADR 21940136. This case is medically confirmed. A 12-year-old female patient received an injection of GARDASIL (batch no, dose in series and site of administration not reported) 0.5 mL intramuscularly on 12-Sep-2012 and on the same day she experienced tight chest and pounding headache. The reporter stated that, although this was not life threatening at the time, if the reaction became more severe with subsequent injections it would become severe, therefore parents decided to withdraw her from subsequent vaccines. The patient''s medical history included a pneumonia earlier in the year. The patient had fully recovered on 12-Sep-2012. The duration of the reactions and recovery time for the two reactions were reported as one day. The MHRA considered this case to be serious as a life threatening condition.

VAERS ID:483870 (history)  Vaccinated:2012-09-12
Age:4.0  Onset:0000-00-00
Gender:Male  Submitted:2013-02-06
Location:Foreign  Entered:2013-02-08, Days after submission: 2
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: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201301649
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4399AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Local reaction
SMQs:
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 30 January 2013 by the Sanofi Pasteur affiliate who received the report from the foreign Ministry of Health. A male patient (age reported as 4-years-old), whose medical history and concomitant therapies were not reported, had received his "campaign dose" (unknown) of FLUZONE, lot number U4399AA, (route and anatomical site of administration not reported) on 12 September 2012. On an unspecified date post-vaccination the patient experienced "Other local reactions". The patient''s outcome was recovered ("cure") with no sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Documents held by sender: None.

VAERS ID:487034 (history)  Vaccinated:2012-09-12
Age:1.3  Onset:2012-10-22, Days after vaccination: 40
Gender:Unknown  Submitted:2013-03-18, Days after onset: 147
Location:Foreign  Entered:2013-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1303POL006503
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0083490SCLA
Administered by: Other     Purchased by: Other
Symptoms: Parotid gland inflammation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: This spontaneous report as received from regulatory authority refers to a 16 month old(also reported as "15 month old") patient. On 12-SEP-2012 the patient was vaccinated with the first dose of M-M-RVAXPRO (lot # H008349; expired date: 12-APR-2014) 0.5 ml, subcutaneously in the left arm. On 22-OCT-2012, the patient experienced inflammation of the parotid gland and was hospitalized for two days. Subsequently the patient recovered from inflammation of the parotid gland on an unknown date. There were no previous incidents after vaccines in patient medical history. The reporter provided information that other children who were vaccinated with the same lot number of this vaccine did not experience any adverse events. The reporter considered inflammation of the parotid gland to be related to M-M-RVAXPRO. Additional information is not expected.

VAERS ID:491943 (history)  Vaccinated:2012-09-12
Age:17.0  Onset:2012-10-01, Days after vaccination: 19
Gender:Female  Submitted:2013-05-17, Days after onset: 228
Location:Foreign  Entered:2013-05-17
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: CYKLO-F; Celecoxib
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305SWE010662
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Case received from a consumer/non health care professional via the Health Authorities on 07-May-2013 under the reference number SE-KRMPAWWW-1366716889945. Case is medically not confirmed. This case is linked to case E2013-03553 and E2013-03556 (same patient, different AEs after the different doses). A 17-year-old female patient had received the first dose of GARDASIL (batch number unknown) via not reported route and site of administration on 12-Sep-2012. In Oct-2012 the patient developed shingles. On an unspecified date, the patient was hospitalized. Concomitantly the patient received CELEBREX and CYCLO-F. At the time of reporting, the patient was recovered with sequelae.

VAERS ID:495136 (history)  Vaccinated:2012-09-12
Age:0.5  Onset:2013-05-01, Days after vaccination: 231
Gender:Female  Submitted:2013-06-25, Days after onset: 55
Location:Foreign  Entered:2013-06-25
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: Immunisation; Selective IgA immunodeficiency
Preexisting Conditions: Campylobacter gastroenteritis; Infection; ROTATEQ
Diagnostic Lab Data: A culture stool performed on an unspecified date showed a positive result for rotavirus test.
CDC Split Type: WAES1305ESP017116
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case received from a health care professional, a physician, through a company representative on 24-MAY-2013. Case medically confirmed. A female patient (age not reported), had received a dose of ROTATEQ (batch number not reported) on an unspecified date; and later, (date not reported), the patient presented with gastroenteritis rotavirus. According to the reporter, a culture stool performed on an unspecified date showed a positive result for rotavirus test. At time of reporting the outcome was not reported. No further information was reported. Follow-up information received on 17-JUN-2013 from the physician. PV form was provided. This case has been upgraded to serious. The new information was: The patient was 13 months-old at time of adverse event, date of birth: 9-MAR-2012. The patient received the third dose of ROTATEQ (batch number: 1863AA) via oral route on 12-SEP-2012. According to the physician the patient developed moderate rotavirus gastroenteritis on May-2013 (exact date not reported), she presented a picture of diarrhea and fever (40 degrees C) with culture stool positive for rotavirus (date not reported). The patient didn''t receive any concomitant medication and she didn''t receive corrective treatment. The patient received two previous doses of a ROTATEQ, the first one (batch and lot number: 1815AA) was administered on 05-JUN-2012 via oral route and the second one (batch number: 1863AA) was administered on 10-JUL-2012 via oral route. It was not reported whether the patient presented with any adverse event or not after these vaccine administrations. The patient had a medical history of IgA deficiency, habitual infections, campylobacter jejuni gastroenteritis when she was 12 months-old. Weight-height development in percentile 3, for this reason a test was performed and it was showed IgA deficiency. She recovered from gastroenteritis rotavirus 15 days after onset. According to the physician the gastroenteritis rotavirus were considered as moderate and serious. According to the reporter this case was considered as vaccination failure.

VAERS ID:514951 (history)  Vaccinated:2012-09-12
Age:1.3  Onset:2012-09-12, Days after vaccination: 0
Gender:Male  Submitted:2013-11-26, Days after onset: 440
Location:Foreign  Entered:2013-11-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2013333599
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Abnormal faeces, Crying, Diarrhoea, Enteritis infectious, Immunodeficiency, Insomnia, Lethargy, Mood altered
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report obtained from a contactable physician through from foreign Health Authority; regulatory authority report number: SK-SUKLSK-20130854. A 14-month-old male patient received, on 12Sep2012, a third dose of intramuscular PREVENAR 13 0.5 ml, single dose and third dose of intramuscular INFANRIX HEXA 0.5 ml, single dose. On 12Sep2012, the patient started to cry, had bad mood, and then, on 15Sep2012, he was lethargic. On an unspecified date, after vaccination, he experienced also insomnia, diarrhoea, stool odor abnormal, abdominal pain and enteritis infectious in the frame immunodeficiency. On 13Nov2012, the patient was examined by immunoallergologist who diagnosed enteritis infectious in the frame of suspect post vaccination immunodeficiency. The immunoallergologist did not recommend next vaccination until the patient''s gastrointestinal system recovered. The parents refused a next childhood vaccination with MMR vaccine on 06Jun2013. On 31Jul2013, immunoallergologic results revealed no contraindication for continuing in routine vaccination. At the time of this report, the patient recovered from the events.

VAERS ID:464972 (history)  Vaccinated:2012-09-13
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-13
Location:Unknown  Entered:2012-09-13
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
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1476AA2IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1121AA0SCLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF924733IMRL
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0599AF0SCRL
Administered by: Military     Purchased by: Military
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Wrong Vaccine given. Zoster given instead of varicella vaccine. No reaction as of this time.

VAERS ID:465046 (history)  Vaccinated:2012-09-13
Age:53.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 0
Location:Georgia  Entered:2012-09-13
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: High cholesterol
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA689AA UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Red, itchy rash on hands, arms, feet, face, neck & chest.

VAERS ID:465076 (history)  Vaccinated:2012-09-13
Age:84.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 1
Location:Michigan  Entered:2012-09-14
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0025AE0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PT PRESENTED SWOLLEN INJECTION SITE, ABOUT 5 INCHES IN DIAMETER. IT WAS ALSO RED AND WARM.

VAERS ID:465083 (history)  Vaccinated:2012-09-13
Age:37.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-13, Days after onset: 0
Location:South Carolina  Entered:2012-09-14, 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: Needle stick prophylaxis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4490AA0IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Injury associated with device
SMQs:
Write-up: Needle stick during imm. process.

VAERS ID:465124 (history)  Vaccinated:2012-09-13
Age:47.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 1
Location:Arizona  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin 875 mg; Zolpidem; Wellbutrin XL
Current Illness: Recovering from bronchitis
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH719AE SYRUN
Administered by: Unknown     Purchased by: Private
Symptoms: Chest discomfort, Cough, Dyspnoea, Heart rate increased, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Rapid heart beat, fever 102, extreme body aches, heaviness in chest, short breaths with cough.

VAERS ID:465242 (history)  Vaccinated:2012-09-13
Age:68.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 1
Location:Oregon  Entered:2012-09-14
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: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12235P0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1505AA0IMLA
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: Redness from injection site to below elbow swelling on inside of elbow (sent patient to see doctor).

VAERS ID:465244 (history)  Vaccinated:2012-09-13
Age:37.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-14, Days after onset: 0
Location:California  Entered:2012-09-14
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: Sulfa; Aspirin; Latex; non latex gloves were used
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH747AA IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Left top quadrant of thoracic area has 4 round shaped red outbreaks smallest 1 cm & largest 4 cm diameter looking like ringworm marks.

VAERS ID:465256 (history)  Vaccinated:2012-09-13
Age:34.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 1
Location:Washington  Entered:2012-09-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: No history
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204101 UNRA
Administered by: Unknown     Purchased by: Private
Symptoms: Headache, Neuralgia, Pain, Pain in jaw, Toothache
SMQs:, Peripheral neuropathy (narrow), Osteonecrosis (broad)
Write-up: Severe nerve pain shooting last -3 seconds (legs) - Day 1 relieved with NEURONTIN (husband''s prescription med). Sharp shooting headache (random places in head) Day 2 last 1-3 seconds not as severe as legs. Toothache/jaw ache lasting hours Day 2.

VAERS ID:465146 (history)  Vaccinated:2012-09-13
Age:76.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-16, Days after onset: 3
Location:California  Entered:2012-09-16
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: Emphysema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 6:00 PM Fever, chills, weak, nausea.

VAERS ID:465175 (history)  Vaccinated:2012-09-13
Age:34.0  Onset:2012-09-16, Days after vaccination: 3
Gender:Female  Submitted:2012-09-16, Days after onset: 0
Location:Florida  Entered:2012-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pain, Rash pruritic, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Approximately 3 to 4 days after the flu shot was administered, the patient noticed a rash on her arm(raised round bumps). The rash started on her arms, then moved to her leg and also on her back. Rash was itchy and sore. The bumps swelled up.

VAERS ID:465179 (history)  Vaccinated:2012-09-13
Age:65.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-09-16, Days after onset: 1
Location:North Carolina  Entered:2012-09-16
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRRA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Gait disturbance, Hemiparesis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad)
Write-up: Weakness in right side - could not walk straight without holding on to something - dizzy.

VAERS ID:465323 (history)  Vaccinated:2012-09-13
Age:68.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-16, Days after onset: 2
Location:Louisiana  Entered:2012-09-16
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4494AA0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0217AE0IMLA
Administered by: Other     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: Patient has redness & swelling at site of injection & it was hot to the touch. Patient told to take BENADRYL for swelling.

VAERS ID:465273 (history)  Vaccinated:2012-09-13
Age:51.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-17, Days after onset: 4
Location:Mississippi  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203901 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMRA
Administered by: Public     Purchased by: Other
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: Red hot swollen rt arm, back of arm about a 4 inches above elbow.

VAERS ID:465275 (history)  Vaccinated:2012-09-13
Age:71.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-09-17, Days after onset: 2
Location:South Carolina  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H011335 SCLA
Administered by: Other     Purchased by: Unknown
Symptoms: Induration, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.

VAERS ID:465278 (history)  Vaccinated:2012-09-13
Age:75.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Mississippi  Entered:2012-09-17
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: Extremely allergic to eggs and dairy products
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203901 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0105151IMRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, 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)
Write-up: Painful, swelling from above the right elbow to 4 inches below the elbow in iner arm.

VAERS ID:465284 (history)  Vaccinated:2012-09-13
Age:47.0  Onset:2012-09-17, Days after vaccination: 4
Gender:Female  Submitted:2012-09-17, Days after onset: 0
Location:Oregon  Entered:2012-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NONE
Diagnostic Lab Data: Verbally stated she is on antibiotics and diagnosis was cellulitis.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4467AA0IDRA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Diagnosed with cellulitis. Right upper/outer arm was red.

VAERS ID:469325 (history)  Vaccinated:2012-09-13
Age:  Onset:2012-09-13, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-17, Days after onset: 4
Location:Wisconsin  Entered:2012-09-17
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: WAES1209USA006185
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0363AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age who on 13-SEP-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0363AE, Exp. Date: 16-MAR-2013) instead of intended VARIVAX (Merck). This would have been the patient''s second dose of VARIVAX (Merck). No adverse effects were reported. Additional information has been requested.

VAERS ID:465427 (history)  Vaccinated:2012-09-13
Age:36.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:New Jersey  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07049221A0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia, Tenderness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Symtoms: left upper arm swollen, arm & fingers numbness and tingling, pain to the touch; Lasting 3 days. Treatment: applied ice ibuprofen 3xday.

VAERS ID:465438 (history)  Vaccinated:2012-09-13
Age:73.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:Georgia  Entered:2012-09-18
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204801 IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0468AE IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Headache, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen, red, very warm to touch, painful when sun shines on it and headaches.

VAERS ID:465506 (history)  Vaccinated:2012-09-13
Age:60.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-14, Days after onset: 1
Location:North Carolina  Entered:2012-09-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Latex; TYLENOL/Codeine
Diagnostic Lab Data: Antihistamine (CLARITIN 10 mg QD) TYLENOL or Ibuprofen cold compresses & pt instructed to call on Monday 9-17-12 to give update
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA690BA SYRLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9-13-12. Pt received flu vaccine (lt) arm & afterwards received 5 cm across/4 cm down red, indurated area that''s tender to touch. Red area goes out & circulates area where injection given which is below deltoid area. 9-17-12. Pt notified to check on area same size: red, less swelling. Pt will call on Wed with update.

VAERS ID:465536 (history)  Vaccinated:2012-09-13
Age:68.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-14, Days after onset: 1
Location:Connecticut  Entered:2012-09-18, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR 0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dry throat, Eye discharge, Headache, Ocular hyperaemia, Throat irritation, Tinnitus, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow)
Write-up: Within 3 hours of vaccination developed dry cough, scratchy dry throat, blurred vision, bloodshot eyes with mucous formation; severe headache developed & stayed all night with ringing ears (tinnitus). Blurred vision & cough subsided in 4 hours from onset but headache continued until next day.

VAERS ID:465555 (history)  Vaccinated:2012-09-13
Age:4.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Male  Submitted:2012-09-18, Days after onset: 3
Location:Georgia  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Minor to cod fish & grass
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4050AA4IMLL
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.AH2108 IN 
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13303SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H0119061SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0096341SCLL
Administered by: Private     Purchased by: Private
Symptoms: Gait disturbance, Intensive care, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Hives head to toe & "drunken gait" admitted ICU x 36 hour observation.

VAERS ID:465576 (history)  Vaccinated:2012-09-13
Age:72.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:Louisiana  Entered:2012-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA or Dx
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4492BA0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Diarrhoea, Dyspnoea, Feeling cold, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)
Write-up: During the evening, patient began to experience labored breathing, nausea, diarrhea and she felt cold at times. No emergency services were rendered.

VAERS ID:465589 (history)  Vaccinated:2012-09-13
Age:0.1  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-19, Days after onset: 6
Location:Virginia  Entered:2012-09-19
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: Gas relief drops
Current Illness: Poss congestion and or constipation
Preexisting Conditions: R/O sepsis for hypothermia concerns high Thyroid and TSH
Diagnostic Lab Data: Left temporal lobe seizures
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4298AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF940010IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB292A0PO 
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Muscle twitching, Posture abnormal, Temporal lobe epilepsy, Tic
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Hypersensitivity (narrow)
Write-up: Immediately after immunizations were given per mom infant had a hyperextension of the neck and seemed to develop a "tic" or twitch. Later that day mother had to call 911 for a poss seizure.

VAERS ID:465623 (history)  Vaccinated:2012-09-13
Age:42.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-09-19, Days after onset: 4
Location:North Carolina  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: BIAXIN; Clarithromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP588070UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0098260UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC4147AA1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Erythema, Oedema peripheral, Pyrexia, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Reaction to Influenza immunization. Left arm is swollen and red. Started after Flu shot on 9/13/2012, fever, chills. Naproxen 500mg 1 tablet 2 times daily as needed. Ice 10 minutes 3-4 times a day.

VAERS ID:465635 (history)  Vaccinated:2012-09-13
Age:25.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-19, Days after onset: 6
Location:Minnesota  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Syphilis (late latest)
Preexisting Conditions: None
Diagnostic Lab Data: CXR = normal, D-Dimer, CBC, BMP, EKG normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B081AA IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Chest X-ray normal, Chest pain, Contusion, Dizziness, Dyspnoea, Electrocardiogram normal, Fall, Fibrin D dimer normal, Full blood count normal, Metabolic function test normal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Onset of dyspnea, leading to lightheadedness and fall resulting in low back contusions. Also chest pain with the dyspnea.

VAERS ID:465671 (history)  Vaccinated:2012-09-13
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-19
Location:Louisiana  Entered:2012-09-19
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: Allergic Rhinitis; Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH712AA IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site pruritus, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt. rec. flu vaccine 9-13-12 - with mother - pt. went to father''s house - mom didn''t see her for 2 days - pt. returned home c/o itching to site - mother noticed red rash.

VAERS ID:469816 (history)  Vaccinated:2012-09-13
Age:19.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-19, Days after onset: 6
Location:Unknown  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA007015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Underdose
SMQs:
Write-up: This spontaneous report as received from a certified medical assistant refers to a 19 years old patient. The patient was vaccinated with a pediatric 0.5 ml dose of VAQTA (Lot # not reported) on 13-SEP-2012. No adverse effects were reported. Additional information has been requested.

VAERS ID:469859 (history)  Vaccinated:2012-09-13
Age:84.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-19, Days after onset: 6
Location:Unknown  Entered:2012-09-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA006870
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1354Z SCRA
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report was received from an advance registered nurse practitioner refers to a 84 years old female patient who on 13-SEP-2012, was vaccinated subcutaneously on her upper right arm with a 0.65 ml dose of ZOSTAVAX (lot number 667609/1354Z) that was expired. The vaccine expired on 26-OCT-2011. No adverse effects were reported. Additional information is not expected.

VAERS ID:465849 (history)  Vaccinated:2012-09-13
Age:73.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-20, Days after onset: 6
Location:Iowa  Entered:2012-09-21, 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: Eczema
Preexisting Conditions: Hypertension; Metabolic syndrome; Heart murmur
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA730AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Pruritus, Rash erythematous, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Received flu shot afternoon of 9/13/12. Reporting having red rash on stomach, breasts, back and neck on 9/14/12. Pt. had dermatology appointment on 9/18/12 for eczema. Practitioner gave her medication for itching and told her she had reaction to flu shot. She called on 9/19/12 at 4PM to report.

VAERS ID:465884 (history)  Vaccinated:2012-09-13
Age:56.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-21, Days after onset: 8
Location:Louisiana  Entered:2012-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07049221A IMLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Hives around injection site.

VAERS ID:465921 (history)  Vaccinated:2012-09-13
Age:31.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-21, Days after onset: 7
Location:Michigan  Entered:2012-09-21
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: Transposition of vessel. I have an artificial heart valve and take coumadin daily.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Bone pain, Musculoskeletal stiffness, Respiratory tract irritation
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Arthritis (broad)
Write-up: Bone/joint pain/aches. Stiff neck. Lung irritation.

VAERS ID:465971 (history)  Vaccinated:2012-09-13
Age:77.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-14, Days after onset: 1
Location:Illinois  Entered:2012-09-21, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH720AB1IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1477AA1IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient complaining of swollen left arm where pneumonia vaccine administered. Site was also red & warm, patient stated he worked out with weights after being injected on 9-13-12. I spoke to patient again today at 5:50 pm & he stated arm does not hurt & swelling went down.

VAERS ID:465978 (history)  Vaccinated:2012-09-13
Age:64.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Virginia  Entered:2012-09-21, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H011049 SCUN
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling, warm to touch, itchy, knot where injection was given. Pt was told to take BENADRYL and use ice for swelling. Pt came in office to be rechecked on 9-17-12.

VAERS ID:466004 (history)  Vaccinated:2012-09-13
Age:11.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-20, Days after onset: 7
Location:Arizona  Entered:2012-09-21, 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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.A721040IN 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0450AE0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR04253AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUH4106AA0UNLA
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: (+) Erythema and swelling right and left deltoid.

VAERS ID:465937 (history)  Vaccinated:2012-09-13
Age:87.0  Onset:2012-09-17, Days after vaccination: 4
Gender:Male  Submitted:2012-09-22, Days after onset: 5
Location:Pennsylvania  Entered:2012-09-22
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: ON COUMADIN FOR BLOOD CLOTS
Diagnostic Lab Data: DR. DID NOT ORDER ANY DIAGNOSTIC TESTS FOR BLOOD CLOTS. SPOKE WITH PATIENT ON 09/22/2012 AND HE IS FEELING MUCH BETTER. HE IS TO FOLLOW UP AGAIN WITH HIS DR. ON 09/24/2012.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0467AE SCRA
Administered by: Other     Purchased by: Private
Symptoms: Gait disturbance, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: PATIENT COMPLAINS OF SEVERE PAIN IN THIGHS AND LOWER CALFS TO THE POINT WHERE HE IS HAVING DIFFICULTY WALKING. STARTED ON 09/17/2012 AND HAS SUBSIDED SOMEWHAT SINCE THIS REPORT BUT STILL CONTINUES TO HAVE PAIN. HAS A HISTORY OF BLOOD CLOTS SO RECOMMENDED SEEING HIS PHYSICIAN FOR EVALUATION AS SOON AS POSSIBLE.

VAERS ID:466016 (history)  Vaccinated:2012-09-13
Age:47.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-09-22, Days after onset: 7
Location:Rhode Island  Entered:2012-09-22
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: PAXIL, Trazodone (allergic per pt)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP59107 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: After 2 days 9/15/12 after school, had rash on knees, inner thigh & lower back (size of oatmeal grain) & small rash over all body. Pt went to the MD 9/17/12 MD confirm possible reaction on vaccine. Pt if followed up by MD right now, given prednisone.

VAERS ID:470657 (history)  Vaccinated:2012-09-13
Age:0.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-23, Days after onset: 10
Location:Unknown  Entered:2012-09-23
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: WAES1209USA006253
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1483Y0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of RECOMBIVAX HB (lot# 666186/1483Y, Expiration Date: 10-SEP-2012) intramuscular on 13-SEP-2012. The reporting nurse noted this was the first dose in the RECOMBIVAX HB vaccination series for this patient. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.

VAERS ID:466088 (history)  Vaccinated:2012-09-13
Age:69.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-14, Days after onset: 0
Location:Georgia  Entered:2012-09-24, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204701 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 11PM - pt said she threw up 3 times.

VAERS ID:466111 (history)  Vaccinated:2012-09-13
Age:51.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-09-18, Days after onset: 3
Location:Virginia  Entered:2012-09-24, 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: CEFTIN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12050012IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0422AE0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Two days after pt. received ZOSTAVAX vaccine, she came in and had large red circle at injection site and it was warm to touch.

VAERS ID:466123 (history)  Vaccinated:2012-09-13
Age:1.2  Onset:2012-09-19, Days after vaccination: 6
Gender:Male  Submitted:2012-09-24, Days after onset: 5
Location:Oklahoma  Entered:2012-09-24
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
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC4129AA3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS0100AE0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1760AA0SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172422IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0142AE0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Decreased activity, Decreased appetite, Diarrhoea, Faeces pale, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow)
Write-up: FIRST VOMITING, THEN PALE YELLOW LOOSE STOOLS, LOSS OF APPETITIE, FUSSINESS, LESS ACTIVE. MOTHER PLANS TO TAKE SON TO DOCTOR.

VAERS ID:466128 (history)  Vaccinated:2012-09-13
Age:50.0  Onset:2012-09-18, Days after vaccination: 5
Gender:Male  Submitted:2012-09-24, Days after onset: 6
Location:Michigan  Entered:2012-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Testosterone cream 15%
Current Illness: None aware of
Preexisting Conditions: None aware of
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR 1IDLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Dysuria, Fatigue, Injection site pruritus, Pain, Pyrexia, Viral test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad)
Write-up: Fatigue, body ache and fever begin to set in. High discomfort in passing urine. Fever peaked at 11:30 pm at 102.1 and began to subside at at 1:30 AM. Extreme joint pain continued through most of the night, but painful urination subsided around 1:30 AM. Generally achey for the day of 09/19/2012. Temperature returns to normal by 3:00 PM on the 19th. Primary Physician runs viral test but test result is negative. Injection site is still mildly itchy on this date 12/24/2012.

VAERS ID:466135 (history)  Vaccinated:2012-09-13
Age:1.1  Onset:2012-09-18, Days after vaccination: 5
Gender:Male  Submitted:2012-09-24, Days after onset: 6
Location:Illinois  Entered:2012-09-24
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0069511SCLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Bump/ hive at varicella injection site size of a penny with redness around it.

VAERS ID:466174 (history)  Vaccinated:2012-09-13
Age:49.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:Wisconsin  Entered:2012-09-24, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC4181AA IDRA
Administered by: Private     Purchased by: Private
Symptoms: Hot flush, Injection site swelling, Lymphadenopathy, Pain, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Lymphadenopathy, swelling at site, pain, tenderness, hot flashes.

VAERS ID:466181 (history)  Vaccinated:2012-09-13
Age:49.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-17, Days after onset: 4
Location:Idaho  Entered:2012-09-24, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic to ANECTINE
Diagnostic Lab Data: Was given 2 shots: oxycodone for pain, Ketorolac for inflammation
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDP58807 SYRLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0109AE0SYRRA
Administered by: Other     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Dyspnoea, Erythema, Extensive swelling of vaccinated limb, Feeling cold, Oedema peripheral, Pain in extremity, Skin warm, Tremor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Thursday, September 13, 2012, at 8:30 a.m., at the direction of my employer, I reported to my scheduled appointment with a Pharmacy where I received a Health Screening. Since I have had both the flu and pneumonia in the past, I spoke with the Pharmacist and requested both the flu and pneumonia shots. I received the flu shot in my left arm and the pneumonia shot in my right. I was told to "work" my arms and that would lessen the pain and prevent them from "stiffening up". I spent the rest of the day doing housework. My left arm was feeling fine, but my right arm was intensely painful. As time went by and my right arm, shoulder, chest and back were now red, hot and swollen, I realized I was not getting any better, but, I just thought I was not "working" it enough. By evening, my right arm was four times its size. I was freezing cold, shaking uncontrollably, putting on warmer clothing and turning up the heat in my home. I had no idea that I was not only getting worse but, by now, I was having trouble breathing and was in serious trouble. At approximately 8 p.m., I telephoned my Mother, who sent my daughter to transport me to the Emergency Department where I was seen immediately by the physician on duty. Upon my arrival in the emergency room, I was given two shots, (one for pain and one for inflammation) one in each hip and was told my pneumonia shot had been administered improperly. The shot needed to be given into the muscle of my arm. Instead, when person gave me the shot, she placed it into the fatty tissue of my right arm. Upon leaving the Emergency Department, I was given two prescriptions: Ketorolac Tablets, an anti-inflammatory drug and Oxycodone, for pain. And, as of this date, have not been able to return to work.

VAERS ID:466526 (history)  Vaccinated:2012-09-13
Age:91.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Florida  Entered:2012-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203801 IMRA
Administered by: Public     Purchased by: Other
Symptoms: Injection site haematoma, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Firm knot, swollen, lightly bruised area approx 2.5cm to right upper arm.

VAERS ID:466534 (history)  Vaccinated:2012-09-13
Age:32.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Missouri  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:
Current Illness:
Preexisting Conditions: Darvocet
Diagnostic Lab Data:
CDC Split Type: MO201210
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4384AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Client states headace started 30-45 minutes after vaccine administration. States it progressively got worse over the evening leading to vomiting. No fever, redness, swelling at site reported. Still has headache almost 24 hrs post vaccination accompanied with nausea.

VAERS ID:469628 (history)  Vaccinated:2012-09-13
Age:22.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Unknown  Entered:2012-09-26
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: WAES1209USA009006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1745AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Information has been received from a health care professional regarding a female who was vaccinated with GARDASIL (lot number 672547/1745AA, expiration 13-SEP-2012, dose 1 on 07-JUN-2012; dose 2 on 09-AUG-2012 and dose 3 on 13-SEP-2012 (inappropriate schedule of drug administration). The health care professional reported no adverse effect has been observed or reported. No additional information currently available. Additional information is not expected.

VAERS ID:470841 (history)  Vaccinated:2012-09-13
Age:  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-26, Days after onset: 13
Location:Unknown  Entered:2012-09-26
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: WAES1209USA006201
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0562AE SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure, Eye irrigation, Eye irritation
SMQs:, Corneal disorders (broad)
Write-up: Information was received from a pharmacist who on 13Sep2012 while administering an injection of the ZOSTAVAX (vial 19400) (lot # 0562AE, expiration date 20Mar2013) to a patient, had gotten a few drops of the vaccine in her eyes. She immediately flushed her eyes with water. The pharmacist reported that she had a little bit of irritation but no other symptoms. No additional information was provided. No additional information is expected.

VAERS ID:466646 (history)  Vaccinated:2012-09-13
Age:50.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-27, Days after onset: 13
Location:Connecticut  Entered:2012-09-27
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: ANXIETY/PANIC DISORDER OSTEOPOROSIS
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH729AB IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient complains of gradually worsening pain in arm in the exact area where vaccine was administered. There was never swelling or redness observed.

VAERS ID:466739 (history)  Vaccinated:2012-09-13
Age:1.4  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-09-27, Days after onset: 14
Location:New York  Entered:2012-09-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNRA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash generalised, Urticaria, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: My son had a few hives on his chest. Within a week a rash started to appear in the area where the vaccination was given. The rash gradually became worse and red bumps continue to appear on his body.

VAERS ID:467865 (history)  Vaccinated:2012-09-13
Age:80.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Male  Submitted:2012-09-28, Days after onset: 13
Location:Unknown  Entered:2012-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Varicella, had chickenpox at age 10
Diagnostic Lab Data:
CDC Split Type: WAES1209USA008652
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Macular degeneration, Pain, Rash
SMQs:, Anaphylactic reaction (broad), Retinal disorders (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from an approximately 80 year old male oral surgeon with no known drug allergies and a history of chickenpox (age 10) and having been vaccinated with ZOSTAVAX (Merck) (2007). On 13-SEP-2012, the physician reported he received an unspecified flu vaccine. The physician stated he received prostaglandin for his macular degeneration (no date reported). On 15-SEP-2012, the physician reported he had a painful rash which was mid stomach and went up into his back. He was treated with an unspecified antiviral medication, prednisone and topical medication (unspecified). The physician reported he was recovering. Additional information has been requested.

VAERS ID:471122 (history)  Vaccinated:2012-09-13
Age:58.0  Onset:0000-00-00
Gender:Male  Submitted:2012-09-28
Location:Unknown  Entered:2012-09-28
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: WAES1209USA006429
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H011553 IMLA
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: This spontaneous report as received from a physician refers to a patient of unknown demographics. On an unspecified date, the patient was inadvertently vaccinated with 0.5 milliliter (ml) VARIVAX (merck) who was indicated to receive ZOSTAVAX. Lot number and dosing details were not specified. No concomitant medications were reported. The physician stated that this was due to human error and not product confusion. No adverse effect was reported. Additional information has been requested.

VAERS ID:467024 (history)  Vaccinated:2012-09-13
Age:67.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-30, Days after onset: 16
Location:California  Entered:2012-09-30
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: HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1206701 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1947AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Inflammation, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Inflamed and swollen left arm 4 days. Take BENADRYL 50mg q 4 H x 2 days.

VAERS ID:467407 (history)  Vaccinated:2012-09-13
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2012-10-01
Location:Unknown  Entered:2012-10-01
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: WAES1209USA011073
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (Lot#, dose and route not reported) on 13-SEP-2012 and was put on generic cefdinir (manufacturer unknown) on 21-SEP-2012 and experienced a rash (date not reported). The patient was switched to doxycycline (manufacturer unknown) on 24-SEP-2012. On 25-SEP-2012 the patient had a prescription for a steroid pack because the patient had hives all over. It was not reported if the patient sought for medical attention. The patient''s status was unknown. Additional information has been requested.

VAERS ID:467240 (history)  Vaccinated:2012-09-13
Age:2.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Male  Submitted:2012-10-01, Days after onset: 17
Location:North Carolina  Entered:2012-10-02, 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: Upper respiratory illness
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH718AA4IMLL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Left thigh became red 9-13-12. Parents had taken pt. to urgent care at beach after noticing redness. Pt started on antibiotics for cellulitis. Rechecked at our office 9-17-12. Redness better. Recheck today 10-1-12. Left thigh with skin color change, not hot, not tender.

VAERS ID:467452 (history)  Vaccinated:2012-09-13
Age:73.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-10-03, Days after onset: 20
Location:Nevada  Entered:2012-10-03
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: Allergies, IBS
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204201 IM 
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1247AA IM 
Administered by: Other     Purchased by: Private
Symptoms: Feeling abnormal, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Started feeling poorly the night of vaccination. Next day area of sight turned red, edema, warm, painful. Went to ER, gave her Keflex.

VAERS ID:467464 (history)  Vaccinated:2012-09-13
Age:43.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-03, Days after onset: 20
Location:Alabama  Entered:2012-10-03
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
Administered by: Public     Purchased by: Other
Symptoms: Pain
SMQs:
Write-up: Pain after injection lasting days. Will need cortisone injection.

VAERS ID:472469 (history)  Vaccinated:2012-09-13
Age:39.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-03, Days after onset: 20
Location:Unknown  Entered:2012-10-03
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: WAES1210USA000520
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1490Z UNUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:
Write-up: This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX23 during the time period of 14-SEP-2012 thought 18-SEP-2012. The PNEUMOVAX23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested. Follow up information was provided during a phone call on 26-SEP-2012 stating the health care professional could not supply patient names, date of birth, dates of vaccination or dates of events. Follow up was received on 26-SEP-2012 reported that the 39 year old female patient received an expired dose of PNEUMOVAX23 (lot # 669382/1490Z) on 13-SEP-2012. The source case 1209USA008402 was split into three cases. This case is also linked to case 1210USA000521.

VAERS ID:467515 (history)  Vaccinated:2012-09-13
Age:44.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-04
Location:Unknown  Entered:2012-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthenia; Multiple sclerosis
Preexisting Conditions: Dysphagia, unspecified; Trigeminal neuralgia
Diagnostic Lab Data:
CDC Split Type: WAES1209USA010216
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Multiple sclerosis relapse
SMQs:, Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This spontaneous report was received from a health care worker regarding a 44 year old female patient. The patient''s medical history included trigeminal neuralgia, dysphagia unspecified. The patient''s current condition included multiple sclerosis and weakness. The patient had no known drug allergies. The patient was vaccinated with a dose of ZOSTAVAX approximately on 13-SEP-2012 (reported as one week ago) (lot #, dose and route not reported). Concomitant medications included AMITIZA, acetaminophen, VICODIN prn, TRILEPTAL, EFFEXOR and alprazolam. On an unknown date, the patient experienced exacerbation of multiple sclerosis symptoms (medically significant). The patient had a preexisting condition of Multiple Sclerosis and was vaccinated with ZOSTAVAX and it exacerbated her symptoms of multiple sclerosis, caused a flare up. The patient sought medical attention. The outcome of the event was reported as not recovered at the time of this report. Additional information has been requested.

VAERS ID:467522 (history)  Vaccinated:2012-09-13
Age:75.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-18, Days after onset: 5
Location:North Carolina  Entered:2012-10-04, Days after submission: 16
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: Morphine allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA0SYRRA
Administered by: Other     Purchased by: Private
Symptoms: Body temperature, Immediate post-injection reaction, Musculoskeletal pain, Nausea, Pain in extremity, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Immediately after shot (vaccine) was administered, shoulder hurt into fingers. Had temperature overnight. Nauseated & vomited once. Better next day & now fine. Did not seek medical attention.

VAERS ID:467621 (history)  Vaccinated:2012-09-13
Age:80.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-10-04, Days after onset: 19
Location:North Carolina  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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204101 IMUN
Administered by: Other     Purchased by: Public
Symptoms: Decreased appetite, Influenza like illness, Malaise, Oral herpes
SMQs:, Oropharyngeal infections (narrow)
Write-up: Patient states flu like symptoms starting 2 days after receipt of flu vaccine, symptoms include general malaise, loss of appetite, and fever blisters in mouth. These symptoms resolved over about two weeks and patient is now better. Patient reported on 10/3/12.

VAERS ID:467683 (history)  Vaccinated:2012-09-13
Age:74.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-10-04, Days after onset: 21
Location:Tennessee  Entered:2012-10-04
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204801 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1200AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Chills, Contusion, Drug administered at inappropriate site, Injection site erythema, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Thursday night-chills, temps of 100, left upper arm swollen and red 3" above elbow to shoulder. Redness all around. Quarter size bruise to shoulder. Patient said that nurse gave both flu and pneumonia in both arm and about 1" from top of shoulder.

VAERS ID:467684 (history)  Vaccinated:2012-09-13
Age:79.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-04, Days after onset: 21
Location:Tennessee  Entered:2012-10-04
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
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204801 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1200AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Fatigue, Flushing, Injection site pain, Insomnia, Oedema peripheral, Pain, Rash macular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient felt flushed, tired and unable to sleep. Felt soreness the day of vaccine and noticed redness that night. Left arm has 3" red swollen area, splotchy, slightly raised, reddened areas up to shoulder. Soreness at the site but feels it has improved. Patient received both flu and pneumonia in same arm.

VAERS ID:467757 (history)  Vaccinated:2012-09-13
Age:85.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-09-21, Days after onset: 8
Location:Unknown  Entered:2012-10-04, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa; Penicillin; Streptomycin
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Diarrhoea, Fatigue, Malaise, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Approximately 3 hours after receiving flu injection I felt very tired & by 6:30 P.M. felt ill & went to bed with fever, chills, some diarrhea & nausea. Felt somewhat better when I got up at 6:30 A.M. but, went back to bed & slept from 10:30 AM - 11:30 P.M. Took me another day to start feeling better. Next year I plan to stay with the regular flu shot!

VAERS ID:468216 (history)  Vaccinated:2012-09-13
Age:38.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-05, Days after onset: 22
Location:Massachusetts  Entered:2012-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Blepharospasm, Headache, Malaise, Muscle twitching, Nausea, VIIth nerve paralysis
SMQs:, Acute pancreatitis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: 9/18/12 Spoke with employee reports received flu vaccine on 9/13/12 at 12AM from peer. Arrived home at 730AM-8AM noted left side of lips looked lower than right side & was twitching off & on - didn''t feel well T 99.3, headache, nausea later Lt eye started to twitch took BENADRYL & felt better by 9/14/12 evening. Questions from flu vaccine.

VAERS ID:468371 (history)  Vaccinated:2012-09-13
Age:1.1  Onset:2012-09-26, Days after vaccination: 13
Gender:Female  Submitted:2012-10-04, Days after onset: 8
Location:Massachusetts  Entered:2012-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None (except diaper rash)
Diagnostic Lab Data: CBC, NL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0628AE0SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0287AE0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H0065380SCLL
Administered by: Private     Purchased by: Public
Symptoms: Full blood count normal, Pyrexia, Rash papular, Varicella post vaccine
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Day 13 after VARIVAX given; she developed 5 days of fever 103-102 with vesicles-papules (more than 50 lesions) arms - legs - buttocks - face "is chickenpox".

VAERS ID:468030 (history)  Vaccinated:2012-09-13
Age:35.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-06, Days after onset: 23
Location:Texas  Entered:2012-10-06
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: Rhinitis, Dermagraphism, Gerd/VCD, ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEURUT4471BA0IDLA
Administered by: Unknown     Purchased by: Other
Symptoms: Contusion, Erythema, Hypersensitivity, Skin discolouration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Bright red, swelling, hot to touch; migrated down arm. Worsened over the next 48 hrs. Called my Dr. They said it was a "dermal shot" not injected in muscle. Symptoms worsened. Went to ER.-Dr. said it was a moderate allergic reaction. Prescribed Prednisone. It took approx 10 days to go down. 3 weeks later-still have a discolored "bruise" & can see the injection spot. Follow-up with Allergist; she said it was likely the preservatives and the fact it was not injected in the muscle. She said I must get a traditional flu shot injected in the muscle next yr and preservative-free. I had never had a flu shot reaction before.

VAERS ID:468263 (history)  Vaccinated:2012-09-13
Age:68.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-09-17, Days after onset: 3
Location:Pennsylvania  Entered:2012-10-07, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0110470SCUN
Administered by: Other     Purchased by: Private
Symptoms: Hypersensitivity, Induration, Skin warm
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Developed a large allergic reaction that was hot and hard. BENADRYL cream/pill; cleared up in several days reexamined in 4 days and was clearing.

VAERS ID:468640 (history)  Vaccinated:2012-09-13
Age:49.0  Onset:2012-09-16, Days after vaccination: 3
Gender:Male  Submitted:2012-10-09, Days after onset: 23
Location:Texas  Entered:2012-10-09
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
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11078 IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: After 3 days after receiving a meningitis vaccine, patient is experiencing itchiness all over the body. Patient also has redness on groin area. Patient used vasoline to relieve symptoms. Patient is still experiencing these symptoms.

VAERS ID:468641 (history)  Vaccinated:2012-09-13
Age:40.0  Onset:2012-09-16, Days after vaccination: 3
Gender:Female  Submitted:2012-10-09, Days after onset: 23
Location:Texas  Entered:2012-10-09
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
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA11078 IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pruritus generalised, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: After 3 days after receiving a meningitis vaccine, patient is experiencing itchiness all over the body. Patient also has redness and rash on groin area. Patient used Vaseline to relieve symptoms. Patient is still experiencing these symptoms.

VAERS ID:468976 (history)  Vaccinated:2012-09-13
Age:60.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Male  Submitted:2012-10-11, Days after onset: 27
Location:South Carolina  Entered:2012-10-11
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: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1203801 IMRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema, Mass, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Egg size lump, hot to the touch, painful, red and swollen.

VAERS ID:469353 (history)  Vaccinated:2012-09-13
Age:76.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-10-12, Days after onset: 28
Location:Virginia  Entered:2012-10-12
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: Diabetes II, Atrial fib.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR    
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Diarrhoea, Eyelid margin crusting, Nausea, Palpitations, Retching
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: Nausea, retching, diarrhea, racing heart, crusted eyes, weakness.

VAERS ID:469411 (history)  Vaccinated:2012-09-13
Age:62.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Male  Submitted:2012-10-13, Days after onset: 29
Location:Maryland  Entered:2012-10-13
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: Allergies to several pain meds and vaccinations
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1204521 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H010515 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: The morning of 9/14, patient arm was swollen, had a red mark at injection site, was sore, warm to touch and itchy. Patient using Benadryl and Ivarest (poison ivy cream) for itching. Aleve for pain.

VAERS ID:469682 (history)  Vaccinated:2012-09-13
Age:60.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-15, Days after onset: 32
Location:Washington  Entered:2012-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a
Preexisting Conditions: Erythromycin allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1124AA0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Pruritus, Secretion discharge, 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: Received Zostavax in left arm on 9/13/12. Developed itching same day, gradual increasing redness and swelling "like a big hive $g 15cm." Had clear weeping from affected area at the time. Relief with cool packs, reduced over time. Has had continued generalized itching since, worse in the evenings. Initially tried Loratadine daily for 8-9 days, and hydrocortisone bid without notable relief. This weekend noted has continued redness at the site of the injection. On exam: 2.5 x 3cm pink blanching oval on left tricep without edema, erythema or induration. Not tender to palpation. Take Hydroxyzine 12.5-25mg at bedtime daily for one week. May apply hydrocortisone 1% OTC to affected area three times daily. If symptoms persist, follow up with PCP or dermatology within 1-2 weeks.

VAERS ID:470047 (history)  Vaccinated:2012-09-13
Age:68.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:West Virginia  Entered:2012-10-16
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
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA735AA SYRUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0491AF SYRUN
Administered by: Private     Purchased by: Unknown
Symptoms: Back pain, Erythema, Inflammation, Local swelling, Musculoskeletal chest pain, Musculoskeletal pain, Nausea, Oropharyngeal pain, Pain, Pain in extremity, Swelling, Swelling face
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Within an hour of taking the injections I was in severe pain. My (R) shoulder, arm, and hand, as well as my (R) ribs and back, neck and face were swollen and very red and inflamed. Friday, I called my doctor''s office, he was not in. I finally had to go to E.R. Saturday. Was given KEFLEX 500 mg. As of today 10-12-12 I still have a sore throat and nausea. I can explain a lot better when you call me.

VAERS ID:470109 (history)  Vaccinated:2012-09-13
Age:71.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-04, Days after onset: 21
Location:New Jersey  Entered:2012-10-16, 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: Diabetic; COUMADIN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Fatigue, Nasopharyngitis
SMQs:, Dementia (broad)
Write-up: Got vaccine at 2:30 pm by 3:30 I was extremely tired - I had to go to bed. 3 days later I got a bad cold. Had to have Dr give me azithromycin - Z-PAK.

VAERS ID:471331 (history)  Vaccinated:2012-09-13
Age:  Onset:2012-09-13, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-16, Days after onset: 33
Location:Texas  Entered:2012-10-16
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: WAES1209USA007070
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report was received from a certified medical assistant via a medical representative concerning a patient of unknown age and gender. On an unknown date, approximately in September 2008 (about 4 years ago), the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number unspecified as the patient had no record of first dose). No concomitant medications were reported. On 13-SEP-2012, the patient was given the second dose of GARDASIL (dose, route and lot number unspecified). No adverse event was reported. Additional information has been requested.

VAERS ID:473549 (history)  Vaccinated:2012-09-13
Age:  Onset:0000-00-00
Gender:Female  Submitted:2012-10-16
Location:Texas  Entered:2012-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1209USA010078
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE SYRAR
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a licensed vocational nurse refers to a female patient of unknown age. On 13-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot # reported as 0071AE, expiry 03-APR-2013). No concomitant medications were reported. On an unknown date, the patient''s arm became swollen and redness around the injection site was about the size of an orange. Patient also experienced tenderness. Patient sought medical attention by visiting the physician''s office. Patient received treatment with prednisone. The outcome of the events were unknown. The relatedness for the events was unknown for ZOSTAVAX. Nurse requested for lot # check and requested result of the lot # check sent to the office. This is one of the several reports received from the same reporter. Additional information has been requested.

VAERS ID:473564 (history)  Vaccinated:2012-09-13
Age:62.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Female  Submitted:2012-10-17, Days after onset: 34
Location:Unknown  Entered:2012-10-17
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: WAES1209USA007069
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0071AE SCUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure
SMQs:
Write-up: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. On 13-SEP-2012, the pharmacist was injecting a dose of 0.65 milliliter ZOSTAVAX (lot number unspecified) subcutaneously to a patient in the pharmacy. While injecting, the ZOSTAVAX dripped down her arm. No concomitant medications were reported. Additional information has been requested.

VAERS ID:471031 (history)  Vaccinated:2012-09-13
Age:64.0  Onset:2012-09-19, Days after vaccination: 6
Gender:Female  Submitted:2012-10-15, Days after onset: 26
Location:Wisconsin  Entered:2012-10-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B087CB1IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0110491SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: No Rx.

VAERS ID:471035 (history)  Vaccinated:2012-09-13
Age:13.0  Onset:2012-10-03, Days after vaccination: 20
Gender:Male  Submitted:2012-10-11, Days after onset: 8
Location:Arizona  Entered:2012-10-22, Days after submission: 11
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: Acne
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1696AA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Left Bell''s Palsy.

VAERS ID:471337 (history)  Vaccinated:2012-09-13
Age:65.0  Onset:2012-09-14, Days after vaccination: 1
Gender:Female  Submitted:2012-10-23, Days after onset: 39
Location:Ohio  Entered:2012-10-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to Erythromycin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.H0062170UNLA
Administered by: Other     Purchased by: Private
Symptoms: Blister, Palpitations
SMQs:, Severe cutaneous adverse reactions (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Customer had blisters on arm & heart palpitations. She reported symptoms on 9/14/12 (got ZOSTAVAX shot on 9/13/12). Called a pharmacist who told her to take BENADRYL. Symptoms resolved completely.

VAERS ID:472982 (history)  Vaccinated:2012-09-13
Age:77.0  Onset:2012-09-15, Days after vaccination: 2
Gender:Female  Submitted:2012-11-01, Days after onset: 47
Location:Pennsylvania  Entered:2012-11-05, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient has a history of penicillin allergy, reported as PCN, diabetes, hypertension reported as HTN, high cholesterol and a history of shingles.
Diagnostic Lab Data: None
CDC Split Type: 201210096
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH319AD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Facial pain, Herpes zoster, Neck pain, Pain of skin, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Glaucoma (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Initial case received from a consumer on 25 October 2012. A female patient age 77 received a dose of FLUZONE, Lot # reported as UH319AD, (to be confirmed) intramuscularly in the left side, site to be confirmed on 13 September 2012. The patient had a history of penicillin allergy, reported as PCN, diabetes, hypertension reported as HTN, high cholesterol and a history of shingles. Concomitant medications and lab results were not reported. On 15 September 2012, the patient experienced a hurting itch on face and in hair with small bumps and it spread to the side of her neck. The patient was seen by an allergist on 18 September 2012 and was diagnosed with shingles. The patient was prescribed prednisone and an unspecified shingles medicine. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.

VAERS ID:477227 (history)  Vaccinated:2012-09-13
Age:79.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-05
Location:Kansas  Entered:2012-11-05
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: WAES1210USA003804
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This spontaneous report was received from a registered pharmacist refers to an approximately 70-year-old female patient with no drug reactions or allergies. On 13-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0242AE, expiration date 01-APR-2013) dose and route not reported. No concomitant medications were reported. Pharmacist reported that the patient experienced a painful red line going down from injection site down to her elbow after receiving ZOSTAVAX. It was red, little bit swollen and painful, and the red line appeared approximately on an unknown date in September 2012, within a couple of days of receiving ZOSTAVAX. Patient applied some cold packs to the area and pain was relieved. Patient came in on 03-OCT_2012 (reported as yesterday) and spoke to pharmacist. Patient still had about 2 inches of line going down from the injection site. The event pain resolved on an unknown date. The event red line did not resolve at the time of this report. The outcome of other reported events were unknown. The patient sought medical attention by speaking to the pharmacist. The is one of several reports from the same reporter. Additional information has been requested.

VAERS ID:474496 (history)  Vaccinated:2012-09-13
Age:83.0  Onset:2012-09-20, Days after vaccination: 7
Gender:Male  Submitted:2012-10-26, Days after onset: 36
Location:Colorado  Entered:2012-11-07, Days after submission: 12
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Abdominal discomfort, Headache, Rhinorrhoea
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nose running, headache, tummy upset.

VAERS ID:474599 (history)  Vaccinated:2012-09-13
Age:43.0  Onset:2012-09-13, Days after vaccination: 0
Gender:Male  Submitted:2012-10-11, Days after onset: 28
Location:Texas  Entered:2012-11-13, Days after submission: 33
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxybutynin; Sildenafil
Current Illness:
Preexisting Conditions: Hypertension; Spinal cord injury; Neurogenic bladder
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1222034SYRRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling, burning sensation at injection site.

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