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Case Details (Sorted by Vaccination Date)

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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:311425 (history)  Vaccinated:2008-04-18
Age:1.3  Onset:2008-04-29, Days after vaccination: 11
Gender:Female  Submitted:2008-05-01, Days after onset: 2
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: no
Current Illness: no
Preexisting Conditions: eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.042840IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1916U IMLL
Administered by: Private     Purchased by: Private
Symptoms: Blister, Rash maculo-papular
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)
Write-up: diffuse macular papular rash with a few vesicles, no fever or other symptoms

VAERS ID:314744 (history)  Vaccinated:2008-04-18
Age:77.0  Onset:2008-05-13, Days after vaccination: 25
Gender:Male  Submitted:2008-05-27, Days after onset: 14
Location:Ohio  Entered:2008-06-03, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin; Hydroxygenase; Flomax; Fosamax; Atenolol
Current Illness: None
Preexisting Conditions: Polyerythemia Vera
Diagnostic Lab Data: Cultures taken. Diagnosed as chicken pox.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Culture positive, Pyrexia, Rash, Varicella
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: On evening of 5/13/08, started running a temperature (101) and started breaking out with a rash. On 5/15/08, went to doctor. Culture taken. Diagnosed with chicken pox. Put on Tylenol and Valtrex (first for 5 days and then for an additional 7 days.

VAERS ID:318973 (history)  Vaccinated:2008-04-18
Age:15.0  Onset:2008-04-25, Days after vaccination: 7
Gender:Female  Submitted:2008-07-08, Days after onset: 74
Location:Texas  Entered:2008-07-11, 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: Attention deficit/hyperactivity disorder; Penicillin allergy; Drug hypersensitivity; Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA00620
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Lip swelling, No reaction on previous exposure to drug, Oedema mouth, Oedema peripheral, Pruritus, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This is in follow-up to report(s) previously submitted on 7/8/2008. Initial and follow up information has been received from a physician and the mother of a 15 year old female (98 lb; height not reported) with attention deficit/hyperactivity disorder, allergies to penicillin, erythromycin, amoxicillin, azithromycin (ZITHROMAX), PHENERGAN with CODEINE, SILVADENE, and PROMETHAZINE with CODEINE), who on 19-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 659962/1740U; site not reported). On 18-APR-2008, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 660387/1967U; site not reported). Concomitant therapy included ADDERALL TABLETS and ORTHO EVRA. It was reported that the therapy with ORTHO EVRA started "concomitantly with the vaccine" (reported as on 18-APR-2008, 20-APR-2008 and 21-APR-2008). On approximately 25-APR-2008 (also reported as 27-APR-2008 and "within one week of the vaccine") the patient developed hives all over her body. The next morning, 26-APR-2008, the patient had swelling in her hands and feet and the patient was treated with ALLEGRA and prednisone (unspecified) (also reported as treatment occurring on 27-APR-2008 in the ER). On 27-APR-2008, the patient developed swelling on her face, mouth and lips. On 27-APR-2008, the patient went to the emergency room for outpatient treatment and received a "steroid shot" (not further specified), BENADRYL and ZANTAC. "The itching persisted for a little while and then all symptoms resolved" (date unspecified). On approximately 27-APR-2008, the patient discontinued therapy with ORTHO EVRA. It was reported that the patient had no adverse effects or problems with the first dose of GARDASIL. The physician suspected that the reactions were related to either GARDASIL or ORTHO EVRA. Additional information has been requested.

VAERS ID:332608 (history)  Vaccinated:2008-04-18
Age:0.0  Onset:2008-04-18, Days after vaccination: 0
Gender:Male  Submitted:2008-11-17, Days after onset: 213
Location:Virginia  Entered:2008-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: irregular breathing~Hib + Hep B (Comvax)~1~0.10~Patient
Other Medications:
Current Illness: Healthy newborn baby
Preexisting Conditions: None
Diagnostic Lab Data: They never did any they just looked at him and said what to look out for with his breathing.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Irregular breathing...patient was fine the first two day after he was born, no usual breathing. Right before we left the hospital they gave him the hepatitis vaccine with out consent and within a few hours I noticed he was breathing very funny. I took him to the doctor, they said he looked ok. Just to monitor his breathing. He had several issues with his nose being stuffed and they told me to get a humidifier to help with his breathing. Within a month or so his respiratory issues seemed to have cleared up. (he would breathe ok then suddenly breathe very heavy it went in intervals it continued for several weeks after he received the shot)

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? Yes, ? days
    Extended hospital stay? 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? Yes, 1 days
    Extended hospital stay? 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? Yes, 5 days
    Extended hospital stay? 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? Yes, 0 days
    Extended hospital stay? 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? Yes, 0 days
    Extended hospital stay? 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? Yes, 0 days
    Extended hospital stay? 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), Eosinophilic pneumonia (broad)
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? Yes, ? days
    Extended hospital stay? 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:Georgia  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), Tendinopathies and ligament disorders (broad)
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? Yes, 64 days
    Extended hospital stay? Yes
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), Respiratory failure (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), Tendinopathies and ligament disorders (narrow)
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? Yes, 0 days
    Extended hospital stay? 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:543268 (history)  Vaccinated:2008-04-19
Age:17.0  Onset:2008-09-01, Days after vaccination: 135
Gender:Female  Submitted:2014-09-10, Days after onset: 2200
Location:Foreign  Entered:2014-09-10
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 02/16/2008, GARDASIL, D1 (batch number NG14100)
Diagnostic Lab Data: CSF test, hyperproteinorachy, 0.73 g/l; 09/2008, CSF test, was unremarkable; 09/2008, Liver function test, ASAT: 70 ALAT 105 U/L; Neurological examination, consistent with GBS; 09/13/2008, Neurological examination, tendon reflex absent in lower limbs; Nuclear magnetic resonance imaging, Medullar: normal; Nuclear magnetic resonance imaging, Medullar: normal; Scan brain, Normal
CDC Split Type: WAES1409FRA004661
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1201U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Areflexia, Aspartate aminotransferase increased, Brain scan normal, CSF test abnormal, Diarrhoea haemorrhagic, Dysphagia, Extensor plantar response, Fatigue, Gait disturbance, Gastrointestinal tube insertion, General physical health deterioration, Guillain-Barre syndrome, Headache, Hepatocellular injury, Hypoaesthesia, Hypotonia, Immunoglobulin therapy, Influenza, Mechanical ventilation, Motor dysfunction, Mucous stools, Musculoskeletal stiffness, Neck pain, Neuralgia, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Pain in extremity, Paraesthesia, Plasmapheresis, Quadriparesis, Sensory disturbance, Tracheostomy, VIIth nerve paralysis
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Angioedema (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information received from Sanofi Pasteur MSD (mfr# E2014-08049) on 09-SEP-2014. Case received from the Health Authorities on 04-Sep-2014 under the reference number BX20141192. A 17-year-old female patient had received the first dose of GARDASIL, (batch number NG14100, lot # 0311U, expiry date 13-FEB-2010) on 16-Feb-2008 and the second dose (GARDASIL, batch number NG41880, lot # 1201U, expiry date 02-AUG-2010) on 19-Apr-2008. In Sep-2008, she developed Flu syndrome associated with bloody and mucus diarrhoea. She also experienced a deterioration of her general state, feeling of numbness in the four limbs with walking difficulties, paroxysmal frontal cephalgia and cervical stiffness. On 13-Sep-2008, the patient was hospitalized due to left facial paresthesia, motor deficiency of lower limbs and cervical pain. Tendon reflexes were absent in lower limbs and the patient was found to have epicritic sensibility disorder. Slight hepatic cytolysis with ASAT at 70 U/I and ALAT 105 U/I. There was no Guillain-Barre or myelitis sign at the first lumbar puncture. Brain scan and medullar MRI were normal. Delay of albumino-cytological dissociation up to 15 days strongly put forward a Guillain-Barre syndrome. The symptoms aggravated with impairment of the upper limbs and facial palsy, in spite of intravenous polyvalent immunoglobulins. On 17-Sep-2008, neurological functional examination was consistent with Guillain-Barre syndrome. It was confirmed at the second lumbar puncture which evidenced hyperproteinoarchy at 0.73 g/l. On 18-Sep-2008, vital capacity decreased and artificial ventilation was supplied. The patient experienced deglutition disorder and was fed by naso-gastric tube. 24-Sep-2008: tracheotomy. On 22-Oct-2008, plasma exchanges were initiated and there was an improvement at the level of the lower limbs. Artificial ventilation was stopped on 27-Oct-2008. The patient went to a rehabilitation center from 03-Nov-2008 to 25-Jun-2009 (quadriparesia prevailing on the right, global hypotonia, tendon reflexes all absent, Babinski''s sign on the right, sitting position not possible). The disease was fluctuating, alternating aggravating and stationary phases. In July 2014, the patient was found to have fatigue, numbness/formication in feet, and sometimes walking difficulties. Extended standing position was painful. She experienced intermittent pain in hands since January 2013. The Health Authorities reported the outcome of Guillain-Barre syndrome as recovered with sequelae. No assessment of the causal relationship was reported by the Health Authorities. Upon medical review the company judged relevant to code the adverse events fatigue, neuralgia, numbness of lower extremities, walking difficulties and pain in hands which were mentioned by the competent authorities in the narrative but not coded.

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:310378 (history)  Vaccinated:2008-04-21
Age:16.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-21, Days after onset: 0
Location:Connecticut  Entered:2008-04-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Ceclor
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2613AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Felt dizzy/nausea after vaccines. Had pt lie down for 15 min. 11R:64. Drank water. Sat for another 10 min. felt well at this point/no further nausea/no vomiting.

VAERS ID:310420 (history)  Vaccinated:2008-04-21
Age:2.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-21, Days after onset: 0
Location:Virginia  Entered:2008-04-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Patient observed in private PCP''s office.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHA03215AA1IMLL
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives, itching.

VAERS ID:310563 (history)  Vaccinated:2008-04-21
Age:26.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-22, Days after onset: 0
Location:Massachusetts  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:
Preexisting Conditions: cat and spider bites
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Diarrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Diarrhea, abdominal pain mild.

VAERS ID:310599 (history)  Vaccinated:2008-04-21
Age:0.5  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-22, Days after onset: 1
Location:Pennsylvania  Entered:2008-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride drops
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2651AA2UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF119AA2UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700C2UNLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1389U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Vomiting x3, afebrile- no previous illness, no family illness-discussed re-hydration and signs and symptoms of dehydration.

VAERS ID:310613 (history)  Vaccinated:2008-04-21
Age:23.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-21, Days after onset: 0
Location:Washington  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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)SANOFI PASTEURA02570IMLA
Administered by: Other     Purchased by: Private
Symptoms: Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: as soon as the injection was given patient c/o nausea and bent forward in the chair, then slipped forward onto floor and had LOC approximately 5 seconds. Assisted onto the bed, cold packs applied legs elevated, water given. Felt better after approximately 10 minutes and was ok to leave.

VAERS ID:310716 (history)  Vaccinated:2008-04-21
Age:43.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-22, Days after onset: 0
Location:Virginia  Entered:2008-04-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2826AA IMLA
Administered by: Military     Purchased by: Other
Symptoms: Arthralgia, Body temperature increased, Influenza like illness, Pain, Pharyngolaryngeal pain, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad)
Write-up: Complained of low grade temp. 99.4, flu like symptoms, body aches, sore throat, and achy joints; The patient had a mild to moderate reaction to a Tdap

VAERS ID:310740 (history)  Vaccinated:2008-04-21
Age:15.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-23, Days after onset: 2
Location:New York  Entered:2008-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2550AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Chest X-ray, Dyspnoea, Pyrexia, Tremor, Urine analysis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad)
Write-up: Fever, breathing difficulties and shaking. Chest xray, bloodwork, IV fluids and urine test.

VAERS ID:310755 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-23, Days after onset: 2
Location:California  Entered:2008-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU1965AB4UNLA
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2512AA2UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA034223UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1747U1UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness & swelling on arm at site of DTaP administration. Swelling started within 1 hour of vaccine & has been stable for 2 days.

VAERS ID:310758 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-23, Days after onset: 1
Location:Florida  Entered:2008-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSC2950AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR9424403IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1924U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 24 hours after administration, right thigh swollen 15 x 10cm where 5th DTAP was given. Advised Benadryl every 6 hours PRN.

VAERS ID:310843 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-24, Days after vaccination: 3
Gender:Female  Submitted:2008-04-24, Days after onset: 0
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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2355CA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURAO11123SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1672U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1577U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: LEFT DELTOID SWOLLEN ABOUT SIZE OF 4X5CM AND RED.

VAERS ID:310847 (history)  Vaccinated:2008-04-21
Age:0.5  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-24, Days after onset: 2
Location:Illinois  Entered:2008-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B137AA2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF221AB2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC413362IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Temp of 105F, 11 1/2 hrs post vaccine administration.

VAERS ID:310875 (history)  Vaccinated:2008-04-21
Age:1.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-24, Days after onset: 3
Location:Missouri  Entered:2008-04-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0147X0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1493U0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Reddened area on (L) thigh. Prescribed Keflex 250/5 1 tsp po bid x 10 days.

VAERS ID:310877 (history)  Vaccinated:2008-04-21
Age:2.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-24, Days after onset: 2
Location:New Jersey  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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURERU2355BA3UNRL
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURERUF239AA3UNRL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER1483U0UNRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC650432UNLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 7 cm by 5 cm swollen with induration rt upper thigh lateral area

VAERS ID:310949 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Male  Submitted:2008-04-23, Days after onset: 1
Location:Virginia  Entered:2008-04-25, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B051AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA2IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ05473SCLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0789U2SCRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Started with redness and swelling, no fever.

VAERS ID:311044 (history)  Vaccinated:2008-04-21
Age:0.4  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-22, Days after onset: 1
Location:Alabama  Entered:2008-04-28, 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: Lactulose
Current Illness: Constipation
Preexisting Conditions: Constipation
Diagnostic Lab Data: WBC 13.2, hemoglobin 11.1, platelets 189, 46 lymphs; 46 neuts
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B145AA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF193AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC575431IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1828U1PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Irritability, Lymphocyte count increased, Neutrophil count decreased, Pyrexia
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Fussiness; fever to 104 on evening of 4/21/08, leg swelling at injection site

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? Yes, 1 days
    Extended hospital stay? 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:, Tendinopathies and ligament disorders (broad)
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:311372 (history)  Vaccinated:2008-04-21
Age:11.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-30, Days after onset: 9
Location:Wisconsin  Entered:2008-04-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Over the counter Vitamin with Iron
Current Illness: None
Preexisting Conditions: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0086X1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site induration, 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: Within 24 hours arm at injection site approximately 5 - 6" in diameter, is hard, hot and itchy. Mother gave daughter Benadryl. Remained swollen approximately 48 hours. Did not miss school. Did not see a doctor.

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), Tendinopathies and ligament disorders (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:311699 (history)  Vaccinated:2008-04-21
Age:0.5  Onset:2008-04-23, Days after vaccination: 2
Gender:Male  Submitted:2008-05-05, Days after onset: 12
Location:New Jersey  Entered:2008-05-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: eczema-milk allergy 6/12/08-records received-PMH:eczema. RAST negative. Milk protein and soy allergy.
Diagnostic Lab Data: Rotavirus-stool x 1= NEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC2B14502IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURF356AA2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499172IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1636U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Oral intake reduced, Rotavirus test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Patient received Pediarix, Hib, Prevnar and Rotateq. Started with gastroenteritis later (vomiting + diarr)- Required 2 ER visits and finally admitted for Bowel Rest 1 week later 6/12/08-records received for DOS 4/27-4/30/08-presented to ED with nonbloody vomiting and diarrhea times 5 days. Two days after vaccination began having loose stools. Decreased oral intake, watery stools. Third visit to ED with dehydration and vomiting. DX:acute gastroenteritis.

VAERS ID:311755 (history)  Vaccinated:2008-04-21
Age:43.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-05-06, Days after onset: 15
Location:Arizona  Entered:2008-05-06
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: CAT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB438AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Computerised tomogram, Head injury, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: It appeared as if the patient had syncope within one minute of injection completion. She had a loss of consciousness for approx. 10-15 seconds. The patient became extremely diaphoretic with nausea and vomiting. While unconscious, her head fell back hitting a wall quite hard.

VAERS ID:311971 (history)  Vaccinated:2008-04-21
Age:64.0  Onset:2008-04-22, Days after vaccination: 1
Gender:Female  Submitted:2008-04-23, Days after onset: 1
Location:Illinois  Entered:2008-05-09, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillin, Sulfa, CHF, Hypothyroid, GERD, Osteoarthritis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1429U0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Rash macular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt reported onset of red, blotching, itchy rash on side of torso - adjacent to vaccinated arm, approx 24 hrs after vaccine admin. Advised pt to use Benadryl 1 tabs/cream and call MD. Pt called MD but did not require visit. Since symptoms resolved within next 24 hrs (48 hrs after vaccine admin.).

VAERS ID:312102 (history)  Vaccinated:2008-04-21
Age:1.3  Onset:2008-04-27, Days after vaccination: 6
Gender:Female  Submitted:2008-05-06, Days after onset: 9
Location:Alabama  Entered:2008-05-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ibuprofen (as needed)
Current Illness: none
Preexisting Conditions: GERD (when younger)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0526U0SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.158460SCRL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Fever - started 10 day after immunizations & lasted 4 days. Rash - started 6 days after immunizations & lasted 6 days.

VAERS ID:312146 (history)  Vaccinated:2008-04-21
Age:1.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-04-23, Days after onset: 2
Location:North Carolina  Entered:2008-05-12, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: NC08053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF242AB2IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1669U0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1797U0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: After patient received varicella vaccine her left thigh became red about the size of a quarter with a puffy area in center (about the size of a pencil head). The area continued to increase in redness. PAC consulted with Dr. and Benadryl 0.4ml given IM L thigh; kept patient an additional 15 minutes; no further reaction noticed.

VAERS ID:312174 (history)  Vaccinated:2008-04-21
Age:0.3  Onset:2008-05-05, Days after vaccination: 14
Gender:Female  Submitted:2008-05-12, Days after onset: 7
Location:Michigan  Entered:2008-05-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None. PMH: colic, neonatal jaundice. NKDA
Diagnostic Lab Data: Abdominal X-ray; Air enema. Labs and Diagnostics: Barium enema (+) for IS. Stool heme (+).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURUF236AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC547630IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1888U0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal X-ray, Barium double contrast, Enema administration, Haematochezia, Intussusception, Irritability, Large intestinal obstruction reduction, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Intussusception 5/5/08. Treated with air enema with full recovery. 5/22/2008 MR received for DOS 5/6-7/2008 with D/C DX: S/P reduction of Intussusception by Barium Enema. Infant presented to ER with 2 day hx of bloody stool and irritability. Barium Enema (+) for ileocolic IS which was fully reduced on 2nd attempt. D/C next day tolerating feeds and in no distress.

VAERS ID:312213 (history)  Vaccinated:2008-04-21
Age:10.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-08, Days after onset: 17
Location:South Carolina  Entered:2008-05-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0091X1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Local reaction, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Child had painful arm for 2 days 4/21-4/23 & noted (local) swelling - (local 10-15 cm right arm red) & erythema 4/22 - seen in clinic 4/23. Mom gave BENADRYL, 4/22 PM.

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), Tendinopathies and ligament 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:313211 (history)  Vaccinated:2008-04-21
Age:4.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Female  Submitted:2008-05-24, Days after onset: 31
Location:Massachusetts  Entered:2008-05-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354CA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273-23IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site discolouration
SMQs:
Write-up: Two weeks of painless dusky discoloration around shot site

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), Tendinopathies and ligament disorders (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:315697 (history)  Vaccinated:2008-04-21
Age:76.0  Onset:2008-05-01, Days after vaccination: 10
Gender:Female  Submitted:2008-05-30, Days after onset: 29
Location:Washington  Entered:2008-06-09, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cozaar, Coreg, Detrol, Tramadol, Myrazole
Current Illness: None
Preexisting Conditions: Allergy - Sulfa; GERD; increased lipid; Diverticulosis; Eczema,
Diagnostic Lab Data: CPR 0.5; ETR 26
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0204X0SCLA
Administered by: Private     Purchased by: Military
Symptoms: C-reactive protein decreased, Polyarthritis, Rash, Red blood cell sedimentation rate increased, Serum sickness
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Inflammatory arthritis, diffuse rash, probably serum sickness.

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:317211 (history)  Vaccinated:2008-04-21
Age:1.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-25, Days after onset: 34
Location:New Mexico  Entered:2008-06-24, Days after submission: 30
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B073AA IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF341AC IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0869U0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC49923 IMRL
Administered by: Private     Purchased by: Public
Symptoms: Abnormal behaviour, Convulsion, Diarrhoea, Haematochezia, Injection site mass, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Seizure, fever, diarrhea, bump where shot was given, rash, blood in stool, acting abnormal and fever lasted for 1 1/2 weeks. - Infants Motrin Drops was given for fever. - Blood work done at hospital

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? Yes, 3 days
    Extended hospital stay? 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: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: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:319939 (history)  Vaccinated:2008-04-21
Age:17.0  Onset:2008-05-21, Days after vaccination: 30
Gender:Female  Submitted:2008-07-15, Days after onset: 55
Location:North Carolina  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA03111
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 17 year old female with no relevant medical history who on 21-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On approximately 21-MAY-2008, also reported as 1 month after the first dose was given, the patient experienced myalgia and arthralgia. The patient''s myalgia and arthralgia persisted. No other doses have been given yet. Additional information has been requested.

VAERS ID:319945 (history)  Vaccinated:2008-04-21
Age:17.0  Onset:2008-05-01, Days after vaccination: 10
Gender:Female  Submitted:2008-07-15, Days after onset: 75
Location:North Carolina  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Erythrocyte, 06/16/08, 30 mm/hr, elevated; WBC count, 06/24/08, 6.3X10^3; lymphocyte count, 06/24/08, 11.3 %; monocyte count, 06/24/08, 9.9 %; blood granulocyte count, 06/24/08, 78.8 %; lymphocyte count, 06/24/08, 0.7X10^3; monocyte count, 06/24/08, 0.6X10^3; blood granulocyte count, 06/24/08, 5.0X10^3; red blood cell count, 06/24/08, 4.52X10^6; hemoglobin, 06/24/08, 12.5 g/dL; hematocrit, 06/24/08, 38.8 %; mean corpuscular volume, 06/24/08, 85.9 fL; mean corpuscular, 06/24/08, 27.6 pg; mean corpuscular, 06/24/08, 32.1 g/dL; RDW, 06/24/08, 12.2 %; platelet count, 06/24/08, 176X10^3; mean platelet volume, 06/24/08, 7.6 fL; serum ANA, 06/17/08, 78 AU/mL; component C3 test, 06/17/08, 29 mg/dL; component C4 test, 06/17/08, 171 mg/dL; serum rheu
CDC Split Type: WAES0806USA03365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1265U0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Antinuclear antibody negative, Arthralgia, Arthritis, Culture urine negative, Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Mean cell volume normal, Monocyte count normal, Myalgia, Red blood cell count normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated intramuscularly with first dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that on unspecified date the patient developed arthritis. Unspecified medical attention was sought. On unspecified date erythrocyte sedimentation rate test was performed, result was reported as "elevated". At the time of this report, the outcome was unknown. Additional information has been requested. 10/08/2008 This is in follow-up to report(s) previously submitted on 7/15/2008. Initial and follow-up information has been received from a physician concerning a 17 year old female with no relevant medical history or allergies who on 21-APR-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot# 659435/1265U) in the left deltoid. There was no concomitant medication. On 24-MAY-2008 the patient was seen in urgent care for questionable mononucleosis. In June 2008, the patient developed myalgias and arthralgias. On 16-JUN-2008 the patient was seen by the physician and had the following laboratory tests performed: ANA which was negative, erythrocyte sedimentation rate 30 mm/hr, rheumatoid arthritis factor which was negative and urine culture (no growth). The patient''s CBC was within normal limit on 24-JUN-2008. The physician reported that the diagnosis was arthritis. The patient was referred to a rheumatologist on 02-JUL-2008 and a positive sedimentation rate was noted. The patient was again diagnosed with arthritis. The patient did not receive any more doses of GARDASIL. At the time of this report, the patient had not recovered from the events. Additional information is not expected. This is a consolidation of two reports concerning the same patient.

VAERS ID:320035 (history)  Vaccinated:2008-04-21
Age:77.0  Onset:2008-05-07, Days after vaccination: 16
Gender:Female  Submitted:2008-06-18, Days after onset: 42
Location:Ohio  Entered:2008-07-22, Days after submission: 34
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: Darvocet; Lipitor
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1429U SCRA
Administered by: Private     Purchased by: Private
Symptoms: Polymyalgia rheumatica
SMQs:, Vasculitis (narrow)
Write-up: Polymyalgia rheumatica like syndrome, w/u in progress.

VAERS ID:326236 (history)  Vaccinated:2008-04-21
Age:51.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Male  Submitted:2008-05-01, Days after onset: 10
Location:North Carolina  Entered:2008-08-26, Days after submission: 117
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: CAD, rosacea, allergies
Diagnostic Lab Data:
CDC Split Type: 200801266
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0490 SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937A IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial report received on 24 April 2008 from a health care professional in the USA. A 51 year old male patient received on 21 April 2008 a left deltoid intramuscular injection of ADACEL (lot# C2937AA) and a left arm subcutaneous injection of IPOL (lot # A0490). On the evening of vaccination, the patient developed muscle pain, described as "feeling bruised", to the right lower extremity behind the thigh and also weakness in the leg. The patient self-medicated with an unspecified muscle relaxant, which seemed to help somewhat. The patient had no illness at the time of vaccination and had a history of coronary artery disease (CAD), rosacea, and allergies. Concomitant medications were unknown. At the time of the report, 24 April 2008, the patient had not recovered.

VAERS ID:326521 (history)  Vaccinated:2008-04-21
Age:22.0  Onset:2008-04-23, Days after vaccination: 2
Gender:Female  Submitted:2008-09-29, Days after onset: 159
Location:Arizona  Entered:2008-09-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04225
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Impaired work ability, Muscle spasms
SMQs:, Dystonia (broad)
Write-up: Information has been received from a nurse concerning a 22 year old female who on 21-APR-2008 was vaccinated with the first dose of GARDASIL and on 23-APR-2008 developed back spasms. The patient''s father called the office stating his daughter was off from work for 1 week due to the back spasms. The patient stated that she was not going to continue the GARDASIL series. At time of report, the patient was not having any problems. Back spasms were considered to be disabling. Additional information is not expected.

VAERS ID:328384 (history)  Vaccinated:2008-04-21
Age:5.0  Onset:2008-10-09, Days after vaccination: 171
Gender:Female  Submitted:2008-10-09, Days after onset: 0
Location:Connecticut  Entered:2008-10-13, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Lyme DX in 5/07, Abx X 8 months.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2920AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04904SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1803U1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Fatigue, Rhinorrhoea, Skin lesion, Varicella
SMQs:
Write-up: Varicella eruption noted on 10/9/08 per APRN. Pt presented day #3 illness with 18 lesions on trunk only. No fever, tired, runny nose.

VAERS ID:332351 (history)  Vaccinated:2008-04-21
Age:42.0  Onset:0000-00-00
Gender:Female  Submitted:2008-11-11
Location:Arkansas  Entered:2008-11-14, 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:
Current Illness:
Preexisting Conditions: The patient had a pre-existing medication of a hand laceration. Past history included three c-sections, dilation and curettage, tubal ligation and bladder scar removal. The patient had not been taking any concomitant medications.
Diagnostic Lab Data: 05/Nov/2008: Bloodwork (results pending)
CDC Split Type: 200803497
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DECAVAC)SANOFI PASTEURU1958B UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Radiculitis brachial
SMQs:
Write-up: A 43 year-old female patient with a hand laceration received a right arm (route unknown) injection of DECAVAC, lot number U1958BA, on 21 April 2008 during an emergency room visit. The patient was subsequently evaluated by her physician on 05 November 2008 who diagnosed her with brachial neuritis. Laboratory testing was performed and the results were pending at the time of the report. According to the reporter, the patient initially refused vaccination and emergency room personnel would not discharge the patient without vaccination. Per the reporter, "the patient reacts like this to vaccines". No further information was provided at the time of the report. Documents held by sender: None.

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? Yes, 1 days
    Extended hospital stay? Yes
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
Lot
Dose
Route
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:343527 (history)  Vaccinated:2008-04-21
Age:8.0  Onset:2009-04-02, Days after vaccination: 346
Gender:Male  Submitted:2009-04-02, Days after onset: 0
Location:California  Entered:2009-04-03, 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: None
Preexisting Conditions: Asthma, Allergic Rhinitis, Eczema
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1973U1UNLA
Administered by: Private     Purchased by: Private
Symptoms: Varicella post vaccine
SMQs:
Write-up: Ameliorated Varicella rash (Sib with same despite 2 VARIVAX immunizations).

VAERS ID:344741 (history)  Vaccinated:2008-04-21
Age:15.0  Onset:2008-11-05, Days after vaccination: 198
Gender:Female  Submitted:2009-04-14, Days after onset: 159
Location:Tennessee  Entered:2009-04-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 1/25/2008
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA04377
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial and follow-up information has been received from a pediatrician, a physician and a registered nurse for the pregnancy registry for GARDASIL concerning a 15 year old female patient who in September 2007 was vaccinated with her first dose of GARDASIL (Lot # 658094/0524U). On 21-APR-2008, was vaccinated with her second dose of GARDASIL (Lot # 659657/1487U). The patient became pregnant during her series of vaccination. No adverse events were reported. As of 22-AUG-2008 she was at 27 weeks gestation. In follow-up information the registered nurse reported that the patient with a history of 0 pregnancies and 0 live births who was vaccinated on 18-SEP-2007 with the first dose of GARDASIL (Lot # 658094/0524U) became pregnant on 29-OCT-2008 (EDD 31-OCT-2008 also reported 01-NOV-2008) and on 29-OCT-2008 delivered a normal, healthy male baby weighing 7 pounds 11 ounces. Follow-up information was received from a health professional who reported that the baby with no known drug allergies was seen at the doctor''s office on 05-NOV-2008. The baby weighted 6 lbs, 15 oz, the length was 20 inches, the head circumference was 31.5 inches and the temperature was 97.2F. The baby was fed with formula received 2-3 times a day. The baby did not present any problem with exception that was spitting up a little. The diagnostic impression indicated a well newborn. Additional information is not expected.

VAERS ID:351846 (history)  Vaccinated:2008-04-21
Age:28.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 141
Location:Texas  Entered:2009-07-14, Days after submission: 308
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lithium, LOMENTIL
Current Illness:
Preexisting Conditions: History of sulfa drug allergy and bipolar disorder. The patient had not received any other vaccines during the four weeks prior to receipt of ADACEL and Hepatitis B vaccines.
Diagnostic Lab Data:
CDC Split Type: 200801962
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB448AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899A IMLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This non-serious case was received from a health professional on 11 June 2008. A 29-year-old female patient, with a history of sulfa drug allergy and bipolar disorder, received an intramuscular left deltoid injection of ADACEL (lot number not known) on 21 April 2008. The same day, she also received an intramuscular right deltoid injection of Hepatitis B (manufacturer and lot number not known). Approximately 24 hours after vaccination, the patient complained of left shoulder pain. Three days later, the pain intensified, and at the time of the report was still ongoing. The patient had undergone unspecified testing, the results of which were not known by the reporter. She had been referred to an occupational medicine clinic for additional evaluation. Follow-up information was received 09 September 2008 from a health care professional. The patient had been vaccinated during a new hire physical and had received ADACEL, lot number C2899AA (expiration 09 May 2010) and a sixth dose of Hepatitis B, lot number AHBVB448AA (expiration 24 January 2010. The patient had not received any other vaccines during the four weeks prior to receipt of ADACEL and Hepatitis B vaccines. No additional information was provided at the time of the report.

VAERS ID:354655 (history)  Vaccinated:2008-04-21
Age:11.0  Onset:2009-07-25, Days after vaccination: 460
Gender:Female  Submitted:2009-08-19, Days after onset: 25
Location:Louisiana  Entered:2009-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: 10/6/09 PCP medical records received DOS 7/30/08 to 8/27/08. LABS and DIAGNOSTCS: CBC - RBC 3.84 Mill/uL (L) Hematocrit 34.3% (L) Abs Lymph 1409 cells/uL (L). TSH 3rd Gen 4.62 mIU/L (H). EEG - Normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1758U1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone increased, Computerised tomogram, Convulsion, Electroencephalogram normal, Gaze palsy, Haematocrit decreased, Hypotonia, Lymphocyte count decreased, Muscle twitching, Nuclear magnetic resonance imaging, Primary hypothyroidism, Red blood cell count decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Had seizure 7/25/09. Had Mri & Ct scan & blood work. In August diagnosed with Hashimoto Thyroiditis & compensated hypothyroidism. 10/6/09 PCP medical records received DOS 7/30/08 to 8/27/08. Assessment: Syncope Follow up from ER. Seizure?. Eyes rolled back, twitching, then limp. Lasted 30 seconds.

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