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Case Details (Sorted by Vaccination Date)

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VAERS ID:326404 (history)  Vaccinated:2008-09-20
Age:17.0  Onset:2008-09-20, Days after vaccination: 0
Gender:Male  Submitted:2008-09-22, Days after onset: 2
Location:California  Entered:2008-09-29, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2662AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA6IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0443X1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient complained of swelling in area afternoon after shot. Some itching. Pink area 7 cm x 5.5 x cm with dark, red area in center 3 cm x 3 cm.

VAERS ID:329720 (history)  Vaccinated:2008-09-20
Age:22.0  Onset:2008-09-20, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 24
Location:Illinois  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives; ASACOL
Current Illness: Colitis; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA03809
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a mother concerning her 22 year old female daughter with colitis and allergies to Ceclor, who on 20-SEP-2008 was vaccinated with the second dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified) and ASACOL. The mother reported that her daughter developed a fever, nausea, vomiting and a rash on her chest about 8 hours after receiving her second dose of GARDASIL. The patient sought medical attention by a phone call. At the time of report the patient had not recovered. Additional information has been expected.

VAERS ID:333178 (history)  Vaccinated:2008-09-20
Age:7.0  Onset:2008-09-21, Days after vaccination: 1
Gender:Female  Submitted:2008-11-24, Days after onset: 64
Location:Texas  Entered:2008-11-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Erythema Multiforme~Influenza (no brand name)~0~7~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER?0IN 
Administered by: Private     Purchased by: Private
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow)
Write-up: Developed Erythema Multiforme within a few days of flu mist vaccine. Developed same reaction one year ago after injectable flu vaccine.

VAERS ID:325779 (history)  Vaccinated:2008-09-21
Age:31.0  Onset:2008-09-21, Days after vaccination: 0
Gender:Female  Submitted:2008-09-22, Days after onset: 1
Location:Arizona  Entered:2008-09-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Headache, Neck pain, Pain
SMQs:, Arthritis (broad)
Write-up: 4 hours after injection, sharp pains in head and neck. 10 hours after injection chills and all over body pain. 18 hours after injection pain is less.

VAERS ID:326589 (history)  Vaccinated:2008-09-21
Age:35.0  Onset:2008-09-22, Days after vaccination: 1
Gender:Male  Submitted:2008-09-30, Days after onset: 8
Location:Ohio  Entered:2008-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Neut 11; Lymph 73; Mono 16; CSF protein 48.7; CSF glucose 71. 9/25/2008 CSF culture: Gram stain-rare WBC; no organisms seen; culture no growth @24hrs, 48hrs. Pending: LFTs, West Nile studies, CSF for HSV PCR, enteroviral PCR. 9/25/2008 CT brain (non-contrast): normal LABS: WBC 13.0(H). CSF: WBC 103(H), RBC 46(H), neutros 11(H), culture neg, protein 48.7(H), glucose 71(N). CT brain WNL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1481SCUN
Administered by: Military     Purchased by: Military
Symptoms: CSF culture negative, CSF glucose normal, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Chills, Computerised tomogram normal, Fatigue, Headache, Injection site erythema, Injection site nodule, Joint stiffness, Liver function test, Lumbar puncture, Lymphocyte count normal, Malaise, Meningitis viral, Monocyte count normal, Musculoskeletal stiffness, Nausea, Neutrophil count increased, No reaction on previous exposure to drug, Pharyngolaryngeal pain, Polymerase chain reaction, Pyrexia, Red blood cells CSF positive, Scan brain, Sick relative, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad)
Write-up: 35 y/o WM, who received AVA#2 9/21/2008; was well prior to and day of vaccinations. On 9/22 he developed malaise, fatigue, joint stiffness; on 9/23 he developed fever (no temp taken) & chills; on 9/24 he awoke with severe headache & nausea w/o vomiting; headache was worsened with movement. He did have mild sore throat. On 9/25 he presented to ER and was admitted. Spinal tap was positive for viral meningitis. He was discharged 9/27/2008. As of 9/30 he is headache-free, but continues with mild joint stiffness and intermittent mild fatigue. SM has 2 children ages 2 & 4 y/o who were both ill w/nausea & vomiting from 9/18-9/19-2008 but recovered with 24 hrs. SM received AVA#1, HepB#2, & Flu Mist on 9/7/2008 w/o reactions. Symptoms: Headache, general, Nausea w/o vomiting, Fever, Chills, Fatigue, Malaise <60 Days, Joint Pain, multiple joints. 10/7/08 Reviewed medical records of 9/25-9/30/2008. FINAL DX: viral meningitis Records reveal patient hospitalized 9/25-9/27/08, 4 days s/p anthrax #2, after experiencing malaise, fatigue, joint stiffness, fever, chills, severe HA, nausea, mild neck stiffness, mild sore throat, small injection site nodule w/minimal redness. ID consult included. Patient w/2 young children who were ill w/vomiting 2-3 days prior to patient''s vaccination. No reaction to previous vaccines: anthrax #1, Hep B #2 & Flumist received on 9/7/08.

VAERS ID:335881 (history)  Vaccinated:2008-09-21
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:2008-12-18
Location:Florida  Entered:2008-12-22, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER09296803IMLA
HEP: HEP B (FOREIGN)MERCK & CO. INC.0434H2UNRA
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER09344403IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR4525932PO 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0955H0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Spots on back, chest , legs and face.

VAERS ID:328919 (history)  Vaccinated:2008-09-21
Age:0.4  Onset:2008-10-07, Days after vaccination: 16
Gender:Male  Submitted:2008-10-16, Days after onset: 9
Location:Foreign  Entered:2008-10-17, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810MYS00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Barium enema, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: Information has been received from a physician concerning a 20 weeks old male who on 21-SEP-2008 was vaccinated with the second dose of ROTATEQ, 2 mL, oral administration. On 07-OCT-2008, the patient experienced intussusception and was hospitalized on 07-OCT-2008 (morning). Patient was treated with barium enema. The patient''s "symptoms of intussusception reduced" but persisted. Intussusception was considered to be immediately life-threatening. Hospitalization was prolonged due to the intussusception. Causality was reported as unknown. No further information is available.

VAERS ID:325840 (history)  Vaccinated:2008-09-22
Age:17.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-09-23, Days after onset: 1
Location:Florida  Entered:2008-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cindamycin 300mg oral capsule 1 tab PO QID; Analapril 5mg PO daily; Vitamin D; Flovent 2 puffs inhaled; Laclulose 30ml PO BID; Asacol 800mg PO BID; Non-formula continuous infusion; Prednisone 20mg PO daily; Alampin 150mg PO daily; Alampin 3
Current Illness:
Preexisting Conditions: Primary sclerosing cholangitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2791AA0UNRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X0UNLA
Administered by: Private     Purchased by: Other
Symptoms: Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received PNEUMOVAX vaccine. Arm became swollen, warm to touch, down into chest few hours after receiving injection. Went to ER around 11:00 PM.

VAERS ID:325880 (history)  Vaccinated:2008-09-22
Age:11.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-23, Days after onset: 0
Location:Michigan  Entered:2008-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Caritin 10mg
Current Illness: none
Preexisting Conditions: allergic rhinitis
Diagnostic Lab Data: None completed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB244BA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives located on arms, neck and trunk. Parents gave oral benadryl and put anti itch cream on hives

VAERS ID:325881 (history)  Vaccinated:2008-09-22
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-23
Location:Illinois  Entered:2008-09-23
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0293X0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Gave Zostavx to person less than 60 yrs of age

VAERS ID:325883 (history)  Vaccinated:2008-09-22
Age:25.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-09-23, Days after onset: 1
Location:Florida  Entered:2008-09-23
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
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500552P1IN 
Administered by: Military     Purchased by: Military
Symptoms: Loss of consciousness, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 5 min after receiving flu mist, pt went unconscience for aprox 45 sec. due to vasovagal episode. Pt was given O2 and fully recovered.

VAERS ID:325884 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-23, Days after onset: 0
Location:Massachusetts  Entered:2008-09-23
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: Hx of recurrent infection
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500543P5IN 
Administered by: Private     Purchased by: Private
Symptoms: Chills, Enuresis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, chills, nocturnal enuresis within 12 hours of flumist

VAERS ID:325888 (history)  Vaccinated:2008-09-22
Age:2.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-23, Days after onset: 0
Location:Utah  Entered:2008-09-23
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 PASTEURUT2782CA2IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAAAHAVB51IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1119X0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness, Swelling, Hot to touch. Celluitis was put on Augmentin 400/5.

VAERS ID:325898 (history)  Vaccinated:2008-09-22
Age:21.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-09-23, Days after onset: 1
Location:Oregon  Entered:2008-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Cold sweat, Dizziness, Feeling cold, Myalgia, Nausea, Tunnel vision
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (narrow), Vestibular disorders (broad)
Write-up: Pt states that about 12 hours Tdap immunization she was having dinner, felt very nauseated, dizzy, tunnel vision, cold sweats. Pt sat down for about 10 minutes and felt better. Then about 1 hour later, pt felt very cold, had chills. Pt states that she woke up repeatedly during the night with sore muscles. Pt states that she now feels fine.

VAERS ID:325908 (history)  Vaccinated:2008-09-22
Age:4.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-23, Days after onset: 0
Location:Virginia  Entered:2008-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2772AA4IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Skin tightness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Arm became red and swollen from elbow to shoulder, tight, tense skin, itchy, painful.

VAERS ID:326023 (history)  Vaccinated:2008-09-22
Age:60.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-09-24, Days after onset: 2
Location:Arizona  Entered:2008-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: Hepatitis C
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2751AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Faeces discoloured, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient received flu shot on 9/22/08. When she went home, she developed vomiting, nausea and dark colored diarrhea. No treatment given as yet.

VAERS ID:326041 (history)  Vaccinated:2008-09-22
Age:7.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-29, Days after onset: 6
Location:North Carolina  Entered:2008-09-24, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0430X1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen right arm.

VAERS ID:326043 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-09-24, Days after onset: 2
Location:Alabama  Entered:2008-09-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Multiple insect bites
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.028541UNLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Local reaction, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Local reaction (L) deltoid area reddened hot to touch.

VAERS ID:326225 (history)  Vaccinated:2008-09-22
Age:11.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-24, Days after onset: 1
Location:New York  Entered:2008-09-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0980X1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Rash pustular
SMQs:, Hypersensitivity (narrow)
Write-up: Rash (pustular) - generalized since 09/23/2008 - No fever

VAERS ID:326286 (history)  Vaccinated:2008-09-22
Age:14.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-23, Days after onset: 0
Location:Georgia  Entered:2008-09-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient|None~ ()~~0~In Sibling|None~ ()~~0~In Sibling
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2689AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Headache, Pain, Pruritus, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Red papules on face, headache and body ache with itching within 18 hours of administration of MENACTRA and GARDASIL immunization.

VAERS ID:326316 (history)  Vaccinated:2008-09-22
Age:49.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-26, Days after onset: 3
Location:New York  Entered:2008-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2805AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient developed an erythematous, pruritic cutaneous rash on her arms and legs twenty four hours after vaccine administration. Patient was treated with benadryl.

VAERS ID:326328 (history)  Vaccinated:2008-09-22
Age:49.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-26, Days after onset: 3
Location:California  Entered:2008-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: synthroid
Current Illness: none
Preexisting Conditions: Latex
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2785GA4IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Approximately 12 hours after recieving the vaccine I broke out in hives. Benadryl 25mg. Taken at that time and every 4-6 hours after.Hives lasted for 2 days.

VAERS ID:326406 (history)  Vaccinated:2008-09-22
Age:11.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-25, Days after onset: 2
Location:New York  Entered:2008-09-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None Stated.

VAERS ID:326407 (history)  Vaccinated:2008-09-22
Age:64.0  Onset:2008-09-24, Days after vaccination: 2
Gender:Female  Submitted:2008-09-25, Days after onset: 1
Location:Pennsylvania  Entered:2008-09-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2760AA IMRA
Administered by: Public     Purchased by: Private
Symptoms: Cellulitis
SMQs:
Write-up: Cellulitis right arm

VAERS ID:326410 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-24, Days after vaccination: 2
Gender:Male  Submitted:2008-09-25, Days after onset: 1
Location:Oregon  Entered:2008-09-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfa; Mediphendryl
Current Illness: Getting molars
Preexisting Conditions: Allergies; Past Hx pneumonia 1 yr ago.
Diagnostic Lab Data: Child given sulfa by MD several days ago. Child had fever 1 day prior to vaccine (T 99).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2356CA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA10683IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0951X1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives on trunk starting 2 day after immunizations. Grandmother gave Benadryl 9/24/08 in PM after call to nurse and hives had resolved by late 9/24/08. Sulfa stopped by grandmother on 9/24/08 PM.

VAERS ID:326426 (history)  Vaccinated:2008-09-22
Age:35.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-29, Days after onset: 6
Location:Missouri  Entered:2008-09-29
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
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Cough, Feeling hot, Injection site pain, Myalgia, Retching, Sensation of foreign body, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad)
Write-up: At 7:00 PM I received the flu shot. At 12:15 AM I start coughing because I felt like something was suddenly in my throat. My throat quickly warmed and the warming sensation traveled along my throat down into my chest. I then start having chills and shaking. Vomiting and dry heaving followed with extreme muscle ache. The muscle was so intense that it hurt to lay down and I could not get comfortable. These symptoms lasted until about 4:00 Am. I had muscle soreness and a tender arm where I received the injection for 2 days following.

VAERS ID:326467 (history)  Vaccinated:2008-09-22
Age:4.0  Onset:2008-09-28, Days after vaccination: 6
Gender:Male  Submitted:2008-09-29, Days after onset: 1
Location:Massachusetts  Entered:2008-09-29
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
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2356CA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA099623SCRA
Administered by: Private     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash on (L) upper arm since yesterday. No c/o itching. Afebrile Flat rash with central clearing.

VAERS ID:326529 (history)  Vaccinated:2008-09-22
Age:70.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-25, Days after onset: 2
Location:California  Entered:2008-09-30, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prostate cancer
Preexisting Conditions: PMH: DVT on long term anticoagulant therapy.
Diagnostic Lab Data: WBC 13.6, 9/24
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.97221060IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Leukocytosis, Pyrexia, Vaccination complication, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine given 9/22/08 10:30 am side effect 5am 9/23/08 was fever - large left upper arm pain and swelling. WBC increased 13.5. 12/23/08 Reviewed hospital medical records of 9/17-9/26/2008. FINAL DX: prostate carcinoma; radical retropubic prostatectomy & bilateral pelvic lymphadenectomy; adverse reaction pneumovax vaccine. Records reveal patient experienced prostate cancer, underwent radical surgery w/o complication. Received pneumovax on post op day 5. Developed left shoulder injection site swelling, fever & leukocytosis on post op day 6. Treated w/antibiotics. Resolved by post op day 9. D/C to home with indwelling Foley catheter, on continued antibiotics.

VAERS ID:326541 (history)  Vaccinated:2008-09-22
Age:56.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-23
Location:North Carolina  Entered:2008-09-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF452CA1IMUN
Administered by: Public     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Patient presented to Health Dept requesting TDAP - denied having TD in last 5 years. NCIR unable to see record. TDAP given then once NCIR accessible saw TDAP given 4/14/08 - patient unaware of this, when notified. No complications.

VAERS ID:326558 (history)  Vaccinated:2008-09-22
Age:25.0  Onset:0000-00-00
Gender:Male  Submitted:2008-09-24
Location:Oregon  Entered:2008-09-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: fisickle~Tetanus Toxoid (no brand name)~1~25~In Patient
Other Medications: None
Current Illness: None/Just a fisikle
Preexisting Conditions: Treits = tics
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Back pain, Feeling cold, Movement disorder, Pain
SMQs:, Retroperitoneal fibrosis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Arthritis (broad)
Write-up: My whole body hurts. My knees hurts real bad. They are cold. My back hurts. Both my arms hurts. Its just getting worse. It hurts when I move.

VAERS ID:326561 (history)  Vaccinated:2008-09-22
Age:10.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-24, Days after onset: 1
Location:Oregon  Entered:2008-09-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB246AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0085X1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Developed 5cm x 7cm area erythema at injection site w/in 24 hours of vaccine. (+) pruritis.

VAERS ID:326590 (history)  Vaccinated:2008-09-22
Age:2.0  Onset:2008-09-27, Days after vaccination: 5
Gender:Female  Submitted:2008-09-30, Days after onset: 3
Location:Ohio  Entered:2008-09-30
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 34 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Rhinorrhea and cough
Preexisting Conditions: Febrile seizures Aug 07 and Dec 07. PMH: febrile seizure
Diagnostic Lab Data: Labs and Diagnostics: CT head and spine (-).PMH: febrile seizure 12/2007. Somatosensory evoked potentials unobtainable. Visual evoked potential WNL. Brain MRI WNL. MRI of spine (+) for abnormal signal in cervical and thoracic cord as well as swelling noted of cervical spinal cord. CSF with 4 WBC and (+) RBCs protein 34.6, glucose 66. No oligoclonal bands. Myelin Basic Protein WNL 2.5. IgG slightly increased at 0.7. Repeat with CSF glucose 108, Myelin Basic Protein 10.9 (H). CSF cx (-). Blood and urine cx (-) initially. UC later (+) for enterococcus. Viral tests all (-). Hgb 9.6. Hct 29.3. Follow-up 05-NOV-2008: Neuro imaging MRI, CT, ANAQ, CSF
CDC Split Type:
Vaccination
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Lot
Dose
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Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50054480IN 
Administered by: Private     Purchased by: Private
Symptoms: Anaemia, Areflexia, Autonomic nervous system imbalance, Blood culture negative, CSF culture negative, CSF glucose increased, CSF immunoglobulin increased, CSF myelin basic protein increased, CSF oligoclonal band absent, CSF protein normal, CSF white blood cell count, Computerised tomogram normal, Constipation, Cough, Culture urine positive, Dyspnoea, Endotracheal intubation, Enterococcal infection, Haematocrit decreased, Haemoglobin decreased, Heart rate abnormal, Hypokinesia, Myelitis transverse, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Paralysis flaccid, Plasmapheresis, Pyrexia, Quadriplegia, Red blood cells CSF positive, Respiratory distress, Respiratory failure, Rhinorrhoea, Screaming, Somatosensory evoked potentials abnormal, Swelling, Tracheostomy, Urinary tract infection, Viral test negative, Visual evoked potentials normal, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: 2 yr old with sudden onset of flaccid quadriplegia on 9/27/08. Pt awakened from a nap unable to move arm or legs. Pt had spontaneous respirations and was able to move head. Pt had received FLUMIST on 9/22/08 during her 2-yr well exam. Mom reported by Friday 9/27/08 she had a fever of 101. Around 12:30 pm pt was put to bed for a nap. The pt awoke at 2 pm screaming and unable to move. Neuro exam on 9/29 - abdominal and deep tendon reflexes are absent. Decreased chest wall movement, labored breathing noted - pt intubated. MRI - swelling of C-spine C2-C7. 1/22/09 MR received for DOS 9/28-~11/3/2008 with D/C DX: Longitudinally extensive Transverse Myelitis. Flaccid Quadriplegia. Respiratory Failure. S/P Tracheostomy. Constipation. UTI (enterococcus), resolved. Pt presented after abrupt onset of inability to move arms and legs. Pt had had 1 wk hx of rhinorrhea and cough & received Flumist 6 days prior to admission. Pt noted to have no movement in arms and legs in ED. Absent reflexes. 1 episode of emesis. T=101''F. Initially able to breathe on own however developed respiratory difficulty requiring intubation and later a trach. Some fluctuations of HR due to autonomic instability. Tx with solumedrol and plasmapheresis with some improvement in lower extremities only. Developed anemia during plasmapheresis. D/C to rehab. Follow-up Information 05-NOV-2008: 2yo female present with sudden onset flaccid quadriplegia. No trauma - taken to hospital where head and spine CT nl. Approx 1 week hx of rhinorrhea and cough. Received FluMist vaccine 6 days PTA.

VAERS ID:326825 (history)  Vaccinated:2008-09-22
Age:19.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2008-09-27, Days after onset: 4
Location:Wisconsin  Entered:2008-10-02, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Sense of unbalance, light headedness, dizziness -brain feels like its being jostled in head, can''t focus

VAERS ID:326829 (history)  Vaccinated:2008-09-22
Age:0.3  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-29, Days after onset: 6
Location:Connecticut  Entered:2008-10-02, 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: ZANTAC
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2952AA1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04741SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631101IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0211X1PO 
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Loose stools started 24 hrs after vaccines. Vomited for 1 day - started 24 hrs. No fever.

VAERS ID:326860 (history)  Vaccinated:2008-09-22
Age:12.0  Onset:2008-09-25, Days after vaccination: 3
Gender:Male  Submitted:2008-10-02, Days after onset: 7
Location:California  Entered:2008-10-02
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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2995BA5IMLA
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: L arm red, swollen 1/2 inch x 2 inches

VAERS ID:327009 (history)  Vaccinated:2008-09-22
Age:20.0  Onset:2008-10-04, Days after vaccination: 12
Gender:Male  Submitted:2008-10-04, Days after onset: 0
Location:Virginia  Entered:2008-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None. PMH: Pleuritis 9/21/08.
Preexisting Conditions: None.
Diagnostic Lab Data: EKG with diffuse ST elevation and PR depression. CK-MB, Trop-I, myoglobin, and LDH all elevated. CXR w/o obvious cardiomegaly. Labs and Diagnostics: EKG abnormal with ST elevations. CKMB and Troponin (+). Echo with EF 57%.
CDC Split Type:
Vaccination
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ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1741SCRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURW04003A0OTLA
Administered by: Military     Purchased by: Military
Symptoms: Asthenia, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Cardiac murmur, Chest X-ray normal, Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram PR shortened, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Heart rate increased, Myoglobin blood increased, Myopericarditis, Pyrexia, Troponin I increased, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (narrow), Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow)
Write-up: 20y/o w/ hx small pox vac on 22Sep08, c/o 2d retrosternal chest pain. Pain 5/10 severity, non-radiating, non-positional, non-exertional. No prior hx of pain. Denies SOB, fever, chills, n/v/d. No hx HTN, HLD, DM, tob use, or fam hx of cardiac dz. PE only sig for known heart murmur. EKG with diffuse ST elevation and PR depression. CK-MB, Trop-I, myoglobin, and LDH all elevated. CXR w/o obvious cardiomegaly. Patient given ASA 325mg, and then ibuprofen 800mg Q8. Patient is stable currently. Dx: myopericarditis. MR received with DX: Acute Myopericarditis. Adverse Effect of Drug Therapy-Vaccine Smallpox. Pt presented with chest pain, worsened by deep breathing. Pt noted to have increased pulse and low grade fever. Tx with Motrin. F/u 10/15/08 with report of decreased stamina or exertional tolerance. Currently w/o CP.

VAERS ID:327219 (history)  Vaccinated:2008-09-22
Age:13.0  Onset:2008-10-04, Days after vaccination: 12
Gender:Female  Submitted:2008-10-06, Days after onset: 2
Location:New York  Entered:2008-10-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572X1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0789X1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis at injection site. Rx for Keflex.

VAERS ID:327343 (history)  Vaccinated:2008-09-22
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-22
Location:Alaska  Entered:2008-10-07, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2658AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0789X0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Large, swollen, red area on left posterior upper arm. 8 x 6.5cm. First day after vaccine was swollen. Next day was larger after being seen and taking Benadryl area was not swollen anymore. Swelling resolved on 3rd day.

VAERS ID:327387 (history)  Vaccinated:2008-09-22
Age:2.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-29, Days after onset: 6
Location:Florida  Entered:2008-10-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2762DA2UNRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Following immunizations large swollen knot on thigh around injection site, red and hot, no fever reported. Came to doctor after, no treatment, symptoms resolved.

VAERS ID:327390 (history)  Vaccinated:2008-09-22
Age:72.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-09-29, Days after onset: 7
Location:California  Entered:2008-10-07, 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
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Headache, Psychomotor hyperactivity, Sleep disorder
SMQs:, Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Unable to sleep - headache - very hyper.

VAERS ID:327435 (history)  Vaccinated:2008-09-22
Age:16.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-09-25, Days after onset: 3
Location:Hawaii  Entered:2008-10-07, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No known drug allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572X0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.VFC0391X1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 3 days after immunization Left arm posterior distal aspect has red, itchy 5 x 9 cm area.

VAERS ID:327912 (history)  Vaccinated:2008-09-22
Age:77.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-10-06, Days after onset: 13
Location:Ohio  Entered:2008-10-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown - given at hospital
Preexisting Conditions: Unknown No record in office
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Other
Symptoms: Erythema, Induration, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Erythemia, induration, fever

VAERS ID:328047 (history)  Vaccinated:2008-09-22
Age:14.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-10, Days after onset: 18
Location:Missouri  Entered:2008-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No report of Illness
Preexisting Conditions: No known allergies etc.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB246AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2688AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2998BA5IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash erythematous, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt. states that he started getting a rash on his forearms about 4 hours after immunizations. Rash is itchy, red. Later spread to his abdomin. Came to school nurse office on 10/10/08 rash continues to spread. Advised referral to Dr. to identify rash and possible cause.

VAERS ID:328325 (history)  Vaccinated:2008-09-22
Age:44.0  Onset:2008-09-25, Days after vaccination: 3
Gender:Female  Submitted:2008-10-13, Days after onset: 18
Location:California  Entered:2008-10-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Penicillin allergy
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2996AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Anxiety, Diarrhoea, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Localized urticaria, diarrhea, anxiety.

VAERS ID:328559 (history)  Vaccinated:2008-09-22
Age:1.0  Onset:2008-10-04, Days after vaccination: 12
Gender:Male  Submitted:2008-10-09, Days after onset: 5
Location:Vermont  Entered:2008-10-15, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB245AA IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC256553IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0273Y SCLL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Injection site abscess
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Abscess at vaccine injection site. 3 given - same thigh. About 2 x 2 cm erythematous area. Rx with antibiotics and warm soaks to area.

VAERS ID:328565 (history)  Vaccinated:2008-09-22
Age:0.9  Onset:2008-09-24, Days after vaccination: 2
Gender:Male  Submitted:2008-10-02, Days after onset: 8
Location:New York  Entered:2008-10-15, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MOTRIN (infants)
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B114BB2IMLL
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Multiple disevete erythematous papules on scalp, trunk and extremities.

VAERS ID:329100 (history)  Vaccinated:2008-09-22
Age:0.2  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-13, Days after onset: 21
Location:Nebraska  Entered:2008-10-16, 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: Gastrooesophageal reflux; Cow''s milk intolerance; Hypersensitivity; Protein allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04471
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0641X0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Condition aggravated, Food allergy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a registered nurse (RN) concerning an approximately 9 week old female with gastroesophageal reflux, milk, soy and protein intolerance who on 22-SEP-2008 was vaccinated PO with the first 2.0 ml dose of ROTATEQ (lot # 661037/0641X). Concomitant therapy included (ZANTAC). On an unspecified date between 22-SEP-2008 and 25-SEP-2008, the registered nurse reported that the patient''s mild, soy and protein intolerance was aggravated after receiving the first dose of vaccine. The patient''s symptoms were described as "colicky". No treatment was reported. The RN reported that the patient sought medical attention with a phone call. The outcome was reported as not recovered / not resolved. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:329028 (history)  Vaccinated:2008-09-22
Age:77.0  Onset:2008-10-01, Days after vaccination: 9
Gender:Male  Submitted:2008-10-17, Days after onset: 16
Location:Colorado  Entered:2008-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: HTN, BPH, HYPERLIPIDEMIA
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICSAFLLA181AA IMLA
Administered by: Military     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad)
Write-up: 10/2: Vet phones in to report what he suspects to be an adverse reaction to his flu vaccine received on 22 Sep 08; he describes the immediate surrounding area to be slightly reddened, tender and raised also experiencing mild soreness in left deltoid. Denies resp. problems, denies n/v/d or headache, afebrility noted; PCP made aware, MD to eval.

VAERS ID:330739 (history)  Vaccinated:2008-09-22
Age:27.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-14
Location:California  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA00122
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0573X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 27 year old female who about 1 week ago, on approximately 22-Sep-2008, was vaccinated with an unspecified dose of GARDASIL (lot#0373X), intramuscularly. Subsequently on an unspecified date the patient experienced sever arm pain at the site of her last GARDASIL vaccination. The patient sought medical attention in the office. At the time of reporting her symptoms had continued. This is one of two reports received from the same source. Additional information has been requested.

VAERS ID:329352 (history)  Vaccinated:2008-09-22
Age:14.0  Onset:2008-09-26, Days after vaccination: 4
Gender:Female  Submitted:2008-10-15, Days after onset: 19
Location:Washington  Entered:2008-10-21, 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: Throwing up, slight fever, stomach pain
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER    
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Private
Symptoms: Condition aggravated, Dehydration, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: was vaccinated on 9/22/08 started throwing up on 9/26/08 continued being sick, on 10/5/08 was taken to emergency room and was given an IV to rehydrate. was back to normal by 10/9/08

VAERS ID:329388 (history)  Vaccinated:2008-09-22
Age:68.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-21, Days after onset: 29
Location:Nevada  Entered:2008-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDU1463AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1541U1IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: REDNESS AND SWEELING FROM SHOULDER TO BELOW THE ELBOW

VAERS ID:329425 (history)  Vaccinated:2008-09-22
Age:45.0  Onset:2008-10-17, Days after vaccination: 25
Gender:Female  Submitted:2008-10-21, Days after onset: 4
Location:Alaska  Entered:2008-10-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: migraines otherwise none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLA
Administered by: Military     Purchased by: Unknown
Symptoms: Pruritus, Swelling face, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: The MMR was given on 9/29/08. On 10/17/08 mild to moderate swelling in front of the left ear down to jaw and into top part of neck. No fever, mild tenderness and itching sensation in swollen areas. No pain in the ear or throat.

VAERS ID:329492 (history)  Vaccinated:2008-09-22
Age:4.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-24, Days after onset: 1
Location:Virginia  Entered:2008-10-21, Days after submission: 27
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
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14BO85AA3UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA10603UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0842X1UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1911U1UNRL
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Local swelling, erythema, induration and warmth of (L) leg about 3 x 3" diameter.

VAERS ID:329780 (history)  Vaccinated:2008-09-22
Age:54.0  Onset:2008-10-04, Days after vaccination: 12
Gender:Female  Submitted:2008-10-10, Days after onset: 6
Location:Indiana  Entered:2008-10-23, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa; Spironolaetine; Cephalexin
Current Illness: None
Preexisting Conditions: Depression
Diagnostic Lab Data: Rubeola - 06 - (pos $g 1.10) 9/15/08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0917X0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Lymphadenopathy, Measles antibody positive, Muscle spasms, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: 10/4/08 - rash, fever, diarrhea, leg cramps, lymphadenopathy (mild), sx''s resolved 10/9/08.

VAERS ID:329949 (history)  Vaccinated:2008-09-22
Age:54.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-24, Days after onset: 32
Location:Utah  Entered:2008-10-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: unk.
Current Illness: None.
Preexisting Conditions: Unknown.
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Dysphonia, Dyspnoea, Pruritus
SMQs:, Anaphylactic reaction (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Employee came to office on 09/22 at 1530 to rcv Tdap shot. At 1540 she developed difficulty breathing, itching, and hoarse throat. She spoke to her office coordinator and they sent her to the ED. She was treated with IM Benadryl, monitored and sent home.

VAERS ID:330366 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-10-18, Days after vaccination: 26
Gender:Male  Submitted:2008-10-28, Days after onset: 10
Location:Ohio  Entered:2008-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: unknown
Diagnostic Lab Data: Received First varicella vaccine 02-24-2004. Location and lot number unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0319X SC 
Administered by: Public     Purchased by: Public
Symptoms: Skin lesion
SMQs:
Write-up: less than 50 lesions.

VAERS ID:331408 (history)  Vaccinated:2008-09-22
Age:21.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-05
Location:California  Entered:2008-11-05
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
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1490SCRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin negative
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Pt discovered to be pregnant. Urine pregnancy test obtained prior to vaccination. Urine HCG negative. Pt discovered a couple weeks later that she was pregnant. LMP-31Aug2008.

VAERS ID:334244 (history)  Vaccinated:2008-09-22
Age:15.0  Onset:2008-10-17, Days after vaccination: 25
Gender:Female  Submitted:2008-11-14, Days after onset: 28
Location:Louisiana  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA03415
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on 22-Sep-2008 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL. Subsequently the patient developed a pea sized "knot" or lump under the skin at the injection site. The time frame development of the lump was not specified at the time of the report. The lump was tender or sore to the touch. The patient was seen by a nurse and used warm compresses on the lump. At the time of reporting (17-Oct-2008) the patient was not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Follow up information was received from a registered nurse reporting that the 15 year old female patient with no reported relevant history was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot #) on 22-Sep-2008 at 10:00. There was no illness at the time of vaccination. On 17-Oct-2008 at 9:45 the patient had a bump on her right arm where she received her first GARDASIL. The bump was tender to touch. The patient tried warm compress without success. The patient was a student. No treatment provided. No relevant diagnostic test or laboratory test were performed. The outcome was unknown. Additional information has been requested.

VAERS ID:332877 (history)  Vaccinated:2008-09-22
Age:76.0  Onset:2008-10-29, Days after vaccination: 37
Gender:Male  Submitted:2008-11-17, Days after onset: 19
Location:Illinois  Entered:2008-11-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 27 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known PMH: atrial fib on anticoagulation therapy. BPH. GERD.
Diagnostic Lab Data: Unknown LABS: CT & MRI abnormal. EMG abnormal. CSF protein elevated. H/H 10.4/30.9(L). BUN 35(H)Thoracic spine MRI abnormal revealing multiple lesions, multiple liver nodules & right renal mass. MRI brain abnormal. Spinal angiogram WNL. EKG & CXR WNL. Echocardiogram abnormal. PSA 15.3(H). Ca19-9 48.8(H) CSF: protein 91(H), glucose 51, WBC 4, RBC 75. CRP 6.4(H). Bone scan c/w likely bony hemangiomas. CT of chest/abdomen c/w liver hemangiomas.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS89745 IMRA
Administered by: Other     Purchased by: Other
Symptoms: Angiogram, Areflexia, Arteriovenous malformation, Asthenia, Atrial fibrillation, Bladder disorder, Blood urea increased, Bone scan abnormal, C-reactive protein increased, CSF glucose normal, CSF protein increased, CSF white blood cell count, Carbohydrate antigen 19-9 increased, Chest X-ray normal, Computerised tomogram abnormal, Echocardiogram abnormal, Electrocardiogram normal, Electromyogram abnormal, Gastrointestinal disorder, Haemangioma, Haemangioma of liver, Haematocrit decreased, Haemoglobin decreased, Hypoaesthesia, Ileus, Intensive care, Intestinal functional disorder, Liver disorder, Mass, Muscular weakness, Nodule, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraplegia, Plasmapheresis, Prostatic specific antigen increased, Red blood cells CSF positive, Renal disorder, Sensory loss, Spinal cord disorder, Spinal haemangioma, Upper respiratory tract infection, Urinary retention
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver neoplasms, benign (incl cysts and polyps) (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic erythropenia (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Tumour markers (narrow), Gastrointestinal obstruction (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteonecrosis (broad), Prostate tumours of unspecified malignancy (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Pt''s wife mentioned that her husband was hospitalized 1 month after receiving flu shot and that the neurologist thought that it might be Guillain-Barre Syndrome and that it may be from the flu shot. We have not spoken to the doctor. Wife has come in a few times afterwards but has not mentioned anything else. 1/29/2010 Patient had found out later he had had a stroke in his spinal cord. They ruled out the flu shot as being the course of paralysis. He has since passed away due to complications from sepsis. 3/9/09 Received hospital medical records of 11/13/2008-11/25/2008 FINAL DX: No d/c summary available. Recent onset paraplegia; spinal vascular malformation, unlikely GBS. Records reveal patient experienced s/s as noted above including progressive parapesis, sensory loss & bowel/bladder dysfuntion, paraplegia T8 & had been transferred from outlying hospital. Admitted to ICU & continued on steroids. Neuro, Neurosurg, Medicine, Heme, Nephro & Uro consults done. 12/11/08 Reviewed hospital medical records of 10/29-11/7/08. FINAL DX: Guillain Barre syndrome; paraplegia; atrial fib; ileus; urinary retention. Records reveal patient experienced Gi symptoms & URI approx 1 wk prior to admit. On admit had LE numbness & weakness, areflexia. Neuro & cardio consults done. Tx w/plasmapheresis. Transferred to inpatient rehab. Worsened & returned to acute care 11/10 for further treatment & evaluation. 1/23/09 Reviewed hospital medical records of 11/9-11/12/2008. FINAL DX: paraplegia perhaps secondary to some spinal cord hemorrhage Records reveal patient experienced initial leg weakness that rapidly progressed to complete paralysis which had been dx as GBS. Pt had been transferred to rehab where neurologists felt presentation atypical for GBS & repeated MRI which revealed possible bony metatases & spinal cord abnormality. Readmitted to acute care where exam revealed complete paralyisis & anesthesis from waist down w/loss of bowel & bladder control. Transferred to higher level of care.

VAERS ID:334169 (history)  Vaccinated:2008-09-22
Age:16.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-24, Days after onset: 63
Location:Michigan  Entered:2008-12-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin with iron daily
Current Illness: None
Preexisting Conditions: Allergic to Amoxicillin and Penicillin
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2688AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Gait disturbance, Tenderness
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Client received Menactra and HPV4 vaccines during day on 9-22-08. Client states that by 9:00 pm on 9-22-08, her entire body was very sore. Client states it was painful to walk. Client did not seek medical attention but client''s mother did call an after hours health access phone line.

VAERS ID:334757 (history)  Vaccinated:2008-09-22
Age:1.3  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-11-24, Days after onset: 63
Location:Alaska  Entered:2008-12-09, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B064AA3IMLL
Administered by: Private     Purchased by: Public
Symptoms: Crying, Discomfort, Flushing
SMQs:, Anaphylactic reaction (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: "Cried from 10 pm to midnight, uncomfortable, flushing". No vomit and no fever, no diarrhea, no pain, no SOB. No lump at site, no swelling, no redness at site of injection". Next day recovered reports mom.

VAERS ID:336045 (history)  Vaccinated:2008-09-22
Age:18.0  Onset:2008-10-06, Days after vaccination: 14
Gender:Male  Submitted:0000-00-00
Location:Illinois  Entered:2008-12-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 28 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: 2/9/09-records received-Ten days prior had upper respiratory tract infection which resolved after 4 days.
Preexisting Conditions:
Diagnostic Lab Data: 2/9/09-records received-CT head and MRI head normal. CXR infiltration. Electrodiagnostic studies abnormal-non-recordable latency of bilateral phrenic motor nerves and highly suggestive of acute demyelinating and axonal polyneuropath predomi
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
BCG: BCG (NO BRAND NAME)UNKNOWN MANUFACTURER520640IM 
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500560P0IN 
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHAB128AB0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0356X0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2656AA0IM 
TDAP: TDAP (ADACEL)SANOFI PASTEURC2998BA0IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.09730SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood product transfusion, Chills, Computerised tomogram normal, Echocardiogram normal, Guillain-Barre syndrome, Haemolysis, Hyperbilirubinaemia, Hypertension, Hypoaesthesia, Mechanical ventilation, Nasal congestion, Nausea, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging normal, Orchitis, Oropharyngeal pain, Paraesthesia, Paraesthesia oral, Plasmapheresis, Pneumonia aspiration, Polyneuropathy, Productive cough, Pyrexia, Respiratory failure, Reticulocyte count increased, Rhinorrhoea, Sensorimotor disorder, Tachycardia, Tracheostomy, Upper respiratory tract infection, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Demyelination (narrow), Hypersensitivity (broad)
Write-up: See attached progress notes patient is still hospitalized as of see 3/2008. He is on a ventilation recently complicated by aspiration pneumonia. 12/29/08-records received-C/O fever, chills, congestion, runny nose, sore throat, nausea and productive cough, febrile on 10/6/08-DX:upper respiratory infection. fever. 10/15/08-C/O numbness of feet and numbness of hands and mouth. Assessment:polyneuropathy idiopathic progressive. 10/16/08-developed progressive neurologic symptoms consistent with GBS. Stable. 10/20/08-In rehabilitation center neuro symptoms not progressing. GBS not confirmed. 2/9/09-records received for DOS 10/15-11/13/08-DC DX:Guillain Barre syndrome with respiratory failure requiring ventilator support. HCAP. Presented with C/O tingling in feet bilaterally and in both hands and roof of mouth, weakness in lower extremities while trying to go upstairs. Aphonia, dysphagia. Acute sensory motor neuro deficit, respiratory ventilator and subsequent tracheostomy. IVIG and plasmapheresis. Developed orchitis. Tachycardia and hypertesion.

VAERS ID:337489 (history)  Vaccinated:2008-09-22
Age:9.0  Onset:0000-00-00
Gender:Female  Submitted:2008-09-22
Location:North Carolina  Entered:2009-01-15, Days after submission: 115
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
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1719U0UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB246AA0UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0482X1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0537X0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Client given Tdap - recommended for ages 11-64 only. ADACEL- lot # C3027AA in right deltoid.

VAERS ID:338353 (history)  Vaccinated:2008-09-22
Age:0.5  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-12-18, Days after onset: 86
Location:Florida  Entered:2009-01-16, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: A0751468A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B192DA2UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0964X2UNLL
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of hive-like rash over the body in a 6-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, HEPATITIS B RECOMBINANT and (PEDIARIX, GlaxoSmithKline), rotavirus vaccine (MERCK) for prophylaxis. There were no concurrent medications. On 22 September 2008 at 10:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh and 3rd dose of ROTAVIRUS vaccine (MERCK). On 23 September 2008, 1 day after vaccination with PEDIARIX, at an unspecified time after vaccination with ROTAVIRUS vaccine, the subject experienced hive-like rash all over the body. At the time of reporting the event was improved but not completely resolved. The healthcare professional considered the event was probably related to vaccination with PEDIARIX.

VAERS ID:339268 (history)  Vaccinated:2008-09-22
Age:42.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2009-01-26, Days after onset: 125
Location:Oregon  Entered:2009-02-09, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: OR200904
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB438AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever of 101 degrees F $g Broke out in Hives $g Pt. called into H. Dept 9/23 c/o of these symptoms did not seek medical care- Never returned phone calls from many messages left by doctors office- Eventually phone disconnected

VAERS ID:340363 (history)  Vaccinated:2008-09-22
Age:1.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2009-01-30, Days after onset: 129
Location:California  Entered:2009-02-23, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Right sided plagrociphely $g treated & resolved
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0841X0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC861422IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Blanchable nonspecific rash. Described as hives by parents.

VAERS ID:340530 (history)  Vaccinated:2008-09-22
Age:50.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-09-24, Days after onset: 1
Location:Michigan  Entered:2009-02-24, Days after submission: 153
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Digoxin; ALLEGRA; LEXAPRO
Current Illness: Cervical spinal stenosis (C2-C7); Cardiac Dysrhythmia (scheduled for surgical rpr 9/28/08)
Preexisting Conditions: Ibuprofen - CHF
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVA251CA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC288BAA1IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain and warmth and firmness felt at injection site on upper left arm. 2 1/2 cm at area of induration felt there, no erythema

VAERS ID:341390 (history)  Vaccinated:2008-09-22
Age:75.0  Onset:2008-09-25, Days after vaccination: 3
Gender:Female  Submitted:2008-10-01, Days after onset: 6
Location:Washington  Entered:2009-03-09, Days after submission: 159
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARICEPT, 10 mg; BENADRYL, 25 mg; FOSAMAX, 70 mg; Hydrochlorothiazide, 25 mg; INDERAL LA, 60 mg; MECAVOR, 40 mg; Vitamin D, 50000 Unit.
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1715U IDRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Excoriation, Injection site erythema, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 11 x 19 cm raised, red urticarial-appearing patch upper outer L arm at site of Tdap immunization mile excoriation at lower edge. BENADRYL 25mg @ hs

VAERS ID:345133 (history)  Vaccinated:2008-09-22
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2009-04-10
Location:Unknown  Entered:2009-04-24, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: Physical examination (results: normal (Language/Speech, Emotional/Social, Fine/Gross Motor Skills, Cognitive thinking)) was done in 2008. Today temperature (results: spikes to 104 degrees F.) was done in Sep-2008.
CDC Split Type: USWYEH06142508
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC277012IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Body temperature increased, Decreased appetite, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Additional Information provided test results and a possible cause for the reported events. Information regarding PREVNAR was received from a healthcare professional regarding a 4-year-old female patient who experienced poor appetite, fever spiking to 104 degrees F., abdominal pain and possible community acquired infection. At 4 years of age, the patient received the third dose on 22-Sep-2008. The patient experienced poor appetite in Sep-2008 and fever spiking to 104 degrees F. and abdominal pain on 22-Sep-2008. The reporting healthcare professional stated that community acquired infection could be a possible explanation for the reported symptoms of poor appetite, pyrexia and abdominal pain. Outcome was reported as not recovered. No additional information was available at the time of this report.

VAERS ID:346918 (history)  Vaccinated:2008-09-22
Age:14.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Female  Submitted:2009-05-14, Days after onset: 233
Location:New Mexico  Entered:2009-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0904USA03746
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0UNUN
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information hs been received from a nurse practitioner concerning a 14 year old female student with no pertinent medical history and no known drug allergies who on 22-SEP-2008 at 16:00, was vaccinated with the first dose of GARDASIL (lot # 660616/0570X) into her right deltoid. There was no illness at time of vaccination. On 23-SEP-2008 AM the patient experienced bilateral lower extremity red raised rash. No lab diagnostic studies were performed. One week later, the patient recovered. The patient did not seek medical attention. Additional information is not expected.

VAERS ID:349258 (history)  Vaccinated:2008-09-22
Age:73.0  Onset:2008-10-28, Days after vaccination: 36
Gender:Unknown  Submitted:2009-06-16, Days after onset: 231
Location:Michigan  Entered:2009-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: PMH: COPD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dyspnoea, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 10/28/2008 with Pneumonia. Vaccination took place on 9/22/2008. According to the physician the relationship is ''None''. We would be happy to forward the Study''s SAE reporting form upon request. 6/19/09 Received SAE hospitalization of 10/28-11/1/2008. FINAL DX: pneumonia Records reveal patient experienced increased work of breathing, fever, chills. Tx w/IV antibiotics & steroids. Improved & d/c to home on continued oral antibiotics & steroids. ICD9 codes: 486.00.

VAERS ID:349259 (history)  Vaccinated:2008-09-22
Age:73.0  Onset:2008-12-21, Days after vaccination: 90
Gender:Unknown  Submitted:2009-06-16, Days after onset: 176
Location:Michigan  Entered:2009-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: PMH: COPD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angina pectoris, Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (narrow), Other ischaemic heart disease (narrow)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 12/21/2008 with atrial fibrillation. Vaccination took place on 9/22/2008. According to the physician the relationship is ''None''. We would be happy to forward the Study''s SAE reporting form upon request. 6/19/08 Received SAE for hospitalization of 12/21-12/24/2008. FINAL DX: atrial fibrillation Records reveal patient experienced sudden atrial fib w/rapid ventricular response & associated anginal pain. Tx w/meds, no recurrence & d/c to home. ICD9 Codes: 427.31.

VAERS ID:353678 (history)  Vaccinated:2008-09-22
Age:46.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 311
Location:Unknown  Entered:2009-08-06, 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: PROAIR HFA; CYANOCOBALAMIN; VERAMYST; ADVAIR; SYNTHROID
Current Illness: Chronic obstructive pulmonary disease; Sulfonamide allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0809USA04150
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0619X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, 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: Information has been received from a nurse practitioner concerning a 46 year old female with chronic obstructive pulmonary disease and a sulfonamide allergy, who on 01-FEB-2008 was vaccinated with a first dose of PNEUMOVAX. On 22-SEP-2008 the patient was vaccinated IM with a 0.5mL second dose of PNEUMOVAX (Lot# 660685/0619X). Concomitant therapies included ADVAIR, VERAMYST, PROAIR HFA and SYNTHROID. On 22-SEP-2008 the patient developed a red, warm, painful, swollen area, about 10 centimeters by 18 centimeters on her arm at the injection site post vaccination. The patient was seen at the office. No laboratory diagnostics were performed. At the time of report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:355080 (history)  Vaccinated:2008-09-22
Age:1.0  Onset:2008-09-28, Days after vaccination: 6
Gender:Male  Submitted:2009-08-24, Days after onset: 330
Location:Utah  Entered:2009-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXIL 400mg/5mL; MUPIROCIN 21
Current Illness: Eczema
Preexisting Conditions: Eczema. Ear tubes.
Diagnostic Lab Data: HVA; VMA. LABS and DIAGNOSTICS: Urinary HVA (-) VMA (-). MRI Brain - Normal. X-ray Femur - Normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2755AA0IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB297AA1IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0453X0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0971X0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Abasia, Cold sweat, Dermatitis diaper, Diarrhoea, Dyskinesia, Gait disturbance, Hypersomnia, Intention tremor, Irritability, Laboratory test, Liver palpable subcostal, Lymphadenopathy, Musculoskeletal stiffness, Neutropenia, Nuclear magnetic resonance imaging brain normal, Pharyngitis, Rash erythematous, Tremor, Upper respiratory tract infection, Vanillyl mandelic acid urine
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: On 9/28/08 he developed a tremor and stopped walking. Tremor persisted through 8/24/09 10/01/09 PCP medical records, consults received DOS 9/22/09 to 6/10/09. Assessment: Viral upper respiratory infection. Tremor-post vaccine. Ataxia. Parent states child began to fuss, then arms and legs began to shake. Jerky movements. Erythematous diaper rash. Diarrhea. Anterior cervical lymphadenopathy. Sleeping more than usual. Cold sweats. Tremor when reaching for objects. Neutropenia. Pharyngitis. Legs stiff. Trouble walking. Unsteady gait. Liver palpable.

VAERS ID:373040 (history)  Vaccinated:2008-09-22
Age:1.0  Onset:2009-05-23, Days after vaccination: 243
Gender:Female  Submitted:2009-12-14, Days after onset: 205
Location:Pennsylvania  Entered:2009-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hib (dose 3), mmr (dose 1), and hep a (dose 1)given on 9/22/2008 with varicella vaccine. Unable to enter shot information in box 10.
Current Illness:
Preexisting Conditions: anemic, GERD
Diagnostic Lab Data: clinical diagnosis only
CDC Split Type: Z3603
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Herpes zoster
SMQs:
Write-up: herpes zoster in a vaccinee.

VAERS ID:381774 (history)  Vaccinated:2008-09-22
Age:16.0  Onset:2008-09-24, Days after vaccination: 2
Gender:Male  Submitted:2010-03-03, Days after onset: 525
Location:Guam  Entered:2010-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergic to penicillin and amoxicillin.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Back pain, Eye swelling, Lip swelling, Pruritus, Swelling, Swelling face, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Itchy hives in multiple areas on body, some facial swelling of lips, eyes, and forehead. Back pain and continuous vomiting.

VAERS ID:384657 (history)  Vaccinated:2008-09-22
Age:0.5  Onset:0000-00-00
Gender:Female  Submitted:2010-04-01
Location:Ohio  Entered:2010-04-08, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA0UNRL
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B138BA1UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC659281UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0642X2PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Patient was given a PEDIARIX vaccine and a normal DTaP on 9-22-2008. No reaction.

VAERS ID:388079 (history)  Vaccinated:2008-09-22
Age:1.0  Onset:2009-07-27, Days after vaccination: 308
Gender:Male  Submitted:2010-05-14, Days after onset: 291
Location:Tennessee  Entered:2010-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reactive airways disease
Preexisting Conditions: Tick bite
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA03436
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0869U0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Rash erythematous, Rash generalised, Varicella, Varicella post vaccine
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a Licensed Practical Nurse concerning a 22 month old male patient with a history of tick bite, reactive airways disease, and drug reactions or allergies reported as none who on 22-SEP-2008 was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2009 the patient experienced chickenpox. Symptoms presented as a "rash all over". The patient was advised to use oatmeal bath, calamine (+) zinc oxide lotion and BENADRYL. The patient sought an unspecified medical attention. The patient was completely recovered on 10-AUG-2009. Follow up information received from a licensed practical nurse indicated that he was a male patient who on 22-SEP-2009 was vaccinated subcutaneously with his first dose of VARIVAX (Merck) in his right arm, suspect therapy included his first dose of MMR II (Lot # 656614/0869U) which was administered subcutaneously in his left arm. There were no illnesses reported at the time of vaccination. Concomitant therapy included HAVRIX received intramuscularly in his right thigh and a fourth dose PREVNAR administered intramuscularly in his left thigh. According to the reporter, the adverse event began on 27-JUL-2009 (previously reported as 30-JUL-2009) as the patient presented to the office/clinic with numerous red bumps. A diagnosis of chickenpox was done at the clinic. The patient recovered on Aug-2009 (previously reported as 10-AUG-2009). There were no laboratories diagnostics studies performed. This is one of four reports from the same source. No further information is available.

VAERS ID:393270 (history)  Vaccinated:2008-09-22
Age:96.0  Onset:2010-05-17, Days after vaccination: 602
Gender:Male  Submitted:2010-07-21, Days after onset: 65
Location:Michigan  Entered:2010-07-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with chest pain. Vaccination took place on 09.22.2008. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.

VAERS ID:398119 (history)  Vaccinated:2008-09-22
Age:0.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 681
Location:Washington  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Beta-human chorionic, positive
CDC Split Type: WAES0810USA03193B1
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure before pregnancy, Neonatal disorder, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician concerning a baby patient who was exposed through his mother who on 22-SEP-2008 was vaccinated with the first dose of GARDASIL IM and was pregnant. There was no concomitant medication. On 13-OCT-2008, the patient reported she had done a home pregnancy test and also went to the primary care physician who did a urine beta-human chorionic gonadotropin test that was positive. The patient reported that at the time of the report was 6 weeks pregnant. The patient''s LMP was approximately on 04-SEP-2008 (previously reported as 28-AUG-2008). The estimated delivery date is 15-JUN-2009 (previously reported as 16-JUN-2009). The patient reported she was seeing a midwife for the pregnancy. Follow up information has been received from a nurse practitioner concerning the patient. The nurse stated that the patient does not qualify for the pregnancy registry since GARDASIL was given prior to conception date. Follow up information has been received from a registered nurse and a nurse practitioner concerning the patient''s pregnancy. It was confirmed that the patient''s last menstrual period was on 04-SEP-2009. On an unknown date, at 10.5 weeks of gestation, a first trimester ultrasound was performed which confirmed that the estimated delivery date was 15-JUN-2009. On 16-JUN-2009, the patient was seen in the office when she was 40 weeks and 1 day pregnant. Some time after the last office visit, in June 2009, the patient delivered a healthy normal baby with no congenital abnormalities. Additional information has been received from a physician via medical records concerning the male patient who was born on 21-JUN-2009, weight 9 lbs and 1 oz and diagnosed with feeding problems, pyogenic granuloma and prenatal jaundice. On 24-JUN-2009, the baby''s weight was 8 lbs and 3.5oz. The mother went to hospital for newborn follow up. The patient was discharged on 23-JUN-2009. It was not any complications, currently breast feeding q a lot each time, mother''s milk had not come in and special concerns were jaundice and urine color. On 25-JUN-2009, the mother had pink crystals in diaper, breast feeding milk not in yet and was with fine urination. The baby''s general appearance was alert and NAD; head was normal shape and AF normal; eyes normal and BRR; ENT was normal and palate intact; neck was full ROM and no masses; chest with lungs clear to auscultation and clavicles intact, CV was RRR, no murmur and normal femoral pulses; abdomen was soft, nontender, no masses and no HSM; genitalia was normal and urate crystals diaper; extremities hips full ROM, without hip click and feet straight; back was normal; neuro was intact, normal tone and moro present and skin was with moderate jaundice extending to ambilicus. The physician''s assessment was well child. The physician''s plan was given newborn information sheet, discussed sleep position, feeding, growth, crying, smoke detector, smoke exposure, limit visitors and exposure to crowds, frequent hand washing to limit spread of infections and monitor for increasing jaundice put in sunlight; weight check 2 days and follow up in 1 month HS. On 26-JUN-2009, the baby was with no known allergies and was ordered laboratory (chemical cautery granulant tissue) (result not provided). The baby''s weight was 8 lb and 15 oz and it was not pain reported. Breast feeding approximately 10 minutes each side q 1 hour. The physician''s subjective was Bw 9-1 breast feeding-wt 2 days prior 8-4; breast milk in good urination, stooling (yellow seedy, check umbilicus cord fell off 1 day prior some clear discharge, check jaundice breast feeding- mom type a blood). The baby''s general appearance, head, eyes, ears, nose and OP were normal, neck was supple, in chest lungs were clear to auscultation, good air exchange, normal AP diameter abd umbilical granuloma, and skin was mild jaundice to lower abd. The physician''s assessment was umbilical granuloma. Follow up will be at one week. The baby was vaccinated with PE

VAERS ID:406879 (history)  Vaccinated:2008-09-22
Age:73.0  Onset:0000-00-00
Gender:Male  Submitted:2010-11-04
Location:Michigan  Entered:2010-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad)
Write-up: Subject in pneumococcal vaccine trial with severe COPD was hospitalized with Pneumonia. Vaccination took place on 9.22.2008. According to the physician the relationship to study is none. We would be happy to fax the Study''s SAE report.

VAERS ID:444340 (history)  Vaccinated:2008-09-22
Age:0.2  Onset:2008-09-30, Days after vaccination: 8
Gender:Female  Submitted:2011-12-02, Days after onset: 1158
Location:California  Entered:2011-12-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B127AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF160AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54013K0IMRL
Administered by: Unknown     Purchased by: Private
Symptoms: Eczema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash, eczema. Finally was given hydrocortisone around age two. Child still suffers from eczema.

VAERS ID:499740 (history)  Vaccinated:2008-09-22
Age:11.0  Onset:2013-08-13, Days after vaccination: 1786
Gender:Female  Submitted:2013-08-19, Days after onset: 6
Location:Unknown  Entered:2013-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1308USA006913
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report was received from a Nurse Practitioner refers to a 16 year old female patient. On 22-SEP-2008, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported). Nurse practitioner reported that the patient was in the office today on 13-AUG-2013 to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.

VAERS ID:326665 (history)  Vaccinated:2008-09-22
Age:65.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-09-30, Days after onset: 8
Location:Foreign  Entered:2008-10-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Multimorbidity
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04406
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1077F0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (narrow)
Write-up: Information has been received from a general practitioner (physician) concerning a 65 year old male patient with a history of multimorbidity (infarction, aneurysm etc.) who on 22-SeP-2008 was vaccinated IM into the right upper arm with a first dose of PNEUMOVAX 23 (batch # NF13540) (lot # 656229/1077F). On 22-SEP-2008, few hours after the vaccination the patient developed severe injection site inflammation with redness, pain and warmth. On 23-SEP-2008 the patient developed vertigo and dyspnoea and was hospitalized. The patient''s symptoms were ongoing at the time of reporting. The other business partner number included: E200808774. Additional information is not available.

VAERS ID:327029 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-03, Days after onset: 11
Location:Foreign  Entered:2008-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0539675A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B058AA IMUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Myoclonus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority(foreign regulatory agency # 89891) and described the occurrence of loss of consciousness in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline) and MMR vaccine. On 22 September 2008 the subject received unspecified dose of INFANRIX (intramuscular), unspecified dose of MMR vaccine (intramuscular). On 22 September 2008, less than one day after vaccination with INFANRIX and MMR vaccine, the subject experienced loss of consciousness and myoclonus of limbs. This case was assessed as medically serious by GSK. On 22 September 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and MMR vaccine.

VAERS ID:327718 (history)  Vaccinated:2008-09-22
Age:0.3  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-10-08, Days after onset: 15
Location:Foreign  Entered:2008-10-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory test, 30?Sep08, all "examinations" (not specified) showed normal results - no cause for diarrhea found
CDC Split Type: WAES0810USA00593
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bronchitis, Diarrhoea, Laboratory test normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 4 month old male who on 22-SEP-2008 was vaccinated with a second dose of ROTATEQ (Lot # not reported). Suspect therapy included INFANRIX HEXA (GSK) (Lot # not reported). The first dose of ROTATEQ was well tolerated. One day "p.v.", the patient developed a slight fever which resolved after 24 hours and, according to the reporter, was most likely caused by the INFANRIX HEXA. Then "10 days p.v.", the patient experienced diarrhea (10 times daily). He was hospitalized on 30-SEP-2008. Mild "bronchitis-like symptoms" were seen. The baby was in good general condition. He was not dehydrated and drank well. All examinations (not specified) showed normal results and no cause for the diarrhea was found. At the time of reporting, the patient had not recovered. No further information is available. Other business partner numbers include: E2008-09073.

VAERS ID:328015 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-10, Days after onset: 18
Location:Foreign  Entered:2008-10-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0540535A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B050A SCLA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Eye movement disorder, Hypertonia, Loss of consciousness, Trismus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (# 90037) and described the occurrence of loss of consciousness in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR II vaccine. The past subject''s history was negative for epilepsy. On 22 September 2008, the subject received unspecified dose of INFANRIX (subcutaneous, unknown injection site), unspecified dose of MMR II vaccine (subcutaneous, unknown). On 22 September 2008, less than one day after vaccination with INFANRIX and MMR II vaccine, the subject experienced loss of consciousness, generalized hypertonia, trismus and ocular deviation. This case was assessed as medically serious by GSK. On 22 September 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and MMR II vaccine.

VAERS ID:328399 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-10-13, Days after onset: 21
Location:Foreign  Entered:2008-10-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA01783
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14R058AA IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0684U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness, Myoclonus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a health authority (case n. 89891) (local case n. IT380/08) concerning a 5 year old female who on 22-SEP-2008 was vaccinated with the second dose of MMR II (Lot # 656987/0684U) (batch number NG52840), IM, injection site not reported. Suspect therapy included the booster dose of INFANRIX (batch n. AC14R058AA), IM, injection site not reported. On the same day she presented with loss of consciousness and myoclonic jerks of the limbs. She was actively monitored (NOS). The outcome is recovered on 22-SEP-2008. The case was reported as not serious by both HA and the reporter but was upgraded to serious by Company according to internal rules. The case is closed. Loss of consciousness and myoclonic jerks were considered to be other important medical events. Other business partner numbers included: E2008-09119.

VAERS ID:328911 (history)  Vaccinated:2008-09-22
Age:5.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2008-10-16, Days after onset: 24
Location:Foreign  Entered:2008-10-17, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA01939
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B050AE SCUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 1SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epilepsy, Eye movement disorder, Hypertonia, Loss of consciousness, Respiratory distress, Trismus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a health authority (case #90037) concerning a 5 year old male with a negative history for epileptic fits who on 22-SEP-2008 was vaccinated subcutaneously with a second dose of MMR II (Enders-Edmonston) (Jeryl Lynn) (Wistar RA 27/3) (dose and lot # not reported). Suspect therapy included a subcutaneous booster dose of INFANRIX (dose not reported; batch # AC14B0505AE). On the same day he presented with loss of consciousness, diffuse hypertonia, trismus, ocular deviation and an epileptic-like crisis that lasted a few seconds. He received immediate assistance (not otherwise specified) due to respiratory distress (possible airway obstruction). The outcome was recovered. The case was reported as closed. Upon internal review, epileptic fit, loss of consciousness, diffuse hypertonia, trismus, ocular deviation were considered to be an other important medical event. Other business numbers include: E2008-09270 and IT383/08.

VAERS ID:330427 (history)  Vaccinated:2008-09-22
Age:4.0  Onset:2008-09-23, Days after vaccination: 1
Gender:Male  Submitted:2008-10-28, Days after onset: 35
Location:Foreign  Entered:2008-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone propionate
Current Illness: Asthma
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0543437A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B071AI IMRA
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURERNH04960 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphadenitis
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (# 90721) and described the occurrence of axillary adenitis in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), M-M-RVAX (Sanofi). Concurrent medical conditions included asthma. Concurrent medications included FLUTICASONE. On 22 September 2008, the subject received unspecified dose of INFANRIX (intramuscular, right deltoid), unspecified dose of M-M-RVAX (intramuscular, right deltoid). On 23 September 2008, 1 day after vaccination with INFANRIX and M-M-RVAX, the subject experienced axillary adenitis, hotness at injection site, swelling injection site and injection site pain. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved with sequelae. The vaccination course with INFANRIX was discontinued. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and M-M-RVAX.

VAERS ID:335562 (history)  Vaccinated:2008-09-22
Age:2.0  Onset:2008-09-22, Days after vaccination: 0
Gender:Female  Submitted:2008-12-17, Days after onset: 86
Location:Foreign  Entered:2008-12-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: body temp, 22Sep08, 39.8 centi-degree
CDC Split Type: WAES0812CHN00010
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Febrile convulsion, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 2 year old female who on 22-SEP-2008 was vaccinated with PNEUMOVAX 23. There was no concomitant medication. On 22-SEP-2008 10:30AM the patient experienced febrile convulsion and vomit whose body temperature was 39.8 centi-degree. After taking some therapies of azlocillin, andrographolide and two medicines (composition unspecified), the patient recovered from febrile convulsion and vomit on 25-SEP-2008. The reporter felt that febrile convulsion and vomit were related to therapy with PNEUMOVAX 23. Upon internal review, the febrile convulsion was decided to be an other important medical event. No further information is available.

VAERS ID:336464 (history)  Vaccinated:2008-09-22
Age:0.3  Onset:2008-12-03, Days after vaccination: 72
Gender:Male  Submitted:2009-01-05, Days after onset: 33
Location:Foreign  Entered:2009-01-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 05Dec2008, abnormal
CDC Split Type: B0551683A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Laparotomy, Pyrexia, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad)
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileo-ileal intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 21 July 2008. On 22 September 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 3 December 2008, 72 days after vaccination with ROTARIX, the subject started with vomiting, bloody stools, fever and abdominal pain. The patient was admitted at ER on 4 December 2008 and showed at physical exam abdominal pain and bowel sounds decreased. Abdominal x-ray suggested intestinal obstruction. Ileo-ileal intussusception was confirmed by laparotomy and reduced by taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). The subject was treated with AMIKACIN, AMPICILLIN TRIHYDRATE and PARACETAMOL. On 11 December 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.

VAERS ID:337597 (history)  Vaccinated:2008-09-22
Age:0.2  Onset:2008-09-22, Days after vaccination: 0
Gender:Male  Submitted:2009-01-15, Days after onset: 115
Location:Foreign  Entered:2009-01-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0901AUS00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Crying, Cyanosis, Hypotonic-hyporesponsive episode, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 10 week old male patient who on 22-SEP-2008 was vaccinated with ROTATEQ. Other suspect therapy included INFANRIX HEXA and PREVENAR. On 22-SEP-2008 the patient experienced cyanosis, apnoea, crying and hypotonic-hyporesponsive episode and was hospitalised. It was described that the child had a weak cry, then became blue/grey in colour, was limp and unresponsive. The child appeared not to be breathing. The mother picked him up and blew in his face, stimulated him and baby gasped for air but remained drowsy. The baby was transferred to hospital by an ambulance. At the time of reporting to the agency on 30-SEP-2008, the patient had recovered from cyanosis, apnoea, crying and hypotonic-hyporesponsive episode. The agency considered that cyanosis, apnoea, crying and hypotonic-hyporesponsive episode were possibly related to therapy with ROTATEQ, INFANRIX HEXA and PREVENAR. The original reporting source was not provided. Additional information is not expected.

VAERS ID:339606 (history)  Vaccinated:2008-09-22
Age:35.0  Onset:2008-10-24, Days after vaccination: 32
Gender:Female  Submitted:2009-02-13, Days after onset: 112
Location:Foreign  Entered:2009-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Brain computerized tomography, 06Nov2008, abnormal; C-reactive protein, 2008, 3mcg/L; Laboratory test, Nov2008, normal; Nuclear magnetic resonance ima, 11Nov2008, normal
CDC Split Type: B0558337A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB111BH0IMLA
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein decreased, Computerised tomogram abnormal, Dizziness, Dyspnoea, General physical health deterioration, Headache, Hypoaesthesia, Laboratory test normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This case was reported by a regulatory authority (# FI-NAM-2009-0082) and described the occurrence of paresthesia skin in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject was healthy. On 22 September 2008, the subject received 1st dose of TWINRIX (intramuscular, left deltoid). On 24 October 2008, 32 days after vaccination with TWINRIX, the subject experienced respiratory infection symptoms and dizziness. Treatment with azithromycin was started and discontinued after 2 days due to allergic symptoms with dizziness, dyspnea and deterioration of general condition. Cephalosporin was started and discontinued after 3 days due to the same symptoms: dizziness, dyspnea and deterioration of general condition. On 5 November 2008, the subject experienced unilateral paresthesia symptoms with numbness in the left cheek, arm and leg as well as severe headache. The subject went to hospital. No findings at examination. The brain CT showed an undefined hypodense area in the pons region. On 6 November 2008, the subject was hospitalised for 7 days with the diagnosis of skin paresthesia. The subject was prescribed Klotriptyl mite which will be continued after her discharge from hospital. On 9 November 2008, the respiratory symptoms, dizziness, dyspnea, deterioration of general condition, numbness in the left cheek and headache were resolved. On 11 November 2008, the brain MRI showed a completely normal pons region, without changes in the white matter. The laboratory tests were normal, c-reactive protein was low (2-3 mcg/L). No symptoms of infection was detected. The subject just had a squeezing sensation in the left wrist and the left ankle without functional handicap. The subject still experienced numbness in hands and legs during the night. On 12 November 2008, the subject was discharged from hospital. On 18 November 2009, during a scheduled phone call, the subject related that nearly all left-sided limbs symptoms had disappeared during the week. Some times, she still has minor sensations w

VAERS ID:340437 (history)  Vaccinated:2008-09-22
Age:0.4  Onset:2008-10-15, Days after vaccination: 23
Gender:Male  Submitted:2009-02-23, Days after onset: 131
Location:Foreign  Entered:2009-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 16Oct2008, IS
CDC Split Type: B0560449A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR  IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Anorexia, Haematochezia, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; intradermal given on 23 May 2008; DTPa-IPV-HIB; manufacturer unspecified; intramuscular given on 21 July 2008 and 22 September 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular given on 23 May 2008 and 21 August 2008; ROTARIX; GlaxoSmithKline; oral given on 21 July 28; pneumococcal vaccines (non-gsk); manufacturer unspecified; intramuscular given on 21 August 2008. The subject''s medical conditions included a healthy baby. On 22 September 2008 the subject received 2nd dose of ROTARIX (oral) lot number not provided. On 15 October 2008, 23 days after vaccination with ROTARIX, the subject started with abdominal pain, irritability, nausea, vomiting and hyporexia. On 16 October 2008 the subject was admitted to the emergency room. Bloody stools like black currant jelly were found. Relevant test included abdominal x-ray which showed fluid levels and dilated bowel loops. Plain abdominal radiography showed non specific abnormalities. Therefore the same day the subject underwent a laparotomy which showed ileocecocolic intussusception. It was remitted by taxis without complications. No bowel resection was required. On 19 October 2009 the subject was discharged in good clinical conditions. The subject was hospitalized for 4 days and the physician considered the events were clinically significant (or requiring intervention). The physician considered the events were possibly related to vaccination with ROTARIX.

VAERS ID:343303 (history)  Vaccinated:2008-09-22
Age:0.3  Onset:2008-10-23, Days after vaccination: 31
Gender:Female  Submitted:2009-04-01, Days after onset: 160
Location:Foreign  Entered:2009-04-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Gastrooesophageal reflux; Congenital stridor
Preexisting Conditions: Neonatal respiratory distress syndrome
Diagnostic Lab Data: chest X-ray, 23Oct08, thoracic distension and bronchial right hilum overloaded; pharyngoscopy, 23Oct08, negative
CDC Split Type: WAES0903USA05337
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bronchiolitis, Chest X-ray abnormal, Gastrointestinal tube insertion, Intercostal retraction, Lobar pneumonia, Pharyngoscopy, Stridor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received on 24-MAR-2009 from a health authority (reference number 200900011) via an investigator concerning a 12 week old female who participated in a study. It was reported that she had a medical history of gastrooesophageal reflux (from 27-JUL-2008, ongoing), newborn respiratory distress syndrome (on 25-JUL-2008), congenital stridor (from 27-JUL-2008, ongoing) and family histories of allergic status for older brother and asthma for older sister who had received an injection of ROTATEQ (lot # not reported) as per os on 22-SEP-2008. Secondary suspect vaccinations given on 22-SEP-2008 included PREVENAR and INFANRIX QUINTA. On 23-OCT-2008, the patient developed right inferior lobar pneumonia, inspiratory stridor, intercostal retraction and bronchiolitis. She was hospitalized on 23-OCT-2008. Aetiological investigations were performed. On 23-OCT-2008, body temperature and expiratory wheezing were normal. Pharyngeal examination was negative; chest X-ray showed thoracic distension and bronchial right hilum overloaded. Gastric tube feeding was implemented on 28-OCT-2008 onwards. Oxygen therapy, respiratory physical therapy was also implemented. The patient also received corrective treatment with amoxicillin + clavulanic acid and corticotherapy. Desaturation was reported with albuterol spray administration. Albuterol babyhaler was tested on 28-OCT-2008 and improved pulmonary examination. Treatment with omeprazole, then domperidone and alginates was implemented for control of gastrooesophageal reflux. At the time of reporting, the patient was recovering from lobar pneumonia, inspiratory stridor, intercostal retraction and bronchiolitis. She did not return to consult the paediatrician after the first vaccine administration. The investigator considered that the most likely cause was other for bronchiolitis; the sponsor considered that there was a reasonable possibility that the event of bronchiolitis and lobar pneumonia were related to the study drug and that lobar pneumonia was related to one of the co

VAERS ID:374849 (history)  Vaccinated:2008-09-22
Age:0.3  Onset:2008-10-08, Days after vaccination: 16
Gender:Female  Submitted:2009-12-22, Days after onset: 440
Location:Foreign  Entered:2009-12-23, 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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient previously experienced motor dysfunction, feeding disorder of infancy or early childhood and sleep phase rhythm disturbance after receiving the first dose PREVENAR and feeding disorder of infancy or early childhood after receiving the second dose of PREVENAR. Past vaccinations included the first two doses of INFANRIX HEXA which were administered on 21-Jul-2008 and on 1
Diagnostic Lab Data: Body temperature, 18-Jan-2009, 38.3 deg. C., 19-Jan-2009, 40 deg. C., 20-Jan-2009, 38 deg. C.
CDC Split Type: DEWYEG05143609
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH323232IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acute tonsillitis, Body temperature increased, Chills, Electrolyte imbalance, Feeding disorder of infancy or early childhood, Headache, Kinematic imbalances due to suboccipital strain, Meningitis, Motor dysfunction, Pyrexia, Screaming, Sleep disorder, Thirst, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow)
Write-up: This case was considered medically important for meningitis and KISS. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 4-months-old female patient who experienced screamingmotor dysfunction, lost 100 g body weight, screaming, feeding problem in child, KISS syndrome, sleep disorder, headache, fever, excessive thirst, suspected fluid and electrolyte imbalance, angina tonsillaris, vomiting, shivering and focal meningitis. The patient received the third dose on 22-Sep-2008. On 22-Sep-2008 the patient received the third dose of PREVENAR and according to the patient''s mother statement on 09-Oct-2008 she only moved her head to the right side and not the the left side and she did not use her left arm. On 30-Oct-2008 the patient received physiotherapy and the physiotherapist stated that the patient suffered from blockade of cervical spine and left scapula. On 25-Nov-2008 KISS syndrome (kinematic imbalances due to suboccipital strain) was diagnosed as reason for blockade. In the 47th calendar week the patient lost 100g of body weight because the patient still suffered from feeding problems as after the first two vaccinations. In Nov-2008 the patient also experienced severe screaming. For therapy physiotherapy continued. On 18-Jan-2009 the patient had a body temperature of 38.3 degrees C, on 19-Jan-2009 of 40 degrees C and on 20-Jan-2009 of 38.0 degrees C. In Mar-2009 the patient started to crawl but without using her left arm. After physiotherapy was discontinued the patient experienced excessive thirst in Mar-2009. Fluid and electrolyte imbalance was suspected. During three months the volume increased from 150 ml of 1 liter. On 26-Mar-2009 the patient also experienced angina tonsillaris as well as vomiting on 27-Mar-2009. For therapy the patient received homeopathic drugs like apis and zincum metallicum. Since April-2009 the patient shivered a lot and on 28-Apr-2009 the patient also experienced headache. The patient''s mother also mentioned that the patient

VAERS ID:386488 (history)  Vaccinated:2008-09-22
Age:13.0  Onset:2009-07-25, Days after vaccination: 306
Gender:Female  Submitted:2010-04-30, Days after onset: 279
Location:Foreign  Entered:2010-05-03, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immunisation; Deliberate self-harm
Diagnostic Lab Data: magnetic resonance imaging, 29Jul09, spinal column: normal results; electromyography, 29Jul09, generalised leg-emphasised radicular neurogenic lesion with absent F-answer for all examined nerves; magnetic resonance imaging, 31Jul09, cerebrum and spinal column: normal values; Mycoplasma PCR, negative; enterovirus PCR, negative; serum creatine kinase, 406 U/L; serum ganglioside GD1b IgM antibody, 11.5; serum ganglioside GM-1 IgM antibody, 13.1; cerebrospinal fluid culture, normal, the culture was sterile; serum Borrelia burgdorferi antibody test, negative, IgG; clinical serology test, CSF serology: see narrative; stool analysis, Negative. See narrative
CDC Split Type: WAES1004USA04281
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0354U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Antibody test positive, Areflexia, Asthenia, Blood creatine phosphokinase increased, Blood immunoglobulin M increased, Borrelia test negative, CSF culture negative, Dermatitis allergic, Dizziness, Electromyogram abnormal, Enterovirus test negative, Guillain-Barre syndrome, Hyporeflexia, Hypotonia, Immunoglobulin therapy, Laboratory test normal, Mastitis, Muscular weakness, Mycoplasma test, Nerve conduction studies abnormal, Nerve root lesion, Nuclear magnetic resonance imaging normal, Posture abnormal, Quadriparesis, Stool analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Vasculitis (broad), Functional lactation disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Information has been received from health authority (PEI2010003696). A general practitioner reported that a 13 year old female patient with a history of deliberate self-harm was vaccinated with a third dose of GARDASIL (lot number 0354U; batch number NF58150) on 22-SEP-2008. On 25-JUL-2009, the patient developed weakness of her leg, then she limped. As from 27-JUL-2009 the symptoms were increasing. On 28-JUL-2009 she was not any longer able to walk and was admitted to hospital. In addition, she experienced weakness of her hands up to the proximal wrists. A few weeks before admission she experienced recurrent dizziness from which she recovered spontaneously. One week before admission to hospital the patient had a left-sided mastitis. After oral treatment with cefuroxime (250 mg/twice a day) until 28-JUL-2009 she recovered from mastitis. Physical investigation revealed an absent patellar reflex, a hardly redeemable Achilles tendon reflex, missing muscle tone and strength in her legs and slightly reduced muscle tone and strength of her hands and arms. She could neither sit or stay. At admission routine laboratory values were within normal limits. During the further course CK increased up to 406. Serology was negative for Borrelia-IgC, mycoplasmas and enteroviruses-PCR. Gangliosid-antibodies had values of GM 1-antibodies IgM 13.1 and GD 1b-antibodies IgM 11.5. CSF was normal, the culture was sterile. CSF serology showed the following results: HSV- (herpes simplex virus) and VZV (varicella zoster virus) antibodies IgM were negative, HSV-DNA and picornavirus-RNA, enteroviruses-PCR negative. Stool sample was negative for rotavirus-antibodies, Helicobacter pylori-antibodies, picornavirus-RNA and enteroviruses-PCR. Shigella, Salmonella, Yersinia and Campylobacter had not been detected. An MRI of spinal column was performed on 29-JUL-2009 and showed normal results. An EMG (electromyogram) and nerve conduction velocity test revealed electroneurographical a generalized leg-emphasised radicular neurogenic lesion with absent F-answer of all examined nerves. On 31-JUL-2009 another MRI of cerebrum and spinal column with contrast medium showed again normal values of neurocranium without pathological contrast medium enhancement. Diagnosis of polyradiculitis of the extremities without involvement of the cranial nerves were established. Finally following diagnosis were established: Guillain-Barre syndrome, quadriparesis and suspicion of an allergic erythema. The patient was treated intravenously with OCTAGAM for five days. On 14-AUG-2009 the patient was discharged in a significant improved condition. Final outcome was not reported. Previous doses of GARDASIL were given on 24-JAN-2008 (first dose, lot number 0354U; batch number MF58150) an don 03-APR-2008 (second dose, lot number 0483U; batch number NG20170), toleration was not reported. Other business partner numbers include E2010-02619. A lot check has been initiated. Case was closed. No further information is available.

VAERS ID:386489 (history)  Vaccinated:2008-09-22
Age:17.0  Onset:2009-03-20, Days after vaccination: 179
Gender:Female  Submitted:2010-04-30, Days after onset: 406
Location:Foreign  Entered:2010-05-03, 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: Immunisation; Immunisation;
Diagnostic Lab Data: Magnetic resonance imaging, ??Mar?09, nuclear spin resonance topography and see narrative; Magnetic resonance imaging, 06Apr09, See narrative; Magnetic resonance imaging, 18Sep09, check up of cervical, thoracal spine and cranium: see narrative; Cerebrospinal fluid analysis, ??Mar?09, 18 cells/mcl, lymphocytic pleocytosis and oligoclonal bands
CDC Split Type: WAES1004USA04282
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1172U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF lymphocyte count abnormal, CSF oligoclonal band present, Central nervous system lesion, Demyelination, Disability, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Optic neuritis, Pleocytosis, Sensorimotor disorder, Spinal disorder, Visual impairment
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Malignant lymphomas (broad)
Write-up: Information has been received from an health authority (reference PEI2009032426). A neurologist reported that a previous healthy 17 year old female patient received a complete vaccination series with three doses of GARDASIL IM on 22-SEP-2008 ( first dose, lot number 1172U; batch number NH13130), on 24-NOV-2008 (second dose, lot number 1147U; batch number NH17630) and on 10-MAR-2009 (third dose, lot number 1147U; batch number NH17630). Approximately on 20-MAR-2010, ten days post vaccination, the patient experienced a first exacerbation of sensorimotor disorder of her right arm. The following nuclear spin resonance tomography showed multiple inflammatory cranial lesions with a cerebral focus in the area of cervical spin vertebral body 2/3. CSF showed lymphatic pleocytosis with 18 cells/mcl and oligoclonal bands. That time the patient was treated with a steroid high dose therapy and the immunomodulator COPAXONE. In May 2009 the patient experienced a left-sided optic neuritis and was again treated with a steroid high dose therapy. On 04-JUN-2009 the patient presented again to the outpatient department. The neurological examination showed an expanded disability status score (EDSS) of 1.0 points with a slight visual disturbance. The physician decided to continue immunomodulatory treatment with COPAXONE. On 18-SEP-2009 an MRI check-up of cervical, thoracal spine and cranium was performed. It showed right-sided frontal new demyelinating focuses with signs of activity. The other demyelinating focuses were unchanged since last MRI on 06-APR-2009. Further the MRI check-up of cervical and thoracal spine showed a regression of the multiple sclerosis plaque in the area of cervical spin vertebral body 2/3 since the last MRI on 06-APR-2009 but without being a normal results. Currently no signs of activity. HA coded: multiple sclerosis, sensory disturbance. Sensorimotor disorder, oligoclonal band CSF abnormal, Left-sided optic neuritis and expanded disability status score of 1.0 points with a slight visual disturbance were consider to be other important medical events. The final outcome was not reported. Case was closed. Other business partner numbers include E2010-02618. No further information is available.

VAERS ID:446594 (history)  Vaccinated:2008-09-22
Age:  Onset:0000-00-00
Gender:Female  Submitted:2011-12-27
Location:Foreign  Entered:2012-01-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Serum potassium, low level
CDC Split Type: WAES1112USA02960
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Blindness, Blood potassium decreased, Dizziness, Headache, Malaise, Tachypnoea, Tremor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Information received from Merck through agency on 14-DEC-2011. The information was gathered was retrieved from an internet article, a blog about GARDASIL. Case not medically confirmed. According to the article, a female patient, who was 13 years old when she was vaccinated with either the first or the second dose of GARDASIL, received the first dose on 22-SEP-2008 (batch number: NG432200, dose, route not reported). She received the second dose of 24-NOV-2011 (batch#N643220, dose, route not reported). After vaccination (date not reported, it was not reported whether the patient presented the adverse events after the first dose or the second dose of vaccine), she was unable to do physical education. Her medical test showed a low level of potassium- she had tremors, she got sick, she had headaches and experienced loss of sight and dizziness. After being admitted to the emergency unit of the hospital she discharged after 7 hours resting. She had advised to see a psychologist, but her mother said her daughter was not a crazy girl. Her condition became worsening almost always when she had her menstrual cycle. The patient also presented with shaking and tachypnea that took her to the hospital. According to the reporter the patient had not recovered. To be noted that the diagnosis reported was incapacity which was added as serious criteria. The reported batch number for both dose 1 and dose 2 did not exist and the closer batch number distributed was NG43220 (lot # 168U). Other business partner number included: E2011-08230. No further information reported.

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