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Case Details (Sorted by Vaccination Date)

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VAERS ID:327218 (history)  Vaccinated:2008-10-01
Age:33.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 0
Location:Minnesota  Entered:2008-10-06, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2997A1IMRL
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: ADACEL given 10-1-08. Pt. was previously vaccinated on 3-8-07

VAERS ID:327220 (history)  Vaccinated:2008-10-01
Age:4.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Female  Submitted:2008-10-06, Days after onset: 3
Location:Georgia  Entered:2008-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: B/P meds, MOTRIN
Current Illness:
Preexisting Conditions: Hypertension, allergies to trees, dogs, cats
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0811X SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Headache, Inappropriate schedule of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Received on MMR II and Tdap on 10/1/08. Pt is a nurse and saw a PA at the hospital where she works. The pt. c/o aching all over, headache, soreness in the arms and joints. The MMR II shot was raised with redness more than a 50c piece, hurt to touch, hot to touch and red. Is having some itching at the site now.

VAERS ID:327229 (history)  Vaccinated:2008-10-01
Age:42.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-06, Days after onset: 5
Location:Georgia  Entered:2008-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Premarin; Alebrot
Current Illness: Abrasion right upper arm
Preexisting Conditions: Left uriel pain; TMJ disorder; Menopause
Diagnostic Lab Data: Normal CBC, but with 110 bands (WBC 4.4), NL CPK, NL CORP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LAB  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Asthenia, Blood creatine phosphokinase normal, Chills, Fatigue, Flushing, Full blood count, Injection site erythema, Injection site swelling, Malaise, Pain, Somnolence, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Severe body aches, generalized weakness, fatigue, chills, fluid flushing, looking sick, sleepiness, poor appetite (could not eat) drank for (24 h), + redness, swelling at the injection site. Treated with Tylenol, Motrin, fluids after 48-72 hours.

VAERS ID:327331 (history)  Vaccinated:2008-10-01
Age:1.1  Onset:2008-10-02, Days after vaccination: 1
Gender:Male  Submitted:2008-10-03, Days after onset: 1
Location:New York  Entered:2008-10-07, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2008-10-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Polyvitamins with fluoride
Current Illness: No
Preexisting Conditions: Ex 31 wk preemie, patent foramen ovale
Diagnostic Lab Data: Intracranial bleed on head CT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0428U0SCUN
Administered by: Private     Purchased by: Public
Symptoms: Brain oedema, Computerised tomogram abnormal, Contusion, Death, Haemorrhage intracranial, Respiratory arrest, Resuscitation, Scan brain, Subdural haematoma, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic cerebrovascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Pt found unresponsive & not breathing after nap. Resuscitated by EMS & in ER, never regained consciousness & later died in PICU at hospital. Intracranial bleed on head CT. 10/9/2008 Forensic Autopsy Summary Sheet received, COD pending further studies. Infant found unresponsive and transported to ER & dx with subdural hematoma. Transferred to higher level of care. Despite resuscitation efforts, infant pronounced dead. Autopsy findings of 2 small abraded contusions to L side of head, subdural hematoma overlying the L temporal lobe. Marked brain edema and pulmonary edema. Otherwise unremarkable

VAERS ID:327346 (history)  Vaccinated:2008-10-01
Age:21.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-07, Days after onset: 5
Location:Unknown  Entered:2008-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Meningitis, Aug 08
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1552SCRA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Induration, Mass, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: - Red bump size of palm. Itches from wrist to base of neck on right side. 9x6cm area of wheal and induration.

VAERS ID:327354 (history)  Vaccinated:2008-10-01
Age:15.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Male  Submitted:2008-10-07, Days after onset: 4
Location:Texas  Entered:2008-10-07
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.500560P IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA IM 
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2732AA IM 
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1017X SC 
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 1.reddness,swelling 2inches in diameter,tenderness at injection site.

VAERS ID:327393 (history)  Vaccinated:2008-10-01
Age:57.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:North Carolina  Entered:2008-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Osteo-Bi-Flex tabs; Benadryl
Current Illness: None
Preexisting Conditions: Dyspnea; abnormal EKG; compression arthiz
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2747AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0224X0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain, Chills, Dyspnoea, Erythema, Headache, Malaise, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Fever, chills, malaise, ha, chest pain, dyspnea, edema and erythema of left deltoid area.

VAERS ID:327395 (history)  Vaccinated:2008-10-01
Age:73.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-07, Days after onset: 6
Location:Oregon  Entered:2008-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins; Propranolol; ASA 81mg; Vitorin; Loritidine
Current Illness: No
Preexisting Conditions: Egg allergy as child; attempted flu vaccine the last 5 yrs without any reaction - until this event.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2759AA IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0224X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received vaccine at 3:00pm on 10/1/08; started feeling chills and fatigue during evening, noting large, reddened area (size of orange) at injection site at hospital. Continued to feel very tired next day with some improvement of symptoms on 3rd day. Now on day 6, swelling/redness gone, but still feels tired.

VAERS ID:327397 (history)  Vaccinated:2008-10-01
Age:19.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2008-10-06, Days after onset: 5
Location:Washington  Entered:2008-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER    
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.SON549P IN 
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
Administered by: Military     Purchased by: Military
Symptoms: Rash, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient with smallpox vaccine on 1 Oct 08. That evening w/ flesh closed papules on forehead which progressed to back of ears by the morning. No pustules. Rash did not improve or worsen. Seen in clinic on 6 Oct 08. No other symptoms. Likely not vaccine related due to timing and recent change of laundry detergent. No history of atopic dz.

VAERS ID:327420 (history)  Vaccinated:2008-10-01
Age:8.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Male  Submitted:2008-10-06, Days after onset: 3
Location:D.C.  Entered:2008-10-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB246AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1012X1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Injection site pustule
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 8 y.o. male presented to clinic 2 days after varicella administration with erythematous, edematous left tricep area with small pock mark at injection site. Patient afebrile with no other symptoms. Patient & mother were counseled r.e. expected adverse reactions to varicella vaccine; also, cold compresses & ibuprofen PRN were recommended.

VAERS ID:327543 (history)  Vaccinated:2008-10-01
Age:1.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-08, Days after onset: 6
Location:Indiana  Entered:2008-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Not known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB268AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0890X0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1016X0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Balance disorder, Body temperature fluctuation, Decreased appetite, Fall, Rash papular, Unresponsive to stimuli, Urine output decreased
SMQs:, Acute renal failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad)
Write-up: Mother states child has had decreased response to verbal stimuli, poor balance with increased falling, decreased urine output and decreased appetite since 1-2 days after vaccination. Temperature varies from 99-101. On 10--7-2008 red raised rash noted on outer thighs, back and ankles. Recommended that child be seen by physician. Mother states she will scheduled appointment.

VAERS ID:327662 (history)  Vaccinated:2008-10-01
Age:15.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-06, Days after onset: 4
Location:Michigan  Entered:2008-10-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB247AA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR626439A0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B029AA7IMLA
Administered by: Public     Purchased by: Public
Symptoms: Burning sensation
SMQs:, Peripheral neuropathy (broad)
Write-up: 24 hours after receiving vaccines 10/1/08 complaints of burning sensation from RT deltoid muscle RT arm down to RD hand fingers; 48 hours later complained of burning in RT chest area to parent - parent will me know if she takes her in for medical evaluation (RN). 10/6/08 10:15 pt back to parent - child doing fine - burning numbness resolved - did not seek medical assessment.

VAERS ID:327667 (history)  Vaccinated:2008-10-01
Age:66.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-05, Days after onset: 4
Location:Illinois  Entered:2008-10-09, 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: Unknown
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89882 IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0551X IMLA
Administered by: Other     Purchased by: Public
Symptoms: Hypoaesthesia, Injection site swelling, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient''s left arm began to hurt at about 12:30PM and by 4PM the same day, her arm was swelling about 4 inches around the site of injection. Her arm was also starting to feel numb. The pharmacy advised her to put ice on the swelling and take benadryl. By Thursday morning, her arm was still swollen so she called her doctor and she was advised to take Benadryl and Zyrtec. By Friday, patient was feeling much better & the swelling had gone down.

VAERS ID:327670 (history)  Vaccinated:2008-10-01
Age:54.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-03, Days after onset: 1
Location:Pennsylvania  Entered:2008-10-09, 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: LANTUS; HUMALOG; CRESTOR; DARVOCET
Current Illness: DM; hypothyroidism; hx breast CA; hyperlipidemia
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2763AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0047X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Lymphadenopathy, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Severe redness, warmth, itching swelling (R) upper arm shoulder and lymphadenopathy (R) supraclavicular and (R) axillary within 24-48 hours of vaccination. No SOB.

VAERS ID:327677 (history)  Vaccinated:2008-10-01
Age:3.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-13, Days after onset: 11
Location:Wisconsin  Entered:2008-10-09, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2397AA IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBV555AA IMRA
HIBV: HIB (ACTHIB)SANOFI PASTEURUF399AB IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0906X SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0996X SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient here for TB test reading. Noted that patient had red area on dorsal aspect of left arm. Area about 50x50 cm. Mother reports was larger and "itchy"yesterday. Area warm to touch, not raised. Mother reports area much improved today.

VAERS ID:327692 (history)  Vaccinated:2008-10-01
Age:32.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2008-10-08, Days after onset: 7
Location:Massachusetts  Entered:2008-10-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient has a history of asthma. The patient denied having any other vaccinations within four weeks of receiving the YF-VAX vaccine.
Diagnostic Lab Data: "None per reporter"
CDC Split Type: 200803025
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF307A0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Ear discomfort, Erythema, Nausea, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Initial report received on 01 October 2008 from a nurse. A 32-year-old male patient, who has past medical history of asthma, had received a first dose of YF VAX (Lot # UF307AB) on 01 October 2008. The route and site of administration were not reported. Approximately 20 minutes post-vaccination, the patient experienced throat swelling, nausea, burning sensation of ears, redness of the face, chest, back and hands. The patient required medical evaluation and was treated with SOLU-MEDROL, BENADRYL and "ZOPHRAN." Treatment medication routes were not provided. Per the reporter, no diagnostic testing''s were performed. At an unspecified amount of time later, on 01 October 2008, the patient''s symptoms resolved.

VAERS ID:327857 (history)  Vaccinated:2008-10-01
Age:18.0  Onset:2008-10-05, Days after vaccination: 4
Gender:Female  Submitted:2008-10-09, Days after onset: 4
Location:Texas  Entered:2008-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Condition aggravated, Cough, Rhinorrhoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Wheezing, runny nose, coughing, asthma. Treated with Albuterol through nebulizer.

VAERS ID:327858 (history)  Vaccinated:2008-10-01
Age:9.0  Onset:2008-10-05, Days after vaccination: 4
Gender:Male  Submitted:2008-10-09, Days after onset: 4
Location:Texas  Entered:2008-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Nausea and vomiting, diarrhea

VAERS ID:327924 (history)  Vaccinated:2008-10-01
Age:76.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-06
Location:Pennsylvania  Entered:2008-10-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Type II DM; hypercholesterolemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2952BA0IMLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2758AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Adult patient inadvertently received incorrect vaccine on 10/1/08. Patient received pediatric Dtap. Patient stated he had no adverse effects from the vaccine.

VAERS ID:327987 (history)  Vaccinated:2008-10-01
Age:64.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-03, Days after onset: 2
Location:Massachusetts  Entered:2008-10-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: Allergic to IVP Contrast Dyes
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFUA191AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1132U IMLA
Administered by: Public     Purchased by: Public
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left and right arms, warm, swollen. Increased pain started to hurt at 8 PM 10/01/08. Took Tylenol with no relief. 10/03/08 no improvement. 10/6/08 Improved.

VAERS ID:327991 (history)  Vaccinated:2008-10-01
Age:87.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-03, Days after onset: 2
Location:Massachusetts  Entered:2008-10-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFUA191AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1132U IMRA
Administered by: Public     Purchased by: Public
Symptoms: Balance disorder, Injection site erythema, Injection site rash, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: FLU AND PNEUMO in (R) arm, Wed NOC, redness, rash at injection site, weakness of legs, unsteady - Improved by Mon 10/6/08

VAERS ID:327996 (history)  Vaccinated:2008-10-01
Age:6.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Female  Submitted:2008-10-06, Days after onset: 3
Location:Utah  Entered:2008-10-10, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2763AA4IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Erythema, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: red spot - sore to touch - hot to touch - antibiotic & benedryl treatment

VAERS ID:328006 (history)  Vaccinated:2008-10-01
Age:0.2  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2008-10-01, Days after onset: 0
Location:Missouri  Entered:2008-10-10, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZANTAC
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B192DA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF399AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC683061IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0467X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Cried for 4 hours. Left leg redness and swelling.

VAERS ID:328012 (history)  Vaccinated:2008-10-01
Age:71.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-10, Days after onset: 9
Location:Florida  Entered:2008-10-10
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: Metoprolol succinate; Sertraline hydrochloride; Omega-3 marine triglyceri; Ascorbic acid; Vitamin E; Ubidecarenone
Current Illness: Anxiety; Premature ventricular contraction
Preexisting Conditions: The subject has received flu vaccine in the past and has no history of any reactions following flu vaccine or any previous vaccinations.
Diagnostic Lab Data: October 2008: Physicians performed a CAT scan and an MRI which were both negative. An EEG was also performed, but the results were pending.
CDC Split Type: A0751380A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Altered state of consciousness, Computerised tomogram normal, Electroencephalogram, Gaze palsy, Increased bronchial secretion, Nuclear magnetic resonance imaging normal, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a consumer and described the occurrence of not responsive in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included anxiety and premature ventricular contraction. Concurrent medications included TOPROL XL, ZOLOFT, Omega 3 fish oil, Vitamin C, Vitamin E and Co q 10. On 1 October 2008 at 10:00 the subject received a dose of FLULAVAL in the left arm. On the night of 1 October 2008, less than one day after vaccination with FLULAVAL, the subjects husband reported that she was in bed making funny gurgling noises. At that time, the subject was also unresponsive and her eyes were rolled back. The subject awoke in an ambulance and was unsure how she got there. She was taken to the emergency room and was admitted to the hospital. Physicians performed a CAT scan and an MRI which were both negative. An EEG was also performed, but the results were pending. The subject was discharged the following day. The physicians told the consumer that it appeared as if she might have experienced a seizure, but they weren''t sure what the cause might have been. One physician apparently questioned whether the event was a result of the subject receiving the FLULAVAL vaccine. A sleep apnea study was planned at the time of reporting. The outcome of the events was not reported.

VAERS ID:328050 (history)  Vaccinated:2008-10-01
Age:58.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Female  Submitted:2008-10-06, Days after onset: 3
Location:Alabama  Entered:2008-10-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Arthritis, Cholesterol
Current Illness: None
Preexisting Conditions: Arthritis, High Cholesterol
Diagnostic Lab Data:
CDC Split Type: AL0826
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA349BB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Headache, Oedema peripheral, Paraesthesia, Rash, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient called on 10-03-08 at 8:55 A.M. Complained of left arm being red, hot tender to touch with swelling. Stated she halos had a rash and was having tingling to same arm which was "getting worse". Patient also complained of having a headache. Patient stated this was noticed some time on the A.M. of 10-03-08.Patient was prescribed Prednisone by her private physician.

VAERS ID:328079 (history)  Vaccinated:2008-10-01
Age:14.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2008-10-10, Days after onset: 9
Location:Missouri  Entered:2008-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Eye swelling, Paraesthesia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Right eye swelling, throat tightness, and legs tingling.

VAERS ID:328259 (history)  Vaccinated:2008-10-01
Age:52.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 0
Location:Arizona  Entered:2008-10-13, 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: Allegra; Synthroid
Current Illness: None
Preexisting Conditions: Takes ALLEGRA has been off allergy shots for 5 years. Also allergic to Epinephrine.
Diagnostic Lab Data: Also allergic to Epinephrine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA755AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Adverse drug reaction, Chest discomfort, Erythema, Immediate post-injection reaction, Injection site induration, Injection site mass, Injection site swelling, Local reaction, Palpitations, Rash macular, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Pt. received flu shot and site immediately began to swell. A lump formed at the site and increased. Pt. stated heart was racing, no shortness of breath. Neck became blotchy and red. 911 was called. Epi was given 1 dose at the site. Paramedics responded and took pt. to hospital. 2/2/09 MR received for ER visit 10/1/08 with DX: Medication reaction. Pt developed local reaction, chest tightness and redness to neck and chest after receipt of Flu shot. Epipen given on scene after which pt became tachycardic at 160 BPM. Chest tighness resolving on arrival to ER. In sinus tach on arrival. Ice placed on hard area at injection site. Tx with Benadryl and D/C

VAERS ID:328264 (history)  Vaccinated:2008-10-01
Age:11.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-06, Days after onset: 5
Location:Utah  Entered:2008-10-13, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2763AA4IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU261PAR0IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEURUF452AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Pain, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Redness, itching, pain, spot sore/hot to touch -(antibiotic course, BENADRYL) headache - redness at injection site as large as a baseball)

VAERS ID:328266 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-02, Days after onset: 1
Location:Colorado  Entered:2008-10-13, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2744AA3IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Dyspnoea, Eye swelling, Feeling hot, Headache, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Dizziness, headache, felt like something caught in throat, felt feverish, swollen eyes/shortness of breath.

VAERS ID:328276 (history)  Vaccinated:2008-10-01
Age:24.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-10-08, Days after onset: 6
Location:Kentucky  Entered:2008-10-13, 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: Birth control pill, ADEROL
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2739AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2996AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Nodule, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: On 10/2 it was warm and red. Continues to be warm, red + very painful. On 10/7 2 knots formed.

VAERS ID:328277 (history)  Vaccinated:2008-10-01
Age:71.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Male  Submitted:2008-10-03, Days after onset: 1
Location:Massachusetts  Entered:2008-10-13, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFUA191AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1132U IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
SMQs:, Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received injections @ 5pm increased pain and red swollen, cramping at sites by 12am next day.

VAERS ID:328278 (history)  Vaccinated:2008-10-01
Age:69.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-02, Days after onset: 1
Location:Massachusetts  Entered:2008-10-13, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Influenza (no brand name)~UN~0~In Patient
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFUA191AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Oedema peripheral, Similar reaction on previous exposure to drug, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Upon leaving clinic pt could not raise or move her R arm. Red, warm swollen, stiff TYLENOL taken with zero relief pt states plus reaction from flu years ago.

VAERS ID:328280 (history)  Vaccinated:2008-10-01
Age:46.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 0
Location:Indiana  Entered:2008-10-13, 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: None
Current Illness: None
Preexisting Conditions: Drug Allergy to CODIENE and SULFA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA350CA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Back pain, Chest discomfort, Chest pain, Erythema, Headache, Malaise, Pain
SMQs:, Anaphylactic reaction (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: 10/01/2008 - at 1:30pm symptoms started: chest tightness, pain from left clavicle to mid-sternum and in back. Face was red. Took 3- ADVIL, and worked entire shift to 7pm. Took 3 more ADVIL at 9pm. Thurs. 10/2 had headache across back of head, no fever, mild aching, didn''t "feel good" and actually drove out in front of another car. Fri 10/3- no symptoms

VAERS ID:328286 (history)  Vaccinated:2008-10-01
Age:65.0  Onset:2008-10-04, Days after vaccination: 3
Gender:Female  Submitted:2008-10-06, Days after onset: 2
Location:Pennsylvania  Entered:2008-10-13, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient does have allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Soreness, redness, itching onset 2 days after injection. Patient seen by doctor and Allegra was given.

VAERS ID:328343 (history)  Vaccinated:2008-10-01
Age:4.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-13, Days after onset: 12
Location:Florida  Entered:2008-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pulmicort
Current Illness: no
Preexisting Conditions: amoxicillin
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2952AA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA09963SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0481X1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1004X1SCRA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vaccine injection was given on 10/01/08. area of left deltoid-red, warm, tender site approximately 5x4.5cm noted at approximately 3:00pm 10/02/08. Recommended ice to area 5-10 minutes four times a day. Return to clinic if area worsens.

VAERS ID:328346 (history)  Vaccinated:2008-10-01
Age:37.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-13, Days after onset: 12
Location:Illinois  Entered:2008-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 10/14/08-records received-PMH:Has had an abscess before. HIV, HCV and schizophrenia. Alcohol abuse. Smoker. Cocaine and heroin use.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess limb, Chills, Cough, Decreased appetite, Incisional drainage, Influenza like illness, Injection site erythema, Injection site swelling, Nausea, Pyrexia, Rhinorrhoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right upper arm abscess. Vaccine was administerd about 2 weeks prior to admission to hospital on 10/12/2008. Patient experienced fever, chills, runny nose, cough, decreased appetite, nausea, vomiting. 10/14/08-records received for DOS 10/12-10/13/08-DC DX: Right arm abscess. Presented to ED with right upper arm abscess after receiving flu shot in same area 2 weeks ago. One week ago noticed redness and swelling at site progressed to erythematous abscess. C/O flu-like symptoms for past week, low grade fever, chills, runny nose, clear sputum, flushing, decreased appetite. Abscess I & D.

VAERS ID:330781 (history)  Vaccinated:2008-10-01
Age:0.2  Onset:2008-10-07, Days after vaccination: 6
Gender:Male  Submitted:2008-10-30, Days after onset: 23
Location:Washington  Entered:2008-10-30
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: diflucan, omperazole, tylenol
Current Illness: uri sx week before, severe reflux, severe protien allergy
Preexisting Conditions: severe protien allergy. grade 4 reflux ,delayed gastric emptying. PMH: 36 wk premie. Maternal drug use with (+) tox screen. Born with pneumothorax and pneumonia and tx with abx. Candida esophagitis
Diagnostic Lab Data: mri and us found intracranial swelling and sub dural bleeding. Labs and Diagnostics: US abd WNL. Cranial US (+) for increased extra-axial fluid over the convexities, ? subdural. Upper GI with SB follow through WNL. Skeletal Survey (+) fo
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B143AA IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF364AA IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC27701 IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Conjunctival haemorrhage, Crepitations, Crying, Fall, Fontanelle bulging, Head circumference abnormal, Headache, Injury, Irritability, Lethargy, Moaning, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Retinal haemorrhage, Retinopathy haemorrhagic, Rib fracture, Skeletal survey abnormal, Somnolence, Subdural haematoma, Ultrasound abdomen normal, Ultrasound scan abnormal, Vomiting, Vomiting projectile, Weight gain poor, X-ray with contrast upper gastrointestinal tract
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic cerebrovascular conditions (narrow), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Retinal disorders (narrow), Depression (excl suicide and self injury) (broad), Conjunctival disorders (narrow), Osteoporosis/osteopenia (broad), Neonatal disorders (narrow)
Write-up: initally sleepy. within 6 days began fever. high temp to 101.5 with tylenol .progessing irritablity and lethargy. by 10/15 unable to hold head up and acting as if his head hurt. crying. Taken to Urgent Care worked up for meningitis unable to get a spinal tap after 5 attempt. continues to get worse. projectile vomiting by 20 days after injection. admitted to hospital. 11/10/2008 MR received for several outpatient, ER and inpatient records. Infant with previous hx of GERD. Seen in ER 10/14/08 after falling from parent''s arms and hit bathtub. PE WNL except clicking near 12th rib. DX: Back pain and d/c home. Returned 10/21/08 with fever and vomiting. Pt moaning, lethargic with projectile vomiting on triage. Recent poor weight gain. GI and Immunology consults showed concern for non-accidental trauma-large head and full fontanelle. Ophth consult (+) for subconjunctival hemorrhages, pre-retinal and intraretinal hemorrhage with old hemorrhages visible. Impression: Hemorrhagic retinopathy in the context of subdural hematoma. Final DX: Non-accidental trauma. GERD. Emesis resolved.

VAERS ID:330825 (history)  Vaccinated:2008-10-01
Age:37.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Male  Submitted:2008-10-29, Days after onset: 27
Location:Unknown  Entered:2008-10-31, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline; Sodium Chloride; Acetaminophen
Current Illness:
Preexisting Conditions: Secondary cardiomyopathy; Hypertension; Low back pain
Diagnostic Lab Data: Chest x-ray - thickening area from infection; lungs + rhonchi bil
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERAFLLA181AA IMUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER0224X IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Dehydration, Feeling hot, Headache, Nasal congestion, Nasopharyngitis, Nausea, Pain, Productive cough, Pyrexia, Respiratory tract congestion, Sinus congestion, Tenderness, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Patient received influenza and pneumovax vaccinations on 10/1/08 in the clinic. Patient reported that on 10/2/08, he had new onset of head congestion, nasal congestion, headache with facial tenderness, feeling hot, generalized body aches, chest congestion with frequent cough of yellow secretions. Patient was seen to rule out pneumonia and dehydration due to fever and nausea and vomiting. Patient was treated with antibiotics, promethazine, acetaminophen and recovered. Symptoms: Fever, Wheeze, dehydration, nausea, vomiting.

VAERS ID:331163 (history)  Vaccinated:2008-10-01
Age:6.0  Onset:2008-10-11, Days after vaccination: 10
Gender:Male  Submitted:2008-10-23, Days after onset: 12
Location:California  Entered:2008-11-03, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: PMH: folliculitis, influenza A&B 2/15/08.
Diagnostic Lab Data: Blood Culture, 10/18/08, Positive Salmonella; Stool Culture, 10/18/08, Positive Salmonella LABS: WBC 10.4(N), H/H 11.8/33.9, monos 14.4%(H). ESR 68(H). CRP 5.6(H). Stool culture done by PCP (+) for salmonella, blood c/s (+) gm neg rods
CDC Split Type: MEDI0007328
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500540P OTUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Bacteraemia, Bacteria blood identified, Bacteria stool identified, Blood chloride decreased, Blood sodium decreased, C-reactive protein increased, Diarrhoea, Diarrhoea haemorrhagic, Gastroenteritis salmonella, Gram stain positive, Haematocrit normal, Haemoglobin normal, Headache, Monocyte percentage increased, Myalgia, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow)
Write-up: A serious spontaneous report of positive salmonella culture in blood and stool, bloody diarrhea and fever was received from a physician concerning a six-year-old male, subsequent to FLUMIST. The patient''s medical history and concomitant medications were not reported. The patient received one dose of FLUMIST on 01-Oct-2008. The patient received a total of one dose before onset of the events 10 days later. On 11-Oct-2008 the physician reported her patient had symptoms of fever and bloody diarrhea. On 18-Oct-2008 the patient was hospitalized and noted to have positive blood and stool cultures for Salmonella. The patient was placed on intravenous antibiotics. it was reported that the patient is improving but remains hospitalized. The causality of the events to FLUMIST was not reported. 11/7/08 Reviewed hospital medical records of 10/18-10/23/2008. FINAL DX: salmonella gastroenteritis; bacteremia, resolved; diarrhea, resolved. Records reveal patient experienced HA, myalgia, fever & diarrhea x 7 days; developed bloody stools 10/13 & seen by PCP. Peds ID consult done.

VAERS ID:332427 (history)  Vaccinated:2008-10-01
Age:52.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Pennsylvania  Entered:2008-11-14
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: Vitals on 10/1/08 WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSGSKAFLLA174AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Hypoaesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Patient received influenza vaccine on 10/1/08. 15 minutes after the injection, patient reported her lip went numb and her jaw went numb. Vitals were checked and were WNL. Symptoms resolved.

VAERS ID:332514 (history)  Vaccinated:2008-10-01
Age:69.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-02, Days after onset: 1
Location:Colorado  Entered:2008-11-17, Days after submission: 46
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: Rheumatoid arthritis, Hx breast cancer.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2768AA UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0813X1UNLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Similar reaction on previous exposure to drug, Vaccine positive rechallenge
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt describes hard swelling et pain to (L) deltoid after receiving PNEUMOVAX. Reports a similar response to first dose. Pt has Hx of double mastectomy with lymphectomy in 1989.

VAERS ID:332528 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-11-13, Days after onset: 42
Location:Pennsylvania  Entered:2008-11-17, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 200803427
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise
SMQs:
Write-up: Initial report received on 24 October 2008 from a consumer. A female patient (demographics not provided) had received a dose of Influenza vaccine on an unspecified date. The trade name, manufacturer name, route and site of administration of the flu vaccine was not provided. The patient reported that she thinks she might be developing Bell''s Palsy after receiving the flu shot. It was not reported whether the patient had any concurrent illnesses, or past medical history at the time of the Influenza vaccination. The patient was subsequently evaluated by a physician; however the outcome of the physician evaluation was not provided. It was not reported whether any relevant diagnostic testings had been completed. The recovery status of the patient was not reported. Follow-up information received on 03 November 2008 from a physician. Per the reporter, the female patient had received vaccination with FLUZONE SV 2008-2009 (date of vaccination, lot number, route and site of administration were not provided) approximately one week prior to this report, which would make the vaccine administration date some time in October 2008. The patient was anxious about receiving the vaccination since she had never received a flu shot before. Approximately a day or two following the vaccination, the patient stated she did not feel well and believed she received Bell''s Palsy from the vaccine. The facility where the patient was vaccinated is awaiting a complete diagnosis from the patient''s family physician. The nurse at the facility where the patient had received the vaccination will stay in touch with the manufacturer and will ensure all proper VAERS forms and paperwork is completed. Documents held by sender: None.

VAERS ID:332544 (history)  Vaccinated:2008-10-01
Age:47.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-11-13, Days after onset: 42
Location:New Jersey  Entered:2008-11-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: IVF''s given on day 2 for dehydration.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2795DA UNLA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Dehydration, Dizziness, Gait disturbance, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Immediately after vaccinated, felt weak, dizzy, and nausea''s. Symptoms persisted throughout the day and worsened next day to generalized weakness requiring assistance to walk.

VAERS ID:333789 (history)  Vaccinated:2008-10-01
Age:0.3  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Unknown  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA00236
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Infantile spitting up, Regurgitation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 8 week old white female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2ml second dose of ROTATEQ. There was no concomitant medication. The physician reported that the patient immediately spit up what appeared to be entire dose of ROTATEQ as well as the milk just given. The physician stated they could see the ROTATEQ in the milk. Unspecified medical attention was given in the physician''s office. No laboratory diagnosis were done. A product quality complaint was not involved. Follow up information was received on 21-OCT-2008. The patient was reported to be 16 weeks old. It was reported the patient experienced emesis on "08-OCT-2008". The patient vomited up ROTATEQ and formula immediately after dose. The patient recovered the same day. Additional information has been requested. 12/03/08 This is in follow-up to report(s) previously submitted on 11/14/2008. In formation has been received from a physician concerning an 8 week old female with no allergies or pertinent medical history who on 01-OCT-2008 was vaccinated po with a 2 ml second dose of ROTATEQ. There was no concomitant medication. The physician reported that the patient immediately spit up what appeared to be the entire dose of ROTATEQ as well as the milk just given. The physician stated they could see the ROTATEQ in the milk. Unspecified medical attention was given in the physician''s office. No laboratory diagnostics were done. A product quality complaint was not involved. Follow-up information was received on 21-OCT-2008. The patient was reported to be 16 weeks old. It was reported the patient experienced emesis on "08-OCT-2008". The patient vomited up ROTATEQ and formula immediately after dose. The patient recovered the same day. Additional information has been requested.

VAERS ID:333970 (history)  Vaccinated:2008-10-01
Age:19.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:New Hampshire  Entered:2008-11-17, 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: Bog vaccine; Meningococcal vaccine
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA00594
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X3UNUN
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician and a consumer concerning her 19 year old daughter with no previous medical history and allergies reported, who on 01-OCT-2008 a nurse practitioner inadvertently gave another dose of GARDASIL. The patient experienced injection site pain after received the fourth dose of GARDASIL . The patient had completed a series during the summer. Concomitant therapy included meningitis vaccine (manufacturer unspecified) and TB shot (manufacturer unspecified). The patient did not seek medical attention. The patient did not have illness at time of vaccination. Additional information has been requested.

VAERS ID:333979 (history)  Vaccinated:2008-10-01
Age:20.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Unknown  Entered:2008-11-17, 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: Unknown
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA00803
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pain in extremity
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a nurse for the pregnancy registry for GARDASIL vaccine concerning a female who on 12-May-2008 was vaccinated IM with the first dose of GARDASIL (lot no. unknown). On 01-Oct-2008 she was vaccinated IM with the second dose of GARDASIL (lot no. 359182/1757U). The patient found out on 05-Oct-2008 that she was pregnant. the patient has also experienced soreness of her arm after the second dose of the vaccine. Additional information has been requested.

VAERS ID:334024 (history)  Vaccinated:2008-10-01
Age:15.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Missouri  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA01837
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aura, Feeling abnormal, Headache, Influenza like illness, Injection site erythema, Injection site pain, Oropharyngeal pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a nurse concerning a 15 year old female who on 01-OCT-2008 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently, the patient had an injection site reaction "later in the day" following vaccination with GARDASIL that lasted for 24 to 48 hrs. The injection site reaction was described as painful, red injection site. Subsequently, the patient developed a severe headache with aura and felt "dazed" with syncope for about 20 minutes on 08-OCT-2008. The patient had a sore throat and flu like symptoms earlier in the day on 08-OCT-2008, outcome of visit was unspecified.

VAERS ID:334791 (history)  Vaccinated:2008-10-01
Age:12.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Michigan  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA03955
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 12 year old female with no pertinent medical history, no known allergies or drug reactions, who on 01-OCT-2008 was vaccinated with the first dose of GARDASIL IM. Concomitant therapy included VARIVAX (route and site not reported). On 01-OCT-2008 the patient experienced syncope. The patient was exiting the office and fainted hitting her head. On 20-OCT-2008, the patient recovered. A computed axial tomography was performed (results not reported). Additional information has been requested.

VAERS ID:334970 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Indiana  Entered:2008-11-17, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA05253
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a Registered Nurse concerning a female who in October 2008 was vaccinated with a first dose of GARDASIL, single dose vial, in physician''s office. The patient experienced abdominal pain within 24 hours of receiving her first dose of GARDASIL. Unspecified medical attention was sought. At the time of reporting, the patient''s outcome was unspecified. Additional information has been requested.

VAERS ID:332760 (history)  Vaccinated:2008-10-01
Age:52.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 44
Location:Unknown  Entered:2008-11-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Vitals checked 10/1/08 and were WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSGSKAFLULA171AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Hypoaesthesia oral, No reaction on previous exposure to drug
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Patient received influenza vaccine on 10/1/08. 15 minutes after the injection, patient reported her lip went numb and her jaw went numb. Vitals were checked and were WNL. Symptoms resolved. No other vaccines in past month and never had a reaction to the influenza vaccine.

VAERS ID:332926 (history)  Vaccinated:2008-10-01
Age:60.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-11-20, Days after onset: 50
Location:Illinois  Entered:2008-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA185AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Decreased appetite, Dizziness, Malaise, Tenderness, Vomiting, Wrong drug administered
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This nurse realized she gave (2) flu shots to (1) person vs giving a flu and pneumonia as intended. She indicated there were (2) people in line and that she drew up (2) syringes with flu vaccine. While patient was filling out consent form the client decided to get a pneumonia shot so nurse drew up a pneumonia shot and laid it by glove to know that is what it was. She then gave flu shot and when she was supposed to grab the pneumonia she accidently grabbed the other syringe with the flu vaccine and administered. Nurse stated that she did not notice this error until serving the next client. Nurse noticed that the syringe was still sitting by the glove and she knew that is where she sat the pneumonia vaccine filled syringe. Flu coordinator notified patient of possible side effects. Flu coordinator verified possible side effects with flu manufacturer. Flu coordinator notified patient physician...no orders given Right arm sore. Patient complained of chills, sick to stomach, lack of hunger, vomited, dizziness.

VAERS ID:335019 (history)  Vaccinated:2008-10-01
Age:0.5  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-17, Days after onset: 16
Location:Illinois  Entered:2008-11-20, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007286
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment of accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.

VAERS ID:335020 (history)  Vaccinated:2008-10-01
Age:0.8  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-17, Days after onset: 16
Location:Illinois  Entered:2008-11-20, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007287
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a nine-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.

VAERS ID:335021 (history)  Vaccinated:2008-10-01
Age:0.5  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-17, Days after onset: 16
Location:Illinois  Entered:2008-11-20, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007288
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2000 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.

VAERS ID:335022 (history)  Vaccinated:2008-10-01
Age:1.3  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-17, Days after onset: 16
Location:Illinois  Entered:2008-11-20, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007289
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: A non serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a fifteen-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.

VAERS ID:332944 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-03, Days after vaccination: 2
Gender:Female  Submitted:2008-11-21, Days after onset: 49
Location:California  Entered:2008-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: cough
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
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Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICSUNK0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: injection site rash

VAERS ID:333388 (history)  Vaccinated:2008-10-01
Age:74.0  Onset:2008-10-03, Days after vaccination: 2
Gender:Unknown  Submitted:2008-11-26, Days after onset: 54
Location:Alabama  Entered:2008-11-26
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: COPD
Preexisting Conditions: PMH: COPD, HTN, diabetes, chronic oxygen therapy, smoker.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Atrioventricular block, Cardiac pacemaker insertion, Dizziness, Hyperhidrosis, Intensive care, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a complete heard block. Vaccination took place on 10/1/2008. According to the physician, relationship to treatment is ''None''. We would be happy to forward the Study''s SAE Report Form upon request. 12/31/08 Reviewed study SAE report. Hospitalized 10/8-10/11/2008. FINAL DX: complete heart block Records reveal patient experienced dizziness, diaphoresis, weakness & pain in left arm. Intensive care. Pacemaker inserted.

VAERS ID:333658 (history)  Vaccinated:2008-10-01
Age:37.0  Onset:2008-10-16, Days after vaccination: 15
Gender:Female  Submitted:2008-12-02, Days after onset: 47
Location:Illinois  Entered:2008-12-02
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 22 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none 1/7/09-records received-Allergy to Penicillin and tetracycline. PMH;upper respiratory infection.
Diagnostic Lab Data: There was many tests that include many blood tests.Two spinal taps.Many Ct scans and Mri''s.Development of Miller Fisher syndrome and Ocular Myasthenia Gravis 1/7/09-records received- MRI brain unremarkable. CSF protein 39. CSF cultures negative. 2/17/09-records received-Electrodiagnostic study without any evidence of deficit at Neuromuscular junction. PE demonstrates bilateral horizontal gaze paralysis with preservation of superior and inferior ductions. No upper or lower extremity weaknesses. CSF culture no growth, protein 29 and Glucose 64.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLL185AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Areflexia, Blood pressure decreased, Blood product transfusion, Blood test, CSF culture negative, CSF protein normal, Computerised tomogram, Diplopia, Dizziness, Eyelid ptosis, Facial palsy, IIIrd nerve paralysis, Leukocytosis, Lumbar puncture, Miller Fisher syndrome, Nausea, Nuclear magnetic resonance imaging brain normal, Ocular myasthenia, Ophthalmoplegia, Plasmapheresis, Vertigo, Vision blurred, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Extreme nausea, dizziness along with bouncing vision and double vision.There also was a loss of reflexes in many extremities.There also was a drop in blood pressure.Had eye drooping. paralysis of eyes.Treatments included plasmaphresis and Ivig treatments.There was also many medicines after discharge from hospital.This was an horrible time in our families lifes. 1/7/09-records received for DOS 10/16-10/22/08-DX DC: Blurred vision probably related to Miller Fisher variant of Guillain-Barre syndrome. Vertigo. Mild leukocytosis without clear source. Admitted with C/O increased blurred vision. Left eye ptosis, nausea. Dizziness began 12 days prior.Plasmapheresis. Transferred to tertiary care center. 2/17/09-records received for DOS 10/22-11/4/08-transferred to rehab facility with IVIG. 02/01/2010 I still experience dizziness and double vision at times. My left side of my face is also still affected at times.

VAERS ID:334082 (history)  Vaccinated:2008-10-01
Age:4.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-07, Days after onset: 67
Location:California  Entered:2008-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient
Other Medications: Ethedent 0.5 mg Tab Chewable is patient''s only prescription medication taken on a regular basis.
Current Illness: None
Preexisting Conditions: None.
Diagnostic Lab Data: 10/1/2008 urine sample at Dr''s office. 10/1/2008 Flu shot at Dr''s office. 10/1/2008, temperature taken, urine sample taken, and an ultrasound at hospital. 10/2/2008, urine sample at Dr''s office. 10/3/2008 urine sample and blood work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2786BA0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Back pain, Blood pressure increased, Blood test, Blood urine present, Dehydration, Pyrexia, Ultrasound scan, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)
Write-up: The flu shot was administered at approximately 9:50 am on 10/1/08, this was 10 minutes AFTER providing the doctor with a urine sample (9:40 am) for patient''s annual preventative examination. No blood was present in this urine sample. At approximately 1:30 pm on 10/1/2008, there was blood visible in patient''s urine. I called Dr''s office to have them make sure they test for a bladder infection because I saw blood in her urine. At 5:15 pm on 10/1/2008 after her nap, there was still blood in patient''s urine and at this time she was complaining of pain in her abdominal area and lower back area. We then went to hospital at 5:30 pm on 10/1/2008 where the hospital took her temperature (low grade fever around 99), did a urine sample, and an ultrasound. Patient vomited around 10:00 pm while at the emergency room and on the way out of the emergency room. The emergency room physician did not know what was wrong so he released patient when he felt comfortable that her blood pressure had come down. He instructed us to take her to Dr. the next morning. The last time I "visibly" saw blood in patient''s urine was at approximately 8:00 pm on 10/1/2008. The morning of 10/2/2008 I took patient back to Dr. where they did another urine sample. Since the night before, I had not seen any more blood in her urine; however, the urine sample still showed signs of blood. Dr. was not able to identify why there was blood in patient''s urine. Dr. scheduled us to go to another hospital to see Dr. in the Pediatric Nephrology department. Our appointment was on 10/3/2008. Patient gave a urine sample which, when tested, still had blood present (although the blood was NOT visible to the eye.) Dr. examined patient and asked us questions, trying to rule out kidney diseases and a bladder infection (FYI, patient NEVER experienced pain while urinating). Dr. did not know what the cause was so he ordered blood work that was done at that visit on 10/3/2008. Dr''s office called me and said they wanted another blood panel done because when they

VAERS ID:334581 (history)  Vaccinated:2008-10-01
Age:41.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2008-12-09, Days after onset: 68
Location:Massachusetts  Entered:2008-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fentanyl
Current Illness: none
Preexisting Conditions: migraines
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.004206IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Day after Hep B #1 injection developed pain, redness and swelling in R deltoid. Swelling is now barely visible but pain and pale redness remain. Has very limited internal rotation/extension of R arm. i.e. cannot hook bra. Patient contacted me on 12/4/08 with above complaints. Instructed to contact personal MD in the AM, apply heat. 12/9/08 pc to patient. Saw MD on 12/5/08. Referal to neurologist. Was to see neurologist 12/8/08 but was to ill to see MD. Will reschedule appointment 12/9/08 Dr. notified of adverse event.

VAERS ID:334665 (history)  Vaccinated:2008-10-01
Age:0.2  Onset:2008-10-02, Days after vaccination: 1
Gender:Male  Submitted:2008-12-01, Days after onset: 60
Location:Texas  Entered:2008-12-09, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC29SSBA0UNLL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERUFSISAA0UNRL
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA09960SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH0068030UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1034X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vomited x3d. Starting the night after IZ. given

VAERS ID:336543 (history)  Vaccinated:2008-10-01
Age:18.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 72
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA03822
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed, Menstruation irregular, Metrorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)
Write-up: Information has been received from a consumer who is the mother of the 18 year old female patient. The patient at the beginning of October 2008, was vaccinated with a first dose of GARDASIL. When the patient received the first dose of GARDASIL, she was supposed to get her menstrual period that next week, but she ended up being two weeks later and when she did get her period it was very light and then it stopped. Then a few days later she had gotten her period again which it was light again and then it stopped. Then a few weeks later the patient got her period again which the bleeding was heavier than it ever has been before. Last week the patient was spotting again. As of 24-NOV-2008, the patient had not started her period again. No further information is available.

VAERS ID:336746 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 72
Location:Unknown  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA01098
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a medical assistant concerning a female patient who in approximately October 2008, was vaccinated with GARDASIL vaccine. The patient experienced rash from waist up after receiving GARDASIL vaccine. On an unknown date in 2008, the patient recovered from the rash. Additional information has been requested.

VAERS ID:336752 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-12-12, Days after onset: 72
Location:Washington  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA00912
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL (lot number was not provided) within the last week (in October 2008). The patient fainted in the waiting room of the physician''s office after receiving her first dose of GARDASIL. She was taken to the emergency room for x-rays of her neck, but results were not provided. It was not known if she was admitted to the hospital. The patient recovered on an unspecified date. Additional information has been requested.

VAERS ID:338039 (history)  Vaccinated:2008-10-01
Age:38.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-12, Days after onset: 103
Location:California  Entered:2009-01-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Epoetin alfa; VENOFER; Esomeprazole; Amitriptyline; Calcium acetate
Current Illness: Dialysis; Hypertension
Preexisting Conditions: The subject has no history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0751452A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB670AA2UNRL
Administered by: Public     Purchased by: Public
Symptoms: Headache, Incorrect route of drug administration
SMQs:
Write-up: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included dialysis and hypertension. Concurrent medications included EPOGEN, VENOFER, NEXIUM, PHOS-LO. On 1 October 2008 at 15:00 the subject received 3rd dose of ENGERIX B at 40 mcg, intravenously. This was the wrong route of administration. ENGERIX B should be given intramuscularly. On 1 October 2008, less than one day after vaccination with ENGERIX B, the subject experienced headache. At the time of reporting the event of headache was unresolved. The healthcare professional considered the event of headache to be unrelated to vaccination with ENGERIX B and related to the subject''s dialysis.

VAERS ID:338065 (history)  Vaccinated:2008-10-01
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2008-10-02
Location:Idaho  Entered:2009-01-23, Days after submission: 113
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Redness, Swelling~Measles + Mumps + Rubella (MMR II)~1~2~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ID08041
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSSKB14064AA4IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSSKBB289AAC1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.MSD0665XC1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.MSD1900UC1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Redness occurred evening of vaccination of left arm. Patient states it resolved in 2-3 days".

VAERS ID:338297 (history)  Vaccinated:2008-10-01
Age:10.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2008-10-01, Days after onset: 0
Location:Kansas  Entered:2009-01-26, Days after submission: 117
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: KS200819
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.100X1UNLA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Erythema, Tenderness
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Redness, Tenderness, difficulty breathing.

VAERS ID:338556 (history)  Vaccinated:2008-10-01
Age:2.0  Onset:2009-01-01, Days after vaccination: 92
Gender:Unknown  Submitted:2009-01-27, Days after onset: 26
Location:Unknown  Entered:2009-01-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: It was not reported whether the patient had any concurrent illnesses at the time of the vaccination in October 2008. The patient has a history of respiratory syncytial virus (RSV) and was taking Synergis at the time of vaccination.
Diagnostic Lab Data: Flu test positive for influenza B (date not provided)
CDC Split Type: 200900243
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza, Influenza serology positive
SMQs:
Write-up: Initial report received on 21 January 2009 from a health care professional. A 2-year-old child, who has past medical history of respiratory syncytial virus (RSV), had received on an unknown day in October 2008 a dose of FLUZONE SV 2008-2009 (lot number unknown, route and site of administration not provided). At the time of the vaccination, the patient was taking Synergis. Approximately three months post vaccination in January 2009; the patient was hospitalized and diagnosed per a flu test with influenza B. It was unknown what type of flu test was administered, or if a sub-strain had been identified. It was reported the patient had received two previous doses of flu vaccine in 2007. The recovery status of the patient was not provided. Documents held by sender: None

VAERS ID:338706 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-30, Days after onset: 121
Location:Maryland  Entered:2009-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: vaccine withheld today
Preexisting Conditions: none noted
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Dyspnoea, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Pt states that the Last flu vaccine caused difficulty breathing and tighness in his chest for 3 days. He said that he did not go to the doctors because these symptoms have appeared each year following a flu shot, and assumed that "things are just that way, and has lived with it his whole life". I encouraged him to see his PCM for a professional assessment.

VAERS ID:338965 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 98
Location:Connecticut  Entered:2009-01-30, Days after submission: 23
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: A0755868A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA175AA UNRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008, the subject received a dose of FLULAVAL at 0.5 ml. At an unknown time after vaccination with FLULAVAL, the subject experienced injection site pruritus. Later, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The outcome of the events was unknown at the time of reporting. Follow-up information received on 19 December 2008 via the initial reporter, indicated that there is no further information to provide concerning the reported events.

VAERS ID:338966 (history)  Vaccinated:2008-10-01
Age:82.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 98
Location:Connecticut  Entered:2009-01-30, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol; Lovastatin
Current Illness: Hyperlipidemia; Hypertension
Preexisting Conditions: Shoulder replacement; The subject has no relevant medical history. No known history of drug, egg or chicken allergies. The subject has previously received flu shots. Reactions, if any, were not known. The subject occasionally consumes a glass of wine and never used tobacco.
Diagnostic Lab Data: 17 December 2008, Skin allergy test, glutaraldehyde (glutaral - test score 5), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5).
CDC Split Type: A0755860A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA175AA UNUN
Administered by: Other     Purchased by: Private
Symptoms: Allergy test positive, Erythema, Immediate post-injection reaction, Injection site pruritus, Injection site rash, Pruritus, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 at 12:01 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 1 October 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus. Over the next two weeks, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The subject treated herself with BENADRYL. the events were ongoing, but improved at the time of reporting. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 05 January 2009, via healthcare professional who reported the subject had received her shot on 01 October 2008. On 02 October 2008, she started itching. The rash started on 02 October 2008, but later in the day. The symptoms were very acute , one night the subject almost went to the emergency room. The subject was "trying to stick it out to see if it would run its course but it got too bad that I had to go to my doctor. I was red all over and itching like mad." The subject''s primary care physician started the subject on ATARAX. Per subject rash and itching persisted. The subject was referred to an allergist. The subject reported to the healthcare professional on 19 December 2008, that she had been seeing a dermatologist who prescribed Triamcinolone Acetonide Ointment 0.1% twice daily, which has helped with pruritus; "itched for 57 days and two days later I stopped itching". "Rash is gradually disappearing, but I still have a little". The subject also stated that on 17 December the she had seen an allergist, "they did 96 patch test on me, they said I was allergic to glutaraldehyde (glutaral - test score 45), kathon (test score 17), neomycin (test score 3), and benzocaine

VAERS ID:338995 (history)  Vaccinated:2008-10-01
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2009-01-07
Location:Unknown  Entered:2009-01-30, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.
Diagnostic Lab Data: UNK
CDC Split Type: A0752837A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA208AA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an Unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752836A.

VAERS ID:338996 (history)  Vaccinated:2008-10-01
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2009-01-07
Location:Unknown  Entered:2009-01-30, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A
Diagnostic Lab Data: UNK
CDC Split Type: A0752836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA208AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL. On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752835A and A0752837A.

VAERS ID:339055 (history)  Vaccinated:2008-10-01
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2009-01-07
Location:Virginia  Entered:2009-01-30, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.
Diagnostic Lab Data: UNK
CDC Split Type: A0752835A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA208AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.

VAERS ID:339056 (history)  Vaccinated:2008-10-01
Age:81.0  Onset:2008-10-05, Days after vaccination: 4
Gender:Female  Submitted:2009-01-07, Days after onset: 94
Location:Virginia  Entered:2009-01-30, Days after submission: 23
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: The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A.
Diagnostic Lab Data: UNK
CDC Split Type: A0752833A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA208AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752835A, A0752836A and A0752837A. Follow-up information received on 31 October 2008 indicated that the subject was an 81 year old female. The events of injection site redness and soreness began 4 days following administration of FLULAVAL and resolved 4 days later on 08 October 2008. In the reporter''s opinion, the events were considered related to treatment with FLULAVAL.

VAERS ID:339057 (history)  Vaccinated:2008-10-01
Age:33.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-01-07, Days after onset: 98
Location:Kentucky  Entered:2009-01-30, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant medical history and no known history of adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0752564A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLLA158AA0SCUN
Administered by: Public     Purchased by: Other
Symptoms: Incorrect route of drug administration, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concomitant medications. On 1 October 2008 the subject received a dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm. On 1 October 2008, within a few hours following vaccination with FLULAVAL, the subject experienced injection site redness. The area of redness was about 1 inch in diameter and resolved on 4 October 2008. It was also noted that the FLULAVAL was administered via the wrong route. The vaccine should have been administered intramuscularly. The healthcare professional considered that the injection site redness was possibly related to vaccination with FLULAVAL.

VAERS ID:341733 (history)  Vaccinated:2008-10-01
Age:1.0  Onset:2009-03-11, Days after vaccination: 161
Gender:Female  Submitted:2009-03-13, Days after onset: 2
Location:Iowa  Entered:2009-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: VIRAL CULTURE PENDING
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2759AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF491AB3IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0811X0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0393X0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Herpes zoster, Pain, Rash pruritic, Rash vesicular, Virus culture
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: DEVELOPED HERPES ZOSTER 5 MONTHS AFTER RECEIVING VARICELLA VACCINE. UNILATERAL VESICULAR RASH FROM MID ABDOMEN ALL THE WAY AROUND TO MID BACK, PAINFUL, PRURITIC. NO PREVIOUS EXPOSURE TO WILD VARICELLA IS KNOWN.

VAERS ID:342053 (history)  Vaccinated:2008-10-01
Age:65.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2009-03-18, Days after onset: 168
Location:New York  Entered:2009-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D; ZINC; calcium chew; vitamin chew
Current Illness: no
Preexisting Conditions: possible ulcer; colitis; multiple sclerosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Like usual after vax, jogged for 3 1/2 hours with 2-3lb weights. At 2p had lunch and became nauseous, dizzy and weak so went to sleep. Woke up at 6pm and only ate some dinner because felt physically exhausted and woke up by noon next day. Problems resolved, no recurrence since then. No pain at site of injection or scratchy throat.

VAERS ID:343101 (history)  Vaccinated:2008-10-01
Age:50.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2009-03-06, Days after onset: 155
Location:Unknown  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Furosemide; ATIVAN; BENICAR
Current Illness: Hypertension
Preexisting Conditions:
Diagnostic Lab Data: Skin biopsy, "possible drug reaction"
CDC Split Type: WAES0812USA00053
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (FOREIGN)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Biopsy skin, Hypoaesthesia, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a 50 year old female with hypertension and no history of drug reactions/allergies, who on 1-OCT-2008, was vaccinated with HEPTAVAX. Concomitant therapy included influenza virus vaccine (unspecified), BENICAR, furosemide and ATIVAN. On 2-OCT-2008 the patient developed an itchy rash from her neck to her knees. The patient had been treated with unspecified steroids and antihistamines but the rash persisted. A skin biopsy, performed by an unspecified dermatologist, revealed "possible drug reaction". The patient also developed numbness of the fingers of her left hand. At the time of reporting, the patient has not yet recovered. The patient sought medical attention with an office visit. No product quality complaint involved. Additional information has been requested.

VAERS ID:342822 (history)  Vaccinated:2008-10-01
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-26
Location:Arizona  Entered:2009-03-27, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0903USA04016
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Ovarian cyst, Surgery
SMQs:
Write-up: Information has been received from a medical assistant concerning a 15 year old female who in approximately March 2008 and in October 2008, was vaccinated with first and second doses GARDASIL (dose, route and lot number not provided). The medical assistant reported that on 13-FEB-2009 the patient had surgery for ovarian cysts. The reporter stated that the patient was hospitalized (name, address and phone number of hospital unspecified) but did not specify how long the patient was in the hospital. The reporter considered ovarian cysts as an other important medical event. Additional information has been requested.

VAERS ID:343598 (history)  Vaccinated:2008-10-01
Age:60.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-04-06, Days after onset: 187
Location:Washington  Entered:2009-04-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL
Current Illness: Allergy (NOS); High blood pressure
Preexisting Conditions: The subject had no reaction after her first flu shot and had no adverse reactions following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0776925A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Chest discomfort, Muscle spasms
SMQs:, Anaphylactic reaction (broad), Dystonia (broad)
Write-up: This case was reported by a consumer and described the occurrence of feels like having a heart attack in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received Omeprazole. A physician or other health care professional has not verified this report. Concurrent medical conditions included severe allergies and high blood pressure. Concurrent medications included Lisinopril. In October 2008 the subject received unspecified dose of FLUARIX (unknown). The following day, the subject took Omeprazole. That same day, she experienced leg cramping. The leg cramping became worse as the days progressed and she soon developed a funny feeling in her chest and she felt that she was having a heart attack. The subject consulted a healthcare professional regarding the events. Medical attention was required at a doctor''s office. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.

VAERS ID:343770 (history)  Vaccinated:2008-10-01
Age:52.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2009-04-08, Days after onset: 189
Location:Tennessee  Entered:2009-04-08
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
Diagnostic Lab Data: Hep titer ordered 4/8/09.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0398X1IM 
Administered by: Public     Purchased by: Public
Symptoms: Vaccination complication
SMQs:
Write-up: Pt states today that he had a reaction to RECOMBIVAX HB #2 in October 20008.

VAERS ID:345557 (history)  Vaccinated:2008-10-01
Age:84.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-03-27, Days after onset: 177
Location:Massachusetts  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA04568
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from an 81 year old female who in October 2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65ml/once, SC Subsequently the patient developed shingles since vaccination. The patient sought medical attention. Additional information has been requested.

VAERS ID:345659 (history)  Vaccinated:2008-10-01
Age:67.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-03-27, Days after onset: 177
Location:New Jersey  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypertension; Hypothyroidism; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0812USA02032
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 66 year old female patient with codeine allergy, hypertension and hypothyroidism who 2 months ago, in approximately October 2008, at a different facility, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.5 mL SQ. There was no concomitant medication. One week after the vaccination, in approximately October 2008, the patient developed injection site reaction. The patient had been having pain, redness and swelling at the injection site. The patient''s injection site reaction persisted. The patient sought medical attention, she saw the physician. Additional information has been requested.

VAERS ID:344764 (history)  Vaccinated:2008-10-01
Age:0.5  Onset:2009-04-07, Days after vaccination: 188
Gender:Unknown  Submitted:2009-04-23, Days after onset: 16
Location:Louisiana  Entered:2009-04-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA03237
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rotavirus infection
SMQs:
Write-up: Information has been received from a physician concerning a 12 month old patient who on 20-JUN-2008, 06-AUG-2008 and 01-OCT-2008 was vaccinated with the first, second and third dose of ROTATEQ respectively. On 07-APR-2009 the patient experienced rotavirus and was hospitalized. The patient had no long-term effects and recovered. It is unknown if the patient sought medical attention. Additional information has been requested.

VAERS ID:345396 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Unknown  Submitted:2009-04-10, Days after onset: 191
Location:Unknown  Entered:2009-04-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness:
Preexisting Conditions: None provided
Diagnostic Lab Data: None provided
CDC Split Type: USWYEH06552508
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced decreased appetite and widespread rash. The patient received a dose in Oct-2008. The patient experienced decreased appetite and widespread rash in Oct-2008. On 09-Oct-2008, the patient was examined by a physician and prescribed BENADRYL. The patient recovery status was unknown. No additional information was available at the time of this report.

VAERS ID:345102 (history)  Vaccinated:2008-10-01
Age:81.0  Onset:0000-00-00
Gender:Female  Submitted:2009-04-28
Location:Florida  Entered:2009-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu like symptoms~Influenza (no brand name)~UN~0~Patient
Other Medications: Cintrold, red yeast rice.
Current Illness: No
Preexisting Conditions: Hernia in stomach. Allergic to VICODEN; TAXOL; TALWIN; CITRICAL; CENTRUM SILVER
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Back pain, Condition aggravated, Fall, Hand fracture, Hernia, Musculoskeletal stiffness, Surgery
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Arthritis (broad)
Write-up: 2 days later had bad stiffness on back of neck and then it went down both sides of torso. Called doctor but said not related to vax. Pain on back subsided after a week; however it made hernia worse to the point that required surgery on 3/4/09. Weeks after surgery fell backwards and fractured right hand in landing.

VAERS ID:345909 (history)  Vaccinated:2008-10-01
Age:1.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2009-05-01, Days after onset: 211
Location:Washington  Entered:2009-05-07, Days after submission: 6
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: Fluoride drop
Current Illness: None
Preexisting Conditions: Positional plagiocephaly 5/7/09-records received-Adopted from another country.
Diagnostic Lab Data: Essential nl MRI as reported by Peds Neuro. CT (+) for calcification (L) medial Lt occipital/parietal region - neuro has no concern. 5/7/09-records received- CT area of calcification left occipital region. MRI brain T2 flaire signal in per
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B150AA1IMUN
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB245AA0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF466AA1IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1926U0SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC990801IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0955X0SCUN
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Computerised tomogram abnormal, Convulsion, Electroencephalogram normal, Febrile convulsion, Grand mal convulsion, Nuclear magnetic resonance imaging abnormal, Upper respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Pt was adopted at about 7 m/o from a foreign country. Her shot records weren''t available to us. With consultation, the recommendations was to immune the child assuming none was previous given. Family actually initiated the consultation on their own and was in agreement with the immunizations as recommended by the AAP/CDC. Other than mild motor delay, she was thriving. On 14 day her 1st y/o WCC, she was behind on immunization and she rec''d 6 shots as listed. In early AM of 10/2, she preceded to have seizure. Her sz episode was GTC in nature and estimated to be between 10-15 min. Over the next 24 hrs, she had recurrent sz. Temp of 103 was documented by EMT at the scene (at home). She was initiated stabilized at a local community hospital where a LP was performed, as was head CT. She was then transferred to another hospital, where she was evaluated by Peds Neuro who dx her w/ complex febrile sz. She had had regular outpt f/u''s w/ Peds Neuro and no AED was recommended. Pt clinically continues to do very well. Adoptive parents subsequently brought in immunization record which revealed that she had rec''d the following back at home (Please see copy submitted by adoptive mom). Family requested that a report be filed via VAERS. 5/7/09-records submitted with VAERS report. 2/3/09-seen in office for follow-up visit for seizures associated with fever. Complex febrile seizure. URI with elevated temperature. First seizure generalized tonic-clinic in nature with temperature 103, followed by another seizure.

VAERS ID:347118 (history)  Vaccinated:2008-10-01
Age:15.0  Onset:2009-01-01, Days after vaccination: 92
Gender:Female  Submitted:2009-05-15, Days after onset: 133
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: Information has been received from a public health nurse concerning a 15 year old female child who in 1999 was vaccinated with her first dose of VARIVAX (Oka/Merck). The child received her second dose of VARIVAX (Oka/Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.

VAERS ID:347119 (history)  Vaccinated:2008-10-01
Age:7.0  Onset:2009-01-01, Days after vaccination: 92
Gender:Male  Submitted:2009-05-15, Days after onset: 133
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902USA00005
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: Information has been received from a public health nurse concerning a 7 year old male child who in 2002 was vaccinated with her first dose of VARIVAX (Merck). The child received her second dose of VARIVAX (Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.

VAERS ID:347430 (history)  Vaccinated:2008-10-01
Age:1.0  Onset:2008-12-26, Days after vaccination: 86
Gender:Male  Submitted:2009-05-15, Days after onset: 139
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREVNAR
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0901USA00142
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0512X UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Ear infection, Rash erythematous, Rash papular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 14 month old male patient with no pertinent medical history and known allergies who on 01-OCT-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (Lot # 660944/0512X). Concomitant therapy included MMR II, PREVNAR and COMVAX received on the same day (01-OCT-2008). Around 26-DEC-2008 the patient developed a rash described as papular with some vesicles, erythematous on his chest and back. In the information received on 05-JAN-2009 contained the following adverse experiences: ear infection (in December 2008) and was prescribed antibiotics. Additional information has been requested.

VAERS ID:347540 (history)  Vaccinated:2008-10-01
Age:16.0  Onset:2009-01-01, Days after vaccination: 92
Gender:Female  Submitted:2009-05-15, Days after onset: 133
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901USA04409
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Varicella post vaccine
SMQs:
Write-up: Information has been received from a public health nurse concerning a 16 year old female child who in 2004 was vaccinated with her first dose of VARIVAX (Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.

VAERS ID:352505 (history)  Vaccinated:2008-10-01
Age:1.3  Onset:2008-10-01, Days after vaccination: 0
Gender:Male  Submitted:2009-07-24, Days after onset: 296
Location:Unknown  Entered:2009-07-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA03060
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Speech disorder
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a registered nurse concerning a now 24 months old male who in October 2008, at the age of "15 months old" was vaccinated with MMR II and VARIVAX. Apparently within 24 hours of receiving both vaccinations, the patient developed a decreasing ability to speak. Unspecified medical attention was sought. At the time of the report, the patient had not improved. The decreasing ability to speak was considered to be disabling. Additional information has been requested.

VAERS ID:353349 (history)  Vaccinated:2008-10-01
Age:81.0  Onset:2008-10-02, Days after vaccination: 1
Gender:Female  Submitted:2009-07-30, Days after onset: 301
Location:Pennsylvania  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: LIPITOR; LOVENOX; LEXAPRO; NEXIUM; GLUCOTROL; KEPPRA; SYNTHROID; CLARITIN; metformin; CORGARD; ACTOS; SENOKOT (SENNA); vitamins (unspecified)
Current Illness: Latex allergy; Drug hypersensitivity; Hypertension; Hypothyroidism; Diabetes; Hospitalisation
Preexisting Conditions: Stroke; Acute myocardial infarction
Diagnostic Lab Data: complete blood cell
CDC Split Type: WAES0810USA05305
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0991U IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Erythema, Full blood count, Oedema peripheral, Tenderness
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 pharmacist concerning an 81 year old female inpatient (acute ischemic MI) with diabetes, hypertension and hypothyroidism; history of ischemic stroke (admitted to hospital on 26-SEP-2008) and allergy to latex, codeine and PERCOCET who on 01-OCT-2008 was vaccinated with one dose of PNEUMOVAX 23 (lot #658493/0991U) IM in the left arm. Concomitant therapy included LEXAPRO, unspecified multivitamin, KEPPRA, ACTOS, CLARITIN, SENOKOT, NEXIUM, metformin, SYNTHROID, CORGARD, GLUCOTROL, LOVENOX and LIPITOR. On 02-OCT-2008 the patient developed cellulitis on the left arm. It was swollen, red and tender to the touch. The cellulitis prolonged the hospitalization. The patient was treated with KEFLEX. Complete blood cell count was performed. Subsequently, she recovered from the cellulitis. Additional information has been requested.

VAERS ID:355176 (history)  Vaccinated:2008-10-01
Age:24.0  Onset:2008-10-06, Days after vaccination: 5
Gender:Female  Submitted:2008-10-06, Days after onset: 0
Location:Tennessee  Entered:2009-08-13, Days after submission: 311
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 06-Oct-2008-Chest X-ray, unknown result; 06-Oct-2008-EKG, unknown result; 06-Oct-2008-Blood work, unknown result
CDC Split Type: MEDI0007201
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50045P IN 
Administered by: Public     Purchased by: Other
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Pleurisy, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: A non-serious, spontaneous report of pleurisy, chest pain, shortness of breath and fever was received from a pharmacist concerning a 24 year-old female patient subsequent to FLUMIST. The patient reported no relevant medical history. Concomitant medications include birth control. The patient received FLUMIST at agency on 01-Oct-2008. On 06-Oct-2008 the patient was seen by a health care provider in the emergency room for symptoms of chest pain, shortness of breath and fever. An electrocardiogram, chest x-ray and blood work were collected, although results were not reported. The patient was diagnosed with pleurisy and treated with ACETAMINOPHEN, HYDROCODONE and NAPROXEN. The patient recovered from the events on 10-Oct-2008.

VAERS ID:355308 (history)  Vaccinated:2008-10-01
Age:69.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Unknown  Submitted:2008-10-20, Days after onset: 19
Location:Texas  Entered:2009-08-13, Days after submission: 297
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007302
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500543P IN 
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: A non-serious, spontaneous report of administered FLUMIST to an adult greater in age than 49, was received from a physician, involving a a 69-year-old patient subsequent to FLUMIST. The event was reported 19 days after the administration and the physician indicated that the patient was doing fine and no reactivity was reported. There was no adverse associated with this medication error; therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.

VAERS ID:355411 (history)  Vaccinated:2008-10-01
Age:33.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-25
Location:Michigan  Entered:2009-08-26, 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: The patient had no concurrent illnesses, or use of other medication at the time of vaccination in October 2008.
Preexisting Conditions: The patient has allergy to NEOSPORIN, and a history of childhood eczema and scarlet fever.
Diagnostic Lab Data: Not reported
CDC Split Type: 200903477
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dyspnoea, Pharyngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Initial report received on 13 August 2009 from a physician. A 33 year old female patient, who had no concurrent illnesses, but who has allergy to NEOSPORIN and a history of childhood eczema and scarlet fever, had received a first dose of influenza vaccine in October 2008. The trade name, manufacturer name, lot number, route and site of administration was unknown. Three to four hours post-vaccination, the patient experienced difficulty breathing, swelling of her throat and coughing. The patient contacted her primary care physician and was directed to take BENADRYL. The patient had no further reactions. The recovery status of the patient was not reported. Documents held by sender: None.

VAERS ID:365544 (history)  Vaccinated:2008-10-01
Age:61.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-11-05, Days after onset: 400
Location:Unknown  Entered:2009-11-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0910USA03235
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Disorientation, Malaise, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a 61 year old female patient who in October 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided). The patient stated that she received the vaccine and 24 hours later she became very ill and was hospitalized. She was very disoriented and sick. Health Care Professional at hospital determined it was ZOSTAVAX (Merck) that caused her to become ill. The patient has sought medical attention. At the time of this report, the patient was recovered. Additional information has been requested.

VAERS ID:398394 (history)  Vaccinated:2008-10-01
Age:  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 672
Location:Texas  Entered:2010-09-08, Days after submission: 35
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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02336
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Laboratory test normal, Loss of consciousness, No reaction on previous exposure to drug
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician concerning a healthy female who never had any problems, who in approximately October 2008, was vaccinated intramuscularly with her second 0.5mL dose of GARDASIL (lot number not reported). The physician reported that the patient "passed out within 24 hours of getting the second dose of GARDASIL" (in approximately July 2008). The series was discontinued after the second dose. The patient was sent to the emergency room for "a complete work up" and "all tests came back normal". The patient was not admitted. The physician noted that there was no adverse event after the first dose of GARDASIL. The patient recovered within an unspecified time. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:399316 (history)  Vaccinated:2008-10-01
Age:26.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 672
Location:California  Entered:2010-09-08, Days after submission: 35
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: Unknown
CDC Split Type: WAES0911USA04820
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Vaccine positive rechallenge, Vaginal discharge
SMQs:
Write-up: Information has been received from a physician concerning a 26 year old female patient who in October 2008 and December 2008 was vaccinated with the first and second dose of GARDASIL. Both times after receiving the vaccine the patient had vaginal discharge that went away in about a week. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered. This is one of several reports from the same source. Additional information has been requested.

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