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Case Details (Sorted by Vaccination Date)

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VAERS ID:299071 (history)  Vaccinated:2007-12-06
Age:16.0  Onset:2007-12-07, Days after vaccination: 1
Gender:Female  Submitted:2007-12-08, Days after onset: 1
Location:New Jersey  Entered:2007-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Crying, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: C/O pain in both arms and legs, severe headache and fever....crying...gave tylenol and slept for 16 hours

VAERS ID:299090 (history)  Vaccinated:2007-12-06
Age:11.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:California  Entered:2007-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1025U SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Cellulitis in L deltoid and L arm.

VAERS ID:299359 (history)  Vaccinated:2007-12-06
Age:0.7  Onset:2007-12-06, Days after vaccination: 0
Gender:Male  Submitted:2007-12-12, Days after onset: 6
Location:Michigan  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Just prescribed Zithromax for ear.
Current Illness: Left Otitis media
Preexisting Conditions: Left otitis media
Diagnostic Lab Data: Otitis media on exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B110432IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2477042IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08690C2IMRL
Administered by: Private     Purchased by: Public
Symptoms: Otitis media, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 102.2 Fever brought down with Tylenol, also had otitis media diagnosis (No fever at time of administration of vaccines)

VAERS ID:299897 (history)  Vaccinated:2007-12-06
Age:0.3  Onset:2007-12-07, Days after vaccination: 1
Gender:Female  Submitted:2007-12-14, Days after onset: 7
Location:Ohio  Entered:2007-12-14
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
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2797AA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0820U0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03011IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5401401IMRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Progressive rash extending from abdomen to thorax and upper extremities. Rash is dry scaling with mild erythema. No papules or vesicles. No obvious itching, fever, vomiting, or diarrhea. No rash at injection site. Rash present for 1 week and patient placed on topical hydrocortisone today. Patient seen at both and urgent care and physicians office

VAERS ID:300097 (history)  Vaccinated:2007-12-06
Age:11.0  Onset:2007-12-12, Days after vaccination: 6
Gender:Male  Submitted:2007-12-17, Days after onset: 5
Location:New York  Entered:2007-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2490AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2540AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1509U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: R deltoid w/ exfoliated area 4x6cm, no tenderness/swelling. Advised to keep clean & observe.

VAERS ID:300338 (history)  Vaccinated:2007-12-06
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-19
Location:Georgia  Entered:2007-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOne
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS806823IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0806F1SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2172AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR2759AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Adm vaccine on 12/06/2007 and client inform us of pregnancy 12/14/2007

VAERS ID:303145 (history)  Vaccinated:2007-12-06
Age:24.0  Onset:2007-12-06, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 122
Location:South Carolina  Entered:2008-01-16, Days after submission: 81
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypersensitivity; Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: blood pressure, 110/8; blood pressure, 12/06/07, 162/8 mm/Hg, Taken at 14:13; pain prophylaxis, 12/06/07, 0/10, Taken at 14:13; physical examination, 12/06/07, Lungs clear; pulse oximetry, 12/06/07, 99%, Taken at 14:13 on room air; total heartbeat count, 60''s; body temp, 12/06/07, 98.7F, Taken at 14:13; total heartbet count, 12/06/07, 75 min, Taken at 14:13; respiratory rate, 12/06/07, 18 min, Taken at 14:13;
CDC Split Type: WAES0712USA02134
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Drug hypersensitivity, Erythema, Feeling abnormal, Feeling hot, Immediate post-injection reaction, Injection site erythema, Oedema mouth, Pharyngeal oedema, Rash, Rash generalised, Seasonal allergy, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Conjunctival disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 25 year old female with a history of allergies and who has swelling with topical benzoyl peroxide who on 06-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot# 659055/1522U). Concomitant therapy included montelukast sodium, (dose, duration and indication not reported). Other concomitant therapy included ZYRTEC. On 06-DEC-2007 the patient experienced redness at injection site within seconds of receiving the injection, redness on face and neck and felt "weird". No shortness of breath was noted. The patient was taken by ambulance to the hospital. The doctor did not want the staff to give the patient an epi pen since he wanted to check her first. The patient''s redness at injection site, redness on face and neck and feeling "weird" persisted. The patient sought unspecified medical attention. Additional information has been requested. Information has been received from a physician concerning a 25 year old white female with seasonal allergies and who has swelling with topical benzoyl peroxide who on 06-DEC-2007 at 1:10 pm was vaccinated IM into left deltoid with a first 0.5ml dose of GARDASIL (lot# 659055/1522U). Concomitant therapy included MSD, (dose, duration and indication not reported). Other concomitant therapy included ZYTREC. On 06-DEC-2007 at 1:10 pm, the patient experienced redness at injection site that was probably 10x10 cm. At 1:20 pm, after receiving the injection, the patient felt hot all over and experienced redness on her face and neck anad felt "weird." No shortness of breath was noted. Her pulse was in the 60s and her blood pressure was 110/80. The patient was taken by ambulance to the hospital. The doctor did not want the staff to give the patient an epi pensince he wanted to check her first. Upon arrival to the hospital, at 2:15 pm, the patient''s vital signs were as follows: Temperature of 98.7, her pulse was 75/min, her respirations were 18/min, her blood pressure was 162/85 mm/hg and her pulse ox was 99% on room air. She rated her pain a 0 out of 10. At 2:13 pm, the patient''s examination started. Her history and presentation was consistent with an acute allergic dermatitis. This was a new problem, with no prior history of similar episodes. No itching was present. The patient presented with a generalized non urticarial skin rash. She denied any trouble breathing, no nausea or vomiting. She did have an isolated localized skin rash. The patient complainted of feeling a lump in her throat, but no other airway or throat symptoms. It was reported that this reaction was due to the GARDASIL. The patient developed a trace sense of swelling in the back of the throat and mouth. No evidence of upper airway stidor, loss of voice, or trouble swallowing prior to the exam. Symptoms were currently rated as merely annoying. The patient denied any chest pain, trouble breathing or audible wheezing. A primary diagnosis of allergic reaction was made at the hospital. On 06-DEC-2007, the patient recovered and was discharged from the hospital. The primary care physician spoke to the patient at 16:40 and she was on her way home. She stated she felt better and that she received BENADRYL and steroids (PREDNISONE) at the hospital. (The patient was prescribed PREDNISONE 40 mg PO daily for 5 days). It was reported that the patient understood her after care instructions, the need for follow up and how to access follow up care and signs and symptoms to return to the emergency department. The patient also verbalized that she should not receive another GARDASIL injection. No product quality complaint was involved. Additional information is not expected.

VAERS ID:303233 (history)  Vaccinated:2007-12-06
Age:16.0  Onset:2007-12-08, Days after vaccination: 2
Gender:Female  Submitted:2008-01-14, Days after onset: 37
Location:Pennsylvania  Entered:2008-01-22, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Chest pain 2 days after HPV # 1

VAERS ID:337873 (history)  Vaccinated:2007-12-06
Age:1.3  Onset:2007-12-09, Days after vaccination: 3
Gender:Male  Submitted:2008-12-01, Days after onset: 358
Location:Georgia  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: Unknown
CDC Split Type: WAES0712USA06094
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes virus infection
SMQs:
Write-up: Information has been received from a healthcare professional concerning a 16 month old male who on 06-DEC-2007 was vaccinated (route and site not reported) with CONVAX (lot # not reported). On 09-DEC-2007, post vaccination, the patient contracted herpes. The patient received unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.

VAERS ID:299053 (history)  Vaccinated:2007-12-07
Age:23.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-07, Days after onset: 0
Location:Virginia  Entered:2007-12-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500502P1IN 
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA2IMRA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUE912AA0SCLA
Administered by: Military     Purchased by: Military
Symptoms: Dyspnoea, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.

VAERS ID:299076 (history)  Vaccinated:2007-12-07
Age:4.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-09, Days after onset: 2
Location:New Jersey  Entered:2007-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 102 Degree fever. General lethargy. Lack of appetite. Symptoms presented themselves within hours of the vaccine and have continued for 2 days so far.

VAERS ID:299123 (history)  Vaccinated:2007-12-07
Age:79.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2007-12-10, Days after onset: 2
Location:Delaware  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPROL,LEVOTHYROXINE,FLOMAX
Current Illness:
Preexisting Conditions: SINUS ALLERGIES,ASTHMA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1412U0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Hypersensitivity, Pruritus, Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Shingles vaccine administered Friday at 2PM.Reaction started on the next day (Sat)about 4PM while I was driving a car to my house. As soon as entering my house about 6PM, I took 2 pills of Zyrtek. This removed the "bloom" of itching swolen spots in 2 hours. I use this medication when I occasionally get similar, but less extreme, rashes in some skin locations. After 40 hrs have passed since the successful medication result I have received no further reaction to the Shingles vaccination.Ignore 14.

VAERS ID:299128 (history)  Vaccinated:2007-12-07
Age:26.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-10, Days after onset: 2
Location:Texas  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pt. also given PPD with tubersol same day as Influenza vaccine.
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA067AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Migraine, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: States redness and induration at site of injection. Severe migraine, body aches day after vaccination. No temp noted 3 days after vaccination.

VAERS ID:299187 (history)  Vaccinated:2007-12-07
Age:7.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:New Hampshire  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metamucil, MVI, Albuterol PRN
Current Illness: Well
Preexisting Conditions: Stable asthma
Diagnostic Lab Data: N/A
CDC Split Type: NH0746
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA4UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1559U2UNLA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Inadvertently administered three doses of varicella (2/14/03) (12/01/06). No known s/sx.

VAERS ID:299189 (history)  Vaccinated:2007-12-07
Age:56.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 3
Location:Massachusetts  Entered:2007-12-10
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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR62862AA0IM 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythema, induration at site, faint regular rash on abdomen and extremities.

VAERS ID:299194 (history)  Vaccinated:2007-12-07
Age:11.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-10, Days after onset: 2
Location:Texas  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Erythema~Influenza (no brand name)~1~7~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma-mild, infrequent, Allergic Rhinitis. Bactrim, Macrodantin/Furadanitn
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2493AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Reaction around the injection site (R) arm erythema 24 hr later, with area swelling. Erythema extending to mid arm 48 hr later. No lymphadenopathy

VAERS ID:299199 (history)  Vaccinated:2007-12-07
Age:68.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Wisconsin  Entered:2007-12-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft; Zocor
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.13844 IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1412U IMLA
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 12/8/07 had temp of 102.4 w/red blotches from neck down right arm. Took hydrocodone-As of 12/10/07 had slight rash down back of arm.

VAERS ID:299249 (history)  Vaccinated:2007-12-07
Age:50.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2007-12-11, Days after onset: 3
Location:Washington  Entered:2007-12-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Did not see a physician (yet).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Pain, Pyrexia, Respiratory tract congestion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Cold-like congestion, followed by fever (102F) and severe aches for four days; missed one day work on third day (Mon.)

VAERS ID:299335 (history)  Vaccinated:2007-12-07
Age:10.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-11, Days after onset: 3
Location:California  Entered:2007-12-11
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: Sulfa
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1341U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Oedema, Pallor, Pruritus, Swelling, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local reaction within 24 hours of Varivax #2 administered on 12/7/07. Redness/swelling/tenderness at site, 1" x 1" within 24 hours then increased sxs locally at 48 hours, on 12/10/07 site measured 4 3/4" long x 3" wide: erythema, edema, pallor with c/o pruritus, tenderness improving; no vesicles; no fever; pt. not ill.

VAERS ID:299448 (history)  Vaccinated:2007-12-07
Age:0.5  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2007-12-13, Days after onset: 6
Location:Wisconsin  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: nkda
Diagnostic Lab Data: Abcess culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B113AA2IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR    
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08681A2IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1129U2  
Administered by: Public     Purchased by: Public
Symptoms: Abscess, Culture, Injection site erythema, Injection site vesicles, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: R thigh became red and warm after immunization. Fever spiked to 102 48 hours after immunization. 72 hours after immunization blister appeared and popped. 4 days after immunization child was brought to clinic. Drained abcess and cultured, began Augmentin.

VAERS ID:299529 (history)  Vaccinated:2007-12-07
Age:1.3  Onset:2007-12-10, Days after vaccination: 3
Gender:Female  Submitted:2007-12-13, Days after onset: 3
Location:Ohio  Entered:2007-12-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: lacrimal duct obstruction PMH: parent sick w/URI. GERD, nasolacrimal duct stent. Uncle w/MS.
Diagnostic Lab Data: negative Urine culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2481GA1IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB211AA1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0527U0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1505U0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Culture urine negative, Dyskinesia, Familial risk factor, Febrile convulsion, Gaze palsy, Grand mal convulsion, Hypotonia, Irritability, Loss of consciousness, Oxygen saturation decreased, Oxygen supplementation, Pyrexia, Respiratory arrest, Skin discolouration, Somnolence, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 3 days after receiving MMR, Varivax, Hep A and influenza vaccines, patient had a temp of 102 and a generalized tonic clonic seizure. Per parents, had stopped breathing during this episode and was given chest compression. EMS arrived and brought patient to Hospital. There she was observed overnight. She had no further episodes and was released the next day. 1/15/08 Reviewed hospital medical records which reveal patient experienced fever, irritability, involuntary jerking all extremities, eyes rolling back, loss of consciousness, hypotonia, ashen gray. Family felt was in cardiac arrest & started cpr for short time before patient began to breath. EMS foung patient groggy alternating w/irritability/crying. O2 sat dropped to 94% & placed on blowby O2. Admitted 12/10-12/11/2007. Returned to baseline while in ER but admitted for observation. No further fever or seizure activity while in hospital. D/C to home & pcp f/u. FINAL DX: febrile seizure.

VAERS ID:300054 (history)  Vaccinated:2007-12-07
Age:0.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2007-12-17, Days after onset: 10
Location:New York  Entered:2007-12-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none (newborn)
Preexisting Conditions: none
Diagnostic Lab Data: FSBG <46. Labs and Diagnostics: CBC WNL. CMP with Creatinine 0.8. Na+ 146. CO2 21. BUN 9.0. ALT 14. AST 56. Albumin 4.5. Total bili 7.6. Labs and Diagnostics: Head CT (-), LP (-). CSF cx (-). CSF PCR for HSV and Enterovirus (-) Blood
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.ME0570U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood bilirubin normal, Blood creatinine normal, Blood culture negative, Blood glucose decreased, Blood sodium increased, Blood urea normal, Body temperature increased, CSF culture negative, Computerised tomogram normal, Full blood count normal, Hyperreflexia, Hypertonia, Hypoglycaemia, Irritability, Lumbar puncture normal, Myoclonus, Polymerase chain reaction, Tonic clonic movements, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow)
Write-up: Inc temp 38.5 (rectally), irritability, tremulous, hypoglycemia (<46). 12/31/2007 MR received for DOS 12/7/2007. Newborn infant with newborn exam WNL noted to have developed temperture elevation of 38.5''C and tremulousness of feet bilat. Initially hypoglycemic but tremors did not resolve with improvement in BS. Tonic-clonic tremors of L foot $gR foot, progressed to R arm. Transfered to higher level of care on date of birth. 01/14/2008 MR received for DOS 12/07-10/2007 with D/C Dx: Fever. Hypertonia. Newborn infant admitted from hospital of birth with fever and seizure like activity (hypertonia/hyperreflexia with ? of myoclonus). Txd with empiric abx x 48hrs. Neuro status greatly improved

VAERS ID:300088 (history)  Vaccinated:2007-12-07
Age:0.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-17, Days after onset: 10
Location:Virginia  Entered:2007-12-17
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: Vitamin K; Ampicillin trihydrate; Ceftazidime sodium; Erythromycin; Eye medication
Current Illness: Unknown
Preexisting Conditions: The subject had not previously received any flu shots.
Diagnostic Lab Data: UNK
CDC Split Type: A0699261A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental overdose, Inappropriate schedule of drug administration, Medication error
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of inappropriate schedule of drug administration in a 2-day-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccinations included Engerix B 1st dose, given on 06 December 2007. Concurrent medications included Vitamin K, Ampicillin Ceftazidime, Erythromycin and Eye medication. On 7 December 2007 the subject inadvertently received a 2nd dose of Engerix B at 10 mcg. This was considered to be a medication error and an inappropriate schedule of drug administration. The subject received a dose of Engerix B one day following the first administration. It was reported that the subject was hospitalised. No adverse events were reported.

VAERS ID:300231 (history)  Vaccinated:2007-12-07
Age:23.0  Onset:2007-12-09, Days after vaccination: 2
Gender:Male  Submitted:2007-12-18, Days after onset: 9
Location:Virginia  Entered:2007-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Complained of chest congestion and feeling feverish prior to flu mist administration.
Preexisting Conditions: Complained of chest congestion and feeling feverish prior to flu mist administration.
Diagnostic Lab Data: Upper respiratory infection common viral cold.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500502P1IN 
Administered by: Military     Purchased by: Military
Symptoms: Nasopharyngitis, Respiratory tract congestion, Upper respiratory tract infection
SMQs:
Write-up: States he felt congested and feverish prior to flu mist administration. Temp was taken prior to flu mist was 98.8 by medical rep. Went to another medical rep for the flu mist administration and answered all questions on the flu mist questionnaire as no. After being administered the flu mist, states he progressively felt worse until Sunday night about 7 PM, he headed to the ER. Stated his chest was further congested and he was feeling even more feverish. At ER, he was diagnosed with an upper respiratory infection and told to go home and drink fluids and rest. By Tuesday Dec 11th, was feeling better.

VAERS ID:300267 (history)  Vaccinated:2007-12-07
Age:57.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 3
Location:California  Entered:2007-12-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2509AA0IM 
Administered by: Other     Purchased by: Private
Symptoms: Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)
Write-up: Patient felt tightness in throat. No distress except for lump in throat. Had patient sit for observation. Patient called her physician. Advised to give Edipen and Diphenhydramine 50 mg. Had patient stay 30 min. No change. Sent back to work in taxi. Called next morning. Patient was fine.

VAERS ID:300279 (history)  Vaccinated:2007-12-07
Age:16.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 3
Location:Arkansas  Entered:2007-12-18, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2514AA7IM 
HPV4: HPV (GARDASIL)MERCK & CO. INC.0802U IM 
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pruritus, Skin nodule
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient complained of getting "knot" and red itchy area down left arm. This started on Friday, 12-7-07. Patient was given Benadryl 25mg and PO OTCq 4 hours for itching and Dexamethasone 4mg IM to right UOQG was given.

VAERS ID:300288 (history)  Vaccinated:2007-12-07
Age:30.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-10, Days after onset: 2
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURC2511AA0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Nausea and vomiting starting 12/8/07 in morning. Also, diarrhea, abdominal cramping, aches and low grade fever. No respiratory symptoms.

VAERS ID:300317 (history)  Vaccinated:2007-12-07
Age:8.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-11, Days after onset: 4
Location:Washington  Entered:2007-12-18, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2508AA5UNRA
Administered by: Private     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 hrs after flu shot hives, no respiratory Sx, no Hx egg allergy; Benadryl.

VAERS ID:300486 (history)  Vaccinated:2007-12-07
Age:5.0  Onset:2007-12-10, Days after vaccination: 3
Gender:Male  Submitted:2007-12-19, Days after onset: 9
Location:Kansas  Entered:2007-12-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA3IMLL
Administered by: Public     Purchased by: Unknown
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Body rash 2-3 days following administration of DTaP vaccination. Seen in clinic 12/19/07 wiht improved but persistent rash. Treated with short course of oral steroid.

VAERS ID:300584 (history)  Vaccinated:2007-12-07
Age:75.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-20
Location:Oregon  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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1081U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site pruritus, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: pt called 12/13/07 to report feeling a hard bump at injection site and also had some small bumps and itching. the site has cleared up but the bumps moved up his arm to his bicep area. pt given triamcinolone acetanide cream and advised to call if any further problems come up.

VAERS ID:300740 (history)  Vaccinated:2007-12-07
Age:54.0  Onset:2007-12-21, Days after vaccination: 14
Gender:Female  Submitted:2007-12-21, Days after onset: 0
Location:Pennsylvania  Entered:2007-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1412U0IMUN
Administered by: Unknown     Purchased by: Private
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: patient experiencing more shingles (she had numerous times before vaccine) this time worse than usual

VAERS ID:300805 (history)  Vaccinated:2007-12-07
Age:3.0  Onset:2007-12-14, Days after vaccination: 7
Gender:Male  Submitted:0000-00-00
Location:Wisconsin  Entered:2007-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA3IMRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0376U2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0869U0SCRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother states one week after Pt received Comvax started with fever that went up to 104.9. Went to ER. Fever x3 days. Site red & tender Rt thigh.

VAERS ID:300983 (history)  Vaccinated:2007-12-07
Age:1.3  Onset:2007-12-14, Days after vaccination: 7
Gender:Male  Submitted:2007-12-17, Days after onset: 3
Location:Iowa  Entered:2007-12-26, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA3 RL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0676U2 LL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1360U0 RL
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis
SMQs:
Write-up: Local cellulitis

VAERS ID:301056 (history)  Vaccinated:2007-12-07
Age:60.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2007-12-18, Days after onset: 11
Location:Arkansas  Entered:2007-12-26, 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: Cipro, Prevacid, Miacalcin, Entex, Ambien, Toprol, HCTZ, Xanax, acyclovir
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: NAT adverse reaction zoster vs Cipro
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0967U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Sinusitis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 12/7/2007 given zoster vaccine. Seen 12/10/07 for sinusitis, taking Cipro 500 mg one BID & pen 8 mg/Celestone 6 mg IM. Urticaria rash on 12/15/07.

VAERS ID:301139 (history)  Vaccinated:2007-12-07
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-20
Location:Massachusetts  Entered:2007-12-27, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Dysphonia, Fatigue, Headache, Pain, Pyrexia, Respiratory tract congestion, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 100 deg F Feever, Vomiting, Headache, Tiredness, Hoarseness, Heavy Congestion, Body Aches. 12-07-07 had a yearly physical also T-dao shot and Meningococcal Vaccine at 4:30 by 8:00 Symptoms started to occur seen by doctor Sunday. Also called Doctor Saturday. Somewhat Still Congested

VAERS ID:301294 (history)  Vaccinated:2007-12-07
Age:1.5  Onset:2007-12-17, Days after vaccination: 10
Gender:Female  Submitted:2007-12-27, Days after onset: 10
Location:Tennessee  Entered:2007-12-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Mild URI
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2769AA3IMLL
Administered by: Private     Purchased by: Public
Symptoms: Bronchiolitis, Cough, Febrile convulsion, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vaccines given 12-7-07. 1 week later (presumably unrelated) patient developed cough, runny nose. 12-17-07, office visit. Bronchiolitis, Otitis media, fever. In office: Febrile seizure. Lasted less than 1 minute. Recovered fully.

VAERS ID:301295 (history)  Vaccinated:2007-12-07
Age:10.0  Onset:2007-12-18, Days after vaccination: 11
Gender:Female  Submitted:2007-12-27, Days after onset: 9
Location:California  Entered:2007-12-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.07821 LA
Administered by: Private     Purchased by: Unknown
Symptoms: Skin induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Wheal left arm 5 cm.

VAERS ID:301797 (history)  Vaccinated:2007-12-07
Age:22.0  Onset:2007-12-28, Days after vaccination: 21
Gender:Female  Submitted:2008-01-07, Days after onset: 10
Location:California  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: B-HCG LOW FOR GESTATIONAL AGE. NO DEFINITE FETAL POLE SEEN ON ULTRASOUND AS OF YET. MEAN GESTATIONAL SAC SIZE 15 MM, JUST BELOW DISCRIMINATORY LEVEL OF 16 MM.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500501P0IN 
Administered by: Military     Purchased by: Military
Symptoms: Abortion threatened, Blood gonadotrophin decreased, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: PATIENT WAS UNAWARE SHE WAS PREGNANT AT TIME OF FLU MIST ADMINISTRATION. AFTERWARDS SHE FOUND OUT SHE WAS PREGNANT. IT APPEARS SHE WAS APPROXIMATELY 4 WKS PREGNANT AT TIME OF ADMINISTRATION. PATIENT IS NOW EXPERIENCING THREATENED ABORTION. SHE HAS BEEN BLEEDING AND CRAMPING FOR LAST SEVERAL WEEKS. THERE IS STILL FETAL HEART SOUNDS, BUT PER OB-GYN ER NOTE, APPEARED TO BE TISSUE PROTRUDING FROM CERVICAL OS.

VAERS ID:302232 (history)  Vaccinated:2007-12-07
Age:44.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-11, Days after onset: 3
Location:Idaho  Entered:2008-01-10, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cenestin, Prometrium, Paxil, Chantix
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ID07051
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2512AA IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107BA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0804U1IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA0IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ047920IMLA
Administered by: Public     Purchased by: Private
Symptoms: Back pain, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Client''s R arm sore after immunizations on 12-7-07. On 12-8-07 p.m. client''s back started hurting. R arm getting very sore and flu-like symptoms. Client had to take 2 extra strength Tylenol then and later as needed. On 12-9-07 Sunday night, client noticed that her R arm had a 3" x 5" to 6" long raised, warm and rough to touch, red hives which was following her bicep & it was itching at and around injection site.

VAERS ID:302797 (history)  Vaccinated:2007-12-07
Age:36.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2007-12-13, Days after onset: 5
Location:Florida  Entered:2008-01-14, Days after submission: 32
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: MEDI0006287
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Military     Purchased by: Other
Symptoms: Decreased appetite, Lip swelling, Night sweats, Productive cough, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A nonserious report of chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite has been received from a consumer concerning her son, a three-year-old male. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age Flumist. No medical history nor concomitant medication were provided. The patient received Flumist on 07-Dec-2007. On 08-Dec-2007, the child experienced chest congestion, coughing with phlegm, night sweats, nasal congestion, lip swollen, and poor appetite. No outcome for the events was provided by the reporter; although the symptoms were reported to be somewhat better. The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor''s comment is not applicable. This case is linked to MEDI-0006289, a report for the patient''s mother.

VAERS ID:303482 (history)  Vaccinated:2007-12-07
Age:0.2  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 39
Location:Unknown  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06671
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0667U0PO 
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Faeces discoloured
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a registered nurse concerning an approximately 56 day old female with no pertinent medical history and no drug reactions/allergies, who on 07-DEC-2007 was vaccinated po with a "first dose of series" ROTATEQ (lot number: 657514/0667U). Concomitant therapy included: ''routine two month old vaccines". On 07-DEC-07 the patient had two liquid black stools. No further information was provided regarding this adverse experience. No lab diagnostic studies were performed. The outcome was reported as recovered on 08-DEC-07. There was no product quality complaint. Additional information has been requested.

VAERS ID:303661 (history)  Vaccinated:2007-12-07
Age:33.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 39
Location:Unknown  Entered:2008-01-21, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0712USA02809
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Injection site pain, Malaise, Myalgia, Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 33 year old female who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil (659055/1522U). On 07-DEC-2007 the patient experienced injection site pain. The patient''s injection site pain started shortly after vaccination with Gardasil and resolved the next day. On 08-DEC-2007 the patient experienced body rash, muscle aches and malaise. The rash on the patient''s chest was the size of her palm, red and itchy. After the rash the patient developed muscle aches over the whole body and flu-like symptoms. The patient stated that "she felt like she was run over by a truck". The muscle aches and flu symptoms resolved by 10-DEC-2007. The patient still has the rash as of 11-DEC-2007. The patient sought unspecified medical attention. There is no other information to report. Additional information has been requested.

VAERS ID:303689 (history)  Vaccinated:2007-12-07
Age:27.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 39
Location:Florida  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA06765
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1UNLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain, Injection site rash, Injection site vesicles, Mobility decreased, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse concerning a 27 year old female, who, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient developed an injection site rash and injection site soreness. The patient contacted the physician. At the time of the report, the outcome of the patient was unknown. No product quality compliant was involved. Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 27 year old female with an allergy to codeine, who on 07-DEC-2007 at 09:30 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659055/1522U). There were no illnesses at the time of the vaccination. On 07-DEC-2007 at approximately 10:30 the patient experienced a weak arm, the patient developed an injection site rash, and injection site soreness. The weak arm lasted for 4 weeks after the injection. The patient could not lift a hose. Around the third day post vaccination the patient developed "blister like fever blisters" all around the injection site. The blisters lasted seven to ten days. The patient was seen by the physician and was instructed to take BENADRYL. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:303172 (history)  Vaccinated:2007-12-07
Age:0.4  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-18, Days after onset: 42
Location:Unknown  Entered:2008-01-22, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2007-12-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Underweight; Vomiting
Preexisting Conditions: Constipation; Fever
Diagnostic Lab Data: autopsy 12/16?/07 - "there was cocaine metabolized in her hair"
CDC Split Type: WAES0801USA01850
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAAC21B084BA1IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0064U1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700D1IMLL
Administered by: Other     Purchased by: Other
Symptoms: Asphyxia, Autopsy, Bronchopneumonia, Death, Drug screen positive, Injury, Malaise
SMQs:, Drug abuse and dependence (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a mother concerning her 5 month old underweight daughter who "had been throwing up a lot since around the time she was born and who in August 2007 "was really constipated and had a fever of 103F" who on 24-OCT-2007 was vaccinated with a first dose of PEDVAXHIB. A second dose of PEDVAXHIB was administered on 07-DEC-2007. The mother reported that the patient "was given a lot of other shots" on the same days. The patient was reportedly "really sick" after the second dose of PEDVAXHIB on 07-DEC-2007. The patient was being seen by the health department. Subsequently the patient died on 16-DEC-2007. It was reported that they were awaiting autopsy results but an initial report from the medical examiner that stated "there was cocaine metabolized in her hair." Additional information has been requested. 3/5/08 Autopsy report states COD & manner of death as undetermined. Circumstances suggested smothering & mechanical asphyxia w/blunt force injuries, acute bronchopneumonia RUL.

VAERS ID:303230 (history)  Vaccinated:2007-12-07
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-01-11
Location:Pennsylvania  Entered:2008-01-22, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CXR, EKG, Echo
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.152202UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: CP 2 days after Gardasil

VAERS ID:303550 (history)  Vaccinated:2007-12-07
Age:17.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-01-24, Days after onset: 48
Location:New York  Entered:2008-01-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 11/15/2007)
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0801USA03327
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received through the Merck pregnancy registry from a health professional concerning a female who on 07-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. Per the reporter, the patient was 3 weeks pregnant at the time of vaccination and subsequently experienced vaccine exposure during pregnancy. On approximately 05-JAN-2008 the patient experienced elective termination of pregnancy (gestation = 7 weeks). No other information was available. Elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.

VAERS ID:304234 (history)  Vaccinated:2007-12-07
Age:0.6  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2008-01-31, Days after onset: 55
Location:Kentucky  Entered:2008-02-04, 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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA2UNRL
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0377U2UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700E2UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.090442PO 
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vomiting, high temperature. Vaccine was recalled by manufacturer.

VAERS ID:304878 (history)  Vaccinated:2007-12-07
Age:25.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-13, Days after onset: 68
Location:Connecticut  Entered:2008-02-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN LO
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA03619
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1211U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial and follow up information has been received from a physician, regarding a 25 year old caucasian female patient, and editor, with no known drug allergies, who on 07-DEC-2007 at 4:30 pm, was vaccinated IM in the left deltoid, with the second dose, 0.5 ml, of Gardasil (lot #655322/1211U). There were no side effects associated with the first dose of Gardasil (date not specified). There was no illness at the time of vaccination. Concomitant therapy included ORTHO TRI-CYCLEN LO. On approximately 27-DEC-2008, the patient called the physician''s office and stated that post vaccination, her left arm had been sore, but it had gotten better (duration not specified). She added though, that on approximately 20-DEC-2007, her arm had become sore again. The patient also reported weakness in her arm. There was no redness or fever. Treatment with MOTRIN was recommended by the physician. On 10-JAN-2008, the patient called the physician back with complaints of continued pain in her arm, described as pain when she lifted her arm over her head and when she lay on her side on the arm. At the time of this report, the symptoms continued, but had lessened. The physician considered arm sore again with weakness to be persistent or significantly disabling or incapacitating. Additional information has been requested.

VAERS ID:304931 (history)  Vaccinated:2007-12-07
Age:0.2  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2008-02-04, Days after onset: 59
Location:New Jersey  Entered:2008-02-14, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSIB137AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF204AE0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54014D0IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1319U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Non-stop inconsolable crying x 4-5 hrs

VAERS ID:305200 (history)  Vaccinated:2007-12-07
Age:19.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-02-19, Days after onset: 73
Location:Texas  Entered:2008-02-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible pharyngitis
Preexisting Conditions: None
Diagnostic Lab Data: Diagnostic tests: Anthrax vaccine skin testing completed 2/11/2008 negative - full dose #2 administered in graded amounts.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)MICHIGAN DEPT PUB HLTHFAV1580UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA03940UNUN
Administered by: Military     Purchased by: Military
Symptoms: Dysphagia, Injection site pruritus, Nasal congestion, Pharyngolaryngeal pain, Pruritus, Rash, Skin test negative, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 19y airman in good health when she received anthrax and typhoid vaccines left upper arm on 7 Dec 2007 at the immunizations clinic in preparation for deployment. Approximately 24-36 hours after the vaccinations she developed itching on her neck and lower face that soon after showed small red bumps. Over the next few days the rash and pruritis spread to include her torso and arms. The rash would come and go, most individual lesions were present for about 30 minutes before resolving. If she scratched the individual area the rash would persist longer periods of time. The small red bumps would appear in groups. The rash was present intermittently for approximately 2 weeks. She did not have a rash or swelling at site of vaccine, however did have some itching at sites of vaccination. A few days after the vaccinations she developed a mild sore throat which progressed until she went to the ER on 23 Dec 2007. The sore throat was accompanied by difficulty swallowing and congestion. She denies having fever, cough, nasal discharge, shortness of breath, throat tightness that caused difficulty breathing, chest tightness or joint aches. The rash resolved without symptoms or difficulty. Patient describes a rash consistent with urticaria within a few days of receiving both the typhoid and anthrax vaccines. This rash could represent and IgE mediated reaction to the vaccines, but other potential causes, although less likely given the time course, could be viral infections, foods, and medications. Assuming the vaccinations caused the urticaria, at this time unable to determine which vaccine is the likely culprit.

VAERS ID:305627 (history)  Vaccinated:2007-12-07
Age:15.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 69
Location:Texas  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory complete metabolic panel within normal range; hepatic function tests within normal range; erythrocyte within normal range; serum amylase test within normal range.
CDC Split Type: WAES0801USA02218
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain lower, Blood amylase, Blood amylase normal, Laboratory test normal, Liver function test normal, Red blood cell sedimentation rate normal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a registered nurse concerning a 15 year old female patient who in December 2006 and March 2007, was vaccinated with a first a second dose of Gardasil, respectively. On 07-DEC-2007, the patient was vaccinated IM with a third 0.5ml dose of Gardasil (Lot# 659435/1265U). There was no concomitant medication. On approximately 07-DEC-2007 about a month ago, the patient experienced intermittent abdominal pain in the right lower quadrant. There was no report of radiation of pain, nausea, vomiting or diarrhea. Unspecified medical attention was sought. Laboratory diagnostic studies included liver function tests, complete metabolic panel, sedimentation rate and amylase. All results were reported to be within normal ranges. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:305833 (history)  Vaccinated:2007-12-07
Age:18.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 68
Location:Unknown  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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02972
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 655620/0171U). There was no concomitant medication. On 08-DEC-2007 the patient developed a "full body rash." The patient reported that the rash was itchy. No shortness of breath or difficulty breathing was reported. The rash resolved within one week. The patient recovered on 14-DEC-2007. On 14-JAN-2008 the patient was seen in the office. No laboratory diagnostics were performed. No product quality complaint was involved. Additional information has been requested.

VAERS ID:305920 (history)  Vaccinated:2007-12-07
Age:15.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 69
Location:Texas  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA03780
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 15 year old female patient who on 07-DEC-2007 was vaccinated IM with the first dose of Gardasil (lot# 659437/1266U). Concomitant therapy included LOESTRIN. On 07-DEC-2007 the patient experienced pain at the injection site. Medical attention was sought. As of 21-DEC-2007 the patient''s pain at the injection site persisted. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Initial information has been received from a physician concerning a 15 year old female student patient who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot# 659437/1266U). Concomitant therapy included LOESTRIN. On 07-DEC-2007 the patient experienced pain at the injection site. Medical attention was sought. As of 21-DEC-2007 the patient''s pain at the injection site persisted. No quality complaint was involved. Follow-up information received from the registered nurse indicated that the patient had pain at the injection site for 2 weeks. Additional information has been requested.

VAERS ID:306327 (history)  Vaccinated:2007-12-07
Age:0.1  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2008-02-18, Days after onset: 73
Location:Maryland  Entered:2008-02-20, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06328
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC218125BB0IMLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0820U0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH854014D0IMRA
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0902U PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This is a follow-up to report(s) previously submitted on 2/18/2008. Information has been received from a physician and a licensed practival nurse concerning a 2 month old patient with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (Lot# 657386/0820U). Concomitant suspect vaccinations included ROTATEQ (Lot# 657671/0902U) administered by mouth. Other concomitant vaccinations included PEDIARIX (Lot# AC218125BB) administered intramuscularly in the left arm and a first dose of PREVNAR (Lot# 854014D) administered intramuscularly in the right arm. There were no illnesses at the time of the vaccinations. On 07-DEC-2007 the patient developed a localized reaction and a red mark at the injection site. The patient sought unspecified medical attention. No laboratory diagnostics were performed. No treatment was required. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information is not expected.

VAERS ID:306329 (history)  Vaccinated:2007-12-07
Age:0.4  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2008-02-18, Days after onset: 72
Location:Nevada  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: Diphtheria toxoid (+) pertussis
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06375
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 1UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Lethargy, Medication error, Moaning, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a consumer concerning his 18 week old son with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a second dose of PEDVAXHIB (OMPC). Concomitant suspect vaccinations included ROTATEQ and pneumococcal vaccine (manufacturer unspecified). Other concomitant vaccinations included poliovirus vaccine, and DtAP (unspecified). On 08-DEC-2007 the patient experienced diarrhea, fever, was moaning, and was very lethargic. It was reported that the patient''s symptoms lasted for about thirty six hours, but the patient was still experiencing diarrhea. The physician was contacted by phone. No laboratory diagnostics were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.

VAERS ID:306345 (history)  Vaccinated:2007-12-07
Age:0.3  Onset:2007-12-13, Days after vaccination: 6
Gender:Unknown  Submitted:2008-02-18, Days after onset: 67
Location:Unknown  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: INFANTS MYLICON DROPS
Current Illness: Gas
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA07119
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0435U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Flatulence, Nasal congestion
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse concerning an 18 week old patient (gender not reported) with a history of gas who on 07-DEC-2007 was vaccinated (route and site not reported) with a 0.5 ml dose of PedvaxHIB (lot#656520/0435U). Dose of the series of PedvaxHIB vaccine which was given was unknown. Concomitant therapy included INFANTS MYLICON DROPS. On 13-DEC-2007, the patient developed stuffiness, nasal congestion and gas. The patient''s mother was convinced that the patient had these experiences because of the "recall of the vaccine". The patient did receive unspecified medical attention but at the time of this report it is unknown if the patient recovered. Additional information has been requested.

VAERS ID:306439 (history)  Vaccinated:2007-12-07
Age:4.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-02-18, Days after onset: 72
Location:Georgia  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: methotrexate; naproxen
Current Illness: Juvenile arthritis; Hypersensitivity reaction
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08057
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site erythema, Injection site mass, Oedema peripheral, Pain in extremity, Skin striae, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a consumer concerning her 4 year old grand daughter with juvenile arthritis and history of allergic reaction to child hood shots who on 07-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included methotrexate and naproxen. The reporter that after one day of receiving Hib conj vaccine (OMPC) on 09-DEC-2007 her grand daughter developed red streaks on her right arm and the entire arm was swollen. Her right arm was three times bigger than her left arm and was very red and warm. She was prescribed extra strength BENADRYL and an antimicrobial (unspecified). She no longer had a swollen arm and the pain had gone away except at the injection site where she still had a red knot. The knot was the size of a half dollar. No further information was available. The patient was recovering. Additional information has been requested.

VAERS ID:306443 (history)  Vaccinated:2007-12-07
Age:0.0  Onset:2007-12-12, Days after vaccination: 5
Gender:Male  Submitted:2008-02-18, Days after onset: 68
Location:Indiana  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: Constipation
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08309
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)SANOFI PASTEURC2807AA0UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.D377U0UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC. 0UNUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA01690UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016D0UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0904U0PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a consumer concerning her 3 weeks old son who on 07-DEC-2007 was vaccinated with a first dose of Hib conj vaccine (OMPC) (lot # unknown). Concomitant therapy included ROTATEQ and unspecified vaccination. The reporter that her son had a bump at the injection site that would not go away. No further information was provided. Unspecified medical attention was sought. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on2/18/2008. Initial and follow up information has been received from a consumer and a healthcare professional from a physician''s office concerning approximately a ten week old male infant with constipation who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC) (lot # not reported). In follow up report it was indicated that on 07-DEC-2007 concomitant suspect therapy included a first dose of ROTATEQ (MSD) lot # 657673/0904U and on same day the infant received into right leg a first dose of COMVAX (OMPC) lot # 657380/0377U (route not reported.). Other concomitant therapy included DTP, poliovirus vaccine and PREVNAR. On approximately 12-DEC-2007 the patient experienced injection site bump. The patient''s injection site bump persisted. In the follow up report it was reported that the physician''s office was not informed about the injection site bump. Additonal information is not expected.

VAERS ID:307606 (history)  Vaccinated:2007-12-07
Age:18.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-07-08, Days after onset: 212
Location:Missouri  Entered:2008-03-17, Days after submission: 113
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: Tonsillectomy; Heavy periods; Anaemia
Diagnostic Lab Data: [procedure unspecified]
CDC Split Type: WAES0802USA03368
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a consumer concerning her daughter, an 18 year old with a history of tonsillectomy, and heavy periods which cause anaemia. On 07-DEC-2007, the patient was vaccinated with her first dose of Gardasil. On 08-DEC-2007 the patient experienced fine rash on legs. On 08-Feb-2008, the patient received her second dose of Gardasil. Concomitant therapy included ZYRTEC-D and hormonal contraceptives (unspecified). On 09-FEB-2008 the patient experienced fine rash on legs. The patient''s fine rash on legs persisted. The patient sought unspecified medical treatment and unspecified lab diagnostics were performed. The report states the therapy was discontinued on 08-Feb-2008. Additional information has been requested. On 14-FEB-2008 the patient was diagnosed with eczema on her legs and stomach. Follow up information indicated the patient recovered on an unknown date. Additional information has been requested.

VAERS ID:307861 (history)  Vaccinated:2007-12-07
Age:15.0  Onset:2007-12-10, Days after vaccination: 3
Gender:Female  Submitted:2008-03-14, Days after onset: 94
Location:Florida  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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA05019
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 15 year old female who on 10-OCT-2007 was vaccinated with GARDASIL (lot # not specified). On approximately 07-DEC-2007, the patient was vaccinated intramuscularly with her second GARDASIL (lot#658556/1060U). There was no concomitant medication. On 10-DEC-2007 (2-3 days later), the patient experienced pain in right bicep (it was hard for her to write). 5-7 days after she was still experiencing pain. Unspecified medical attention was sought. The physician told her to take ADVIL as an anti-inflammatory. The patient''s pain in right bicep persisted. No further information was provided. Additional information has been requested.

VAERS ID:308562 (history)  Vaccinated:2007-12-07
Age:13.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 101
Location:California  Entered:2008-03-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Adverse events following previous vaccinations with hepatitis and meningitis vaccine caused a fever of 101.
Diagnostic Lab Data: UNK
CDC Split Type: A0700189A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA305AA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth, Medication error
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Medication errors (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of injection site redness in a 13-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline). No concurrent medications. On 7 December 2007 at 15:00 the subject received 1st dose of Fluarix (unknown, left arm). Immediately after vaccination with Fluarix, the subject experienced injection site soreness and within hours experienced injection site redness and heat at injection site. The subject also experienced vaccination error. At the time of reporting the outcome of the redness at the injection site and heat at the injection site was resolved. Soreness at the injection site was unresolved.

VAERS ID:308676 (history)  Vaccinated:2007-12-07
Age:11.0  Onset:2008-01-01, Days after vaccination: 25
Gender:Female  Submitted:2008-03-26, Days after onset: 84
Location:Pennsylvania  Entered:2008-04-01, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Skin papilloma
SMQs:
Write-up: Plantar warts after one month of injection.

VAERS ID:308732 (history)  Vaccinated:2007-12-07
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-27
Location:New York  Entered:2008-04-01, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1356U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Pt. was given VARICELLA vaccine 1 week prior to 12 mos. birthday.

VAERS ID:309134 (history)  Vaccinated:2007-12-07
Age:17.0  Onset:2007-12-09, Days after vaccination: 2
Gender:Female  Submitted:2008-04-02, Days after onset: 114
Location:Texas  Entered:2008-04-08, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~HPV (Gardasil)~3~17~In Patient
Other Medications: birth control
Current Illness: None
Preexisting Conditions: allergic to PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U2UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Headache, Pain, Rash, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Severe H/A''s on 1st & 2nd vaccine. Rash on back ~8 spots on middle/left side of back on 12/9/07 - extremely painful/blisters/itchy.

VAERS ID:309834 (history)  Vaccinated:2007-12-07
Age:93.0  Onset:2007-12-13, Days after vaccination: 6
Gender:Female  Submitted:2008-03-26, Days after onset: 103
Location:Pennsylvania  Entered:2008-04-16, 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: FOSAMAX; aspirin
Current Illness: Cardiac failure congestive; Drug hypersensitivity; Shellfish allergy
Preexisting Conditions:
Diagnostic Lab Data: Lyme disease assay, negative
CDC Split Type: WAES0712USA06378
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology negative, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a registered nurse concerning an approximately 93 year old female with cardiac failure congestive, drug hypersensitivity to narcotics, codeine and shellfish allergy who on 07-DEC-2007 (reported as 6 days ago), was vaccinated with a dose of Zostavax (Oka/Merck) subcutaneously. Concomitant therapy included alendronate sodium (MSD) and aspirin. Subsequently the patient developed a 2 inch wide erythema at the injection site. The patient saw a physician on 05-DEC-2007. The outcome was reported as not recovered. There was no product quality complaint. Further Information has been received from the physician concerning this retired 93 year old female with allergy to DEMEROL. The physician reported that the patient developed an expanding erythema for one week following injection. The patients Lyme titer was negative. The physician reported that the patient recovered on 21-DEC-2007. Additional information is not expected.

VAERS ID:310186 (history)  Vaccinated:2007-12-07
Age:75.0  Onset:2007-12-09, Days after vaccination: 2
Gender:Male  Submitted:2008-03-26, Days after onset: 107
Location:Unknown  Entered:2008-04-16, 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: Allergic reaction to bee sting
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02502
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1088U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site rash, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist concerning a 75 year old male with allergic reaction to bee sting who on 07-DEC-2007 was vaccinated with Zostavax (Oka/Merck) ( lot # 658604/1088U). On 09-DEC-2007, two days after vaccination the patient developed injection site rash. The rash was on the injection site arm and the whole lower arm was swollen, warm and red. The pharmacist reported that on 10-DEC-2007 the patient was treated with a steroid dose pack. The patient sought medical attention. No product quality complaint was involved. The physician reported that the patient recovered. Additional information has been requested.

VAERS ID:310192 (history)  Vaccinated:2007-12-07
Age:87.0  Onset:2007-12-18, Days after vaccination: 11
Gender:Female  Submitted:2008-03-26, Days after onset: 98
Location:Iowa  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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08561
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 an 87 year old female who on 07-DEC-2007 was vaccinated with ZOSTAVAX. On 18-DEC-2007 the patient developed shingles. The patient''s shingles persisted. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.

VAERS ID:310205 (history)  Vaccinated:2007-12-07
Age:51.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-03-26, Days after onset: 109
Location:Unknown  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Attention deficit disorder
Preexisting Conditions: Vaccination adverse reaction
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00044
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)
Write-up: Information has been received from a 51-year-old female consumer with attention deficit disorder and a "drug reaction to almost every vaccination" who on 07-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included RITALIN. The patient experienced swelling at the injection site right after receiving the vaccination. Unspecified medical attention was sought. There were no laboratory or diagnostic studies performed. The patient reported that the swelling was gone within a week. No product quality complaint was involved. Additional information has been requested.

VAERS ID:312546 (history)  Vaccinated:2007-12-07
Age:0.2  Onset:2008-01-24, Days after vaccination: 48
Gender:Male  Submitted:2008-05-19, Days after onset: 115
Location:Maryland  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Labs consistent with Kawasaki disease LABS: WBC 22.3, plts 454, sodium 135. UA (+) for pyruria. Sed rate 41 (H). Echocardiogram WNL. Rapid strep (-). RSV (-). Viral cultures (-). Blood & urine c/s (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B113AA0UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70143T0UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1128U0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Blood culture negative, Blood product transfusion, Blood sodium decreased, Chapped lips, Culture urine negative, Echocardiogram normal, Immunoglobulins, Irritability, Kawasaki's disease, Laboratory test abnormal, Lip exfoliation, Ocular hyperaemia, Platelet count increased, Pyrexia, Rash erythematous, Rash maculo-papular, Red blood cell sedimentation rate increased, Streptococcus identification test negative, Swollen tongue, Urine analysis abnormal, Virus culture negative, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Glaucoma (broad), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: Pt treated for Kawasaki disease ?related to vaccine? 5/27/08 Reviewed hospital medical records of 1/29-1/31/2008. FINAL DX: Kawasaki disease Records reveal patient experienced fever, irritability, maculopapular erythematous rash & red eyes w/conjuntivitis, cracked & swollen lips, & strawberry tongue x 4 days. Tx w/IVIG & high dose ASA. Improved & was afebrile but had continued red eyes & slightly swollen tongue, cracked peeling lips, & faint rash at D/C to home on continued high dose ASA.

VAERS ID:312795 (history)  Vaccinated:2007-12-07
Age:25.0  Onset:2008-01-01, Days after vaccination: 25
Gender:Female  Submitted:2008-05-14, Days after onset: 133
Location:South Carolina  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 1/1/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 01/01/08, IUG-6W4D, vitamins (unspecified)
CDC Split Type: WAES0803USA01559
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1211U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Nausea, Ultrasound abdomen, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 25 year old female with a history of 1 pregnancy and 1 live birth who was vaccinated on 12-OCT-2007 with her first dose of GARDASIL (lot# 0530U). On 07-DEC-2007 the patient was vaccinated with her second dose of GARDASIL (lot# 655322/1211U) and became pregnant. Concomitant therapy included prenatal vitamins (unspecified). The patient''s LMP was reported as 01-JAN-2008 with an estimated due date of 10-OCT-2008. The patient had an ultrasound on 01-JAN-2008 and the results of the test were IUG-6W4D. On 17-MAR-2008 the patient developed nausea and vomiting which were treated with PHENERGAN. At the time of this report it was unknown if the patient had recovered from nausea and vomiting. No further information was available.

VAERS ID:313922 (history)  Vaccinated:2007-12-07
Age:7.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-05-16, Days after onset: 159
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: body temp - 12/08/07 - 103 degree
CDC Split Type: WAES0712USA08065
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB225AA0UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.659355/1518U1SCRL
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse concerning a 7 year old 49 lb. 49 inch female with no pre-existing allergies, birth defects, or medical conditions, who on 07-DEC-2007 was vaccinated with a second 0.5 ml subcutaneous dose in the right anterior thigh of varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U)$g Concomitant vaccination included a first dose in the left anterior thigh of hepatitis A virus vaccine inactivated (HAVRIX) (lot#AHAB225AA). There was no reported illness at the time of vaccination, and no concomitant medication. On 08-DEC-2007, within 24 hours of the vaccination, the patient developed a 103F fever, "a reddened area as large as a softball, slight swelling, and small bumps at the injection site". The reddened area was not tender to the touch. The patient''s mother sought medical attention by phone and was instructed to apply a compress to the patient''s right thigh and give the patient ibuprofen (ADVIL). On 09-DEC-2007, the patient was seen in follow-up. The area was improved, slightly reddened and warm. Follow up information from the nurse indicated that "immunization reaction protocols" were used, and on an unspecified date, the patient had recovered. There were no other symptoms and no other treatment was given. Additional information is not expected.

VAERS ID:313973 (history)  Vaccinated:2007-12-07
Age:  Onset:2007-12-09, Days after vaccination: 2
Gender:Unknown  Submitted:2008-05-16, Days after onset: 158
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01489
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.659355/1518U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a patient who on 07-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U). On 09-DEC-2007 the patient developed "a softball sized limp at the injection site." The patient developed a fever of 103 F (date not provided). This report is one of several from the same source. Further information has been requested.

VAERS ID:316946 (history)  Vaccinated:2007-12-07
Age:0.3  Onset:2007-12-10, Days after vaccination: 3
Gender:Female  Submitted:2008-05-20, Days after onset: 161
Location:Texas  Entered:2008-06-23, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURC2760AA1IMLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0377U1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02731UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54016A1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1461U1PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site calcification, Injection site erythema, Injection site haematoma, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: INJECTION SITE RED & SWOLLEN. CALCIFIED HEMATOMA. WARM COMPRESS & MASSAGE 3 X A DAY.

VAERS ID:318835 (history)  Vaccinated:2007-12-07
Age:12.0  Onset:2007-12-14, Days after vaccination: 7
Gender:Female  Submitted:2008-07-08, Days after onset: 206
Location:New York  Entered:2008-07-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: migraine
Diagnostic Lab Data: CBC/SMA12/Abd sono/physical exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1428F0IMUN
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Full blood count, Laboratory test, Nausea, Pain in extremity, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pt states after receiving GARDASIL, has had pains to feet. Persistent nausea. Abdominal pains.

VAERS ID:323830 (history)  Vaccinated:2007-12-07
Age:60.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-07-30, Days after onset: 235
Location:Indiana  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Arthritis, Gastrooesophageal reflux disease, Hyperlipidaemia, Pain in leg, Allergic reaction to antibiotics, Drug hypersensitivi
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA02642
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1380U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial and follow up information has been received from a physician and a physician''s office concerning a 60 year old retired female with a history of allergies to erythromycin, acetaminophen (+) propoxyphene napsylate (DARVOCET), doxycycline (DOXYCLIN, as reported as doxycline). On 07-DEC-2007, between 10 and 10:30 am, the patient was vaccinated subcutaneous in the left arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 658450/1380U). On 07-DEC-2007, between 10 and 10:30 am, the patient experienced a site reaction following pneumococcal 23v polysaccharide vaccine. A knot formed and there was swelling, redness and tenderness at the site. Follow up information indicated that the patient stated "having a great deal of pain". The left arm did not appear to be particularly swollen. The patient stated "it hurt to move: move muscle". No relevant diagnostic studies or laboratory tests were performed. Physicial illness at time of vaccination included: hyperlip, GERD, arthritis, and leg pain. In follow up it was reported that the patient recovered on an unspecified date.

VAERS ID:323844 (history)  Vaccinated:2007-12-07
Age:49.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-07-30, Days after onset: 234
Location:New Jersey  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tamoxifen citrate
Current Illness: Breast cancer
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0712USA06321
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0989U0SC 
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician, concerning a 49 year old female patient with breast cancer, who on 07-DEC-2007 was vaccinated, SQ, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included tamoxifen citrate. On 08-DEC-2007, the patient developed redness and warmth at the injection site. The patient was examined in the office later that day, and the area of redness measured 6 cm but was resolving without requiring medical therapy. No further information was available. This is one of three reports from the same source. Additional information has been requested.

VAERS ID:324580 (history)  Vaccinated:2007-12-07
Age:33.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2007-12-13, Days after onset: 5
Location:Florida  Entered:2008-08-15, Days after submission: 245
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: MEDI0006209
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Military     Purchased by: Other
Symptoms: Cough, Nasal congestion, Pharyngolaryngeal pain
SMQs:, Anaphylactic reaction (broad)
Write-up: A non-serious report was received from a consumer concerning a 33-year-old female, who experienced head congestion, cough and sore throat one day after receiving FLUMIST. No medical history and concomitant medications were reported. The patient received one dose of FLUMIST on 07-Dec-2007 in a military clinic. On 08-Dec-2007, the patient began to experience head congestion, cough and sore throat. On 13-Dec-2007, the patient reported that the symptoms were somewhat better and indicated that she will be followed up by a military doctor. The patient did not experience a rechallenge while receiving the suspect vaccine. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor''s comment is not applicable. This case is linked to MEDI-0006287, which is the adverse event report fort the above patient''s son.

VAERS ID:327161 (history)  Vaccinated:2007-12-07
Age:17.0  Onset:2008-08-18, Days after vaccination: 255
Gender:Female  Submitted:2008-09-15, Days after onset: 28
Location:New York  Entered:2008-09-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, several other tests; complete blood cell;
CDC Split Type: WAES0808USA04085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Full blood count, Hypoaesthesia, Laboratory test, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a nurse practitioner concerning a 17 year old female who in June 2008 (date discrepant), was vaccinated with the first dose of GARDASIL. On 07-DEC-2007 the patient vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. On 10-AUG-2008 the patient returned to the physician''s office with numbness, tingling and weakness in her arms and fingers after receiving her third dose of GARDASIL. At the time of this report, the patient''s symptoms persisted. The physician felt that the patient''s condition was not a result of GARDASIL. Additional information has been requested.

VAERS ID:330730 (history)  Vaccinated:2007-12-07
Age:25.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Female  Submitted:2008-10-14, Days after onset: 311
Location:California  Entered:2008-10-30, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamins
Current Illness: Pregnancy NOS (LMP = 11/06/2007); Asthma; Cervical dysplasia; Migraines; Routine health maintenance
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 03/10/08, normal anatomy: routine screen; serum alpha-fetoprotein, 02/05/08, 1st trimester screen: low risk x 2. routine screening; serum alpha-fetoprotein, 03/05/08, modified MSAPP: Negative x 2. Routine screening
CDC Split Type: WAES0810USA00045
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Drug exposure during pregnancy, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 26 year old female with mild asthma, cervical dysplasia and migraine and no history of pervious pregnancies who on 10-SEP-2007 was vaccinated with the first dose of GARDASIL (lot# 657868/05230). On 07-DEC-2007, the patient was vaccinated with a second dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) daily for routine health maintenance. Subsequently, she became pregnant on approximately 20-NOV-2008 (LMP: 06-NOV-2007, estimated delivery date: 12-AUG-2008). On 05-FEB-2008, as routine screening a serum alpha-fetoprotein test (MSAFP) was performed at first trimester and the results showed low risk pregnancy. On 06-MAR-2008, as routine screening a modified serum MSAFP was performed and the result was negative. On 10-Mar-2008, was performed to the patient an ultrasound as routine screening which showed normal anatomy. On 29-JUL-2008, the patient delivered a normal, healthy female baby at 38 weeks from LMP. The baby had a face presentation at time of delivery (mal presentation). The baby''s weight was 2977 grams, with a length of 18 inches, apgar score was 9/9 and a head circumference of 34. Additional information has been requested.

VAERS ID:332497 (history)  Vaccinated:2007-12-07
Age:40.0  Onset:2008-01-01, Days after vaccination: 25
Gender:Male  Submitted:2008-11-14, Days after onset: 318
Location:Texas  Entered:2008-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Recent history of URI and viral syndrome, but does not believe significant symptoms were present on day of vaccine
Preexisting Conditions: One episode of tachycardia with negative functional and laboratory Cardiology evaluation. Hypertriglyceridemia- Diagnosed in 2000. Taking Lipid. Allergic rhinitis complicated by two episodes of acute sinusitis. Maintenance medications include ALLERGA + FLONASE. GERD, reflux- Diagnosed in 2001, Previously took PRILOSEC, but now controls with diet and prn OTC ZANTAC. History of Epididymitis Anxiety- Hx of "anxiety attack" while in Recruiting Command. Takes SERTRALINE 50 mg tab daily. Suspected low cortisol and hypoglycemia with negative laboratory Endocrinology evaluation. History of head trauma with resultant concussions. Neck Pain/Cervicalgia: Recurrent neck pain with radiating to arms bilaterally and occasional pin and /or numbnes
Diagnostic Lab Data: 10/1/08, Cortisol 18.150; 8/10/08, C-peptide 1.0; 1/5/08, Thyroxine Free 0.59; Glu 94, BUN/Cr 23/1.1, K+, CBC: WBC, 18.8, RBC, 4.67, h/h, 14.9/43, Plt 290 1?5?08, CT, Head/Brain w/o contrast, IMPRESSION: Normal head CT 1/11/08, ECG: HR 60, Sinus rhythm, normal axis, and normal intervals. No ST-T wave abnormalities noted. 4/11/08, MRI, Brain w, w/o contrast: IMPRSSION: 1. Mild paranasal sinus mucosal disease. 2. Few scattered nonspecific puncatate subcortical focl of T2 high signal. These may represent migraine related change, small vessel disease, with Lyme disease not excluded. 3. Otherwise unremarkable contrast-enhanced brain MRI. 6/7/08, CT, lumbar spine: Conclussion:1. No contrast is seen within the nucleus pulposus of the L5-S1 l
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV112 SCUN
Administered by: Military     Purchased by: Military
Symptoms: Anorexia, Blindness transient, Blood cortisol, Blood glucose normal, Blood potassium, Blood urea increased, Computerised tomogram normal, Confusional state, Dyskinesia, Electrocardiogram normal, Eye pain, Headache, Insulin C-peptide normal, Loss of consciousness, Migraine, Motor dysfunction, Mydriasis, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Photophobia, Red blood cell abnormality, Thyroxine normal, Tremor, Vision blurred, Visual impairment, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: May have started experiencing headaches around time of 2nd or 3rd anthrax vaccine, but his headaches did not become severe enough to seek medical evaluation and treatment until 5 January 2008 (within 30 day of receiving 3rd anthrax vaccine). Neurology first saw patient in May 2008 for evaluation of headaches and diagnosed him with likely migraine vs other h/a syndrome. Characteristics of headaches include: 1) Two types of headaches: a. Constant, dull headaches, low intensity, occasional gradual increase in intensity. b. Intermittent, lancinating, throbbing, excruciating headaches primarily affecting left side of head (from occiput ? parietal and temporal areas). Positive photophobia and anorexia, but no nausea or vomiting. During the peak of their course, headaches were occurring every 2-3 days. 2) Associated visual changes: Experiences blurred vision and transient partial (left lower field) vision loss in left eye during severe headaches. (Reports that he has experienced these visual changes in the absence of intense headaches.) Also on at least 2 occasions, his left pupil was dilated and was painful. Episodes of visual changes usually do not last for $g 30 minutes. 3) Associated tingling in left face, tongue and increased pressure sensation in ears with some of intense headaches. No focal weakness, visual changes, dysarthria, or dysphasia. 4) No specific triggers identified ( e.g., wine, cheese, chocolate, sleeping changes) except headaches are worse with intense heat and with prolonged computer use. 5) Evaluation included negative head CT and ophthalmologic exam, but those records not visible to VHC. 6) Loss of consciousness (LOC) associated with some of intense headaches. First episode of headache-associated LOC was in June 2008. At the time, SM was evaluated where they noted motor disturbances (trouble getting things out of pocket) and tingling in hands, but no lightheadedness, dizziness or nausea. In August 2008, his roommates found SM face down with bilateral arms jerking. When they turned him over, he made eye contact with them, but was confused for several minutes. Approximately 10-12 episodes of LOC have been reported, some associated with bilateral shaking of hands, with duration estimated to be < 5 minutes up to 45 minutes. Denies associated bowel or bladder incontinence or tongue biting. 7) Medications for headaches have included: VERAPAMIL, ZOMIG 5 mg, INDOCIN, and Naprosyn.

VAERS ID:337865 (history)  Vaccinated:2007-12-07
Age:0.4  Onset:2007-12-10, Days after vaccination: 3
Gender:Female  Submitted:2008-12-01, Days after onset: 357
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0712USA06545
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0377U0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning an 18 week old female who on 07-DEC-2007 was vaccinated (does not reported) with COMVAX (lot # 657380/0377U). The patient''s mother called the office to inform them that on 10-DEC-2007 her daughter had developed redness at the injection site which was reported to be the size of a dime or nickel and hard at the injection site. The mother reported that the child did not seem to be in any pain. The mother was instructed to put a warm compress on the area and gently massage the area. At the the time of this report the mother had not contacted the office again and the physician was not aware of the patient''s recovery status. Additional information has been requested.

VAERS ID:337591 (history)  Vaccinated:2007-12-07
Age:13.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2009-01-15, Days after onset: 404
Location:Florida  Entered:2009-01-16, 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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: plasma creatine kinase, elevated 2/17/09-records received-MRI brain normal, MRI cervical spine minimal bulge at C5 to C6. Pseudotumor Chiari malformation and spinal instability ruled o ut. EMG and nerve conductions tudies normal. CPK sligh
CDC Split Type: WAES0901USA01201
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase increased, Electromyogram normal, Fibromyalgia, Insomnia, Myalgia, Nerve conduction studies normal, Nuclear magnetic resonance imaging brain normal, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 15 year old female with no previous medical, family, or social history who on 19-NOV-2007 was vaccinated with a first dose of GARDASIL IM. The patient''s mother told the physician that a few weeks after the GARDASIL, the patient had body aches and generalized pain. The patient was seen by her pediatrician and a neurologist, and they both thought that it was from GARDASIL. The neurologist had diagnosed the patient with fibromyalgia. CPK was elevated. At the time of reporting, the patient was being treated with cyclobenzapine hydrochloride (MSD), melatonin, imipramine, and chiropractic therapy for the pain and insomnia. The patient has missed many days from school and volleyball because of the fibromyalgia. At the time of reporting, fibromyalgia persisted. The reporter considered fibromyalgia to be disabling. Additional information has been requested. 1/29/09-According to the general practitioner, fibromyalgia persisted while insomnia was being controlled on medication (not recovered).Onset Date: Approximately December 2007 ("a few weeks after Gardasil", per pt''s mother) 2/17/09-records received for DOS 7/23/08-neurology notes-C/O muscle aches and pains as well as sleep disturbance. Previously evaluated on 5/12/08, continues with pain on an almost daily basis. However no discomfort in past few days. Impression:history of severe pain in legs and arms and along cervical spine. Sleep disturbance resolved with use of Seroquel. No neurological cause of pain. No rheumatology consult at this time due to insurance issues.

VAERS ID:342918 (history)  Vaccinated:2007-12-07
Age:56.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2009-03-26, Days after onset: 473
Location:Unknown  Entered:2009-03-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: denied
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Military     Purchased by: Military
Symptoms: Activities of daily living impaired, Asthma, Cough, Dyspnoea, Fatigue, Nasal congestion, Respiratory tract congestion, Similar reaction on previous exposure to drug, Sinus congestion, Sinusitis, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: The patient reported receipt of IM influenza vaccination at NMCP while working the ER in 2002 or 2003. He denied any illness (URI) prior to this vaccination (date unknown). Approximately 12-24 hours post vaccination, he complained of feeling tired, had a stuffy nose, sinus and chest congestion. These symptoms worsened over the next few days to include shortness of breath and a cough which disrupted his ability to sleep. He was evaluated by his PCP and placed on an antibiotic and TUSSINEX. The cough medicine made him sleepy and he was unable to work for approximately one week before symptoms resolved. He did not receive any further influenza vaccination until 12/7/2007 (AFLU #A312BA). He again reported experiencing similar nasal, sinus and chest congestion, cough, and difficulty sleeping at night due to coughing and shortness of breath as in 2002/2003. Early winter is a time period he experiences sinus infections. He reported being out of work 2 weeks before symptoms eased. However symptoms persisted for the next several months. He was treated by his PCP with two antibiotics, FLONASE, PROVENTIL, ADVAIR, etc. (There are no available records of evaluation by his Allergist). In January 2009 he was referred to pulmonology where he was diagnosed with asthma and placed on SIMACORT. One month later "all asthma medications were stopped due to worsening breathing difficulty".

VAERS ID:345568 (history)  Vaccinated:2007-12-07
Age:85.0  Onset:2008-12-16, Days after vaccination: 375
Gender:Female  Submitted:2009-03-27, Days after onset: 100
Location:Unknown  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIOVAN
Current Illness: Blood pressure
Preexisting Conditions: Shingles
Diagnostic Lab Data: diagnostic procedure, 12/16/08 - diagnosed with neuropathy in her legs and feet
CDC Split Type: WAES0812USA04103
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diagnostic procedure, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: Information has been received from an 86 year old female with blood pressure and a history of shingles in April 2006, who on 07-DEC-2007 was vaccinated with a single dose of series ZOSTAVAX (Oka/Merck) (dose, route and lot # not reported). Concomitant therapy included DIOVAN. On 16-DEC-2008 the patient went to see a neurologist and she thought the test she had was a molecular gram, and from that test she was diagnosed with neuropathy in her legs and feet. The patient was not recovered form the neuropathy in her legs and feet. No further information provided. Additional information is not expected.

VAERS ID:351671 (history)  Vaccinated:2007-12-07
Age:69.0  Onset:2007-12-10, Days after vaccination: 3
Gender:Female  Submitted:2009-06-24, Days after onset: 561
Location:Maine  Entered:2009-07-13, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Xanax(unspecified) ; Estrogens(unspecified) ; Minerals (unspecified) ; Vitamins (unspecified)
Current Illness: Hypertension ; Arthritis; Drug hypersensitivity; Contrast media allergy; Allergic reaction to antibiotics
Preexisting Conditions: Gastric bypass
Diagnostic Lab Data: Biopsy - cellulitis
CDC Split Type: WAES0904USA04215
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.    
Administered by: Private     Purchased by: Other
Symptoms: Biopsy, Cellulitis, Erythema, Inflammation, Oral herpes, Oral pain
SMQs:, Anaphylactic reaction (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 69 year old female patient with hypertension, arthritis, drug hypersensitivity to "NASOTEC", Prednisone, Piperacillin/ Tazobactam and a history of gastric bypass who in December 2007, was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included Alprazolam, Estrogens, vitamins and minerals. In January 2009, the patient experienced a herpes lesion (cold sore) on her lip which had then expanded to the inside of her mouth. The patient said if felt like a "blister that won''t open and is inflamed". The patient had been using hot compresses and had a biopsy by her plastic surgeon. She went to the ER as a result of complication of the biopsy. The patient had sought medical attention and was not recovered at the time of reporting. Follow up information has been received from a medical assistant concerning the 69 year old retired female patient with drug hypersensitivity to mylogram dye, enalapril maleate (MSD), Prednisone and Piperacillin / Tazobactam (ZOSYN) who on 07-Dec-2007 at 14:36 was vaccinated with ZOSTAVAX (Merck) subcutaneous injection into the left upper arm(lot# 68396/ 0967U). On 10-Dec-2007, the patient experienced redness and pain-increased pain with movement and cellulitis. She had sought medical attention and subsequently recovered. Follow up information has been received from a nurse that the 69 year old female patient had cellulitis at the site where the lesion was biopsied. The patient had pain with movement of her mouth at the time. The patient subsequently experienced allergy while on therapy with Enalapril maleate (MSD, WAES#0905USA02813) Additional information has been requested.

VAERS ID:383075 (history)  Vaccinated:2007-12-07
Age:70.0  Onset:0000-00-00
Gender:Female  Submitted:2010-03-18
Location:California  Entered:2010-03-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypersensitivity; reaction to monosodium glutamate; redness generalised
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES1003USA01617
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Condition aggravated, Eye swelling, Generalised erythema, Tinnitus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 71 year old female with allergies, nervousness to monosodium glutamate and subcutaneous redness all over who on 07-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included estrogen, PRILOSEC and ZYRTEC. A couple of months after therapy the patient had experienced a burning sensation from head to toe on the surface of the skin. It was more intense during the evening. She also stated that she was also experiencing ringing in her ear. She also had a slight redness on parts of her body and her eyes were very puffy in the morning. Consumer mentioned she had "subcutaneous redness all over" and noticed it more after getting vaccine. The patient was hospitalized. At the time of the report the patient had not recovered. Additional information has been requested.

VAERS ID:400224 (history)  Vaccinated:2007-12-07
Age:26.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-04
Location:Arkansas  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: colposcopy, 09/03/09, no dysplasia or malignancy found; biopsy, 09/03/09, no dysplasia or malignancy found; Pap test; abnormal test, positive for HPV 16; Pap test, atypical cells of undetermined significance; cervix HPV DNA assay, 08/11/09, high risk HPV 16
CDC Split Type: WAES0908USA04782
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy, Colonoscopy normal, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:
Write-up: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated intramuscularly with three 0.5 mL doses of GARDASIL. On an unspecified date, "recently", the patient had an abnormal Papanicolaou (PAP) test that was positive for HPV 16. The physician was questioning vaccine failure. The physician did not know how much time there was between the completion of the series and the abnormal PAP test. The patient sought unspecified medical attention. At the time of the report, the patient''s outcome was unknown. Follow up information indicated that the approximately 27 year old patient was vaccinated with a first dose of GARDASIL on 07-DEC-2007, a second dose on 07-FEB-2008 and a third dose on 18-JUN-2008. On an unknown date a "PAP test" revealed atypical cells of undetermined significance and could not exclude high grade squamous intraepithelial lesions (SIL). ON 11-AUG-2009 an HPV DNA test returned "high risk 16". On 03-SEP-2009 a colposcopy and a biopsy test revealed no dysplasia or malignancy. No further information is available.

VAERS ID:427080 (history)  Vaccinated:2007-12-07
Age:68.0  Onset:2011-06-24, Days after vaccination: 1295
Gender:Female  Submitted:2011-07-11, Days after onset: 17
Location:New Jersey  Entered:2011-07-11
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: N/A
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IMAR
Administered by: Unknown     Purchased by: Private
Symptoms: Back pain, Burning sensation, Bursitis, Herpes zoster, Joint injection, Rash pustular
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: I had a cortisone injection in left hip for bursitis and was prescribed Prednisone for 6 days by Dr. After taking the Prednisone I developed lower back pain (LT SIDE) and then developed burning of the left upper thigh. The burning persisted and on 7/7/11 at 4 PM, 8 pustules appeared on my upper left thigh. Since I was scheduled to leave out of town and it was Friday, I called the Dermatologist immediately and was seen that day at 11:30 AM. Dr. diagnosed it as Shingles and I was prescribed Valacyclovir 1 gm tablets 3x/day for 10 days.

VAERS ID:450648 (history)  Vaccinated:2007-12-07
Age:7.0  Onset:2007-12-07, Days after vaccination: 0
Gender:Male  Submitted:2011-07-28, Days after onset: 1328
Location:Texas  Entered:2012-02-23, Days after submission: 210
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Seasonal allergy; Hives
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0013472
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a verbatim narrative as reported on the internet, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Dec 07, 2007. Male patient, child 7 years of age, was vaccinated with FLUMIST on Dec 07, 2007. "Had Intranasal Flu vaccine at around 2:00 p.m. and went back to school, after receiving 2 tsp. Ibuprofen syrup. Mother brought him back about 4 p.m. saying he got off the bus itching and with hives on neck, chest, abdomen, back, no difficulty breathing. We gave him ZYRTEC 7.5 ml and kept him about 40 minutes. He developed no further symptoms but remained with hives. Sent him home with BENADRYL chewable tablets to take at bedtime for hives. Called mother this morning, she said he was fine, hives were gone by time they got home yesterday." "Ibuprofen syrup 2 tsp., ZYRTEC 7.5 ml." "Seasonal allergies, history of hives". Patient recovered."

VAERS ID:463514 (history)  Vaccinated:2007-12-07
Age:78.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-08
Location:Unknown  Entered:2012-08-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA001063
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (Lot#, dose number, dose and route were unspecified) on 07-DEC-2007. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date the patient showed up at the physicians office with shingles even though the patient received the vaccine in 2007. The patient had a rash around her waist area and no pain issues. The patient had sought medical attention via visiting physician office. No treatment was given for the AE. The outcome was reported as not recovered/not resolved. Additional information is not expected.

VAERS ID:471359 (history)  Vaccinated:2007-12-07
Age:  Onset:2007-12-07, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-17, Days after onset: 1775
Location:Unknown  Entered:2012-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210USA007377
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age, unknown gender. The patient was vaccinated intramuscularly with first and second doses of GARDASIL (lot number not reported) on 17-JAN-2007 and 07-DEC-2007 respectively. No other co-suspects were reported. No concomitant medications were reported. The patient would be administered the third dose in the vaccination schedule on 15-OCT-2012. No adverse effect reported. Additional information has been requested.

VAERS ID:300919 (history)  Vaccinated:2007-12-07
Age:0.2  Onset:2007-12-16, Days after vaccination: 9
Gender:Female  Submitted:2007-12-21, Days after onset: 5
Location:Foreign  Entered:2007-12-26, 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: sulfamethoxazole/trimethoprim
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: hemoglobin 16Dec07 7.6 gms/dl 9.9-15.6; blood Plasmodium malariae observation 16Dec07 negative; respiratory rate measurement 16Dec07 58 breaths/minute
CDC Split Type: WAES0712USC00059
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia, Blood test normal, Diarrhoea, Diet refusal, Eyes sunken, Fluid intake reduced, Fontanelle depressed, Gastroenteritis, Haemoglobin decreased, Malaria antibody test, Mucous membrane disorder, Respiratory rate decreased, Skin turgor decreased, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)
Write-up: Information has been received from an investigator concerning an 11-week-old female with no prior medical history, who entered a study. On 25-OCT-2007 and 07-DEC-2007, the patient was vaccinated with the first and second doses of blinded therapy. Concomitant therapy included Cotrimoxazole (sulfamethoxazole trimethoprim). On 16-DEC-2007, nine days after the second dose of therapy, the patient presented to the hospital with a three day history of diarrhea and vomiting. The diarrhea was watery, but not bloody, and happened four times in 24 hours. The vomiting was post prandial and occurred three times in 24 hours. On examination, the patient was sick looking and unable to drink, had a sunken anterior fontanel, sunken eyeballs, dry mucous membranes and reduced skin turgor. On admission, the respiratory rate was 58 breaths/minute and auscultation did not reveal anything. A malaria blood film was negative and hemoglobin level was 7.6gm/dl. The patient was diagnosed with acute gastroenteritis and intravenous fluids were started. At the time of this report the event of gastroenteritis was ongoing. The reporting investigator considered the event of gastroenteritis to be of severe intensity and possibly related to study therapy. Additional information has been requested regarding any additional laboratory tests, anemia, gastroenteritis stop date, final outcome and the hospital discharge date.

VAERS ID:302810 (history)  Vaccinated:2007-12-07
Age:2.0  Onset:2008-01-07, Days after vaccination: 31
Gender:Male  Submitted:2008-01-14, Days after onset: 7
Location:Foreign  Entered:2008-01-16, 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: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None provided
CDC Split Type: CZWYEH02061008
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haemolysis
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad)
Write-up: This case was considered medically important. Information regarding Prevenar was received from a pediatrician regarding a 2-year-old male patient who received a dose on 07-Dec-2007 and experienced a hemolytic reaction. Relevant medical history was not provided. Concomitant medications were not reported. On 07-Dec-2007, the patient received a dose of Prevenar. On 07-Jan-2008, the patient experienced a hemolytic reaction. It was unknown if the patient recovered from the event. According to the reporting physician, the event was "possibly related" to Prevenar. No additional information was available at the time of this report.

VAERS ID:303323 (history)  Vaccinated:2007-12-07
Age:16.0  Onset:2007-12-09, Days after vaccination: 2
Gender:Female  Submitted:2008-01-15, Days after onset: 37
Location:Foreign  Entered:2008-01-23, 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: Unknown
Current Illness:
Preexisting Conditions: Infectious mononucleosis; Hepatic function abnormal; Rhinitis allergic
Diagnostic Lab Data: serum C-reactive protein 24Dec07 0.18; serum alanine aminotransferase 24Dec07 432; serum alanine aminotransferase 24Dec07 262; serum aspartate aminotransferase 24Dec07 176; serum aspartate aminotransferase 24Dec07 131; serum direct bilirubi
CDC Split Type: WAES0801USA01865
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.82200IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood bilirubin increased, C-reactive protein normal, Chromaturia, Jaundice, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with a history of infectious mononucleosis with hepatic function alteration (May 2007, total recovery by the end of June 2007) and allergic rhinitis who on 07-DEC-2007 was vaccinated IM with a first dose of Gardasil (batch # reported as 8220). On 09-DEC-2007, the patient started to complain about pruritis which the physician initially thought was related to the suspension of antihistaminic treatment of the patient''s allergic rhinitis. Seven to ten days later, on approximately 16-DEC-2007 the patient experienced epigastralgia and dark urine. On 24-DEC-2007, the patient was addressed in the emergency department due to persistent pruritis, abnormal urine and the appearance of sclerotic jaundice. Laboratory tests showed a serum aspartate aminotransferase test (AST) of 176, a serum alanine aminotransferase test of 432, a total serum bilirubin test of 2.63, a direct serum bilirubin test of 2.06, and a serum c-reactive protein test of 0.18. Repeat tests were performed on 30-DEC-2007 in another hospital and the results were a serum aspartate aminotransferase test of 131, a serum alanine aminotransferase test of 262, a serum c-reactive protein test of 0.06, a direct serum bilirubin test of 2.06, and a total serum bilirubin test of 1.21. It was also reported that the patient received hepatitis A and hepatitis B vaccines (date was not specified). There was no suspicion of toxic abuse. The physician decided not to administer a second dose of the human papillomavirus vaccine. It was reported that further laboratory tests were expected. At the time of this report, the symptoms were residual and the patient was recovering. Pruritis, dark urine, epigastralgia, abnormal hepatic function, and sclerotic jaundice were considered to be other important medical events. Other business partner numbers include: E200800139 and RA0022008. No further information is available.

VAERS ID:305151 (history)  Vaccinated:2007-12-07
Age:21.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Male  Submitted:2008-02-19, Days after onset: 73
Location:Foreign  Entered:2008-02-19
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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase Dec2007 540unit; Alanine aminotransferase 04Jan2008 206unit; Aspartate aminotransferse Dec2007 777unit; Aspartate aminotransferase 12Feb2008 129unit; Bilirubin total Dec2007 5.6unit; Bilirubin total 04Jan2008 35unit
CDC Split Type: B0507674A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNRL
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood bilirubin increased, Blood bilirubin unconjugated increased, Cholestasis, Dehydration, Hepatitis A, Hepatitis A antibody, Jaundice, Pyrexia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of jaundice in a 21-year-old male subject who was vaccinated with Havrix adult, GlaxoSmithKline for prophylaxis. Since November 2007, at the subject''s work place, 25 hepatitis A positive workers were diagnosed, leading to a vaccination campaign. On 7 December 2007, the subject received 1st dose of Havrix adult (parenteral, unknown injection site), lot number not provided. On 8 December 2007, 1 day after vaccination with Havrix adult, the subject experienced jaundice with pain in abdomen, epigastre and right hypochondrium, severe dehydration, vomiting and fever. Laboratory tests revealed hepatopathy with elevated ALT (540 unit) and AST (777 unit), total bilirubin 5.6 unit, direct bilirubin 2.8 unit and indirect bilirubin 2.8 unit. On 27 December 2007, the subject was hospitalised for 72 hours. A viral hepatitis A was diagnosed. On 4 January 2008, the subject experienced liver cholestasis with hepatitis A IgM value more than 0.5 unit. The subject was hospitalised several times while he was sick and from 16 January 2008 until 12 February 2008. At the time of reporting, the subject was asymptomatic. However, laboratory test showed AST 129 unit, ALT 306 unit, total bilirubin 8.7 unit, direct bilirubin 7.9 unit and indirect bilirubin 0.7 unit. On 12 February 2008, the events were resolved.

VAERS ID:320383 (history)  Vaccinated:2007-12-07
Age:54.0  Onset:2007-12-08, Days after vaccination: 1
Gender:Female  Submitted:2008-07-24, Days after onset: 228
Location:Foreign  Entered:2008-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Glomerulonephritis
Diagnostic Lab Data: UNK
CDC Split Type: B0527365A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVBB088CD1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Oedema peripheral, Pain in extremity, Vaccine positive rechallenge
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of swelling of fingers in a 54-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). The subject''s medical history included glomerulonephritis and allergy to penicillin. The subject was non smoker and drank alcohol occasionally. On unspecified dates, the subject received 1st dose and 2nd dose of ENGERIX B adult (intramuscular, site of administration unknown). At an unspecified time after 1st vaccination and after 2nd vaccination with ENGERIX B adult, the subject experienced swelling of fingers. At the time of reporting, the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B adult. Follow-up information received on 07 July 2008: Lot numbers of both suspect ENGERIX vaccines were provided. On 7 December 2007, the subject received 1st dose of ENGERIX B adult (intramuscular, unknown injection site). On 8 December 2007, 1 day after 1st vaccination with ENGERIX B adult, the subject experienced swelling and pain of the hands on both sides, especially of the knuckles on both hands and also on both feet. However the swelling improved, the pain persisted for about half a year. On 7 January 2008, the subject the subject received 2nd dose of ENGERIX B adult (intramuscular, unknown injection site). At an unspecified time after 2nd dose of ENGERIX B adult, the events recurred. Altogether the subject received the ENGERIX B adult vaccination twice and in each case, she showed the same symptoms, meaning swelling and pain. For further treatment the subject sought out an ambulance for rheumatism which was unsuccessfully according to her own accounts. Moreover she used lymph drainage and homeopathy. The vaccination was not given anymore and therefore the condition of the subject improved. The physician reported that it was unknown if the subject was hospitalized or if the event was severe or permanently disabling. The duration of the event was also unknown. The physician reported that causality was unknown and that she was unable to judge causality. Follow-up received on 14 July 2008 from Regulatory Authority: The case was assessed as serious by the Regulatory Authority (medically significant).

VAERS ID:322079 (history)  Vaccinated:2007-12-07
Age:0.2  Onset:2007-12-22, Days after vaccination: 15
Gender:Male  Submitted:2008-08-13, Days after onset: 234
Location:Foreign  Entered:2008-08-13
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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray 22DEC2007 showed air fluid levels and dilated bowel loops
CDC Split Type: B0532385A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Apnoea, Dehydration, Gastrointestinal necrosis, Haematochezia, Intussusception, Oral intake reduced, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of intussusception of intestine in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included combined DTAP, IPOL and HIB; manufacturer unspecified; intramuscular given on 17 December 2007; RECOMBIVAX HB; manufacturer unspecified; intramuscular given on 13 October 2007 and 17 December 2007; PREVNAR, unspecified; manufacturer unspecified; intramuscular given on 17 December 2007; tuberculosis vaccine; non-GSK manufacturer; intradermal given on 13 October 2007. On 7 December 2007 the subject received 1st dose of ROTARIX (oral). On 22 December 2007, 15 days after vaccination with ROTARIX, the subject was brought to the emergency room due to 2 days of evolution with abundant vomiting, intolerance to oral intake, non assess fever and bloody stools (like black currant jelly). The subject was admitted with severe dehydration. Relevant test included abdominal x-ray which showed air fluid levels and dilated loops. The same day the subject underwent a surgery in which ileocecal intussusception was confirmed. In the last portion of the ileo and before the cecal and first portion of colon 5 cm of necrosis was found. A resection was performed in the last portion of ileum, cecal and xyphoid, performed a terminal union without complication. On 01 January 2008 the subject presented apnea and he was intubated for a few hours. Two days after the subject presented a favorable evolution. On 05 January 2008 the subject was discharged. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On 6 January 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX. On 18 February 2008 the subject received the 2nd dose of ROTARIX. No adverse event has been reported.

VAERS ID:449665 (history)  Vaccinated:2007-12-07
Age:  Onset:2007-12-13, Days after vaccination: 6
Gender:Male  Submitted:2012-02-15, Days after onset: 1525
Location:Foreign  Entered:2012-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Stool culture, 17Dec2007, negative
CDC Split Type: B0781154A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test negative, Culture stool negative, Rectal fissure, Rectal haemorrhage, Viral test negative
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)
Write-up: This case was reported by the foreign regulatory authority (# MA20070923) and described the occurrence of rectorrhagia in a 2.5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical conditions and concurrent medications, if any, were unspecified. On 07 December 2007, the subject received a 1st dose of ROTARIX (batch unknown, oral). From 13 to 30 December 2007, the subject had 5 episodes of rectorrhagia. A stool culture made 10 days after vaccination was negative for vaccinal virus or bacteria. A pediatrician evidenced a small fissure. This case was assessed as medically serious by GSK. At the time of reporting, the event was resolved. The agency, based on the foreign method of assessment, assessed the role of ROTARIX in the occurrence of event as dubious.

VAERS ID:300630 (history)  Vaccinated:2007-12-08
Age:3.0  Onset:2007-12-08, Days after vaccination: 0
Gender:Female  Submitted:2007-12-20, Days after onset: 12
Location:Foreign  Entered:2007-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0700116A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLL089AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Nausea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of nausea in a three and a half year-old female subject who was vaccinated with influenza vaccine trivalent (Fluviral, GlaxoSmithKline) for prophylaxis. On 8 December 2007 the subject received 1st dose of Fluviral (unknown, left deltoid). On 8 December 2007, approximately 90 minutes after vaccination with Fluviral, the subject experienced nausea, vomiting, loss of appetite and rash palm of hands. The subject may have had faint rash on her legs, however the subject''s mother was not able to say if there was a rash or not. The subject did not have a fever. She continued to vomit and was taken to the hospital at 1930. The subject was advised not to have food or liquid. At approximately midnight, the subject''s vomiting resolved. On 09 December 2007, the subject was able to drink small amounts. On 10 December 2007, the rash resolved. At the time of this report, on 13 December 2007, the subject''s full appetite had not returned. The subject was hospitalised. At the time of reporting the events were improved.

VAERS ID:330087 (history)  Vaccinated:2007-12-08
Age:0.3  Onset:2008-01-10, Days after vaccination: 33
Gender:Male  Submitted:2008-10-24, Days after onset: 287
Location:Foreign  Entered:2008-10-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions: unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810AUS00107
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Bradycardia, Inappropriate schedule of drug administration
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Medication errors (narrow)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail form and a Case Line Listing concerning a 13 week male who on 08-DEC-2007 was vaccinated with ROTATEQ. Other suspect therapy included COMVAX, PNEUMOVAX 23, and DTAP-IPV. On 10-JAN-2008 33 days after vaccination with ROTATEQ, COMVAX, PNEUMOVAX 23, and DTAP-IPV, the patient developed apnoea and associated bradycardia. The apnoea and bradycardia resolved with stimulation. At the time of reporting to the agency on 26-FEB-2008, the patient had recovered from the apnoea and bradycardia. The agency considered that apnoea and bradycardia were possibly related to therapy with ROTATEQ, COMVAX, PNEUMOVAX 23 and DTAP-IPV. It was also reported that the patient was readmitted with apnoea after the third dose of ROTATEQ was administered on 08-APR-2008. The original reporting source was not provided. Additional information is not expected.

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