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Found 508628 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:299374 (history)  Vaccinated:2007-12-10
Age:4.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2007-12-12, Days after onset: 0
Location:Texas  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA4IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0414U1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1354U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left upper are swollen, hot to touch. 2 days after immunizations given. Mom states school nurse said "liquid was coming from swollen area". Ice and heat were applied, told to keep arm moving and take ibuprofen.

VAERS ID:299401 (history)  Vaccinated:2007-12-10
Age:54.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Male  Submitted:2007-12-12, Days after onset: 1
Location:Virginia  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Anframil
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2531AA IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989V IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fever 8:30 PM with chill on 12/11/07, took 3 Advil, 2 PM 12/12/07 broke with sweating, no fever on 12/12/07 at 9.30 AM, but still warm, swelling, erythema at site of injection.

VAERS ID:299402 (history)  Vaccinated:2007-12-10
Age:12.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-11, Days after onset: 0
Location:North Dakota  Entered:2007-12-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No meds
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: ND0718
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2428AA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Exfoliative rash, Headache, Malaise, Pyrexia
SMQs:, Severe cutaneous adverse reactions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Approx. 24 hours post Menactra/Tdap immunizations - temp 101.3, severe H/A, malaise, dizzy, fine scaly rash forehead cheeks, up trunk - improving over course of day. Recommended Tylenol PRN.

VAERS ID:299406 (history)  Vaccinated:2007-12-10
Age:22.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-12, Days after onset: 2
Location:Pennsylvania  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: Sudafed, Mercury allergy
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling tenderness at site without erythema or fluctuance. About 5 cm diameter.

VAERS ID:299416 (history)  Vaccinated:2007-12-10
Age:59.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-11, Days after onset: 1
Location:Indiana  Entered:2007-12-12, 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: Inhalers
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0964U IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Injection site pain, 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: Received vaccine 12/10/07 (AM). Noticed redness the evening of injection. Area swollen with elevated redness within 24 hours. Complained of pain at site. Stated received same vaccine 5 years ago but did not have any side effects from injection.

VAERS ID:299589 (history)  Vaccinated:2007-12-10
Age:11.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-13, Days after onset: 3
Location:Virginia  Entered:2007-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1245U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2277AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Pain, numbness tingling in lower left arm; keeping arm bent as forearm and wrist hurt. Pt guarding arm distal to injection site. No site reaction.

VAERS ID:299673 (history)  Vaccinated:2007-12-10
Age:1.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-13, Days after onset: 3
Location:Missouri  Entered:2007-12-13
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: None
Diagnostic Lab Data: CBC-nl, Hgv-nl, HC-nl
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA3 LL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT24770A0 RL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.049943 LL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH80870043 RL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1470U0 RL
Administered by: Private     Purchased by: Public
Symptoms: Convulsion, Full blood count, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient was transported via ambulance to emergency room after having a seizure per mother. She had a fever of 103.8 after motrin.

VAERS ID:299894 (history)  Vaccinated:2007-12-10
Age:79.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-14, Days after onset: 3
Location:Ohio  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None UTI 11/8/07
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0990U UNUN
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Joint swelling, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: 12/11/07 Redness of right upper arm, axilla, elbow and below elbow, Edema right elbow, painful. Nothing at 12/13/07 right arm and elbow reddness, edema, pain has decreased. Dx - cellulitis - duricef 500 bid.

VAERS ID:299898 (history)  Vaccinated:2007-12-10
Age:9.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2007-12-14, Days after onset: 2
Location:California  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: note: influenza vaccine was given at Church. Takes albuterol prn, none recently
Current Illness: none
Preexisting Conditions: asthma - mild intermittent
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1246U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Induration, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and tenderness of lower 1/2 of left upper arm. Seen in emergency room 12/12/2007 and treated with cephalexin for possible cellulitis. Seen 12/14/2007 in office for follow-up. Still has 8cm area of swelling with mild firmness distal outside of left upper arm. No tenderness at all, no redness.

VAERS ID:300241 (history)  Vaccinated:2007-12-10
Age:48.0  Onset:2007-12-17, Days after vaccination: 7
Gender:Female  Submitted:2007-12-18, Days after onset: 1
Location:Massachusetts  Entered:2007-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa 40mg qAM; Ambien 10mg at bedtime prn
Current Illness: None reported
Preexisting Conditions: demerol
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0185U SCLA
Administered by: Public     Purchased by: Private
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Reported fever of: and rash on neck; resolved spontaneously within 24 hours without treatment.

VAERS ID:300242 (history)  Vaccinated:2007-12-10
Age:52.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-18, Days after onset: 7
Location:Florida  Entered:2007-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc,Diazide,Singulair,naprosyn,benadryl,and claritin
Current Illness: Patient treated for skin infection between toes on L foot.
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURERTD170 IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Skin infection
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Patient has an area 3 cm x 3cm of induration and 1 cm of redness surrounding the injection site at the R deltoid. She is experiencing pain wanted to know if this normal. The patient was being treated for a skin infection with ciprofloxacin 500 mg one P.O. BID.

VAERS ID:300268 (history)  Vaccinated:2007-12-10
Age:1.2  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 0
Location:Wisconsin  Entered:2007-12-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B046AA3IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2473HA1IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA1IMRL
Administered by: Public     Purchased by: Public
Symptoms: Discomfort, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: At 3pm client started to vomit every 15 mins until 6:30pm. Mom gave child Tylenol at 1:30 for discomfort from the DTaP vaccine. Mom gave infant Pedialyte at 11pm when she woke up, but she vomited the Pedialyte up in 15 mins. When child woke up at 8:30am she was better, no more vomiting.

VAERS ID:300269 (history)  Vaccinated:2007-12-10
Age:75.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Male  Submitted:2007-12-12, Days after onset: 2
Location:New Mexico  Entered:2007-12-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril 40 mg po qday
Current Illness: none
Preexisting Conditions: All PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS789942IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1035F1IMLA
Administered by: Public     Purchased by: Other
Symptoms: Chills, Musculoskeletal stiffness, Myalgia, Oedema peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: chills, myalgias, (L) arm swelling x 24 hrs; stiff neck persisting until present time (12/12/07 0800). Pt instructed to RTc no improving or worsening myalgia; ok to take ibuprofen prn

VAERS ID:300454 (history)  Vaccinated:2007-12-10
Age:1.0  Onset:2007-12-18, Days after vaccination: 8
Gender:Male  Submitted:2007-12-19, Days after onset: 1
Location:Pennsylvania  Entered:2007-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD test given ID to left forearm, C2679AC, 0 previous doses
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0866U0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1505U0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, warmth, induration, tenderness 8 days after vaccination at site of varicella vaccine. Treated with oral antibiotic.

VAERS ID:300455 (history)  Vaccinated:2007-12-10
Age:0.2  Onset:2007-12-12, Days after vaccination: 2
Gender:Male  Submitted:2007-12-15, Days after onset: 3
Location:Illinois  Entered:2007-12-19, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0376U0 RL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08702E0 LL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Minimal local reaction 2 days after vaccination, mild erythema approximately pencil point in size with no induration on R upper thigh.

VAERS ID:300585 (history)  Vaccinated:2007-12-10
Age:32.0  Onset:2007-12-15, Days after vaccination: 5
Gender:Female  Submitted:2007-12-20, Days after onset: 5
Location:California  Entered:2007-12-20
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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1217F IM 
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Nausea, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: MMR received on 12/10/2007, on 12-15-07 pt experienced a raised red rash beginning on her forehead-$gneck -$gchest, mild nausea.

VAERS ID:300643 (history)  Vaccinated:2007-12-10
Age:3.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Male  Submitted:2007-12-12, Days after onset: 0
Location:New Mexico  Entered:2007-12-20, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 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 PASTEURU2454AA2IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site pruritus
SMQs:
Write-up: Large, non-tender, itchy area to skin at left deltoid injections site.

VAERS ID:300993 (history)  Vaccinated:2007-12-10
Age:64.0  Onset:2007-12-15, Days after vaccination: 5
Gender:Female  Submitted:2007-12-17, Days after onset: 2
Location:North Carolina  Entered:2007-12-26, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advicor, Pepcit, Fish Oil, Naproxen, Vitamin E, Calcium
Current Illness: None
Preexisting Conditions: Osteoarthritis, hyperlipidemia, high blood pressure, PUD, dysphagia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1414U0 LA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Rash, Rash macular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Blistering pururitic rash in left facial dermatome with isolated other hemorrhagic macules with overlying vesicles.

VAERS ID:301016 (history)  Vaccinated:2007-12-10
Age:3.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2007-12-20, Days after onset: 8
Location:Indiana  Entered:2007-12-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2530AA1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site pain, Injection site warmth, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt had swelling the size of quarter or a little bigger. Injection site had some fever & was sore to touch and was increasing in size. This shot was given on 12/10/07 & child was seen for swelling on 12/12/07. Pt was treated with Amoxicillin for cellulitis.

VAERS ID:301019 (history)  Vaccinated:2007-12-10
Age:0.7  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-20, Days after onset: 9
Location:Tennessee  Entered:2007-12-26, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B127AA2UNLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0499U2UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700H UNRL
Administered by: Public     Purchased by: Public
Symptoms: Contusion, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow)
Write-up: Mom stated to this nurse her daughter ran a fever up to 103 couple days after her vaccines. Stated had a bruise area on her leg, but mom stated she had fat legs. Mom stated she never had to take her to the doctor or anywhere else and she is doing fine.

VAERS ID:301025 (history)  Vaccinated:2007-12-10
Age:22.0  Onset:2007-12-19, Days after vaccination: 9
Gender:Male  Submitted:2007-12-20, Days after onset: 1
Location:California  Entered:2007-12-26, 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: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV158 SCLA
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500488P IN 
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH4020076 IDLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA02212 IMRA
Administered by: Military     Purchased by: Military
Symptoms: Nodule
SMQs:
Write-up: Patient noticed bump similar to his smallpox vaccination site about 2 cm from the vaccination site.

VAERS ID:301085 (history)  Vaccinated:2007-12-10
Age:23.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Male  Submitted:2007-12-27, Days after onset: 15
Location:Unknown  Entered:2007-12-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MA20071674
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS69690 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Vaccination complication
SMQs:
Write-up: We received on 13 DEC 2007 the following information from a health care professional: A 23-year-old male patient, born on 29 AUG 1984, was vaccinated i.m. with Fluvirin 2006/2007 (expired on 30 JUN 2006), batch no. 69690, on 10 DEC 2007. On 12 DEC 2007 the patient developed an adverse vaccination reaction (not further specified) and was hospitalized. The patient was still hospitalized at time of reporting. Further information was requested. Company assessment: seriousness criterion: hospitalization. Causality: insufficient data. The amount of data is insufficient to assess causality of this case. Expectedness assessment: Administration of expired vaccine is not expected. No change in benefit-risk-ratio. No measures necessary. Ref no.: NA07-007052.

VAERS ID:301100 (history)  Vaccinated:2007-12-10
Age:  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2007-12-27, Days after onset: 15
Location:Washington  Entered:2007-12-27
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2607AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08733SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0413U1SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Child seen in clinic on 12/12 for large area of redness and swelling, hot to touch and painful. treated with antibiotics.

VAERS ID:301201 (history)  Vaccinated:2007-12-10
Age:66.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-19
Location:California  Entered:2007-12-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1417U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: swelling, erythema, cellulitis 4 days post

VAERS ID:301770 (history)  Vaccinated:2007-12-10
Age:62.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-30, Days after onset: 19
Location:New Mexico  Entered:2008-01-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prescribed meds from #19
Current Illness: None
Preexisting Conditions: High blood pressure, cholesterol, low thyroid
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1414U SCRA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Erythema, Induration, Pain, Pruritus, Skin exfoliation, Skin nodule, Skin warm
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: 12-10-07 Received Zostavax, Lot # 1414U Right Subq, Treatment: Benadryl PRN. 12-11-07 Slight redness, sore to touch. 12-12-07 Induration, 8cm x 3cm, warm to touch, knot felt, fiery red, Outside of induration, 12cm x 6cm, warm to touch, red, itching. 12-13-07 Same as 12-12 except tiny blisters in induration. 12-14-07 Same. 12-15-07 Same. 12-16-07 Same. 12-17-07 Induration, 6cm x 2.5cm, redness getting lighter, outer redness gone, no heat noted, only few blisters remain, slight itching. 12-18-07 Induration, 6cm x 2.5cm, redness getting lighter, all blisters gone, itching occasional. 12-19-24-07 Same as 12-18-07. 12-25-07 Same except redness is still visible but is peeling as if blistered from the sun. 12-26-29-07 Redness is still visible, but no peeling, itching. 12-30-07 Same as 29th, but I am going to submit report.

VAERS ID:301985 (history)  Vaccinated:2007-12-10
Age:9.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Male  Submitted:2008-01-04, Days after onset: 24
Location:West Virginia  Entered:2008-01-08, 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: PPD given, C2369AA, interdermal L forearm, no previous doses. Amoxicillin, Albuterol inhaler
Current Illness: URI
Preexisting Conditions: Asthma, URI, eczema
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0723U1SCUN
Administered by: Public     Purchased by: Unknown
Symptoms: Rash generalised, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Mother phoned 12/11/07 stating when patient woke up at 9AM had a fine generalized rash over entire body. No fever. Has been on Amoxicillin & Albuterol for URI since 12/3/07. Hx of asthma & eczema. Referred him to another facility. He was seen there on 12/11/07, dx with macro-papular type eruption. Unsure if secondary to varicella vaccine. Benadryl ordered TID & to return if no better. Pt never returned. Phoned 1/4/08, spoke with grandmother & he is doing fine.

VAERS ID:302788 (history)  Vaccinated:2007-12-10
Age:27.0  Onset:2007-12-13, Days after vaccination: 3
Gender:Male  Submitted:2007-12-19, Days after onset: 6
Location:North Carolina  Entered:2008-01-15, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: Hx increased BP 1998
Diagnostic Lab Data: None
CDC Split Type: NC08006
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB080AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Reported 12/13 dizziness and headache. Took BP and was elevated. Reports SOB also at that time. Continues to have problems today since 12/13. BP 166/100, no SOB noted. Leaving here to go to ER.

VAERS ID:304176 (history)  Vaccinated:2007-12-10
Age:21.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 4
Location:Virginia  Entered:2008-01-29, Days after submission: 46
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: Exercise induced asthma
Diagnostic Lab Data: None
CDC Split Type: AE0734
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA IMLA
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD168 IDLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2860AA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Incorrect route of drug administration, Induration, Local reaction, Pain, 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: The patient received Td vaccine intradermally in her left forearm by mistake on 12/10/07; she was supposed to have received PPD. Two days later, on 12/12/07, the patient returned to the doctor''s office to have her PPD test read; it was at this time that it was discovered that Td had been injected instead of the PPD. The patient had a local site reaction approximately the size of a silver dollar consisting of swelling, redness, hardness, and pain. She has to systemic adverse reactions, and the patient was walking, talking, and acting normal. The patient will be returning to the doctor''s office to receive the PPD correctly in one week. The local reaction will also be monitored at this time. Follow up information received 01/02/2008: A representative from the practice stated that the patient had recovered from the local site reaction.

VAERS ID:304345 (history)  Vaccinated:2007-12-10
Age:47.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-02-04, Days after onset: 56
Location:North Carolina  Entered:2008-02-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA625AA IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad)
Write-up: Received Tdap vaccine on 12/10/07 in right deltoid has had burning, painful sensation since receiving vaccine to right shoulder.

VAERS ID:305425 (history)  Vaccinated:2007-12-10
Age:25.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 66
Location:New York  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA00578
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician, via a company representative, concerning a 25 year old female patient, who on 10-DEC-2007 was vaccinated with the first dose, 0.5 ml, of GARDASIL (lot # nor reported). There was no concomitant medication. On the same day, the patient developed a lump at the injection site. At then time of this report, the outcome of the event was unknown. The patient sought out unspecified medical attention. Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a physician, concerning a 25 year old female patient, an office manager, with a penicillin allergy, who on 10-DEC-2007, at 5:10 pm, was vaccinated in the right deltoid muscle with the first dose, 0.5 ml, of GARDASIL (lot # 657868/0523U). There was no concomitant medication. There was no illness at the time of vaccination. At 11:00 that night, the patient had developed a slight lump at the injection site, that "was a little tender". After approximately 2 weeks, the symptoms had resolved. The patient intended to pursue the second vaccination with GARDASIL. Additional information is not expected.

VAERS ID:306141 (history)  Vaccinated:2007-12-10
Age:0.2  Onset:2007-12-10, Days after vaccination: 0
Gender:Male  Submitted:2008-02-18, Days after onset: 70
Location:New Jersey  Entered:2008-02-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA03910
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2797AA0IMUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Crying, Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a physician concerning a 53 day old male with no past medical history or allergies who on 10-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC). Concomitant vaccinations included doses of poliovirus vaccine, pneumococcal conj vaccine (unspecified) and DtAP (unspecified). On 10-DEC-2007, according to the patient''s mother, the patient developed twitching, jerking with facial muscles and arms, low grade temperature and lots of crying. The patient was seen by the physician who told the mother to "make sure the patient does not have a seizure." By 6:00 am on 11-DEC-2007, the patient recovered from twitching, jerking with facial muscles and arms, low grade temperature and lots of crying. Additional information has been requested. 02/18/09 This is in follow-up to report(s) previously submitted on 2/18/2008. Initial and follow up information has been received from two physicians and a mother concerning a 53 day old male patient with no past medical history or allergies who on 10-DEC-2007, at a 2 month check up, was vaccinated with a first dose of Hib conj vaccine (OMPC). Concomitant vaccinations included first doses of poliovirus vaccine, PREVNAR and DTAP 0.5 ml IM x 1 (lot #C2797AA). On 10-DEC-2007, according to the patient''s mother, the patient developed twitching right side of face, jerking with facial muscles and arms, low grade temperature, irritability and lots of crying. The mother called within 3-4 hours after child received vaccinations. The patient was seen by the physician who told the mother to "make sure the patient does not have a seizure". The patient was treated with BENADRYL and TYLENOL 80 mg every 4 hours po 10-DEC-2007 until 11-DEC-2007. By 6:00 am on 11-DEC-2007, the patient recovered from twitching, irritability, jerking with facial muscles and arms, low grade temperature and lots of crying. Additional information is not expected.

VAERS ID:306324 (history)  Vaccinated:2007-12-10
Age:0.4  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2008-02-18, Days after onset: 68
Location:Virginia  Entered:2008-02-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06281
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dysphonia, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad)
Write-up: Information has been received from a consumer concerning her 4 month old daughter with no medical history and no drug allergies, who on 10-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC). There was no concomitant medication. On 12-DEC-2007 the patient experienced a fever, runny nose, and hoarseness. The patient did not seek medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:306332 (history)  Vaccinated:2007-12-10
Age:3.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2008-02-18, Days after onset: 69
Location:Utah  Entered:2008-02-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Fever; Immunisation
Diagnostic Lab Data: rapid Streptococcus, negative
CDC Split Type: WAES0712USA06438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Erythema, Malaise, Oedema peripheral, Pyrexia, Streptococcus test, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a consumer concerning her 39 month old daughter with a history of "fever with all vaccines" who when she was ''less then 1 year old was vaccinated with a dose of Hib conj vaccine (OMPC). On approximately 10-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC). There was no concomitant medication. On 11-DEC-2007 the patient experienced "very high fever, constant throwing up, and leg also became swollen and red." The patient was described as "violently ill." Unspecified medical attention was sought. At the time of the report, the patient was recovering. It was reported that her "stomach still hurts." Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/20078. Previous vaccines included: ACTHIB (lot # ub878aa) on 03-Nov-2004, FLUARIX (lot # UT2459HA) (date not reported), HAVARIX (lot #AHAVB2066A) (date not reported), PEDIARIX (lot # AC21B30AA) on 03-Oct-2004 and PREVNAR (lot # 80865) on 03-Nov-2004. Additional information is not expected.

VAERS ID:306348 (history)  Vaccinated:2007-12-10
Age:0.3  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-02-18, Days after onset: 70
Location:Texas  Entered:2008-02-20, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA07158
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 1UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Crying, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a consumer concerning her 4 month old female infant with no pertinent medical history who in October 2007, was vaccinated with a first dose of PedvaxHIB. The patient did not have irritability or crying. On 10-DEC-2007 the patient was vaccinated with a second dose of PedvaxHIB. Concomitant vaccinations on the same day included DTaP and poliovirus vaccine. On 10-DEC-2007 the patient had an increase in irritability and increased crying. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:307453 (history)  Vaccinated:2007-12-10
Age:0.7  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-03-14, Days after onset: 94
Location:Tennessee  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06343
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: Information has been received from an office manager in a physician''s office concerning an 8 month old female who on 10-DEC-2007 was vaccinated with her third dose of Rotateq when she was older than 32 weeks. No symptoms or problems were noted. The patient did not seek medical attention. There was no product quality complaint. Additional information has been requested.

VAERS ID:309789 (history)  Vaccinated:2007-12-10
Age:  Onset:2007-12-10, Days after vaccination: 0
Gender:Unknown  Submitted:2008-03-26, Days after onset: 106
Location:Unknown  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02637
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a pharmacist concerning a patient who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX and later that day developed a rash on her neck. The patient did not have any other symptoms. No further information was available. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.

VAERS ID:309817 (history)  Vaccinated:2007-12-10
Age:64.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 106
Location:Virginia  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOXYL; DIOVAN
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02797
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Balance disorder, Blood pressure decreased, Cough, Dizziness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a 64 year old female consumer with no known allergies or pertinent medical history who on 10-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included DIOVAN and LEVOXYL. Approximately 15 minutes after vaccination on 10-DEC-2007 the patient felt off balance and experienced dizziness coughing, weakness and a drop in her blood pressure. Medical attention was sought. There were no lab studies performed. The patient was treated with diphenhydramine hydrochloride (manufacturer unknown) which did not help her dizziness and weakness. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.

VAERS ID:309825 (history)  Vaccinated:2007-12-10
Age:75.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 106
Location:Delaware  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DYAZIDE; SYNTHROID (micro gm); MACRODANTIN (mg); PHENTERMINE (mg); ACTONEL (mg)
Current Illness: Osteoporosis; Rheumatoid arthritis; Hypothyroidism; Microscopic haematuria; Leukopenia
Preexisting Conditions: Shingles
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA03904
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1087U SC 
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Burning sensation, Discomfort, Incorrect dose administered
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad)
Write-up: Information has been received from a health professional concerning a 75 year old female with osteoporosis, rheumatoid arthritis, hypothyroidism, microscopic haematuria and leukopenia with a history of shingles in 1970 and September 2006. On 10-DEC-2007 she was vaccinated with a 0.7 milliliter dose of ZOSTAVAX (lot# 658398/1087U). Concomitant therapy included risedronate sodium (ACTONEL) 35 mg, nitrofurantoin (MACRODANTIN) 50 mg once daily, HCTZ/triamterene (DYAZIDE) 25/37.5 mg, levothyroxine sodium (SYNTHROID) 50 mcg, and phentermine 37.5 mg. On 11-DEC-2007 the patient developed pain on the back, burning sensation on the back and discomfort. It was reported that the patient called the physician''s office and reported that she had been treating herself with gabapentin "that she had" from the September 2006 shingles episode. At the time of this report, it was reported that the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.

VAERS ID:310190 (history)  Vaccinated:2007-12-10
Age:64.0  Onset:2007-12-14, Days after vaccination: 4
Gender:Male  Submitted:2008-03-26, Days after onset: 102
Location:Virginia  Entered:2008-04-16, Days after submission: 21
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: Hyperlipidaemia; Hypertension; Asthma; Eczema; Coronary artery disease
Diagnostic Lab Data:
CDC Split Type: WAES0801USA02869
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a pharmacist concerning a 64 year old male patient with hyperlipidaemia, hypertension, asthma, eczema and coronary artery disease who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown). On 14-DEC-2007, the patient experienced a shingles like rash on the upper right hand quadrant of his torso and was seen by his physician. The patient''s outcome was unknown. There was no quality complaint. Additional information has been requested.

VAERS ID:310193 (history)  Vaccinated:2007-12-10
Age:67.0  Onset:2007-12-16, Days after vaccination: 6
Gender:Female  Submitted:2008-03-26, Days after onset: 100
Location:Pennsylvania  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism; Penicillin allergy; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Herpes simplex virus, 12/17/07, negative
CDC Split Type: WAES0712USA08575
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0887U SCUN
Administered by: Other     Purchased by: Other
Symptoms: Facial pain, Lacrimation increased, Lip swelling, Oral pain, Rash pustular, Virus culture negative
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 67-year-old female with hypothyroidism and an allergy to penicillin allergy and DEMEROL who on 10-DEC-2007 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 658212/0887U). Concomitant therapy included SYNTHROID. On 16-DEC-2007 the patient developed a right upper lip pustule with swelling. The patient also developed soreness of the right upper cheek and the roof of her mouth. A pustule developed near her right eye. The patient was examined in the office on 17-DEC-2007 and a culture of a pustule was taken. The culture results were negative for virus. On 21-DEC-2007, the patient was examined in the office again. The exam revealed tearing of the right eye. The patient was started on VALTREX and referred to an ophthalmologist for consultation. At the time of the report the patient''s status was not recovered. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:312035 (history)  Vaccinated:2007-12-10
Age:52.0  Onset:2007-12-11, Days after vaccination: 1
Gender:Female  Submitted:2007-12-18, Days after onset: 7
Location:Maryland  Entered:2008-04-28, Days after submission: 131
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no illness at the time of vaccination, no past medical history, and was on no other medications.
Diagnostic Lab Data:
CDC Split Type: 200704282
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1954B IMRA
Administered by: Private     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: Initial report received on 14 December 2007 from a health care professional. A 52-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of DECAVAC, lot number U1954BB, on 10 December 2007. One day post-vaccination, the patient developed cellulitis from the shoulder to the elbow of her right arm which was diagnosed by a physician. She was treated with BACTRIM and recovered from the event.

VAERS ID:314051 (history)  Vaccinated:2007-12-10
Age:1.0  Onset:2008-01-27, Days after vaccination: 48
Gender:Male  Submitted:2008-05-16, Days after onset: 109
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA00405
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: Varicella post vaccine
SMQs:
Write-up: Information has been received from a health professional concerning a 13 month old male with no known drug allergies and no pertinent medical history who on 10-DEC-2007, was vaccinated with a 0.5 cc subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 1350U). Concomitant vaccination included measles-mumps-rubella vaccine (MSD). There was no concomitant medication. On 27-JAN-2008, the patient developed breakthrough chickenpox. No laboratory studies were done. It was indicated that at the time of this report, the patient was recovering. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:317504 (history)  Vaccinated:2007-12-10
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-30
Location:Unknown  Entered:2008-06-18, Days after submission: 19
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: WAES0712USA07915
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pruritus
SMQs:
Write-up: Information has been received from a consumer concerning her 4 year old daughter who on 10-DEC-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the patient developed injection site itching. Subsequently, the patient recovered from the injection site itching. The patient did not seek medical attention. There was no product quality complaint. No further information is available.

VAERS ID:320925 (history)  Vaccinated:2007-12-10
Age:12.0  Onset:2008-01-18, Days after vaccination: 39
Gender:Female  Submitted:2008-07-30, Days after onset: 193
Location:Pennsylvania  Entered:2008-07-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None 8/27/08-records received-PMH:headache once per month. Head trauma. Eczema.
Diagnostic Lab Data: electroencephalography, Unequivocal result 8/8/08-records received-MRI brain normal.EEG on 1/22/08-borderline abnormal EEG somehwhat prominent sharp activity seen bilaterally left more than right. No clear cut spike discharges are noted. F
CDC Split Type: WAES0807USA04054
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1UNUN
Administered by: Private     Purchased by: Private
Symptoms: Aura, Contusion, Convulsion, Dizziness, Electroencephalogram abnormal, Menstruation irregular, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain normal, Pain, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 12 year old female with no known allergies or pertinent medical history who on 14-SEP-2007 was vaccinated in right arm with first dose of GARDASIL. (Lot# 658558/1061U). On 10-DEC-2007 was vaccinated in left arm with second dose of GARDASIL (Lot # 659055/1522U). There was no illness at the time of vaccination. The nurse reported the following the second vaccine of GARDASIL on 18-JAN-2008 the patient experienced seizure and on 05-FEB-2008 the patient experienced seizure. The patient did not receive other injections on or near those dates. Electroencephalogram (EEG) was performed (Unequivocal result). The patient is now on unspecified medication. On unspecified date the patient recovered. The patient sought medical attention "required emergency room/doctor visit". Upon internal seizures were determined to be an other important medical event. Additional information is not expected. 8/8/08-records received-presented to ED 1/18/08-passed out/seizure, head injury. Seizure occurred while walking to school. Bump on forehead. PE normal. Impression: Seizure activity. Contusion of forehead. 8/27/08-records received for DOS 2/15/08-has had only 1 menarche times 1 lasted for 1 day but none since last Gardasil vaccination. PE:normal. Assessment:one-time seizure versus syncope. multiple neurocutaneous lesions. Second seizure 3/4/08. 4/21/08-felt aura, dizzy and body tingled all over. Whole body aching afterwards. 9/2/08-records received for DOS 2/15/08-pediatric neurology clinic as a follow up to 1 time seizure-like episode. DX: One-time seizure. Versus syncope. Multiple neurocutaneous lesions.

VAERS ID:322037 (history)  Vaccinated:2007-12-10
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-13
Location:California  Entered:2008-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin, Actos,Lisinopril, HCTZ,PremPro
Current Illness: none
Preexisting Conditions: Diabetes Mellitus - stable
Diagnostic Lab Data: Rheumatoid Factor 200 on 06/30/08
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Arthralgia, Joint swelling, Rheumatoid factor positive, Synovitis
SMQs:, Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: Joint pain, swelling, synovitis within 24 hours of administration of vaccine. RA Factor positive on 6/30/08. Patient is missing multiple days of work due to symptoms. Patient recently changed primary care physicians and we have been unable to access information regarding lot number and manufacturer of vaccine, date of vaccination. please contact Dr. for information.

VAERS ID:337879 (history)  Vaccinated:2007-12-10
Age:1.3  Onset:2007-12-10, Days after vaccination: 0
Gender:Male  Submitted:2008-12-01, Days after onset: 357
Location:Illinois  Entered:2008-12-16, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 102-; body temp, 12/10/07, 0-, fever
CDC Split Type: WAES0712USA04615
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1157U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from the agency (case #2007023-2447519) via a physician concerning a 15 month old male on 10-DEC-2007 was vaccinated with COMVAX (lot # 656271/1157U) 0.5 ml. On 10-DEC-2007, five hours after being vaccinated in the evening, the patient experienced a fever. On 12-DEC-2007, the patient was assessed in the emergency room for persistent fever (102-103). A CBC and blood culture were planned. At the time of reporting, the patient had not recovered. Additional information has been requested.

VAERS ID:338219 (history)  Vaccinated:2007-12-10
Age:63.0  Onset:2007-12-13, Days after vaccination: 3
Gender:Female  Submitted:2009-01-21, Days after onset: 405
Location:Louisiana  Entered:2009-01-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: High Cholesterol; Triglycerides, High Blood pressure; MS, in remission
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Chills, Fatigue, Herpes simplex, Lymphadenopathy, Myalgia, Neck pain, Pruritus, Pyrexia, Rash papular, Red blood cell sedimentation rate increased, Rhinitis, Rhinorrhoea, Upper respiratory tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad)
Write-up: Three days after I received the ZOSTAVAX injection , I broke out with a rash on my right arm. It was 2-3 cm wide, consisted of pruritic small red papules and extended from the medical aspect of my wrist across my arm and ended at my elbow. The rash persisted for about 10 days. IN August 2008, I noted a 1.5 cm tender lymph node in my right axillary are, with no other signs or symptoms of infection. It lasted about one week. The following week, I began having chills, fever, and symptoms of a mild URI. About the third day of chills and fever, I also noted a purulent nasal discharge and pain in my posterior neck. I consulted a doctor at a local walk-in clinic, and he drew a CBC and sed rate and gave me a prescription of CIPRO. He did not tell me the results of the CBC, but he did say the sed rate was elevated "indicating that I had some type of infection". The next day, I broke out with a large herpes simplex lesion inside my nasal passage, and the chills, fever, and pain in my neck disappeared. After that, I had another outbreak of herpes simplex in my nose about one month and two months from the initial outbreak. On Friday January 16th, 2009, I had fatigue and muscle aches. The next day, I broke out with 2 herpes simplex lesions on my upper lip. I also kissed my husband on January 16th, and the next day he broke out with herpes simplex lesions on his lip. I do feel that the rash on my arm was a direct result of the ZOSTAVAX injection, even though it did not appear vesicular. I cannot prove that the herpes simplex lesions are a result of the vaccination, however before I took it, I was not prone to have recurrent herpes outbreaks, and certainly not this frequently, and not with severe prodromal symptoms like I have had. My husband and I are both 65, happily married, monogamous and devout Christians. I did previously work in public health as a nurse practitioner and examined patients in the family planning and STD clinics, but I retired 2 years ago, and have no contact with the patients since then. I seek no damages or compensation for this report. My only wish is to record my experience in case other patients have had or will in the future have problems with ZOSTAVAX. I have no regrets for taking the vaccine. Herpes simplex will be a small price to pay to prevent herpes zoster.

VAERS ID:341696 (history)  Vaccinated:2007-12-10
Age:2.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Male  Submitted:2009-02-18, Days after onset: 434
Location:New York  Entered:2009-03-12, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: WBC count, 12/12/07, elevated; Erythrocyte, 12/12/07, elevated; Serum immunoglobulin M, 12/12/07, negative for lyme''s disease; Serum immunoglobulin G, 12/12/07, positive for lyme''s disease.
CDC Split Type: WAES0712USA09091
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0259U IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M normal, Joint effusion, Muscular weakness, Red blood cell count increased, Swelling, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Information has been received from a Nurse Practitioner, (N.P.), concerning a 2 year old male patient who on 10-DEC-2007 was vaccinated IM i "left arm" with a dose of PEDVAXHIB , 656519/0259U. Two days post vaccination the patient was taken to the emergency room with left leg weakness, swelling, and left knee joint effusion. CBC blood work tests were performed, white blood count was elevated, sedimentation rate elevated. Also, blood work tests for Parvovirus B19, Streptococcus, and Lyme disease performed. Result for Lyme disease was IGM negative, and IGG positive. The child was not hospitalized. He was scheduled for follow up with an orthopedic specialist the next day and treated with AMOXICILLIN and NAPROXEN. The reporter stated the child''s adverse event resolved by itself. Additional information has been requested.

VAERS ID:343235 (history)  Vaccinated:2007-12-10
Age:0.0  Onset:2007-12-21, Days after vaccination: 11
Gender:Male  Submitted:2009-03-06, Days after onset: 441
Location:Pennsylvania  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA02481
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Candidiasis, Conjunctivitis, Rash, Upper respiratory tract infection
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician, concerning a 1 day old Caucasian male infant (a normal 9 lb 0.2 oz, male infant with no abnormalities or anomalies), who on 10-DEC-2007 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer not specified). On 21-DEC-2007 the infant was seen for a 2 week check up, and had a nonspecific rash. On 08-JAN-2008 the infant was seen for a 4 week check up with no findings noted, and was vaccinated with the second dose of RECOMBIVAX HB (manufacturer no specified). On 21-JAN-2008, the infant, whose brother had an upper respiratory infection (URI) was seen by the physician; his mother expressed concern about his wheezing, and reported "cough, rhinorrhea, congestion for 3 days." There was no fever. The physician assessed an upper respiratory infection, and prescribed treatment with a cool mist machine for coughing and saline nasal suction. On 11-FEB-2008, the infant was seen by the physician for a 2 month check up. At this visit, the infant was vaccinated with the first dose of ROTATEQ, the first dose of DTAP (manufacturer not specified), the first doe of IPOL (manufacturer not specified), the first dose of PEDVAXHIB (manufacturer not specified), and the first dose of PREVNAR (manufacturer not specified). On 03-MAR-2008, the infant was seen by the physician, who noted the infant''s brother had conjunctivitis; the infant was diagnosed with blepharo conjunctivitis (symptom onset documented as 2 days prior to visit), and thrush. Treatment included nystatin and sulfacefamide 1.0 % ophthalmic drops. The outcome of the individual events was not specified. Additional information is not expected.

VAERS ID:370614 (history)  Vaccinated:2007-12-10
Age:6.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Male  Submitted:2009-11-25, Days after onset: 716
Location:Virginia  Entered:2009-11-30, 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: ALBUTEROL
Current Illness:
Preexisting Conditions: The patient had no concurrent illness at the time of vaccination. Patient had a past medical history of asthma and had been taking ALBUTEROL concomitantly.
Diagnostic Lab Data: Not reported
CDC Split Type: 200904991
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2513AA1UNLA
Administered by: Private     Purchased by: Public
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial report received from a health care professional on 16 November 2009. An eight-year-old male patient (date of birth reported as 03 March 2001) with a medical history of asthma, had received a second dose of left deltoid injection of FLUZONE, lot number U2513AA on 10 December 2007 and that same day upon standing after receiving the vaccine, the patient fainted and fell to the floor. The patient had previously received a first dose of FLUZONE (lot number, route and site not reported) on 09 November 2007. The patient had no concurrent illness and he had been taking Albuterol concomitantly at the time of vaccination. The reporter noted that the event required an emergency room or doctor''s visit (not specified) and the patient recovered. The reporter for this case is the same as for case number 2009-04495. Documents held by sender: None.

VAERS ID:383333 (history)  Vaccinated:2007-12-10
Age:65.0  Onset:0000-00-00
Gender:Female  Submitted:2010-03-20
Location:Virginia  Entered:2010-03-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes and elevated cholesterol.
Diagnostic Lab Data: skin biop for SPD
CDC Split Type:
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Lot
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.14140 UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Biopsy skin abnormal, Genital herpes, Subcorneal pustular dermatosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow)
Write-up: I developed genital herpes - in less than 2 mos. I then was diag with subcorneal pustular dermatosis 2009 - and urticaria in neck and face.

VAERS ID:300365 (history)  Vaccinated:2007-12-10
Age:17.0  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2007-12-18, Days after onset: 8
Location:Foreign  Entered:2007-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypothyroidism
Preexisting Conditions:
Diagnostic Lab Data: blood pressure measurement 10Dec07 80/40 mm/Hg
CDC Split Type: WAES0712USA04302
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1518F0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Convulsion, Hypotension, Immediate post-injection reaction, Syncope, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a pediatrician concerning a 17 year old female with hypothyroidism who on 10-DEC-2007 was vaccinated with a first dose of Gardasil (lot# 1518F; batch # NF27880) IM into the deltoid muscle. There was no concomitant medication. On 10-DEC-2007, a few minutes post-vaccination, the patient began to shiver and experience a syncope. She experienced "mild signs of convulsion" with a tongue bite. The patient recovered within a short time. Blood pressure was low (80/40 mg/Hg) and only improved after i.v. volume substitution within 1 hour. The patient was admitted to the hospital for monitoring and clarification the same day. Additional information is not expected. Other business partners include are: E2007-09086.

VAERS ID:300749 (history)  Vaccinated:2007-12-10
Age:16.0  Onset:2007-12-12, Days after vaccination: 2
Gender:Female  Submitted:2007-12-20, Days after onset: 8
Location:Foreign  Entered:2007-12-21, 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: No reaction on previous exposure to vaccine.
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA07347
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Facial paresis, Headache
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a pediatrician, concerning a 16 year old female patient with a history of no reaction on previous exposure to vaccine (dose 1 and dose 2), who on 10-DEC-2007 was vaccinated IM in the left deltoid with the third dose of Gardasil (lot # not reported). On 12-DEC-2007 the patient experienced parietal headache. On 13-DEC-2007 the patient developed right facial paresis, and was hospitalized. At the time of this report, the patient had not recovered. The reporting physician did not see a causal relationship to the vaccine, however she reported the events due to the close temporal relationship. Other business partner numbers include: E2007-09199.

VAERS ID:300756 (history)  Vaccinated:2007-12-10
Age:  Onset:0000-00-00
Gender:Female  Submitted:2007-12-20
Location:Foreign  Entered:2007-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA05362
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Gait disturbance, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a health professional (ref #63195) concerning a female with no reported medical history who on 10-DEC-2007 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast). In December 2007 (post vaccination), the patient experienced dizziness, nausea and unsteady gait. At the time of the report the patient''s status was unknown. The events of dizziness, nausea and unsteady gait was considered as an other medically important event (OME) by the reporter. Other business partner numbers included: E2007-09184. No further information is available.

VAERS ID:303471 (history)  Vaccinated:2007-12-10
Age:25.0  Onset:2007-12-28, Days after vaccination: 18
Gender:Female  Submitted:2008-01-25, Days after onset: 28
Location:Foreign  Entered:2008-01-24, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2008-01-11
   Days after onset: 14
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMBIVIR (ZIDOVUDINE/LAMIVUDINE) 04/20/2007:PRESENT; KALETRA (KALETRA) 09/24/2007:PRESENT
Current Illness:
Preexisting Conditions: HIV POSITIVE
Diagnostic Lab Data: 05-Jan-08 Chest X-ray: Increased heart area; pulmonary infiltrates; 05-Jan-08 ECG: Premature ventricular contractions; 10-Jan-08 ECG: Atrial flutter; 10-Jan-08 pCO2: 26.9 mmHg (ref. range 35-45 mmHg); 10-Jan-08 pO2: 41.9 mmHg (ref. range 83
CDC Split Type: 2008A4000000
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB265BI0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Acidosis, Activated partial thromboplastin time normal, Activated partial thromboplastin time prolonged, Aspartate aminotransferase increased, Atrial flutter, Base excess decreased, Blood glucose decreased, Blood lactate dehydrogenase increased, Blood potassium increased, Cardioversion, Chest X-ray abnormal, Coagulopathy, Death, Dyspnoea, Electrocardiogram abnormal, Fatigue, Haemoglobin decreased, Heart rate increased, Hypotension, Intensive care, Intubation, Lung infiltration, Mechanical ventilation, Oedema peripheral, Oxygen saturation decreased, PCO2 abnormal, Palpitations, Platelet count normal, Prothrombin level increased, Prothrombin time prolonged, Pulmonary oedema, Pyrexia, Rales, Shock, Sputum culture, Supraventricular tachycardia, Tachycardia, Tachypnoea, Thrombocytopenia, Unresponsive to stimuli, Ventricular extrasystoles
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad)
Write-up: The patient was enrolled in study ATN 024, a Randomized Open-Label trial. This study is exempt from IND reporting requirements. The patient received a dose of 20 mcg of Engerix B intramuscularly on 10-Dec-07. This was her first dose in a series of three doses. On 04-Jan-08, the patient, a 25 year old female, was hospitalized after a 7-day history of fatigue and a 3-day history of low grade fever (up to 100.4 F), tachycardia, tachypnea, and palpitations. Her physical examination at admission was as follows: heart rate 144 beats/min, respiratory rate 28-32 respiration/min, blood pressure 80/50 mmHg, oxygen saturation 97% on room air. Auscultation showed crackies on the lower left lung area, regular heart rhythm, S3 gallop, no murmurs. No hepatomegaly, splenomegaly, or edema on extremities were noted. The neurological exam was normal. A chest X-ray done on 05-Jan-08 demonstrated increased heart area and pulmonary infiltrates, which were judged to be consistent with pulmonary edema. An ECG from the same day was notable for premature ventricular contractions. Three days later the patient''s tachycardia, tachypnea, and hypotension improved. Her heart rate was 124 beats/min, respiratory rate 28/min, blood pressure 120/80 mmHg, oxygen saturation 97% on room air. Her lungs were clear on auscultation and the rest of her examination remained unchanged. This event is ongoing and a follow-up report is expected. Study vaccine causality has been assessed by the investigator as probably not related to Engerix B. Study vaccine causality has been assessed by the medical monitor as probably not related to Engerix B. Follow-up 11-Jan-08: On 10-Jan-08 the patient''s condition worsened and she was transferred to a larger institution for further management. She had shortness of breath, tachypnea of 32 respirations/min, and tachycardia over 140 beats/min. Her oxygen saturation dropped to 91% on 8 L/min oxygen via mask. A lower extremities edema of 2/4+ was noted. Auscultation revealed bilateral basilar rales and regular heart rhythm was S

VAERS ID:306551 (history)  Vaccinated:2007-12-10
Age:0.3  Onset:2007-12-31, Days after vaccination: 21
Gender:Female  Submitted:2008-03-05, Days after onset: 65
Location:Foreign  Entered:2008-03-06, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: stool culture ??Dec07 Comment: confirmed rotavirus and salmonella
CDC Split Type: WAES0803AUS00010
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.15974 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture stool positive, Diarrhoea, Haematochezia, Malaise, Rotavirus infection, Rotavirus test positive, Salmonellosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received via CSL as part of a business agreement, concerning a 14 week old female who on 10-DEC-2007 was vaccinated with the second dose of Rotateq Batch # 15974 - not valid for this item). Concomitant therapy included INFANRIX-IPV, COMVAX and PREVENAR. On approximately 31-DEC-2007, three weeks post vaccination with the second dose of Rotateq, the patient was admitted to hospital with gastro-type symptoms (diarrhoea). The patient had blood in the faeces and a stool culture test was done which confirmed rotavirus and salmonella in the faeces. The patient was unwell for a further 2 1/2 weeks after the vaccination and the mother was anxious about allowing the child to receive the third dose of Rotateq. Additional information is not expected.

VAERS ID:306913 (history)  Vaccinated:2007-12-10
Age:12.0  Onset:2008-01-11, Days after vaccination: 32
Gender:Female  Submitted:2008-03-11, Days after onset: 59
Location:Foreign  Entered:2008-03-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Haemangioma; Pain of lower extremities
Preexisting Conditions: Anti-borrelia antibody positive; Knee effusion; No reaction on previous exposure to vaccine
Diagnostic Lab Data: diagnostic laboratory test 11?Jan08 Comment: inconspicuous; lower extremity X-ray 11?Jan08 Comment: normal; ophthalmological exam 11?Jan08 Comment: normal; diagnostic laboratory test 30?Jan08 Comment: normal; magnetic resonance imaging 30?J
CDC Split Type: WAES0803USA01142
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody, Arthralgia, Burning sensation, Dissociative disorder, Lumbar puncture, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Rheumatoid factor negative, Sensory disturbance, Serology normal, Streptococcus identification test negative, X-ray limb normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad)
Write-up: Information has been received from a gynecologist, concerning a 12 year old female patient with haemangioma (one in loge of left quadriceps muscle; one in medial of left femur condyle) and intermittent pain of the legs (one year), and a history of anti-borreliosis and knee effusion, who on 11-OCT-2007 was vaccinated with the first dose of GARDASIL, which was well tolerated (lot #0251U; batch NF56480). On 11-JAN-2008 the patient was hospitalized because of sensory disorder in both legs up to the knees, pain in the knees and weakness of legs. The patient was regularly seen in an orthopedic department for 1 year for her history of hemangioma (as above). A sonography of the knees, left thigh and abdomen were normal. The patient was treated symptomatically with ibuprofen and recovered completely within 2 days. Lab findings were inconspicuous and included: rheumatoid factor (RF), serum antinuclear antibodies test (ANA), serology (chlamydia, mycoplasma and borrelia), antistreptolysin (ASL) and "ASK." An ophthalmological exam was normal. The physicians assessed that the pre-existing hemangioma caused the symptoms. The patient was discharged on 15-JAN-2008. On 30-JAN-2008, she was again hospitalized because of pain in the lower legs, changing sides and resulting in a burning sensation that disappeared. She also complained about weakness in her legs. Clinical examination was normal. Routine lab findings were normal. Borrelia serology was negative. Cranial and spinal magnetic resonance imaging (MRI) were normal. An orthopedist stated that the patient complained about intermittent pain in her legs for 1 year and that she had a history of borreliosis and effusion of the knee. Cerebrospinal fluid (CSF) was normal except a discrete barrier disorder. A psychologist suspected a dissociative disorder, because of a strong psychological strain and a psychotherapy was planned. At discharge on 06-FEB-2008, the patient''s neurological examination was normal, and she did not complain of pain anymore. In the reporting form dated 03-MAR-20

VAERS ID:335702 (history)  Vaccinated:2007-12-10
Age:0.2  Onset:2007-12-10, Days after vaccination: 0
Gender:Female  Submitted:2008-12-18, Days after onset: 374
Location:Foreign  Entered:2008-12-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812AUS00263
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Febrile convulsion, Feeding disorder of infancy or early childhood, Gaze palsy, Inappropriate schedule of drug administration, Musculoskeletal stiffness, Pyrexia, Screaming, Somnolence, Tonic convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ocular motility disorders (narrow), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad)
Write-up: Information was obtained on request by the Company from the agency, via a Case Line Listing and Public Case Details Form, concerning a 59 day old female infant who on 10-DEC-2007 was vaccinated with COMVAX. Other suspect therapy included ROTATEQ, INFANRIX-IPV and PREVENAR, all of which were administered on 10-DEC-2007 as prophylactic vaccination. On 10-DEC-2007 the patient experienced tonic convulsion, pyrexia and somnolence and was hospitalized. It was described that the patient was initially OK, then later she was not feeding properly (was drowsy) and was febrile. The infant stiffened, with eyes fixed, and screamed. She was taken to hospital. Subsequently, the patient experienced ongoing episodes, 1-2 per day. At the time of reporting to the agency on 22-JUL-2008, it was not known if the patient had recovered from tonic convulsion, pyrexia and somnolence. The agency considered that tonic convulsion, pyrexia and somnolence were possibly related to therapy with COMVAX and/or ROTATEQ and/or INFANRIX-IPV and/or PREVENAR. The original reporting source was not provided by the agency. Additional information is not expected.

VAERS ID:413311 (history)  Vaccinated:2007-12-10
Age:1.4  Onset:2007-12-10, Days after vaccination: 0
Gender:Male  Submitted:2010-12-20, Days after onset: 1106
Location:Foreign  Entered:2010-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: 2010169907
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Inflammation, Injection site pruritus, Pruritus, Skin plaque
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: This is a spontaneous initial report received from the Foreign Health Agency, regulatory authority report number BX20101012. A 17-month-old male patient received a dose of suspected vaccines: PREVENAR, IM, on 10Dec2007 and a dose of PENTAVAC, IM, on 10Dec2007, both vaccines given as immunization and both vaccines reported as a "booster" (exact dose number not specified). The patient had no relevant medical history; No concomitant medication was reported. On 10Dec2007, at 17 months, following the booster vaccines, the patient developed pruritus which constituted a serious condition from a medical standpoint. The patient developed inflammatory reaction with bilateral erythematous plaques, followed by persistent pruritus predominantly on the injection site. There was no general impact on the patient''s behaviour. The pruritus and rash completely resolved on 19Dec2010. The patient recovered without sequelae. Based on the Official Foreign Method of Causality Assessment, all suspected medicinal products were rated by the agency as likely. No FU attempts needed. No further information expected.

VAERS ID:299237 (history)  Vaccinated:2007-12-11
Age:28.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-11
Location:Pennsylvania  Entered:2007-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, Flonase, Cortisporin
Current Illness: None
Preexisting Conditions: IBS, Ear Canal Eczema at visit 12/3/07
Diagnostic Lab Data: None at this time
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0143U SCLA
Administered by: Private     Purchased by: Private
Symptoms: Medication error
SMQs:
Write-up: None at this time, vaccine error was realized by myself, Office Mgr., after patient left the office today. We will notify patient and follow.

VAERS ID:299326 (history)  Vaccinated:2007-12-11
Age:0.8  Onset:0000-00-00
Gender:Female  Submitted:2007-12-11
Location:Maine  Entered:2007-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2469AA1UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Incorrect dose administered
SMQs:
Write-up: Pt came in for 2nd dose of flu shot. Pt was supposed to receive .25 cc. Received .50cc instead

VAERS ID:299354 (history)  Vaccinated:2007-12-11
Age:19.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-12, Days after onset: 1
Location:New Jersey  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient|None~ ()~NULL~~In Sibling1
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0490U0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0868U0SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B012AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1355U0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:299581 (history)  Vaccinated:2007-12-11
Age:63.0  Onset:2007-12-12, Days after vaccination: 1
Gender:Male  Submitted:2007-12-13, Days after onset: 1
Location:Nevada  Entered:2007-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin, Caduet, Celebrex, Lasur, Lisinopril, Kaon-C1
Current Illness: None
Preexisting Conditions: No known drug allergies. History of CAD, Arthritis, Hypertension.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2525AA IM 
Administered by: Other     Purchased by: Private
Symptoms: Asthenia, Blood pressure diastolic increased, Blood pressure increased, Chills, Pyrexia, Sensation of heaviness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad)
Write-up: Approximately 8 hours after administration of vaccine, patient developed weakness, chills, fever, arms felt heavy. Slept for several hours. Wife took blood pressure of patient which was up to 150/132. Patient returned to clinic. Blood pressure read to be 146/88 and patient was feeling better.

VAERS ID:299600 (history)  Vaccinated:2007-12-11
Age:2.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-12, Days after onset: 1
Location:New York  Entered:2007-12-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None, but recuperating from s/p bilateral otitis media 12/4/07
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2456EA UNUN
Administered by: Private     Purchased by: Public
Symptoms: Rash erythematous, Rash papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 12/12/07 Patient present to clinic with a papular erythematous rash, afebrile, good appetite. 12/11/07 Influenza vaccine administered.

VAERS ID:299631 (history)  Vaccinated:2007-12-11
Age:5.0  Onset:2007-12-12, Days after vaccination: 1
Gender:Female  Submitted:2007-12-13, Days after onset: 1
Location:Michigan  Entered:2007-12-13
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1343U0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Hyperaemia, Induration
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Localized swelling and hyperemia around injection site approx 8cm x 6cm induration of left thigh. 5x3cm hyperemia.

VAERS ID:299674 (history)  Vaccinated:2007-12-11
Age:52.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-13, Days after onset: 2
Location:Wyoming  Entered:2007-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies - Internal iodine, environmental allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1381U1IM 
Administered by: Private     Purchased by: Other
Symptoms: Chills, Crying, Erythema, Feeling cold, Injection site mass, Injection site pain, Injection site warmth, Oedema peripheral, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: 12/11/07 - Patient reports pain, warmth, and a knot "goose egg" at injection site. Pain brought crying to patient. 12/12/07 - patient reports cold chills, fever 100.2 - swelling, warmth, redness to right arm to elbow. Ibuprophen 400mg morning and night. 12/13/07 - patient reports to public health - right arm swollen, warm red from shoulder to fingertips. Patient reports pain less but pain continues. 400mg Ibuprophen. 12/13/07 - measurement upper arm 11''14".

VAERS ID:299736 (history)  Vaccinated:2007-12-11
Age:25.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-14, Days after onset: 3
Location:Arizona  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2463AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Myalgia, Pyrexia, Rash maculo-papular, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Within a few hours of vaccintion, he experience low grade fever and myalgias. Next day, a pruritic maculopapular rash appeared over the trunk and extremities.

VAERS ID:299817 (history)  Vaccinated:2007-12-11
Age:71.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-14, Days after onset: 3
Location:Texas  Entered:2007-12-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Denied
Preexisting Conditions: Idiopathic pulm fibrosis; myalgia/myositis; spondylolithesis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U1UNRA
Administered by: Military     Purchased by: Military
Symptoms: Abnormal behaviour, Body temperature decreased, Injection site discomfort, Injection site reaction
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)
Write-up: Pt in usual state of health prior to receiving pneumocoaal vaccine #2 on 11 Dec 07 (first one was 19 Feb 2002). States later that night developed large local reaction and temp spikes to 103. Also describes that was "off" - spouse commented like acted as if "was demented". LLR is resolving; temps normalized and currently pt feels at baseline outside of some discomfort about injection site. Never had respiratory or GI sx. No other skin lesions. Pt did not seek medical care at the time of episode. No treatment given today, though did recommend that pt f/u with PCM or ER if again develops and neuro changes.

VAERS ID:299867 (history)  Vaccinated:2007-12-11
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-12
Location:New Hampshire  Entered:2007-12-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: NH0747
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA1  
Administered by: Private     Purchased by: Unknown
Symptoms: No adverse reaction
SMQs:
Write-up: None noted

VAERS ID:299887 (history)  Vaccinated:2007-12-11
Age:0.8  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-12, Days after onset: 1
Location:Pennsylvania  Entered:2007-12-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA0IMRL
HPV4: HPV (GARDASIL)MERCK & CO. INC.0930U0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: Child given wrong vaccines. Given HPV, Fluzone 12/11/07 1140 AM.

VAERS ID:299930 (history)  Vaccinated:2007-12-11
Age:10.0  Onset:2007-12-13, Days after vaccination: 2
Gender:Female  Submitted:2007-12-13, Days after onset: 0
Location:Michigan  Entered:2007-12-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: None
Preexisting Conditions: Down''s Syndrome; Hypothyroidism
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB171AA IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0807U SCRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Local erythema/wheal approx 4" diameter.

VAERS ID:301431 (history)  Vaccinated:2007-12-11
Age:0.3  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 9
Location:South Carolina  Entered:2008-01-02, 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: None
Current Illness: None
Preexisting Conditions: Umbilical hernia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1417F0UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02730UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH870143H0UNRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 12/11/07 w/in 5 min after injection (R) leg had redness size of quarter then blotchy macular rash all over body at 9:15am Benadryl was given. Child responded.

VAERS ID:301441 (history)  Vaccinated:2007-12-11
Age:15.0  Onset:2007-12-12, Days after vaccination: 1
Gender:Male  Submitted:2007-12-26, Days after onset: 14
Location:Pennsylvania  Entered:2008-01-02, 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: PPd placed
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Had annual PE on 12-11-07 afternoon. Well adolescent. 12-12-07, 10 am family called, client experiencing severe headache with nausea. Temp between 100.1 to 100.8. Instructed to go to most convenient ped. hosp er - chose AI Dept. Moderate distress from headache. Dx: headache 2 hours to Menactra side effects.

VAERS ID:301452 (history)  Vaccinated:2007-12-11
Age:62.0  Onset:2007-12-13, Days after vaccination: 2
Gender:Female  Submitted:2008-01-04, Days after onset: 22
Location:Oregon  Entered:2008-01-02, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Toprol XL
Current Illness: None
Preexisting Conditions: HTN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS784785UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Local swelling, Lymphadenopathy, Pain
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local swelling, swollen lymph nodes, localized pain.

VAERS ID:301807 (history)  Vaccinated:2007-12-11
Age:0.6  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None PMH: allergy amoxicillin. C-section, uncomplicated birth.
Diagnostic Lab Data: MRI, LP LABS 12/13-15/2007: Multiple MRIs revealed worsening infarct in left basal ganglia & adjacent white matter. MRA of brain WNL. Echocardiogram showed small PDA. LABS 12/21-23/2007: CSF glucose 46 (N), protein 28.9 (N), culture neg. EEG WNL.
CDC Split Type: FL2008001
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2481GA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, CSF glucose normal, CSF protein normal, Cerebral infarction, Cerebrovascular accident, Echocardiogram abnormal, Electroencephalogram normal, Facial paresis, Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging brain normal, Paresis, Patent ductus arteriosus
SMQs:, Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Stroke vs acute disseminated Encephalomyelitis. 1/8/08 Received vax record which confirms Aventis flu vaccine given 12/11. 1/8/08 Reviewed hospital medical records which reveal patient experienced right facial & RUE paresis x 2 days starting 2 hours s/p flu shot. Seen in ER on 12/12, diagnosed w/weakness & d/c to home. No improvement. Admitted 12/13-12-15/2007 to PICU. Neuro consult done. FINAL DX: stroke, left basal ganglia infarct. 01/11/2008 Received additional hospital medical records which reveal patient experienced suspected ADEM vs stroke syndrome. Admitted to PICU 12/21-12/23/2007. Neuro consult done & tx w/high dose steroids. Stable & d/c to home on continued steroids & neuro f/u. FINAL DX: none provided on d/c summary except ADEM vs stroke syndrome. Neuro consult dx stroke.

VAERS ID:302032 (history)  Vaccinated:2007-12-11
Age:65.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-17, Days after onset: 6
Location:Unknown  Entered:2008-01-09, Days after submission: 23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Caucasian, allergy to Rrequip
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient c/o: "pain & redness & edema to elbow from shoulder, ? cellulitis".

VAERS ID:302296 (history)  Vaccinated:2007-12-11
Age:46.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-10
Location:New York  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexipro
Current Illness: none
Preexisting Conditions: allergic to clams
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA020925IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Erythema, Joint swelling, Oedema peripheral, Pyrexia, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Received rabies booster due to low titer. Had post-exposure treatment in 1998. Joint pains within 24 hrs. of administration. 13 days after administration hands and knees were swollen, knees were red. The next day, face was swollen, knees were more swollen and she had a fever of 100 degrees. She was seen in ER, given epinephrine and started on a 5 day course of steroids. Saw her PCP on 1/2/08 with persistent symptoms and was started on another course of steroids.

VAERS ID:302534 (history)  Vaccinated:2007-12-11
Age:61.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-11
Location:California  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None on File
Current Illness: None noted
Preexisting Conditions: None Noted
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2499AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Discomfort, Injected limb mobility decreased, No reaction on previous exposure to drug, Pain in extremity
SMQs:
Write-up: Patient describes since recieving flu shot on 12/11/07 she has been experiencing discomfort in her upper arm making it painful to move arm in certain directions. She doesn''t believe this is a normal reaction because she has had flu shots in the past with no difficulty. She spoke to a pharmacist at a local pharmacy, not ours who stated that the needle may have punctured a vein or nerve.

VAERS ID:302755 (history)  Vaccinated:2007-12-11
Age:47.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 35
Location:Unknown  Entered:2008-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: takes 10 mg Claritin daily
Current Illness:
Preexisting Conditions: Allergic to Ampicillin, Bactrim and PCN.
Diagnostic Lab Data: Urinalysis labs were done to screen rbc, wbc, epithelial cells, glucose, color, etc and all findings were normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1583SCRA
Administered by: Military     Purchased by: Military
Symptoms: Nausea, Retching, Urine analysis normal, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt received 4th anthrax injection, felt nauseated 30 minutes afterward and went to sleep. She did not take any meds for it. She woke up the next day, nauseated, this time vomiting to the point of dry heaves. She reports that was 6 hours after her injection. The symptoms eventually went away on their own. No meds were administered.

VAERS ID:302823 (history)  Vaccinated:2007-12-11
Age:52.0  Onset:2007-12-12, Days after vaccination: 1
Gender:Female  Submitted:2007-12-13, Days after onset: 1
Location:Michigan  Entered:2008-01-16, Days after submission: 34
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: Allergies penicillin, sulfa, red dye, multiple foods, Ceclor
Diagnostic Lab Data: None
CDC Split Type: MI2008002
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEURU2526AAC0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB173AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Rash pruritic, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Developed itchy B-B size elongated bumps on arms & legs evening of 12-12-07. Throat is scratchy but no difficulty breathing. Bumps are not red. Advised medical care.

VAERS ID:313627 (history)  Vaccinated:2007-12-11
Age:7.0  Onset:2007-12-13, Days after vaccination: 2
Gender:Male  Submitted:2008-05-16, Days after onset: 154
Location:Oregon  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA00592
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1246U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a medical assistant concerning a 7 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information has been received on 24-MAR-2008 from a medical assistant concerning a 7 year old male patient with no pre-existing allergies, birth defects, or medical condition who, on 11-DEC-2007, was vaccinated with a second dose of VARIVAX (Merck) (Lot #658412/1246U) subcutaneously in the left thigh at 9:30 AM. It was also reported that the patient did not have any illnesses at the time of vaccination. Other vaccinations received the same day included VAQTA (lot number 659186/1258U) intramuscularly in right thigh. On 13-DEC-2007 (also reported as 13-DEC-2008), the patient developed redness, pain, 2 mm red indurated area around VARIVAX (Merck) (lot 658432/1246U) injection site on left thigh. On an unspecified date, the patient recovered. No further information is available.

VAERS ID:316901 (history)  Vaccinated:2007-12-11
Age:25.0  Onset:2007-12-12, Days after vaccination: 1
Gender:Female  Submitted:2008-06-13, Days after onset: 183
Location:New York  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NUVARING; LEVAQUIN
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Migraine
Diagnostic Lab Data: None
CDC Split Type: WAES0805USA03788
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia facial, Injection site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health professional from a physician''s office a 25 year old female with type 2 diabetes mellitus and a history of migraines who on 18-OCT-2007 and 11-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first and second dose of GARDASIL (Lot #''s 658563/1063U and 659441/1446U), respectively. Concomitant therapy included NUVARING and LEVAQUIN. The caller reported that the patient was in the office today (16-MAY-2008) to receive the third dose of GARDASIL. At that time the patient stated that "the day after receiving the second dose, on 12-DEC-2007, she experienced pain in her arm at injection site and numbness in her face lasting 4 days". The patient was seen by her family doctor for symptoms. The third dose of GARDASIL was not administered. No laboratory diagnostic studies were performed. Subsequently, on approximately 16-DEC-2007 the patient recovered. No product complaint was involved. Additional information has been requested.

VAERS ID:324809 (history)  Vaccinated:2007-12-11
Age:0.4  Onset:2007-12-13, Days after vaccination: 2
Gender:Female  Submitted:2008-09-09, Days after onset: 270
Location:New Jersey  Entered:2008-09-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: CBC, Comprehensive metabolic panel results - WNL; ESR increased 65 mm/hr; CRP increased 11.1 mg/l
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC270AA0IMLL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0538U1IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02980SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016A1IMLL
Administered by: Private     Purchased by: Private
Symptoms: C-reactive protein increased, Eye rolling, Full blood count normal, Hypotonia, Metabolic function test, Red blood cell sedimentation rate increased
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: ? seizure-like episode $g 48 hours, less than 72 hours following DAPT, HEP B-HIB, IPV, Pneumococcal, parents noted eyes rolling momentarily, then child was limp for few seconds before recovering completely.

VAERS ID:325736 (history)  Vaccinated:2007-12-11
Age:12.0  Onset:2008-01-22, Days after vaccination: 42
Gender:Female  Submitted:2008-09-20, Days after onset: 241
Location:Texas  Entered:2008-09-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchitis; Afebrile
Preexisting Conditions: Chiari one malformation PMH: bronchiolitis, vaginitis, pharyngitis, OM. Family hx epilepsy..
Diagnostic Lab Data: Normal brain MRI, Chiori one malformation, normal EKG and Echo, normal EEG. LABS: CBC WNL. Rapid strep (-). MRA circle of Willis WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U2IMUN
Administered by: Private     Purchased by: Private
Symptoms: Arnold-Chiari malformation, Body temperature increased, Bronchitis, Cough, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal, Headache, Loss of consciousness, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Orthostatic hypotension, Pharyngitis, Pharyngolaryngeal pain, Presyncope, Pyrexia, Rales, Rhonchi, Streptococcus identification test, Streptococcus identification test negative, Upper respiratory tract congestion, Visual disturbance
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient had multiple "black out" episodes without loss of consciousness. Evaluated by cardiology and neurology without being given a diagnosis. Treated as orthostatic hypotension. First episode 1 1/2 months after 3rd Gardasil. 9/30/08 Reviewed PCP medical records of 12/11/07-5/15/2008. Records reveal patient experienced low grade temp w/cough & congestion x 1 week on 12/11/07. Exam revealed rhonchi/rales & sore throat. Dx w/bronchitis & possible pneumonia. Tx w/antibiotics. RTC 1/22/08, had seen eye surgeon day before due to having trouble w/vision & black out spells. Dx w/near syncope. Referred for EKG/EEG. RTC 5/15/08 w/sore throat, fever, HA x 2 days. Dx w/pharyngitis. 10/7/08 Reviewed hospital lab reports of 2/14-3/4/2008. 10/24/08 Reviewed cardiac consultant records of 5/14- FINAL DX: none provided Records reveal patient experienced recurrent pre syncope attacks w/blackouts since 9/2007. Neuro & ophtho consults had been done & were WNL.

VAERS ID:335592 (history)  Vaccinated:2007-12-11
Age:39.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2008-11-17, Days after onset: 342
Location:Unknown  Entered:2008-11-25, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVETIRACETAM
Current Illness: Unknown
Preexisting Conditions: Epilepsy; Hepatitis A; Typhoid; No adverse events following previous vaccinations.
Diagnostic Lab Data: Unk
CDC Split Type: A0699862A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Diarrhoea, Erythema, Fatigue, Pain, Paraesthesia, Pyrexia, Thirst
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a consumer and described the occurrence of soreness (generalized) in a 39-year-old female subject who was vaccinated with TWINRIX, GlaxoSmithKline. A physician or other health care professional has not verified this report. The subject''s medical history included hepatitis A and typhoid. Concurrent medical conditions included epilepsy. Concurrent medications included Levetiracetam (Keppra). On an unspecified date the subject received 1st dose, 2nd dose of TWINRIX and on 11 December 2007 at 09:00 the subject received 3rd dose of TWINRIX (1 ml, left arm). At an unspecified time after vaccination with the first and second dose of TWINRIX, the subject experienced tiredness. On 11 December 2007 in the early afternoon following vaccination with the third dose of TWINRIX, the subject experienced soreness all over and in the evening she experienced tiredness. In the morning of 12 December 2007, one day after vaccination with TWINRIX, she experienced cheeks that were beet red, fever, tingling from waist down, tingling on her cheeks, two episodes of diarrhea and increased thirst. She also reported that she has been so tired that she was unable to get out of bed. The reporter noted that the soreness, tiredness, tingling from the waist down and tingling on her cheeks improved. The diarrhea and the beet red cheeks resolved. The tiredness that she experienced following the first two doses also resolved in a couple of days. At the time of reporting the outcome of the fever, increased thirst and inability to get out of bed were unspecified.

VAERS ID:336909 (history)  Vaccinated:2007-12-11
Age:1.4  Onset:2008-11-05, Days after vaccination: 330
Gender:Male  Submitted:2008-12-12, Days after onset: 37
Location:Louisiana  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Stool analysis, 11/05/08, the patient had rotavirus. stool culture, 11/05/08, final: positive to rotavirus; stool Clostridium, 11/05/08, negative for clostridium difficile toxin A and/or B; stool culture, 11/05/08, preliminary: no Salmonella, shigella, Campylobacter, or Shiga-toxins 1 and 2
CDC Split Type: WAES0811USA01755
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1390U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Clostridium test, Clostridium test negative, Diarrhoea, Rotavirus infection, Stool analysis abnormal
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 12/12/2008. Initial and follow-up information has been received from a physician concerning an approximately 17 month old male patient who at 11 weeks old on 15-AUG-2007 was vaccinated with the first dose of ROTATEQ (Lot # 657522/0769U), the second dose of ROTATEQ (Lot # 657045/1053U) was given at 6 months old on 16-OCT-2007 and then the third dose of ROTATEQ (Lot # 657668/1390U) was given at 6 months old on 11-DEC-2007. Concomitant therapy included DTAP-IVP and PREVNAR. The physician reported that on 05-NOV-2008 the patient went to the emergency room and had a stool culture test, preliminary the test showed no Salmonella, Shigella, Campylobacter, or Shiga-toxins 1 and 2 producing strains of E. coli (including E. coli 0157) isolated in 24 hours and final results were positive to rotavirus: C Difficile Toxin Assay final result were negative for Clostridium difficile toxin A and/or B. The physician reported that the patient had diarrhea and rotavirus. The patient was not admitted to the hospital, on the emergency room was given 500cc and he felt much better on 10-NOV-2008. The patient was recovered. Additional information is not expected.

VAERS ID:337575 (history)  Vaccinated:2007-12-11
Age:0.2  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2008-12-01, Days after onset: 356
Location:Pennsylvania  Entered:2008-12-16, 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: ZANTAC
Current Illness: Gastrooesophageal reflux
Preexisting Conditions: Hospitalization
Diagnostic Lab Data: Diagnostic test, pulse oximetry, 12/13/07, 98%; blood culture, 12/13/07, no growth 5 days; temperature measurement, 12/13/07, 98.9; hemoglobin, 12/13/07, 8.7 gm/dL; red blood cell count, 12/13/07, 2.59 M/mm3; lymphocyte count, 12/13/07, 54%
CDC Split Type: WAES0801USA02043
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0377U0IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Blood culture negative, Body temperature increased, Crying, Diarrhoea, Eosinophil percentage increased, Haematocrit decreased, Haemoglobin decreased, Heart rate increased, Irritability, Lymphocyte percentage increased, Monocyte percentage increased, Neutrophil percentage decreased, Oxygen saturation, Red blood cell count decreased, Respiratory rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Initial and follow-up information has been received from a physician and medical record concerning a 2 month old white female with gastroesophageal reflux since 2 weeks old, no acute illness at the time of being vaccinated, and no known drug allergies, and a history of hospitalization and born via caesearan section. No family history of asthma, seizures, birth defects, seasonal allergies. On 11-DEC-2007, the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot # 657380/0377U) IM in the right upper thigh at approximately 9:45 AM. Concomitant therapy also given on 11-DEC-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, (PREVNAR) vaccine (CRM197), poliovirus vaccine and ROTATEQ vaccine live (human-bovine) (MSD). Other concomitant therapy included (ZANTAC). On 11-DEC-2007, approximately afternoon, the infant developed crying off and on for 48 hours, loose diarrhea for 48 hours, one episode of vomiting, was very fussy and inconsolable. There was no fever. The infant was examined by the physician. The injection sites looked good without erythema, swelling, nor drainage. Otherwise the exam was normal. The infant was referred to the emergency room because of symptoms concerning possible sepsis as the baby received hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC), vaccine lot that was recalled. The baby was evaluated and discharged home, On 13-DEC-2007, the patient became very fussy. As a precaution the patient was sent to an emergency room for evaluation. It was reported, the lot # administered was one of those in the recent recall. On 13-DEC-2007, the patient was seen in the emergency room. The emergency room record revealed that the infant was feeding well with no vomiting. BM''s were normal, she wet her diaper fine, no sick contacts. Development was age appropriate. Vital signs revealed: temperature 98.9, pulse 199, repirations 24 and pulse oximetry 95%. Exam was normal, tanner stage 1.

VAERS ID:337858 (history)  Vaccinated:2007-12-11
Age:0.2  Onset:0000-00-00
Gender:Female  Submitted:2008-12-01
Location:Unknown  Entered:2008-12-16, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA07115
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0376U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site vesicles
SMQs:
Write-up: Information has been received from a nurse concerning a 2 month old female who on 11-DEC-2007 was vaccinated with her first dose of COMVAX (Lot #0376U/Batch #657379). There was no concomitant medication. The nurse reported that after receiving the vaccination the patient had small bubble at the injection site. The nurse reported that the patients mother called them about this and they told the mother to put a cold compress on the bubble. Additional information has been requested.

VAERS ID:337868 (history)  Vaccinated:2007-12-11
Age:0.6  Onset:2007-12-11, Days after vaccination: 0
Gender:Female  Submitted:2008-12-01, Days after onset: 356
Location:Unknown  Entered:2008-12-16, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness: Upper respiratory tract infection; Nasal congestion; Cough
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06317
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0377U2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a nurse concerning an 8 month old female who on 11-DEC-2007 was vaccinated with her third dose of COMVAX (Lot #0377U/Batch #657380) intramuscularly in the left thigh. Her second dose was received on 02-JUL-2007 intramuscularly in the left thigh (same lot and batch number). Concomitant therapy included influenza virus vaccine (unspecified), PREVNAR and TYLENOL. On 11-Dec-2007 the patient developed redness and swelling at the injection site. Patient''s illnesses at the time of vaccination were an upper respiratory infection with nasal congestion and cough. Further information is not expected.

VAERS ID:337870 (history)  Vaccinated:2007-12-11
Age:2.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2008-12-01, Days after onset: 356
Location:Missouri  Entered:2008-12-16, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06262
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0377U2IMUN
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Irritability
SMQs:, Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow)
Write-up: Initial and follow up information have been received from a physician and the mother of a 24 month old white son with no pertinent medical history or drug reactions/allergies who at 10:48 on 11-DEC-2007 was vaccinated intramuscularly (site not reported) with the third 0.5 ml dose of COMVAX (lot # 657380/0377U). There was no concomitant medication usage. On 11-DEC-2007 the patient became very fussy. On 13-DEC-2007 the patient developed diarrhea. Per the patient''s mother, there were no symptoms after the first 2 doses of the vaccine were given. The patient did receive unspecified medical treatment. No diagnostic labs test were performed. At the time of this report the patient was recovering. Additional information is not expected.

VAERS ID:567893 (history)  Vaccinated:2007-12-11
Age:15.0  Onset:2014-12-15, Days after vaccination: 2561
Gender:Female  Submitted:2015-03-03, Days after onset: 78
Location:California  Entered:2015-03-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NO prescriptions.
Current Illness: No illness. HPV was the vaccine,: #1 12/11/2007 #2 2/12/2008 #3 7/22/2008.
Preexisting Conditions: No pre-existing conditions.
Diagnostic Lab Data: Gynecological exam and STD testing. Diagnosed with HPV.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0133X2IM 
Administered by: Public     Purchased by: Public
Symptoms: Gynaecological examination, Human papilloma virus test positive, Papilloma viral infection
SMQs:
Write-up: Came down with the illness the vaccine was to protect.

VAERS ID:300860 (history)  Vaccinated:2007-12-11
Age:14.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-19, Days after onset: 8
Location:Foreign  Entered:2007-12-26, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had asthma and polyvalent allergy in the past. He had received Engerix and tetanus vaccine with no adverse reaction (since moving in 2003). The patient had also received 4 previous doses of oral polio vaccine.
Diagnostic Lab Data: not reported
CDC Split Type: 200704274
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB02154SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Case received from a healthcare professional on 13 December 2007. A 14-year-old male patient with medical history of asthma and polyvalent allergy in the past, had received a subcutaneous dose of Imovax Polio, batch number B0215-1, in the right forearm, on 11 December 2007. He had received Engerix and tetanus vaccine with no adverse reaction (since moving in 2003). The patient had also received 4 previous doses of oral polio vaccine. Three hours post-vaccination, the patient experienced pain and swelling of his right arm (from fingers to shoulder), resulting in limited ability to move his arm. The patient returned to the physician''s office. The patient was hospitalized in the infection unit on 11 December 2007. He was discharged on 13 December 2007. The diagnosis was allergic reaction to vaccination. The outcome was not reported.

VAERS ID:301178 (history)  Vaccinated:2007-12-11
Age:47.0  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-28, Days after onset: 17
Location:Foreign  Entered:2007-12-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: There were no relevant concurrent medical conditions and risk factors.
Preexisting Conditions:
Diagnostic Lab Data: Computerized tomogram head, 12Dec2007, normal; electrocardiogram, 12Dec2007, normal; thorax X-ray, 12Dec2007, normal
CDC Split Type: D0055490A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB101AE IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Cold sweat, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Feeling hot, Hyperhidrosis, Hypokalaemia, Hypotension, Hypotonia, Incontinence, Intensive care, Loss of consciousness, Muscular weakness, Tachycardia, Tremor, Urinary incontinence, Vaccination complication, X-ray normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 47-year-old male subject who was vaccinated with Twinrix adult (GlaxoSmithKline). On an unspecified date the subject received 3rd dose of Twinrix adult (unknown route and application site). Approximately 18 hours after vaccination with Twinrix adult, the subject experienced anaphylaxis. The subject was hospitalised for an unknown period of time. At the time of initial reporting the event was improved. Follow-up information was received from the reporting physician and via the foreign regulatory authority (PEI-DE-PEI-PEI2007012492): Previous vaccinations included Twinrix adult, given on 15 June 2000 and 04 August 2000). These vaccinations were well tolerated. There were no relevant concurrent medical conditions and risk factors. On 11 December 2007 at 09:00 the subject received the third dose of Twinrix adult (intramuscular, left deltoid). According to a questionnaire, provided via the regulatory authority and received on 27 December 2007, on an unspecified date the subject developed anaphylactic reaction, severe hypotension and tachycardia. On an unspecified date the events resolved. According to the questionnaire received on 27 December 2007 directly from the reporting physician, the events were resolved on 13 December 2007. The physician considered the events were life-threatening and probably related to vaccination with Twinrix adult. The subject was hospitalized on 12 December 2007. A hospital report was provided by the reporting physician and received on 27 December 2007: Overall diagnosis was anaphylactic reaction to vaccination and hypokalemia. The following anamnesis was provided: The subject had been vaccinated approximately at 09:00 on 11 December 2007. Two hours later the subject had felt dizziness. During the following night, on 12 December 2007, he felt hot and was sweating. According to his wife, subsequently the subject was found upright with tremor. Suddenly he fell unconscious and lost urine involuntarily. Acco

VAERS ID:304650 (history)  Vaccinated:2007-12-11
Age:0.1  Onset:2007-12-11, Days after vaccination: 0
Gender:Unknown  Submitted:2008-02-08, Days after onset: 59
Location:Foreign  Entered:2008-02-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: 200800281
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20905010C UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER06006 UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURZ20788 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: Initial report received from health authorities on 28 January 2008. A 46-day-old patient of unspecified gender and medical history experienced hypotonic-hyporesponsive episode at 14.00 hrs on 11 December 2007, the day the patient received Act-HIB, lot no: Z20788-1, Euvax-B, lot no: 06006, and DTP, lot no: 20905010C. The patient was hospitalised at an unspecified time and recovered with in an unspecified time frame.

VAERS ID:310887 (history)  Vaccinated:2007-12-11
Age:17.0  Onset:2008-01-04, Days after vaccination: 24
Gender:Female  Submitted:2008-04-24, Days after onset: 110
Location:Foreign  Entered:2008-04-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: ethinyl estradiol (+) gestodene, Unk - Unk
Current Illness: Contraception
Preexisting Conditions: Epilepsy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0804CZE00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Condition aggravated, Grand mal convulsion, Incontinence
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from an agency concerning a 17 year old female with contraception and a history of epilepsy who on 11-DEC-2007 was vaccinated with Gardasil. Concomitant therapy included LOGEST. On 04-JAN-2008 the patient experienced grand mal with incontinence and amnesia and was hospitalized from 4-Jan-2008 to 11-Jan-2008. Therapy Agapurin i.v., administration of specific epileptic therapy. From that time the patient was followed again in outpatient office for epilepsy. The reporter felt that grand mal was related to therapy with Gardasil. Additional information has been requested.

VAERS ID:311250 (history)  Vaccinated:2007-12-11
Age:0.3  Onset:2008-01-09, Days after vaccination: 29
Gender:Female  Submitted:2008-04-29, Days after onset: 110
Location:Foreign  Entered:2008-04-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: TIORFAN (ACETORPHAN), unknown, 08-Jan-2008; Advil (IBUPROFEN), unknown, 08-Jan-2008; DOLIPRANE (PARACETAMOL), unknown, 08-Jan-08
Current Illness: A concurrent history of gastroenteritis manifested by 10 liquid, glary and bloody stools per day, vomiting, fever at 38.7 C and
Preexisting Conditions: The patient had a past history of normal full-term newborn, a medical history of unspecified reflux, no history of allergy.
Diagnostic Lab Data: On 09-Jan-2008 test results were: ultrasound scan (results: acute intestinal intussusception suspected); heart rate (results: 156/min); and blood pressure (results: 107/77).
CDC Split Type: FRWYEG01473408
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEUR  IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Enema administration, Fatigue, Haematochezia, Heart rate, Intussusception, Irritability, Pain, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 4-month-old female patient who experienced acute intestinal intussusception. The patient received the second dose on 11-Dec-2007. On 09-Jan-2008, the patient was admitted to emergency unit due to pain and blood in stools. On admission the patient was tired and irritable. Physical examination was unremarkable, she had no fever and no sign of dehydration. Acute intestinal intussusception was suspected on ultrasound scan. The patient was hospitalized and intussusception was reduced with water-soluble enema. The patient recovered without sequelae. No additional information was available at the time of this report.

VAERS ID:315860 (history)  Vaccinated:2007-12-11
Age:17.0  Onset:2008-01-14, Days after vaccination: 34
Gender:Female  Submitted:2008-06-05, Days after onset: 142
Location:Foreign  Entered:2008-06-10, Days after submission: 5
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: gastroscopy, no pathological findings; duodenoscopy, no pathological findings; abdominal ultrasound, no pathological findings; laboratory test, blood count no pathological findings; laboratory test, inflammatory parameters no pathological f
CDC Split Type: WAES0806USA00523
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0276U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Blood count normal, Diarrhoea, Endoscopy small intestine, Endoscopy upper gastrointestinal tract, Laboratory test normal, Ultrasound abdomen normal, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (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 17 year old female who on 11-DEC-2007 was vaccinated with a first dose of GARDASIL (lot number 0276U, batch number NF58550) I.M. into the upper arm. Since 14-JAN-2008 the patient experienced stomach pain, diarrhoea and lost weight of 8 kg. She was admitted to hospital on 26-MAY-2008 for in-patient examinations. Gastroscopy, duodenoscopy, abdominal sonography and laboratory tests including blood count and inflammatory parameters showed no pathological finding. A psychological check-up is planned. Symptoms were ongoing at the time of reporting. Other business partner numbers include E200804923. Additional information has been requested.

VAERS ID:322562 (history)  Vaccinated:2007-12-11
Age:0.2  Onset:2007-12-11, Days after vaccination: 0
Gender:Male  Submitted:2008-08-18, Days after onset: 250
Location:Foreign  Entered:2008-08-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test, ??Dec07, no abnormalities detected; electrocardiogram, ??Dec07, no abnormalities detected; body temp, ??Dec07, no fever
CDC Split Type: WAES0808AUS00069
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature, Diet refusal, Electrocardiogram normal, Hyperhidrosis, Irritability, Laboratory test normal, Pallor, Rash erythematous, Rash macular, Screaming
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and Public Case Detail Form concerning an 8 week old male who on 11-DEC-2007 was vaccinated with ROTATEQ, MSD. Other suspect therapy included DTaP. On 11-DEC-2007 the patient developed an erythematous rash, pallor, hyperhidrosis and screaming. It was described that the child had a blanching erythematous, macular rash on the trunk which was presumed to be a vaccination reaction. Four hours after vaccination the patient developed pallor, diaphoresis (hyperhidrosis), irritability, episodes of screaming and refusal to feed. The patient had no fever. The patient was taken to a physician who noted a blanching erythematous macular rash on the patient''s trunk. Routine blood tests and ECG were performed with no abnormalities detected (NAD). The patient''s symptoms settled after 90 minutes. No other aetiology was identified on review at the hospital emergency department. At the time of reporting to the agency on 11-DEC-2007, the patient had recovered from the erythematous rash, pallor, hyperhidrosis and screaming. The agency considered that erythematous rash, pallor, hyperhidrosis and screaming were related to therapy with ROTATEQ, MSD and DTaP. The original reporting source was not provided. Erythematous rash, pallor, hyperhidrosis and screaming were considered to be disabling by the reporting agency. Additional information is not expected.

VAERS ID:384492 (history)  Vaccinated:2007-12-11
Age:0.3  Onset:2008-01-09, Days after vaccination: 29
Gender:Female  Submitted:2010-04-07, Days after onset: 818
Location:Foreign  Entered:2010-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bloody diarrhea; fever; mucous diarrhea; reflux unspecified; vomiting; weight loss
Preexisting Conditions: Subject born at 40 weeks and 4 days of amenorrhea, birth weight 3.27 kg, birth height 49.5 cm, birth cranial perimeter 34.5 cm. No known allergies. At the time of event, there were gastroenteritis cases in the family.
Diagnostic Lab Data: Blood pressure, 09Jan2008, 107/77; Body temperature, 09Jan2008, normal; Heart rate, 09Jan2008, 156bpm; Ultrasound abdomen, 09Jan2008, see text; 09 January 2008, Abdominal ultrasound scan: suspicion of intussusception of intestine
CDC Split Type: B0645474A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMAR
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMAR
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMAR
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA392A PO 
Administered by: Other     Purchased by: Other
Symptoms: Body temperature normal, Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Ultrasound abdomen abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a foreign regulatory authority (reference PV20080062) and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, PREVENAR, non-gsk and PENTAVAC, non-gsk. The subject was born at 40 weeks and 4 days of amenorrhea (birth weight 3.27 kg, birth height 49.5 cm and birth cranial perimeter 34.5 cm). She had no known allergy. Medical condition included unspecified reflux. At the time of the events, there were gastroenteritis cases in the subject''s family. The subject weighted 7.18 kg. On 11 December 2007, the subject received an unspecified dose of ROTARIX (batch A41CA392A oral), a 2nd dose of PREVENAR (intramuscular, batch and injection site unknown), and a 2nd dose of PENTAVAC (intramuscular, batch and injection site unknown). On 08 January 2008, a physician was consulted for acute diarrhea with several vomiting and fever at 38.7 degrees Celsius. Diarrhea had become a mucous bloody diarrhea (10 liquid stools per day; with a weight loss of four percent (incidental events). TIORFAN, ADVIL, DOLIPRANE and oral rehydration solution were prescribed. Vomiting and diarrhea persisted. On 09 January 2008, 29 days after vaccination with PENTAVAC, PREVENAR and ROTARIX, the subject was admitted to emergency service for bloody diarrhea and pain. On admission, blood pressure was at 107/77, heart rate at 156 bpm and body temperature was normal. The subject was irritable and tired. There was no sign of dehydration. The rest of physical examination was normal. At abdominal ultrasound scan, acute intussusception of intestine was suspected. The subject was hospitalized and intussusception was reduced by hydrosoluble enema. Intussusception of intestine resolved at an unspecified date. Outcome of pain, blood in stool, irritability and fatigue was unspecified. According the foreign method of assessment, the relationship between vaccinations with ROTARIX, PREVENAR and PENTAVAC and intussusception was dubious.

VAERS ID:385592 (history)  Vaccinated:2007-12-11
Age:17.0  Onset:2008-01-31, Days after vaccination: 51
Gender:Female  Submitted:2010-04-20, Days after onset: 809
Location:Foreign  Entered:2010-04-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance imaging, diabetes insipidus was diagnosed; diagnostic laboratory test, endocrinological examinations : diabetes insipidus was diagnosed
CDC Split Type: WAES1004USA02225
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0253U1IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diabetes insipidus, Laboratory test abnormal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal
SMQs:
Write-up: Case received from Health Authority on 12-APR-2010 (reference # PEI2010005944) : A 17 year old female on 04-OCT-2007 was vaccinated with the first dose of GARDASIL (lot # 1536F, batch # NG01520) which was well tolerated. On 11-DEC-2007 the patient received the second dose (IM, lot # 0253U, batch # NF58540) IM into the upper arm. On 31-JAN-2008 the patient was presented to a physician and diabetes insipidus was diagnosed which was confirmed by MRI and endocrinological examinations (not otherwise specified). The patient was treated ambulatory. Upon reporting form dated 02-MAR-2010 the patient had not recovered and "permanently damage" was ticked. Diabetes insipidus was considered to be disabling. Other business partner numbers included E2010-02328.

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