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Case Details (Sorted by Vaccination Date)

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VAERS ID:310143 (history)  Vaccinated:2008-04-18
Age:17.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Male  Submitted:2008-04-18, Days after onset: 0
Location:Pennsylvania  Entered:2008-04-18
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: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB223AA IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2558AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure, Hypotonia, Memory impairment, Muscle twitching
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient given immunizations-about 2-5 min afterwards slumped in chair arms and head began to twitch. Upon touching arm calling name child-said what, assisted to chair vitals stable BP102/80-no knowledge of event. Kept in office for

VAERS ID:310580 (history)  Vaccinated:2008-04-18
Age:1.5  Onset:2008-04-21, Days after vaccination: 3
Gender:Male  Submitted:2008-04-22, Days after onset: 1
Location:North Carolina  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: ASTHMA
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEUR42355BA3IMLL
Administered by: Military     Purchased by: Unknown
Symptoms: Dyskinesia, Gaze palsy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow)
Write-up: ARMS RHYTHMICALLY MOVING AND EYES ROLLING BACK; FEVER TO 103

VAERS ID:310589 (history)  Vaccinated:2008-04-18
Age:8.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Male  Submitted:2008-04-22, Days after onset: 4
Location:California  Entered:2008-04-22
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1498U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Lip swelling, Tachycardia, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: LIP SWELLING, HIVES, ERYTHEMA OF TRUNK, EMESIS WITHIN 15 MIN. OF VACCINATION. GIVEN EPINEPHRINE SUBCUTANEOUS, SOLUMEDROL AND BENADRYL IM, ALBUTEROL NEB TREATMENT. WENT TO ER AFTER 30 MIN. OF REACTION. GOOD PULSE OX. MONITORING AND STABLE VITALS. TACHYCARDIA RESOLVED. ALL ABOVE SX. RESOLVED. GIVEN IV FLUID HYDRATION ONLY IN THE ER.

VAERS ID:310603 (history)  Vaccinated:2008-04-18
Age:25.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 3
Location:Texas  Entered:2008-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin
Current Illness: None
Preexisting Conditions: Diabetes
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB448AA5UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2609AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Cough, Dyspnoea, Oral pruritus, Pain, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: 30 min after getting shot mouth began itchy and runny nose. Woke up next day terrible body aches and had trouble breathing. Bad cough also. Took Benadryl, Zyrtec, Advil.

VAERS ID:310607 (history)  Vaccinated:2008-04-18
Age:4.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 3
Location:Virginia  Entered:2008-04-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2799AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01263SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Cellulitis left thigh moderate erythema, tender, warm to touch.

VAERS ID:310842 (history)  Vaccinated:2008-04-18
Age:11.0  Onset:2008-04-20, Days after vaccination: 2
Gender:Female  Submitted:2008-04-24, Days after onset: 4
Location:North Carolina  Entered:2008-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none known
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1577U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm swollen and very tender to palp over deltoid area. No mass noted, no s/s of infection noted.

VAERS ID:311109 (history)  Vaccinated:2008-04-18
Age:65.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 3
Location:Wisconsin  Entered:2008-04-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, Calcium, Glucosamine, Ibuprofen and ASA
Current Illness: None
Preexisting Conditions: Allergic to Penicillin and Duracef/ Arthritis, fibrocystic dx
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0963U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia, Skin warm
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Patient states injection site became sore, hard and red. Felt feverish for 2 days. Face was red and hot for 24 hours.

VAERS ID:311497 (history)  Vaccinated:2008-04-18
Age:76.0  Onset:2008-04-25, Days after vaccination: 7
Gender:Female  Submitted:2008-04-28, Days after onset: 3
Location:New Jersey  Entered:2008-05-02, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Private     Purchased by: Unknown
Symptoms: Rash papular, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Ten vesicular & papular rash both arms & chest wall on 4/26/08. ? post vaccination dermatitis. ? chicken pox.

VAERS ID:311498 (history)  Vaccinated:2008-04-18
Age:1.0  Onset:0000-00-00
Gender:Female  Submitted:2008-05-01
Location:Unknown  Entered:2008-05-02, 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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.04254 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Rash, Rash morbilliform
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 12 month old toddler developed characteristic modromsal fever for 2 days prior to rash on face and behind eyes which then mogressed to involve body c/w measles. Toddler received MMR vaccine 13 days prior to evaluation on 5/1/08 which is about 10-11 days before onset of fever.

VAERS ID:315718 (history)  Vaccinated:2008-04-18
Age:0.6  Onset:2008-04-19, Days after vaccination: 1
Gender:Female  Submitted:2008-06-04, Days after onset: 46
Location:Massachusetts  Entered:2008-06-09, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sl cough had been on amox
Preexisting Conditions: colic
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B137AA1UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF291AC1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB97283C1UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1392U1PO 
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: 4/26 mom called as vomiting/diarrhea on off since vaccinations. Started on CULTURELLE 1/2 daily, PEDIALYTE x12 hrs advance slowly. No fever and good urine output.

VAERS ID:319420 (history)  Vaccinated:2008-04-18
Age:63.0  Onset:2008-04-19, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 66
Location:Texas  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: therapy unspecified, therapy unspecified
Current Illness: Hypertension, Penicillin allergy
Preexisting Conditions: Shingles
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA04494
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1824U0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Headache, Injection site vesicles, Pruritus generalised, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a 63 year old white female consumer with hypertension and penicillin allergy and history of shingles 40 years ago who on 18-APR-2008 was vaccinated subcutaneously with 0.65 ml of zoster vaccine live (Oka/Merck). Concomitant therapy included "a diuretic"(therapy unspecified) and "blood pressure medication" (therapy unspecified). One day post vaccination, on 19-APR-2008, the patient developed blister like eruptions at the injection site and a blinding headache. The consumer also noted that she had started to feel itchy all over her body. At the time of reporting the patient had not yet recovered. Medical attention was not sought. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information was received from a physician who reported on 18 APR 2008 at 10:00 that patient was vaccinated subcutaneously into the right arm with a first dose of zoster vaccine live (Oka/Merck), (lot # 659326/1824U). It was noted that on 21 APR 2008 the patient called the physician stating that she had sores all over and was very itchy, (previously reported by the consumer as "developed blister like eruptions at the injection site and started to feel itchy all over"). An office visit was scheduled, but the patient did not keep the appointment. There was no illness at the time of vaccination. The patient''s status was unknown at the time of reporting. Additional information has been requested.

VAERS ID:320349 (history)  Vaccinated:2008-04-18
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-23
Location:Texas  Entered:2008-07-24, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: allergy test, results pending
CDC 'Split Type': WAES0807USA03903
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test, Fall, Hypoaesthesia, Loss of consciousness, Muscle fatigue, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a registered nurse (R.N.) concerning her 15 year old daughter with no pertinent medical history, drug reactions or allergies who "three months ago", on approximately 18-APR-2008 was vaccinated with a dose of GARDASIL. There was no concomitant medication. "Approximately two months ago", in approximately May 2008, the patient began to experience numbness and tingling in her hands. On 16-JUL-2008 the patient experienced two episodes of syncope during which she lost consciousness and hit the floor. On 17-JUL-2008 the patient noted that all of her muscles felt tired. Allergy tests were performed (results not provided). At the time of the report, the patient''s event persisted. The patient did not seek medical attention. The reporter considered numbness and tingling in hands, syncope and muscles tired to be immediately life-threatening. Additional information has been requested.

VAERS ID:388220 (history)  Vaccinated:2008-04-18
Age:5.0  Onset:2009-03-14, Days after vaccination: 330
Gender:Male  Submitted:2010-05-14, Days after onset: 426
Location:New Jersey  Entered:2010-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0903USA04114
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSB223AA IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1745U SCUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1791U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Blister, Rash papular, Varicella post vaccine
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Information has been received from a registered nurse concerning a 6 year old male with no medical history allergies or drug reactions, who on 15-JUN-2004 was vaccinated with the first dose of VARIVAX (Merck) (Lot no. 648083/0072P) SC and with a dose of MMR (Lot no. 646906/0956N), SC (dose not reported). On 18-APR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot no. 659941/1791U) SC and with a dose of MMR (Lot no. 659540/1745U), SC (dose not reported). Other concomitant therapy included a dose of (Lot no. 495-212) PREVNAR and a dose of (B223AD) HAVRIX. The nurse reported that on 14-MAR-2009 the patient developed many papules and a few vesicles on trunk, arms and legs. It was reported that the patient experienced varicella. The patient was prescribed TYLENOL and BENADRYL. Subsequently, the patient recovered from varicella. The patient sought medical attention by a doctor visit. Additional information has been requested.

VAERS ID:312087 (history)  Vaccinated:2008-04-18
Age:0.4  Onset:2008-04-19, Days after vaccination: 1
Gender:Male  Submitted:2008-05-09, Days after onset: 20
Location:Foreign  Entered:2008-05-12, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Electroencephalogram, 00-Apr-2008, appropriate to his age, exclusion of seizures and West''s syndrome
CDC 'Split Type': DEWYEG01497208
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC21CA362A0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH311030IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Electroencephalogram normal, Muscle twitching, Restlessness
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority (PEI) regarding a 4-month-old male patient who experienced restlessness during night, crying abnormal during night and twitching of arms. The patient received a dose (but not the first one) on 18-Apr-2008. Previous administered doses of Prevenar and Infanrix Hexa had been well tolerated, however it was unknown how many doses already had been administered. Product was administered on 18-Apr-2008. Additional suspect medication included Infanrix Hexa which was administered on the same day. Concomitant medications were not reported. One day after vaccination the patient experienced restlessness during night and crying abnormal during night on 19-Apr-2008. In addition the patient experienced twitching of arms on 21-Apr-2008. The patient was hospitalised. The results of an EEG was appropriate to patient''s age and seizures and West''s syndrome were excluded. The situation was not considered to be life-threatening. The symptoms resolved by 22-Apr-2008 and the patient recovered. Electroencephalogram (results: appropriate to his age, exclusion of seizures and West''s syndrome) was done in Apr-2008. This case is being treated according to the foreign IfSG (Act).

VAERS ID:312293 (history)  Vaccinated:2008-04-18
Age:1.1  Onset:2008-04-20, Days after vaccination: 2
Gender:Female  Submitted:2008-05-13, Days after onset: 23
Location:Foreign  Entered:2008-05-14, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None provided
CDC 'Split Type': DEWYEG01515308
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA386A3IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH310813IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death
SMQs:
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 12-month-old female patient who experienced unexplained death. The patient received the fourth dose on 18-Apr-2008. Past vaccinations included Prevenar and Infanrix Hexa in Aug-2007 (first dose), in Oct-2007 (second dose) and in Nov-2007 (third dose). The patient has been fully immunised. Concomitant medications were not reported. The patient experienced unexplained death on 20-Apr-2008. Except for determination of death no further examination were done. The cause of death was reported as death. This case is being treated according to the foreign Act.

VAERS ID:314648 (history)  Vaccinated:2008-04-18
Age:4.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Unknown  Submitted:2008-05-30, Days after onset: 42
Location:Foreign  Entered:2008-06-03, 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: Not reported
Diagnostic Lab Data:
CDC 'Split Type': 200801736
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2733A IMUN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURERAOPVB37OBL PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Circulatory collapse, Hypotonic-hyporesponsive episode, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (narrow)
Write-up: Initial report received from Health Authorities on 26 May 2008. A 4-year-old patient of unspecified gender with no reported medical history received intramuscular TRIPACEL, lot no. C2733AB and oral polio sabin, lot no: AOPVB370BL, on 18 April 2008. On the same day, at 10.15 hours, the patient experienced hypotonic-hyporesponsive episode, fainting, circulatory collapse and tachycardia. The patient has been admitted to the hospital from 18 to 19 April 2008. The patient recovered within an unspecified time frame.

VAERS ID:314904 (history)  Vaccinated:2008-04-18
Age:0.6  Onset:2008-04-18, Days after vaccination: 0
Gender:Unknown  Submitted:2008-06-03, Days after onset: 46
Location:Foreign  Entered:2008-06-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC 'Split Type': 200801730
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20905008B SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Inguinal hernia, Loss of consciousness, Pallor, Peripheral coldness, Pyrexia, Vaccination complication
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), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial report received from health authorities on 26 May 2008. A 7-month-old patient of unspecified gender with no reported medical history received intramuscular ACTHIB , lot no: A9712-2 and subcutaneous DPT, lot no: 20905008B, on 18 April 2008. On the same day, 2 hours after vaccination, at 15:00 hours, the patient intensely cried, developed paleness and cold skin. The patient has been hospitalized at an unspecified time. At the pediatric unit, the patient had fever at 38.8C (lasting up to 48 hours),. "situation after loss of consciousness, inguinal hernia". The patient has been discharged on 23 April 2008 in a good health state with the diagnosis of "state after loss of consciousness - post-vaccination reaction, fever, inguinal hernia". The subject recovered at an unspecified time.

VAERS ID:316351 (history)  Vaccinated:2008-04-18
Age:6.0  Onset:2008-04-26, Days after vaccination: 8
Gender:Male  Submitted:2008-06-16, Days after onset: 51
Location:Foreign  Entered:2008-06-16
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': B0524615A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash papular, Scab, Skin lesion, Subcutaneous nodule, Varicella
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# 523455232) and described the occurrence of varicella in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 18 April 2008, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site). In April 2008, 8 days after vaccination with INFANRIX, the subject experienced varicella with subcutaneous nodule, papulovesicular rash and scabbed skin lesions of 14-16 cm in diameter. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly linked to vaccination with INFANRIX. Further information is not expected as this was the only information the regulatory authority had. This case has therefore been closed.

VAERS ID:317699 (history)  Vaccinated:2008-04-18
Age:1.0  Onset:2008-04-26, Days after vaccination: 8
Gender:Unknown  Submitted:2008-06-26, Days after onset: 61
Location:Foreign  Entered:2008-06-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: platelet count, ??Apr08, 15-8 G/L; body temp, 28?Apr08, 39-39.4 deg C
CDC 'Split Type': WAES0806POL00007
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.NF44300 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Extravasation blood, Platelet count decreased, Pyrexia, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a physician via an Agency (Authority number: PL-URPL-OCR-20080604007: URPL paper id: N331/2008) concerning a 14 month old patient who on 18-APR-2008 was vaccinated with MMR II (Batch number: NF44300). On approximately 26-APR-2008 the patient experienced pyrexia. Pyrexia lasted from 3 days (39-39.4 deg C). On 28-APR-2008 the patient experienced extravasation blood on shanks and thighs, both lower extremities and was hospitalized. Diagnosis of thrombocytopenia (15-8 G/L) was performed. The patient was referred to haematology department. The reporter felt that pyrexia, thrombocytopenia and extravasatoin blood were related to therapy with MMR II. Additional information is not expected.

VAERS ID:318251 (history)  Vaccinated:2008-04-18
Age:0.2  Onset:2008-04-19, Days after vaccination: 1
Gender:Male  Submitted:2008-07-03, Days after onset: 75
Location:Foreign  Entered:2008-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None Provided.
CDC 'Split Type': ESWYEG01773308
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
MNC: MENINGOCOCCAL (MENINGITEC)PFIZER/WYETH  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chapped lips, Inappropriate schedule of drug administration, Kawasaki's disease, Pericarditis, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Information regarding MENINGITEC was received from a healthcare professional via a regulatory authority regarding a 2-month-old male patient who experienced pericarditis, eruption, pyrexia, Kawasaki''s disease and cracked lips. The patient received a dose on 18-Apr-2008. The patient also received a dose of PREVENAR on 18-Apr-2008. Past therapies included Hepatitis B Surface Antigen on 18-Feb-2008. Additional suspect medication included Hepatitis B Surface Antigen and PENTAVAC. Concomitant medications were not reported. The patient experienced pericarditis, eruption, pyrexia, Kawasaki''s disease and cracked lips on 19-Apr-2008. The patient was hospitalized. Specific treatment with acetyl salicylic acid was administered to the patient (as of 10-Jun-2008 the patient continued treatment). The patient recovered in Jun-2008. No additional information was available at the time of this report.

VAERS ID:354033 (history)  Vaccinated:2008-04-18
Age:0.5  Onset:0000-00-00
Gender:Male  Submitted:2009-08-12
Location:Foreign  Entered:2009-08-13, 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: Concomitant medications were not used.
Current Illness:
Preexisting Conditions: The patient has a past history of pneumonia.
Diagnostic Lab Data: None Provided.
CDC 'Split Type': NLWYEG04202309
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC2735AA IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH254233IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Drug ineffective, Lobar pneumonia, Lung cyst, Surgery
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 6-month-old male patient who experienced lung cyst, pneumonia in the lower left lobe and lack of drug effect. The patient received the fourth dose on 18-Apr-2008. 5 days after the vaccinations on 23-Apr-2008, the patient was hospitalized and it turned out that the patient experienced pneumonia in the lower left lobe. This was the second time that the patient experienced pneumonia in that lobe. Further examination revealed in 2008 that the patient experienced lung cysts which were surgically removed in Oct-2008. The patient has recovered. No additional information was available at the time of this report.

VAERS ID:421477 (history)  Vaccinated:2008-04-18
Age:  Onset:2008-06-08, Days after vaccination: 51
Gender:Male  Submitted:2011-04-20, Days after onset: 1046
Location:Foreign  Entered:2011-04-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0070638A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Diplopia, Infection, Miller Fisher syndrome, Nasopharyngitis, Neurological symptom
SMQs:, Peripheral neuropathy (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician via sales representative and described the occurrence of miller fisher syndrome in an adult male subject who was vaccinated with Tetanus diphtheria vaccine (GlaxoSmithKline). The vaccine contained a polio component, but it was not further specified. On an unspecified date the subject received a dose of Tetanus diphtheria vaccine (unknown route and application site). Directly after vaccination the subject experienced infection. Three weeks after vaccination the subject developed miller fisher syndrome. At the time of reporting the events were resolved. Follow-up information was received on 15 April 2011 from the physician. On 18 April 2008 the subject received a dose of tetanus diphtheria polio vaccine (unknown route and application site). On 8 June 2008, one and a half months after vaccination the subject experienced neurological symptoms with diplopia. The subject was hospitalised on 9 June 2008. At hospital Miller-Fisher-syndrome was diagnosed. One week prior to hospitalisation the subject experienced common cold and diarrhea before this. At the time of reporting the events were completely resolved. No further information will be available.

VAERS ID:421689 (history)  Vaccinated:2008-04-18
Age:22.0  Onset:2008-09-01, Days after vaccination: 136
Gender:Female  Submitted:2011-04-25, Days after onset: 966
Location:Foreign  Entered:2011-04-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1104USA02541
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1339F2IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose abnormal, Blood test abnormal, Dexamethasone suppression test positive, Hypothyroidism, Insulin resistance, Insulin tolerance test abnormal, Polycystic ovaries, Serology abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Hypothyroidism (narrow), Lipodystrophy (broad), Fertility disorders (narrow)
Write-up: Case received from the Health Authorities on 14-APR-2011 (PEI2011010605). Case medically confirmed. A 22-year-old female patient received a complete vaccination series with three doses of GARDASIL (IM) into the upper arm on 19-OCT-2007 (D1, lot# 1339F, Batch # NF23310), on 11-DEC-2007 (D2, lot# 1339F, Batch # NF23310) and on 18-APR-2008 (D3, lot# 1339F, Batch # NF23310). Previous doses of GARDASIL given on 19-OCT-2007 and 11-DEC-2007 were well tolerated. In September 2008 the patient developed latent hypothyroidism and insulin resistance. In September 2009 she developed a polycystic ovarian syndrome. Diagnoses were confirmed by serology, blood-sugar and insulin tolerance test, blood hormone test and dexamethasone suppression test. Cushing syndrome was excluded. Upon reporting form dated 05-APR-2011, the patient had not recovered and the reporter stated a "persisting damage". The adverse events were considered to be disabling. Other business partner numbers include E201102391.

VAERS ID:310587 (history)  Vaccinated:2008-04-19
Age:38.0  Onset:2008-04-22, Days after vaccination: 3
Gender:Female  Submitted:2008-04-22, Days after onset: 0
Location:Georga  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2770AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site is extremely swollen, red, hot, painful, and itchy. The nurse at my work suggested I have the problem noted in my record in case I am asked to get another shot in the future. Condition has worsened in the four days since I got the shot.

VAERS ID:310597 (history)  Vaccinated:2008-04-19
Age:23.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Female  Submitted:2008-04-22, Days after onset: 2
Location:Colorado  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yazmin
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Redness and hot at injection site whole arm swollen and tender up to top of shoulder. 4/20/08 Fever 012 which has not ameliorated with Tylenol 36 hrs. 0900 am shortness of breath for 36 hrs. Better 4-21-08 9:00 PM.

VAERS ID:310604 (history)  Vaccinated:2008-04-19
Age:26.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Male  Submitted:2008-04-20, Days after onset: 0
Location:Wisconsin  Entered:2008-04-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Adverse Reaction
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1633IDLA
Administered by: Other     Purchased by: Military
Symptoms: Adverse drug reaction, Erythema, Injection site irritation, Injection site swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling and burning at the site of injection. Over 24 hrs. erythematic area worsened - ER visit

VAERS ID:310605 (history)  Vaccinated:2008-04-19
Age:54.0  Onset:2008-04-19, Days after vaccination: 0
Gender:Male  Submitted:2008-04-20, Days after onset: 1
Location:Wisconsin  Entered:2008-04-22, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin PRN
Current Illness: None
Preexisting Conditions: Reaction to last vaccine of Anthrax in 2004.
Diagnostic Lab Data: Cellulitis left forearm.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1636IDLA
Administered by: Other     Purchased by: Military
Symptoms: Injection site irritation, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling/burning at injection site - over 24 hours got nurse. Went to ER.

VAERS ID:310606 (history)  Vaccinated:2008-04-19
Age:22.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Female  Submitted:2008-04-20, Days after onset: 0
Location:Wisconsin  Entered:2008-04-22, 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: BCP
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: erythematic area -localized reaction
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1630IDLA
Administered by: Other     Purchased by: Military
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Burning for about 90 sec after injection. Lump at injection site now, slight burning following morning with redness surrounding lump.

VAERS ID:311941 (history)  Vaccinated:2008-04-19
Age:19.0  Onset:2008-04-24, Days after vaccination: 5
Gender:Male  Submitted:2008-04-30, Days after onset: 6
Location:North Carolina  Entered:2008-05-09, 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: NONE
Preexisting Conditions: NKDA; FACIAL ACNE
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURER 0IDUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERA05220IMUN
Administered by: Military     Purchased by: Military
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 19 y/o male ADSM is referred from clinic to FBVHC for evaluation of skin rash eruption in temporal relationship with the receipt of Smallpox vaccine. Symptom: Pruritus Start: 04/24/2008 Comment: Related to skin rash. Symptom: Rash, diffuse Start: 04/24/2008 Comment: See summary for description.

VAERS ID:311953 (history)  Vaccinated:2008-04-19
Age:1.0  Onset:2008-04-26, Days after vaccination: 7
Gender:Female  Submitted:2008-05-02, Days after onset: 6
Location:Arizona  Entered:2008-05-09, 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: Zyrtec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB256AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1672U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575423IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1464U0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 4-26-08 Mother noticed "little red dot" on L leg where varicella had been given on 4-19-08. The red area became larger & tender & more red as time went by. Came to clinic where shots were given. Area was approx 7 cm diameter. Was advised to see her MD which she was. No treatment recommended. Area started to diminish 4/30/08 & on 5/2/08 is almost gone.

VAERS ID:312232 (history)  Vaccinated:2008-04-19
Age:41.0  Onset:2008-04-24, Days after vaccination: 5
Gender:Male  Submitted:2008-05-03, Days after onset: 9
Location:Michigan  Entered:2008-05-13, 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:
Preexisting Conditions: ASA, PCN, IVP dye
Diagnostic Lab Data: (pending documentation)
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA022122IMLA
Administered by: Military     Purchased by: Military
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Rec. typhoid c/o cephalgia, arm pain, n/v and loose stools x 4 days. Seen at facility. Dx''d with adverse rx and given IV hydration with ZOFRAM. Now asymptomatic.

VAERS ID:312287 (history)  Vaccinated:2008-04-19
Age:4.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Female  Submitted:2008-05-06, Days after onset: 16
Location:Arizona  Entered:2008-05-13, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1925U1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1807U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (L) deltoid erythema, warmth, swelling x 3 days proximal/upper 1/3 of UE Motrin for tx

VAERS ID:312591 (history)  Vaccinated:2008-04-19
Age:23.0  Onset:2008-04-20, Days after vaccination: 1
Gender:Female  Submitted:2008-05-19, Days after onset: 29
Location:Colorado  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient
Other Medications: Celexa 10mg
Current Illness: None
Preexisting Conditions: Depression/anxiety
Diagnostic Lab Data: physican comprehensive metabolic panel, checked thyroid, CBC, and another lab test that checked a blood count. All proved to be within normal limits. Blood work complete 05/15/2008.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF316AA SCRA
Administered by: Unknown     Purchased by: Private
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Headache, Laboratory test normal, Thyroid function test normal
SMQs:, Dementia (broad)
Write-up: A few hours after the yellow fever injection the patient felt extremely tired for 3-4 days. Patient also report headaches in front of head and on top of head. Headaches would come and go every few hours. Eventually the headaches have made the patient miserable most of the day. Patient continues to feel "foggy" and increased amount of headaches. Patient has taken acetimenophen. It takes a long time to take effect, and then does not work well. Patient requests immediate contact with CDC/vaccine manufacturer.

VAERS ID:314770 (history)  Vaccinated:2008-04-19
Age:12.0  Onset:2008-05-13, Days after vaccination: 24
Gender:Male  Submitted:2008-06-03, Days after onset: 21
Location:Florida  Entered:2008-06-03
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: PMH: laceration. NKDA.
Diagnostic Lab Data: Initial Labs from TMH: "WBC 5.1; Hemoglobin 14.3; Hematocrit 41.7; MCV 85.6; Platelets 281,000; Glucose 88; BUN 15; Creatinine 0.8; Sodium 133; Potassium 3.2; The CSF shows clear, colorless liquid with 1% segs, 89% lyumphs, 10% monos, 0% eoshinophisl and basophils, 3 RBC, 101 WBC, glucose 52, protein 39. CSF and Blood culture results are unkown. EEG also performed on 5/21/08 Impression:" This is an abnormal EEG due to the presence of a mild degree of diffuse generalized slowing consistent with underlying cerebral dysfunction". Labs and Diagnostics: Brain MRI abnormal. Head CT abnormal. Head MRA c/w ADEM. Spinal MRI WNL. CSF with 101 WBCs, CSF protein 59. CSF (-) for HSV and enterovirus by PCR. CK 576-798. Blood, sputum and urine c
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2380BA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA5IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1179U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abnormal behaviour, Agitation, Biopsy brain abnormal, Blood creatine phosphokinase increased, Blood creatinine normal, Blood culture negative, Blood glucose normal, Blood potassium decreased, Blood product transfusion, Blood sodium decreased, Blood urea normal, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased, CSF neutrophil count, CSF protein increased, CSF virus no organisms observed, CSF white blood cell count increased, Candidiasis, Chest tube insertion, Clumsiness, Computerised tomogram abnormal, Confusional state, Convulsion, Cough, Disorientation, Dizziness, Electroencephalogram abnormal, Endotracheal intubation, Gastrointestinal tube insertion, Haematocrit normal, Haemoglobin normal, Headache, Influenza like illness, Leukoencephalomyelitis, Mean cell volume normal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Panic reaction, Platelet count normal, Pneumothorax, Polymerase chain reaction, Posturing, Pyrexia, Red blood cells CSF positive, Scan brain, Urinary tract infection, Verbigeration, Viral test negative, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (narrow), Dementia (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Malignant lymphomas (broad)
Write-up: On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache. He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head". Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit. Child is currently a patient at Medical Center Pediatric ICU. Dx: Acute Disseminated Encephalomyelitis 06/23/2008 Partial MR received for DOS 5/22-7/25/2008 with DX: Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx. Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2'' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx''d with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.

VAERS ID:319414 (history)  Vaccinated:2008-04-19
Age:  Onset:2008-04-21, Days after vaccination: 2
Gender:Female  Submitted:2008-06-24, Days after onset: 64
Location:Unknown  Entered:2008-07-11, Days after submission: 17
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': WAES0804USA04865
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0158X SC 
Administered by: Other     Purchased by: Other
Symptoms: Blister, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad)
Write-up: Information has been received from a pharmacist concerning a female who on 19-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL, subcutaneously (LOT # 659268/0158X). On 21-APR-2008 the patient developed two vesicular lesions over on her ribs. No other symptoms were noted. The patient contacted the pharmacist. No further information was available.

VAERS ID:338778 (history)  Vaccinated:2008-04-19
Age:41.0  Onset:2008-04-23, Days after vaccination: 4
Gender:Male  Submitted:2009-01-29, Days after onset: 281
Location:Indiana  Entered:2009-02-02, 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: SERTRALINE; XANAX
Current Illness:
Preexisting Conditions: The patient has no known allergies, and had no illnesses or use of other medications at the time of the vaccination. From new information received on 12 December 2008, at the time of the vaccination, the patient had history of chronic generalized anxiety and depression that continues. The patient never had a reaction to any prior tetanus vaccination in the past.
Diagnostic Lab Data: The patient''s neurological exam was normal, therefore no neurological tests were performed. The patient had an X ray of the left humerus on 06 October 2008 to assess for calcifications or other injury. The results were normal. 11-DEC-200
CDC 'Split Type': 200803085
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767A0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Bursitis, Injection site pain, Neurological examination normal, Nuclear magnetic resonance imaging normal, Tendonitis, X-ray normal
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Initial report received on 07 October 2008 from a physician. A 41-year-old male patient, with no concurrent illnesses, no known allergies, and no use of other medications, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (Lot # C2767AA) on 29 April 2008. The size of needle used for the administration of the ADACEL was unknown. Approximately four hours post-vaccination, the patient experienced soreness at the left deltoid injection site which persisted. The site appeared to be normal, but the soreness did not resolve. The patient subsequently required medical evaluation and an x-ray of the left arm was performed which was reported to be negative. At the time of this report, the patient had not recovered. Follow up information was received on 24 November 2008 from a health care professional. The patient was seen in the office on 03 October 2008. During the visit the doctor assessed the site as "normal in appearance". The patient''s neurological exam was normal, therefore no neurological tests were performed. The patient had an X ray of the left humerus on 06 October 2008 to assess for calcifications or other injury. The results were within normal limits. The patient was scheduled for a follow up appointment on 20 November 2008. No further information was provided. Follow-up information received on 12 December 2008 from a physician. At the time of the vaccination on 29 April 2008, the patient was taking Sertraline and Xanax for chronic generalized anxiety and depression which continues. The patient had not recovered at the time of the office visit on 03 October 2008. The patient was re-evaluated by neurology on 20 November 2008 and an Magnetic Resonance Imaging test of the left upper extremity was "ordered." The results of the MRI were still pending at the time of this report. The physician did not feel the events were related to any immunization issues. The reporter stated "see attached office visit notes", but there were no office visit notes provided. At the time of

VAERS ID:311251 (history)  Vaccinated:2008-04-19
Age:1.9  Onset:2008-04-20, Days after vaccination: 1
Gender:Male  Submitted:2008-04-29, Days after onset: 9
Location:Foreign  Entered:2008-04-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: The patient''s concurrent illness includes asthma.
Preexisting Conditions: Patient also experienced fever and rash with the first dose of PREVENAR therapy.
Diagnostic Lab Data: Platelet count (results: 12,000) was done on 21-Apr2008. Platelet count (results: 52,000) was done on 23-Apr-2008.
CDC 'Split Type': PHWYEH03681508
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood product transfusion, Ecchymosis, Haematoma, Idiopathic thrombocytopenic purpura, Immunoglobulins decreased, Petechiae, Platelet count decreased, Rash maculo-papular, Reaction to previous exposure to any vaccine, Tongue haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional regarding a 23-month-old male patient who experienced maculopapular rash and idiopathic thrombocytopenic purpura. The patient received the second dose on 19-Apr-2008. On 19-Apr-2008, the patient received the second dose of PREVENAR therapy. On 20-Apr-2008 patient experienced experienced bleeding tongue and maculopapular rash. On 21-Apr-2008, patient was admitted to the hospital with petechial rash, hematoma and ecchymosis on his extremities. Treatment consisted of gamma globulin. The recovery status of the patient at the time of report was unknown.

VAERS ID:326741 (history)  Vaccinated:2008-04-20
Age:25.0  Onset:2008-05-01, Days after vaccination: 11
Gender:Female  Submitted:2008-09-15, Days after onset: 137
Location:Alabama  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Papilloma viral infection
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0808USA00221
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anogenital warts, Condition aggravated
SMQs:
Write-up: Information has been received from a 25 year old female patient with papilloma viral infection, without developed of genital warts before her first vaccination with GARDASIL vaccine (yeast), and no known drug reactions/allergies, who on 20-FEB-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 20-APR-2008, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), 5 ml. Lot# was not provided. There was no concomitant therapy. The patient reported that in May-2008, after the vaccination she experienced a few lesions. The patient sought unspecified medical attention. At the time of the report the patient was expecting to receive her third dose of GARDASIL vaccine (yeast) on 20-AUG-2008. Additional information has been requested.

VAERS ID:323680 (history)  Vaccinated:2008-04-20
Age:25.0  Onset:2008-04-30, Days after vaccination: 10
Gender:Female  Submitted:2008-08-28, Days after onset: 120
Location:Foreign  Entered:2008-08-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Chemotherapy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0808ISR00015
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Breast cancer
SMQs:, Malignant tumours (narrow), Breast malignant tumours (narrow)
Write-up: Information has been received from a 25 year old female with chemotherapy who on 19-FEB-2008 was vaccinated with GARDASIL first dose. On 20-APR-2008 was vaccinated with GARDASIL second dose. On approximately 30-APR-2008 the patient experienced breast cancer. The patient''s breast cancer persisted. Upon internal review, breast cancer was considered to be an other important medical event. On 16.7.2008 the patient was placed on the first chemotherapy cycle with DOCETAXEL TAXOTERE and CYCLOFOSFAMIDE (dose and duration not reported). The patient was placed on the second chemotherapy cycle with DOCETAXEL TAXOTERE and CYCLOFOSFAMIDE (Date, dose and duration not reported). Patient stated that prior to each therapy with chemotherapy she was placed on therapy with STEROIDS. Also once a month therapy with ZOLADEX injection, and NEUPOGEN injection on the eighth and twelfth day post chemotherapy. The patient is scheduled for the third course of chemotherapy in a few days time. The patient is scheduled for a total of 4 chemotherapy cycles. Additional information has been requested.

VAERS ID:311057 (history)  Vaccinated:2008-04-21
Age:1.2  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-28, Days after onset: 6
Location:North Carolina  Entered:2008-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Left AOM (afebrile)
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B142AA2IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF232AD2IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Hep A and Pediarix Vaccines administered on 04/21/08 at 15 month WCC IM in the right thigh. Pt seen in office 04/24/08 with a large (4x7cm) area of erythema around the injection sites. Injection sites were around 1/2 inch apart from one another. Pt had no fever of other symptoms. Area was red, but soft and without heat or warmth.

VAERS ID:311060 (history)  Vaccinated:2008-04-21
Age:48.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-28, Days after onset: 6
Location:California  Entered:2008-04-28
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: Allergy to Methprime
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1669U0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pyrexia, Tenderness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: 12.5cm X 9.5cm reddened area, mildly tender, no swelling noted. Pt. c/o "fever" X 2 days.

VAERS ID:311067 (history)  Vaccinated:2008-04-21
Age:16.0  Onset:2008-04-24, Days after vaccination: 3
Gender:Female  Submitted:2008-04-28, Days after onset: 4
Location:Oregon  Entered:2008-04-28
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Headache X 4 days with fever to 101: Rash on chest and face.

VAERS ID:311074 (history)  Vaccinated:2008-04-21
Age:0.3  Onset:2008-04-26, Days after vaccination: 5
Gender:Female  Submitted:2008-04-28, Days after onset: 2
Location:Florida  Entered:2008-04-28
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: 5/6/08-records received-Ultrasound of abdomen showed small bowel intussusception but very small at approximately 1 cm. KUB normal. Subsequent abdominal ultrasound negative for intussusception. WBC increased 16,000.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF236AA1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03011IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499191IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0018Y1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Abdominal pain, Crying, Intussusception, Irritability, Pharyngitis, Pyrexia, Rhinorrhoea, Screaming, Ultrasound abdomen abnormal, Upper respiratory tract congestion, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Patient developed acute onset episodic abdominal pain 5 days after Rotateq administered in office. Found to have 1 cm segment of intussusception by abdominal ultrasound; appeared to be small bowel to small bowel segment involved. Reduced spontaneously after ~ 12 hours. On day 7 had fever and pharyngitis - ? viral infection. 5/6/08-records received for DOS 04/26-04/27/9/08-DC DX: Small bowel intussusception. Seen in ER with intense crying and screaming with stiffening of lower extremities and upper extremities, no decrease in appetite. Fussy. No vomiting or diarrhea. Rhinorrhea and congestion on day of admission. Admitted for observation.

VAERS ID:311105 (history)  Vaccinated:2008-04-21
Age:14.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Female  Submitted:2008-04-23, Days after onset: 0
Location:North Carolina  Entered:2008-04-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB215AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1515U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Right upper arm 1 in x 1 annular area of warmth/redness. Motrin and cool compresses

VAERS ID:311110 (history)  Vaccinated:2008-04-21
Age:8.0  Onset:0000-00-00
Gender:Female  Submitted:2008-04-23
Location:Maine  Entered:2008-04-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1258U0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1975U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Quarter-sized area erythema induration around injection site approximately 48 hours.

VAERS ID:311206 (history)  Vaccinated:2008-04-21
Age:5.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Male  Submitted:2008-04-29, Days after onset: 6
Location:Virginia  Entered:2008-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1996U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site rash, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 6x4cm pink macular rash below injection site on L arm in deltoid area. No fever or itching.

VAERS ID:311207 (history)  Vaccinated:2008-04-21
Age:5.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-29, Days after onset: 7
Location:Virginia  Entered:2008-04-29
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: No
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1996U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 9x8cm pink pruritic, macular, rash below injection site. Fever 101.3 tender to touch.

VAERS ID:311223 (history)  Vaccinated:2008-04-21
Age:40.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 8
Location:Minnesota  Entered:2008-04-29
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: onychomycosis, previous history of basal cell carcinoma
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB103AA2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:
Write-up: Arm pain (not at injection site) within minutes of injection, decreasing but still persisting 8 days later.

VAERS ID:311278 (history)  Vaccinated:2008-04-21
Age:21.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-23, Days after onset: 2
Location:Oklahoma  Entered:2008-04-30, 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: MUI; Loestrin; Singulair
Current Illness: None
Preexisting Conditions: Known history asthma
Diagnostic Lab Data: Normal CBC
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U2IMLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Axillary pain, Dizziness, Full blood count normal, Headache, Injection site pain, Injection site warmth, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Complained of H/A, Excedrin relief 1730 4/21/08. Site pain warmth axilla to elbow left UE, injection site. No redness 4/23/08, dizziness and blurring eyes OU 20/20 uncorrected, no injection site pain 4/23/08 cont with dizziness.

VAERS ID:311298 (history)  Vaccinated:2008-04-21
Age:20.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-23, Days after onset: 1
Location:Nebraska  Entered:2008-04-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1117U SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Tenderness
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Patient had Varivax administered 4/21/08 in right arm. 4/22 developed reddened and tenderness at site. Seen in office 4/23 with 3cm x 4cm area. Treated with Benadryl and ice to area.

VAERS ID:311304 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Male  Submitted:2008-04-23, Days after onset: 0
Location:Texas  Entered:2008-04-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2933AB4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.192461UNRL
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: swelling/redness injection site (DTaP, IPV).

VAERS ID:311312 (history)  Vaccinated:2008-04-21
Age:6.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-25, Days after onset: 3
Location:New Jersey  Entered:2008-04-30, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Injection site inflammation, Pruritus, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: On 4-21-08 Varicella given left arm. 4/25/08 returned to clinic. Immunization site inflammation, warm, tender to touch, itching, localized 25mm x 40mm, temperature 96. Mom states cold compresses applied since shot given. No improvement seen by provider. Benadryl 2 tsp given PO.

VAERS ID:311369 (history)  Vaccinated:2008-04-21
Age:5.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-29
Location:California  Entered:2008-04-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01693UNRL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1230U1UNRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site papule, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: 1 in. erythema, papular rash to left thigh no induration

VAERS ID:311397 (history)  Vaccinated:2008-04-21
Age:  Onset:2008-04-23, Days after vaccination: 2
Gender:Unknown  Submitted:0000-00-00
Location:Michigan  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None just birth control
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2766AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Axillary pain, Chills, Headache, Injected limb mobility decreased, Muscle spasms, Muscle twitching, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 2 days post vaccine. Limited motion of left arm with vomiting, headache, fever & chills. Left arm muscle spasms & twitching. No visual difference in size of arms. No redness or heat to site. Complaints of arm pit soreness. To see care at urgent care. Client put on Zithromax, Medrol pack & Motrin.

VAERS ID:311441 (history)  Vaccinated:2008-04-21
Age:50.0  Onset:2008-04-30, Days after vaccination: 9
Gender:Female  Submitted:2008-05-01, Days after onset: 1
Location:Indiana  Entered:2008-05-01
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: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2767AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Pain in extremity, Paraesthesia, Tenderness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: (R) deltoid pain, pain down (R) arm, tingling in (R) hand, tender area (R) arm just below acromion. Shot given 4/21/08. Pt called 4/30/08. Pt seen back in clinic 5-1-08. Pat given a Medrol dose pak.

VAERS ID:311442 (history)  Vaccinated:2008-04-21
Age:19.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-01, Days after onset: 10
Location:Ohio  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U2UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Asthenia, Blood test normal, Dizziness, Headache, Hyperventilation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: 1 hrs after receiving Gardasil pt felt weak, dizzy, hyperventilated. Pt felt dizzy & weak with a headache for 5 days post injection. Pt went to pediatrician had blood tests-all were WNL. Pt has fully recovered. Pt. also complained of joints aching.

VAERS ID:311445 (history)  Vaccinated:2008-04-21
Age:2.0  Onset:2008-04-30, Days after vaccination: 9
Gender:Female  Submitted:2008-05-01, Days after onset: 1
Location:California  Entered:2008-05-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: CBC done at ED -$g nl
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2749AA3UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1485U0SCLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC631113UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1791U0SCRL
Administered by: Private     Purchased by: Private
Symptoms: Feeling hot, Full blood count, Grand mal convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: One week after immunizations, patient developed a low-grade fever (100.3 deg) - then patient felt warm and suddenly had a one-minute generalized tonic-clonic seizure. Paramedics arrived - patient had fever $g101 deg and was post-ictal. seen in local ED, discharged home.

VAERS ID:311472 (history)  Vaccinated:2008-04-21
Age:19.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 8
Location:New Jersey  Entered:2008-05-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: No adverse effect~Rabies (Imovax)~1~0~In Patient
Other Medications: MINOCYCLINE
Current Illness:
Preexisting Conditions: No known allergies; history of acne.
Diagnostic Lab Data:
CDC 'Split Type': 200801181
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA023921IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardiac flutter, Chest discomfort, Tachycardia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Tachyarrhythmia terms, nonspecific (narrow)
Write-up: This case was received from a health professional on 21 April 2008. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 19-year-old female patient, with no known allergies, received a second intramuscular injection of Imovax Rabies (lot number A0239-2) on 21 April 2008. The dose was given as part of a pre-exposure series, and no adverse effects had been reported following dose one. Approximately 45 minutes after vaccination, the patient developed tachycardia (112 beats per minute), chest discomfort described as "fluttering", and shaking of the arms and legs. At the time of the report, the event had been ongoing for approximately one and one-half to two hours. The patient had a history of acne, and was taking Minocycline concomitantly.

VAERS ID:311480 (history)  Vaccinated:2008-04-21
Age:20.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-25, Days after onset: 3
Location:Oregon  Entered:2008-05-02, 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: Ortho-Novum 1/35
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURER    
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: Nausea, itch.

VAERS ID:311499 (history)  Vaccinated:2008-04-21
Age:8.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-02, Days after onset: 11
Location:New Jersey  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: N/A~ ()~NULL~~In Sibling1|N/A~ ()~NULL~~In Sibling2|N/A~ ()~NULL~~In Patient
Other Medications: none
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2497AA0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04744IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0807U1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0084X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Fear of needles, Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Child fainted on the chair 30 minutes after receiving IPV,MMR,Varicella,Flu and Mantoux testing.Episode lasted for 1-2 minutes. As per father child was scared of needles. Child was observed in the clinic half hour.Follow up call on 4/22 child was doing well,active and playing complaining of just soreness from the injection site.

VAERS ID:311518 (history)  Vaccinated:2008-04-21
Age:26.0  Onset:2008-04-26, Days after vaccination: 5
Gender:Female  Submitted:2008-05-02, Days after onset: 6
Location:California  Entered:2008-05-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NKDA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV174 SCLA
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1837U IMLA
Administered by: Military     Purchased by: Military
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: PT REACTED TO ANTHRAX VACCINE AFTER 4 DAYS OF RECEIVING THE IMMUNIZATION. PT WENT TO THE ER FOR COMPLAINS OF HIVES AND WAS GIVEN ATARAX AND PREDNISONE.

VAERS ID:311532 (history)  Vaccinated:2008-04-21
Age:45.0  Onset:2008-04-25, Days after vaccination: 4
Gender:Male  Submitted:2008-05-05, Days after onset: 10
Location:Oklahoma  Entered:2008-05-05
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
SMALL: SMALLPOX (NO BRAND NAME)UNKNOWN MANUFACTURERVV04-003A1IDLA
Administered by: Military     Purchased by: Military
Symptoms: Influenza, Injection site pustule, Malaise, Nasopharyngitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Received Small Pox vaccine as a child. 1st Small Pox vaccine on 9 Apr''08 did not take. Small Pox re-vaccinated on 21 Apr''08. Within 5 days, caught very hard cold/flu. Coincided with Small Pox vaccination site pussing and reacting. Fever (100.8) and malaise for 4 days. Cold symptoms very, very strong.

VAERS ID:311600 (history)  Vaccinated:2008-04-21
Age:60.0  Onset:2008-04-25, Days after vaccination: 4
Gender:Female  Submitted:2008-04-29, Days after onset: 4
Location:South Carolina  Entered:2008-05-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions:
Diagnostic Lab Data: Received TB Skin test at same visit.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA0IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Pt had swelling, heat and redness of arm vaccinated from elbow to shoulder. Dx began 4 days post vaccine - seen private MD - Pt states PMD advised was reaction to pertussis portion of Tdap. gave Pt "steroid" and advised pt to avoid pertussis containing vaccines in future.

VAERS ID:311610 (history)  Vaccinated:2008-04-21
Age:5.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Arkansas  Entered:2008-05-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: "Runny nose"
Preexisting Conditions: Asthma; (mild, seasonal no reported med)
Diagnostic Lab Data: None
CDC 'Split Type': AR0819
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B073AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1311U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1653U1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, swollen area to left arm (deltoid), fever to area; site approximately 14cm in diameter. Afebrile.

VAERS ID:312568 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-21, Days after onset: 0
Location:Oregon  Entered:2008-05-19, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD, C2682AA, 1/4/10, L forearm, #1 prev. dose; PEPTO BISMOL in AM
Current Illness: No
Preexisting Conditions: Heart problems
Diagnostic Lab Data: Sent to hospital
CDC 'Split Type': OR200809
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01694IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1323F1SCLL
Administered by: Private     Purchased by: Public
Symptoms: Anaphylactic reaction, Blood pressure decreased, Lethargy, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Immunizations, PPD, & bloodwork were done for 4yo well child check. Pt <5 min broke out in hives body, decreased BP, vomiting, & lethargic. IM/PO BENADRYL given. O2 via blowby. Sent to DCH via ambulance. Rx for anaphylaxis-observed & sent home.

VAERS ID:312602 (history)  Vaccinated:2008-04-21
Age:20.0  Onset:2008-05-07, Days after vaccination: 16
Gender:Male  Submitted:2008-05-19, Days after onset: 12
Location:Florida  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY 30 MG PO DAILY; RISPERIDOL 2MG PO DAILY; CELEXA 60 MG PO DAILY; KLONAPIN 0.5 MG PO BID; CHILDREN''S BENADRYL LIQUID 10 CC PO BID
Current Illness: NONE
Preexisting Conditions: PERVASIVE DEVELOPMENTAL DISORDER DX PER MOTHER''S REPORT AT AGE 4; OCD
Diagnostic Lab Data: NONE PERFORMED
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1096U0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: CLT''S MOTHER WHO IS THE CLT''S GUARDIAN REPORTED THAT SHE TOOK HER SON TO THE BARBER SHOP FOR A HAIR CUT ON 5/7/08 WHEN SHE NOTICED HE HAD "PIMPLE LIKE" SPOTS ON HIS HEAD APPROXIMATELY 1:00PM. SHE THEN CHECKED HIS NECK AND FOUND 2 MORE SIMILAR SPOTS THERE TOO. ON 5/9/08 CLT''S MOTHER REPORTED THAT THE "SPOTS" HAD SPREAD TO HIS BODY TO HIS CHEST, BACK AND ARMS. CLT''S MOTHER DESCRIBED "SPOTS" AS HAVING A "WHITE HEAD" ON SOME OF THEM. CLT''S MOTHER DENIES ANY FEVER WITH "SPOTS" AND THAT THE "SPOTS" DID ITCH AND SCABBED OVER. CLT''S MOTHER REPORTED THAT THE SYMPTOMS LASTED APPROXIMATELY 5 DAYS AND THAT CLT IS NO LONGER ITCHING AND THE "SPOTS" ARE HEALING (ONLY PINKISH SPOTS LEFT ON SKIN). CLT''S MOTHER REPORTS SHE WAS UNABLE TO TAKE CLT TO HIS PRIVATE PHYSICIAN BECAUSE SHE WAS GOING OUT OF TOWN. CLT''S MOTHER RERPORTED THAT SHE PLACED CALAMINE LOTION ON "SPOTS" AND THAT CLT WAS ALREADY TAKING ORAL BENADRYL WITH MEDICATIONS HE TAKES ON A DAILY BASIS TO PREVENT SIDE EFFECTS OF THOSE MEDICATIONS. THE OFFICE OF DR. CALLED TO ORIGINALLY REPORT TO HEALTH DEPARTMENT ADVERSE REACTION THAT MOTHER HAD CALLED INTO THEM.

VAERS ID:313241 (history)  Vaccinated:2008-04-21
Age:11.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-05-14, Days after onset: 22
Location:Florida  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA04876
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Allodynia, Hyperaesthesia
SMQs:
Write-up: Information has been received from a pharmacist concerning her 11 year old daughter with allergic reaction to AUGMENTIN who on 21-APR-2008 was vaccinated into the arm (which arm not specified) with a dose of GARDASIL. Concomitant suspect therapy included PNEUMOVAX 23 (manufacturer unknown) into the other arm. The reporter reported that on 22-APR-2008, her daughter experienced allodynia or hyperestesia on the left thigh. She sought medical attention from her physician father. The patient had not recovered. No other details available. Additional information has been requested.

VAERS ID:313248 (history)  Vaccinated:2008-04-21
Age:23.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-14, Days after onset: 23
Location:Unknown  Entered:2008-05-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO-CYCLEN
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0804USA04961
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Myalgia, Oral contraception
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad)
Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who on 21-APR-2008 was vaccinated with her first dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included ORTHO-CYCLEN. On 21-APR-2008 the patient experienced generalized muscle aches and dizziness. The patient sought unspecified medical attention by contacting the nurse practitioner. No further information was provided. Additional information has been requested.

VAERS ID:312979 (history)  Vaccinated:2008-04-21
Age:33.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Male  Submitted:2008-05-21, Days after onset: 28
Location:New Mexico  Entered:2008-05-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none known~ ()~~0~In Patient
Other Medications:
Current Illness: None
Preexisting Conditions: History of MRSA 11/07 with reoccurrence in 01/08 treated with BACTRIM x3
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2512AA0IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB116AA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2571AA0IMRA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30013390PO 
Administered by: Private     Purchased by: Private
Symptoms: Lymphadenopathy
SMQs:
Write-up: 34 y.o. male traveling to numerous countries received MENACTRA in R delt, TWINRIX & flu in L delt. Two days later reported lymphadenopathy-size of a golf ball in R axilla-was out of town-called to be examined. Monitored daily over phone with no worsening sx. Improvement. Has history of MRSA in R groin hospitalized. Vanc. BACTRIM in 11/07 with reoccurrence in 01/08.

VAERS ID:314903 (history)  Vaccinated:2008-04-21
Age:22.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-06-03, Days after onset: 42
Location:Tennessee  Entered:2008-06-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills
Current Illness:
Preexisting Conditions: The patient had a history of kidney stones. She had no known allergies and no illness at the time of vaccination.
Diagnostic Lab Data: None.
CDC 'Split Type': 200801717
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA04840IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Anger, Anxiety, Chills, Crying, Dysphagia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad)
Write-up: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a patient''s parent, who is also a health care professional, on 23 May 2008. A 22-year-old female patient with a medical history of kidney stones, had received an intramuscular injection of IMOVAX RABIES, lot number A0484-2, as part of a pre-exposure series. Two hours later, the patient experienced chills and muscle aches. 24 hours after vaccination, the patient developed behavioral changes described as "crying, angry, anxious". She also had difficulty swallowing for 48 hours. The patient was treated with MOTRIN and XANAX and the events resolved within 48 hours. The patient had no complaints of shortness of breath or facial or throat swelling. The patient recovered from the events.

VAERS ID:317056 (history)  Vaccinated:2008-04-21
Age:23.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 53
Location:Unknown  Entered:2008-06-16, 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: Genital wart
Preexisting Conditions: Papilloma viral infection
Diagnostic Lab Data:
CDC 'Split Type': WAES0806USA00098
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise
SMQs:
Write-up: Information has been received from a 23 year old female with genital warts and a history of papilloma viral infection who on 21-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot # not provided). On 21-APR-2008 the patient reported she went to see her physician because she was "sick" (NOS) and was prescribed unspecified antibiotics. She reported that she mentioned to her physician that she was due for her second dose of GARDASIL and was then given her second dose of GARDASIL (Lot # not provided) that same day. On an unspecified date the patient returned to the clinic because she was concerned that she had received her second dose of GARDASIL when she was "sick and on antibiotics". She was seen by a different physician who she reported stated that "she should not have taken the second dose of the vaccine because she was sick and her immune system was low at that time". Additional information has been requested.

VAERS ID:317129 (history)  Vaccinated:2008-04-21
Age:0.2  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-06-13, Days after onset: 53
Location:Unknown  Entered:2008-06-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA06209
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Bowel movement irregularity, Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 12-week-old male, with no pertinent medical history or allergies, who on 21-APR-2008 or 22-APR-2008 was vaccinated orally with 1 dose of ROTATEQ. There was no concomitant medication. On approximately 21-APR-2008, post vaccination the patient developed a relatively watery stool that day and a fever that night. It has become more watery since, almost as watery as urine. The patient used to have 2 stools per day that were seedy and typical of breast feeding stools. Now the child has 1 stool every other day. The patient sought medical attention at the office. 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. This is in follow-up to report (s) previously submitted on 6/13/2008. Follow-up information received 07-Aug-2008 and 11-Aug-2008. On 22-Apr-2008 the patient experienced watery stools approximately every other day for over a month (recovered approximately 05-Jun-2008. It was also reported the patient''s symptoms eventially resolved. The patient was not immunized at the reporting healthcare facility. No further information is available.

VAERS ID:318106 (history)  Vaccinated:2008-04-21
Age:69.0  Onset:2008-05-01, Days after vaccination: 10
Gender:Male  Submitted:2008-06-27, Days after onset: 57
Location:Michigan  Entered:2008-07-02, Days after submission: 5
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: trigeminal neuralgia. craniotomy 2004. sleep apnea. restless leg syndrome. HTN.
Diagnostic Lab Data: I have visited 2 neurosurgeons and will have balloon surgery to relieve the pain July 2, 2008.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURERAHBVB5201IMLA
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURERAHAVB2361IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.01580IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Condition aggravated, Diarrhoea, Facial nerve disorder, Facial pain, Hypoaesthesia oral, Presyncope, Pyrexia, Surgery, Trigeminal neuralgia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Demyelination (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: I have a history of trigeminal neuralgia having had shin surgery in 2004. For four years I was pain-free. April 22, 2008 I had a shingles shot; by May 1, 2008 my trigeminal neuralgia was back; this time with a vengeance. Since shingles is a nerve disease and the vaccine is live I am exploring whether there is a relation between the two events. 8/19/08 Reviewed hospital medical records of 7/2-7/3/2008 FINAL DX: right trigeminal neuralgia Records reveal patient experienced recent severe worsening of sharp right facial pain w/occasional right tongue numbness. Had foreign travel approx 6 wks prior & had presyncopal episode preceded by viral illness w/fevers, chills & significant diarrhea. Resolved completely. Admitted for percutanous balloon compression of right trigeminal nerve. Did well postoperatively & d/c to home w/numbness across right distribution of trigeminal nerve w/o sharp pain as preoperative. No difficulty swallowing & temporal & masseter muscles were intact. Follow-up: To whom it may concern, I am 70 years old. In July 2004 I under went micro vascular decompression surgery to relieve cranial pain due to trigeminal neuralgia. The pain was excruciating to the extent that I didn''t know if I really wanted to continue the daily battle to endure this pain. My mental condition was that I would not let this pain rob me of everything that I hold so dearly; such as, my family, friends and pleasures of life that I really enjoy. Dr. performed the micro vascular decompression surgery. The surgery was a total success!! The pain was gone!! Recovery was pain free and soon I was back playing golf and really appreciating life. My family and friends were very supporting. In April 2008 my wife and I went on a trip; however, we needed various shots for disease prevention in this foreign country. I decided to have an additional vacciantion for ''shingles'' as several of my friends had, somehow, gotten this disease. We arrived in late April 2008. We continued our trip to the next city on our tour. It was about May 3rd or the 4th that I started to feel symptoms of trigeminal neuralgia (TN). This was mild, quick, electrical ''shots'' associated with my upper teeth on the right side of the face. At times these penetrating ''shots'' went to my right ear and toward the right temporal are. I kept this condition a secret from my wife and friends until I returned. Because of my past TN experiences I immediately contacted my Neurologist. After diagnostic evaluation Dr. sent me to Neurosurgeon. After discussions with Dr. I elected to have the percutaneous balloon compression of the trigeminal nerve procedure because it is less invasive that the procedure I had in 2004. I suffer from some numbness to the right side of the face and am experiencing some problems with chewing my food!! Small price to pay for the relief from the TN pain. I began asking myself why this condition recurred when it seemed to be gone, completely. I asked myself, what changed in my life? The only significant event was that I got several vaccinations. I don''t know if this caused or contributed to the recurrence of TN, or not. I did read, that people with shingles could suffer from the pain associated with nerve abrasion of the myelin sheath around the nerve. Therefore, I asked myself, could the shingles vaccination exacerbated a latent TN condition or brought about a recurrence of the TN pain. At this point I decided to contact the NIH. Now, I am NOT looking to file a lawsuit against anyone! Period!! I just want someone to make a microbiolgical, or pharmacological evaluation as to what I propose may have occurred. If there is some creditability to my assumptions then other, with the same TN history should be made aware of the potential side effects of having the shingles vaccination. That is it, pure and simple!! Thank you for reviewing my concerns. If you require further information contact me.

VAERS ID:319418 (history)  Vaccinated:2008-04-21
Age:45.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Unknown  Submitted:2008-06-24, Days after onset: 64
Location:New York  Entered:2008-07-11, Days after submission: 17
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': WAES0804USA04513
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Information has been received from a licensed practical nurse concerning a 45-year-old patient who on 21-APR-2008 was inadvertently vaccinated subcutaneously with 0.65 mL dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). This was not a case of product confusion, but related to an order written as "varicella vaccine." No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:319419 (history)  Vaccinated:2008-04-21
Age:  Onset:2008-04-21, Days after vaccination: 0
Gender:Unknown  Submitted:2008-06-24, Days after onset: 64
Location:New York  Entered:2008-07-11, Days after submission: 17
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': WAES0804USA04512
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from a physician concerning a patient who on 21-MAR-2008 was vaccinated with the first dose of varicella virus vaccine Live (Oka/Merck). On 21-APR-2008 the patient returned to the office and received zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (human error). No product quality complaint involved. The patient did not seek medical attention. Additional information has been requested.

VAERS ID:319455 (history)  Vaccinated:2008-04-21
Age:70.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 63
Location:Florida  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Rib fracture; Gastrooesophageal reflux disease; Cholesterol high; Hypertension; Arthritis
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0804USA06000
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1826U0SC 
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a nurse practitioner concerning a female who on 21-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The next day, on 22-APR-2008, when the patient tried to get up she had a headache and felt dizzy. The patient lied back down and she tried to get up again she "started throwing up profusely." No medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received from a health professional, concerning a 70-year-old retired female with GERD, high cholesterol, hypertension and arthritis. On 21-Apr-2008 at 10:15 the patient was vaccinated subcutaneously with a first dose of zoster vaccine live (Oka/Merck: 659404/1826U). It was reported that at the time of vaccination the patient was recovering from a fractured rib. On 22-Apr-2008 (also reported as 22-May-2008) the patient notified the physician''s office that she had nausea and vomiting which improved within 24 hours. There was no fever and no abdominal pain. There were no diagnostic or laboratory tests performed. The patient recovered from the nausea and vomiting on 23-Apr-2008. Additional information has been requested.

VAERS ID:319587 (history)  Vaccinated:2008-04-21
Age:69.0  Onset:2008-04-25, Days after vaccination: 4
Gender:Female  Submitted:2008-06-24, Days after onset: 60
Location:Missouri  Entered:2008-07-11, Days after submission: 17
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: Unknown
CDC 'Split Type': WAES0805USA03972
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed nurse concerning a 69 year old white female who on 21-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) injection (lot# 659763/1875U). On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and right back. The patient was being treated by a physician at the time of reporting. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a licensed practical nurse concerning a 69 year old female with no drug allergies who on 21-APR-2008 was subcutaneously vaccinated into left arm with ZOSTAVAX (Merck) injection (lot# 659761/1875U). On 25-APR-2008, the patient experienced a rash under her right breast spreading to the right side and rigth back. The patient was being treated by a physician. The physician did diagnose with shingles when the patient was seen. As the time of report the patient didn''t recover. No further information is available.

VAERS ID:319612 (history)  Vaccinated:2008-04-21
Age:60.0  Onset:2008-04-28, Days after vaccination: 7
Gender:Female  Submitted:2008-06-24, Days after onset: 57
Location:Ohio  Entered:2008-07-11, Days after submission: 17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified); PAXIL; vitamins (unspecified)
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA04094
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Oral herpes
SMQs:, Oropharyngeal infections (narrow)
Write-up: Information has been received from a 60-year-old female, with no pertinent medical history or allergies, who on 21-APR-2008 was vaccinated in the arm with a "single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified), "WELCORE'' and PAXIL. On approximately 28-APR-2008, "about 3 weeks ago," the patient developed two cold sores on her lip both in different locations. She developed the first cold sore three weeks ago and the second cold sore one week ago. The patient reported she has never had any cold sores in her lifetime until after receiving zoster vaccine live (Oka/Merck). The patient did not seek medical attention. No diagnostic labs or procedures 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:319010 (history)  Vaccinated:2008-04-21
Age:15.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-07-08, Days after onset: 77
Location:Iowa  Entered:2008-07-15, 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: FOCALEN XR 20mg
Current Illness: cold/sinus infection
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2551AA0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Dyspnoea, Eye swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Swelling in eyes, coughing, trouble breathing.

VAERS ID:321724 (history)  Vaccinated:2008-04-21
Age:14.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-08-08, Days after onset: 109
Location:Unknown  Entered:2008-08-11, 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: DEPO-PROVERA
Current Illness: Pregnancy NOS (LMP = 1/25/2008)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 7/24/08, possible atrial septal defect of the fetus; beta-human chorionic, positive
CDC 'Split Type': WAES0806USA07784
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a physician concerning a 14 year old female who in February of 2008 was seen for an emergency contraceptive prevention. On 21-APR-2008 the patient was vaccinated with a first dose of GARDASIL (lot number) 0.5 ml by intramuscular injection (injection site not reported). Concomitant therapy included DEPO-PROVERA. Later the patient was found to be pregnant. At the time of this report the patient was in her 21st week of gestation. Unspecified medical attention was sought. Follow-up information was received from a nurse practitioner who reported that on 24-JUL-2008 the patient had a prenatal ultrasound performed, which revealed possible atrial septal defect of the fetus. Possible atrial septal defect was considered to be a congenital anomaly. Additional information has been requested.

VAERS ID:324300 (history)  Vaccinated:2008-04-21
Age:17.0  Onset:2008-04-28, Days after vaccination: 7
Gender:Unknown  Submitted:0000-00-00
Location:North Carolina  Entered:2008-09-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B019AA6IMRA
Administered by: Private     Purchased by: Public
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Per phone call - sx appeared 7d after injection - mom describes. Rash that looked like large whelps resembling "ring-worm" - faded away after 5-7d with meds - rash was on back arms - hips.

VAERS ID:331122 (history)  Vaccinated:2008-04-21
Age:71.0  Onset:2008-07-01, Days after vaccination: 71
Gender:Female  Submitted:2008-11-03, Days after onset: 125
Location:Wisconsin  Entered:2008-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: metoprolol prilosec
Current Illness: None
Preexisting Conditions: osteoporosis mild, occasional irregular heath beat.
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
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Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1822U PRI0UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Anaplastic large cell lymphoma T- and null-cell types, Condition aggravated, Local reaction
SMQs:, Malignant tumours (narrow), Skin malignant tumours (broad), Malignant lymphomas (narrow)
Write-up: Large reaction measuring 2.5 inches by 1.5 inches. Possibly caused CTCL (cutaneous T cell lymphoma) to spread over the entire length of arms when it previously was confined to two patches.

VAERS ID:337638 (history)  Vaccinated:2008-04-21
Age:43.0  Onset:2008-05-07, Days after vaccination: 16
Gender:Male  Submitted:2009-01-19, Days after onset: 257
Location:Texas  Entered:2009-01-19
Life Threatening? Yes
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: Pt had mid LAD lesion on coronary catherization requiring mid Left anterior descending TAXIS (drug eluting) stent placement. After 180 days of rehabilitation pt was returned to duty. Follow-up coronary artery calcium score was low for calcium deposition and pt does not have HTN/HLP. 4-5 cases of MI have been reported associated with anthrax vaccination. 1/27/09-records received-Echocardiogram: Moderate apical wall hypokinesis and moderate anterior wall hypokinesis.
CDC 'Split Type':
Vaccination
Manufacturer
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Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSUNKNOWN1IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB525BA1IMUN
Administered by: Military     Purchased by: Military
Symptoms: Catheterisation cardiac abnormal, Computerised tomogram coronary artery, Coronary arterial stent insertion, Coronary artery occlusion, Echocardiogram, Hypokinesia, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt developed Myocardial infarction and MI a week after administration of Anthrax vaccination. Pt did not have any coronary risk factors (no family history of CAD/MI, No HTN, No HLP). Pt is healthy and active. 1/27/09-records received-Acute myocardial infarction.

VAERS ID:347772 (history)  Vaccinated:2008-04-21
Age:1.3  Onset:2008-05-09, Days after vaccination: 18
Gender:Female  Submitted:2009-05-15, Days after onset: 371
Location:Massachusetts  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA03797
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1918U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Varicella post vaccine
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 16 month old female with no known allergies or pertinent medical history who on 21-APR-2008 was vaccinated with a single dose of VARIVAX (Merck) (lot # 659432/1918U). There was no concomitant medication. The physician reported that on 09-MAY-2008 the patient developed a rash at the injection site and soon after developed chickenpox. Viral count was performed (result was not provided). The patient''s rash at the injection site and chickenpox persisted. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:350335 (history)  Vaccinated:2008-04-21
Age:16.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2009-06-26, Days after onset: 431
Location:Unknown  Entered:2009-06-29, 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: ABILIFY; PROZAC; TRILEPTAL
Current Illness: Pregnancy NOS (LMP = 8/8/2008); Depression; Attention deficit disorder; Obsessive-compulsive disorder; Post-traumatic stress dis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0810USA01631
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a healthcare professional through a Pregnancy Registry for GARDASIL concerning a 17 year old female with depression, attention deficit disorder, obsessive compulsive disorder and post-traumatic stress disorder who on 20-FEB-2008, 21-APR-2008 and 26-AUG-2008 was vaccinated with the first, second and third dose of GARDASIL, the second dose on 21-APR-2008 and third dose on 26-AUG-2008 (lot#s 659653/1448U, unidentifiable and 660620/0571X respectively). Concomitant therapies included ABILIFY, PROZAC and TRILEPTAL. The patient''s last menstrual period was reported as 08-AUG-2009, EDD: 15-MAY-2009. Follow up information was received from nurse in physician''s office via a phone call who reported the patient had a termination in November 2008. The patient was doing fine and there was no sequelae from the vaccination. Upon internal review, a termination (abortion) was determined to be an other important medical event. Additional information has been requested.

VAERS ID:455306 (history)  Vaccinated:2008-04-21
Age:0.2  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2012-05-10, Days after onset: 1480
Location:West Virginia  Entered:2012-05-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None at the time
Diagnostic Lab Data: My child was a typical baby until he received the 12 month vaccine. Then there was a significant change. He was diagnosed with autism at 26 months.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSACZ1B145AA0IMRL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERUF240AB0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458870UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0019X0PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Autism spectrum disorder, Body temperature increased, Crying
SMQs:, Neuroleptic malignant syndrome (broad), Depression (excl suicide and self injury) (broad)
Write-up: Temperature of 101.0 for about a day. My child was inconsolable for 6 hours after the vaccination. He cried the entire 6 hours nonstop. At birth he was given the same vaccine without my knowledge and as a result had a high fever and was given IV antibiotics. My son now has an Autism spectrum disorder.

VAERS ID:311226 (history)  Vaccinated:2008-04-21
Age:26.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-29, Days after onset: 8
Location:Foreign  Entered:2008-04-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cileste (ethinyloestradiol + norgestimate)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0517559A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB392A0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Body temperature increased, Dizziness, Gait disturbance, Malaise, Pallor, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional (nurse) and described the occurrence of mild anaphylactic reaction in a 26-year-old female subject who was vaccinated with Engerix B adult (GlaxoSmithKline). The subject had neither relevant medical history nor allergy. Concurrent medication included Cilest. On 21 April 2008, the subject received unspecified dose of Engerix B adult (unknown route and injection site, not number not provided). On 21 April 2008, less than one day after vaccination with Engerix B adult, the subject experienced lightheadedness, wobbly legs and her temperature raised slightly. At the time of reporting, the events were unresolved. Follow up information received on 25 April 2008; On 21 April 2008, the subject received 1st dose of Engerix B adult (intramuscular, left deltoid). On 21 April 2008, 3 hours after vaccination with Engerix B adult, the subject experienced mild anaphylactic reaction with wobbly legs, lightheadedness, general malaise, pallor and fever. The healthcare professional considered the events were clinically significant (or requiring intervention). On 22 April 2008, the events were unresolved. The vaccination course with Engerix B was discontinued. The healthcare professional considered the events were almost certainly related to vaccination with Engerix B adult.

VAERS ID:311535 (history)  Vaccinated:2008-04-21
Age:0.1  Onset:2008-04-24, Days after vaccination: 3
Gender:Male  Submitted:2008-05-02, Days after onset: 8
Location:Foreign  Entered:2008-05-02
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UPPER RESPIRATORY TRACT INFECTION
Preexisting Conditions:
Diagnostic Lab Data: Eosinophil percentage 25Apr2008 2%; Hematocrit 25Apr2008 31%; Lymphocyte percentage 25Apr2008 63%; Monocyte percentage 25Apr2008 5%; Segmented neutrophil percentage 25Apr2008 30%; White blood cell count 25Apr2008 8900/mm3
CDC 'Split Type': A0725161A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMRL
Administered by: Other     Purchased by: Other
Symptoms: Cyanosis, Eosinophil count normal, Haematocrit decreased, Hypotonic-hyporesponsive episode, Lymphocyte count increased, Monocyte count normal, Neutrophil count decreased, Upper respiratory tract infection, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: This male subject was enrolled in the prophylactic double-blind study. On 21 April 2008, he received the 1st dose of 10-PN-PD-DIT or control ENGERIX B (IM R thigh) and co-administration of either INFANRIX HEXA or INFANRIX-IPV/HIB (IM L thigh). Other vaccinations also included: BCG vaccine (unknown manufacturer) administered on 03 March 2008, and hepatitis B vaccine (unknown manufacturer) administered on 06 March 2008. The subject had been randomized to receive the control ENGERIX B and co-administration of INFANRIX-IPV/HIB. Medical conditions at the time of the event included upper respiratory tract infection. On 24 April 2008, three days after the 1st dose of Blinded vaccine, this two-month-old subject developed hypotonic-hyporesponsive episode. The subject was hospitalised and the event was life-threatening. The subject was treated with observation. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the hypotonic-hyporesponsive episode may have been caused by investigational product and that the event was possibly an incidental illness or due to his medical condition. Investigator comments: 24 April 2008, while the subject was sleeping, he presented generalized hypotonic episode with peribuccal and acral cyanosis that lasted seconds. He consulted at the emergency room and the physician decided on hospitalization. Hospital admission was on 25 April 2008 with diagnosis of generalized hypotonic episode and upper respiratory tract infection. Physical examination was normal. Hospital treatment was observation.

VAERS ID:311924 (history)  Vaccinated:2008-04-21
Age:1.5  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-05-08, Days after onset: 16
Location:Foreign  Entered:2008-05-09, 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: Familial risk factor; Milk allergy
Preexisting Conditions: Immunodeficiency; Rash
Diagnostic Lab Data: Body temperature 24-Apr-2008 38 deg. C.; C-reactive protein 25-Apr-2008 increased; Red blood cell sedimentation rate 25-Apr-2008 increased; White blood cell count 25-Apr-2008 leucocytosis
CDC 'Split Type': SKWYEH03800308
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein increased, Injection site reaction, Leukocytosis, Oedema peripheral, Pyrexia, Rash erythematous, Rash generalised, Rash macular, Red blood cell sedimentation rate increased, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Follow-up information was received that upgraded the case to serious, as the physician considered the events to be medically important and also a provided medical history update, laboratory results, event details including the additional events of macular rash and ankle edema, treatment and recovery status. This case was considered medically important. Information regarding Prevenar was received from a healthcare professional regarding an 18-month-old male patient who experienced exanthema generalized, injection site reaction and fever. The patient received the first dose on 21-Apr-2008. The patient''s concurrent illnesses include familiar risk factor (family history of atopic dermatitis (mother)) and milk allergy with a past history of immunodeficiency (in past therapies with Zaditen, Dimentiden Maleas/Fenistil/, Desloratadine/Aerius.) and rash (of unknown origin). Product was administered on 21-Apr-2008. Concomitant medications were not reported. The patient experienced exanthema generalized described as maculous and confluens associated with ankle edema and injection site reaction on 22-Apr-2008 and fever on 24-Apr-2008. The reporter noted the events could have been an (possible) allergic reaction to the vaccine or an allergic reaction to a food component. Treatment included Zyrtec. On 28-Apr-2008 the patient had recovered from all the events. The Pediatrician decided not to continue with Prevenar. Body temperature (results: 38 deg. C.) was done on 24-Apr-2008. On 25-Apr-2008 test results were: white blood cell count (results: leucocytosis); red blood cell sedimentation rate (results: increased); and c-reactive protein (results: increased). No additional information was available at the time of this report.

VAERS ID:312164 (history)  Vaccinated:2008-04-21
Age:2.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-12, Days after onset: 21
Location:Foreign  Entered:2008-05-13, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: physical examination 25Apr08 Comment: see narrative; WBC count 25Apr08 18.6 x10[9]; blood CD4/CD8 ratio 25Apr08 26.4%; body temp 25Apr08 36.7; hemoglobin 25Apr08 110 g/L; neutrophil count 25Apr08 64.9%; platelet count 25Apr08 112 x10[9]
CDC 'Split Type': WAES0804CHN00029
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.J2065 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, CD4/CD8 ratio, Haemoglobin normal, Injection site erythema, Injection site induration, Injection site infection, Injection site pain, Injection site pustule, Injection site swelling, Neutrophil percentage, Pharyngeal erythema, Platelet count decreased, Pyrexia, Rhinorrhoea, Skin warm, Tonsillar hypertrophy, Upper respiratory tract infection, White blood cell count increased
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician at epidemiology department of local CDC through hospitalization record and vaccination investigation form concerning a 26 month old male who on 21-APR-2008 was vaccinated with PNEUMOVAX, 0.5ml, IM. Before vaccination, the boy was healthy and no concomitant therapy was reported. On 21-APR-2008 the boy experienced injection site swelling and pain with fever (detail unknown) and runny nose. On 25-APR-2008 the boy was sent to hospital and physical examination showed a little pustule on injection site, injection site erythema, swelling and induration, pain was obvious when pressing the injection site and skin temperature was higher than normal. His body temperature was 36.7 and lab examination showed WBC was 18.6, neutrophil was 64.9, blood CD4/CD8 ratio was 26.4, hemoglobin was 110 and platelet count was 122. He was hospitalized with the admitting diagnosis of reactive infection in left arm injection site and acute upper respiratory tract infection (suspected). Physical examination showed pharynx a little red and I degree of tonsil enlargement. The boy was recovered from reactive infection in left arm injection site with the treatment of anti-infection (detail unknown) and was discharged from the hospital on 28-APR-2008. The boy''s discharge diagnosis was reactive infection in left arm injection site. The reporter felt that reactive infection in left arm injection site were related to therapy with PNEUMOVAX. Additional information has been requested.

VAERS ID:312426 (history)  Vaccinated:2008-04-21
Age:0.3  Onset:2008-04-24, Days after vaccination: 3
Gender:Female  Submitted:2008-05-15, Days after onset: 21
Location:Foreign  Entered:2008-05-16, 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: abdominal X-ray, 24?Apr08, results: intussusception
CDC 'Split Type': WAES0805AUS00131
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal X-ray, Angiopathy, Barium double contrast, Enema administration, Intestinal mass, Intussusception, Irritability, Lethargy, Rectal haemorrhage, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Information has been received from a physician in the form of a completed questionnaire as part of a study conducted by the foreign Paediatric Unit (APSU). This report is part of a post-marketing surveillance program. The patient is a four month old female infant who was full term and weighed 3.354 kg at birth. On 25-FEB-2008 the infant was vaccinated with her first dose of Rotateq and on 21-APR-2008 she was vaccinated with her second dose of Rotateq. According to the current immunisation schedule recommendations in the country, the infant was up-to-date - she had received her four-month immunisation three days prior to vaccination. There was no concomitant therapy and the infant had not received any other vaccines within the previous two weeks. Subsequently, on 24-APR-2008 the infant was admitted to hospital with intussusception. The infant did not have a previous history of intussusception and it was not known if there was a family history of intussusception. She had not had any previous significant illnesses, hospitalisations or operations. The infant was fed a formula and it was not known if there was any feeding intolerance/food sensitivities or changes to her diet in the last week prior to hospitalisation. The diagnosis of intussusception was made by an abdominal x-ray of the mid-transverse colon. The signs and symptoms of intussusception included features of intestinal invagination with intestinal mass and a plain abdominal x-ray showing IS; and intestinal vascular compromise or venous congestion with passage of blood per rectum. Other symptoms included vomiting, lethargy and irritability. The signs and symptoms of intussusception were present 12-23 hours prior to diagnosis. No faecal samples were collected. The infant was successfully treated with an air enema. There was no lead point or other pathology identified. The infant was discharged alive on 25-APR-2008. It was not reported whether or not intussusception was related to Rotateq. Additional information is not expected.

VAERS ID:312941 (history)  Vaccinated:2008-04-21
Age:0.6  Onset:0000-00-00
Gender:Male  Submitted:2008-05-21
Location:Foreign  Entered:2008-05-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0057355A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA362A0IMLA
PNC: PNEUMO (PREVNAR)PFIZER/WYETH289430IMRA
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Crying, Febrile convulsion, Pyrexia, Restlessness, Systemic inflammatory response syndrome, Vaccination complication, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Tumour lysis syndrome (broad)
Write-up: This case was reported by a regulatory authority ((vaccines, biologicals) # DE-PEI-PEI2008006255) and described the occurrence of systemic inflammatory response syndrome in a 6-month-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline). Co-suspect vaccination included PREVENAR (Wyeth). On 9 February 2008 the subject received 1st dose of INFANRIX (unknown route and application site) and 1st dose of PREVENAR (unknown route and application site). The vaccine was reported as INFANRIX, but the lot number was INFANRIX HEXA. At an unspecified time after vaccination with INFANRIX HEXA and PREVENAR the subject developed fever, restlessness, crying and infection-induced convulsion. On 21 April 2008 the subject received 2nd dose of INFANRIX HEXA (intramuscular, unknown thigh) and 2nd dose of PREVENAR (intramuscular, unknown thigh). On the same day the subject experienced vaccination complication with systemic inflammatory response syndrome (SIRS). The subject was hospitalised. On 27 April 2008, the events were resolved. After the next vaccination with INFANRIX HEXA the events recurred. No further information will be available.

VAERS ID:313042 (history)  Vaccinated:2008-04-21
Age:17.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-22, Days after onset: 31
Location:Foreign  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0057331A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NG34780 UNUN
TD: TD ADSORBED (TD-RIX)GLAXOSMITHKLINE BIOLOGICALSAC12B016GA UNRA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (vaccines, biologicals) # DE-PEI-PEI2008006370) and described the occurrence of burning sensation in a 17-year-old female subject who was vaccinated with TD-RIX (GlaxoSmithKline). Co-suspect vaccination included GARDASIL (Sanofi Pasteur MSD). Previous vaccination included a booster dose of TD-RIX (GlaxoSmithKline) given in 1996 and GARDASIL (Sanofi Pasteur MSD) given on 25 February 2008. On 21 April 2008 the subject received a dose TD-RIX (unknown route, right upper arm) and a dose of GARDASIL (unknown route, left upper arm). Few hours after co-administered vaccination with GARDASIL and TD-RIX, the subject experienced burning sensation, tingling and itching of both feet, lower legs, both hands and arms over a period of 10 days. The subject was hospitalised. No further information will be available.

VAERS ID:313152 (history)  Vaccinated:2008-04-21
Age:2.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-22, Days after onset: 31
Location:Foreign  Entered:2008-05-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: culture stool (results: detection of rotavirus); electroencephalogram (results: no results provided); base excess (results: -10.3 mmol/L); c-reactive protein (results: 9 mg/L); alanine aminotransferase (results: 34 IU/L); and pH body fluid (results: 7.355)
CDC 'Split Type': DEWYEG01544508
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA386A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH311081IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Base excess negative, Blood pH normal, C-reactive protein increased, Culture stool positive, Diarrhoea, Electroencephalogram, Pyrexia, Rotavirus infection, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority (PEI) regarding a 23-month-old female patient who experienced rotavirus infection, fever, diarrhoea and vomiting. The patient received the second dose on 21-Apr-2008. The patient previously experienced pyrexia and diarrhoea after first vaccination with PREVENAR and third vaccination with INFANRIX HEXA on 21-Nov-2006 (see related case DE-WYE-G01545408). Past vaccinations also included INFANRIX HEXA, PREVNAR on 27-Jul-2006 (first dose) and on 25-Aug-2007 (second dose). Concomitant medications were not reported. After vaccination the patient experienced fever on 21-Apr-2008 and diarrhoea and vomiting on 24-Apr-2008. The patient was hospitalised on an unknown date in Apr-2008. In hospital, a stool culture revealed rotavirus. The patient''s fever resolved by 26-Apr-2008 and the diarrhoea and vomiting by 27-Apr-2008. It was unknown on which date the patient recovered from rotavirus. Overall, the patient recovered completely. The healthcare professional''s assessment of relatedness between the adverse events and INFANRIX HEXA was possibly related. In Apr-2008 test results were: culture stool (results: detection of rotavirus); electroencephalogram (results: no results provided); base excess (results: -10.3 mmol/L); c-reactive protein (results: 9 mg/L); alanine aminotransferase (results: 34 IU/L); and pH body fluid (results: 7.355). See related case (s): DE-WYE-G01545408 (adverse event, non-expedited). This case is being treated according to the foreign Act.

VAERS ID:314031 (history)  Vaccinated:2008-04-21
Age:0.3  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-05-28, Days after onset: 36
Location:Foreign  Entered:2008-05-29, 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: diagnostic laboratory test, 22Apr08, WBC test; serum C-reactive protein, 22Apr08; hepatic function tests, 22Apr08, seemed disturbed
CDC 'Split Type': WAES0805USA04822
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein, Cyanosis, Diarrhoea, Laboratory test, Liver function test abnormal, Lividity, Moaning, Peripheral circulatory failure, Pyrexia, Somnolence, White blood cell count
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a health authority concerning a 3 month old (6 kg) female on 21-APR-2008 was vaccinated PO with a dose of ROTATEQ (batch# not reported, lot# not reported and dose series not reported). On 22-APR-2008 (12 hours later) the patient experienced peripheral circulatory failure, had a grey skin color (lividity) and blue feet (acrocyanosis); he was sleepy and moaning, and had fever and diarrhea. The patient was hospitalized. Laboratory diagnostic studies included: a CRP and WBC test (no results reported) as well as some liver tests which seemed disturbed. The patient recovered on 25-APR-2008. The events were also considered to be other important medical events by the reporter. Other business partner numbers include: E2008-04475. Additional information has been requested.

VAERS ID:316306 (history)  Vaccinated:2008-04-21
Age:0.6  Onset:2008-05-01, Days after vaccination: 10
Gender:Male  Submitted:2008-06-13, Days after onset: 43
Location:Foreign  Entered:2008-06-16, 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: The patient previously experienced pyrexia, febrile convulsion, crying, restlessness, chills, gastroenteritis norovirus with diarrhoea after first vaccination with PREVENAR on 09-Feb-2008 (see related case DE-WYE-G01550508) and systemic inflammatory response syndrome, acute tonsillitis, epipharyngitis and inflammation of the auditory tube on both sides after second vaccination with
Diagnostic Lab Data: In May-2008 test results were: culture stool (results: no detection of E. coli, Enterococcus sp., Rotavirus, Adenovirus, Norwalk virus); coagulation test (results: Quick 90%, INR 1.1, PTT 30.7 sec, Fibrinogen 656 mg/dL); blood gases (result
CDC 'Split Type': DEWYEG01682108
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA362A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH289431IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase normal, Antimitochondrial antibody normal, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Aspartate aminotransferase normal, Base excess decreased, Base excess negative, Basophil percentage decreased, Blood alkaline phosphatase normal, Blood bicarbonate decreased, Blood bilirubin normal, Blood calcium normal, Blood creatinine normal, Blood culture negative, Blood fibrinogen increased, Blood glucose normal, Blood immunoglobulin E, Blood magnesium normal, Blood pH normal, Blood phosphorus normal, Blood potassium normal, Blood pressure, Blood sodium normal, Blood urea normal, Blood uric acid normal, Body height above normal, Body temperature increased, C-reactive protein increased, Complement factor C3, Complement factor C4, Culture stool negative, Cyclic citrullinated peptide A increased, Eosinophil percentage decreased, Fluid intake reduced, Gamma-glutamyltransferase normal, Gene mutation identification test positive, General physical health deterioration, Haematocrit decreased, Haemoglobin decreased, Head circumference abnormal, Heart rate increased, Hyperaesthesia, Inflammation, International normalised ratio, Lipase normal, Lymphocyte percentage, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Monocyte percentage, Nasopharyngitis, Neutrophil percentage decreased, Oxygen saturation normal, PCO2 normal, Platelet count increased, Prothrombin time, Pyrexia, Respiratory rate increased, Rheumatoid factor negative, Urine analysis normal, Virus serology test, Weight below normal, White blood cell count, pH urine
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Noninfectious diarrhoea (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 7- month-old male patient who experienced inflammatory reaction of unclear genesis, fever up to 40C, common cold, general condition worsened, lower limbs touch-sensitive and increase of drinking refusal. The patient received the second dose on 21-Apr-2008. The patient experienced fever up to 40C on 02-May-2008. Except of mild common cold the patient did not show any other signs of infection. The patient experienced increase of drinking refusal and his general condition worsened. The patient''s mother felt that the patient''s lower limbs were touch-sensitive. No other findings were reported by the parents. The patient was hospitalised again on 03-May-2008. The diagnosis was inflammatory reaction of unclear genesis. The patient was treated with CEFUROXIME (intravenous) and IBUPROFEN (oral, as juice) and inhaled with solution of sodium chloride. The fever already resolved by the second day in hospital and the patient''s general condition improved. No focus of infection was diagnosed. Due to no clear results of gene tests the hospital recommended further testing, especially regarding familial Mediterranean fever. The patient recovered and was discharged on 09-May-2008.

VAERS ID:317979 (history)  Vaccinated:2008-04-21
Age:14.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-06-30, Days after onset: 70
Location:Foreign  Entered:2008-07-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA08417
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0275U2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Glomerulonephritis minimal lesion, Nephrotic syndrome, Wrong technique in drug usage process
SMQs:, Chronic kidney disease (broad)
Write-up: Information has been received from a physician concerning a 14 year old with no relevant medical history reported, who on 21-APR-2008 was vaccinated with the third dose of GARDASIL (Lot # 0275U, Batch NF54050) via intramuscular route in her buttock. Approximately 2 months after vaccination the patient experienced a lipoid nephrosis with a nephrotic syndrome. She was prescribed 1 mg/kg/day of corticosteroids not otherwise specified. Renal puncture biopsy was not scheduled up today. The reporter considered this case medically significant and potentially serious. At the time of the reporting the patient had not recovered. Lipoid nephrosis was considered to be an other important medical event. Other business partner numbers included: E2008-05670. Additional information has been requested.

VAERS ID:333828 (history)  Vaccinated:2008-04-21
Age:0.2  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-12-03, Days after onset: 225
Location:Foreign  Entered:2008-12-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811AUS00212
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21FA289A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21FA289A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21FA289A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21FA289A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH28591 UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1260U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gastrointestinal tube insertion, Somnolence, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information was obtained on request by the Company from the agency via a Public Case Detail Form and a Case Line Listing concerning a 9 week old female who on 21-APR-2008 was vaccinated with ROTATEQ (Batch # 1260U, Lot #658617/1260U, Expiry date 31-MAR-2009). Other suspect therapy included INFANRIX HEXA (Batch # A21FA289A) and PREVENAR (Batch #28591). On 22-APR-2008 the patient experienced somnolence and was hospitalised. It was described that the vaccines were given at lunchtime. The next morning, the child was unable to rouse for feeding at 8 am and 1 pm. The child was being fed via a tube. At the time of reporting to the agency on 11-JUN-2008, the outcome of somnolence was unknown. The agency considered that somnolence was possibly related to therapy with ROTATEQ, INFANRIX HEXA and PREVENAR. The original reporting source was not provided. Additional information is not expected.

VAERS ID:335270 (history)  Vaccinated:2008-04-21
Age:18.0  Onset:2008-07-16, Days after vaccination: 86
Gender:Female  Submitted:2008-12-12, Days after onset: 149
Location:Foreign  Entered:2008-12-15, Days after submission: 3
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KESTINE; NASACORT; SERETIDE; albuterol
Current Illness: Pollen allergy; Allergic asthma; Overweight
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812USA02421
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autopsy, Death, Headache, No reaction on previous exposure to drug, Pain, Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic cerebrovascular conditions (narrow)
Write-up: Information has been received from a general practitioner concerning an 18 year old female with pollen allergy, allergic asthma and who was overweight, with a family history of the mother having multiple sclerosis, who on 12-MAR-2008 was vaccinated with the first dose of GARDASIL, lot # not reported, which was well tolerated. It was reported that the second dose of GARDASIL, lot # not reported, was given intramuscularly (IM) to the right deltoid on 21-APR-2008. Concomitant therapy included SERETIDE, albuterol, NASACORT and KESTINE. There was no contraceptive use. On 16-JUL-2008 the patient experienced sudden brutal cephalgia and then she suffered from a pain evocating an aneurysm during rupture. The patient suddenly died in spite of resuscitation technique performed by the agency which evoked a ruptured aneurysm. An autopsy was on-going and the results would be provided. As to the reporter there may not be any link between adverse effect and vaccination. The reported cause of death by the ageny was ruptured cerebral aneurysm, but it had not been confirmed yet by the results of the autopsy which were still pending. Additional information has been requested. Other business partner numbers include E2008-11575.

VAERS ID:387058 (history)  Vaccinated:2008-04-21
Age:14.0  Onset:2008-05-26, Days after vaccination: 35
Gender:Female  Submitted:2010-05-07, Days after onset: 711
Location:Foreign  Entered:2010-05-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electroencephalography, ??May?08, normal; Magnetic resonance imaging, ??May?08, normal
CDC 'Split Type': WAES1005USA00230
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a nurse from the County Health Unit concerning a 14 year old female who on 21-APR-2008 was vaccinated with a third dose of GARDASIL at school. On 26-MAY-2008, 35 days after the patient received her third dose, she began suffering from seizures and has continued since then. When the patient first started having seizures she was admitted to the epilepsy unit of a hospital for 1 week. Her EEG (electroencephalography) was normal then as well as her MRI (magnetic resonance imaging). It was reported that the patient has continued to have seizures, she could sometimes have clusters of them that could last up to 40 minutes. The seizures sometimes occurred daily and other times she only had them 2 or 3 times a week. Causal relationship between GARDASIL and seizures was not reported. Additional information has been requested.

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