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Case Details (Sorted by Vaccination Date)

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VAERS ID:281423 (history)  Vaccinated:2007-06-08
Age:50.0  Onset:2007-06-09, Days after vaccination: 1
Gender:Female  Submitted:2007-06-12, Days after onset: 3
Location:Wisconsin  Entered:2007-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2731AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Chills, Erythema, Injection site inflammation, Injection site pain, Injection site warmth, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tdap given 6/8/07. 6/9/07a.m. arm sore at injection site. 6/9/07 p.m. soreness turned to burning and moved distal to injection site down to elbow. Upper arm red, hot, burning, swollen from below inj. site to elbow. Chills 6/9/07 night. 6/10/07 arm same, no chills. 6/11/07 and 6/12/07 less soreness, less redness, less swelling each day but arm symptoms still present. Did not wish to take any Tylenol or Advil or generic of same. 6/12/07 Returned for assessment where vaccination had been given. Assessed by Registered Nurse. She knows she can, for comfort, use ice or heat 15 minute maximum length, and not placed directly on skin. She will see her personal physician if symptoms do not continue to improve or if concerned.

VAERS ID:282903 (history)  Vaccinated:2007-06-08
Age:63.0  Onset:2007-06-09, Days after vaccination: 1
Gender:Female  Submitted:2007-06-26, Days after onset: 17
Location:Connecticut  Entered:2007-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient
Other Medications: Flonase, Optivar
Current Illness: none
Preexisting Conditions: bilat breast cancer 1989 (intraductal)
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.G740U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site reaction, Oral herpes, Rash, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Oropharyngeal infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 1 day after vaccination with Zostavax the patient developed an intense local reaction at the injection site. 10 days post-vaccination the patient developed cold sores (herpes labialis) which she has had before. 14 days post-vaccination the patient developed a typical zoster rash on the L chest starting at about T12 and radiating anteriorly to the mid-axillary line.

VAERS ID:282905 (history)  Vaccinated:2007-06-08
Age:18.0  Onset:2007-06-09, Days after vaccination: 1
Gender:Female  Submitted:2007-06-22, Days after onset: 13
Location:Maryland  Entered:2007-06-27, 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: Singulair, Allegra
Current Illness:
Preexisting Conditions: History included "Cequor", Vocal cord dysfunction, and ADD.
Diagnostic Lab Data:
CDC Split Type: 200702215
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2234AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Headache, Insomnia, Musculoskeletal stiffness, Photophobia
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad)
Write-up: A case was received from a health professional on 15 June 2007. An 18-year-old female patient with a medical history of "cequor", vocal cord dysfunction, and ADD (attention deficit disorder) had received an intramuscular left deltoid injection of Adacel (lot number C2644AA) and an intramuscular right deltoid injection of Menactra (lot number U2234AA) on 08 June 2007. Beginning one day after vaccination, on 09 June 2007, she developed a stiff neck, photophobia, severe headache, loss of appetite, and difficulty sleeping. She presented to an emergent care facility where diagnostic testing, including CT scan and hematology, were within normal limits. She was treated with intravenous steroids and Valium. Concomitant medications included Singulair and Allegra. The events remained ongoing.

VAERS ID:295271 (history)  Vaccinated:2007-06-08
Age:66.0  Onset:2007-07-09, Days after vaccination: 31
Gender:Female  Submitted:2007-09-24, Days after onset: 77
Location:New York  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA01999
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Excoriation, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Accidents and injuries (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician assistant concerning a 66 year old female who on 08 JUN 2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). On 09 JUL 2007, the patient came into the doctor''s office because she experienced a three by three centimeter rash on her mid-back. The rash was excoriated from scratching. There was no signs of vesicles. The patient experienced itching but no pain. The rash started off as spots. The patient was treated with antihistamine and the reporter has not heard back from the patient. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:305130 (history)  Vaccinated:2007-06-08
Age:17.0  Onset:2007-06-08, Days after vaccination: 0
Gender:Female  Submitted:2008-02-19, Days after onset: 256
Location:Texas  Entered:2008-02-19
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.02634 IDRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: CHILD FELL AND FAINTED AFTER VACCINE ADMINISTRATION.

VAERS ID:328243 (history)  Vaccinated:2007-06-08
Age:81.0  Onset:2008-08-01, Days after vaccination: 420
Gender:Male  Submitted:2008-09-24, Days after onset: 54
Location:Pennsylvania  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cholesterol high
Preexisting Conditions: Varicella
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA03677
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Blood testosterone decreased, Herpes zoster, Hypothyroidism, Immediate post-injection reaction, Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypothyroidism (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pharmacist concerning an 82 year old male who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient experienced shingles at an unspecified time after receiving ZOSTAVAX (Oka/Merck). The patient sought medical attention and was seen by the physician. Additional information is not expected. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Initial and follow-up information has been received from a pharmacist concerning an 82 year old male with high cholesterol and history of varicella as a child, who on 08-JUN-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # reported as 020900-invalid) 0.5 mL into his right arm. Concomitant medication included LIPITOR, aspirin and omega-3 marine triglycerides. On 01-AUG-2008, the patient experienced shingles after receiving ZOSTAVAX (Oka/Merck). The patient developed a rash and multiple lesions on his right axilla and chest. Distribution of herpes zoster lesions were found in T3 right dermatome. There was no pain in the lesions. Immediately post vaccination the patient was found to be hypothyroid with low testerone. He was good on prior testing. Patient was found to have hypothyroidism and low testosterone post zoster. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. The patient sought medical attention and was seen by the physician. Additional information is not expected.

VAERS ID:281950 (history)  Vaccinated:2007-06-09
Age:51.0  Onset:2007-06-12, Days after vaccination: 3
Gender:Female  Submitted:2007-06-15, Days after onset: 3
Location:Nevada  Entered:2007-06-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Private
Symptoms: Dizziness, Haemorrhage, Injected limb mobility decreased, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: Four days after receiving vaccine, developed such extreme pain at vaccination sight that I could hardly use that arm and very painful to try to work. Still extremely painful today and doesn''t seem to be getting better -maybe worse. I also (thought) I had completed menopause, but three days after receiving vaccine started bleeding extremely heavily - to the point where I was often light-headed. It finally seems to be letting up today. Might be coincidental and not related to the vaccine - or maybe not....

VAERS ID:282178 (history)  Vaccinated:2007-06-09
Age:4.0  Onset:2007-06-10, Days after vaccination: 1
Gender:Male  Submitted:2007-06-18, Days after onset: 8
Location:Illinois  Entered:2007-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2490AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ03243IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0861F1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1493F1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Within 24 hours of receiving DTaP and IPV in left arm, the left deltoid became very swollen warm to touch and a rash appeared in the injection site area.Child was taken to Medical Center on Sunday where he was given prescription for Qdryl qid, Cephalexin qid and Tylenol prn. Child was seen at Health Center on Monday for follow-up, where the doctor diagnosed it a reaction to DTaP and ordered DT for future diphtheria tetanus injections.

VAERS ID:282288 (history)  Vaccinated:2007-06-09
Age:24.0  Onset:2007-06-18, Days after vaccination: 9
Gender:Male  Submitted:2007-06-19, Days after onset: 1
Location:Maryland  Entered:2007-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: benydryl 25 mgm 1 Qid prn, Motrin 800 mgm 1 q6h prn
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1056IDLA
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40200720OTRA
Administered by: Military     Purchased by: Military
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Paraesthesia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: finger tingling, swelling, pain, swollen lymph nodes with pain

VAERS ID:282675 (history)  Vaccinated:2007-06-09
Age:5.0  Onset:2007-06-10, Days after vaccination: 1
Gender:Female  Submitted:2007-06-18, Days after onset: 8
Location:Florida  Entered:2007-06-22, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.02460IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0454U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Vaccine given 6/9/07 - 6/11/07 had localized redness, (cellulitis) on left thigh Ice, Ataset, Keflex.

VAERS ID:282695 (history)  Vaccinated:2007-06-09
Age:21.0  Onset:2007-06-21, Days after vaccination: 12
Gender:Male  Submitted:2007-06-22, Days after onset: 1
Location:Maryland  Entered:2007-06-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: 1 Vertic at time of doctors appointment, bed rest x 1 day
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV 1051IMLA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)PFIZER/WYETHZ11020IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red spots about 1/4 inch in size, on rright rib cage and stomach. Low grade fever x 3 days,

VAERS ID:282768 (history)  Vaccinated:2007-06-09
Age:15.0  Onset:2007-06-11, Days after vaccination: 2
Gender:Female  Submitted:2007-06-15, Days after onset: 4
Location:California  Entered:2007-06-25, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0210U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2227AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0600U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Swollen right arm, asthma attack on 6-13-07.

VAERS ID:286301 (history)  Vaccinated:2007-06-09
Age:57.0  Onset:2007-06-11, Days after vaccination: 2
Gender:Female  Submitted:2007-07-27, Days after onset: 46
Location:New Mexico  Entered:2007-07-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin, see #18
Current Illness: Minor infection on finger from cat bite - was taking Augmentin
Preexisting Conditions: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 3 LA
Administered by: Other     Purchased by: Other
Symptoms: Muscle atrophy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Severe deep aching pain in muscle of upper left arm developed within the first couple of days after the injection and has continued to the present (currently about 7 weeks duration). Some muscle wasting in upper left arm also noted by doctor.

VAERS ID:286139 (history)  Vaccinated:2007-06-09
Age:4.0  Onset:2007-06-11, Days after vaccination: 2
Gender:Female  Submitted:2007-07-27, Days after onset: 46
Location:Foreign  Entered:2007-07-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0480434A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cold compress therapy, Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 4 year old female subject who was vaccinated with Infanrix for prophylaxis. On 9 June 2007 the subject received unspecified dose of Infanrix (.5 ml, unknown, lot number not provided). On 11 June 2007, 2 days after vaccination with Infanrix, the subject developed an injection site inflammation. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with Corticoid, antibiotics, and cool compress. At the time of reporting the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. No further information is available, this case has therefore been closed.

VAERS ID:289389 (history)  Vaccinated:2007-06-09
Age:16.0  Onset:2007-06-11, Days after vaccination: 2
Gender:Female  Submitted:2007-08-30, Days after onset: 80
Location:Foreign  Entered:2007-08-30
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: C-reactive protein increased; Platelet count No influence; Rapid streptococcal test Negative; Serum creatinine No influence; Urine analysis Negative
CDC Split Type: B0484601A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood creatinine normal, C-reactive protein increased, Chills, Henoch-Schonlein purpura, Petechiae, Platelet count, Pyrexia, Streptococcus identification test, Urine analysis normal, Vasculitis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of vasculitis in a 16-year-old female subject who was vaccinated with Twinrix adult, GlaxoSmithKline for prophylaxis. The girl has no other medication but discontinued a treatment regimen with Roaccutan (isotretinoin) 3-4 months prior to vaccination. On 9 June 2007 the subject received 1st dose of Twinrix adult (1 iu, intramuscular, unknown, lot number not provided). On 11 June 2007, 2 days after vaccination with Twinrix adult, the subject experienced abdominal pain, she also had some fever and shivers. C-reactive protein was slightly increased. Leukocytes test showed a partial concentration. The subject developed also petechial like purpura on feet, lower part of the leg and in palm. Lab tests showed no influence on blood status including platelet or serum creatinine. The strep-A test was negative. Blood was found in urine caused by menstruation. The following urine test was negative. The patient was referred to the emergency unit, where the diagnosis of Henoch-Schonlein purpura disease was confirmed. The subject was hospitalised. The second dose of Twinrix was not given as a connection between the vaccination and the Henoch-Schonlein purpura event was suspected. A trip abroad was also cancelled. At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with Twinrix adult.

VAERS ID:293938 (history)  Vaccinated:2007-06-10
Age:  Onset:2007-06-10, Days after vaccination: 0
Gender:Male  Submitted:2007-09-24, Days after onset: 106
Location:New Hampshire  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisone, mL
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02103
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect dose administered, Injection site rash, Injection site scab
SMQs:, Hypersensitivity (narrow), Medication errors (narrow)
Write-up: Information has been received from a physician concerning an "over 60 year old" male who "in the last couple of days" on approximately 10-JUN-2007 was vaccinated in his arm with a "0.5" dose of Zostavax (Oka/Merck). Concomitant therapy included prednisone 5 ml daily. Subsequently "in the last couple of days" on approximately 10-JUN-2007 the patient developed a large scabby rash approximately an inch in diameter at the injection site on his arm. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.

VAERS ID:515030 (history)  Vaccinated:2007-06-10
Age:25.0  Onset:2009-08-02, Days after vaccination: 784
Gender:Female  Submitted:2013-11-27, Days after onset: 1578
Location:Unknown  Entered:2013-11-27
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:
Diagnostic Lab Data: several labs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Aphagia, Arthralgia, Fatigue, Infertility female, Joint swelling, Laboratory test, Local swelling, Rash erythematous, Rheumatoid arthritis, Stomatitis, Trigeminal neuralgia
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (broad), Fertility disorders (narrow), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: red bumps covered joints, then hands became severely swollen, couldn''t open doors, tie shoes, write my name. after that my joints became sore and swollen and my mouth was covered in sores to the point where I could not eat. I was later diagnosed with rheumatoid arthritis and possibly lupus. I also suffered from chronic fatigue. in 2011 my husband and I started trying for our second child. we later found out I had unexplained secondary infertility and are still struggling and spending countless dollars trying to conceive. this past year I was diagnosed with trigeminal neuralgia. I was being treated for the rheumatism with several medications and injections however those meds are on hold while trying to conceive. I have also had to take several infertility medications, none of which have worked.

VAERS ID:281191 (history)  Vaccinated:2007-06-11
Age:3.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-11, Days after onset: 0
Location:Wisconsin  Entered:2007-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None at time of vaccine. Is not on Loratidine to treat the hives
Current Illness: none
Preexisting Conditions: History of allergy to Omnicef
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB162DB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Reaction to preservatives, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, starting 3.5 hours after administrating of Hepatitis A vaccine. No other explanation except vaccine allergic reaction.

VAERS ID:281429 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-06-12, Days after onset: 1
Location:California  Entered:2007-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no illness 6/11, 6/12 exam showed oral pharynix redness
Preexisting Conditions: none
Diagnostic Lab Data: none done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B092BA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF115AA1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845D1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0847F1PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying, Decreased appetite, Irritability, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: set of 4 month shots given at about 330p, baby started with 104ax fever about 530pm 6/11. mom gave tylenol, fever came down to 101ax. baby irritible and breastfeeding less than normal. no redness or induration at site of pneum/HIB injections, but cried whenever his left leg was touch or moved. slight redness oral pharynix that was not present at well visit 6/11/07

VAERS ID:281435 (history)  Vaccinated:2007-06-11
Age:16.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-12, Days after onset: 1
Location:California  Entered:2007-06-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sports Px
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0 RA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Within 10 minutes of injection, patient became light headed and passed out. Approximately 20 minutes after injection nausea and vomiting began. Sent to ER due to persistence of feeling ill.

VAERS ID:281436 (history)  Vaccinated:2007-06-11
Age:31.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-12, Days after onset: 1
Location:Oregon  Entered:2007-06-12
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
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Flushing, Lip swelling, Malaise, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: About 50 min after vaccine patient complained of flushing and itching on face-one hive. She was advised to take Benadryl 50 mg by mouth. She left for lunch then with husband. Patient returned at 1:20 pm-had taken Benadryl but complained of lips swelling, feeling worse. Dr. ordered Epinephrine 0.1mL and Dauadion 4 mg IM. Patient felt well enough to go home after 45 minutes.

VAERS ID:281558 (history)  Vaccinated:2007-06-11
Age:9.0  Onset:2007-06-13, Days after vaccination: 2
Gender:Male  Submitted:2007-06-13, Days after onset: 0
Location:Virginia  Entered:2007-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0593U1SCRA
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: Redness/swelling locally at injection site

VAERS ID:281561 (history)  Vaccinated:2007-06-11
Age:18.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-13, Days after onset: 1
Location:Pennsylvania  Entered:2007-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline 100 mg 1po qd
Current Illness: none
Preexisting Conditions: NKDA, acne
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2276BA0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0173U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient had a localized swelling and erythema at injection site. Also two varicella-form pustules distal to site

VAERS ID:281577 (history)  Vaccinated:2007-06-11
Age:4.0  Onset:2007-06-13, Days after vaccination: 2
Gender:Female  Submitted:2007-06-11, Days after onset: 2
Location:Georgia  Entered:2007-06-13, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSU1857BA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ00013IMLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0345U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: PT COMES IN TODAY ON 6-13-07 C/O SMALL REACTION NOTED FROM SHOTS RT UPPER ARM RED AND WARM TO TOUCH DOESN''T HURT

VAERS ID:281587 (history)  Vaccinated:2007-06-11
Age:12.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-13, Days after onset: 1
Location:California  Entered:2007-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR 0IMLA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site warmth, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm hot to touch cant tell if red. Patient is dark/fever/ a little sore.

VAERS ID:281583 (history)  Vaccinated:2007-06-11
Age:11.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-13, Days after onset: 1
Location:Ohio  Entered:2007-06-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0388U2 LA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2610AA0 RA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rt arm sore and swollen, + 2 edema in office, fever (101.3), Tx with Tylenol, rest and increase fluids.

VAERS ID:281680 (history)  Vaccinated:2007-06-11
Age:4.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-13, Days after onset: 1
Location:Texas  Entered:2007-06-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2156CA4 LA
HEPA: HEP A (VAQTA)MERCK & CO. INC.1282F1 RA
HIBV: HIB (ACTHIB)SANOFI PASTEURUE973AA3 LA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ054823 RA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Pain, Pruritus, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: redness, swelling, itching, pain

VAERS ID:281692 (history)  Vaccinated:2007-06-11
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2007-06-14
Location:Illinois  Entered:2007-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0451U1SC 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Expanding injection-site erythema ~10x10 cm, warmth, tenderness.

VAERS ID:281694 (history)  Vaccinated:2007-06-11
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2007-06-14
Location:Illinois  Entered:2007-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0451U1SC 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Expanding injection-site erythema 10x10cm, warmth, and tenderness.

VAERS ID:281695 (history)  Vaccinated:2007-06-11
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2007-06-14
Location:Illinois  Entered:2007-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0451U1SC 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Expanding injection-site erythema ~10x10cm, warmth, and tenderness.

VAERS ID:281713 (history)  Vaccinated:2007-06-11
Age:32.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-14, Days after onset: 2
Location:Missouri  Entered:2007-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lotrel 10/20mg daily and Nexium 20mg daily
Current Illness: None
Preexisting Conditions: Hypertension and Reflux. Patient had no known drug allergies.
Diagnostic Lab Data: None at present.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF057AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Feeling cold, Feeling hot, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: EVENT: Patient called the office on 06/14/2007, stating that starting on the afternoon of 06/12/2007, she felt like the inside of her body would get really hot and then it would cool off and then she gets nauseated. She states that this happens intermittantly and only last for about 10 minutes. She also noticed that the injection site was red and puffy and was warm to the touch. TREATMENT: Instructed patient to take Tylenol and Benadryl OTC as directed. If her symptoms continued or became worse - or if she developed any fever or neurological symptoms, i.e. confusion, dizzyness, to return to the clinic or go to the ER immediately.

VAERS ID:281742 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-14, Days after onset: 3
Location:North Carolina  Entered:2007-06-14
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:
Preexisting Conditions:
Diagnostic Lab Data: LABS: CSF, urine & blood c/s were neg. Echocardiogram WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2059BA0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0066U0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ042120SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5884K0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Blood culture negative, CSF culture negative, Cardiac murmur, Cough, Crying, Culture urine negative, Cyanosis, Decreased appetite, Echocardiogram normal, Listless, Nasal congestion, Pallor, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Previously well child. Rec''d 2 mo immunizations (including Dtap) on 6/11/07. Approx 4 hours later child had poor feeding, then episode of cyanosis, limpness. Admitted to hospital. Never any fever. Neg septic work up. 7/17/07 Received hospital medical records which reveal patient experienced crying, pallor, cyanosis & not eating well after awakening from nap on 6/11/07 after receiving vax same date. Seen in ER w/fever, runny nose, nasal congestion, cough. Admitted 6/12-6/13/07 & tx w/IV antibiotics. Cardio consult done for murmur. Continued to be febrile in hospital but all c/s neg. D/C to home FINAL DX: fever & cyanotic spell.

VAERS ID:281745 (history)  Vaccinated:2007-06-11
Age:65.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Unknown  Submitted:2007-06-14, Days after onset: 3
Location:Pennsylvania  Entered:2007-06-14
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: Hypertension, Hypercholestrolemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU1933AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Cold compress therapy, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received DT injection in Rt arm 6/11/07. That night at 6:30 IM injection site became sore and as the night went on noticed swelling. Pt called office 06/12/07. Pt was instructed to apply cool compresses and take Tylenol for pain. Pt called 06/13/07 and stated swelling increasing. Recom. Pt come in. Arm was checked 6/14/07

VAERS ID:281747 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-15, Days after onset: 3
Location:Guam  Entered:2007-06-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Proventil
Current Illness: Congestion - recovering
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2156BA0IMRL
HEP: HEP B (FOREIGN)MERCK & CO. INC.1245F1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUE955AB0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ05470 RA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08679D0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site rash, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mother noticed little bumps on/around injection sites. child had fever day after injections.

VAERS ID:281916 (history)  Vaccinated:2007-06-11
Age:11.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-11, Days after onset: 0
Location:Pennsylvania  Entered:2007-06-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2144AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Fall, Head injury, Hyperhidrosis, Immediate post-injection reaction, Muscle rigidity, Rash, Tremor, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Approx 1400 administered Tdap and Menactra vaccine. Pt looked out of room and immediately fell to floor and hit head on floor. Eyes were open, extremities rigid, Sl shaking, unresponsive for approx 15-20 sec. rash developed on upper chest and arms, perspiring. BP 90/48. Rash disappeared after 15 min and then came back and disappeared. Sent home with mother in stable condition.

VAERS ID:281926 (history)  Vaccinated:2007-06-11
Age:15.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-12, Days after onset: 1
Location:Ohio  Entered:2007-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: PCN allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU1967AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Passed out

VAERS ID:281952 (history)  Vaccinated:2007-06-11
Age:5.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2007-06-15, Days after onset: 3
Location:New York  Entered:2007-06-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1|NONE~ ()~NULL~~In Sibling2
Other Medications: Miralax, daily vitamin
Current Illness: none
Preexisting Conditions: AMOXIL ALLERGY
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01083IMRA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0231U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Right arm with 5cmX5cm and Left arm with 5cmX6cm areas that are red, painful, firm, warm. No fever or other symptoms. Immunization given on 6/11/07 reaction started 6/12/07 and got progessivly worse. Seen in office 6/14/07. RX cool compresses, Benadryl, Keflex 250/5 1 1/2 tsp BID X 10 days

VAERS ID:283566 (history)  Vaccinated:2007-06-11
Age:14.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-06-24, Days after onset: 13
Location:New York  Entered:2007-07-02, 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: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR    
Administered by: Private     Purchased by: Unknown
Symptoms: Pruritus, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Two hours after having a MCV vaccine my son got rash all over his body (very small dots) and very itchy.

VAERS ID:283629 (history)  Vaccinated:2007-06-11
Age:65.0  Onset:2007-06-17, Days after vaccination: 6
Gender:Male  Submitted:2007-07-02, Days after onset: 15
Location:Texas  Entered:2007-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: MRI, Brain Scan, Blood work
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0329U0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Balance disorder, Blood test, Nausea, Nuclear magnetic resonance imaging, Scan brain, Sudden hearing loss, Tinnitus, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (narrow)
Write-up: Pt experienced sudden hearing loss in right ear. The right ear also has constant ringing. He experienced nausea and vertigo. His balance is off. He has been hospitalized and has seen an eye/ear/nose Dr with no conclusive results. 1/11/2010 Had a Baha device in right ear for hearing lost. 6 days after receiving vaccination had problems with ear still has ringing in ear.

VAERS ID:283672 (history)  Vaccinated:2007-06-11
Age:26.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-03, Days after onset: 22
Location:North Carolina  Entered:2007-07-03
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: allergic to sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.000000IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Discomfort, Dizziness, Injection site irritation, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Intense pain and burning sensation at injection site that occurred 3 hours after vaccination was given. Pain and burning made me dizzy and nauseated. The discomfort lasted about 30 minutes and the injection site remained sore for 4 days.

VAERS ID:283856 (history)  Vaccinated:2007-06-11
Age:13.0  Onset:2007-07-02, Days after vaccination: 21
Gender:Female  Submitted:2007-07-02, Days after onset: 0
Location:Maine  Entered:2007-07-05, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0246U0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2327AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0362U1SCLA
Administered by: Private     Purchased by: Other
Symptoms: Pyrexia, Rash papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: papules on back noted on 07/02/07 low grade fever.

VAERS ID:283884 (history)  Vaccinated:2007-06-11
Age:20.0  Onset:2007-06-16, Days after vaccination: 5
Gender:Female  Submitted:2007-06-20, Days after onset: 4
Location:California  Entered:2007-07-05, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURZ09430UNLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt came 6/18/07 for 2nd dose of Rabies vaccination. When questioned about current health status or adverse reactions from 1st dose, pt. stated that she developed a "shooting" and "tingling" pain down left arm the Saturday after being vaccinated. Pt. discussed pain as being painful to light touch. We contacted the CDC and vaccine manufacturer re reaction and decided to withhold the 2nd dose until symptoms had fully resolved and reevaluated

VAERS ID:283890 (history)  Vaccinated:2007-06-11
Age:45.0  Onset:2007-06-23, Days after vaccination: 12
Gender:Female  Submitted:2007-06-26, Days after onset: 3
Location:Tennessee  Entered:2007-07-05, 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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1409F1SCRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness and warm to touch with quarter size knot 2 weeks past injection at injection site. Was given PO antibiotics and steroids.

VAERS ID:283922 (history)  Vaccinated:2007-06-11
Age:13.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Washington  Entered:2007-07-05
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: 0
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B009AA0IM 
Administered by: Private     Purchased by: Public
Symptoms: Aphonia
SMQs:
Write-up: Loss of voice

VAERS ID:283999 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-06-11, Days after onset: 0
Location:Texas  Entered:2007-07-06, Days after submission: 25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B110AB0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF090AB0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08692C0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0238U0PO 
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Vomiting and watery diarrhea shortly after receiving shots. Instructed to increase fluids, monitor for signs of dehydration, F/U in clinic or ER if worsens.

VAERS ID:284331 (history)  Vaccinated:2007-06-11
Age:65.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-07-02, Days after onset: 20
Location:Washington  Entered:2007-07-11, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vytorin, Attenald, Cosopt
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0329U SC 
Administered by: Public     Purchased by: Other
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: Redness, soreness and swelling at site of injection. Also some itching. Later that day and next some slight headache and dizziness. Symptoms lasted 5-6 days

VAERS ID:284386 (history)  Vaccinated:2007-06-11
Age:38.0  Onset:2007-06-14, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:Wisconsin  Entered:2007-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU1703BA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Reddish, raised softball size area. Warm to touch.

VAERS ID:284410 (history)  Vaccinated:2007-06-11
Age:1.0  Onset:2007-06-22, Days after vaccination: 11
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2007-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin and then another antibiotics for ear infection prior to having MMR
Current Illness:
Preexisting Conditions: NKDA; PMH "none"
Diagnostic Lab Data: No lab work done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0346U0 LL
Administered by: Public     Purchased by: Public
Symptoms: Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt developed maculopapular rash

VAERS ID:284422 (history)  Vaccinated:2007-06-11
Age:12.0  Onset:0000-00-00
Gender:Male  Submitted:2007-07-12
Location:Michigan  Entered:2007-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: not applicable
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU18576A5IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Dtap given instead of Tdap for childs age.

VAERS ID:284993 (history)  Vaccinated:2007-06-11
Age:2.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-18, Days after onset: 37
Location:Michigan  Entered:2007-07-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB148AA1IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pharyngeal oedema, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hep A injection received at approx. 1pm. At approx. 7pm childs shirt removed and rash noticed covering trunk, front and back. On one side of face and one arm also. Child given Beandryl by mom per Dr. recommendation over phone and taken to ER. Mom states childs throat appeared swollen. Arrived to St. ER approx. 9pm, give Prednisone x3days. Mom states rash gone next day. Was told by ER doctor reaction was probably due to the Hep A vaccination.

VAERS ID:285097 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-07-16, Days after onset: 35
Location:New York  Entered:2007-07-18, 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: Unknown
Current Illness: Hiccups
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA01844
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1114F PO 
Administered by: Other     Purchased by: Other
Symptoms: Hiccups, Infantile spitting up
SMQs:, Neonatal disorders (narrow)
Write-up: Information has been received from a physician concerning a 10-week-old male with no other pertinent medical history on 11-JUN-2007 was vaccinated PO with a dose of Rotateq (Lot #655406/1114F) (patient was noted to have hiccups at the time of vaccination). On 11-JUN-2007, while being administered Rotateq, the patient spit it up and regurgitated some saliva. Unspecified medical attention was sought. No laboratory/diagnostic tests were performed. The patient recovered in 2-3 minutes. Additional information has been requested.

VAERS ID:285101 (history)  Vaccinated:2007-06-11
Age:  Onset:2007-06-11, Days after vaccination: 0
Gender:Unknown  Submitted:2007-07-16, Days after onset: 35
Location:Texas  Entered:2007-07-18, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA01986
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0236U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (narrow)
Write-up: Information has been received from a registered nurse (RN) concerning a patient who on 11-JUN-2007 was vaccinated with a dose of Rotateq (Lot # 656390/0236U). The RN reported that, after receiving the dose of Rotateq, the patient vomited. The dose was re-administered (Lot # 656193/0023U). No additional symptoms were reported. At the time of this report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:285126 (history)  Vaccinated:2007-06-11
Age:  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-07-16, Days after onset: 35
Location:Unknown  Entered:2007-07-18, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04687
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse effect
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a physician concerning a male who on 26-FEB-2007 was vaccinated with the first dose of Rotateq. On approximately 11-JUN-2007 (16 weeks after the first dose of Rotateq)) the patient was vaccinated with the second dose. No problems reported. Additional information has been requested.

VAERS ID:285377 (history)  Vaccinated:2007-06-11
Age:16.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:California  Entered:2007-07-18, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA01928
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a 16 year old female with no medical history or allergies, who on 11-JUN-2007 was vaccinated with a 0.5mL first dose of Gardasil. There was no concomitant medication. After receiving the vaccination the patient passed out for about five minutes and when she "came to", she began to vomit. The patient did go to the emergency room. At the time of the report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.

VAERS ID:285384 (history)  Vaccinated:2007-06-11
Age:16.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:Unknown  Entered:2007-07-18, 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: Unknown
CDC Split Type: WAES0706USA02063
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a registered nurse, concerning a 16 year old female patient, who on 11-JUN-2007 was vaccinated with a dose of Gardasil (Lot # not provided). On 11-JUN-2007, following the vaccination, the patient turned pale white, and then fainted. At the time of this report, the patient was recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:285410 (history)  Vaccinated:2007-06-11
Age:17.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:Pennsylvania  Entered:2007-07-18, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02135
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Immediate post-injection reaction
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 17 year old female who on 11-JUN-2007 was vaccinated with Gardasil. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Additional information has been requested. Information has been received from a nurse concerning an 18 year old female with a history of migraines and exercise induced allergies/asthma who on 11-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # 657868/0523U) in the left arm IM. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Follow-up information was received. The patient''s age, medical history and concurrent conditions were updated. The headache lasted for 3 to 5 minutes in duration. On 11-JUN-2007 the patient had recovered. Additional information is not expected.

VAERS ID:285654 (history)  Vaccinated:2007-06-11
Age:23.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:Tennessee  Entered:2007-07-18, 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: Loestrin 24 FE
Current Illness: Drug hypersensivity
Preexisting Conditions:
Diagnostic Lab Data: body temp 100-101F
CDC Split Type: WAES0706USA03494
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0523U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Body temperature increased, Lip blister, Musculoskeletal stiffness, Pyrexia, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a office assistant concerning a 23 year old female with drug hypersensitivity to aspirin who on 11-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot # 657868/0523U). Concomitant therapy included ethinyl estradiol (+) ferrous fumarate (+) Norethindrone acetate (LOESTRIN 24 FE). On 11-JUN-2007 in the evening, the patient experienced fever 100-101F, stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips. Unspecified medical attention was sought. The patient''s fever 100-101F and stiff limbs, joint aches and pains, and swollen, sore, blistery, and peeling lips persisted. There were no laboratory or diagnostic tests performed. Additional information has been requested.

VAERS ID:285678 (history)  Vaccinated:2007-06-11
Age:11.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:Virginia  Entered:2007-07-18, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04025
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician concerning a female who was vaccinated IM with a second dose of GARDASIL. Shortly after being vaccinated the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a physician concerning a 11 year old female with rhinitis and cough at the time of the vaccination who on 11-JUN-2007 was vaccinated with IM with a second dose of GARDASIL (lot # 655205/1426F). Concomitant therapy on 11-JUN-2007 included, IM first dose of MENACTRA (lot #C2559AA) and subcutaneously a seconde dose of VARIVAX (MED) (lot # "04434"). On 1-JUN-2007 the patient fainted wna collapsed in the hallway while going from the exam room to the waiting room. The patient was taken back to the exam room, evaluated, rested and did fine. On 11-JUN-2007, the patient recovered. Additional information is not expected.

VAERS ID:285810 (history)  Vaccinated:2007-06-11
Age:13.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-07-16, Days after onset: 34
Location:Kentucky  Entered:2007-07-18, 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: Slight fever
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04102
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning an 13 year old female who on 11-JUN-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection in the right arm and received concomitant suspect therapy which included Vaqta, injection in the left arm. Concomitant therapy included Menactra on the left arm. The physician reported that patient had a low grade fever on 10-JUN-2007 before receiving Gardasil. On 12-JUN-2007 the patient experienced vomiting. Medical attention was sought. The patient was given a medication to control the vomiting. On an unspecified date the patient had recovered. At the time no further adverse event information is available. Additional information has been requested.

VAERS ID:285826 (history)  Vaccinated:2007-06-11
Age:17.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-16, Days after onset: 35
Location:Pennsylvania  Entered:2007-07-18, 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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04434
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Pain, Tenderness
SMQs:
Write-up: Information has been received from a physician concerning a 17 year old female who on approximately 11-JUN-2007 (2 weeks ago), was vaccinated with a dose of Gardasil (lot number unknown). The physician reported that the patient developed pain to arm, tenderness and inflammation (3 cm) since being vaccinated with Gardasil. The outcome of the events were not reported. Additional information has been requested.

VAERS ID:285190 (history)  Vaccinated:2007-06-11
Age:11.0  Onset:2007-07-07, Days after vaccination: 26
Gender:Male  Submitted:2007-07-10, Days after onset: 3
Location:Tennessee  Entered:2007-07-19, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cold
Preexisting Conditions: none
Diagnostic Lab Data: Positive strep test 7-6-2007
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2323AA0UNAR
TDAP: TDAP (ADACEL)SANOFI PASTEURC2690AA0UNAR
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0606U UNAR
Administered by: Private     Purchased by: Unknown
Symptoms: Rash, Streptococcus identification test positive, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash described as chickenpox by MD after examination on 7-7-07. No fever. Diagnosis confirmed on 7-9-07, after examination by MD. On 7-10-07, approximately 167 skin lesions; still developing and spreading.

VAERS ID:285196 (history)  Vaccinated:2007-06-11
Age:1.3  Onset:2007-06-20, Days after vaccination: 9
Gender:Female  Submitted:2007-06-28, Days after onset: 8
Location:California  Entered:2007-07-19, 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: Amoxicillin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0294U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Otitis media, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received ProQuad 3/1/07 and it was given again at 6/11/07 visit. On 6/25/07 patient developed a fever, rash and otitis media. There was concern, the rash may have been due to the duplicate vaccines.

VAERS ID:285245 (history)  Vaccinated:2007-06-11
Age:1.2  Onset:2007-06-14, Days after vaccination: 3
Gender:Male  Submitted:2007-06-28, Days after onset: 14
Location:Missouri  Entered:2007-07-19, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0679F1 LA
Administered by: Private     Purchased by: Private
Symptoms: Injection site bruising, Injection site mass
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: On 6-25-07, patient returned to office for additional vaccines. Mother informed us of a knot with bruising at site. Doctor examined the area. Advised mom to watch it and put some ice on it, call in 2 - 3 days if not better.

VAERS ID:285299 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-07-20, Days after onset: 39
Location:D.C.  Entered:2007-07-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Eucerin cream, hydrocortisone cream
Current Illness: no
Preexisting Conditions: atopic dermatitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B114CA0UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.1125F0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHBO8692H0UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0407U0UNUN
Administered by: Military     Purchased by: Military
Symptoms: Cyanosis, Pallor, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received Pediarix, Hib, Prevnar, and Rotavirus vaccines at approximately 1300 on 6/11/07. Mother reports that patient developed hives at approximately 1600. He became very pale with blue lips. He was taken to the Emergency room and evaluated. He was sent home without medical intervention after observation.

VAERS ID:285975 (history)  Vaccinated:2007-06-11
Age:4.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-06-13, Days after onset: 1
Location:California  Entered:2007-07-25, Days after submission: 42
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: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2289BA4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ05483UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0498F1UNRL
Administered by: Private     Purchased by: Other
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Large cellulitis left thigh extending up into femoral area. Hot tender erythemic

VAERS ID:286332 (history)  Vaccinated:2007-06-11
Age:2.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-06-11, Days after onset: 0
Location:Texas  Entered:2007-07-31, Days after submission: 50
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: (+)Blood culture, Rocephin given
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0017U1IMLL
Administered by: Private     Purchased by: Other
Symptoms: Blood culture positive, Body temperature increased, Fear, Foaming at mouth, Oxygen supplementation, Staring
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt had temp earlier in day-mom not sure how much-presented to clinic fine-v.s. WNL. When vaccine administered-pt. had staring spell, foaming at mouth, extreme fearfulness. O2 given, Tylenol supp and 911 called

VAERS ID:287825 (history)  Vaccinated:2007-06-11
Age:17.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Female  Submitted:2007-08-10, Days after onset: 59
Location:South Dakota  Entered:2007-08-10
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Candidiasis, Diet refusal, Dizziness, Feeling hot, Oral soft tissue disorder, Pharyngeal oedema, Pharyngolaryngeal pain, Pyrexia, Skin warm, Speech disorder, Stomatitis, Swollen tongue, Weight decreased
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On the day of the vaccination later that evening, she noticed she was dizzy and she felt warm like she had a fever. On June 12th, she woke up, went to brush her teeth and found 4-5 white sore spots/lesions on the inside of her lower lip. She went to a doctor appointment right away that day. Throughout the day and over the next few days the spots got worse and spread to the all over the inside of her mouth, tongue and on the outside of her lips. She said this lasted for 1 week. She went to the doctor that day on June 12th. Doctor diagnosed her with stomatitis and thrush. She said her tongue and throat were very sore and swollen. She could barely talk and could not eat for 1 week. She said that she lost 11lbs in that week. Her doctor gave her Valtrex and that cleared up the sore spots/lesions. She was also given a ''cocktail'' to rinse her mouth.

VAERS ID:288310 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 64
Location:Unknown  Entered:2007-08-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA00567
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0624U0PO 
Administered by: Private     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This is in follow-up to report (s) submitted on 8/14/2007. Information has been received from a physician concerning a 2 month old female with pertinent medical history and drug reactions/allergies reported as non who on 11-JUN-2007 was vaccinated with ROTATEQ a first dose (lot #656835/0624U), oral. Concomitant medication was reported as none. In approximately June 2007, several weeks post vaccination, the patient experienced stools that were looser than normal. No other symptoms were noted. The patient sought unspecified medical attention. The outcome and causality of the event were not reported. No product quality complaint was involved. Additional information has been requested.

VAERS ID:288894 (history)  Vaccinated:2007-06-11
Age:16.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-08-14, Days after onset: 64
Location:Colorado  Entered:2007-08-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0707USA01650
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0181U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Hypokinesia
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This is in follow-up to report(s) previously submitted on 8/14/2007. Additional and follow up information has been received from a medical assistant concerning a 15 year old female who on 11-JUN-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot#656371/0181U). On 11-JUN-2007, post vaccination while still in the physician''s office the patient experienced "numbing of her entire arm and she couldn''t move it". The medical assistant reported that after the patient waited approximately 15 minutes in the office she was fine". Follow-up information received stated that the patient found the injection site very painful. The patient was considered to have recovered from the event. Additional information has been requested.

VAERS ID:288522 (history)  Vaccinated:2007-06-11
Age:30.0  Onset:2007-08-15, Days after vaccination: 65
Gender:Male  Submitted:2007-08-21, Days after onset: 6
Location:Unknown  Entered:2007-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN0SCUN
Administered by: Unknown     Purchased by: Military
Symptoms: Herpes zoster
SMQs:
Write-up: The patient received his first Anthrax immunization on June 11, 2007 and developed herpes zoster to chest and back areas. Preventative medicine consulted and agrees with assessment

VAERS ID:289223 (history)  Vaccinated:2007-06-11
Age:5.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2007-06-15, Days after onset: 3
Location:Hawaii  Entered:2007-08-28, Days after submission: 74
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051BA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURY06383SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1323F1SCLL
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURERC2551AA2IDLA
Administered by: Military     Purchased by: Military
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Large localized redness, swelling and inflammation extending to entire upper arm and to scapular region of back.

VAERS ID:289308 (history)  Vaccinated:2007-06-11
Age:0.5  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-06-12, Days after onset: 1
Location:Kansas  Entered:2007-08-29, Days after submission: 78
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type: KS2007010
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B084BA1IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF072AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08649F1IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0600F1PO 
Administered by: Public     Purchased by: Public
Symptoms: Crying, Decreased appetite, Eye swelling, Lacrimation increased, Ocular hyperaemia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Depression (excl suicide and self injury) (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 6/11/07 Beginning at 8:00-9:00pm, child had watery eyes, crying (parent says she was able to comfort child) and decreased appetite. 6/12/07 Child went to babysitters. Babysitter tells mom he vomited twice during the day. Mom says child had red, puffy eyes when she picked him up at 4:00. Child was somewhat better at 4:30 pm with puffy eyes and a decreased appetite. Tylenol was given for comfort and according to mother on 6/12/07 5:00pm appetite increased and feeling ok.

VAERS ID:289761 (history)  Vaccinated:2007-06-11
Age:49.0  Onset:2007-06-15, Days after vaccination: 4
Gender:Female  Submitted:2007-07-06, Days after onset: 21
Location:Oklahoma  Entered:2007-09-04, Days after submission: 60
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Allergy shot Q month and Albuterol inhr PRN
Current Illness: NONE
Preexisting Conditions: States has only seasonal allergies and denies personal and family H/O heart problems.
Diagnostic Lab Data: States doctor did blood work, all came back WNL. No diagnosis made. Came to Health Department on 07-06-07 to report abnormal symptoms to PHN
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB412AA0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB114AN0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0094F0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2631AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure increased, Blood test normal, Headache, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad)
Write-up: States 4 days after immunization, started to develop severe H/A''s and "pressure in the head" Starting around 07-04-07, began having heart palpitations in the evenings. Went to PCP, who was unable to diagnosis client. Also states B/P increasing to an average of 140/80''s; usual B/P 120/60''s. Denies any h/o anxiety disorder

VAERS ID:295988 (history)  Vaccinated:2007-06-11
Age:66.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-09-24, Days after onset: 105
Location:Texas  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA00416
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an "about 66 year old" female who "a few weeks ago" on approximately 11-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On the same day as the vaccination the patient developed a rash about 2 inches around the injection site. Unspecified medical attention was sought. There were no lab studies performed. Subsequently the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.

VAERS ID:295993 (history)  Vaccinated:2007-06-11
Age:80.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-09-24, Days after onset: 105
Location:Washington  Entered:2007-09-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, eleva, "FED rate"
CDC Split Type: WAES0707USA00600
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pustule, Injection site reaction, Laboratory test abnormal, Rash pustular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse concerning an "around 80-year-old female" who on approximately 11-JUN-2007 was vaccinated with an injection of Zostavax (Oka/Merck). "Immediately after getting the vaccination, the patient presented with a little shingles case around the injection area (pustules)". Also the patients "FED blood rate was elevated". It is unspecified if medical attention was sought. It is reported that the patients condition is improving. No product quality complaint was involved. Additional information has been requested.

VAERS ID:296503 (history)  Vaccinated:2007-06-11
Age:1.1  Onset:2007-06-20, Days after vaccination: 9
Gender:Male  Submitted:2007-10-06, Days after onset: 108
Location:Unknown  Entered:2007-10-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA04700
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0487U0SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 13 month old male who on 11-JUN-2007 was vaccinated subcutaneously with the "first dose" of PROQUAD (lot # 657555/0487U). Concomitant therapy included HAVRIX and PREVNAR. On 20-JUN-2007 the patient experienced nickel size hive by injection site. The patient sought unspecified medical attention. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:301826 (history)  Vaccinated:2007-06-11
Age:60.0  Onset:2007-07-22, Days after vaccination: 41
Gender:Male  Submitted:2007-12-21, Days after onset: 152
Location:New York  Entered:2007-12-28, 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: Therapy unspecified
Current Illness: Blood pressure high, cholesterol high
Preexisting Conditions: Kidney stone
Diagnostic Lab Data: Fasting blood glucose - 08/22/07 - 125 mg/dl (value) - 70-99 (normal range) Serum Vitamin B (12) - 08/22/07 - 957.7 pg/ml (value) - 211.0 (normal range)
CDC Split Type: WAES0709USA01267
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0618U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose increased, Erythema, Feeling of body temperature change, Hypertension, Oedema peripheral, Paraesthesia, Rash, Vitamin B12 abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial information has been received from a consumer concerning her 60 year old husband with hypertension and high cholesterol and a history of kidney stone (1990) who on 11-Jun-2007 was vaccinated with Zostavax. Concomitant therapy included blood pressure and cholesterol medicines (therapy unspecified). The patient''s wife reported that the 14 or 15 Jun 2007 the patient was vaccinated into the left arm with Zostavax. It was also reported that the patient developed a rash on his body, particularly on his upper legs and on one arm, approximately 4-6 weeks post vaccination. He had tingling in his fingers and his legs felt like they were going to sleep. His feet were also swelling up and turned red. The wife also reported that the physician did not think the patient had shingles from the look of the rash. Follow up information was received from a physician who reported that on approximately 22-Jul-2007 the patient developed "hot, cold, numb, swelling sensation in feet and hands". It was noted that on 11-Jun-2007 the patient was vaccinated into the left arm with Zostavax. There were no adverse events reported with previous vaccinations. The patient had no illness at the time of vaccination. There was no product quality complaint. Diagnostic lab studies, performed 22 Aug 2007, were essentially unremarkable, with the exception of Vit B12 957.7 pg/ml (211.0-946.0), fasting glucose 125 mg/dl (70-99). At the time of reporting the patient was not yet recovered. The physician noted it was not clear if it is secondary to vaccination. Additional information is not expected.

VAERS ID:301894 (history)  Vaccinated:2007-06-11
Age:57.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 193
Location:New York  Entered:2007-12-28, 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: AMBIEN; therapy unspecified
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA02511
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Eye pain, Herpes zoster, Inappropriate schedule of drug administration, Stomatitis
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 57-year-old female with no pertinent medical history or allergies who on 11-JUN-2007 was vaccinated intramuscularly with (1 vial once) dose of Zostavax. Concomitant therapy included "FIORCET" and AMBIEN. On 06-AUG-2007 the patient developed "shingles like" symptoms after vaccination. The patient presented with sores in her mouth and pain on her right eye brow. She saw a nurse practitioner and then an ophthalmologist. The ophthalmologist prescribed VALTREX for the symptoms. No diagnostic labs were performed. At the time of the report the patient''s status was not recovered. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:302205 (history)  Vaccinated:2007-06-11
Age:70.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-12-21, Days after onset: 193
Location:Florida  Entered:2007-12-28, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: allergy test - A test
CDC Split Type: WAES0710USA03964
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test, Postnasal drip, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a consumer concerning her 70 year old husband with no pertinent medical history who on 11-JUN-2007 was vaccinated SC with one 0.65 ml dose of ZOSTAVAX (no lot number available). There was no concomitant medication. On approximately 11-JUN-2007 "shortly after vaccination," the patient experienced sneezing and post nasal drip. Unspecified medical attention was sought. An "A test for allergies" was performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.

VAERS ID:301931 (history)  Vaccinated:2007-06-11
Age:25.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2008-01-07, Days after onset: 210
Location:Unknown  Entered:2008-01-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 6/18/2007), endometriosis
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 08/09/07, within normal limits; ultrasound, 10/22/07, within normal limits
CDC Split Type: WAES0708USA01059
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0522U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Stillbirth, Ultrasound scan normal
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 from a nurse through a Merck pregnancy registry concerning a 25 year old caucasian female with endometriosis who on 26-Mar-2007 was vaccinated IM in the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #655503/0012U). Concomitant therapy included folic acid and unspecified prenatal vitamins. On 11-Jun-2007 the patient was vaccinated IM in the left deltoid with a second dose (lot #657737/0522U). The patient now is pregnant. The patient''s LMP was 18-Jun-2007. Her estimated delivery date is 25-Mar-2008. The patient will be in the office on 07-Aug-2007. Follow-up information received indicates that the patient had ultrasound testing on 09-Aug-2007 and 22-Oct-2007, results of both were reported to be within normal limits. Follow up information received on 02-Jan-2008, indicated that on 28-Dec-2007, the patient had a fetal death/stillbirth, weeks from LMP 27. Autopsy being done. No other information available. Upon internal review fetal death/stillbirth considered to be an other important medical event.

VAERS ID:302026 (history)  Vaccinated:2007-06-11
Age:70.0  Onset:0000-00-00
Gender:Unknown  Submitted:0000-00-00
Location:California  Entered:2008-01-09
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0290U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (narrow)
Write-up: Zostavax vaccine was given IM instead of SQ. Pt did not report any adverse effects.

VAERS ID:315033 (history)  Vaccinated:2007-06-11
Age:8.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2008-05-16, Days after onset: 339
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02534
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0334U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning an 8 year old male who on 11-JUN-2007 was vaccinated with a second dose of 0.5 mL varicella virus vaccine live (Oka/Merck) (lot # 656999/0334U). On 12-JUN-2007, the patient developed swelling and redness, approximately 14 X 18.5 centimeters at the injection site. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.

VAERS ID:315096 (history)  Vaccinated:2007-06-11
Age:  Onset:2007-06-18, Days after vaccination: 7
Gender:Female  Submitted:2008-05-16, Days after onset: 333
Location:Unknown  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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA03962
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Headache, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a pharmacy student concerning a female patient who on 11-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 18-JUN-2007, the patient experienced dizziness, rapid heart rate, weakness, shortness of breath, headache and diarrhea. It was reported that the symptoms resolved in 2 days with no medical treatment. Unspecified medical attention was sought. On 20-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:315120 (history)  Vaccinated:2007-06-11
Age:1.0  Onset:2007-06-21, Days after vaccination: 10
Gender:Male  Submitted:2008-05-16, Days after onset: 330
Location:California  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: WAES0706USA04308
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 12 month old male who on 11-JUN-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Ten days later, on approximately 21-JUN-2007, the patient developed a diffuse rash. No further information is available.

VAERS ID:327312 (history)  Vaccinated:2007-06-11
Age:24.0  Onset:2007-07-01, Days after vaccination: 20
Gender:Female  Submitted:2008-09-15, Days after onset: 442
Location:Massachusetts  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: computed axial, negative; spinal tap, negative; magnetic resonance, negative
CDC Split Type: WAES0808USA04819
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: CSF test normal, Computerised tomogram normal, Facial palsy, Hypoaesthesia, Lumbar puncture, Nuclear magnetic resonance imaging normal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)
Write-up: Information has been received from a clinical director/ registered nurse, concerning a 25 year old female patient, who on 11-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5mL IM, the second dose of GARDASIL (Lot #658094/0524U) on 13-AUG-2007 and the third dose of GARDASIL (Lot #659439/1267U) on 02-JAN-2008. The patient experienced facial paralysis and numbness and tingling of the hands and feet one and a half months (approximately in July 2007) after get the first dose of GARDASIL. The patient had been seen by the primary care physician and a neurologist for the symptoms. All laboratories and diagnostic studies came back negative (computed tomography scan, spinal tap and magnetic resonance imaging) for cause and GARDASIL is now the primary suspect. At the time of reporting the patient did not recovered. There was no product quality complaint. Additional information has been requested.

VAERS ID:327411 (history)  Vaccinated:2007-06-11
Age:31.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2008-09-30, Days after onset: 477
Location:Florida  Entered:2008-10-07, 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:
Current Illness: Burning
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV105 UNUN
Administered by: Military     Purchased by: Military
Symptoms: Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pain and prolonged induration at the injection site x 1 year.

VAERS ID:337412 (history)  Vaccinated:2007-06-11
Age:78.0  Onset:2008-08-25, Days after vaccination: 441
Gender:Female  Submitted:2008-12-23, Days after onset: 120
Location:Unknown  Entered:2008-12-29, 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: atenolol; PLAQUENIL; SYNTHROID; lovastatin; RECLAST
Current Illness: Hypothyroidism; Hypercholesterolaemia; Lupus erythematosus; Hypertension; Osteoporosis; Drug hypersensitivity
Preexisting Conditions: Chickenpox
Diagnostic Lab Data: body temp 98.6 -
CDC Split Type: WAES0809USA00772
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0461J SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Pain, Rash vesicular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a nurse practitioner concerning a 79 year old female with hypothyroidism, hypercholesterolaemia, lupus erythematosus, hypertension, osteoporosis and allergic to "EES" and lisinopril (Refer to WAES # 0809USA01786) and a history of chickenpox in childhood who on 11-JUN-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck), Lot # 657558/0461U, 0.65 mL, in her right deltoid, subcutaneously. Concomitant therapy included ATENOLOL, LOVASTATIN (manufacturer unknown), SYNTHROID, PLAQUENTL, and RECLAST. On 25-AUG-2008 the patient experienced shingles. It was reported that the patient had vesicular rash with more than 20 lesions in her right T4 - T5 dermatome under breast. The patient had severe pain and had a maxim of temperature of 98.6 degrees. It was reported that the patient was not exposed recently to chickenpox or herpes ZOSTER, there was no direct fluorescent antibody done and there was no specimen collected for PCR. The patient sought medical attention, contracted physician''s office. At the time of the report the patient recovered from shingles, but was still being treated with VICODIN and NEURONTIN. Additional information has been requested.

VAERS ID:282188 (history)  Vaccinated:2007-06-11
Age:17.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2007-06-18, Days after onset: 6
Location:Foreign  Entered:2007-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CONGENITAL INSUFFICIENCY OF AORTIC
Diagnostic Lab Data: UNK
CDC Split Type: D0053575A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dysstasia, Face oedema, Fatigue, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of tiredness in a 17-year-old male subject who was vaccinated with Twinrix adult, GlaxoSmithKline, MMR, Priorix for prophylaxis. Concurrent medical conditions included mild congenital insufficiency of aortic value. On 25 May 2007 the subject received 1st dose of Priorix (unknown route and application site) and on 11 June 2007 at 18:30 the subject received 1st dose of Twinrix adult (unknown route and application site). On 12 June 2007, 1 day after vaccination with Twinrix adult, 18 days after vaccination with Priorix, the subject experienced tiredness, feeling of powerlessness, face edema and weakness of the arm and the legs. The patient could hardly stand. There was no injection site reaction. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:284267 (history)  Vaccinated:2007-06-11
Age:28.0  Onset:2007-06-16, Days after vaccination: 5
Gender:Male  Submitted:2007-07-10, Days after onset: 24
Location:Foreign  Entered:2007-07-10
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: Alanine aminotransferase 16May2007 normal U/l, Alanine aminotransferase 16Jun2007 82U/L, Aspartate aminotransferase 16May2007 normal U/L, Aspartate aminotransferase 16Jun2007 195U/L
CDC Split Type: D0053813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of increased transaminases in a 28-year-old male subject who was vaccinated with Twinrix adult, GlaxoSmithKline. At the time of vaccination the subject was completely healthy. On 11 June 2007 the subject received an unspecified dose of Twinrix adult (1 ml, unknown). Approximately 16 days post vaccination with Twinrix adult, on 16 June 2007, the subject experienced increased transaminases with increased alanine aminotransferase (ALAT: 195 U/l) and increased aspartate aminotransferase (ASAT: 82 U/l). Prior to vaccination, on 16 May 2007, both transaminases had been within normal range. This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:285496 (history)  Vaccinated:2007-06-11
Age:78.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2007-07-20, Days after onset: 38
Location:Foreign  Entered:2007-07-23, 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: Hypertension
Diagnostic Lab Data: vascular ultrasound thrombosis could be ruled out 15Jun07, diagnostic microbiology test negative 15Jun07, WBC count 15Jun07 normal, serum C-reactive protein 15Jun07 103 mg/ml
CDC Split Type: WAES0707USA02627
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1094R1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Erythema, Inflammation, Joint effusion, Microbiology test, Secretion discharge, Swelling, Ultrasound Doppler, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 78 year old male with arterial hypertension who in 2001 was vaccinated with Pneumovax 23 (batch # HC52190) that was well tolerated. On 11-JUN-2007 the patient was vaccinated IM into the left upper arm with a second dose of Pneumovax 23 (lot # 653878/1094R, batch # ND35830). Within 24 hours post vaccination, the patient experienced localized inflammation with massive swelling and redness concerning the left upper arm. Despite cooling and administration of external nonsteroidal anti-inflammatory drugs, swelling extended and involved the left forearm too. On 15-JUN-2007 he went to see a surgeon. There was a difference of 4 cm between both forearms. Thrombosis could be ruled out by a color duplex ultrasound. Over the left elbow, an effusion with fluctuation and redness was also present and 2 ml of dark yellow serous liquid was punctured. The microbiological exam of the punctuate was negative. Among the lab tests, the serum C-reactive protein test was elevated 103 mg/ml, white blood cell count was within normal range. The patient recovered from all the symptoms of inflammation localized and effusion of the elbow after 10 days. Additional information is not expected. This case is closed. Other business partner numbers E2007-04549 and PEI2007006468.

VAERS ID:286263 (history)  Vaccinated:2007-06-11
Age:0.9  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-07-30, Days after onset: 49
Location:Foreign  Entered:2007-07-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Culture urine (LLT: Urine culture) 11-Jun-2007 Positive, Laboratory test (LLT: Laboratory test) 11-Jun-2007 No pathological manifestations.
CDC Split Type: SEWYE091126JUL07
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH242090UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Culture urine positive, Cyanosis, Dyspnoea, Febrile convulsion, Hypersomnia, Laboratory test normal, Lethargy, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was considered medically important. Information regarding Prevenar was received from a healthcare professional regarding a 11-month-old female patient who experienced lethargy, cyanosed, difficulty breathing and fever convulsions. The patient received a dose on 11-Jun-2007. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced lethargy, cyanosed, difficulty breathing and fever convulsions on 11-Jun-2007. After being immunized, the child got fever and was mainly sleeping, quite lethargic. At 15 hrs the fever had risen to 39 degrees celsius. at 17.30 hrs the child got fever convulsions, had difficulty to breath and was cyanotic. The child was taken by ambulance to hospital, where the fever had risen to 40.1 degrees celsius. The patient was given fever suppressants and was discharged the next day in good condition. The fever went down gradually, but the patient had fever (around 38-39 degrees celsius) still on the 15-Jun-2007. The patient recovered from the lethargy, cyanosis, difficulty of breathing and fever convulsions. Culture urine (results: Positive) and laboratory test (results: No pathological manifestations) were done on 11-Jun-2007. No additional information was available at the time of this report.

VAERS ID:287353 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-08-06, Days after onset: 56
Location:Foreign  Entered:2007-08-08, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First injection of Act-Hib on 11 April 2007: during one hour the patient was weepy. First injection of Infanrix on 11 May 2007.
Diagnostic Lab Data:
CDC Split Type: 200702638
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Cyanosis, Erythema, Pain, Skin discolouration
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from a health care professional on 27 July 2007 under the reference number: I-50-PRIVAT. A 4-months-old male patient, with no reported medical history received intramuscular injections of Hib Vaccine (Act-Hib), Infanrix (injection sites and batch numbers not reported) and an oral dose of Poliosabin (manufacturer and batch number not reported) on 11 June 2007. Two hours after vaccination, after sleeping, the child was awake and started to cry inconsolably. Inconsolable crying lasted two hours. At the administration site of Act-Hib vaccine, his skin was red (diameter up to 3 cm) and painful to touch. Parents said that his gluteal region turned blue (purple-blue). Outcome was unknown at the time of the report. He had received his intramuscular injection of Act-Hib on 11 April 2007. It was reported that the patient was weepy during 1 hour after this injection. He also had his first intramuscular dose of Infanrix on 11 May 2007.

VAERS ID:287761 (history)  Vaccinated:2007-06-11
Age:2.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-08-09, Days after onset: 59
Location:Foreign  Entered:2007-08-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp 12Jul07 39.6C, body temp 13Jul07 40.5 C, body temp 14Jul07 41.6 C, body temp 15Jul07 39.5 C, body temp 16Jul07 Comment: normal
CDC Split Type: WAES0708USA00122
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Crying, Delirium, Diet refusal, Erythema, Gait disturbance, Hypersomnia, Injection site inflammation, Injection site reaction, Listless, Moaning, Mood altered, Oedema peripheral, Oral intake reduced, Pain in extremity, Pyrexia, Rash, Skin discolouration, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional concerning a 24 month old male who on 11-JUN-2007 was vaccinated with a first dose of MMR (manufacturer unknown) in the forearm (route and site of administration not reported). Concomitant vaccination on the same day included PEDIACEL in the thigh, number 4 in the series (batch number, route and site of administration not reported). The patient received the vaccinations later than normal (compared to the national vaccination program). MMR was administered in the arm and PEDIACEL in his leg. After his afternoon sleep, he had some difficulty in walking, but no symptoms were visible. He cried a bit more than usual. The next morning, he seemed all right but at the day care center he was moody. He had more difficulty in walking and sometimes expressed that he had pain. In the evening he developed fever up to 39.6C, for which he received a paracetamol suppository of 240 mg. The next morning, his upper leg was warm and showed a red glow on the front side, and it was swollen. He received a paracetamol suppository. He slept a lot. In the afternoon, his whole upper leg was swollen, tense, and it was bluish red. The GP was visited. That night, his temperature rose to ca 40.5C, despite paracetamol suppositories. He was moaning. The next day his condition was worse, he was delirious and did not want to eat or drink. His temperature was maximally 41.6 degrees C, the leg was scarlet and glowing, not blue anymore. He slept the whole day. On the 4th day the GP was visited again. His temperature had lowered (39.5 degrees C) and he started playing again and walked a bit. The following day his condition improved and his temperature decreased to a normal level in 2 days, though he still was a bit listless. On the 6th day after vaccination, a red rash developed, consisting of fine spots, that remained until 10 days after vaccination. He did go to the day care center. He recovered. Fever, Inflammation injection site, difficulty walking, rash, oral intake reduced, sleep excessive,

VAERS ID:289552 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-08-30, Days after onset: 80
Location:Foreign  Entered:2007-08-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Heart rate (results: 180/min) was done on 11-Jun-2007. Heart rate (results: following pressure with spatula in the mouth the patient''s heart rate veered from 180/min to 120/min) was done on 12-Jun-2007. Electrocardiogram (results: resting E
CDC Split Type: DEWYE191120AUG07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC21FA295A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAC21FA295A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSAC21FA295A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC21FA295A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH25676 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Electrocardiogram abnormal, Heart rate increased, Pallor, Pyrexia, Tachycardia, Wolff-Parkinson-White syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was considered medically important for the event of pre-excitation syndrome. Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 4-month-old male patient who experienced fever of 38.5 C, tachycardia with heart rate of over 180/min and suspected pre-excitation syndrome and who was pale and agitated. The patient received a dose on 11-Jun-2007. In the evening after vaccination the patient experienced fever of 38.5 C and tachycardia with heart rate of over 180/min on 11-Jun-2007. The patient was seen by a paediatrician in a paediatric clinic and was pale and agitated. During patient''s examination his heart rate veered from 180/min to 120/min following pressure with spatula in his mouth. Whether the pateint was hospitalized or not was unknown. During the tacycard phase no ECG was done. A resting ECG was done on 12-Jun-2007 and showed that the PQ time was shortened with 0.07 and the patient was diagnosed with suspected pre-excitation syndrome (Wolff-Parkinson-White syndrome). The patient recovered except of possible pre-excitation syndrome. A medication treatment was planned to start

VAERS ID:290455 (history)  Vaccinated:2007-06-11
Age:2.0  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2007-09-12, Days after onset: 93
Location:Foreign  Entered:2007-09-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA01064
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Crying, Delirium, Diet refusal, Gait disturbance, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth, Listless, Moaning, Mood altered, Pain in extremity, Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information was received from a health care professional concerning a 2-year-old boy who on 11 JUN 2007 was vaccinated with a first dose, into the arm, with MMR II (manufacturer unknown) (lot number and route of administration not reported) and a fourth dose, into the thigh, of Pediacel (batch number and route of administration not reported). The boy received the vaccinations later than normal (compared to the national vaccination program). After his afternoon sleep, he had some difficulty in walking, but no symptoms were visible. He cried a bit more than usual. The next morning he seemed all right, but at the day care center he was moody. He had more difficulty in walking and sometimes expressed that he had pain in his leg. In the evening he developed a fever up to 39.6C for which he received a paracetamol suppository of 240 mg. The next morning, at his injection site leg, his upper leg was very warm and a red glow on the front side, and it was swollen. He received a paracetamol suppository. He slept a lot. In the afternoon his whole upper leg was swollen, tense and it was bluish red. The GP was visited. That night his temperature increased to 40.5 C, despite paracetamol suppositories. He was moaning. The next day his condition was worse, he was delirious and did not want to eat or drink. His temperature was maximally 41.6C, the leg was scarlet and glowing, but not blue anymore. He slept the whole day. On the 4th day the GP was visited again. His temperature had lowered to (39.50C) and he started playing again and walked a bit. The following day his condition improved and his temperature decreased to a normal level in 2 days, though he was still a bit listless. On the 6th day after vaccination, a red rash developed, consisting of fine spots that remained until 10 days after vaccination. He did go to the day care center. He recovered. The case is closed. Other business partner numbers included: E2007-04997, 200700552 The event of hyperpyrexia, injection site reaction, edema lower limb, medication error, and rash

VAERS ID:291296 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-06-11, Days after vaccination: 0
Gender:Female  Submitted:2007-09-21, Days after onset: 102
Location:Foreign  Entered:2007-09-25, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Lymphocyte count (results: lymphocytosis) was done in Jun-2007. Body temperature (results: 40 deg. C.) was done on 11-Jun-2007. Culture stool (results: enterovirus was isolated) was done in Jul-2007
CDC Split Type: NLWYE342520SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Culture stool positive, Enterovirus infection, Enterovirus serology test positive, Lymphocyte count increased, Lymphocytosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 3-month-old female patient who experienced fever and enteroviral infection. The patient received the first dose on 11-Jun-2007. The patient experienced fever on 11-Jun-2007 up to 40 deg. Celsius. The fever occurred intermittently for over a month. Despite the fever, the child for not look/feel ill. Initially no cause for the fever was identified. A blood test showed a lymphocytosis. 1 month after the vaccinations the child was hospitalised for further diagnostics. From the faeces a enterovirus was isolated and a enteroviral infection was diagnosed in Jul-2007. During the hospitalisation the child did not have a fever and after discharge the fever did not reoccur. The child has recovered. Lymphocyte count (results: lymphocytosis) was done in Jun-2007. Body temperature (results: 40 deg. C.) was done on 11-Jun-2007. Culture stool (results: enterovirus was isolated) was done in Jul-2007. No additional information was available at the time of this report.

VAERS ID:291831 (history)  Vaccinated:2007-06-11
Age:57.0  Onset:2007-06-13, Days after vaccination: 2
Gender:Female  Submitted:2007-10-01, Days after onset: 110
Location:Foreign  Entered:2007-10-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Vertebral Spine Syndrome
Preexisting Conditions:
Diagnostic Lab Data: Body temperature 12Jun2007 38.5deg C, Heart rate 13Jun2007 65/min, Electrocardiogram (13 June 2007): horizontal heart, sinusrhythm and fibrillation alternating; no sign of infarction; in subsequent electrocardiogram (date unspecified; durin
CDC Split Type: D0054680A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (FOREIGN)PASTEUR MERIEUX INST.Z08502 UNUN
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAAHABBB079DA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aneurysm, Arrhythmia, Atrial fibrillation, Body temperature increased, Echocardiogram abnormal, Electrocardiogram abnormal, Headache, Heart rate irregular, Infection, Nervousness, Oedema peripheral, Pain in extremity, Pruritus, Tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (vaccines, biologicals) #DE-PEI-PEI2007008970) and described the occurrence of intermittent atrial fibrillation in a 57-year-old female subject who was vaccinated with Twinrix, GlaxoSmithkline. Co-suspect vaccines included another manufacturer''s Revaxis. Concurrent medical conditions included vertebral spine syndrome. On 11 June 2007 the subject received a dose of Twinrix adult (left arm) together with a dose of Revaxis (right arm). A few hours after vaccination, on 11 June 2007, the subject developed pain in her right arm. In the evening of the following day, on 12 June 2007, the subject developed headache and a body temperature of 38.5 deg C. On 13 June 2007 her arm was swollen and itching. In the afternoon she was nervous and had an irregular pulse. On 13 June 2007 the subject was hospitalized. Overall diagnosis was intermittent atrial fibrillation and infection. At the time of hospitalization the subject had been in a good general condition. An electrocardiogram at the time of hospitalization revealed horizontal heart and alternating phases of sinusrhythms and fibrillations. No signs of myocardial infarction were found neither by laboratory examinations nor by electrocardiogram. In echocardiogram (date unspecified) a mildly dilated atrium and an aneurysm of aorta ascens of 4.1 cm were detected. The subject was treated with propafenone hydrochloride (Rytmonorm). In 24-hour-long-term electrocardiogram (date unspecified; during the following 5 days) stabile sinus rhythm was observed. No signs of disturbance of repolarization was found. After six days, on 18 June 2007, the subject was discharged from the hospital. At the time of reporting the fibrillation was resolved, but on unspecified dates nocturnal tachycardia recurred. The outcome of the other events was unresolved. According to the reporter, the patient''s cardiologist had considered the heart disorder to be related to the vaccination with Twinrix adult.

VAERS ID:302593 (history)  Vaccinated:2007-06-11
Age:0.2  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2008-01-11, Days after onset: 214
Location:Foreign  Entered:2008-01-14, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: D-Fluoretten (cholesterol/colecalciferol/sodium fluoride), 500 IU 1x per 1 day, unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Blood culture 00-Jun-2007 detection of pneumococci (serotype unknown); Body temperature 11-Jun-2007 39 deg. C.; Brain stem auditory evoked response 00-Jun-2007 negative; CSF culture 00-Jun-2007 detection of pneumococci (serotype unknown); C
CDC Split Type: DEWYE384027SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA291G IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA291G IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA291G IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA291G IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH254710IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Audiogram abnormal, Blood culture positive, Body temperature increased, Brain stem auditory evoked response normal, CSF culture positive, CSF pressure normal, Deafness, Drug ineffective, Ear, nose and throat examination, Encephalitis, Epilepsy, Hypotonia, Meningitis pneumococcal, Neuropsychological test abnormal, Nuclear magnetic resonance imaging abnormal, Otoacoustic emissions test, Partial seizures, Pneumococcal bacteraemia, Pneumococcal sepsis, Pyrexia, Status epilepticus, Tonic convulsion, Ultrasound scan abnormal, Vaccination failure
SMQs:, Agranulocytosis (broad), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Additional information was received regarding patient''s demographics, treatment, additional events, lab test and result and assessment of relatedness. Information regarding Prevenar was received from a healthcare professional regarding a 2-month-old male patient who experienced fever over 39 C, pneumococcal bacteraemia, drug ineffective, pneumococcal meningitis, pneumococcal sepsis, meningoencephalitis, status epilepticus with complex focal seizures and tonic epileptic seizure. The patient received the first dose on 11-Jun-2007. Relevant medical history was not provided. Concomitant therapy included D-Fluoretten (cholesterol/colecalciferol/sodium fluoride). Four hours after vaccination the patient experienced fever over 39 C on 11-Jun-2007. The patient was treated with Paracetamol every 6 hours and the child was diagnosed with suspected pneumococcal meningitis on the next day and was hospitalised immediately on 12-Jun-2007. In hospital a done blood culture and CSF culture test detected pneumococci and confirmed the diagnosis of pneumococcal meningitis (drug ineffective) with a differential diagnosis of pneumococcal sepsis and pneumococcal bacteraemia and meningoencephalitis. After the administration of Dexamethasone the patient was treated with Ceftriaxone for 21 days. The patient''s condition impaired and therefore the child was transferred to the ICU. The patient experienced tonic epileptic seizure and status epilepticus with complex focal seizures which increased in seriousness. Therefore an antiepileptic therapy with Levetiracetam began and the patient''s seizures improved. The patient was deaf and his trunk and arms were hypotone. The reporting physician''s and the treating pediatrician''s assessment of relatedness between the adverse events and Prevenar was not related, they considered the situation to be coincidental; however, the patient''s parents remained sceptically. The physician stated that the patient was probable vaccinated while the pneumococcal meningitis was in the incubation phase. The reporting eve

VAERS ID:304816 (history)  Vaccinated:2007-06-11
Age:0.3  Onset:2007-07-01, Days after vaccination: 20
Gender:Female  Submitted:2008-02-12, Days after onset: 226
Location:Foreign  Entered:2008-02-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: Body temperature (results: 40 deg. C.) was done on 12-Jun-2007. White blood cell analysis (results: Lymphocytosis) was done in Jul-2007.
CDC Split Type: NLWYEG01033408
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Enterovirus infection, Lymphocytosis, Pyrexia, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 3-month-old female patient who experienced enterovirus infection. The patient received the first dose on 11-Jun-2007. The patient experienced fever within one day after the vaccinations. Her temperature increased to 40 degrees Celcius. The fever was present intermittently during one month. At first, no cause was found. Her blood showed a lymphocytosis. Eventually she was hospitalised for further diagnosis one month after the vaccinations. An entero virus was isolated from her faeces. While in the hospital she did not experience a fever. After release from hospital the fever did not return. The patient has recovered. No additional information was available at the time of this report.

VAERS ID:309546 (history)  Vaccinated:2007-06-11
Age:0.5  Onset:2007-06-11, Days after vaccination: 0
Gender:Male  Submitted:2008-04-16, Days after onset: 310
Location:Foreign  Entered:2008-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Kawasaki disease from vaccination
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEUR    
PNC: PNEUMO (PREVNAR)PFIZER/WYETH    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Kawasaki's disease, Pyrexia, Rash, Skin exfoliation, Vaccination complication
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: High fever, rash, swollen hands and feet, blueish spots and after a few weeks ..peeling of the hands and feet.

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