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Case Details (Sorted by Vaccination Date)

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VAERS ID:438589 (history)  Vaccinated:2008-12-29
Age:1.5  Onset:2011-08-24, Days after vaccination: 968
Gender:Female  Submitted:2011-10-13, Days after onset: 50
Location:Wisconsin  Entered:2011-10-17, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had previously received three doses of DAPTACEL; lot number C2657AA received on 04 September 2007 and 29 October 2007 and lot number C2607AA received on 03 January 2008.
Diagnostic Lab Data:
CDC 'Split Type': 201109596
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2956AA3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Initial report received on 05 October 2011 from the investigator under the reference number M5A16. A case of pertussis disease in a four-year-old female subject was identified by the investigator based on review of data from the surveillance system database. The subject''s vaccine history included 4 doses of DAPTACEL; lot number C2657AA received on 04 September 2007 and 29 October 2007, lot number C2607AA received on 03 January 2008, and lot number C2956AA received on 29 December 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 August 2011, approximately 31 months after the last dose. On 12 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 September 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2011 for five days. The subject was not hospitalized. At the time of final contact on 15 September 2011, the subject''s cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Document held by sender: None.

VAERS ID:341292 (history)  Vaccinated:2008-12-29
Age:0.2  Onset:2008-12-29, Days after vaccination: 0
Gender:Male  Submitted:2009-03-06, Days after onset: 67
Location:Foreign  Entered:2009-03-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, Dec2008, 39.9deg C
CDC 'Split Type': B0562315A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA463A0IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA463A0IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA463A0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH319330IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Cyanosis, Decreased appetite, Hypotonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Nasopharyngitis, Pallor, Pyrexia, Skin warm
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (#NL-LRB-84666) and described the occurrence of unconscious in a 2-month-old male subject who was vaccinated with INFANRIX-IPV/Hib (GlaxoSmithKline), PREVENAR. None concomitant medication was given. The subject did not have any relevant medical history. On 29 December 2008 the subject received 1st dose of INFANRIX-IPV/Hib (intramuscular), 1st dose of PREVENAR (intramuscular). In December 2008, 8 and a half hours after vaccination with INFANRIX-IPV/Hib and PREVENAR, the subject experienced fever 39.9 deg C. Twelve and a half hours later the subject presented pallor, acrocyanosis, warm skin, hypotonia and unconsciousness. At unspecified hours after the subject had decreased appetite. On 31 December 2009, 2 days after vaccination the subject had acute nasopharyngitis. Four days after vaccination the subject was hospitalized due to continuing fever (not responding to Paracetamol) and serious acute nasopharyngitis. At the time of reporting the events were resolved. The regulatory authority reported that the events (regarding to hypotonic-hyporesponsive episode) were possibly related to vaccination with INFANRIX-IPV/Hib and PREVENAR. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:341942 (history)  Vaccinated:2008-12-29
Age:1.9  Onset:2009-01-05, Days after vaccination: 7
Gender:Male  Submitted:2009-03-16, Days after onset: 69
Location:Foreign  Entered:2009-03-17, 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: Unknown
Preexisting Conditions: The subject was born after 35 weeks of gestation (weight 2210 gram)
Diagnostic Lab Data: Blood electrolytes, 09Feb2009, normal; Coagulation test, 07Jan2009, normal; Cytomegalovirus test negative, 09Feb2009, negative; Hemoglobin, 06Jan2009, 10.9; Hepatitis A virus, 09Feb2009, negative; Hepatitis C virus test, 09Feb2009, negative
CDC 'Split Type': B0563970A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood electrolytes normal, Coagulation test normal, Cytomegalovirus test negative, Ecchymosis, Epstein-Barr virus antibody negative, Haemoglobin decreased, Hepatitis A antibody negative, Hepatitis C test negative, Idiopathic thrombocytopenic purpura, Immunoglobulins normal, Neutrophil count normal, Parvovirus B19 serology negative, Petechiae, Platelet count decreased, Spinal myelogram normal, Thrombocytopenia, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: This case was reported by the foreign regulatory authority (AFSSaPS number SE20090070) and described the occurrence of thrombopenia in a 23-month-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline) and MMR II (non-GSK). The subject''s medical history included growth intrauterine retard. He was born after 35 weeks of gestation and weight 2210 grams. Concurrent vaccination included 4 doses of INFANRIXQUINTA (GlaxoSmithKline) given on unspecified dates, four doses of PREVENAR (non GSK) on unspecified date, and two first doses of ENGERIX B (10mcg injection site and batch unknown). On 29 December 2008 the subject received a third dose of ENGERIX B pediatric (10 mcg, injection site and batch unknown), and a second dose of M-M-Rvax (injection site and batch unknown). On 05 January 2009, 7 days after vaccination with ENGERIX B pediatric and M-M-Rvax, the subject developed lower limbs petechia. On 06 January 2009, 8 days after vaccination with ENGERIX B pediatric, ecchymosis appeared. On that same date, the subject experienced thrombpenia with a platelet count at 2000, white blood cell count at 8000, neutrophils at 4.08, and haemoglobin at 11. On 07 January 2009, the subject was hospitalised. Petechia and ecchymosis were persistent. There was no other sign of haemorrhage. On that date, platelet count was still very low (lower than 1000), white blood cell count was at 11.4 and Haemoglobin at 10.9. There was no inflammatory syndrome. Coagulation check-up was normal, as myelogram. The subject was treated with SOLUPRED at 4 mg/kg. On 08 January 2009, the subject was discharge from hospital. On 13 January 2009, platelet count was increased to 121 000. On 09 February 2009, the subject was well. Immunoglobulin dosage was normal. Blood electrolytes were normal. Parvovirus, hepatitis A, hepatitis C, Cytomegalovirus and Epstein Barr Virus serologies were negative. Platelet count were at 300 000. Paediatricians concluded to a probable post M-M-Rvax idiopathic thrombopenic. At the time of reporting, thrombop

VAERS ID:347233 (history)  Vaccinated:2008-12-29
Age:45.0  Onset:2009-01-13, Days after vaccination: 15
Gender:Male  Submitted:2009-05-26, Days after onset: 132
Location:Foreign  Entered:2009-05-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': D0061484A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB147AA1IMUN
Administered by: Other     Purchased by: Other
Symptoms: No reaction on previous exposure to drug, Psoriasis, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of psoriasis in a 45-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On an unspecified date the subject received a dose of TWINRIX adult (unknown route and application site). At an unspecified time after vaccination with TWINRIX adult, the subject experienced exanthema on whole body. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 14 May 2009 by the physician. Previous vaccination with TWINRIX adult was well tolerated. On 29 December 2008 the subject received 2nd dose of TWINRIX adult (intramuscular, left upper arm). The reporter stated, 6 days after vaccination with TWINRIX adult on 13 January 2009, the subject experienced exanthema of whole body without itching and clinically flare up of psoriasis, lasting for 11 days. This case was assessed as medically serious by GSK. On 24 January 2009, the events were resolved. The physician considered the events were probably related to vaccination with TWINRIX adult. No further information will be available.

VAERS ID:336283 (history)  Vaccinated:2008-12-30
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-30
Location:Pennsylvania  Entered:2008-12-30
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: NKDA,H/O HEART MURMUR AS INFANT
Diagnostic Lab Data: SYNCOPAL EPISODE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Bradycardia, Dizziness, Fall, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: ALERT INITIALLY. SOON C/O FEELING LIKE SHE WAS GOING TO PASS OUT (PHYSICIAN CAUGHT PATIENT AS SHE WAS FALLING FACE FIRST OFF EXAM TABLE). WAS PALE X 1 MIN, BRADYCARDIC X 2 MIN. PT WAS LAID ON EXAM TABLE WITH KNEES ELEVATED. COMPLETE SET OF VITALS OBTAINED BY PHYSICIAN AND THOROUGH EXAM PERFORMED WITH NEGATIVE OUTCOME. PT GIVEN POPSICLE AND WAS ABLE TO LEAVE IN 15 MINUTES.

VAERS ID:336288 (history)  Vaccinated:2008-12-30
Age:1.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2008-12-30, Days after onset: 0
Location:South Carolina  Entered:2008-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: redness and swelling~Varicella (Varivax)~1~1~In Patient
Other Medications: Synagis injections, Zantac, Vitamin D
Current Illness: URI
Preexisting Conditions: prematurity, ge reflux
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC683110IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1901U0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local reaction to varicella vaccine. 5cm x 7cm redness and moderate swelling immediately at site of injection. Benedryl given and patient watched in office for 20 minutes. Swelling and redness did decrease and improve before patient discharged to go home.

VAERS ID:336311 (history)  Vaccinated:2008-12-30
Age:79.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2008-12-30, Days after onset: 0
Location:Minnesota  Entered:2008-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pancreatic Ca
Preexisting Conditions: Red dye #1
Diagnostic Lab Data: ABD CT- for cultures; AAP
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.981X IMRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2078DA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abdomen scan, Abdominal pain, Back pain, Dyspnoea, Flushing, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: PNEUMOVAX, TD booster increased ren at principal within seconds- Flush, severe back and abd pain slight SOB, slight itching last 30 min. BP 180/90 - 148/70.

VAERS ID:336333 (history)  Vaccinated:2008-12-30
Age:1.2  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2008-12-31, Days after onset: 0
Location:Pennsylvania  Entered:2008-12-31
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: Hx of penicillin and nut allergy.
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3081AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB04753IMRA
Administered by: Private     Purchased by: Private
Symptoms: Drooling, Dysarthria, Facial palsy
SMQs:, Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Pt on 12/31/2008 - Had episode of drooling, slurred speech, drooping with side of face. - 18 hrs post DAPTACEL and IPOL - Hx of penicillin and nut allergy. Symptoms improved with EPIPEN.

VAERS ID:336336 (history)  Vaccinated:2008-12-30
Age:2.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2008-12-31, Days after onset: 1
Location:Wisconsin  Entered:2008-12-31
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
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2765AA2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: 6 hours after receiving FLU shot developed 101 degrees fever. Mom did not check body, but in the morning noticed child developed hives over body. BENADRYL was given, no respiratory problems.

VAERS ID:336393 (history)  Vaccinated:2008-12-30
Age:17.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-01-02, Days after onset: 2
Location:Washington  Entered:2009-01-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Induration, Skin warm, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Marked local swelling, induration, erythema, warmth, and tenderness resulting in a physician office visit.

VAERS ID:336398 (history)  Vaccinated:2008-12-30
Age:9.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2009-01-03, Days after onset: 4
Location:New Jersey  Entered:2009-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: he is allergic to all childhood antibiotics, watermellon.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1030U / 27JUN091IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Hypersensitivity, Immediate post-injection reaction, Pruritus, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Reaction occurred immediately after the shot was administered. large raised red area approximately 6 inches in circumference with itching and burning. Allergic reaction occurred above the shot and in shoulde area. Benadryl was administered a number of times as the hives came and went. Additionally, the spot would reduce with benadryl administered and then return in size as the medication wore off. This continued for about 4 days. It is now day 6 and the red spot is fading and there are no more hives.

VAERS ID:336399 (history)  Vaccinated:2008-12-30
Age:4.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-03, Days after onset: 4
Location:New Jersey  Entered:2009-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1030U / 27JUN091IMLL
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Raised red area approximately 4 inches in diameter with a pink circular eurthmia approximately another 2 inches surrounding the outer portion of the immediate raised area. Benadryl was administered but to no affect. Over the past 4 days the size of the red raised area has reduced

VAERS ID:336722 (history)  Vaccinated:2008-12-30
Age:62.0  Onset:2009-01-02, Days after vaccination: 3
Gender:Female  Submitted:2009-01-07, Days after onset: 5
Location:Texas  Entered:2009-01-07
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: Codeine; Prednisone; Avelox; ASA; sulfa
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2865AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: On Jan 2, arm began itching. Got worse and 1 day later heat & redness began than increased until the patient took Benadryl. I advised ice- good results.

VAERS ID:336790 (history)  Vaccinated:2008-12-30
Age:18.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2008-12-30, Days after onset: 0
Location:Arizona  Entered:2009-01-08, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2833AA0IMUN
Administered by: Military     Purchased by: Military
Symptoms: Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient administered flu vaccine; patient began to faint (vasovagal episode) occurred; vital signs taken.

VAERS ID:336821 (history)  Vaccinated:2008-12-30
Age:15.0  Onset:2009-01-05, Days after vaccination: 6
Gender:Female  Submitted:2009-01-08, Days after onset: 3
Location:Oregon  Entered:2009-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1225X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Limb immobilisation, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Redness on arm and spreading. Hot to touch, child could not move arm said it felt numb. Swollen

VAERS ID:336866 (history)  Vaccinated:2008-12-30
Age:8.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2008-12-31, Days after onset: 1
Location:Florida  Entered:2009-01-09, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2800EA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pruritus, Injection site swelling, Paraesthesia oral, Pruritus
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Mother states child developed swelling to the left deltoid area approximately 8-12 hours after receiving flu vaccine. Also he complained of itching at the site and itching to his tongue. Mother states that both cold and hot compresses were applied as well as vicks vapor rub. Violet was applied to the tongue by mother. Child returned to Health Center after 24 hours was examined and instructed to use cool compresses only and to give 1 TSP Benadryl every 6 hours as needed.

VAERS ID:336870 (history)  Vaccinated:2008-12-30
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2008-12-30
Location:New Mexico  Entered:2009-01-09, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSA010B1IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSACS2B023AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: Patient was mistakenly administered both DT & TDAP vaccines - no adverse reaction was observed subsequently

VAERS ID:336877 (history)  Vaccinated:2008-12-30
Age:50.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-02, Days after onset: 3
Location:Pennsylvania  Entered:2009-01-09, 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: BUSPAR; ASMAVET; PATENOL
Current Illness: No
Preexisting Conditions: GERD; allergies; central serous retinopathy
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS900005IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1163X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Oedema, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Patient had right deltoid IM injection of PNEUMOVAX and since then had local reaction, large, of pain, edema, a erythema slowly improving.

VAERS ID:336973 (history)  Vaccinated:2008-12-30
Age:1.1  Onset:2009-01-08, Days after vaccination: 9
Gender:Female  Submitted:2009-01-09, Days after onset: 1
Location:Indiana  Entered:2009-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXIL
Current Illness: Otitis
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2739AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.00064681000IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC683113IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.00064827000IMLL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Rash over body started 1/8/09, worsened 1/9/09. Fever.

VAERS ID:336983 (history)  Vaccinated:2008-12-30
Age:0.3  Onset:2009-01-02, Days after vaccination: 3
Gender:Male  Submitted:2009-01-09, Days after onset: 7
Location:Colorado  Entered:2009-01-09
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
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B204BA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF533AB1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD162811IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1168X1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Screaming, Sleep disorder
SMQs:, Hostility/aggression (broad)
Write-up: Within 72 hrs of receiving 4 month vaccine (PEDIARIX; Act HIB; PREVNAR; ROTATEQ) child had sleep disturbance and "high pitched scream-super high pitched scream."

VAERS ID:337086 (history)  Vaccinated:2008-12-30
Age:67.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-01-12, Days after onset: 12
Location:Kentucky  Entered:2009-01-12
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.UNKNOWN0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Erythema, Induration, Mass
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Arm developed a 3 inch diameter redness with hardened lump. The area felt as if it were a severe burn. Problem lasted for 10 days.

VAERS ID:337171 (history)  Vaccinated:2008-12-30
Age:0.3  Onset:2008-12-31, Days after vaccination: 1
Gender:Male  Submitted:2009-01-13, Days after onset: 13
Location:Texas  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Reglan, Zantac, Topical Nystatin
Current Illness:
Preexisting Conditions: GERD, Upper Respiratory Infection at (afebrile) at time of immunization. PMH: hospitalization for URI 1.5 mos prior to admit.
Diagnostic Lab Data: EEG - negative. CT of head - read as negative. LABS: skeletal survey WNL. CT of head revealed bilateral mastoid & middled ear effusions & mucosal thickening of paranasal sinuses. EEG WNL. Scheduled for MRI head as outpatient. Electrolytes imbalance.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B065AA0IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF491AB0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA106020IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram abnormal, Computerised tomogram normal, Convulsion, Effusion, Electroencephalogram normal, Electrolyte imbalance, Fall, Feeding disorder, Gastrooesophageal reflux disease, Head injury, Mastoid disorder, Middle ear effusion, Opisthotonus, Sinus disorder, Tremor, X-ray normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dystonia (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Seizure within 24 hours of vaccination. No history of seizures prior to this episode. None since. 1/19/09 Reviewed hospital medical records of 01/01-01/05/2009. FINAL DX: seizure disorder suspected; child abuse suspected; overfeeding; GERD Records reveal patient experienced shaking of arms, fists clenched, arching of back x 1 day after being dropped & striking head day before episode. No further episodes while hospitalized & d/c to home.

VAERS ID:337343 (history)  Vaccinated:2008-12-30
Age:23.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-14, Days after onset: 15
Location:Utah  Entered:2009-01-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB140AA8IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3032AA IMLA
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30014160PO 
Administered by: Public     Purchased by: Private
Symptoms: Eating disorder, Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia, Malaise, Nausea, Pain, Paraesthesia, Pruritus, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Shots at 2:30pm 12/30/08 Slight headache in afternoon, Oral Typhoid stated that evening, 2 hours later became sick. Symptoms nausea and low grade fever, woke during night feeling sick, 12/31/08 5am feeling rotten. Nausea and vomiting almost constant all morning. Fever 104. Sleeping in afternoon, 800 mg Ibuprofen, antinausea pill, Slept most of evening and night. Left arm where Tdap was given sollen and red, felt fverish and achey. 1/01/09 Same symptoms as day before stated all over again. Not able to sleep. That evening was seen in ER. IV fluids given. 1-2 and 1-3-09 continued sick, couldn''t eat. Ontinued with 102 fever.1/04/09 Feeling itchy upper half of body. It took almost 8 days before feeling well again. Fingers in left arm tingly next day of vaccine.

VAERS ID:337595 (history)  Vaccinated:2008-12-30
Age:59.0  Onset:2009-01-01, Days after vaccination: 2
Gender:Female  Submitted:2009-01-15, Days after onset: 14
Location:Unknown  Entered:2009-01-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown 2/3/09-records received-PMH:subarachnoid intracranial bleed 3/08. orthopedic injuries. Migraines. Lumbar spasm.
Diagnostic Lab Data: VZV strain, 01/??/09, positive for VARICELLA zoster virus 2/3/09-records received-MRI brain normal, Lumbar puncture showed elevated white count 380 and protein 103 with viral pattern, cryptoantigen on CSF negative. Echocardiogram mild tric
CDC 'Split Type': WAES0901USA01139
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Balance disorder, CSF protein increased, CSF white blood cell count increased, Chills, Confusional state, Echocardiogram, Electroencephalogram normal, Encephalitis viral, Lumbar puncture, Mental status changes, Mitral valve incompetence, Nuclear magnetic resonance imaging brain normal, Pyrexia, Viral DNA test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: Information has been received from a physician and a hospital medical librarian concerning a 59 year old female who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided). On 01-JAN-2009 the patient developed fever, joint aches, and mental status changes. The patient was admitted to the hospital. She was subsequently diagnosed with viral encephalitis. The physician stated that the patient''s cerebral spinal fluid had been sent for varicella zoster virus identification polymerase chain reaction testing and it came back positive for varicella zoster virus. Some of the spinal fluid was still frozen and kept in the freezer if further test needed to be done. The patient''s viral encephalitis persisted. Additional information has been requested. 2/3/09-records received for DOS 1/8-1/9/09 DC DX: Viral meningeal encephalitis unknown etiology. Mental status changes and fever secondary to #1. Fever resolved, and mental status changes improved. Admitted for evalutaion of one week of fevers, joint aches and 2-3 days increasing mental changes with word finding difficulties, confusion and balance issues.On 1/1/09 fevers, chilling, arthralgias migratory fashion.

VAERS ID:337610 (history)  Vaccinated:2008-12-30
Age:42.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-16, Days after onset: 17
Location:Tennessee  Entered:2009-01-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1208X0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Patient reported burning and stinging in her hand starting several hours after she received the vaccine on 12/30/2008. The next day she said that the symptoms were less bothersome but still occurred periodically. On 1/16/2009 she reported the symptoms occurred less frequently, but added that she felt a tingling in her elbow and sometimes in her hand. She experiences the tingling in her right arm mostly after holding heavy items such as her books across her college campus. NOTE: this is her first MMR, she had the Measles disease as a child, and received the Rubella and Mumps vaccines in separate shots.

VAERS ID:337766 (history)  Vaccinated:2008-12-30
Age:59.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2009-01-20, Days after onset: 21
Location:Unknown  Entered:2009-01-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.    
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Patient was given Td vaccine and in about 4 to 5 minutes later he was given PNEUMOVAX. After PNEUMOVAX, patient stated that he felt very hot, broke out in rash and turns red. Patient was given 50mg BENADRYL injection, oxygen and IV fluids and is now in stable condition.

VAERS ID:338702 (history)  Vaccinated:2008-12-30
Age:14.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-16, Days after onset: 17
Location:Massachusetts  Entered:2009-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Nickel sensitivity; Rhinitis allergic
Preexisting Conditions: Migraine
Diagnostic Lab Data: None
CDC 'Split Type': WAES0812USA05263
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1387X1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Pallor, Pulse abnormal, Syncope, Tonic clonic movements
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), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 14 year old female who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 660616/0570X) 0.5 ml via IM route into her deltoid. The patient fainted immediately after receiving the vaccine. She also displayed twitching with tonic-clonic motions of her upper extremities. This reaction resolved spontaneously. It was also noted that the patient did not eat breakfast. Unspecified medical attention was sought in the office. The patient was observed resting for about 20 minutes after the episode and given a popsicle. No other treatment and patient was considered fully recovered. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow-up information was received from the nurse practitioner. It was reported that the 14 year old female with allergic rhinitis and an allergy to nickel and a history of migraine headache who on 30-DEC-2008 was vaccinated with GARDASIL (lot # 660616/0570X) via IM route into her right deltoid. Secondary suspect therapy included VARIVAX (Merck) (lot # 662454/1387X) via SC route into her right arm. Immediately after GARDASIL, the patient felt lightheaded and she was positioned to supine. The patient developed loss of consciousness with tonic-clonic movement of her upper extremities. Duration was not more than 30seconds. Her color was pale, pulse was thready. The patient''s heart rate was 82 beats/min by rapidly measured, which was fully alert. Her blood pressure was stable with diet and fluid management (oral). No diagnostic studies were undertaken. All events were recovered in the same date. The events were considered to be non-serious by the physician. No further information is available.

VAERS ID:338703 (history)  Vaccinated:2008-12-30
Age:19.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-16, Days after onset: 17
Location:Nebraska  Entered:2009-01-20, 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: Ocella
Current Illness:
Preexisting Conditions: Asthma; Hirsutism; Polycystic ovarian syndrome
Diagnostic Lab Data: None
CDC 'Split Type': WAES0812USA05239
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0843X1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Consciousness fluctuating, Nausea, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse concerning a 19 year old female with asthma, hirsutism and polycystic ovarian syndrome and no known drug allergies, who 2 years ago was vaccinated with a first dose of GARDASIL. On 30-DEC-2008 the patient received a 0.5 mL second dose of GARDASIL (lot # 659184/0843X), intramuscularly. Concomitant therapy included Ocella. Ten minutes after the administration of the second dose the patient experienced syncope. The patient was "in and out of consciousness" for 4 to 5 minutes. She also experienced nausea and tingling sensation in her arm. There were no laboratory diagnostics studies performed. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:337851 (history)  Vaccinated:2008-12-30
Age:0.4  Onset:2009-01-11, Days after vaccination: 12
Gender:Male  Submitted:2009-01-15, Days after onset: 4
Location:Maine  Entered:2009-01-21, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Congenital talipes equinovarus 1/29/09-records received-PMH:bilateral talipes equinovarus. Cavernous hemangioma.
Diagnostic Lab Data: Abdominal X-rays; blood count; blood cultures (Emergency Room). 1/29/09-records received-CT scan demonstrated extensive intussusception in upper rectum. Air contrast enema reduction.
CDC 'Split Type': ME00209
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3183AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD010741IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0280X1PO 
Administered by: Private     Purchased by: Public
Symptoms: Abdominal X-ray, Abdominal mass, Blood count, Blood culture, Dehydration, Depressed level of consciousness, Enema administration, Haematochezia, Hypothermia, Intussusception, Lethargy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient was admitted to medical center. Abdominal CT was performed. Patient diagnosed with intussusception. 1/29/09-records received for DOS 1/11-1/13/09-DC DX: Intussusception. History of hypothermia (34C), obtundation and hematochezia with clots. Lethargic, dehydrated and minimally arousable to tactile stimulation with bright red blood per rectum, left lower quadrant mass felt.

VAERS ID:338727 (history)  Vaccinated:2008-12-30
Age:61.0  Onset:2009-01-08, Days after vaccination: 9
Gender:Female  Submitted:2009-01-30, Days after onset: 22
Location:Nebraska  Entered:2009-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Avapro Glipizide Metotopol L. Thyroxine(synthroid) Lipitor Fortamet Janumet
Current Illness: none
Preexisting Conditions: diabetes type 2 Began taking insulin just 1 week ago.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: The pain in my upper left arm is something I''v never experienced before. It isn''t like a sore muscle, it is worse. It is a disabling pain. For the past 3-4 weeks I have been having trouble raising my left arm. It aches so bad, most all of the time and has been somewhat tolerable. Today at work I experienced such deep pain that I thought I would have to leave work. It was as if a large hole had been blown into my arm. The pain went all the way into the bone. I felt short of breath and somewhat dizzy. The pain is becoming more intense as time goes on. It actually scares me. It goes up into my shouldger and down the side and back of my left arm. Today I noticed my arm was tingling and felt tingly, like it had gone to sleep. It also seemed like it could becoming numb. I took 2 Tylenol to alieveate the pain and after awhile it was better. I wouldn''t have thought it was the shingles vaccine but it occured to me that the soreness at the injection site never really left, it has just intensified. It''s really making me miserable. I can''t really remember the date I rec''d the injection. I was supposed to get it right after Thanksgiving, but it wasn''t availble for approx. 1 month after that date. The injection was administered by a nurse. Fatigued. I almost called my dr. office today, but since the Tylenol I took for pain helped, I didn''t. When the pain returned tonight I decided to go online and do some investigating about reactions to vaccines and found this site.

VAERS ID:339131 (history)  Vaccinated:2008-12-30
Age:15.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 1
Location:New Hampshire  Entered:2009-02-05, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': NH0815
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient experienced a vasovagal response to HPV. Duration was 4-6 seconds. BP at 09:30 60/40 pulse-50, at 9:45 62/40 p-52, BP at 10:00 72/40 p-60 and at 10:15 80/44 p-68.

VAERS ID:339346 (history)  Vaccinated:2008-12-30
Age:1.5  Onset:2009-01-23, Days after vaccination: 24
Gender:Female  Submitted:2009-02-04, Days after onset: 12
Location:Washington  Entered:2009-02-10, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Intermittent
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2957AA IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2794CA IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB258AA IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1120X SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1331X SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Decreased appetite, Irritability, Mumps, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal infections (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: Mom States child started becoming grouchy. Appetite decreased. Few days later noticed left side of face/jaw swollen. Went to Doctor-who was sure was mumps from vaccine. Has had no fever-swelling now almost gone-states patient feels fine now.

VAERS ID:340204 (history)  Vaccinated:2008-12-30
Age:2.7  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-01-21, Days after onset: 21
Location:Kentucky  Entered:2009-02-17, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007795
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500589P1IN 
Administered by: Other     Purchased by: Other
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: A non-serious spontaneous report of hives has been received from a physician concerning a 32-month-old female, subsequently to FLUMIST. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No past medical history nor concomitant medications were reported. The patient received the first FLUMIST dose on 27-Oct-2008 and the second FLUMIST dose on 30-Dec-2008. On 31-Dec-2008, the patient reported to the physicians office because she got hives all over. The patient was given diphenhydramine and sent home from the physicians office. The outcome was not reported.

VAERS ID:340221 (history)  Vaccinated:2008-12-30
Age:4.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2009-01-02, Days after onset: 3
Location:Ohio  Entered:2009-02-17, Days after submission: 46
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007701
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500561P IN 
Administered by: Private     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious report of "gave patient expired FLUMIST" was received from a nurse concerning a four year old male patient. On 30-Dec-2008, the patient received expired FLUMIST (expiration date not reported). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information received on 04-Aug-2009 included Product complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 13 customers not in some medications errors that occurred shortly after the product expired.

VAERS ID:339781 (history)  Vaccinated:2008-12-30
Age:13.0  Onset:2009-01-07, Days after vaccination: 8
Gender:Female  Submitted:2009-01-12, Days after onset: 5
Location:Alabama  Entered:2009-02-18, Days after submission: 37
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: R knee instability, positive ANA, hypermobility
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURUF452AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1282X0SCRA
Administered by: Private     Purchased by: Private
Symptoms: Rash, Skin lesion
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Multiple lesions ($g250) on extremities, torso, face and bucal mucosa 8 days after receiving first varicella vaccine. Tx: Acyclovir 800 mg every 6 hours x 5 days; Dytan 1-2 by mouth as needed every 12 hours; Zantac OTC, Mylanta and Maalox

VAERS ID:339790 (history)  Vaccinated:2008-12-30
Age:26.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-01-14, Days after onset: 15
Location:West Virginia  Entered:2009-02-18, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ ? antibiotic for URI
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X2UNLA
Administered by: Private     Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt called office and c/o L upper arm still being sore 2 weeks after injection. Received GARDASIL 12/30/08- Called office 1/14/09.

VAERS ID:339806 (history)  Vaccinated:2008-12-30
Age:0.0  Onset:2009-12-30, Days after vaccination: 365
Gender:Female  Submitted:2009-01-15, Days after onset: 349
Location:Nebraska  Entered:2009-02-18, Days after submission: 34
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Newborn
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERAFLUA356AA0IMRL
Administered by: Public     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Pt was given Influenza virus vaccine instead of Hepatitis B on 12-30-08. She was then given Hepatitis B on 01-2-09.

VAERS ID:340323 (history)  Vaccinated:2008-12-30
Age:18.0  Onset:2009-01-04, Days after vaccination: 5
Gender:Female  Submitted:2009-02-13, Days after onset: 40
Location:Massachusetts  Entered:2009-02-18, 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: None
Current Illness: Seasonal allergy
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type': WAES0901USA04367
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X2UNUN
Administered by: Private     Purchased by: Private
Symptoms: Burning sensation, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning an 18 year old female with no medical history who on 30-DEC-2008 was vaccinated with the third 0.5 ml dose of GARDASIL vaccine (lot# unspecified). There was no concomitant medication. On 04-JAN-2009 the patient experienced hives all over the body, itching and burning. The patient recovered on 13-JAN-2009. The first dose was administered on 19-JUN-2008 and second dose on 19-AUG-2009. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information was received from a registered nurse (R.N.) concerning the 18 year old female patient with seasonal allergies who on 30-DEC-2008 at 2:30 PM was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (lot# 661530/0575x). There was no illness at the time of vaccination and adverse event following prior vaccination. On 04-JAN-2009 at 3:00 AM the patient experienced hives on the whole body which burned and were pruritus. The patient saw an allergist who felt it was related to GARDASIL vaccine. Hives lasted through 13-JAN-2009 and finally disappeared. The patient was recovered on 13-JAN-2009. No relelvant diagnostic tests or laboratory data was collected. The patient sought unspecified medical attention. No further information is available.

VAERS ID:340741 (history)  Vaccinated:2008-12-30
Age:17.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-02-13, Days after onset: 45
Location:Massachusetts  Entered:2009-02-18, 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: Unknown
Current Illness:
Preexisting Conditions: Syncope
Diagnostic Lab Data: blood pressure, 114/7 mmHg; 104/60; arterial blood O2, 98%
CDC 'Split Type': WAES0901USA00365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Condition aggravated, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from 2 nurses concerning a 17 year old female with a history of fainting who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL. The patient fainted within an hour after receiving the vaccine. The patient fainted 3 times. The patient recovered that same day and went home. Lot# was not available. Follow-up information was received from a registered nurse (RN) concerning the 17 year old female patient who came to office and was vaccinated intramusculary in the left deltoid with the first dose of GARDISIL (6650555/0279X) on 30-DEC-2008. There was no illness at the time of vaccination. Subsquently the patient experienced a syncopal episode (less than 15 seconds), and it occured twice more. The patient was able to walk out of the office finally after aproximately 1.5 hours. BP: 114/72 mmHg (standing level) 104/60 mmHg; o2 sat, 98%. The patient recovered on 10-DEC-2008. No relevant diagnostic tests or laboratory tests were performed. The patient sought medical attention by visiting the nurse and physician''s office. No further information was available.

VAERS ID:340742 (history)  Vaccinated:2008-12-30
Age:18.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-02-13, Days after onset: 45
Location:Ohio  Entered:2009-02-18, 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: Unknown
Current Illness: Rhinitis allergic; Penicillin allergy
Preexisting Conditions: Vaccination adverse reaction
Diagnostic Lab Data: Unknown; None
CDC 'Split Type': WAES0901USA00353
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X1IMLA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness, Immediate post-injection reaction, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician assistant (P.A.)concerning an 18 year old female with reactions to vaccines who was vaccinated with a dose of GARDASIL (lot# 660557/0072X). On 30-DEC-2008 the patient broke out in hives on the face, "abs", arms, and torso. The patient was given BENADRYL in the office and within 15 minutes, the hives were gone. The patient was sent home with a Prednisone prescription. The patient recovered on 30-DEC-2008. It was unspecified which dose the patient had a reaction from therefore it is unknown which dose is the lot number provided. The patient sought medical attention at the physician''s office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from a Physician''s assistant (P.A.) concerning the 18 year old female patient with penicillin allergy and allergic rhinitis who on 30-DEC-2008 2:00 pm was vaccinated intramuscularly in the left arm with the second dose of GARDASIL. There was no illness at the time of vaccination. On 10-DEC-2008 at 2:05 pm the patient had extensive urticaria including face without angioedema approximately 5 minutes following administration. The patient felt faint. She had no loss of consciousness, dysphagia, or shortness of breath. The patient was given BENADRYL, IM and advised to rest 15 minutes in office. After that, urticaria subsided and the patient was released home with prescription for prednisone (po) and advised to continue BENADRYL (OTC, IM). The patient was advised to emergency room if symptoms worsen. No relevant diagnostic tests or laboratory data was collected. The patient was recovered on 30-DEC-2008. Information was received from a medical assistant reported the patient''s name and the medication was GARDASIL. She did not have any additional information to provide. The reporter considered the patient''s experiences to be other important medical events. The patient sought medical attention at the physician''s office. No further information is available.

VAERS ID:340258 (history)  Vaccinated:2008-12-30
Age:35.0  Onset:2009-01-18, Days after vaccination: 19
Gender:Female  Submitted:2009-02-20, Days after onset: 33
Location:New York  Entered:2009-02-20
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.97243081153X3SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 14-16 days post Varivax immunization ( 1st dose) Employee developed itching rash on arms & legs , tiny, raised " pimple like" ,fluid filled rash Employee denied fever or any other known exposure to a varicella virus. Some areas were dried and others as above. Denied headache or malaise

VAERS ID:341069 (history)  Vaccinated:2008-12-30
Age:22.0  Onset:0000-00-00
Gender:Female  Submitted:2009-03-04
Location:Illinois  Entered:2009-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills (unknown brand)
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA IMUN
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
SMQs:
Write-up: no adverse event Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.

VAERS ID:341070 (history)  Vaccinated:2008-12-30
Age:41.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-03-04, Days after onset: 63
Location:Illinois  Entered:2009-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: sore throat for 24 hours. Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.

VAERS ID:341158 (history)  Vaccinated:2008-12-30
Age:49.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-02-27, Days after onset: 58
Location:North Carolina  Entered:2009-03-05, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0866X0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB252AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3027AA0IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Blister, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Came in today stating that the day after getting her shots she developed Blisters in her scalp and itchy rash on her body. She did not seek medical attention and used Benadryl and Hydrocortisone. Rash left several days.

VAERS ID:343016 (history)  Vaccinated:2008-12-30
Age:39.0  Onset:2009-01-17, Days after vaccination: 18
Gender:Female  Submitted:2009-03-18, Days after onset: 59
Location:Connecticut  Entered:2009-03-30, Days after submission: 12
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: Profound mental retardation; seizures; cerebral palsy; scoliosis
Diagnostic Lab Data: Confirmed to be vaccine, associated rash via culture/sequencing
CDC 'Split Type': CT200906
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1384X0SCUN
Administered by: Other     Purchased by: Public
Symptoms: Culture positive, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Vaccine, associated Varicella rash.

VAERS ID:345495 (history)  Vaccinated:2008-12-30
Age:77.0  Onset:2009-01-09, Days after vaccination: 10
Gender:Male  Submitted:2009-03-27, Days after onset: 76
Location:Unknown  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOTRIL; FLONASE; DYAZIDE
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA01333
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1618X0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Chest pain, Influenza, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)
Write-up: Initial information has been received from a pharmacist concerning a 77 year old male who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck). It was reported that on 11-JAN-2009 the patient started having back pain which spread to the chest and stomach. On 12-JAN-2009, the date of the report, the pain was "all over" when he touched skin. The patient believed this might be from ZOSTAVAX (Oka/Merck). Additional information received from the patient reported that he started to experience the pain all over his body on the evening of 09-JAN-2009. It hurt to even lay down because the pain sensation took over. The patient did not have any other "flu symptoms" which was why he believed it might be because of the ZOSTAVAX (Oka/Merck). At the time of this report, the patient was not recovered. Follow-up information was received from the pharmacist concerning the 77 year old male with no illness at time of vaccination or pre-exisiting allergies who on 30-DEC-2008 at 15:00 was vaccinated SC with the first dose of ZOSTAVAX (lot # 662996/1618X). concomitant therapy included LOTEL, FLONASE and DYAZIDE. ON 13-JAN-2009, at 14:00 the patient experienced pain upon touching skin around torso area which recovered after approximately 1 days without any medication. No further information is available.

VAERS ID:347488 (history)  Vaccinated:2008-12-30
Age:  Onset:2009-01-11, Days after vaccination: 12
Gender:Male  Submitted:2009-05-15, Days after onset: 123
Location:Unknown  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA01324
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a health educator concerning a male teenager who on 30-DEC-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included MENACTRA. On 11-JAN-2009, 12 days post vaccination with VARIVAX (Oka/Merck), the patient developed redness and swelling at the injection site. The patient had sought medical attention from the school nurse. The patient''s redness and swelling at the injection site persisted. No further information is available.

VAERS ID:348262 (history)  Vaccinated:2008-12-30
Age:12.0  Onset:2008-12-31, Days after vaccination: 1
Gender:Female  Submitted:2009-06-01, Days after onset: 151
Location:California  Entered:2009-06-01
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: severe swelling in lympyh node on side of chest. Site swollen, warm to the touch. Lasted approx. 5 days. Doctors perplexed at the location of the swollen node(s) since they bypassed others before settling a distance away for the shot site, but on the same side of the body as injection site. Problem appeared within 48 hours

VAERS ID:351374 (history)  Vaccinated:2008-12-30
Age:82.0  Onset:2009-03-15, Days after vaccination: 75
Gender:Female  Submitted:2009-06-24, Days after onset: 101
Location:Ohio  Entered:2009-07-13, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium (unspecified); Vitamins (unspecified)
Current Illness: Sulfonamide allergy; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0903USA02580
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1554X SCUN
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a 82 female with sulfa allergy and antifungal drugs allergy who on 30-DEC-2008 was vaccinated SQ with 0.65 ml of ZOSTAVAX (Merck) (lot number: 663176/1554X) at 11:00 a.m. Concomitant therapy included vitamins (unspecified) and calcium (unspecified). The patient reported that on 15-MAR-2009 that she developed shingles after getting the vaccine. The patient also reported that her shingles were not painful and she was not developing blisters yet. The patient was not recovered and did not seek medical attention. Follow-up information was received. The reporter stated that the patient''s herpes zoster was confirmed at a dermatologist''s office. The outcome for the patient''s herpes zoster was reported as recovered on 06-APR-2009. Additional information is not expected.

VAERS ID:351415 (history)  Vaccinated:2008-12-30
Age:16.0  Onset:2009-01-05, Days after vaccination: 6
Gender:Male  Submitted:2009-07-07, Days after onset: 182
Location:Nebraska  Entered:2009-07-15, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin C 500 mg daily. 7/29/09 Consultant medical records received DOS 6/30/09. Prilosec and vitamin C.
Current Illness: Had cold dx but deemed stable for flu shot 12/30/08
Preexisting Conditions: Exertional compartment syndrome - bilateral fasciotomy. 7/29/09 Consultant medical records received DOS 6/30/09. Compartment syndrome of legs - fasciotomies. Ear tubes. Allergic esophagitis possibly to dairy products.
Diagnostic Lab Data: Numerous - labs normal; brain MRI essentially normal per neurosurgeon; gall bladder HIDA scan essentially normal; colonoscopy normal. LABS and DIAGNOSTICS: MRI Brain - 3 to 4 mm cerebellar tonsillar ectopia. X-Ray Cervical Spine - Normal
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2849AC1UNLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain, Amnesia, Balance disorder, Colonoscopy normal, Congenital central nervous system anomaly, Disturbance in attention, Dizziness, Dysarthria, Dyspnoea, Exercise tolerance decreased, Fasciitis, Fatigue, Headache, Hepatobiliary scan, Labile blood pressure, Laboratory test normal, Memory impairment, Nausea, Nuclear magnetic resonance imaging brain abnormal, Oesophagitis, Spinal X-ray normal, Tinnitus, Tremor, Vertigo, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (narrow)
Write-up: Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath. 7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.

VAERS ID:351984 (history)  Vaccinated:2008-12-30
Age:0.3  Onset:2009-02-01, Days after vaccination: 33
Gender:Male  Submitted:2009-07-20, Days after onset: 168
Location:North Carolina  Entered:2009-07-21, 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: Hydrocortisone
Current Illness: Dermatitis
Preexisting Conditions: 7/30/09 Hospital records received DOS 5/18/09 to 5/24/09. Premature birth - 1 month early. NICU. Umbilical hernia. Bad cold, choking cough, rash on back. Bronchiolitis.
Diagnostic Lab Data: ultrasound, 05/29/09, showed no evidence of recurring intussusception; KUB X-ray, 05/18/09, showed intussusception. 7/30/09 Hospital records received DOS 5/18/09 to 5/24/09. LABS and DIAGNOSTICS: CXR - Negative. KUB - abnormal gas pattern
CDC 'Split Type': WAES0907USA02033
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3240AA UNLL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0919X UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD01075 UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1101X0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Alanine aminotransferase decreased, Anion gap decreased, Appendicectomy, Barium double contrast, Biopsy colon abnormal, Blood albumin decreased, Blood alkaline phosphatase decreased, Blood creatinine decreased, Blood urea decreased, Bronchiolitis, Colectomy, Decreased activity, Dehydration, Enema administration, Fontanelle depressed, Haematocrit decreased, Haemoglobin decreased, Hypersomnia, Hypophagia, Intestinal perforation, Intussusception, Laparotomy, Lymphocyte count decreased, Mean cell volume decreased, Mean platelet volume decreased, Melaena, Nausea, Pathology test, Platelet count increased, Protein total decreased, Serositis, Stool analysis abnormal, Ultrasound scan normal, Urinary system X-ray, Urine analysis normal, Urine output decreased, Vomiting, X-ray abnormal
SMQs:, Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Myelodysplastic syndrome (broad)
Write-up: Information has been received from a physician and a certified medical assistant concerning a approximately 18 week old male with dermatitis from 02-OCT-2008 who on 30-DEC-2008 was vaccinated with a first 2ml dose of ROTATEQ (lot# 662735/1101X) orally. The patient also received RECOMBIVAX HB (MSD, thimerosal-free, lot # 661596/0919X) into left thigh, PENTACEL (lot#C3240AA) into left thigh and PREVNAR (lot#DD01075) into right thigh at the same day. Other concomitant therapy included topical hydrocortisone. In February 2009, the patient experienced bronchiolitis, from which he recovered. On 15-MAY-2009, the patient developed nausea and vomiting, dehydration, report of one tarry stool and abdominal pain. On 18-MAY-2009 the patient presented to the office, the physician palpated an abdominal mass in the lower left quadrant (LLQ) and sent the baby to the emergency room. There the baby was admitted on 18-MAY-2009. A KUB X-ray was performed on 18-MAY-2009 and showed that the baby had intussusception. At the same day, Barium/air contrast enema was done, but the patient developed a perforated bowel. Partial colectomy and appendectomy were performed on 18-MAY-2009. The baby was discharged on 24-MAY-2009. On 29-MAY-2009, the baby was readmitted with vomiting. An ultrasound was done that day and showed no evidence of recurring intussusception. There was no fever and the baby was discharged the next day. At the baby''s last office visit on 08-JUL-2009, there were no gastrointestinal issues. The patient did not get the second or third dose of ROTATEQ. Additional information is not expected. 7/30/09 Hospital records received DOS 5/18/09 to 5/24/09. Assessment: Bowel perforation, intussusception. Patient presents with moderate intermittent vomiting, hard black tarry stools, decreased oral intake, decreased urine output. Decreased activity and sleeping more. Anterior fontanel sunken. Dehydrated. Small mass in left abdomen. Laparotomy with reduction of ileocolic intussusception, excision of colonic perforation, and appendectom

VAERS ID:354233 (history)  Vaccinated:2008-12-30
Age:1.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 211
Location:Washington  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Bronchiolitis; Reactive airway disease
Diagnostic Lab Data: None
CDC 'Split Type': WAES0901USA00067
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0551X0IMUN
Administered by: Private     Purchased by: Public
Symptoms: Diarrhoea, Vomiting, Wrong drug administered
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a 12 month old female with a history of bronchiolitis at 3 month of age, reactive airway issues when sick and was exposure to the stomach virus on 29-DEC-2008 who on 30-DEC-2008 was vaccinated with PNEUMOVAX (lot # 660718/0551X) by accident, IM, 0.5ml. The office was out of PREVENAR and the nurse who administered the PNEUMOVAX vaccine thought it was the same as PREVENAR because she saw the word pneumococcal. On 31-DEC-2008 the patient vomited once and had watery stools that day. The patient went to the emergency room on 31-DEC-2008 and was treated with PHENEGRAN. On 01-JAN-2009 the patient vomited and had 3 or 4 watery stools. At 3:00 am on 02-JAN-2009 the patient threw up once. The patient also had 2 watery stools on 02-JAN-2009. The patient did not perform any lab diagnostics studies. At time of the report, the patient was recovering. Follow-up information has been received from a physician concerning a 12 month old female who on 30-DEC-2008 at 1:26PM was vaccinated with the first dose of PNEUMOVAX vaccine (lot # 660718/0551X) by accident, IM in left leg, 0.5ml. On 31-DEC-2008 the patient developed vomiting and diarrhea that was more likely related to exposure to another child at daycare. Child did go to ER and received antiemetic and did well subsequently. No further information is available.

VAERS ID:354238 (history)  Vaccinated:2008-12-30
Age:62.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-07-30, Days after onset: 211
Location:Virginia  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Drug hypersensitivity; Penicillin allergy
Preexisting Conditions: Meningitis viral
Diagnostic Lab Data: None
CDC 'Split Type': WAES0901USA00153
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1163X1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, No reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician and a licensed practical nurse concerning a 62 year old female patient with ibuprofen and penicillin allergy and a history of meningitis viral in 1982 who on 30-DEC-2008 was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX (lot # 663012/1163X). Concomitant therapy included "10-12 medications". The patient received PNEUMOVAX in the past with no reactions. On 30-DEC-2008 the patient experienced itching, pain and slight rash at the injection site (left deltoid). The patient sought medical attention by phone. At the time of reporting the patient was recovering. This is one of three reports received from the same source. Additional information has been requested.

VAERS ID:355618 (history)  Vaccinated:2008-12-30
Age:15.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2009-03-20, Days after onset: 79
Location:Texas  Entered:2009-08-13, Days after submission: 146
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007694
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.5005527P IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of one-half dose of expired product was received from a certified medical assistant concerning a 15-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 30-Dec-2008, the reporter administered one-half of FLUMIST dosage when she noticed that the product had expiration date of 26-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 20-Mar-2009: Investigation lot analysis results. Follow-up information was received on 04-May-2009: confirmation that the patient did not experience any adverse events.

VAERS ID:355619 (history)  Vaccinated:2008-12-30
Age:13.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-04-09, Days after onset: 99
Location:Connecticut  Entered:2009-08-13, Days after submission: 126
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007695
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500548P0IN 
Administered by: Private     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of expired FLUMIST administered was received from a registered nurse concerning a 13-year-old female. The child was administered a FLUMIST dose that had expired 12 days earlier. There was no adverse event associated with this inadvertent administration of expired FLUMIST; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 15-Jan-2009 includes: DOB, FLUMIST information and no late adverse events were reported. Additional information was received on 09-Apr-2009: product Complaint Investigation results.

VAERS ID:355699 (history)  Vaccinated:2008-12-30
Age:72.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2009-08-27, Days after onset: 239
Location:Illinois  Entered:2009-08-27
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix, Coreg, KCl, Cozaar
Current Illness: post cardiac catherization
Preexisting Conditions: post cardiac catherization 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. PMH: HTN, CHF, CAD, arthritis, cardiomegaly, appendectomy, knee replacement.
Diagnostic Lab Data: 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. Diagnostics/Labs: Left heart cath, left heart angiocardiogram, coronary arteriogram, stress echo- abnormal- hypokinesia, injection fraction 27.3%.CXR-mild cardiac
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEUR02819AC0IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.L407X0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Abdominal tenderness, Activated partial thromboplastin time, Anaphylactic shock, Anxiety, Aphasia, Arteriogram, Arteriosclerosis, Benign prostatic hyperplasia, Bladder obstruction, Blood creatine phosphokinase increased, Blood creatinine, Blood glucose increased, Blood potassium decreased, Blood urea nitrogen/creatinine ratio increased, Cardiac failure, Cardiac failure congestive, Cardiac murmur, Cerebral artery embolism, Cerebrovascular accident, Chest pain, Computerised tomogram abnormal, Constipation, Crepitations, Dyspnoea, Echocardiogram abnormal, Headache, Heart rate irregular, Hemiplegia, Hyperhidrosis, Hypertensive heart disease, Hypoaesthesia oral, Hypokinesia, International normalised ratio, Loss of consciousness, Platelet count normal, Prothrombin time normal, Restlessness, Speech disorder, Vaccination complication, Visual impairment, X-ray of pelvis and hip normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Pt was due to be discharged after undergoing cardiac catherization. Per chart, pt became restless and nonverbal 5-10 minutes after receiving pneumonia and influenza vaccine. Pt "passed out." Pt also variously decribed to have HA, tongue numbness, and to be diaphoretic and anxious. Pt then reported trouble seeing. CT scan subsequently revealed a CVA. 10/7/09 Medical records an DC summary received for dates 12/25/08 to 1/14/09. DC DX: Hypertensive heart disease, heart failure. Secondary DX: Cerebral embolism w/ infarction, anaphylactic shock, unspecified hemiplegia, systolic heart failure/CHF, coronary atherosclerosis, adverse affect of viral vaccine, low potassium, BPH, urinary obstruction, cataracts, homonymous hemianpsia. Presenting SX: In ER c/o abdominal pain, worsening constipation, chest pain, and SOB, difficulty with speech past 3 days. Assessment: jugular venous distention, systolic murmur, irregular heartbeat, bi-lateral lung crackles, abdominal distention, tenderness, +BS, neuro exam WNL. Pt had cardiac cath completed w/o incident. At some point during inpatient pt had CVA. CT on 1/4/09 results, development of a large intraparenchymal hemorrhage in the right temporal and parietal lobes with significant surrounding edema and resultant right to left subta-cine and transtentoria herniation. Craniotomy performed for a right intraparenchymal hematoma converted to hemorrhage, right frontotemporal craniotomy for evacuation of hematoma, placement of ventricular drain. Pt sent to rehab facility 1/14-2/7/09 had PT and OT, speech therapy. Pt DC home and f/u with PC.

VAERS ID:384556 (history)  Vaccinated:2008-12-30
Age:0.3  Onset:2009-01-19, Days after vaccination: 20
Gender:Male  Submitted:2010-04-02, Days after onset: 437
Location:Tennessee  Entered:2010-04-06, 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: Weight gain poor
Preexisting Conditions: Premature baby
Diagnostic Lab Data: body height measurement 08/31/2008 18 in - at Birth; head circumference 12/30/08 15 - ; temperature measurement 02/09/09 101 -
CDC 'Split Type': WAES0904USA00095
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B198BA1UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF519AB0UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC873101UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1272X1PO 
Administered by: Other     Purchased by: Other
Symptoms: Constipation, Cough, Erythema, Eye discharge, Eyelid oedema, Infantile spitting up, Irritability, Pyrexia, Tympanic membrane disorder
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hearing impairment (narrow), Periorbital and eyelid disorders (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow)
Write-up: Pediatric medical records has been received from a physician''s office concerning a male patient with poor weight gain and a history of premature birth who on 31-OCT-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660878/0502X) (expiration date November 2009). Concomitant vaccinations on the same day included a first dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT) and a dose of PREVNAR (lot # C99098) (expiration date April 2011) in the right thigh (RT). On 30-DEC-2008, the patient was vaccinated orally with a second dose of ROTATEQ (lot # 662652/1272X) (expiration date May 2010). Concomitant vaccinations on the same day included a second dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT), a second dose of PREVNAR (lot # C87310) (expiration date April 2011) in the right thigh (RT) and a first dose of ACTHIB (lot # UF519AB) (expiration date August 2010) in the right thigh (RT). On 19-JAN-2009, the patient experienced low lid swollen/puffy and eye with yellow/green drainage. The patient was prescribed medication (therapy illegible), gtts QID X 7 days. On 09-FEB-2009 the patient experienced fever (101) and cough. It was reported that the fever decreased with TYLENOL. On approximately 13-FEB-2009, the patient experienced fussy, spitting, constipation, and right drum red and bulging. The patient was prescribed AMOXIL 1/2 teaspoon PO BID X 10 days, rest and fluids. At the time of the report, the patient''s status was unknown. On 03-MAR-2009, the patient was vaccinated orally with a third dose of ROTATEQ (lot # 663263/1489X) (expiration date August 2010). Concomitant vaccinations on the same day included a third dose of PEDIARIX (lot # AC21B198BA) (expiration date March 2011) in the left thigh (LT), a third dose of PREVNAR (lot # D07543) (expiration date May 2011) in the right thigh (RT) and a second dose of ACTHIB (lot # UF547AC) (expiration date November 2010). Additional information has been requested. WAES # 0904USA00095 is associated to WAES # 0806USA03426.

VAERS ID:389869 (history)  Vaccinated:2008-12-30
Age:50.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2010-05-31, Days after onset: 516
Location:California  Entered:2010-06-02, Days after submission: 2
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: MRI ?
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3032AA IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthritis, Asthenia, Dizziness, Erythema, Fatigue, Headache, Malaise, Muscle strain, Musculoskeletal pain, Nausea, Osteoarthritis, Pain, Pain in extremity, Skin laceration, Soft tissue disorder, Vomiting, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypersensitivity (broad), Arthritis (narrow)
Write-up: Accidentally cut hand at work - they took me to Urgent Care. 12/30/08 - Light headed and nausea, head hurting real bad, extreme vomiting, arm hurting, red from shot, weak and tired (about 1 hr after shot). Sent home from work. (Daughter called to report to Urgent Care I was sick). Time went on then on 3/1/09, I woke up in excruciating pain. I was told it was (arthritis), (sprain), (rotator cuff muscle) (cervical). I now believe it was brachial neuritis from tetanus vaccine.

VAERS ID:400094 (history)  Vaccinated:2008-12-30
Age:15.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2010-08-04, Days after onset: 581
Location:Illinois  Entered:2010-09-08, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0907USA03370
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 15 year old female patient with pertinent medical history reported as none and amoxicillin allergy developed hives who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # not reported) intramuscularly. On 30-DEC-2008 she received second dose of GARDASIL (lot # 661703/0651X) intramuscularly. There was no concomitant medication. After second dose of vaccine the patient developed rash to her arms and chest. The patient did not seek medical attention for the rash and no treatment was reported. On an unspecified date the patient recovered. On 15-JUL-2009 the patient went to the office for her third dose of GARDASIL but the physician decided not administer any further doses. There were no laboratories diagnostics studies performed. Follow up information has been received from nurse concerning the female patient who received second dose of GARDASIL intramuscularly into left deltoid. On an unknown date after the second dose the patient complained of rash to her arms and chest. On an unknown date, the patient recovered. Additional information is not expected.

VAERS ID:428494 (history)  Vaccinated:2008-12-30
Age:79.0  Onset:2011-08-01, Days after vaccination: 944
Gender:Female  Submitted:2011-08-01, Days after onset: 0
Location:Connecticut  Entered:2011-08-01
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
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.16241SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Onset of herpes zoster in a patient who received the vaccine.

VAERS ID:457342 (history)  Vaccinated:2008-12-30
Age:65.0  Onset:2012-05-28, Days after vaccination: 1245
Gender:Female  Submitted:2012-06-13, Days after onset: 16
Location:Kansas  Entered:2012-06-13
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: Went to Dr. but no lab done
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1624X0UNLA
Administered by: Public     Purchased by: Private
Symptoms: Eye pain, Eye swelling, Herpes zoster, Herpes zoster ophthalmic, Scab, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Lack of efficacy/effect (narrow), Glaucoma (broad), Ocular infections (narrow), Hypersensitivity (narrow)
Write-up: Patient received ZOSTAVAX in 2008. Had shingles outbreak 2012. Eye swelled & was painful May 28th, 2012 shingles appeared 6-3-2012 5 on eyelid 1, on side of forehead, lesions crusted now.

VAERS ID:343843 (history)  Vaccinated:2008-12-30
Age:28.0  Onset:2009-01-05, Days after vaccination: 6
Gender:Male  Submitted:2009-04-09, Days after onset: 93
Location:Foreign  Entered:2009-04-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker
Preexisting Conditions: Infectious Mononucleosis
Diagnostic Lab Data: UNK
CDC 'Split Type': B0568553A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB563AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Erythema, Fatigue, Hepatic function abnormal, Lip swelling, Urticaria
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a foreign regulatory authority (# 041587) and described the occurrence of hepatic function abnormal in a 28-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX and Rabies vaccine (non-gsk). The subject''s medical history included infectious mononucleosis when he was a child. Concurrent medical conditions smoker subject. On 23 December 2008 the subject received unspecified dose of HAVRIX (intramuscular), unspecified dose of Rabies vaccine (intramuscular). On 30 December 2008 the subject received unspecified dose of ENGERIX B (intramuscular). On 5 January 2009, 6 days after vaccination with ENGERIX B, 13 days after vaccination with HAVRIX and Rabies vaccine, the subject experienced hepatic function abnormal, lip swelling, erythema, arthralgia, fatigue and urticaria. The subject was hospitalised. The subject was treated with PIRITON, FLUCLOXACILLIN and PARACETAMOL. At the time of reporting the outcome of the events was unspecified.

VAERS ID:345036 (history)  Vaccinated:2008-12-30
Age:14.0  Onset:2008-12-30, Days after vaccination: 0
Gender:Female  Submitted:2009-04-27, Days after onset: 117
Location:Foreign  Entered:2009-04-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0904USA03604
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a Health Authority (reference number ES-AGEMED-720847241) concerning a 14 year old female who on 30-DEC-2008 was vaccinated with a dose of GARDASIL (batch # not reported) by intramuscular route (site of administration not reported). It was reported that on the day of vaccination, the patient suffered a loss of consciousness, she recovered in 2 or 3 minutes, and fully recovered after a 30 minute period on a high pelvic position (trendelenburg). No further information reported. Case reported as serious by the HA with other medically important condition as criteria. Case was closed. Other business partner numbers include E2009-03463.

VAERS ID:377704 (history)  Vaccinated:2008-12-30
Age:14.0  Onset:2009-01-30, Days after vaccination: 31
Gender:Female  Submitted:2010-01-20, Days after onset: 355
Location:Foreign  Entered:2010-01-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1001USA01337
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1050U0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Henoch-Schonlein purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a gynaecologist concerning a 14 year old healthy female who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL (lot #1050U, batch # NH32130, site and route not reported). Four weeks after vaccination (end of January 2009) the patient developed schoenlein-henoch purpura. The patient was treated with prednisolone and recovered completely within 2 weeks. The reporter assessed the relation to the vaccine was possible. Upon internal review, schoenlein-henoch purpura was considered to be an other important medical event. Case is closed. Other business partner numbers included E2010-00109.

VAERS ID:384021 (history)  Vaccinated:2008-12-30
Age:  Onset:2008-12-30, Days after vaccination: 0
Gender:Male  Submitted:2010-04-01, Days after onset: 456
Location:Foreign  Entered:2010-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prochlorperazine
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic ultrasound, See text; Scan, See text
CDC 'Split Type': B0644299A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA043AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Buried penis syndrome, Congenital cystic kidney disease, Drug exposure during pregnancy, Hydronephrosis, Hypospadias, Ultrasound scan abnormal, Ureteral disorder
SMQs:, Retroperitoneal fibrosis (narrow), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of hypospadias in a male neonate whose mother was vaccinated with CERVARIX (GlaxoSmithKline) before and during the first trimester of pregnancy. On 14 November 2008, the subject''s mother was vaccinated with the first dose of CERVARIX (GlaxoSmithKline; unknown route of administration; unknown injection site). The male neonate was also exposed to PROCHLORPERAZIN (transplacentally), which the mother took since 26 February 2009 to 28 April 2009. On 30 December 2008, the 17-years-old mother of the subject received dose of CERVARIX (unknown injection site) during his pregnancy. The mother''s estimated date of delivery was on 19 August 2009. The male neonate was exposed to the vaccine transplacentally during the first trimester of pregnancy. On July 2009, at 36 weeks gestation, the neonate was delivered by normal vaginal delivery and weighed 2.84 kg. The male neonate presented hypospadias, buried penis with torsion, multicystic displastic left kidney, hydronephrosis and ureteral dilatation. This case was assessed as medically serious by GSK. An antenatal diagnosis of a left multicystic dysplastic kidney was performed, which on postnatal scanning was showed to have some function. The MAG3 showed a left differential of 33 % and a right of 67 %. The analogue images showed a very hydronephrotic kidney with a dilated ureter all the way down to the bladder. The ultrasound similarly confirms the left hydronephrosis with an AP diameter of 5 cm. The subject also presented a very dilated ureter with a maximal diameter of 2 cm.

VAERS ID:425241 (history)  Vaccinated:2008-12-30
Age:17.0  Onset:2009-03-01, Days after vaccination: 61
Gender:Female  Submitted:2011-06-10, Days after onset: 830
Location:Foreign  Entered:2011-06-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Prior to this she was a fit and healthy teenager with no medical problems.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0723712A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Aphasia, Asthenia, Coordination abnormal, Gastrostomy tube insertion, Headache, Vasculitis cerebral
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cerebrovascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (narrow)
Write-up: This case was reported by a regulatory authority (Regulatory Agency # GB-MHRA-EYC 00064771) and described the occurrence of vasculitis cerebral in a 17-year-old female subject who was vaccinated with HPV. On 2 December 2008 the subject received her 1st dose of HPV (intramuscular). On 30 December 2008 the subject received her 2nd dose of HPV (intramuscular). In March 2009, approximately 3 months after the 2nd vaccination with HPV, the subject experienced weakness, headache and lack of coordination. She was eventually admitted for prolonged periods of time and has been extensively investigated and she has a rare cerebral vasculitis of unknown cause, this has been steroid responsive, but she is now unable to speak, walk or co-ordinate her movements. She is fed through a peg tube and cared for 24 hours a day. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved. MHRA Verbatim Text : Human Papilloma Virus (HPV) first vaccine given followed by second HPV 4 weeks later. Approximately 3 months after second vaccine the patient developed headaches, weakness and lack of co-ordination. She was eventually admitted for prolonged periods of time and has been extensively investigated and she has a rare cerebral vasculitis of unknown cause, this has been steroid responsive, but she is now unable to speak, walk or co-ordinate her movements. She is fed through a peg tube and cared for 24 hours a day. Clearly it cannot be proven that her illness is directly linked to the HPV vaccine, but she has a serious disability now. Her illness is rare and unexplained. Her parents are convinced it is the HPV vaccine.

VAERS ID:425345 (history)  Vaccinated:2008-12-30
Age:17.0  Onset:2009-03-01, Days after vaccination: 61
Gender:Female  Submitted:2011-06-13, Days after onset: 833
Location:Foreign  Entered:2011-06-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1106USA00764
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Aphasia, Asthenia, Coordination abnormal, Disability, Gastrostomy, Headache, Movement disorder, Vasculitis cerebral
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cerebrovascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (narrow)
Write-up: This case was received from the Health Authority on 02-JUN-2011. Reference number: ADR 21077360. This case was medically confirmed. A 17 year old female patient received the second dose of GARDASIL (manufacturer, lot and batch number not reported) i.m. on 30-DEC-2008. On an unspecified date in March 2009, approximately three months post vaccination, the patient developed headaches, weakness and lack of coordination. The patient had the first dose of GARDASIL (manufacturer, lot and batch number not reported) on 02-DEC-2008. The patient was eventually admitted to hospital in 2009 for long periods of time and was extensively investigated. The patient had a rare cerebral vasculitis of unknown cause. This was steroid responsive but the patient was unable to speak, walk or coordinate her movements. The patient was fed through a percutaneous endoscopic gastrostomy and was cared for 24 hours a day. At the time of reporting, the patient had not yet recovered (also reported as unknown). The reporter stated that whilst it clearly could not be proven that the patient''s illness was directly linked to GARDASIL vaccine she had a serious disability. The patient''s illness was rare and unexplained and her parents were convinced that it was caused by the vaccine. The events were considered serious due to hospitalization and disability. Other business partner number included: E2011-03389. No further information is available.

VAERS ID:336395 (history)  Vaccinated:2008-12-31
Age:38.0  Onset:2009-01-02, Days after vaccination: 2
Gender:Male  Submitted:2009-01-02, Days after onset: 0
Location:Washington  Entered:2009-01-02
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: Previous heart attack (coronary artery disease)
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1380U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Nausea, Oedema peripheral, Pain, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Patient describes reaction as increased temp of 103F, Red hot swollen right arm, body aches and nausea. Patient was seen at ED and recieved Benadryl, Ibuprofen, Phenergan and Dilaudid as well as a prescription for Oxycontin.

VAERS ID:336396 (history)  Vaccinated:2008-12-31
Age:11.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-01-03, Days after onset: 3
Location:Michigan  Entered:2009-01-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: n/a; Had allergic rhinitis/viral syndrome on 12-02-2008
Preexisting Conditions: History of Asthma/Allergic Rhinitis
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU28418A0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received Menactra vaccine on 12-31-2008. Rapidly developed redness and swelling at injection site only. Area of redness was 5 in x 5 in. Area also was itchy. Physician recommended Benedryl every 6 hours and cold compress application to injection site. On 1-2-09 area of redness and swelling had diminished in size.

VAERS ID:336556 (history)  Vaccinated:2008-12-31
Age:17.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2008-12-31, Days after onset: 0
Location:Missouri  Entered:2009-01-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: BPS, 8:10 92/54 P60, 8:15 98/72 P64, 8:18 96/64 sitting P72, 8:20 112/68 P64
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.148660IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient blacked out after receiving HPV vaccine.

VAERS ID:336867 (history)  Vaccinated:2008-12-31
Age:14.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-01-05, Days after onset: 5
Location:Ohio  Entered:2009-01-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.U266X0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2666AA1SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B030AA1IMLA
Administered by: Military     Purchased by: Public
Symptoms: Asthenia, Eye disorder, Head lag, Pallor
SMQs:, Guillain-Barre syndrome (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: After vaccination patient appeared pale and weak. He was instructed to sit down. His head fell to the side and his eyes closed. He opened his eyes seconds later and took sips of water he was instructed to wait 15 more minutes to monitor.

VAERS ID:336868 (history)  Vaccinated:2008-12-31
Age:11.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-01-05, Days after onset: 5
Location:Ohio  Entered:2009-01-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2666UAA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Fall, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approximately ten minutes after his vaccination, patient was standing by the door and began to faint and slowly fall to floor. No injuries reported. He opened his eyes within seconds and was instructed to wait 15 minutes to monitor.

VAERS ID:337063 (history)  Vaccinated:2008-12-31
Age:42.0  Onset:2009-01-05, Days after vaccination: 5
Gender:Female  Submitted:2009-01-08, Days after onset: 3
Location:West Virginia  Entered:2009-01-12, 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:
Preexisting Conditions: GERD/IBS/Allergic Rhinitis
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3030AA0UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right deltoid developed edema after 2 days.

VAERS ID:337172 (history)  Vaccinated:2008-12-31
Age:63.0  Onset:2009-01-02, Days after vaccination: 2
Gender:Female  Submitted:2009-01-13, Days after onset: 11
Location:Colorado  Entered:2009-01-13
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: MED ALLERGIES: CIPRO, ZOCOR, ZESTRIL, LOTENSIN, ZETIA 3/3/09-records received-PMH: morbid obesity. insulin dependent diabetes type 2. hypothyroidism. gout. hypertension. osteoarthritis of knee.
Diagnostic Lab Data: CSF: 57 wbc: 66% LYMPHS; CSF GLUCOSE 114; CSF PROTEIN 115 3/3/09-records received- Electromyography did not show any neuropathies. MRI spine disk impingemnent. EKG normal. Synovial cyst at L5-S1. Klebsiella pneumonia. Herpes simplex virus negative. CSF and gram stain negative. CSF protein 115, glucse 114, 37 nucleated cells. GGT 1000. ATL 280, AST 149, bilibubinemia 0.3.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1623X0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood bilirubin increased, CSF culture negative, CSF glucose increased, CSF lymphocyte count increased, CSF polymorphonuclear cell count increased, CSF protein increased, CSF white blood cell count increased, Culture positive, Electrocardiogram normal, Electromyogram normal, Gamma-glutamyltransferase increased, Gram stain negative, Herpes simplex serology negative, Hyperbilirubinaemia, Hypoaesthesia, Hyponatraemia, Klebsiella infection, Meningitis aseptic, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyelonephritis, Rash erythematous, Urinary tract infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Malignant lymphomas (broad)
Write-up: WEAKNESS; PAIN & NUMBNESS STARTING IN LOWER EXTREMITIES; RASH LOWER EXTREMITIES (MILD, ERYTHEMATOUS; NO VESCICLES) 3/3/09-records received for DOS 1/11-1/16/09 DC DX:Medication reaction to varicella-zoster vaccine. Aseptic meningitis. Schomberg rash most likely hepatitis.hyponatremia. Presented with rash and ascending pyelonephritis, weakness and numbness in legs times 2 weeks. Rash on chest and legs and face. urinary tract infection.

VAERS ID:337464 (history)  Vaccinated:2008-12-31
Age:0.5  Onset:2009-01-01, Days after vaccination: 1
Gender:Female  Submitted:2009-01-15, Days after onset: 14
Location:Ohio  Entered:2009-01-15
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
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3180AA0IMRL
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0401X0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC990982IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1273X2PO 
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Dyspnoea, Lip swelling, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Motehr called and reported need to go to ER folllowing immunizations given 12/31/2008. She stated respirations became labored and temperature 102.7. Tongue and lower lip were swollen. At ER treated with Benadryl and was fine within 1 hour.

VAERS ID:337981 (history)  Vaccinated:2008-12-31
Age:11.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-22, Days after onset: 22
Location:Minnesota  Entered:2009-01-22
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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR2810AA IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0525U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2661AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS033BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Loss of consciousness, Nausea, Pallor, Syncope
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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Adolescent became lightheaded then fainted several minutes after receiving immunizations. LOC approx 1 min. and color pale. Remained nauseous and lightheaded 10 mins. Walked on own to parking lot accompanied by mother and nurse. Mother called 2 days later and stated adolescent fine after arriving home.

VAERS ID:338112 (history)  Vaccinated:2008-12-31
Age:59.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-23, Days after onset: 23
Location:Montana  Entered:2009-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins only:Time-released Multiple Vitamin, D3, Niacin, Glucosamine, Calcium with vitamin D, and Fish Oil
Current Illness: None
Preexisting Conditions: Pt says she has a condition she refers to as a compromised immune system as a result of a virus that she contracted 2-3 years ago. The virus apparently weakened her immune system and she says she is more susceptible to colds etc. now. Pt says she sees a rhuematalogist for this condition and will try to contact them as to the condition''s effect on vaccinations and vis versa.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB275BA5IMLA
Administered by: Public     Purchased by: Private
Symptoms: Induration, Mobility decreased, Pain, Sleep disorder
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Immediately following venipuncture pt said it hurt. Pt supported and encouraged to provide post-injection pain relief methods. She said it still hurt when leaving office and pt told to call if symptoms did not subside. Three weeks post-injection (1/21/09 pt. called to obtain advice as she felt her pain had not subsided since her Hepatitis A vaccination. She says the pain had gotten worse, although she described the shooting pain she initially experienced went away after the first 1-2 days. She describes her current pain as an ache at 3-4/10 on the pain scale. She says that the pain encompasses her shoulder/upper arm area and the pain feels muscular in nature. She says the pain has awakened her during the night. Pt says she did not take any tylenol/pain reliever and limited movement after injection due to pain. Pt encouraged to try a pain reliever and hot pack as well as exercising the arm. Pt receptive to this information. She then recalled that 2-3 years ago she contracted a virus which has chronically weakened her immune system. Pt plans to contact her rhuematologist about this. Pt was called 2 days after original complaint (as agreed upon) to re-check symptoms. She said she had not taken the tylenol as the pain was, "not that bad." She said she has not had a chance to talk with her rhuematologist. The nurse and pt have agreed to check in again next week.

VAERS ID:338305 (history)  Vaccinated:2008-12-31
Age:0.5  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-05, Days after onset: 5
Location:Kansas  Entered:2009-01-26, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Marked No
Preexisting Conditions:
Diagnostic Lab Data: Chest X ray - RSV- Neg
CDC 'Split Type': KS200902
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B163BC1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF515AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC831431IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0217X1PO 
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Eye discharge, Respiratory syncytial virus test negative, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad)
Write-up: 101-102 Temp- eyes matted - clear nasal discharge - cough - Sx lasted 2 days - to ER Fri, Amoxicillin, and cough med- Dr said ok to proceed with next series

VAERS ID:338567 (history)  Vaccinated:2008-12-31
Age:73.0  Onset:2009-01-16, Days after vaccination: 16
Gender:Female  Submitted:2009-01-27, Days after onset: 11
Location:Unknown  Entered:2009-01-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hyperchol.; Reflux; Osteopenis. No alcohol or drug use.
Diagnostic Lab Data: Clinical exam only, no serologic testing, no cultures
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.00064963410IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Genital pain, Genital ulceration
SMQs:, Severe cutaneous adverse reactions (broad)
Write-up: Shingles vaccine given 12/31/2008. Onset of painful genital ulcerations- two total- on approximately 1/14. Evaluation in office revealed two isolated well- circumscribed genital ulcerations. Pt has been married for 40+ years, no sexual activity for over 12 years, no b/o HSV infection - oral or genital-. Unsure if this lesion could have been related to vaccine.

VAERS ID:339482 (history)  Vaccinated:2008-12-31
Age:16.0  Onset:2009-01-10, Days after vaccination: 10
Gender:Male  Submitted:2009-02-11, Days after onset: 32
Location:Wisconsin  Entered:2009-02-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations.
Diagnostic Lab Data: The subject had abnormal cerebrospinal fluid (CSF) laboratory values indicative of meningitis. All cultures were negative.
CDC 'Split Type': A0767750A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSB292AA1UNUN
Administered by: Private     Purchased by: Private
Symptoms: CSF test abnormal, Culture negative, Headache, Meningitis aseptic, Visual impairment, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of aseptic meningitis in a 16-year-old male subject who was vaccinated with HAVRIX. The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations. On 31 December 2008 the subject received 2nd dose of HAVRIX (.5ml, unknown). On 10 January 2009, 10 days after vaccination with HAVRIX, the subject experienced aseptic meningitis, headache, weakness of left vision and elevated white blood cells. The subject was hospitalised for aseptic meningitis 10 days after vaccination with the second dose of HAVRIX. The physician considered the events were clinically significant (or requiring intervention). The subject had abnormal cerebrospinal fluid (CSF) laboratory values indicative of meningitis. All cultures were negative. On an unspecified date, the subject was discharged from the hospital and all symptoms resolved within five days. On 15 January 2009, the events were resolved. The physician considered the events were possibly related to vaccination with HAVRIX.

VAERS ID:340208 (history)  Vaccinated:2008-12-31
Age:3.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-04-20, Days after onset: 109
Location:New Jersey  Entered:2009-02-17, Days after submission: 61
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007756
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 38-month-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse event.

VAERS ID:340209 (history)  Vaccinated:2008-12-31
Age:4.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-04-10, Days after onset: 99
Location:New Jersey  Entered:2009-02-17, Days after submission: 51
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007755
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient is one of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case in submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse event. Additional information received on 10-Apr-2009. product complaint investigatin results.

VAERS ID:340219 (history)  Vaccinated:2008-12-31
Age:4.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-01-06, Days after onset: 6
Location:New Jersey  Entered:2009-02-17, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007711
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: Expired vaccine used Expired drug administered) A non-serious spontaneous report of administration of expired product s received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 21-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient is one of a pair of sibling who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccine were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse events associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune''s post-marking commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse event.

VAERS ID:340220 (history)  Vaccinated:2008-12-31
Age:2.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-06, Days after onset: 6
Location:New Jersey  Entered:2009-02-17, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007710
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554 IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product was received from a registered nurses concerning a 24-month-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 309 units with same lot # delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccine. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on the day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with the medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune''s post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse event.

VAERS ID:340112 (history)  Vaccinated:2008-12-31
Age:18.0  Onset:2009-01-15, Days after vaccination: 15
Gender:Unknown  Submitted:2009-02-19, Days after onset: 35
Location:Colorado  Entered:2009-02-19
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yaz
Current Illness: none
Preexisting Conditions: none. PMH: OCs
Diagnostic Lab Data: Labs and diagnostics: LP with WBCs 122-100% monos, CSF protein 109, glucose 57. HSV PCR (-). EEG abnormal-temporal slowing.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.UNKNOWN1UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF glucose normal, CSF monocyte count increased, CSF protein increased, CSF white blood cell count increased, Depression, Dysarthria, Electroencephalogram abnormal, Gastrointestinal disorder, Headache, Herpes simplex serology negative, Hypoaesthesia, Lumbar puncture, Meningitis aseptic, Musculoskeletal stiffness, Nausea, Neck pain, Neurological symptom, Obsessive-compulsive disorder, Oxygen saturation decreased, Paraesthesia, Phonophobia, Photophobia, Polymerase chain reaction, Speech disorder, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad)
Write-up: Nausea, headaches, frequent illness including viral spinal menengitis, numbness and tingling in different areas of the body. First shot 10/31/08, second shot 12/31/08. Symptoms began 1/15/09. No physician is interrested in determining if this is related to Gardasil. 3/6/09 MR received for DOS 2/9-10/2009 with D/C DX: Hx of Aseptic meningitis and Headache. Pt initially presented to local hospital with c/o H/A, neck stiffness and pain, phono/photophobia, GI distress, nausea and vomiting. Pt was DX with aseptic meningitis and admitted x week. Pt currently presnting with transient neuro deficits including L & R sided paresthesias, dysarhtria, and difficulty speaking the last half of words. Pt c/o visual obstruction (like TV snow) during episodes. BP 86/58. O2 sat 90% RA. PE (+) for mild facial asymmetry-? chronic. Started on Lexapro for depression and OCD traits and possibly developing migraines.

VAERS ID:340793 (history)  Vaccinated:2008-12-31
Age:1.0  Onset:2009-01-16, Days after vaccination: 16
Gender:Male  Submitted:2009-02-26, Days after onset: 41
Location:Michigan  Entered:2009-02-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC719754IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1381X1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Rash papular, Scab, Varicella post vaccine
SMQs:
Write-up: PT GIVEN VARICELLA VACCINE ON 12/31/08 PRESENTED TO OFFICE ON 01/20/09 WITH PAPULAR RACH EXTENDED FROM HEAD TO EXTREMITIES. INITIAL POX ARE SCABBED OVER AND DRYING ADDITIONA POX BREAKING OUT

VAERS ID:341649 (history)  Vaccinated:2008-12-31
Age:62.0  Onset:2009-01-07, Days after vaccination: 7
Gender:Female  Submitted:2008-03-10, Days after onset: 303
Location:Oregon  Entered:2009-03-12, Days after submission: 367
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
SMQs:
Write-up: Pt states her (L) arm has been sore ever since she had the BOOSTRIX. She has shooting pain with certain movements, for weeks she couldn''t raise her (L) arm. Took ALEVE and used (L) arm as much as she could to try to relieve the pain.

VAERS ID:341808 (history)  Vaccinated:2008-12-31
Age:0.3  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-03-11, Days after onset: 69
Location:Washington  Entered:2009-03-16, 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:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3228AB0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Mom stated child cried 4-5 hours after having PENTACEL. Notified provider prior to next scheduled dose. Next dose not given of PENTACEL. Only HIB :IPV given 0 DTAP.

VAERS ID:343255 (history)  Vaccinated:2008-12-31
Age:0.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-04-01, Days after onset: 90
Location:Nebraska  Entered:2009-04-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin K Injection, Erythromycin Eye Ointment
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA356AA0IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: No adverse event, Wrong drug administered
SMQs:
Write-up: My son received Influenza vaccine (adult dose) instead of Hepatitis B vaccine. He is now 12 weeks of age. To date, we have not experienced an adverse event. We have no way of knowing if there will be any long term effects.

VAERS ID:343894 (history)  Vaccinated:2008-12-31
Age:73.0  Onset:2009-01-14, Days after vaccination: 14
Gender:Female  Submitted:2009-03-27, Days after onset: 71
Location:South Carolina  Entered:2009-04-08, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREMARIN; CRESTOR
Current Illness: Oesophageal reflux; Osteopenia; Cholesterol high
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA04150
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Genital herpes, Genital ulceration, Pain
SMQs:, Severe cutaneous adverse reactions (broad)
Write-up: Information has been received from a physician concerning a 73 year old female patient with reflux, osteopenia and high cholesterol who on 31-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Lot not reported). Concomitant therapy included PREMARIN and CRESTOR. On 14-JAN-2009 the patient developed painful lesions in her genital area. The lesions were described as ulcerative painful herpetic lesions in her perianal area. For her treatment acyclovir was prescribed. On an unspecified date in January 2009 the patient recovered. Additional information has been requested.

VAERS ID:345511 (history)  Vaccinated:2008-12-31
Age:  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-03-27, Days after onset: 85
Location:California  Entered:2009-04-08, Days after submission: 12
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: Shingles
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0901USA00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Accidental exposure, Burning sensation
SMQs:, Peripheral neuropathy (broad)
Write-up: Information has been received from an office manager concerning a female nurse with a history of shingles who on 31-DEC-2008 was reconstituting ZOSTAVAX (Oka/Merck) to give to a patient. When she was injected the diluent into the vial, the pressure was so much that the vaccine sprayed back into face and eyes. Her face feels like it was burning but her eyes have no issues. It was reported that the nurse flushed her eyes and face with water. Additional information has been requested.

VAERS ID:348469 (history)  Vaccinated:2008-12-31
Age:10.0  Onset:2009-03-18, Days after vaccination: 77
Gender:Female  Submitted:2009-05-21, Days after onset: 64
Location:Arizona  Entered:2009-06-04, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1369X1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Abortion, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Pt denied being preg. 12/31/08. Had US on Feb''2009 and was informed baby had problems and abortion done 3/18/09 at OB.

VAERS ID:353218 (history)  Vaccinated:2008-12-31
Age:60.0  Onset:2009-01-11, Days after vaccination: 11
Gender:Female  Submitted:2009-07-31, Days after onset: 200
Location:Unknown  Entered:2009-08-05, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Do not smoke or drink but do have fibromyalgia non specific colitits and interstitial cystitis
Diagnostic Lab Data: It was first believed I had an inner ear problem. An ENT who specializes in inner ear sent me to a neurologist. I was given an MRI, MRA tests on the nerves and balance. Was sent to vestibular rehabilitation.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1557X0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiogram, Nuclear magnetic resonance imaging, Vestibular neuronitis
SMQs:, Vestibular disorders (narrow)
Write-up: Developed vestibular neuritis 12 days after receiving the shingles vaccination.

VAERS ID:355658 (history)  Vaccinated:2008-12-31
Age:5.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Male  Submitted:2009-01-06, Days after onset: 6
Location:New Jersey  Entered:2009-08-13, Days after submission: 218
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': MEDI0007754
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500554P IN 
Administered by: Private     Purchased by: Private
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient''s medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient''s demographics and outcome of adverse events.

VAERS ID:385808 (history)  Vaccinated:2008-12-31
Age:14.0  Onset:2009-01-06, Days after vaccination: 6
Gender:Female  Submitted:2010-04-23, Days after onset: 471
Location:Utah  Entered:2010-04-23
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: CAPD (central auditory processing disorder)
Diagnostic Lab Data: CAT scan, MRI, thyroid testing, bloodwork, heart monitoring
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X3IJRA
Administered by: Public     Purchased by: Other
Symptoms: Activities of daily living impaired, Alopecia, Amnesia, Ataxia, Blood human chorionic gonadotropin negative, Blood test, Burning sensation, Cardiac monitoring, Computerised tomogram head, Computerised tomogram normal, Conversion disorder, Deafness, Dizziness, Dyspnoea, Eating disorder, Echocardiogram normal, Erythema, Fatigue, Feeling cold, Gait disturbance, Headache, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Menstruation irregular, Migraine, Muscle spasms, Muscular weakness, Nausea, Nervous system disorder, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Pain, Pallor, Palpitations, Paraesthesia, Phonophobia, Pyrexia, Rash, Rhinorrhoea, Screaming, Skin warm, Stress, Swelling, Thyroid function test, Tremor, Upper respiratory tract infection, Vision blurred, Weight decreased, Wrong drug administered
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Wrong shot given 12/26/08 (another meningitis shot given, instead of HPV #3). 1/6/09, upper respiratory infection, headache. 1/14/09 headaches worsen. Respiratory cleared up with antibiotics/looked like pneumonia. 1/15/09 dizziness. 1/28/09, headaches spike to levels 5-7 out of 10, 100% of the time. Ibuprofen does not work (800 mg). Mid feb: saw dr. Augmentum given for possible sinus infection. Headaches worsen, nasal fluid leakage continues. Augmentum does nothing. CAT scan MRI to be ordered within 5 days of Augmentum. Headaches spike to 7-8 100% of the time. Dizzy, no focus, loss of memory. Removed from school. Saw chiropractor - no one could touch the back of her head (meninga area) without her screaming. Says her head feels swollen and numb. Spine starts to burn. 2/15/09 8 pm, headaches go to 10/10, patient screaming. Consider possibility of brain tumor and take her to ER. Has trouble walking in straight line. CAT scan ordered by ER. Doctor send her home and tells her to take 2 Tylenols and 3 ibuprofens. CAT scan normal. 2/17 saw pediatrician again. Full blood work ordered: tests vitamin D, thyroid function, regular bloodwork. Referred to neurologist. 2/19/09 Dr. agrees problem could have been caused by cross reactions of Gardasil and Menactra: gives her Topomax at 50 mg/day and orders MRI. 2/20/09: MRI looks normal. Spine still burning, back of head untouchable, having more touble walking in a straight line. 2/23/09 2nd day of Topomax. Can only walk in 45 degree angles....cannot walk to bathroom. Go to ER, where she is seen by a team on neurologists and admitted to hospital for next 3 days. Ibuprofen administered via IV. No repsonse. 2nd day: DHE administered, which takes effect and after 3rd day she is released. March and April ''09: patient can get through 2-4 hours of school each day and in the midst of that, needs a 1 hour rest on couch in office at school. Most days I pick her up at lunch. She is pale and very dizzy, with headaches reoccurring daily. Typically levels 4-5, with 7-8 spikes. She loses 8 lbs (she weighs 104). Picks up a flu bug and end of March due to compromised immune system. Follow up with neurology to see if she has cerebral leakage, as she is complaining of a "dripping" sensation in back of head. End April: Heart palpitations begin, cramping of upper left chest area starts. Topomax reduced to 15 mg, but headaches continue. Does not finish 9th grade. Sleeps all night and approx 6 hours during the day. Starts complaining of breathing problems, as if not getting enough O2. May-July: headaches, dizziness, spine burning, memory loss, breathing issues continue. 2/3 of her hair falls out and hand tremors begin. Can''t work for maore than 2 hours/day on school work (to finish 9th grade.) July 2009: start her on Eastern medical practices: foot zoning (similar to reflexology) every 2 days. This helps her tremendously, but makes her nauseated. Arteries and veins in legs begin burning to level of pain where she is screaming. August 2009: goes to high school 1/2 time...contracts Mono almost immediately. Red rash sets in all over her face and upper torso. Mid-Sept - October 31, 2009: Heart palpitations severe enough to cause new doctor to send her back to Hospital to have heart monitored and a heart exam. Is seen at home by nurse teacher weekly. Take her out of high school Nov. 1 2009 and into Online HS full time. Tremors continue, hair still falling out. Thyroid tested again: all normal. Recovers from Mono, but arteries and veins in legs start to burn again. Level 8-10/ she sits on couch and screams, holding her legs. Put her on Mangosteen/Xango juice to reduce inflammation. This works and pain subsides to manageable level. Memory loss still apparent, but focus improving. Cannot exercise for more than 20 mins at a time at a slow walking pace. Cannot continue playing soccer or refereeing or ballet. Drops all sports. Cannot walk more than .25 miles without being fatigued. Have her on mild exercise

VAERS ID:397212 (history)  Vaccinated:2008-12-31
Age:17.0  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2010-09-01, Days after onset: 608
Location:Louisiana  Entered:2010-09-02, 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: CONCERTA; RITALIN
Current Illness: Pregnancy NOS (LMP = Unknown); Attention deficit/hyperactivity disorder
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0901USA00847
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a nurse through the pregnancy registry for HPV vaccine concerning a 17 year old female with attention deficit/hyperactivity disorder who on 31-DEC-2008 was vaccinated with a dose of GARDASIL (lot # 660616/0570X), 0.5 ml, intramuscular route. Concomitant therapy included CONCERTA and RITALIN. On 07-JAN-2009, the patient called the office to inform office that she was pregnant. No adverse effects were reported. The patient''s LMP and EDD were not reported. Follow-up information was received on 27-AUG-2010 from a medical assistance who reported that the patient had a miscarriage. According to the medical assistance, the doctor said the miscarriage happened early on her pregnancy but she could not provide a specific date. When asked if there was a pathology report she said there was no indication in chart that any testing was performed. She added that the patient was fine afterwards. Upon internal review miscarriage was considered to be an other important medical event. Additional information is not expected.

VAERS ID:432961 (history)  Vaccinated:2008-12-31
Age:67.0  Onset:2010-07-03, Days after vaccination: 549
Gender:Female  Submitted:2011-07-19, Days after onset: 381
Location:Unknown  Entered:2011-08-03, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Shingles
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1008USA00360
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Acne, Blister, Condition aggravated, Herpes zoster, Pruritus
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a 69 year old female patient with a history of shingles in 2007 who at the end of December 2008, was vaccinated with ZOSTAVAX (Merck) (Lot# unknown). The reporter stated that on 03-JUL-2010, she experienced a mild episode of shingles. She also reported that "recently" on 03-JUL-2010, she had been itching like crazy, she got small pimples and water like blisters. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:472448 (history)  Vaccinated:2008-12-31
Age:83.0  Onset:2012-09-05, Days after vaccination: 1344
Gender:Female  Submitted:2012-10-03, Days after onset: 28
Location:Florida  Entered:2012-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1210USA001000
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: This spontaneous report as received from a physician refers to a 83 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX on 31-DEC-2008 (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-SEP-2012 the patient developed shingles, 1345 days after onset of therapy. The patient sought unspecified medical attention and was treated with acyclovir and prednisone. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:338521 (history)  Vaccinated:2008-12-31
Age:0.2  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-01-27, Days after onset: 27
Location:Foreign  Entered:2009-01-28, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC 'Split Type': GBWYEG02976609
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2973AA IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURC2973AA IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURC2973AA IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH328970IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Expired drug administered, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case is life-threatening. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority (MHRA ref: 20367304) regarding a 9-week-old female patient who experienced severe allergic reaction anaphylaxis and expired vaccine used. The patient received the first dose on 31-Dec-2008. The patient experienced severe allergic reaction anaphylaxis and expired vaccine used on 31-Dec-2008. The event was considered to life-threatening. Treatment for the anaphylaxis included oxygen, adrenalin and piriton administration and the anaphylaxis was considered resolved on 31-Dec-2008. No additional information was available at the time of this report.

VAERS ID:342584 (history)  Vaccinated:2008-12-31
Age:0.3  Onset:2008-12-31, Days after vaccination: 0
Gender:Female  Submitted:2009-03-24, Days after onset: 82
Location:Foreign  Entered:2009-03-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient''s mother suffered from oligohydramnios during pregnancy. The patient has a past history of foetal growth retardation and the patient was born via cesarean section and postnatal the patient suffered from hypoglycaemia. After the patient recovered from hypoglycaemia the further postnatal course was without complications. Past vaccinations included the first dose of PREVENAR and INFANRIX HEXA which had been well tolerated.
Diagnostic Lab Data: Weight (results: birth weight: 2140g) was done on 26-Sep-2008. On 31-Dec-2008 test results were: electroencephalogram (results: sleep EEG: without constant focus in form of deceleration focus and no safe hint of epilepsy, the isolated intensive potentials are not typical for epileptic graphoelements); body temperature (results: 38.2 deg. C.); body temperature (results: 38.7 deg. C.); physical examination (results: heart sounds normal and rhythmic, abdomen soft, lungs bilateral ventilated and no hepatosplenomegaly); haemoglobin (results: 6.9 mmol/L); haematocrit (results: 0.33); interleukin level (results: 76.9 pg/mL); platelet count (results: 530 Gpt/l); blood sodium (results: 142 mmol/L) blood potassium (results: 4.84 mmol/L); blood calciu
CDC 'Split Type': DEWYEG03369109
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood albumin decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood potassium normal, Blood pyruvic acid, Blood sodium normal, Body temperature increased, C-reactive protein normal, Convulsion, Diarrhoea, Dyskinesia, Electroencephalogram normal, Epilepsy, Fatigue, Febrile convulsion, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Interleukin level, Nasopharyngitis, Nuclear magnetic resonance imaging normal, Platelet count increased, Pyrexia, Respiratory tract infection, Screaming, Stool analysis normal, Ultrasound scan normal, Urine analysis normal
SMQs:, Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority (PEI) regarding a 3-month-old female patient who experienced epilepsy, convulsion, atypical febrile seizure, fever, rhinopharyngitis, respiratory infection, screaming and diarrhoea. The patient received the second dose on 31-DEC-2008. Additional suspect medication included INFANRIX HEXA which was administered on the same day. On 31-Dec-2008 the patient was vaccinated with INFANRIX HEXA and PREVENAR and at 6 pm the patient experienced a febrile seizure with emphasis of the left side. The seizure was located at left arm and left part of face and lasted for 3 minutes. The patient had a body temperature of 38.2 C. The emergency doctor was called, the patient was hospitalized and atypical febrile seizure was diagnosed. On arrival at hospital the patient was in good general condition, the turgor was normal and there were no signs of an infection. The EEG (sleep-EEG) showed no deceleration and no safe hint of epilepsy. The potentials were not typical for epileptic graphoelements. After the patient received PARACETAMOL for therapy the patient''s body temperature decreased and the patient was discharged from hospital. In Jan-2009 the patient also experienced a respiratory infection and on the night of the 22nd January the patient screamed a lot and at 4 am on 23-Jan-2009 the patient''s arms and legs jerked symmetric. The patient''s temperature was normal. The patient''s mother administered RECTIOLE DIAZEPAM and after 2 minutes the patient''s seizure ceased. The patient was again hospitalized and at hospital the patient experienced one additional convulsion in form of jerking of face, hands, arms, legs and the whole body. The jerking was symmetric. After the administration of DIAZEPAM the seizure ceased. In addition the patient experienced diarrhoea. The patient had a body temperature of 38.5 C. The patient was an in a stable general condition but she was a little bit floppy and tired due to the DIAZEPAM administration. The wake EEG and midday sleep EEG were without any pathological findings and focus and there were no hints of epilepsy. The patient recovered from diarrhoea and the reason for fever was mild rhinopharyngitis. The patient was discharged from hospital in a general condition. On 15-Feb-2009 the patient experienced again rhythmic jerking of right arm and the patient''s hand was tensed up and her arm was stiff. Over night the patient did not experience any symptoms but in the next morning the patient experienced symptoms which were similar to the symptoms she experienced the day before. On 16-Feb-2009 the patient''s left arm was involved. The two seizures lasted for 5 minutes. The seizures ceased without the administration of DIAZEPAM. The patient''s mother did not want to administer DIAZEPAM because she was afraid that her daughter experienced adverse events. The patient did not suffer from fever and on arrival at hospital the patient was in a stable condition. On 19-Feb-2009 the patient again experienced a febrile convulsion which lasted for 15 minutes. The seizure occurred 2 hours after lumbar puncture was performed and ceased after the administration of RIVOTRIL and PHENOBARBITAL. Overall the patient experienced eight seizures and two of the eight seizures occurred after the lumbar puncture. At hospital epilepsy was suspected but the classification was difficult at the time of hospitalisation. The clinician also considered hemi grand mal epilepsy and Dravet-Syndrome as differential diagnosis. An antiepileptic treatment was started with TOPIRAMATE and low dose CLOBAZAM. The patient recovered from diarrhoea, fever, respiratory infection, screaming and nasopharyngitis and the patient has not recovered from epilepsy and febrile convulsion and convulsion.

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