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Case Details (Sorted by Age)

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VAERS ID:349970 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-23
Location:Unknown  Entered:2009-06-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Complete blood cell, low
CDC Split Type: WAES0906USA02844
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Full blood count abnormal, Full blood count decreased
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic leukopenia (broad)
Write-up: Information has been received from a lawyer concerning her approximately 6 year old grand daughter who on an unspecified date was vaccinated with MMR II (lot number not reported). After getting the vaccination the patient experienced low blood count. Subsequently the patient was admitted in hospital for an unspecified number of days. No further information is available.

VAERS ID:350161 (history)  Vaccinated:2009-06-15
Age:6.0  Onset:2009-06-19, Days after vaccination: 4
Gender:Male  Submitted:2009-06-19, Days after onset: 0
Location:New Hampshire  Entered:2009-06-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Rapid strep negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAV0124B1UNLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURD02510UNRA
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash macular, Streptococcus identification test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Extensive macular rash started 2 days after vaccine was given & a fever of ? degree was reported by his mother. He had no fever when seen 6/19/09.

VAERS ID:350492 (history)  Vaccinated:2009-06-22
Age:6.0  Onset:2009-06-23, Days after vaccination: 1
Gender:Female  Submitted:2009-06-24, Days after onset: 1
Location:Colorado  Entered:2009-06-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Local Reaction~Measles + Mumps + Rubella (no brand name)~UN~5~Sibling
Other Medications: Albuterol ; Flovent
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B064AA4UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB047633UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0976X2UNLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Developed 20cm X 25cm area of redness after administration of DTAP + itching. Treating with cool compresses + Benadryl.

VAERS ID:350902 (history)  Vaccinated:2009-06-27
Age:6.0  Onset:2009-06-28, Days after vaccination: 1
Gender:Male  Submitted:2009-06-29, Days after onset: 1
Location:Tennessee  Entered:2009-07-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B03DA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0503Y UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythematous, swelling at site of injection no fever no systemic symptoms. No other sign.

VAERS ID:350918 (history)  Vaccinated:2009-06-27
Age:6.0  Onset:2009-06-28, Days after vaccination: 1
Gender:Male  Submitted:2009-06-29, Days after onset: 1
Location:Tennessee  Entered:2009-07-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B103DA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.05034 UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Erythematous swelling at site of injection (-) fever (-) systemic symptoms. No other signs.

VAERS ID:351068 (history)  Vaccinated:2009-07-07
Age:6.0  Onset:2009-07-08, Days after vaccination: 1
Gender:Unknown  Submitted:2009-07-09, Days after onset: 1
Location:California  Entered:2009-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B066AA4IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Induration, Local reaction, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Severe swelling, induration, pain and fever locally.

VAERS ID:351458 (history)  Vaccinated:2009-07-09
Age:6.0  Onset:2009-07-10, Days after vaccination: 1
Gender:Male  Submitted:2009-07-15, Days after onset: 5
Location:Ohio  Entered:2009-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3139AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB04753SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Mild erythema 4cm X 6cm at injection site on L thigh, tenderness, normal gait. Rec: ice, ibuprofen. Matthew''s mother wanted this reaction reported to VAERS.

VAERS ID:351899 (history)  Vaccinated:2009-07-14
Age:6.0  Onset:2009-07-14, Days after vaccination: 0
Gender:Male  Submitted:2009-07-14, Days after onset: 0
Location:North Carolina  Entered:2009-07-20, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Area of redness.~DTaP (no brand name)~5~5~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0036Y1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0503Y1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 3 x 3 cm area of redness at vaccination site 15 minutes after vaccine (L arm). 15 mg ATARAX given.

VAERS ID:351956 (history)  Vaccinated:2009-06-29
Age:6.0  Onset:2009-06-29, Days after vaccination: 0
Gender:Female  Submitted:2009-07-02, Days after onset: 3
Location:California  Entered:2009-07-20, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0644Y1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: All of patient''s upper arm, where vaccine was administered, became red and swollen. Remained so for 4-5 days.

VAERS ID:352042 (history)  Vaccinated:2009-07-14
Age:6.0  Onset:2009-07-15, Days after vaccination: 1
Gender:Female  Submitted:2009-07-16, Days after onset: 1
Location:Louisiana  Entered:2009-07-21, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B116AB0UNLL
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Developed hives after KINRIX immunization. Came into office 7/16/09. Put on BENADRYL 1 1/2 tsp TID and PERIACTIN 1 tsp TID, no fever or distress.

VAERS ID:352068 (history)  Vaccinated:2009-07-17
Age:6.0  Onset:2009-07-18, Days after vaccination: 1
Gender:Female  Submitted:2009-07-20, Days after onset: 2
Location:Ohio  Entered:2009-07-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB343BA1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: L lump at injection site - egg size, red swollen; tender area on left mid-arm, hives in area with itching and pain. Advised BENADRYL 1 teaspoon every 6 hours. MOTRIN 10mg/kg.

VAERS ID:352286 (history)  Vaccinated:2009-07-16
Age:6.0  Onset:2009-07-17, Days after vaccination: 1
Gender:Female  Submitted:2009-07-23, Days after onset: 6
Location:Maine  Entered:2009-07-23
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
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB282AA1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0059Y1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient arrived at ED 17 Jul 2009 @ 2300 with left sided facial swelling. Onset was 3 hours prior to arrival. She was given Benadryl 25 mg orally @ 0252 18 Jul 2009. She was prescribed Prednisone 5 mg/5 ml, 3 tsp a day x5 days. She was discharged that same day.

VAERS ID:352581 (history)  Vaccinated:2009-07-17
Age:6.0  Onset:2009-07-18, Days after vaccination: 1
Gender:Female  Submitted:2009-07-22, Days after onset: 4
Location:Ohio  Entered:2009-07-28, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3139AA2IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.037741IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.035641SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.068541SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Mom called office and stated child was given immunizations in left thigh, stated leg swollen hip to knee, warm to touch.

VAERS ID:352720 (history)  Vaccinated:2009-07-27
Age:6.0  Onset:2009-07-28, Days after vaccination: 1
Gender:Female  Submitted:2009-07-29, Days after onset: 1
Location:Texas  Entered:2009-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins; CLARITAN; BENADRYL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.4059X1SCRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Right arm posterior area red; very swollen warm to touch, very tender to touch, some pain with movement.

VAERS ID:352790 (history)  Vaccinated:2009-07-27
Age:6.0  Onset:2009-07-28, Days after vaccination: 1
Gender:Female  Submitted:2009-07-30, Days after onset: 2
Location:California  Entered:2009-07-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3081AA5IDLA
Administered by: Unknown     Purchased by: Unknown
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: LEFT ARM SWOLLEN, REDDNESS AND COPLAINS OF PAIN. PATIENT WAS TREATED WITH ANTIBIOTICS CLINDAYCIN 150 MG.

VAERS ID:353256 (history)  Vaccinated:2009-07-30
Age:6.0  Onset:2009-07-30, Days after vaccination: 0
Gender:Male  Submitted:2009-08-06, Days after onset: 7
Location:Nevada  Entered:2009-08-06
Life Threatening? Yes
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 at this time - referred to Allergist
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0660Y1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Anaphylactic reaction, Lip swelling, Nasal congestion, Pruritus, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Anaphylaxis - instant hives - lip swelling, itching, throat closing, nasal congestion within 5-10 minutes of administration. Treatment: BENADRYL, Epinephrine injection, Zyxal suspension.

VAERS ID:354027 (history)  Vaccinated:2008-10-13
Age:6.0  Onset:2008-10-15, Days after vaccination: 2
Gender:Female  Submitted:2009-07-30, Days after onset: 288
Location:Virginia  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0811USA02951
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from an office manager concerning a 6 year old female patient with asthma, no drug reactions/allergies, not immunocompromised, who on 13-OCT-2008 was vaccinated with intramuscularly with a 0.5 mL dose of PNEUMOVAX vaccine because according to the physician had risk of developing pneumonia. There was no concomitant medication. On 15-OCT-2008 the patient developed swelling, warmth and tenderness at the injection site of the left deltoid. The patient was seen in the office on 15-OCT-2008 and was prescribed OMNICEF. The patient had recovered. This is one case of several cases from the same source. Additional information has been requested.

VAERS ID:353439 (history)  Vaccinated:2009-08-04
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-06
Location:California  Entered:2009-08-07, 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: None
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0228B1SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: L arm red in area vaccinated not warm to touch, feels well TYLENOL PRN, warm compress. Prn.

VAERS ID:355119 (history)  Vaccinated:2008-08-01
Age:6.0  Onset:2008-08-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-11, Days after onset: 41
Location:Florida  Entered:2009-08-13, Days after submission: 336
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma ( 10003553)
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007120
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Asthma, Cough, Hypersomnia, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: A non-serious spontaneous report of pneumonia, sleeping a lot, fever, asthma and coughing was received from a mother concerning a six year-old female subsequent to FLUMIST. Medical history included asthma. No concomitant medications were reported for this patient. The patient received FLUMIST in the last week of August 2008. The patient developed a high fever (104 degrees Fahrenheit) 12 hours after receiving FLUMIST. The patient was taken to the emergency room and treated for pneumonia and an asthma attack. The patient was not hospitalized. Subsequently in September 2008, the patient had symptoms of coughing and sleeping a lot. The outcome of the adverse events was not reported. Additional dosing with FLUMIST was not reported. No causality assessment was reported.

VAERS ID:355332 (history)  Vaccinated:2008-10-27
Age:6.0  Onset:2008-10-28, Days after vaccination: 1
Gender:Male  Submitted:2008-10-28, Days after onset: 0
Location:Texas  Entered:2009-08-13, Days after submission: 289
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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: MEDI0007343
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50041P OTUN
Administered by: Other     Purchased by: Other
Symptoms: Lymphadenopathy
SMQs:
Write-up: A non-serious report of swelling of the glands has been received from a certified medical assistant (CMA) concerning a six-year old male patient, subsequent to FLUMIST. No medical and drug history information has been reported for this patient. The patient received 0.2 milliliters of FLUMIST on 27-Oct-2008. According to the patient''s parent, the patient experienced swelling of the glands approximately 16 hours after receiving FLUMIST, at two in the morning of 28-Oct-2008. The patient was taken to the emergency room. Information regarding the care the patient received in the emergency room was not available at the time of this report. The outcome of the adverse event is unknown.

VAERS ID:355390 (history)  Vaccinated:2008-10-30
Age:6.0  Onset:2008-11-01, Days after vaccination: 2
Gender:Female  Submitted:2008-11-03, Days after onset: 2
Location:Pennsylvania  Entered:2009-08-13, Days after submission: 282
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: MEDI0007417
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.   UN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: A non-serious, spontaneous report of fever of 104 and hives was received from a consumer, concerning a six year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F and hives on her feet and lower back. On 02-Nov-2008 the reporter called their pediatrician and on 02-Nov-2008 was instructed to administer diphenhydramine. As of 03-Nov-2008 the fever is no longer present and the hives have subsided somewhat.

VAERS ID:355550 (history)  Vaccinated:2008-11-13
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-17
Location:Virginia  Entered:2009-08-13, Days after submission: 268
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Influenza serology, positive
CDC Split Type: MEDI0007524
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500577P IN 
Administered by: Private     Purchased by: Other
Symptoms: Headache, Influenza, Influenza serology positive, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: A non-serious spontaneous report of tested positive for influenza, fever, vomiting and headache was received from a nurse concerning a six year-old male subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Nov-2008. The next day the patient''s mother reported the patient experienced fever, vomiting and headache. The child also later tested positive for influenza. The events of fever, vomiting and headache lasted for two days and then resolved.

VAERS ID:355560 (history)  Vaccinated:2008-11-14
Age:6.0  Onset:2008-11-14, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 145
Location:Virginia  Entered:2009-08-13, Days after submission: 126
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: MEDI0007531
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500540P IN 
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of expired FLUMIST administered was received from a nurse concerning a six-year-old female. No medical history was provided. A nurse gave the patient FLUMIST that expired on 12-Nov-2008. 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. Follow up received on 02-Dec-2008 includes: patient was not re-dosed and no adverse events occurred. Additional information was received on 09-Apr-2009: Based on the results for the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.

VAERS ID:355582 (history)  Vaccinated:2008-11-18
Age:6.0  Onset:2008-11-18, Days after vaccination: 0
Gender:Female  Submitted:2008-12-08, Days after onset: 20
Location:New York  Entered:2009-08-13, Days after submission: 247
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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: MEDI0007605
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500553P IN 
Administered by: Other     Purchased by: Other
Symptoms: Acarodermatitis
SMQs:
Write-up: A spontaneous non-serious report of scabies was received form a nurse concerning a six year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and her brother, who also received FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL, and acyclovir. The attending physician in the ER diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.

VAERS ID:355584 (history)  Vaccinated:2008-11-26
Age:6.0  Onset:2008-12-01, Days after vaccination: 5
Gender:Male  Submitted:2008-12-10, Days after onset: 9
Location:Indiana  Entered:2009-08-13, Days after submission: 245
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: Fungal infection
Preexisting Conditions: At the time he received FLUMIST the patient had mild skin rash that was diagnosed as a fungal infection.
Diagnostic Lab Data:
CDC Split Type: MEDI0007611
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500585P0OTUN
Administered by: Private     Purchased by: Private
Symptoms: Henoch-Schonlein purpura, Upper respiratory tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: A non-serious spontaneous report of Henoch-Schoenlein purpura and upper respiratory infection was received from a physician concerning a 6 year-old male, subsequent to receiving FLUMIST. At the time of FLUMIST administration the patient had a mild skin rash that the physician diagnosed as a fungal infection. No concomitant medications were reported. The patient received FLUMIST on 26-Nov-2008. Around 01-Dec-2008 the patient experienced a mild upper respiratory infection that was resolving on 04-Dec-2008 at the time the patient was seen due to Henoch-Schoenlein purpura (HSP). No treatment was given for the HSP, the patient was monitored. The HSP resolved later in Dec-2008.

VAERS ID:355598 (history)  Vaccinated:2008-12-11
Age:6.0  Onset:2008-12-12, Days after vaccination: 1
Gender:Female  Submitted:2008-12-15, Days after onset: 3
Location:Ohio  Entered:2009-08-13, Days after submission: 240
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: MEDI0007629
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  OTUN
Administered by: Public     Purchased by: Other
Symptoms: Eye discharge, Eye disorder, Nasal congestion, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: A spontaneous non-serious report of "glassy looking eyes, red eyes, eye discharge and nasal congestion has been received from a consumer concerning a six year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 11-Dec-2008, the patient received FLUMIST. Within 24 hours of administration, the patient developed nasal congestion which progressed to "glassy looking eyes", red eyes and discharge from eyes. These symptoms were not associated with itching or burning of the eyes. The patient''s mother was going to take her to the doctor''s office; however, the symptoms began to clear on 14-Dec-2008 with no discharge and only mild redness of the eyes. The events of "glassy looking eyes", red eyes, discharge and nasal congestion from eyes was recovering/resolving.

VAERS ID:355601 (history)  Vaccinated:2008-12-29
Age:6.0  Onset:2008-12-29, Days after vaccination: 0
Gender:Male  Submitted:2009-04-09, Days after onset: 100
Location:Michigan  Entered:2009-08-13, Days after submission: 126
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: MEDI0007671
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500550P` IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a 6-year 11 month old male. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 10-Mar-2009. The reporter confirmed that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.

VAERS ID:355604 (history)  Vaccinated:2008-12-16
Age:6.0  Onset:2008-12-16, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 113
Location:California  Entered:2009-08-13, Days after submission: 126
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: MEDI0007635
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500546P IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a 6 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 16-Dec-2008, this child was administered FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation of into the cause of medication error.

VAERS ID:355610 (history)  Vaccinated:2008-12-26
Age:6.0  Onset:2008-12-26, Days after vaccination: 0
Gender:Female  Submitted:2009-03-27, Days after onset: 90
Location:Michigan  Entered:2009-08-13, Days after submission: 139
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: Sibling also received expired FLUMIST
Diagnostic Lab Data:
CDC Split Type: MEDI0007687
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.5000551P IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of expired FLUMIST given to this patient was received from a certified medical assistant concerning a six-year-old female. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, the patient and her brother received expired FLUMIST vaccine. The vaccine had an expiration date of 25-Dec-2008. 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. Additional information was received on 03-Feb: reporter confirmed no delayed occurring adverse events related to being given expired FLUMIST. Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired.

VAERS ID:355652 (history)  Vaccinated:2009-01-01
Age:6.0  Onset:2009-01-01, Days after vaccination: 0
Gender:Unknown  Submitted:2009-04-09, Days after onset: 97
Location:Arizona  Entered:2009-08-13, Days after submission: 126
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Second vaccination with FLUMIST
Diagnostic Lab Data:
CDC Split Type: MEDI0007742
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500550P1IN 
Administered by: Public     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: A spontaneous non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a six-year-old patient (gender unknown). The patient''s medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-20098). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.

VAERS ID:355664 (history)  Vaccinated:2009-01-05
Age:6.0  Onset:2009-01-05, Days after vaccination: 0
Gender:Female  Submitted:2009-01-06, Days after onset: 1
Location:New Jersey  Entered:2009-08-13, Days after submission: 218
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: MEDI0007761
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a six-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse event.

VAERS ID:355754 (history)  Vaccinated:2009-01-06
Age:6.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Male  Submitted:2009-03-31, Days after onset: 83
Location:Texas  Entered:2009-08-13, Days after submission: 135
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: MEDI0007878
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.550552P IN 
Administered by: Military     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a six-year-old male. The patient''s medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.

VAERS ID:355767 (history)  Vaccinated:2009-01-06
Age:6.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Male  Submitted:2009-02-05, Days after onset: 30
Location:Texas  Entered:2009-08-13, Days after submission: 188
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: MEDI0007899
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.550552P IN 
Administered by: Military     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a six-year-old female. The patients'' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.

VAERS ID:355779 (history)  Vaccinated:2009-02-05
Age:6.0  Onset:2009-02-05, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 62
Location:South Carolina  Entered:2009-08-13, Days after submission: 126
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: MEDI0007869
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500556P OTUN
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a six-year-old female. FLUMIST that expired on 08-Jan-2009 was administered on 05-Feb-2009. 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of an investigation for a medication error.

VAERS ID:355783 (history)  Vaccinated:2009-01-06
Age:6.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Female  Submitted:2009-03-31, Days after onset: 83
Location:Texas  Entered:2009-08-13, Days after submission: 135
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: MEDI0007877
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.550552P IN 
Administered by: Military     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of "23 patients received expired FLUMIST" was received from a physician concerning a six-year-old female. The patient''s medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.

VAERS ID:355784 (history)  Vaccinated:2009-01-06
Age:6.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Male  Submitted:2009-02-05, Days after onset: 30
Location:Texas  Entered:2009-08-13, Days after submission: 188
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: MEDI0007909
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.550552P IN 
Administered by: Military     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of ''29 patients received expired FLUMIST" was received from a physician concerning a six-year-old male. The patients'' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are

VAERS ID:355802 (history)  Vaccinated:2009-02-20
Age:6.0  Onset:2009-02-20, Days after vaccination: 0
Gender:Female  Submitted:2009-03-31, Days after onset: 38
Location:Maryland  Entered:2009-08-13, Days after submission: 135
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: MEDI0008079
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious, spontaneous report of administered expired products was received from a nurse concerning a six-year-old female. Subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: included Product Complaint Investigative results.

VAERS ID:355803 (history)  Vaccinated:2009-02-20
Age:6.0  Onset:2009-02-20, Days after vaccination: 0
Gender:Male  Submitted:2009-03-31, Days after onset: 38
Location:Maryland  Entered:2009-08-13, Days after submission: 135
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: MEDI0008080
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  OT 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. 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. Based on the results of the investigation, the root cause of the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information on 31-Mar-2009: included Product Complaint Investigative results.

VAERS ID:355805 (history)  Vaccinated:2009-02-26
Age:6.0  Onset:2009-02-26, Days after vaccination: 0
Gender:Male  Submitted:2009-03-31, Days after onset: 32
Location:Maryland  Entered:2009-08-13, Days after submission: 135
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: MEDI0008082
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  OT 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: include Product Complaint Investigative results.

VAERS ID:354500 (history)  Vaccinated:2009-08-10
Age:6.0  Onset:2009-08-12, Days after vaccination: 2
Gender:Male  Submitted:2009-08-12, Days after onset: 0
Location:Nevada  Entered:2009-08-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEUR42472BA4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB04764UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.000743UNLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: L shoulder area is erythematous, mild swollen & not Tender skin feels hot to Touch.

VAERS ID:355055 (history)  Vaccinated:2009-08-19
Age:6.0  Onset:2009-08-19, Days after vaccination: 0
Gender:Male  Submitted:2009-08-24, Days after onset: 5
Location:Texas  Entered:2009-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec prn
Current Illness: slight stuffy nose, cough
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B136AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB326AA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.070741IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.085841IMRL
Administered by: Private     Purchased by: Private
Symptoms: Cold sweat, Eye rolling, Fatigue, Pallor, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: After patient received the immunizations (Kinrix, MMR, Varicella, Hep A) he left the building with his mom and sister. After they got in the car, his sister said his eyes rolled back and he was shaking for approx. 20 seconds. Mom brought him immediately back to the office. He was noted to be alert but extremely pale and clammy. His vital signs were normal but he was given oxygen via mask until he became less pale and he was given some apple juice to drink. The patient was alert and could converse easily. He did not appear to be post ictal. He kept saying "I feel fine." He was observed in the office for approximately 15 minutes and his vital signs remained normal (pulse:90 B/P:90/60)and his color returned. He was then released with his mom. Two days after the event mom states that he had remained asymptomatic other than low grade fever and slightly more tired the rest of the day.

VAERS ID:355562 (history)  Vaccinated:2008-11-24
Age:6.0  Onset:2008-11-24, Days after vaccination: 0
Gender:Female  Submitted:2008-11-24, Days after onset: 0
Location:South Carolina  Entered:2009-08-25, Days after submission: 273
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: MEDI0007546
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure
SMQs:
Write-up: A spontaneous non-serious report of FLUMIST squirted into a child''s eye has been received from the patient''s mother who is a nurse concerning a 6 year old female patient. No medical history or concomitant medications were reported. On 24-Nov-2008, the patient received FLUMIST in the pediatrician''s office. During administration, the patient moved and FLUMIST was squirted into the child''s eye. 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:355716 (history)  Vaccinated:2009-08-25
Age:6.0  Onset:2009-08-25, Days after vaccination: 0
Gender:Female  Submitted:2009-08-27, Days after onset: 2
Location:Maryland  Entered:2009-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3387AA2IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB730CA2IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0426Y1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0800Y1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PT LEFT ARM (DELTOID AREA) BUT ENTIRE UPPER ARM HAD GENERALIZED SWELLING, RED AND WARM TO THE TOUCH. THE PATIENT ALSO EXPERIENCED PURITIS. PATIENT TREATED WITH BENADRYL

VAERS ID:355863 (history)  Vaccinated:2009-08-26
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-08-28
Location:Arkansas  Entered:2009-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL
Current Illness: POISON IVY
Preexisting Conditions: POISON IVY-CURRENT; URI-RESOLVED, STREP PHARYNGITIS-RESOLVED,ALLERGIC RHINITIS-CONTROLLED, ASTHMA-CONTROLLED,
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU1367AA2IMRL
Administered by: Private     Purchased by: Private
Symptoms: No adverse event
SMQs:
Write-up: No adverse events noted to date.

VAERS ID:355886 (history)  Vaccinated:2009-08-21
Age:6.0  Onset:2009-08-22, Days after vaccination: 1
Gender:Male  Submitted:2009-08-28, Days after onset: 6
Location:Texas  Entered:2009-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: unknown~ ()~~0~Patient|unknown~ ()~~0~Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3139AA1IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: The patient was seen 2 days after the immunization Daptacel Dtap R thigh. His right thigh was swollen and tender and there was a rash noted around the injection site. The pt. also had a fever of 103.1. He was immediately referred to Emergency Dept.

VAERS ID:356064 (history)  Vaccinated:2009-08-28
Age:6.0  Onset:2009-08-28, Days after vaccination: 0
Gender:Male  Submitted:2009-08-31, Days after onset: 3
Location:Arkansas  Entered:2009-08-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500675P IN 
Administered by: Private     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Within an hour after receiving immunization child broke out in rash that covered his trunk and extremeties. Was given benadryl and rash began to clear.

VAERS ID:356180 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-08-31
Location:Unknown  Entered:2009-09-01, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA04511
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autism spectrum disorder, Computerised tomogram, Dyspnoea, Pyrexia, Speech disorder developmental, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a consumer concerning her 6 year old son with no pertinent medical history and no known drug allergies who was vaccinated with "one dose" of RECOMBIVAX HB (injection, lot# not reported). There was no concomitant medication. The consumer reported that the patient was already in the hospital when he was administered the "hepatitis B vaccine" (manufacturer unknown). The consumer reported that the patient developed high fever "within hours" of receiving the hepatitis B vaccine and he had difficulty breathing. The consumer also reported that the patient was diagnosed with pervasive developmental disorder (PDD) which was a form of autism and he had a speech delay. Hospital demographics were unspecified. A computed axial tomography (CT scan) and an X-ray were performed but the outcome were unknown. At the time of the report, the patient had not recovered. Upon internal review, pervasive developmental disorder (PDD) which was a form of autism and speech delay was determined to be an other important medical event. No further information is available.

VAERS ID:356184 (history)  Vaccinated:2009-08-20
Age:6.0  Onset:2009-08-20, Days after vaccination: 0
Gender:Female  Submitted:2009-08-29, Days after onset: 9
Location:New Jersey  Entered:2009-09-01, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Question of shrimp and tree nut allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURERD0072 UNUN
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Mother states patient ran a fever of 104 degrees for 8 hours and developed hives fever and hives resolved after 8 hours, but patient continued to be nauseous.

VAERS ID:356261 (history)  Vaccinated:2009-08-31
Age:6.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Male  Submitted:2009-09-01, Days after onset: 0
Location:Ohio  Entered:2009-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent,Albuterol
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: Food allergy testing drawn on 8/31/09.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3204AA6IMRA
Administered by: Private     Purchased by: Private
Symptoms: Allergy test, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Developed hives around injection site less than 24 hours after given.

VAERS ID:356365 (history)  Vaccinated:2009-08-31
Age:6.0  Onset:2009-09-01, Days after vaccination: 1
Gender:Male  Submitted:2009-09-02, Days after onset: 1
Location:Texas  Entered:2009-09-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0055Y1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: SITE OF INJECTION IS SWOLLEN WITH REDNESS AND PAIN ALSO THE ARM FEELS HOT.

VAERS ID:356993 (history)  Vaccinated:2009-09-09
Age:6.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-11, Days after onset: 2
Location:North Carolina  Entered:2009-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3177AA6IMRA
Administered by: Private     Purchased by: Private
Symptoms: Nausea, Pallor, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt left office, vomit x1 on the way home. Mom reports she was pale and complaints of nausea and then vomit x1.

VAERS ID:357130 (history)  Vaccinated:2005-01-11
Age:6.0  Onset:2005-02-01, Days after vaccination: 21
Gender:Male  Submitted:2009-09-11, Days after onset: 1682
Location:Massachusetts  Entered:2009-09-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0909USA00746
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autism, Gastrointestinal disorder, Gluten free diet, Lactose intolerance
SMQs:
Write-up: Information has been received from a consumer concerning her 5 year old son with no drug allergies who on 11-JAN-2005 was vaccinated with a 0.5 ml dose of MMR (lot number not reported). Suspect vaccination included hepatitis B virus vaccine (manufacturer unknown). Concomitant vaccination on the same day included poliovirus and DTaP. After the vaccination, in February 2005, the patient developed a severe lower intestinal reaction. In July 2006 he was diagnosed as lactose intolerant and was put on gluten free diet. After that, in July 2006 the patient''s intestinal issues cleared up. Since then he had also been diagnosed with autism. Unspecified medical attention was sought. No laboratory diagnostics studies were performed. The patient had recovered from lactose intolerant in July 2006. Upon internal review, autism was determined to be other important medical events. Additional information has been requested.

VAERS ID:357213 (history)  Vaccinated:2009-08-29
Age:6.0  Onset:2009-08-31, Days after vaccination: 2
Gender:Male  Submitted:2009-09-14, Days after onset: 14
Location:Nebraska  Entered:2009-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: described above~Influenza (Seasonal) (FluMist)~UN~6~In Patient
Other Medications: None
Current Illness: NO
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500681P1IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Headache, Lethargy, Malaise, Pyrexia, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: 48 hours after nasal flu mist vaccination-became ill with severe headache, fever of 102.5 under armpit and continued for 4 days (missed 4 days of school)-even after fever free,severe headache continued for 2 additional days. Last year, same occurence (did not report last year) but much more severe with uncontrolled 105 temp, severe lethargy and headache and missed 5 days of school-nearly took to ER but out of town and uncomfortable with medical care there

VAERS ID:357297 (history)  Vaccinated:2009-09-10
Age:6.0  Onset:2009-09-10, Days after vaccination: 0
Gender:Male  Submitted:2009-09-11, Days after onset: 1
Location:Virginia  Entered:2009-09-15, 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: None
Current Illness: None
Preexisting Conditions: Fish allergy, seasonal allergies.
Diagnostic Lab Data: All per parent report
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500675P IN 
Administered by: Private     Purchased by: Private
Symptoms: Musculoskeletal pain, Nasal congestion, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pt received FLUMIST at about 14:25. No history of egg allergy. Pt then went to soccer practice. No Hx of trauma per parent. At 1930 pt''s mom called to say his nose was swollen and he c/o pain below collar bone. Unable to breath through nose. No other difficulty breathing, no rash. Better in AM - after 1 dose oral BENADRYL.

VAERS ID:357481 (history)  Vaccinated:2009-09-16
Age:6.0  Onset:2009-09-17, Days after vaccination: 1
Gender:Female  Submitted:2009-09-17, Days after onset: 0
Location:Unknown  Entered:2009-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Mild eczema. No known allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1539X1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Local reaction
SMQs:
Write-up: Large local reaction, 3x4 cm wheal, developed within 18 hours of vaccine adminsitration. No systemic or airway symptoms. Treated with Benadryl and cool compresses

VAERS ID:357711 (history)  Vaccinated:2009-09-14
Age:6.0  Onset:2009-09-15, Days after vaccination: 1
Gender:Female  Submitted:2009-09-18, Days after onset: 3
Location:Ohio  Entered:2009-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: allergy to penicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1  
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pruritus, Rash papular, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 24 hours after second Varivax she developed a 3 1/2 x 3 1/2 red hot warm papule on her right arm that was swollen and puritic. Parents were afraid it wa infected. I told them it was a local reaction to the vaccine and instructed them to use benadryl or loratadine 10 mg a day and cold compresses and to call if it got larger. Today it is smaller but still itches. It is slowly resolving. There were no vessicles.

VAERS ID:357658 (history)  Vaccinated:2009-09-19
Age:6.0  Onset:2009-09-19, Days after vaccination: 0
Gender:Male  Submitted:2009-09-20, Days after onset: 1
Location:Arizona  Entered:2009-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; BENADRYL; Albuterol
Current Illness: None
Preexisting Conditions: Asthma; Seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3216AA1IMLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Nausea, Pyrexia
SMQs:, 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: (L) arm erythematous, hot, edematous from shoulder to elbow. (+) nausea and low grade fever.

VAERS ID:357841 (history)  Vaccinated:2009-09-17
Age:6.0  Onset:2009-09-20, Days after vaccination: 3
Gender:Female  Submitted:2009-09-21, Days after onset: 1
Location:Iowa  Entered:2009-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Zithromax - Rash
Diagnostic Lab Data: None
CDC Split Type: IA090022
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500711P1IN 
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria tx with Celadrin 4mg, antihistamine and Orapred.

VAERS ID:357860 (history)  Vaccinated:2009-09-16
Age:6.0  Onset:2009-09-18, Days after vaccination: 2
Gender:Male  Submitted:2009-09-18, Days after onset: 0
Location:Missouri  Entered:2009-09-21, 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: FLOVENT MDI
Current Illness: No
Preexisting Conditions: ASD - closed 8/05
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3171AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 13 x 13cm erythema left upper arm.

VAERS ID:358029 (history)  Vaccinated:2009-09-21
Age:6.0  Onset:2009-09-22, Days after vaccination: 1
Gender:Female  Submitted:2009-09-22, Days after onset: 0
Location:Virginia  Entered:2009-09-22
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
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.5007098 IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.026741IMRA
Administered by: Private     Purchased by: Private
Symptoms: Muscle swelling, Neck pain
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: A/P neck pain - right side of neck with muscle fullness. Questionable reaction to HeP A. Motrin every 6 hours today.

VAERS ID:358064 (history)  Vaccinated:2009-09-10
Age:6.0  Onset:2009-09-10, Days after vaccination: 0
Gender:Male  Submitted:2009-09-21, Days after onset: 11
Location:Texas  Entered:2009-09-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None Healthy No egg allergy
Preexisting Conditions: Allergic Rhinitis occasional
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3211AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9/10/09 gave Flu shot right deltoid before leaving office was itchy a little red. 9/11/09 24 hr after shot arm was swollen from the shoulder to elbow, red, warm to touch, occ pain, no itching no joint pain. Was told to give BENADRYL when he left and also x 24 hr no help. 9/12/09 started on oral steroids. Noticed improvement. After 36 hr on the steroids oym. were gone

VAERS ID:358395 (history)  Vaccinated:2009-09-24
Age:6.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Male  Submitted:2009-09-25, Days after onset: 1
Location:Utah  Entered:2009-09-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: same reaction~Influenza (Seasonal) (no brand name)~1~5.90~In Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERDONT KNOW IT1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm, Vaccine positive rechallenge
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: He got the flu shot in his L arm and that evening his upper arm got red, swollen, and hot to touch, he has also had fevers off and on since he got it. I have been giving him Motrin and benedryl, as of now its still the same his arm has not gone down, as far as swollen, red, and hot. He got the same reaction last year when given the flu shot.

VAERS ID:358524 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-18
Location:Ohio  Entered:2009-09-25, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA00911
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash maculo-papular, Varicella post vaccine
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 5 year old female who was vaccinated with PROQUAD (Merck) (lot # not reported). The physician reported that the patient developed a breakthrough chicken pox rash more than one year after receiving PROQUAD (Merck) (dates unspecified). The patient, now 6 years old, was seen in the office on 28-MAY-2008 with 15 to 25 maculopapular lesions on the torso, without fever. The patient was not treated. On 05-JUN-2008, a representative from the physician''s called and indicated that she did not think this case was for one of their patients, since their office does not administer PROQUAD. The representative looked in the physician''s database for patients seen on 28-MAY-2008 and confirmed that no 6 year old females were on the schedule that day. Additional information is not expected.

VAERS ID:358405 (history)  Vaccinated:2009-09-23
Age:6.0  Onset:2009-09-23, Days after vaccination: 0
Gender:Female  Submitted:2009-09-26, Days after onset: 3
Location:Tennessee  Entered:2009-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN1IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)
Write-up: Hepatitis A was given at the county health dept and 4 hours later patient get a high fever of 102.2 and was very tired and slept a lot and had lost of appetite for 4 days.

VAERS ID:358487 (history)  Vaccinated:2009-09-25
Age:6.0  Onset:2009-09-27, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Arkansas  Entered:2009-09-28
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: Benefiber; Cholesterol
Current Illness: None
Preexisting Conditions: Hypoplastic (L) heart - corrective surgery x 2; Child has pre-existing heart problems. PMH: hypoplastic left heart syndrome. Smith-Lemli-Opitzrsyndrome. Heart surgery. G-tube. recent URI
Diagnostic Lab Data: Child has pre-existing heart problems. Labs and Diagnostics: CXR WNL for pt. WBC 11.9.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B103DA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0563Y SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0730Y SCLA
Administered by: Public     Purchased by: Other
Symptoms: Breast mass, Chest X-ray normal, Cough, Cyanosis, Dyspnoea, Hypoxia, Immunisation reaction, Injection site erythema, Injection site induration, Injection site pain, Oxygen saturation decreased, Pyrexia, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)
Write-up: A family member called & states child (on Sunday 09/27/09) developed a knot on breast, became short of breath & was admitted to the hospital. Dr states this was caused by the immunizations given on 09/25/09." 10/6/09 MR received for DOS 9/27-28/09 with DX: Hypoxia, Fever. Pt presented with cough, fever, SOB, as well as injection site erythema, tenderness and induration on the left arm. Cyanotic on admission, O2 sat 80%. Assessed as FUO, most likely 2'' to immunizations. Tx abx and IVF and observed o/n.

VAERS ID:358530 (history)  Vaccinated:2009-06-17
Age:6.0  Onset:2009-07-06, Days after vaccination: 19
Gender:Male  Submitted:2009-09-28, Days after onset: 84
Location:Virginia  Entered:2009-09-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flintstones & flouride tablets
Current Illness: None
Preexisting Conditions: None PMH: Juvenile Diabetes Allergies: Amoxicillin
Diagnostic Lab Data: Glucose testing on 8/28/09 10/7/09 Medical records received w/LABS: WBC 12.0(H). Sodium 131(L). HgbA1c 13.9(H). Urine (+) glucose & ketones. Labs: CBC, strep and mono-test (no results noted)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAUB336HA2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood sodium decreased, Condition aggravated, Cough, Decreased appetite, Enuresis, Fatigue, Full blood count, Glucose tolerance test, Glucose urine, Glycosylated haemoglobin increased, Hunger, Hyperglycaemia, Hypersomnia, Mononucleosis heterophile test, Otitis media, Polydipsia, Polyuria, Pyrexia, Streptococcus identification test, Thirst, Type 1 diabetes mellitus, Upper respiratory tract infection, Urine ketone body present, Weight decreased, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Tubulointerstitial diseases (broad)
Write-up: Patient started to display diabetes symptoms (bedwetting) in July. 10/07/09 Received hospital medical records for 8/28-8/30/2009. FINAL DX: new onset diabetes mellitus type 1. Records reveal patient experienced increased bedwetting x 2-3 mo, tiredness, increased sleeping, increased thirst & polydipsia x 3 wks w/2# wt loss. Hyperglycemic. Endocrine consult done. Tx w/DM diet & insulin. Stabilized & d/c home on continued insulin & diet w/endocrine follow up. 12/3/2009 PCP records for ov''s 8/23-11/24/2009. Patient with c/o''s fever, fatigue, cough, poor appetite. Tx''d with abx, dx''d with URI and Otitis Media (bilateral) 12/29/09 Immunization Record received for DOS 06/27/2007-11/15/2008. Hep A received 06/12/2008 (1 of 2).

VAERS ID:358652 (history)  Vaccinated:2009-09-09
Age:6.0  Onset:2009-09-10, Days after vaccination: 1
Gender:Female  Submitted:2009-09-18, Days after onset: 8
Location:Louisiana  Entered:2009-09-29, Days after submission: 11
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: ADHD
Diagnostic Lab Data: Platelet Count: 3000 10/5/09 Discharge summary received for dates of service 9/13/09 to 9/15/09. Diagnostics/Labs: WBC 10.08(H), HgB 12.7(WNL), platelets 3-37(L), ESR 35(H), IgG,IgA,IgM WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3204AA6IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood product transfusion, Haemoglobin normal, Headache, Idiopathic thrombocytopenic purpura, Injection site swelling, Petechiae, Platelet count decreased, Purpura, Red blood cell sedimentation rate increased, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Right arm where vaccine was administered swelled 2x size. Patient then developed thrombocytopenia ITP received IV Igg. Platelet count dropped to 3,000. Hospitalized 9/14/09. 10/5/09 Discharge summary received for dates of service 9/13/09 to 9/15/09. DX: Immune thrombocytopenia purpura. Presenting Symptoms: presented with a four day history of increased petechiae over both arms, trunk, and neck. Purpura on both Periorbital sufaces. Pt started on IVIG. Pt experienced HA, emesis x1 as side effect of tx.

VAERS ID:358720 (history)  Vaccinated:2009-09-21
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-09-29
Location:Oregon  Entered:2009-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness:
Preexisting Conditions: Nasolacrimal duct obstruction.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED05749111A0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Pt never had a reaction to the flu vaccine. Pt had received an adult dose. That is the reason it was reported.

VAERS ID:358936 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:2009-09-14
Gender:Female  Submitted:2009-09-29, Days after onset: 15
Location:Unknown  Entered:2009-09-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Constipation chronic
Preexisting Conditions:
Diagnostic Lab Data: Serum creatine kinase, 09/22/09, 432
CDC Split Type: WAES0909USA03625
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood creatine phosphokinase increased, Blood test, Condition aggravated, Constipation, Enema administration, Pain in extremity, Screaming, Tremor, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered pharmacist concerning a 6 year old female patient with a history of chronic constipation and no drug reactions who on an unspecified date, was vaccinated with a dose of VARIVAX (Merck) (lot# not reported, subcutaneous, 0.5ml) and a dose of MMRII (lot# and route not reported) in bilateral thighs. On an unspecified date, the patient developed thigh pain after the injections. The patient had no rash and no fever. On 14-SEP-2009 the patient developed a urinary tract infection and was placed on therapy with antibiotics. On 21-SEP-2009 the patient developed "shaking, soiled her pants and screaming with leg pain". The patient was taken to emergency room and CT scans were performed. The patient was diagnosed with constipation and was transferred to another hospital. In the emergency room an enema and digital stimulation was attempted for disimpaction and was unsuccessful. On 22-SEP-2009 the patient was then admitted around 2 a.m. to be disimpacted under sedation later today. Due to the patient''s complaint of thigh pain a CK level was drawn at 5:25 a.m. on 22-SEP-2009. The results were elevated at 432 (normal range for the hospital 20-160). Blood work was performed with no results reported. The patient''s thighs were nontender to palpation during assessment. At the time of this report, the patient had not recovered. Additional information has been requested.

VAERS ID:359124 (history)  Vaccinated:2009-09-29
Age:6.0  Onset:2009-09-30, Days after vaccination: 1
Gender:Male  Submitted:2009-10-01, Days after onset: 1
Location:Pennsylvania  Entered:2009-10-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3199AA4IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 8 x 10 cm erythematous welt at injection site-started within 24 hrs and progressed.

VAERS ID:359388 (history)  Vaccinated:2009-09-22
Age:6.0  Onset:2009-09-23, Days after vaccination: 1
Gender:Female  Submitted:2009-09-25, Days after onset: 2
Location:New Jersey  Entered:2009-10-05, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same as above~DTaP (no brand name)~4~1.60~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3176DA0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: About 16 hrs after admin of FLUZONE''0910, (L) tight became very large, swollen, erythema, tender, hot - $g10 cm induration.

VAERS ID:359497 (history)  Vaccinated:2009-09-28
Age:6.0  Onset:2009-09-30, Days after vaccination: 2
Gender:Female  Submitted:2009-10-05, Days after onset: 5
Location:New York  Entered:2009-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin
Current Illness: no
Preexisting Conditions: Omnicef, Augmentin allergy in past
Diagnostic Lab Data: WBC 9.0 ESR 22 CPK 39 ASO pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500715P1IN 
Administered by: Private     Purchased by: Private
Symptoms: Blood creatine phosphokinase increased, Laboratory test, Muscle spasms, Red blood cell sedimentation rate increased, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dystonia (broad)
Write-up: muscle cramps in thighs

VAERS ID:359544 (history)  Vaccinated:2009-10-02
Age:6.0  Onset:2009-10-03, Days after vaccination: 1
Gender:Male  Submitted:2009-10-05, Days after onset: 2
Location:Texas  Entered:2009-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B080CA4UNLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.0739Y1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD748043UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1069Y1SCLL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Edema, erythema + warmth to left anterior thigh. Hydroxyzine syrup 10 mg/tsp 1tsp three times a day PRN.

VAERS ID:359786 (history)  Vaccinated:2009-08-17
Age:6.0  Onset:2009-08-24, Days after vaccination: 7
Gender:Female  Submitted:2009-09-01, Days after onset: 8
Location:Pennsylvania  Entered:2009-10-06, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Similar to patient.~Varicella (Varivax)~2~8.00~Sibling
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Peribronchial cuffing on CXR; see attached
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0803Y1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Bronchiolitis, Chest X-ray abnormal, Cough, Oropharyngeal pain, Pyrexia, Rales, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad)
Write-up: Tachypnea, lung rales and dx''d with bronchiolitis and treated with oral prednisone and albuterol neb q 4 hrs. Child had fever, cough and sore throat beginning 1 wk after VARIVAX vaccination. Sibling had similar C/O''s 1 wk after VARIVAX given @ same time as sister.

VAERS ID:359755 (history)  Vaccinated:2009-10-06
Age:6.0  Onset:2009-10-06, Days after vaccination: 0
Gender:Male  Submitted:2009-10-07, Days after onset: 1
Location:Nebraska  Entered:2009-10-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3193AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: 3"x4" hard red warm swollen area

VAERS ID:360092 (history)  Vaccinated:2009-10-07
Age:6.0  Onset:2009-10-07, Days after vaccination: 0
Gender:Female  Submitted:2009-10-08, Days after onset: 1
Location:California  Entered:2009-10-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Latent Tuberculosis Infection, on isoniazid treatment
Diagnostic Lab Data: Normal head CT. EEG pending.
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEURU3203AA0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Convulsion, Dizziness, Electroencephalogram, Endotracheal intubation, Extubation, Fatigue, Gait disturbance, Grand mal convulsion, Intensive care, Latent tuberculosis, Mental status changes, Nausea, Posturing, Pyrexia, Scan brain, Toxicologic test abnormal, Tremor, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad)
Write-up: New onset seizure, taken to hospital. Given lorazepam and loaded with dilantin. Non-responsive, intubated. Transferred to another hospital.

VAERS ID:360113 (history)  Vaccinated:2009-10-08
Age:6.0  Onset:2009-10-08, Days after vaccination: 0
Gender:Male  Submitted:2009-10-09, Days after onset: 1
Location:Alabama  Entered:2009-10-09
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
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FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)MEDIMMUNE VACCINES, INC.500757P0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: MY SON BROKE OUT IN WHAT APPEARED TO BE BUG BITES AND HE W AS REAL ITCHY THEN IT SPREAD FROM HIS NECK TO UNDERARMS CHEST SCALP STOMACH LEGS AND FEET

VAERS ID:360192 (history)  Vaccinated:2009-10-07
Age:6.0  Onset:2009-10-08, Days after vaccination: 1
Gender:Male  Submitted:2009-10-09, Days after onset: 1
Location:Florida  Entered:2009-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3190AA3IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Skin reaction
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: SKIN REACTION, ERYTHEMA 8CM X 7 1/2CM, NO SIGN INDURATION, NOT PAINFUL, NOT ITCHING

VAERS ID:360195 (history)  Vaccinated:2009-10-07
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-09
Location:North Carolina  Entered:2009-10-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: edema redness at site~Influenza (Seasonal) (Fluzone)~1~8.67~Sibling|edema redness at site~Polio Virus, Inact. (no brand name)~UN
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3173AA7IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The patient got a flu vaccine last night and now has significant edema and erythema of his left upper arm. His brother had a flu vaccine two days before and also had significant erythema and edema. It has started to go down with Benadryl and cephalexin. The patient has also had a previous episode of erythema and edema with a vaccination, which was thought to be the polio vaccine. This same sort of symptoms were present for that. We discussed the ingredients of the flu vaccine and at this point, I do not know what he specifically had that could have caused a reaction. He has had eggs before and it is unlikely that this is a reaction to eggs. However, I do not want him to get the injectable flu vaccine any more. He has had FluMist vaccines in the past. We will record this as an adverse reaction. Benadryl is the best thing in the meantime for edema and they will call if it is persisting.

VAERS ID:360220 (history)  Vaccinated:2009-10-07
Age:6.0  Onset:2009-10-08, Days after vaccination: 1
Gender:Female  Submitted:2009-10-09, Days after onset: 1
Location:New Jersey  Entered:2009-10-09
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: Allergy - PCN; Hx asthma
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3177AA UNLA
Administered by: Public     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Cellulitis Left arm after receiving seasonal flu vaccine via pharmajet. Shoulder to elbow red, hot, swollen. Emergency room visit. Prescribed BACTRIM. Above noted 10/8 pm.

VAERS ID:360312 (history)  Vaccinated:2009-10-08
Age:6.0  Onset:2009-10-09, Days after vaccination: 1
Gender:Female  Submitted:2009-10-10, Days after onset: 1
Location:North Dakota  Entered:2009-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: allergies
Diagnostic Lab Data:
CDC Split Type:
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.    
Administered by: Public     Purchased by: Private
Symptoms: Cough, Oropharyngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: sore throat, fever, cough - gave tylenol and cough syrup, by 5:00 pm she was running a high fever and the tylenol would break it and the fever kept coming back until 10/10/09 about 11:00 AM fever finally broke.

VAERS ID:360441 (history)  Vaccinated:2009-09-25
Age:6.0  Onset:2009-09-25, Days after vaccination: 0
Gender:Male  Submitted:2009-09-25, Days after onset: 0
Location:California  Entered:2009-10-12, Days after submission: 17
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: NKDA; Asthma; Pre-term infant; Speech delays
Diagnostic Lab Data:
CDC Split Type:
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VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1001Y1SCRA
Administered by: Military     Purchased by: Military
Symptoms: Cough, Eyelid oedema, Lip swelling, Retching
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Pt received Varicella in right deltoid/ .5ml/SC. 10 minutes later pt complained of swelling to lips eyelids. Had cough/gagging sensation. Brought to room, 911 called. Pt received .15mg Epipen Jr. and 25mg BENADRYL PO. Pulse ox 98%-100% entire time. Pt transported via ambulance to ER.

VAERS ID:360524 (history)  Vaccinated:2009-10-06
Age:6.0  Onset:2009-10-08, Days after vaccination: 2
Gender:Male  Submitted:2009-10-12, Days after onset: 4
Location:New Mexico  Entered:2009-10-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illness
Preexisting Conditions: bronchial asthma, allergies seasonal and some animals
Diagnostic Lab Data: some sort of allergic reaction to flu vaccine. Patient did have flu vaccincation last year 2008 with no previous complications.
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site swelling, No reaction on previous exposure to drug
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Patient recieved flu vaccine 10/6/09. 48 hrs after injection, patients left arm was still inflammed around injection site (left bicep and around upper arm). Symptoms consisted of swollen, redness and inflammation which left arm was bigger than other arm. No fever or other serious symptoms associated with injection. Patient was given Predisone injection 10/8/08 and predisone dose po qd, day after to reduce inflamation. Prior to MD visit on 10/8/08, parents administered loratidine 5ml, benedryl gel, later cortisone cream which did not reduce inflamation. Parents had also contacted after hours md service which was advised to seek md for visit.

VAERS ID:360625 (history)  Vaccinated:2009-10-07
Age:6.0  Onset:2009-10-07, Days after vaccination: 0
Gender:Female  Submitted:2009-10-13, Days after onset: 6
Location:Ohio  Entered:2009-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: high fever 3 days, bronchitis
Preexisting Conditions: ENURESIS NOS 788.30 ATTN DEFICIT W HYPERACT
Diagnostic Lab Data:
CDC Split Type:
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500677P   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Breath sounds abnormal, Bronchitis, Cough, Nasal congestion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow)
Write-up: Chief complaint of mild nasal congestion and cough. Symptoms began about 3 days ago. Fever has been high-grade. Other associated symptoms include: nosiy breathing at night. High fever 3 days, bronchitis the fever and cough came after the vaccine.

VAERS ID:360713 (history)  Vaccinated:0000-00-00
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-13
Location:Georgia  Entered:2009-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3208AA UNRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness, swelling at the site of the FLUZONE shot.

VAERS ID:360859 (history)  Vaccinated:2009-10-13
Age:6.0  Onset:2009-10-13, Days after vaccination: 0
Gender:Female  Submitted:2009-10-14, Days after onset: 1
Location:California  Entered:2009-10-14
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: NKDA
Diagnostic Lab Data:
CDC Split Type:
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DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0694IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0765Y1SCLA
Administered by: Public     Purchased by: Other
Symptoms: Blindness, Nasal congestion, Pallor
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Per mother pt c/o "I am not able to see and pressure on nose." Pt pale, without SOB, calm. Pt denied any other discomfort. No rash on body or extremities.

VAERS ID:360951 (history)  Vaccinated:2009-10-04
Age:6.0  Onset:2009-10-04, Days after vaccination: 0
Gender:Male  Submitted:2009-10-06, Days after onset: 2
Location:Virginia  Entered:2009-10-15, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3214AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Cough, Eye pain, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad)
Write-up: 5 hours post injection fever 103 degrees persisting for 2 days, sore eyes and body aches wit.h dry cough. Still fever at time of report.

VAERS ID:360964 (history)  Vaccinated:2009-10-12
Age:6.0  Onset:2009-10-12, Days after vaccination: 0
Gender:Female  Submitted:2009-10-15, Days after onset: 3
Location:Virginia  Entered:2009-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Rapid flu A and B test
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3210AA1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Headache, Influenza serology negative, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad)
Write-up: Received a fluzone vaccine in the am of 10/12/2009. That evening developed a fever of 103, headache and back pain. Came to office 10/13/2009 flu test was negative with no signs of illness.

VAERS ID:361031 (history)  Vaccinated:2009-10-14
Age:6.0  Onset:2009-10-15, Days after vaccination: 1
Gender:Male  Submitted:2009-10-15, Days after onset: 0
Location:Ohio  Entered:2009-10-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: slight dry cough
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC. 0IN 
Administered by: Private     Purchased by: Private
Symptoms: Chills, Cough, Croup infectious, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Vomitting, high fever 102.3,chills,muscle aches,croup rough coughing

VAERS ID:361156 (history)  Vaccinated:2009-10-09
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-13
Location:Arizona  Entered:2009-10-16, 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:
Diagnostic Lab Data:
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3175AA0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Diarrhoea, Headache, Heart rate normal, Immediate post-injection reaction, Immunisation reaction, Influenza, Influenza like illness, Pyrexia, Respiratory rate, Respiratory tract congestion, Somnolence, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: The patient came to day at 6 years of age with his mother and his 2 siblings who have similar symptoms with complaint of an illness of 3 days duration. Of note is the fact that the patient receive the injectable flu vaccine on October 9, 2009 and subsequently was not to become ill the next day. The patient''s brother received the FLUMIST vaccine on the same day and also subsequently became ill with a flu like syndrome as did his other brother who also received the FLUMIST vaccine. The patient has complained of fever, headache and diarrhea for the past 3 days area the headache is frontal. He is a temperature elevation of 104 and has been very sleepy. Exam The patient appears to be in no distress. The patient weight is 41 pounds, temp 102.3, pulse 98, resp rate 20, and blood pressure 98/60. There no meningeal signs. Tympanic bilaterally are normal. Examination the nose mouth and pharynx was significant for mucous membranes being moist. There is no adenopathy neck. Auscultation of the chest was clear heart sounds were normal without murmurs. The abdomen was soft without organomegaly or masses. Assessment Viral syndrome (probable influenza) reaction to FLUMIST vaccine that was given to a sibling? Probable influenza immediately after receiving injectable flu vaccine. Plan I discussed symptomatic treatment in details with parents. ALBUTEROL should be used via metered dose inhaler on a prn basis. I would recommend following the action plan provided by the patient''s pulmonologist. The parents informs me that the child has been restarted on SINGULAIR and is also been continously on FLOVENT. Stimulation should be tried for cough and congestion and honey as cough suppressant. If the child develops additional concerning symptoms then he should certainly be reevaluated.

VAERS ID:361176 (history)  Vaccinated:2009-09-30
Age:6.0  Onset:2009-09-30, Days after vaccination: 0
Gender:Female  Submitted:2009-10-12, Days after onset: 12
Location:Indiana  Entered:2009-10-16, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
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DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0804IMLA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Loss of consciousness, Rash, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Mother said child had temp elevated earlier in week up to yesterday. No elevated temp today. Mother took child home. Mother called child vomited lites were worse got rash, passed out. Encouraged mother to take child to ER on to MD. Called mother on second occasion unable to reach her. Still unable to reach 10/12/09.

VAERS ID:361214 (history)  Vaccinated:2009-10-13
Age:6.0  Onset:2009-10-13, Days after vaccination: 0
Gender:Female  Submitted:2009-10-16, Days after onset: 3
Location:New York  Entered:2009-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none, NKDA
Diagnostic Lab Data: none
CDC Split Type:
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FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500705P0IN 
Administered by: Unknown     Purchased by: Public
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Child developed hives and itching lasting 2 days.

VAERS ID:361296 (history)  Vaccinated:2009-10-02
Age:6.0  Onset:2009-10-02, Days after vaccination: 0
Gender:Female  Submitted:2009-10-16, Days after onset: 14
Location:Washington  Entered:2009-10-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO illness at time of vaccine.
Preexisting Conditions: No allergies or birth defects at time of vaccine. PMH: none Allergies: none
Diagnostic Lab Data: Labs/DX studies None
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS98442P1B0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Patient was seen in ER and treated for Bells Palsy. Patient had received flu shot 10 days prior. From notes it appears that symptoms of facial droop began on day of injection. 10/26/2009 hospital records for ED visit 10/11/2009. Presenting sx of rt facial droop, confirmed per PE. Tx: Acyclovir, Prednisone and eye gtts. DC DX: Bells Palsy

VAERS ID:361329 (history)  Vaccinated:2009-10-17
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-18
Location:Unknown  Entered:2009-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
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DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Nausea, headache within 12 hours

VAERS ID:361336 (history)  Vaccinated:2009-10-13
Age:6.0  Onset:2009-10-16, Days after vaccination: 3
Gender:Male  Submitted:2009-10-18, Days after onset: 2
Location:Florida  Entered:2009-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Cleocin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC. 0  
Administered by: Private     Purchased by: Private
Symptoms: Cough, Lethargy, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Fever 102 or 103, runny nose, dry cough, lethargy. Tamiflu given 10/17/2009.

VAERS ID:361418 (history)  Vaccinated:2009-10-14
Age:6.0  Onset:2009-10-15, Days after vaccination: 1
Gender:Female  Submitted:2009-10-18, Days after onset: 3
Location:Nebraska  Entered:2009-10-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Enbrel; Depakote; Prevacid; Prednisone; Atterax; Xyzal; Elavil
Current Illness: Chronic disease only
Preexisting Conditions: Still''s disease; Gerd; Migraines; Seizure disorder PMH: Stills disease, Seizure disorder, GERD, Migraines Allergies: NKDA
Diagnostic Lab Data: Lab: CBC, MCV 91.6 high, ESR normal, Glucose 165 high, K-3.5 low, BUN 23 high, AlkPh 141 high, CRP 2.40 high
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURLLP002AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Blood alkaline phosphatase increased, Blood glucose increased, Blood potassium decreased, Blood urea increased, Body temperature increased, C-reactive protein increased, Full blood count, Joint swelling, Mean cell volume increased, Pain, Pyrexia, Rash, Red blood cell sedimentation rate normal, Tonic convulsion
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: 17 hours post administration - Pt presented w / 105 temperature, B knee edema +1, rash, tonic seizure, body aches, fever 101-103 and body aches lasted 3 days. 10/20/2009 received VAERS report , lab done 10/17/2009 and note from MD office stating that mother called MD office on 10/15/2009 to report that daughter, 1 day post vaccine, had sx of bilateral knee edema, fever of 105, rash, tonic seizure activity and arthralgias.

VAERS ID:361443 (history)  Vaccinated:2009-10-05
Age:6.0  Onset:2009-10-06, Days after vaccination: 1
Gender:Male  Submitted:2009-10-15, Days after onset: 9
Location:North Carolina  Entered:2009-10-19, Days after submission: 4
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: Albuterol
Current Illness:
Preexisting Conditions: Medical history of asthma, obesity, and pre-diabetes.
Diagnostic Lab Data:
CDC Split Type: 200904253
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3210A IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Cellulitis, Erythema, Injection site vesicles, Oedema peripheral, Skin exfoliation, Skin warm
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Initial case was received from a physician on 07 and 08 October 2009. A six-year-old male patient experienced blistering and cellulitis of the vaccinated arm after receiving an intramuscular, right deltoid injection of FLUZONE SV 2009-2010 (lot number U3210AA) on 05 October 2009. The patient had a history of asthma, obesity, and pre-diabetes, and was taking Albuterol concomitantly as needed. on 06 October 2009, the day after vaccination, the patient developed three blisters, five inches from the injection site on the right deltoid. By the next day, he presented with 75 blisters below the injection site; the largest was described as being the size of a 50 cent piece. The blisters ruptured, and the skin subsequently sloughed off. An area of cellulitis developed, described as hot, red, and swollen, in an area approximately 6 inches long by 4-5 inches wide. The reaction was most prominent on the medial aspect of the upper arm, where the patient''s arm rubbed against his chest, but had also spread circumferentially. The patient had no systemic symptoms, and felt well otherwise. The reporter felt that contact dermatitis was unlikely, as the patient had been wearing clothing which covered the area. He was admitted to the pediatric unit of the hospital, and was treated with Clindamycin and Benadryl. As of 08 October 2009, the patient was reported to be improving. Documents held by sender: None.

VAERS ID:361527 (history)  Vaccinated:2009-10-14
Age:6.0  Onset:2009-10-14, Days after vaccination: 0
Gender:Female  Submitted:2009-10-19, Days after onset: 5
Location:Washington  Entered:2009-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Facility FluMist was received is not sure of exact Lot # given to patient, provided both Lot numbers of FluMist available to them.
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Radiology: DX Chest 2V AP/LAT (chest xray) Laboratory: FA Respiratory Virus/Reflex Flu A PCR
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500729P1IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Chest X-ray, Cough, Decreased appetite, Heart rate increased, Influenza, Influenza serology positive, Pneumonia, Polymerase chain reaction, Pyrexia, Respiratory rate increased, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: 10/14/09 - Received FluMist influenza vaccine.Abdominal pain,weakness,loss of appetite, cough started. 10/15/09 - abdominal pain/weakness continued, fever at 100 degrees, moist non productive cough increased 10/16/09 - high fever at 103.8, cough increased, very weak, loss of appetite 10/17/09 - 10/18/09 - coarse cough, rapid breathing at 36 bpm, increased heart rate at up to 130 bpm, abdominal pain with vomiting, fever at 102.7 degrees F, not responding to tylenol given overnight at home. ER visit, Xray confirmed pneumonia, nasal specimen for FA Respiratory Virus/Reflex Flu A PCR test confirmed Influenza A.

VAERS ID:361603 (history)  Vaccinated:2009-10-09
Age:6.0  Onset:0000-00-00
Gender:Male  Submitted:2009-10-19
Location:Arizona  Entered:2009-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500713P0IN 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB327AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0989Y1SCRA
Administered by: Public     Purchased by: Other
Symptoms: Erythema multiforme, Rash erythematous, Rash pruritic, Skin plaque
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Erythema multiforme (see attached progress note). History: Patient came today at 6 years of age with complaint of from onset 2 days ago of a slightly itchy rash on both his inner thighs that has now spread to his lower extremities. The patient reports no other signs of illness. He did get immunizations on October 9 specifically the VARIVAX #2, HAVRIX #1 and FLUMIST. Exam: The patient appears to be in no distress. Examination of the skin did show a confluent erythematous irregular slightly raised rash consisting of flat round and oval plaques as well as target lesions on both inner thighs with some scant lesions on the lateral aspects of the thighs as well as the distal lower extremities consistent with erythema multiforme. Assessment: Erythema multiforme following immunizations. Plan: I provided the mother with written and verbal information on erythema multiforme and recommended topical treatments if he does develop more significant itching. A report will be submitted to VAERS. Mother was advised to contact us if the child develops involvement of mucous membranes, eyes or mouth. I advised mother that the cause of this eruption is unclear, including in this case, though it is generally benign and self-limited. Since it did occur after immunizations we will report to VAERS.

VAERS ID:361645 (history)  Vaccinated:2009-10-14
Age:6.0  Onset:2009-10-15, Days after vaccination: 1
Gender:Male  Submitted:2009-10-19, Days after onset: 4
Location:Rhode Island  Entered:2009-10-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol 90 mcg; FLOVENT 44 mcg
Current Illness: Annual physical
Preexisting Conditions: Amoxicillin-hives; asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3179BA4IMLA
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 10/15/09 seen in office for redness, pain, swelling of L arm, itchy, afebrile. Tx: ice, MOTRIN. 10/16/09 T-100.6, redness and swelling increased and is itchy. Swelling from shoulder to proximal forearm, area warm and indurated. No streaking, normal pulses, tx: clindamycin.

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