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Found 544380 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy

Case Details (Sorted by Age)

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VAERS ID:348790 (history)  Vaccinated:2009-06-08
Age:16.0  Onset:2009-06-08, Days after vaccination: 0
Gender:Female  Submitted:2009-06-08, Days after onset: 0
Location:Iowa  Entered:2009-06-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: IA090007
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1427F0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2824AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2938AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1748X1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness, Dreamy state, Feeling abnormal, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Pt. stated stomach felt queasy; sat down; says her vision was fuzzy; became pale; fainted; assisted to a lying position et fanned; regained consciousness within 1-2 sec.; stated "felt like a dream"; sat up after 5 min. felt faint again; lost color again; laid back down; fanned; talked to staff and family; sat up again after 5min; ate snack good color; strong pulse; stood up - no problems; left.

VAERS ID:348920 (history)  Vaccinated:2009-05-18
Age:16.0  Onset:2009-05-28, Days after vaccination: 10
Gender:Female  Submitted:2009-06-10, Days after onset: 13
Location:Florida  Entered:2009-06-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEPO-PROVERA
Current Illness:
Preexisting Conditions: None 6/22/09-records received- PMH Depo Provera.
Diagnostic Lab Data: Unknown 6/22/09-records received-Two weeks prior platelet count of 26. Rheumatology labs negative.
CDC Split Type: WAES0906USA01158
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0315Y1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody, Biopsy bone marrow, Blood product transfusion, Complement factor C3, Complement factor C4, Full blood count, Idiopathic thrombocytopenic purpura, Metabolic function test, Platelet count decreased, Rheumatoid factor negative
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 16-year-old female patient with no medical history who was vaccinated with the second dose of GARDASIL. Concomitant therapy included Depo-Provera. A week or two after the second dose of GARDASIL the patient developed idiopathic thrombocytopenic purpura and was admitted to hospital and given intravenous immune globulin (IVIG) 2 doses. The following lab diagnostics studies was performed: Complete blood count, Comprehensive Metabolic Panel, Antinuclear Antibody Test, serum complement C3/C4 ratio, Immunoglobulin A, Bone marrow biopsy. The patient has been discharged. The patient''s idiopathic thrombocytopenic purpura was considered to be disabling and an other important medical event. The patient had not been recovered. Additional information has been requested. 6/22/09-records received for DOS 5/28-5/30/09- DC DX: ITP status post 2 doses of IVIG with slight improvement of platelet count. Presented with newly diagnosed ITP with mild bruising. ICD-9 287.31.

VAERS ID:348976 (history)  Vaccinated:2009-06-11
Age:16.0  Onset:2009-06-11, Days after vaccination: 0
Gender:Female  Submitted:2009-06-11, Days after onset: 0
Location:Arkansas  Entered:2009-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: MILD SCOLIOSIS. 7/29/09 Consultant records received DOS 6/11/09. Similar episode Jan 08 - jerking, no loss of consciousness, seen in ER.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Cerumen impaction, Concussion, Contusion, Convulsion, Dizziness, Dyskinesia, Erythema, Face injury, Facial pain, Headache, Incontinence, Injection site pain, Injury, Joint injury, Loss of consciousness, Mydriasis, Posturing, Presyncope, Pupils unequal, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Glaucoma (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (broad)
Write-up: Approx 90 seconds after the first injection my daughter became faint and passed out, she then began having a seizure, the entire episode lasted approx 2 minutes. After being treated and stabilized at the clinic, we saw our family DR approx one hour later. She had multiple xrays due to the injuries when she fainted, she has a mild concussion with slight dilation of the left pupil. She has a lingering headache, (we are sure this is at least in part due to the facial injuries from the fall to the tile floor). There is significant pain at the injection site which is being treated with ice packs and extra strength Tylenol (no Motrin allowed due to the high level of bruising) after seeing our family DR she has referred us to a Neurologist to rule out any underlying factors leading to the fainting and seizures that our daughter experienced today. 7/29/09 Consultant records received DOS 6/11/09. Assessment "faint" vasovagal Patient felt dizzy, passed out, loss of consciousness, posturing, incontinence, hit (R) face, (R) hip, (R) knee, some jerking. Presents with erythema (R) cheek / skin / (R) Hip and knee. Contusion (R) hip (R) knee (R) face. Face and knee feel sore. (L) pupil $g (R) properly responding. Auditory canal blocked with wax.

VAERS ID:349002 (history)  Vaccinated:2009-06-08
Age:16.0  Onset:2009-06-08, Days after vaccination: 0
Gender:Female  Submitted:2009-06-08, Days after onset: 0
Location:Wisconsin  Entered:2009-06-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB42EB0UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0072X0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: After administration of GARDASIL patient got dizzy + started perspiring.

VAERS ID:349005 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-11
Location:Ohio  Entered:2009-06-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA01328
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Toxic shock syndrome
SMQs:, Toxic-septic shock conditions (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female patient who is a tampon user and who on an unknown date was vaccinated with the first dose of GARDASIL. Three days later, the patient experienced toxic shock syndrome and was admitted to the hospital. It was reported that the patient was menstruating and was using a tampon at that time. The physician stated that the patient survived but she spent one week in the hospital. The patient''s final outcome was not reported. Additional information has been requested.

VAERS ID:349115 (history)  Vaccinated:2009-01-22
Age:16.0  Onset:2009-01-23, Days after vaccination: 1
Gender:Female  Submitted:2009-06-15, Days after onset: 142
Location:Connecticut  Entered:2009-06-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZIANA; ORTHO TRI-CYCLEN LO; TYLENOL NO. 3; antibiotics; lignocaine hydrochloride; unknown
Current Illness: ACNE, DYSMENORRHEA, HEAVY PERIOD
Preexisting Conditions: The subject had no known drug allergies. The subject was not sexually active. The subject was a non-smoker and non-drinker.
Diagnostic Lab Data: Potassium hydroxide preparatio, 20Apr2009 - ve yeast
CDC Split Type: A0780629A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB2238A0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  IMLA
Administered by: Private     Purchased by: Other
Symptoms: Cellulitis, Genital swelling, Potassium hydroxide preparation negative, Similar reaction on previous exposure to drug, Vaginal swelling, Vulvovaginal mycotic infection
SMQs:, Angioedema (broad), Hypersensitivity (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of labial swelling in a 16-Year-old female subject who was vaccinated with HEPATITIS A vaccine (unspecified manufacturer). Concurrent medical conditions included acne and heavy period. Concurrent medications included ZIANA, ORTHO TRI-CYCLEN LO, TYLENOL NO. 3, unspecified Antibiotic, Lignocaine gel and Duraplast spray. On an unspecified date in February 2009, the subject received 1st dose of HEP A vaccine (unspecified manufacturer, unknown). On an unspecified date, the subject received the 2nd dose of HEP A vaccine (unspecified manufacturer, unknown). At an unspecified time after vaccination with the first dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. Outcome of the events was unspecified. Causality was not specified. At an unspecified time after vaccination with the second dose of HEP A vaccine, the subject experienced labial swelling and vaginal yeast infection. The events were unresolved at the time of reporting. The healthcare professional considered the events were possibly related to vaccination with HEP A vaccine. The subject''s next follow-up was on 27 April 2009. Follow-up was received from the reporting healthcare professional on 8 June 2009: The HEP A vaccine was confirmed as HAVRIX (GlaxoSmithKline). Concurrent medical conditions included dysmenorrhea. The subject denied history of sexual activity ever. Concurrent vaccination included MENACTRA, non-GSK manufacturer, intramuscular, left deltoid given on 22 January 2009. On 22 January 2009 the subject received 1st dose of HAVRIX (intramuscular, left deltoid). On 23 January 2009, 1 day after vaccination with HAVRIX, the subject experienced labial swelling, vaginal yeast infection and vaginal swelling. The events resolved on an unspecified date. On 16 April 2009 the subject received 2nd dose of HAVRIX (intramuscular, left deltoid). On 20 April 2009, 4 days after vaccination with HAVRIX, the subject experienced labial swelling, vagin

VAERS ID:349164 (history)  Vaccinated:2008-05-19
Age:16.0  Onset:2008-05-19, Days after vaccination: 0
Gender:Female  Submitted:2009-06-12, Days after onset: 389
Location:Minnesota  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = Unknown) Penicillin allergy
Preexisting Conditions: Polycystic ovaries
Diagnostic Lab Data: diagnostic laboratory 01/18/09 - Group B Streptococcus : negative; diagnostic laboratory - gestational diabetes: negative; ultrasound - To track gestation age - 28 wks.; physical examination 12/09/08 - weight: 143 pounds; physical examination 01/14/09 - weight: 147 pounds at 35 weeks gestation; hemoglobin 01/14/09 12 - ; hemoglobin 11.5 - ; hemoglobin 02/25/09 11.8 - ; hemoglobin 03/23/09 14.1 - ; hemoglobin 12/09/08 11.5 -
CDC Split Type: WAES0904USA00153
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Haemoglobin normal, Streptococcus identification test negative
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 16 year old female, who on 26-FEB-2008 was vaccinated with the first dose of GARDASIL, on 19-MAY-2008, was vaccinated with the second dose of GARDASIL and on 08-OCT-2008, was vaccinated with the third dose of GARDASIL. The registered nurse reported that the patient received the GARDASIL vaccine while pregnant. The patient sought medical attention at the nurse''s office. The estimated date of last menstrual period was 14-MAY-2008. The delivery date was 18-FEB-2009. The reporter stated that the pregnancy was normal and the baby was doing fine. Follow-up information was received from questionnaire completed by the registered nurse indicating that she was a patient with a history of 0 previous pregnancies, polycystic ovaries syndrome (so minimal ovulation''s) and no concurrent medical conditions. The patient did not have infections or illnesses during pregnancy . Routine tests performed included: an ultrasound done at 28 weeks of gestation to track gestation age (first prenatal appointment); group B streptococcus test done 3 to 4 weeks before delivery resulting negative and a gestational diabetes test done at 30 to 32 weeks of gestation which resulted negative. Medication taken during pregnancy included children chewable vitamins taken daily since 28 weeks of gestation. The patient was not progressing past 8 centimeters. The patient gave birth to a normal female child, who weighted 8 pounds 3 oz. The baby did not have any congenital anomaly. Follow up information has been received from a physician via medical record which reported that the on 25-FEB-2009 the patient, the patient''s mother and the baby went to the doctor''s office. The baby''s height was 20.5 inches. The baby was feeding with baby feeding formula (SIMILAC ADVANCED IRON) and baby drink 2-3 oz every 2-3 hours. The patient was still taking vitamins (physician suggested to take them until 6 weeks postpartum). Physician stated that the baby had some yellowing jaundice onset (25-FEB-2009 date approximate) to the skin but was otherwise pink. The mother was slightly pale but had hemoglobin of 11.8. A postpartum appointment was scheduled on May for follow up. On 23-MAR-2009 the patient and the baby went to the doctor''s office for follow up. The baby was almost 5 weeks old and was drinking at the time 4 oz formula every 3-4 hours. The baby is pooping and peeing okay according to the mother. The patient had hemoglobin of 14.1 the physician stated that everything was doing fine with the mother and the baby. Additional information is not expected.

VAERS ID:349168 (history)  Vaccinated:2008-03-03
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-12
Location:Maine  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: parasite identification, false positive
CDC Split Type: WAES0905USA00193
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: False positive laboratory result, Parasite blood test
SMQs:
Write-up: Information has been received from a medical assistant concerning a female who was vaccinate with on unspecified dates (doses and LOT# were not reported). When donating blood after vaccinated with GARDASIL the patient''s parasite blood test showed positive for Chagas. Further testing showed the original test was false positive and she did not have Chagas disease. The patient was told that Chagas test showed positive was frequently see in patients that have vaccinated with GARDASIL. Follow-up information has been received via a phone call from the physician concerning a 17 year old female who was vaccinated with GARDASIL on unspecified dates (dose and LOT# were not reported). The patient attempted to donate blood and was told that she had a false positive confirmatory test for Chagas disease. It reported that the false positive test was related to the GARDASIL vaccination. Follow-up information has been received via a phone call from a medical assistant (M.A.) concerning the 17 year old female who on 06-AUG-2007, 15-NOV-2007 and 03-MAR-2008 was vaccinated with a dose of GARDASIL (LOT# not reported, 659435/1265U, 659182/1757U respectively). No other concomitant vaccines were given at the time of the GARDASIL doses. Additional information has been requested.

VAERS ID:349187 (history)  Vaccinated:2009-05-01
Age:16.0  Onset:2009-05-02, Days after vaccination: 1
Gender:Female  Submitted:2009-06-12, Days after onset: 41
Location:California  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Epstein-Barr virus infection; Lymphadenectomy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA00380
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a nurse practitioner concerning a 16 year old female patient with a history of epstein-barr virus infection and lymphadenectomy on 8-JAN-2009 who was vaccinated with the first dose of GARDASIL on 01-MAY-2009 (lot#: 662300/0100Y). When the patient woke up on 02-MAY-2009 she experienced tremors. The nurse practitioner reported that the patient was still experiencing tremors periodically and is coming into the office on 4-MAY-2009. No further AE information provided. Unspecified medical attention had been sought. Additional information has been requested.

VAERS ID:349284 (history)  Vaccinated:2007-11-09
Age:16.0  Onset:2007-11-09, Days after vaccination: 0
Gender:Female  Submitted:2009-06-12, Days after onset: 580
Location:Washington  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA00733
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a healthcare worker concerning her 18 year old daughter who was vaccinated with the third dose of GARDASIL and later experienced intermittent pain or achiness in the arm where she received GARDASIL. Follow up information has been received from the healthcare worker and a nurse. It was reported that the 16 year old patient on 20-APR-2007 was vaccinated with the first dose of GARDASIL (Lot# 657617/0384U), on 8-AUG-2007 was vaccinated with the second dose of GARDASIL (Lot# 655620/0171U) and on 9-NOV-2007 was vaccinated with her third dose of GARDASIL (Lot# 658560/1062U). After vaccinated the third dose of GARDASIL, the patient had pain in the arm where she received the GARDASIL and the pain was "on and off". The patient went on to receive the following vaccinations: MENACTRA, Lot# 02343AA, ADACEL, Lot# AC52B015AA and the first dose of HAVRIX, Lot# 1280F, all administered on 22-JAN-2008. The patient received the second dose of HAVRIX on 21-AUG-2008. Lot# 1280F. The nurse stated that the patient had an appoint to see the physician on 08-MAY-2009. Additional information has been requested.

VAERS ID:349299 (history)  Vaccinated:2007-08-03
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-12
Location:Indiana  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA01447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0702F0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Oropharyngeal pain, Rash generalised
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse concerning her 16 year old daughter with DURICET allergy and no pertinent medical history who on 03-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 653650/0702F). There was no concomitant medication. Subsequently, sore throat was experienced first followed by the rashes all over her body in August 2007. After rash appeared, strep was ruled out, but the patient was still given (LEVAQUIN) for sore throat. The patient recovered from the sore throat in August 2007, but did not recover from the rash until mid-September 2007. The rashes lasted for 1 month. The patient sought medical attention by contacting physician. Additional information has been requested.

VAERS ID:349301 (history)  Vaccinated:2009-04-22
Age:16.0  Onset:2009-05-09, Days after vaccination: 17
Gender:Female  Submitted:2009-06-12, Days after onset: 34
Location:Unknown  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Lactose intolerance
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0905USA01625
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1312X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Crying, Fatigue, Headache, Inappropriate schedule of drug administration, Malaise, Sinusitis, Skin warm
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a consumer concerning her 16 year old daughter with lactose intolerance and not other drug reactions or allergies who was vaccinated with the first two doses of GARDASIL "sometime in 2007". After both doses she did not feel well. On approximately 22-APR-2009, "three weeks ago", the patient was vaccinated with the third dose of GARDASIL. There was no concomitant medication. On the night of 09-MAY-2009 the patient started to have a headache and stomach aches. In the past three days her stomach issues and headache have gotten worse, that she came home crying on 12-MAY-2009 because of the pain. As of 13-MAY-2009, "today", the patient was still experienced these symptoms and now she also felt hot to touch but did not have a fever. It was also reported that the patient just got her menstrual cycle and was going on three days of having that . No lab tests were done. The physician was called and unspecified medical attention was sought. The reporter was not sure the experiences the patient was having was from GARDASIL. Additional information has been requested.Records received 7/2/09-on 5/9/09 C/O headache, feeling feverish, stomach ache, tiredness, office note for 5/22/09-seen for C/O sinusitis no further visits.

VAERS ID:349323 (history)  Vaccinated:2009-01-09
Age:16.0  Onset:2009-01-14, Days after vaccination: 5
Gender:Female  Submitted:2009-06-12, Days after onset: 148
Location:Oklahoma  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALASE
Current Illness: Familial risk factor; Contraception
Preexisting Conditions: 6/23/09 Medical records received PMH: Tonsillectomy and adenoidectomy.
Diagnostic Lab Data: computed axial, 01/16/09 - normal; electroencephalography, 01/16/09 - abnormal; underlying predisposition for seizure 6/23/09 Medical records received LABS and DIAGNOSTICS: EEG - single generalized burst of spike wave activity. Plts 457
CDC Split Type: WAES0905USA02892
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Albumin globulin ratio decreased, Blood alkaline phosphatase increased, Computerised tomogram normal, Convulsion, Cough, Cryotherapy, Distractibility, Dizziness, Electroencephalogram abnormal, Feeling hot, Headache, Hyperhidrosis, Hypersomnia, Hypotonia, Loss of consciousness, Menorrhagia, Myoclonus, Nasal congestion, Otitis media, Pallor, Pelvic pain, Platelet count increased, Pyrexia, Road traffic accident, Sinus headache, Skin papilloma, Staring, Syncope, Upper respiratory tract infection, Vomiting, Weight increased
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician Assistant and a Licensed Practical Nurse concerning a 16 and half years old female with familial risk factor who was vaccinated with three doses of GARDASIL ON 11-APR-2008, 13-JUN-2008 and 9-JAN-2009. Concomitant therapy included ALASE. The patient had no known drug allergies. On 25-AUG-2008 the patient experienced syncope and was sent to the emergency room (hospital name unknown). At the patient''s office visit on 16-JAN-2009 it was reported that on 14-JAN-2009 the patient felt dizzy while driving (with a sibling as passenger), she pulled over then blacked out. On 16-JAN-2009 the patient had CT scan and EEG done and CT scan results were normal but EEG results were abnormal and it showed that she underlying predisposition for seizures. It was known that the patient had a "family history of seizure disorder". The patient was referred to Neurologist. The neurologist did not wish to provide any information on this case. A nurse at the county health department reported that the patient was not in their system. Therefore, lot #''s could not be provided. The patient''s experience was not felt to be life-threatening. The patient''s status was listed as recovering. The health care professionals contacted during telephone follow up could not supply the following information: lot numbers and hospital name (ER visited 25-AUG-2008). No further information is available at this time. 6/23/09 Neurological consult received DOS 4/02/09. Assessment: seizures, syncope. Patient c/o of an episode consisting of stomach hurting, sweating, feeling hot. Pale and unable to recall subsequent events. Lost conciousness. Also slumped over once while driving and had car wreck. Lightheadedness. Episodes of staring. Myoclonic jerks while sleeping. Sleeps a lot, recent weight gain, distractible. ICD-9 Codes: Spells 780.39, Abnormal EEG 794.02, Syncope 780.2, R/O Epilepsy 345.90 6/29/09 Medical records received DOS 8/07/08 to 4/08/09 Assessment: Cephalgia and Syncope. Patient presents with abd

VAERS ID:349329 (history)  Vaccinated:2009-05-18
Age:16.0  Onset:2009-05-18, Days after vaccination: 0
Gender:Female  Submitted:2009-06-12, Days after onset: 25
Location:California  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ
Current Illness:
Preexisting Conditions: Syncope
Diagnostic Lab Data: blood pressure, 05/18/09, 115/68
CDC Split Type: WAES0905USA03248
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1605X UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X0UNRA
Administered by: Other     Purchased by: Other
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 representative reported experience as reported by a nurse concerning a female patient who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml. After receiving the patient fainted. The outcome was unknown. The patient sought medical attention. Later on 27-MAY-2009, C.M.A. provided the following details: a female patient with past history of fainting with blood draw who on 18-MAY-2009 was vaccinated with the first dose of GARDASIL (Lot # 661953/1130X), 0.5ml in the right arm after receiving VAQTA (Lot#663490/1605X) in the left arm. Concomitant therapy is YAZ. After receiving the first dose of GARDASIL (Lot # 661953/1130X) , the patient fainted. When she came to, her B/P was 115/68, she was given something to eat and drink and then fully recovered. Additional information has been requested.

VAERS ID:349366 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-12
Location:Rhode Island  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA03635
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
Administered by: Other     Purchased by: Other
Symptoms: Menorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female patient who "a couple of months ago" was vaccinated with the first and second dose of GARDASIL vaccine (Lot # not reported). It was reported that the patient experienced heavier menstrual cycle after receiving the first and second dose of GARDASIL vaccine. The patient was seen by the physician. The outcome of the patient was unknown. It was reported that the therapy with GARDASIL was discontinued on an unspecified date. Additional information has been required.

VAERS ID:349373 (history)  Vaccinated:2008-10-01
Age:16.0  Onset:2008-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-06-12, Days after onset: 254
Location:Unknown  Entered:2009-06-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Brachial plexus lesion; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0905USA03847
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Brachial plexus injury, Condition aggravated, Laboratory test, Nuclear magnetic resonance imaging
SMQs:, Accidents and injuries (narrow)
Write-up: Information has been received from a consumer concerning his 16 year old daughter with "brachial plexus" of her right arm which was diagnosed a few years ago, and allergy to viral medications (it caused brachial plexus) who on 01-OCT-2008, 02-DEC-2008 and on 21-APR-2009 was vaccinated with the first, second and third doses (o.5 ml) of GARDASIL (Lot # not reported) respectively. Concomitant medication included "pain medication" (unspecified). It was reported that "after first dose" of GARDASIL the nerve damage on her right arm "flared up". After receiving her second dose of GARDASIL the nerve damage (brachial plexus) occurred on her left arm. It was reported that after receiving her third dose of GARDASIL the nerve pain (brachial plexus) "flare up" on her right arm again. The patient sought unspecified medical attention. There were "numerous laboratory work, MRI" performed (results not provided). It was reported that the patient was recovering at the time of the report. No further information is available.

VAERS ID:349177 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-15
Location:Unknown  Entered:2009-06-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA01436
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis
SMQs:
Write-up: Information has been received from a hospice nurse concerning a 16 years old female with unknown drug allergies and unknown medical history who was vaccinated with the first dose of GARDASIL. Subsequently the patient was diagnosed with Amyotrophic Lateral Sclerosis (ALS) shortly after receiving the first dose of GARDASIL. The nurse learned of the patient''s experience when her family called seeking hospice care for her. The family did mention that the first dose of GARDASIL caused that to the patient. Unspecified medical attention was sought. It was unspecified if laboratory studies were performed. At the time of the report, the patient had not recovered. The Amyotrophic Lateral Sclerosis was considered to be disabling. In follow-up with the representative, it was learned that no contact information is available. No further information is available.

VAERS ID:349192 (history)  Vaccinated:2008-04-01
Age:16.0  Onset:2008-04-01, Days after vaccination: 0
Gender:Female  Submitted:2009-06-11, Days after onset: 436
Location:Massachusetts  Entered:2009-06-16, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Migraines
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Light headedness, dizziness since vaccine series completed one year ago. Fainted 6/4/09.

VAERS ID:349236 (history)  Vaccinated:2009-06-08
Age:16.0  Onset:2009-06-09, Days after vaccination: 1
Gender:Female  Submitted:2009-06-09, Days after onset: 0
Location:Minnesota  Entered:2009-06-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA 30 mg; ORTHOTRI-CYCLIN
Current Illness: None
Preexisting Conditions: Anemic
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0653X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Dizziness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Woke up at 2 AM on 6/9/09 with temp of 101.4 & feeling dizzy. As of 8 am was feeling better, temp gone.

VAERS ID:349256 (history)  Vaccinated:2009-06-12
Age:16.0  Onset:2009-06-12, Days after vaccination: 0
Gender:Female  Submitted:2009-06-16, Days after onset: 4
Location:Texas  Entered:2009-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: prednisone, fluorinef
Current Illness: none
Preexisting Conditions: congenital adrenal hyperplasia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2909AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0480Y1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: pt c/o itching at menactra injection site within hours of administration. later same evening pt c/o heat swelling redness at site pt taken to care now dx with local cellulitis 24 hrs after vaccination treated with bactrim reassessed 6/15 with significant improvement. original area of induration 3x4 inches. pt on daily prednisone and fluorinef fpr cong adrenal hyperplasia

VAERS ID:349591 (history)  Vaccinated:2009-06-17
Age:16.0  Onset:2009-06-18, Days after vaccination: 1
Gender:Female  Submitted:2009-06-19, Days after onset: 1
Location:Alabama  Entered:2009-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0651X2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: No reaction on previous exposure to drug, Nodule, Tenderness
SMQs:
Write-up: Client reports back on 6-18-2009, one day after receiving dose #3 of HPV, that she now has Knots on back of head that are tender to touch. No problems with previous HPVs. Instructed client to see PMD today and report back to health dept.

VAERS ID:349604 (history)  Vaccinated:2009-03-09
Age:16.0  Onset:2009-05-25, Days after vaccination: 77
Gender:Female  Submitted:2009-06-21, Days after onset: 27
Location:Unknown  Entered:2009-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: colagenosis estudies( c3 c4 anas), RMN AND ANGIO-RMN, EMG, VDRL, PCR , LUMBAR PUNCTION WITH DIFFERENTS STUDIES FOR MENINGITIS,
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0000001IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cholangiogram, Complement factor C3, Complement factor C4, Electromyogram, Intracranial pressure increased, Lumbar puncture, Neuralgia, Nuclear magnetic resonance imaging, Polymerase chain reaction, Syphilis test
SMQs:, Peripheral neuropathy (narrow)
Write-up: endocraneal hipertension after 1.5 months after the secon dosis and finally results in neuropatic pain ( 1 week after the first symptons)

VAERS ID:349667 (history)  Vaccinated:2008-03-31
Age:16.0  Onset:2008-09-01, Days after vaccination: 154
Gender:Female  Submitted:2009-06-19, Days after onset: 291
Location:Texas  Entered:2009-06-22, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None PMH: scoliosis, costochondritis, sinusitis, pahryngitis, back pain, abdominal pain
Diagnostic Lab Data: magnetic resonance, fine; head computed axial, fine; hematology, immune system is compromised. Labs: Spirometry WNL. O2 sat 97% on RA. H. pylori (+). Abd US WNL.
CDC Split Type: WAES0906USA02285
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Bronchitis, Chest pain, Chronic fatigue syndrome, Computerised tomogram head, Computerised tomogram normal, Contusion, Cough, Depression, Dyspnoea, Fatigue, Gene mutation, Helicobacter pylori identification test positive, Hypophagia, Immobile, Immune system disorder, Immunology test abnormal, Infectious mononucleosis, Injection site pain, Malaise, Myalgia, Nuclear magnetic resonance imaging normal, Oxygen saturation normal, Pain in extremity, Paralysis, Paranasal cyst, Postnasal drip, Rhinitis, Sinusitis, Spirometry normal, Splenomegaly, Surgery, Ultrasound abdomen normal, Viral infection, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a consumer concerning her approximately 17 year old daughter with no medical history or allergies who was vaccinated with three dose of GARDASIL. Concomitant therapy included "LOLESTRA". The consumer reported that after receiving the first and second dose of GARDASIL the patient experienced injection site soreness but then was fine. Then about three weeks after receiving the third dose of GARDASIL. The patient experienced bruising in her leg which caused immobility, which they thought was a blood clot so they took her to the emergency room and had to stabilize her leg and then shortly after the bruising cleared up. Then in September 2008 the bruising came back in her leg and starting in November 2008 the patient started to get sick constantly. The patient could not move, was very exhausted, lost about 7 pounds, could not eat, and had breathing problems. The patient was taken to a pulmonologist because her pediatrician thought she may have walking pneumonia, mono or asthma, but they were all ruled out. Then the patient was taken to a physician who ran a bunch of blood test, and computerized tomography scan (CT) of her brain and a magnetic resonance imaging (MRI) of her left leg. The MRI and CT scan came back fine, but the physician stated that through the blood work the patient''s immune system was compromised and believed it was from GARDASIL " The patient then started to get a lot of sinus infections and developed cyst in her sinus so she had out patient surgery (name of hospital, address and phone number unspecified)." The consumer reported that in mid May 2009 the patient developed mono and had been doing better but still got exhausted pretty fast, and had missed about 45 days of school this past school year. The patient was seen by the pediatrician to seek medical attention. At the time of report, the patient was recovering. Upon internal review, mononucleosis and bruising in leg were considered to be disabling. Additional information has been requested. 7/24/09 Clinical s

VAERS ID:349682 (history)  Vaccinated:2009-06-22
Age:16.0  Onset:2009-06-22, Days after vaccination: 0
Gender:Female  Submitted:2009-06-22, Days after onset: 0
Location:New York  Entered:2009-06-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Head injury, Pallor
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: child received HPV and had fingerstick for hemoglobin. left exam room and was sitting alone in conference room began to feel light headed and was heard to hit her head on desk. She had not eaten breakfast. Child was kept on the floor and given oxygen and felt better. She again sat up and shortly afterwards became pale and light headed again and was laid down on the floor. She was sent to the ER for further evaluation and management since head trauma was unwitnessed

VAERS ID:350093 (history)  Vaccinated:2008-03-19
Age:16.0  Onset:2008-03-19, Days after vaccination: 0
Gender:Female  Submitted:2009-06-24, Days after onset: 462
Location:North Carolina  Entered:2009-06-25, 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: Pregnancy NOS (LMP = 2/25/2008)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic, 03/19/08, positive
CDC Split Type: WAES0803USA03943
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive, Uterine dilation and curettage
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a 16 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). On the same day the patient had a positive pregnancy test in the office. Her estimated LMP was 25-FEB-2008. She sought unspecified medical attention. Follow-up information received on 13-JAN-2009 from a woman from a doctor''s office indicated that they did not follow up with the patient after she became pregnant. The reporter provided the OB/GYN practice information. Follow-up information was received from a person from the doctor''s office indicating that the patient had a miscarriage in early pregnancy and had a dilation and curettage on 25-MAY-2008. It was also reported that the patient did not receive GARDASIL in their office. Upon internal review, miscarriage was determined to be an important medical event. Additional information has been requested.

VAERS ID:350121 (history)  Vaccinated:2009-06-17
Age:16.0  Onset:2009-06-17, Days after vaccination: 0
Gender:Female  Submitted:2009-06-19, Days after onset: 2
Location:Unknown  Entered:2009-06-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.06504 UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR2527CA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Fatigue, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: pt sits on exam table - gave MENACTRA im to LD then HPV im RD. A few second later patient feels dizzy and passed out and lying on exam table, for about one minute then awake and talking but feeling tired. Apply O2 P = 64 BP = 100/64 observe 15 mn then discharge home in a good condition fully awake.

VAERS ID:350305 (history)  Vaccinated:2009-06-12
Age:16.0  Onset:2009-06-12, Days after vaccination: 0
Gender:Female  Submitted:2009-06-26, Days after onset: 14
Location:New Jersey  Entered:2009-06-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Albuterol nebulizer tx in office for bronchospasm.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0279X2UNLA
Administered by: Private     Purchased by: Public
Symptoms: Arthralgia, Bronchospasm, Dysphagia, Dyspnoea, Hypersensitivity, Neck pain, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (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 (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: 30 minutes after receiving GARDASIL vaccine Pt. developed dyspnea, dysphagia, stabbing, sharp pain (R) arm and hip, neck pain. Dx: Allergic reaction. Bronchospasm.

VAERS ID:350335 (history)  Vaccinated:2008-04-21
Age:16.0  Onset:2008-04-21, Days after vaccination: 0
Gender:Female  Submitted:2009-06-26, Days after onset: 431
Location:Unknown  Entered:2009-06-29, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABILIFY; PROZAC; TRILEPTAL
Current Illness: Pregnancy NOS (LMP = 8/8/2008); Depression; Attention deficit disorder; Obsessive-compulsive disorder; Post-traumatic stress dis
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA01631
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a healthcare professional through a Pregnancy Registry for GARDASIL concerning a 17 year old female with depression, attention deficit disorder, obsessive compulsive disorder and post-traumatic stress disorder who on 20-FEB-2008, 21-APR-2008 and 26-AUG-2008 was vaccinated with the first, second and third dose of GARDASIL, the second dose on 21-APR-2008 and third dose on 26-AUG-2008 (lot#s 659653/1448U, unidentifiable and 660620/0571X respectively). Concomitant therapies included ABILIFY, PROZAC and TRILEPTAL. The patient''s last menstrual period was reported as 08-AUG-2009, EDD: 15-MAY-2009. Follow up information was received from nurse in physician''s office via a phone call who reported the patient had a termination in November 2008. The patient was doing fine and there was no sequelae from the vaccination. Upon internal review, a termination (abortion) was determined to be an other important medical event. Additional information has been requested.

VAERS ID:350437 (history)  Vaccinated:2008-02-18
Age:16.0  Onset:2008-02-18, Days after vaccination: 0
Gender:Female  Submitted:2009-06-29, Days after onset: 496
Location:Ohio  Entered:2009-06-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 1/16/2008)
Preexisting Conditions:
Diagnostic Lab Data: urine beta-human, 02/18/08, negat; urine beta-human, 02/27/08, posit, 6 weeks pregnant; serum beta-human, 02/27/08, posit, 6 weeks pregnant
CDC Split Type: WAES0804USA01051
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Caesarean section, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a health professional for the Pregnancy Registry for GARDASIL, concerning a 16 year old female with no known medical history or drug reactions/allergies, who on 18-FEB-2008 was vaccinated (route unknown) with a first dose of GARDASIL (Lot # 659655/1486U). There was no concomitant medication. The nurse reports that on 18-FEB-2008 the patient''s urine pregnancy test in the office was negative and she received her first dose. The patient returned to the office on 27-FEB-2008 for another urine pregnancy test and a Beta HCG (Human Chorionic Gonadotropin) blood test. Both were positive and showed she was 6 weeks pregnant (LMP 16-JAN-2008). No additional information at this time. The patient sought unspecified medical attention in the office. Outcome unknown. No product quality complaint was involved. Follow up information received on 23-JUN-2009 from a licensed practical nurse stated that the patient delivered at term, by cesarean section for macrosomia, confirmed by the baby''s birth weight of 9 LBS, 4 oz. The nurse did not state whether the patient went into labor spontaneously, or was induced. Upon internal review cesarean section for macrosomia was determined to be an other important medical event. Additional information has been requested.

VAERS ID:350472 (history)  Vaccinated:2009-06-23
Age:16.0  Onset:2009-06-23, Days after vaccination: 0
Gender:Female  Submitted:2009-06-23, Days after onset: 0
Location:Kentucky  Entered:2009-06-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: s/p splenectomy @ 5 yr
Diagnostic Lab Data: pulse oximetry- 100%
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0315Y2IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0625Y0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Oedema, Oxygen saturation, Oxygen saturation normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: PNEUMOVAX given @ 0900 on 6/23/09. At 1530 on 6/23/09, pt. seen in office for increased swelling and erythema to site. Circular edema 5" width, 4 1/2 inches in height - Full ROM. No fever. Please not swelling to left deltoid only, right deltoid with no reaction.

VAERS ID:350514 (history)  Vaccinated:2009-06-26
Age:16.0  Onset:2009-06-27, Days after vaccination: 1
Gender:Male  Submitted:2009-06-30, Days after onset: 3
Location:Texas  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB342EB1IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0333Y1SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Fatigue, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Headache, nausea, fatigue

VAERS ID:350564 (history)  Vaccinated:2009-06-30
Age:16.0  Onset:2009-06-30, Days after vaccination: 0
Gender:Female  Submitted:2009-06-30, Days after onset: 0
Location:Hawaii  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0294Y0IMRA
Administered by: Military     Purchased by: Military
Symptoms: Abdominal pain upper, Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt c/o "dizziness", stomach pain within seconds of administration. Pt closed eyes at this time. Pt placed in supine position with knees raised to chest. BP 90/60. Pt left in position for 5 minutes. Hypotension noted when raised from supine to sitting position, 75/42 taken manually on left arm. Pt placed back in supine position with knees raised x 10 min. BP returned to WNL and pt had no c/o dizziness.

VAERS ID:350662 (history)  Vaccinated:2009-07-01
Age:16.0  Onset:2009-07-01, Days after vaccination: 0
Gender:Unknown  Submitted:0000-00-00
Location:South Carolina  Entered:2009-07-02
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: allergy to PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2906AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B031AB UNRA
Administered by: Public     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Vaccines prior to 11:30 AM 7/1/2009. Represented in office with rash at 6:00pm

VAERS ID:350715 (history)  Vaccinated:2009-07-02
Age:16.0  Onset:2009-07-02, Days after vaccination: 0
Gender:Female  Submitted:2009-07-02, Days after onset: 0
Location:Louisiana  Entered:2009-07-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HISTATAD; OMHICEF
Current Illness: Sinus infection
Preexisting Conditions: None
Diagnostic Lab Data: Done at ER
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2910AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Dizziness, Hypotension, Immediate post-injection reaction, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: TDAP administered, then MCV - 4 given & second after this injection Pt. stated "I''m dizzy". Pt be came weak & pale. Checked blood pressure & was low 60/00 & I couldn''t hear it. 911 called & we lowered pt. to floor lying down & ambulance arrived 10-15 min later. Pt. stayed weak, pale & dizzy & was brought to ER by ambulance.

VAERS ID:350753 (history)  Vaccinated:2008-03-28
Age:16.0  Onset:2008-03-28, Days after vaccination: 0
Gender:Female  Submitted:2009-07-02, Days after onset: 461
Location:Rhode Island  Entered:2009-07-06, 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: None
Current Illness: Pregnancy NOS (LMP = 3/28/2008)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA07772
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Breech presentation, Caesarean section, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a registered nurse through the Merck Pregnancy Registry concerning a 16 year old female patient who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL. On 22-MAY-2008 the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient was pregnant. The patient has not experienced any know symptoms. The patient sought medical attention seen by the physician. Follow-up information was received from a health professional. The patient delivered on 05-DEC-2008 via C-section due to breech presentation. The baby was 6 lb 5 oz and completely normal and healthy with no congenital anomalies. Upon internal review, C-section due to breech presentation were determined to be an other important medical event. Additional information has been requested.

VAERS ID:350754 (history)  Vaccinated:2008-08-18
Age:16.0  Onset:2008-08-18, Days after vaccination: 0
Gender:Female  Submitted:2009-07-02, Days after onset: 318
Location:Unknown  Entered:2009-07-06, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 6/17/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0812USA02378
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1978U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Poor weight gain neonatal, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)
Write-up: Initial and follow-up information has been received from a Nurse Practitioner for the pregnancy registry for GARDASIL From a nurse practitioner concerning a 16 year old female patient with a history of no previous pregnancies who on 18-AUG-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (LOT # 659964/1878U) while she was pregnant. The estimated conception date is 01-JUL-2008 and the estimated delivery date is 24-MAR-2009. The nurse reported that on 18-JUN-2008 the patient received a 0.5 mL first dose of GARDASIL (LOT # 659653/1448U). A healthcare worker in the Nurse Practitioner''s office reported that the patient had no prenatal care until she was 5 months along. She delivered her baby 2 months premature. The baby had reflux issues and slow weight gain. Her neurological status was within normal limits. She did confirm that there were no congenital anomalies and the baby was, otherwise, normal. Upon internal review, premature was determined to be an other important medical event. No further information is available.

VAERS ID:350775 (history)  Vaccinated:2009-06-30
Age:16.0  Onset:2009-07-01, Days after vaccination: 1
Gender:Male  Submitted:2009-07-06, Days after onset: 5
Location:New Jersey  Entered:2009-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BENZACLIN
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0655Y/4122X1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: SEEN ON 6/30/09 FOR 16 YEAR OLD WELL CHECK. RECIEVED VARIVAX # 2. ON 7/1/09 WOKE UP WITH RED, SWOLLEN TO TOUCH, WARM RIGHT ARM. SEEN IN OUR OFFICE DIAGNOSED WITH CELLULITIS TO R ARM. TREATED WITH KEFLEX.

VAERS ID:350810 (history)  Vaccinated:2009-06-17
Age:16.0  Onset:2009-06-30, Days after vaccination: 13
Gender:Female  Submitted:2009-07-06, Days after onset: 6
Location:Arkansas  Entered:2009-07-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: YAZ; MAXALT;BACTRIM DS, give at time of injection
Current Illness: UTI 6-17-09; 6-30-09 URI, started XYZAL
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0376X0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Upper respiratory tract infection
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Red, raised area to right upper arm. There was some soreness to the arm as well. Patient developed worse URI s/s on 6/30/09 as well.

VAERS ID:350897 (history)  Vaccinated:2009-06-29
Age:16.0  Onset:2009-06-30, Days after vaccination: 1
Gender:Female  Submitted:2009-07-01, Days after onset: 1
Location:New York  Entered:2009-07-07, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X1IMUN
Administered by: Other     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Patient received HPV #2 @ 4 pm 6/29/09. Developed generalized urticarial rash 6/30/09 @ 8 pm.

VAERS ID:351096 (history)  Vaccinated:2009-05-28
Age:16.0  Onset:2009-05-29, Days after vaccination: 1
Gender:Female  Submitted:2009-06-08, Days after onset: 10
Location:Pennsylvania  Entered:2009-07-09, Days after submission: 31
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: The patient has allergies to Augmentin and Ampicillin. No prior history of medical conditions.
Diagnostic Lab Data:
CDC Split Type: 200902388
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2844A UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3246B UNRA
Administered by: Private     Purchased by: Private
Symptoms: Back pain, Body temperature increased, Bone pain, Headache, Nausea, Neck pain, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Initial report received on 02 June 2009 from a health care professional. A 16 year old female patient with allergies to Augmentin and Ampicillin received ADACEL (lot number C3246B) in the right deltoid and MENACTRA (lot number U2844AA) in the left deltoid on 28 May 2009. On 29 May 2009 the patient developed a temperature of 101, neck pain, headache, nausea, and a rash on head and arms. When the patient was asked to put her chin to her chest the patient complained of severe neck and spinal pain. The patient reported that the evening after the vaccine was administered she was bumped on her back and felt severe back pain. The recovery status was unknown. List of Documents held by Sender: none.

VAERS ID:351150 (history)  Vaccinated:2008-06-26
Age:16.0  Onset:2008-06-27, Days after vaccination: 1
Gender:Female  Submitted:2009-07-10, Days after onset: 378
Location:New York  Entered:2009-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0870X0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Epstein-Barr virus antibody positive, Erythema nodosum, Eye swelling, Headache, Infectious mononucleosis, Lymphadenopathy, Malaise, Mononucleosis heterophile test positive, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: 1 day after GARDASIL developed fever, myalgias, swollen eyes; diagnosed with "mono". Monospot (+) however EBV titers all negative. Never felt completely well -$g recurrent myalgias, swollen glands, headache. EBV IgG titers (+) 11/08. Multiple complaints myalgias, knee pain; erythema nodosum diagnosed 4/09.

VAERS ID:351568 (history)  Vaccinated:2009-04-08
Age:16.0  Onset:2009-04-08, Days after vaccination: 0
Gender:Unknown  Submitted:2009-06-24, Days after onset: 77
Location:California  Entered:2009-07-13, Days after submission: 19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA02306
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Wrong drug administered
SMQs:
Write-up: Information has been received from a medical assistant concerning a 16 year old patient who "last week" was accidentally vaccinated with ZOSTAVAX (Merck). Additional information has been requested.

VAERS ID:351323 (history)  Vaccinated:2009-07-06
Age:16.0  Onset:2009-07-06, Days after vaccination: 0
Gender:Female  Submitted:2009-07-07, Days after onset: 1
Location:Unknown  Entered:2009-07-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS1312X1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.AHAVB334EA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Pt became light headed. Blood pressure 70/40 but elevated to 90/60 within 15 minutes. No other adverse effects observed. Remained alert and oriented.

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? Yes, ? days
    Extended hospital stay? 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:351784 (history)  Vaccinated:2009-05-01
Age:16.0  Onset:2009-05-02, Days after vaccination: 1
Gender:Female  Submitted:2009-07-10, Days after onset: 69
Location:California  Entered:2009-07-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 7/21/09 Medical records received DOS 5/1/09 to 6/08/09. Allergic rhinitis, acne. 9/1/09 Consultant Pain Clinic records received DOS 6/5/09 to 7/10/09. Therapy for stress and anxiety. Asthma. Depression with suicidal thoughts. PMH: Intermittent shortness of breath. Hypersensitivity to sounds and light. Lower back pain. Wrist fracture. Chickenpox. Environmental allergies. Milk allerg
Diagnostic Lab Data: 7/21/09 Medical records received DOS 5/1/09 to 6/08/09. LABS and DIAGNOSTICS: EKG - WNL. CBC - Lymphocytes 48.8% (H) Granulocytes 48.1% (L) MCH 24.5 pg (L) MCHC g/dL (L). Parvovirus B-19 AB (-). ANA (-).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2870AA IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0123Y SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Acupuncture, Adverse drug reaction, Antinuclear antibody negative, Arthralgia, Asthenia, Back pain, Complex regional pain syndrome, Crying, Dizziness, Dyspnoea, Electrocardiogram normal, Emotional distress, Fatigue, Fibromyalgia, Granulocyte percentage, Headache, Hypoaesthesia, Initial insomnia, Injection site erythema, Injection site pain, Lymphocyte percentage increased, Massage, Mean cell haemoglobin concentration, Mean cell haemoglobin decreased, Muscle tightness, Myalgia, Pain, Pain in extremity, Paraesthesia, Parvovirus B19 serology negative, Poor quality sleep, Psychogenic pain disorder, Serology normal, Stress, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt. developed acute arm pain at the site of injection & the following day spread to both arms & legs; diffuse muscle pain throughout developed over 1 week period. Pt had Rheumatology consult to & Normal serology confirm. 7/21/09 Medical records received DOS 5/1/09 to 6/08/09. Assessment: Muscle pains with chronic pain and fatigue. Reaction to vaccination with Varicella or Menactra. Patient presents with left arm pain. Myalgia and arthralgia. Pain in muscles, aching in knees, ankles, wrists, and elbows. Ultracet made her very confused. Trigger point tenderness. Pain management clinic dx: pain amplification syndrome. 9/1/09 Consultant Pain Clinic records received DOS 6/5/09 to 7/10/09. Assessment: Pain Disorder Associated with Both Psychological Factors and a General Medical Condition. Pain and redness at injection site. Pain later extended to entire left arm. In the following weeks pain extended to left leg, right leg, right arm. Pain is throbbing and constantly moves between extremities. Back pain, tense muscles, multiple joint soreness. Stress at school. Acute distress, crying. Exhausted. Shortness of breath, dizziness, paresthesia 4 extremities. Acupuncture. Massage. Poor sleep. 9/10/09 Rheumatology consult records received DOS 5/20/09. Assessment: Juvenile Fibromyalgia. Patient c/o injection pain, redness and numbness along left arm. Pain spread throughout body. Numbness resolved in 2 days. 1 day of severe headaches. Energy decreased. Difficulty falling asleep. Dizziness. Distress, crying.

VAERS ID:351801 (history)  Vaccinated:2009-07-16
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-17
Location:Colorado  Entered:2009-07-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB736BA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site warmth, Skin warm
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: L deltoid injection, 2 hours later L arm red and worn from site down to L hand.

VAERS ID:352243 (history)  Vaccinated:2009-04-01
Age:16.0  Onset:2009-04-01, Days after vaccination: 0
Gender:Female  Submitted:2009-07-15, Days after onset: 105
Location:Missouri  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0906USA04127
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia
SMQs:
Write-up: Information has been received from a consumer concerning her 16-year-old daughter with no medical history nor drug reactions/allergies who was vaccinated with the last dose of GARDASIL in April 2009, the reporter was not sure when the first dose was given but stated that the doses of GARDASIL were given "on time". There were no concomitant medications. After receiving the third dose of GARDASIL the patient''s hair has been "falling out in clumps". The patient had not sought medical attention. At the time of the report, the patient''s status was not recovered. Additional information has been requested.

VAERS ID:352277 (history)  Vaccinated:2009-05-28
Age:16.0  Onset:2009-06-16, Days after vaccination: 19
Gender:Female  Submitted:2009-07-15, Days after onset: 29
Location:Unknown  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA04767
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
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 Registered Nurse concerning a 16 year old female patient who on 23-MAR-2009 was vaccinated with a first dose of GARDASIL (lot# 0702X). On 28-MAY-2009 she received second dose of GARDASIL (lot # not reported). On 16-JUN-2009 she began experiencing a headache, nausea, vomiting and diarrhea. The patient sought unspecified medical attention. The patient''s outcome was not reported. Additional information has been requested.

VAERS ID:352332 (history)  Vaccinated:2009-06-22
Age:16.0  Onset:2009-06-22, Days after vaccination: 0
Gender:Female  Submitted:2009-07-15, Days after onset: 23
Location:Unknown  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0906USA05615
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a Nurse Practitioner (N.P.) concerning a 16 year old female patient who "about one week ago" (on approximately 22-JUN-2009) was vaccinated with the second dose of GARDASIL. It was reported that since receiving the vaccine, "about one week ago" (on approximately 22-JUN-2009) the patient had noticed her left arm, the arm where the injection was administered, had been feeling strange and tingly. It was reported that that patient had been lifting and cleaning at the camp and had reported other muscle type pain. The vaccines was not reintroduced. The patient sought unspecified medical attention. The patient had not recovered at the time of the report. Additional information has been requested.

VAERS ID:352340 (history)  Vaccinated:2009-06-29
Age:16.0  Onset:2009-06-29, Days after vaccination: 0
Gender:Female  Submitted:2009-07-15, Days after onset: 16
Location:New York  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Computed axial, 06/29?/09, CT scan of the head
CDC Split Type: WAES0907USA00034
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1131X IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram, 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: Information has been received from a nurse concerning a 16 year old female patient who on 29-JUN-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1131X) intramuscularly in the upper deltoid. There was no concomitant medication. On 29-JUN-2009 after receiving GARDASIL the patient fainted and fell on the floor of the waiting room. The patient went to the emergency room but was not admitted to the hospital. A CT scan of the head was performed (results not reported). On the same day on 29-JUN-2009, the patient recovered. Additional information has been requested.

VAERS ID:352344 (history)  Vaccinated:2008-09-01
Age:16.0  Onset:2008-09-01, Days after vaccination: 0
Gender:Female  Submitted:2009-07-15, Days after onset: 317
Location:Unknown  Entered:2009-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0907USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse concerning a 16 year old female with no medical history or drugs allergies, who in September 2008, was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL on an unspecified date. The patient experienced nausea, fever and vomiting 6-9 hours after both doses. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had recovered. Additional information has been requested.

VAERS ID:351864 (history)  Vaccinated:2008-09-24
Age:16.0  Onset:2008-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-07-17, Days after onset: 296
Location:Michigan  Entered:2009-07-20, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 8/29/2008)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02010
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0570X0IMUN
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 registered nurse for the pregnancy registry for GARDASIL concerning a 16 year old female who on 24-SEP-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM. Subsequently, the patient was found to be pregnant. On 10-OCT-2008 the patient was 6 weeks gestation. The last menstrual period was approximately 29-Aug-2008. The estimated due date is 05-Jun-2009. The patient sought medical attention by calling the nurse. Follow-up information was received from another registered nurse who reported that the patient was vaccinated with a first dose of GARDASIL (lot# 660616/0570X) 0.5 ml IM on 24-SEP-2008. Concomitant therapy included prenatal vitamins (unspecified). At the end of September 2008 or beginning of October 2008, the patient underwent a routine ultrasound without result provided. At the end of November 2008, after Thanksgiving, the patient experienced spontaneous abortion (less than 20 weeks). The outcome of the patient was not reported. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.

VAERS ID:352251 (history)  Vaccinated:2009-07-02
Age:16.0  Onset:2009-07-02, Days after vaccination: 0
Gender:Female  Submitted:2009-07-23, Days after onset: 21
Location:Missouri  Entered:2009-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: HPV #1 lot# 0171U, exp 6/29/09 was given to pt. on 7/2/09. This vaccine was expired by 3days. Since this was first immunization, and will receive #2 and #3, no additional immunization will be given.

VAERS ID:352252 (history)  Vaccinated:2009-07-15
Age:16.0  Onset:2009-07-15, Days after vaccination: 0
Gender:Female  Submitted:2009-07-23, Days after onset: 8
Location:Missouri  Entered:2009-07-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Expired drug administered
SMQs:
Write-up: Received HPV # 3 on 7/15/2009. This vaccine expired on 6/29/09. Parents contacted. Will receive on additional HPV vaccine in 4 hrs to insure efficacy.

VAERS ID:352387 (history)  Vaccinated:2009-07-22
Age:16.0  Onset:2009-07-23, Days after vaccination: 1
Gender:Female  Submitted:2009-07-24, Days after onset: 1
Location:Georgia  Entered:2009-07-24
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: Amoxicillin, Ceclor, Septra + Codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2868AA0SCLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B038CA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1531X0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Presented with Health Dept today, 7-24-09 at 10:30 am, with very red, raised, swollen, hot and tender area approx 13cm in diameter, around VZV injection site- upper RT arm. Denied respiratory problems sent to PCP for eval since child with need medical exemption or titers to VZV#2 will not be given.

VAERS ID:352390 (history)  Vaccinated:2009-07-24
Age:16.0  Onset:2009-07-24, Days after vaccination: 0
Gender:Female  Submitted:2009-07-24, Days after onset: 0
Location:Florida  Entered:2009-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Fall, Immediate post-injection reaction
SMQs:, Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: Patient tolerated the HPV vaccine injection well. However 5 minutes after the vaccine was given she fell to the floor she was awake and alert and aware of her surroundings. Stayed in office for 30 minutes with no tender complication.

VAERS ID:352552 (history)  Vaccinated:2009-07-09
Age:16.0  Onset:2009-07-09, Days after vaccination: 0
Gender:Female  Submitted:2009-07-13, Days after onset: 4
Location:Arizona  Entered:2009-07-27, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 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.1497X2UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0384X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Dizziness, Erythema, Presyncope, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: VARICELLA - redness / swelling 7/10/09 GARDASIL - Dizziness, light headed - almost fainted, fever X 48 - 72 hours

VAERS ID:352587 (history)  Vaccinated:2009-07-15
Age:16.0  Onset:2009-07-16, Days after vaccination: 1
Gender:Female  Submitted:2009-07-20, Days after onset: 4
Location:Wisconsin  Entered:2009-07-28, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL X 20 mg.
Current Illness: Well check
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.01315Y0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2670AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0695Y1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Induration, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Mom reported posterior right arm, 1 1/2 inch diameter, red, hard and itchy after receiving vaccines 7-15-09. Onset of symptoms; 7/16/09. Still with small redness today. Reports having no pain.

VAERS ID:352615 (history)  Vaccinated:2009-07-13
Age:16.0  Onset:2009-07-13, Days after vaccination: 0
Gender:Female  Submitted:2009-07-16, Days after onset: 3
Location:North Carolina  Entered:2009-07-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MENTAX; DIFLUCAN
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: NC09031
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB312AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1312X0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.02270SCRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt experiencing erythema, warmth, and tenderness at injection site - R arm where varicella vaccination given. Sx x 3days not improving.

VAERS ID:352698 (history)  Vaccinated:2009-07-14
Age:16.0  Onset:2009-07-14, Days after vaccination: 0
Gender:Male  Submitted:2009-07-29, Days after onset: 15
Location:Pennsylvania  Entered:2009-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0798931A
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2907BA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B041BA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Eye rolling, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of passed out in a 16-year-old male subject who was vaccinated BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (non-gsk) (Sanofi) given on 14 July 2009. On 14 July 2009 at 11:30 the subject received unspecified dose of BOOSTRIX (unknown route, right arm). On 14 July 2009, 1 minute after vaccination with BOOSTRIX, the subject experienced passed out, eyes rolling and vomiting. This case was assessed as medically serious by GSK. On 14 July 2009, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. The healthcare professional also reported a female subject who passed out after receiving BOOSTRIX (see case ID A0798941A) and mentioned approximately 7 to 8 other cases where the subject had passed out or vomited after receiving BOOSTRIX (see case ID A0798942A).

VAERS ID:352712 (history)  Vaccinated:2009-06-22
Age:16.0  Onset:2009-06-22, Days after vaccination: 0
Gender:Female  Submitted:2009-07-29, Days after onset: 37
Location:Kentucky  Entered:2009-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRN asthma inhaler.
Current Illness: No complaints
Preexisting Conditions: Asthma; hlo hives.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0312Y0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Hives after injection #1 Gardasil. 1 1/2 hr after given vaccine- hives developed- pt has hlo hives and they did resolve after 2 doses of Benadryl.

VAERS ID:352761 (history)  Vaccinated:2009-07-24
Age:16.0  Onset:2009-07-24, Days after vaccination: 0
Gender:Female  Submitted:2009-07-24, Days after onset: 0
Location:West Virginia  Entered:2009-07-30, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 1/2/09~HPV (Gardasil)~1~16~Patient
Other Medications: NK
Current Illness: NK
Preexisting Conditions: NK
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Loss of consciousness, Pallor
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: Shortly after receiving vaccine, while sitting on table she became ashes in color, used ammonia inhaler but she passed out to lying down position on table. Ice was applied to neck and forehead. Mother was present. I was forewarned as pt. fainted with 1st HPV vaccine. About 20 minutes later pt. stated she was ok, left with family to go eat.

VAERS ID:352987 (history)  Vaccinated:2009-07-27
Age:16.0  Onset:2009-07-27, Days after vaccination: 0
Gender:Female  Submitted:2009-07-31, Days after onset: 4
Location:Unknown  Entered:2009-08-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: tetracycline
Current Illness:
Preexisting Conditions: Acne
Diagnostic Lab Data: None
CDC Split Type: WAES0907USA04871
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1496X UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Grand mal convulsion, Loss of consciousness, Pallor, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (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)
Write-up: Information has been received from a registered nurse concerning a 16 year old female patient with a history of acne and no known drug allergies who on 27-JUL-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1496X). The patient did not receive any concomitant vaccines when the GARDASIL was administered to the patient. Concomitant therapy included tetracycline. There were no concomitant vaccines. On 27-JUL-2009, within five minutes of receiving GARDASIL, the patient became light headed, fainted and passed out while sitting in the waiting room with her mother. Her left arm had seizures movement and her right arm had slight seizure movement, the patient had a tonic-clonic seizure which lasted for 2 to 3 seconds. The patient abruptly awoke. The patient had not eaten prior to the physician''s visit and prior to the GARDASIL vaccination. The nurse stated that the patient was given something to eat and drink after the incident had occurred. The patient was white and shaky for a while. On the same day, 27-JUL-2009, the patient recovered. The Registered nurse did not consider the patient''s experience to be disabling or life-threatening. The registered nurse stated that she spoke with the patient''s mother via a telephone call on 27-JUL-2009 and 28-JUL-2009. The patient''s mother stated that the patient "was doing fine". Upon internal review tonic-clonic seizure was considered as other important medical event. Additional information has been requested.

VAERS ID:353000 (history)  Vaccinated:2009-07-31
Age:16.0  Onset:2009-08-01, Days after vaccination: 1
Gender:Male  Submitted:2009-08-03, Days after onset: 2
Location:Michigan  Entered:2009-08-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2733AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2768BA9IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.069Y1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 2- 2 1/2 inch sized red/hot painful swollen area at site varicella vaccine starting on 8/1/09. Ice was applied intermitently and by 8/3/09 area was no longer painful, redness/warmth were greatly decreased.

VAERS ID:353034 (history)  Vaccinated:2009-07-28
Age:16.0  Onset:2009-07-28, Days after vaccination: 0
Gender:Female  Submitted:2009-07-28, Days after onset: 0
Location:Washington  Entered:2009-08-03, 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 known
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0312Y0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2669AA0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Feeling hot, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Approx. 2 min after injections, became pale, nauseated, dizzy, + felt "hot". Vital signs stable. After 15" up to chair. Denied nausea or dizziness, color improved, skin warm & dry.

VAERS ID:353081 (history)  Vaccinated:2008-05-21
Age:16.0  Onset:2008-05-21, Days after vaccination: 0
Gender:Female  Submitted:2009-08-03, Days after onset: 439
Location:Unknown  Entered:2009-08-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 6/1/2008)
Preexisting Conditions:
Diagnostic Lab Data: head computed axial, 06/18/09, baby: "vastly abnormal"; ultrasound, 06/18/09, baby: "vastly abnormal"
CDC Split Type: WAES0907USA04345
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Neonatal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)
Write-up: Information has been received from a physician and a certified medical assistant, for GARDASIL, a Pregnancy Registry Product, concerning her 17 year old niece no pertinent medical history and no known allergies who on 14-NOV-2007 was vaccinated (injection) with a first dose of GARDASIL (lot# (lot# 659437/1266U) a second dose on 16-JAN-2008 (lot# 659439/1267U), and a third dose was administered on 21-MAY-2008 (lot# 660389/1968U). There was no concomitant medication. In June 2008 the patient found out she was pregnant. The patient then had her baby in March 2009 and the baby was born with brain swelling. The baby then had surgery (name of hospital, address and phone number unspecified) to have the fluid around the brain drained and once the fluid was drained the physician noticed that the baby''s brain was not fully developed in the frontal cortex. The certified medical assistant reported that the patient and baby were under care with the patient''s Obstetrician/Gynecologist (OBGYN). The patient''s last menstrual period (LMP) was reported as "around June 2008". The patient was determined to be pregnant in December 2008 when she was 6 months gestation. The patient delivered a male infant on 23-MAR-2009. The infant was diagnosed with hydranencephaly at birth (also reported by the physician as 2 months after birth). Unspecified medical attention was sought. At the time of the report, the patient had not recovered. The physician reported that she was unsure about the patient''s prenatal care. Follow up information was received on 28-JUL-2009 via telephone call from a registered nurse who reported that concomitant therapy included MENACTRA (lot# U2538AA) and influenza virus vaccine (unspecified) (lot# U2475KA). The nurse confirmed that there was no pertinent medical history and no known drug allergies (NKDA) and the only therapy taken by the patient was pm naproxen for menses. The nurse was not certain, but believed it was the patient''s first pregnancy. LMP date and length of gestation were not available from the nurse''s of

VAERS ID:353096 (history)  Vaccinated:2009-07-15
Age:16.0  Onset:2009-07-16, Days after vaccination: 1
Gender:Female  Submitted:2009-07-29, Days after onset: 13
Location:Illinois  Entered:2009-08-04, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same as above~HPV (Gardasil)~1~14~Sibling
Other Medications:
Current Illness: None
Preexisting Conditions: Tinea pedis; Acne; Chronic knee pain; Overweight
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB342EB0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1531X1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 7-8" of redness, itchy and painful for 1 wk.

VAERS ID:353106 (history)  Vaccinated:2009-07-24
Age:16.0  Onset:2009-07-27, Days after vaccination: 3
Gender:Female  Submitted:2009-07-28, Days after onset: 1
Location:Louisiana  Entered:2009-08-04, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Cyanosis, Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: 7-27-09 1:00 PM Mom called to report daughter''s (R) arm was red, swollen and real sore. She also couldn''t pick up her arm very high. Mom called back at 4: 00 PM. Her (R) arm was hot to touch and her (R) arm from elbow to hands were turning purplish blue - went to ER.

VAERS ID:353275 (history)  Vaccinated:2007-08-01
Age:16.0  Onset:2007-08-01, Days after vaccination: 0
Gender:Female  Submitted:2009-08-05, Days after onset: 735
Location:Pennsylvania  Entered:2009-08-06, 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: None
Current Illness: Allergic reaction to antibiotics; Food allergy
Preexisting Conditions: Eye redness. 8/24/09 Consultant records received DOS 8/20/08 to 8/4/09. Sushi Reaction. Allergies to yellow jacket venom, neomycin, Sudafed, cinnamon. Self inflicted injury (cutting), Scanty menstruation. Scoliosis. Convulsions. Seborrheic dermatitis. Overweight. Seizures.
Diagnostic Lab Data: Unknown. 8/24/09 Consultant records received DOS 8/20/08 to 8/4/09. LABS and DIAGNOSTICS: Complement 199 (H). Sed Rate 115 mm/h (H). Rheumatoid Factor 24 IU/mL (H). CCP (+). ANA (+). MRI Feet - Abnormal, consistant with JIA. CHEM - Globu
CDC Split Type: WAES0908USA00058
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Acanthosis nigricans, Anaemia, Anger, Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody positive, Arthralgia, C-reactive protein increased, Complement factor increased, Complex regional pain syndrome, Contusion, Cyanosis, Enthesopathy, Gait disturbance, Globulins increased, Haematocrit decreased, Haemoglobin decreased, Immunology test abnormal, Joint effusion, Joint stiffness, Juvenile arthritis, Meniscus lesion, Mood swings, Muscular weakness, Musculoskeletal pain, Neck pain, Neutrophil count increased, Nuclear magnetic resonance imaging abnormal, Obesity, Oedema peripheral, Pain in extremity, Pneumonia, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width increased, Rheumatoid factor positive, Sleep disorder, Smear cervix abnormal, Stress, Synovial fluid analysis, Urine leukocyte esterase positive, Vaginal lesion, Wheelchair user, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related conditions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow)
Write-up: Information has been received from a consumer concerning her 16 year old daughter allergy to cinnamon and with a history of an allergic reaction (eye redness) to neomycin (manufacturer unknown) who in August 2007, was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not reported). There was no concomitant medication. After a couple of days the patient experienced severe joint pain that she could not get up from bed and was unable to walk. Patient was given steroid injection in her feet and knees and for almost a year she was in wheel chair. The patient was given the second dose of GARDASIL (route and lot number not reported) in August 2008 and in November 2008, she was diagnosed with "polyarticular JIAR (Rheumatoid arthritis)". The patient''s mother also stated that her daughter had abnormal cervical cells and small vaginal lesion. The patient''s mother stated that soon her daughter will be getting steroid injection on her hands because she is unable to lift them. At the time of reporting the patient had not recovered from the events. Upon internal review polyarticular JIARS+ (Rheumatoid arthritis) and unable to walk were considered to be disabling. Additional information has been requested. 8/24/09 Consultant records received DOS 8/20/08 to 8/4/09. Assessment: Enthesopathy, amplified musculoskeletal pain. Polyarticular JIA RF(+). Patient with acquired acanthosis nigrans and obesity presents with knee, foot and neck pain. ''Walks like a duck''. Feet swollen. Nighttime awakenings secondary to pain. Stressed. Enthesitis multiple sites lower extremities and back. Torn medial menisc knee. Joint effusion. Anemia. Moodiness, anger and bruising. Joint stiffness. Feet turn blue. Wheezing. Pneumonia. Shoulder pain. Limp.

VAERS ID:353335 (history)  Vaccinated:2009-08-05
Age:16.0  Onset:2009-08-05, Days after vaccination: 0
Gender:Female  Submitted:2009-08-06, Days after onset: 1
Location:California  Entered:2009-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Atopic dermatitis. Rash under nose.
Preexisting Conditions: Hx absence sz. Seizure.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF471AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Loss of consciousness, Repetitive speech, Syncope, Tremor
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), Parkinson-like events (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 (broad)
Write-up: About 4 pm, pt was at a restaurant, felt lightheaded, and was trembling. She stood and passed out. Upon awakening pt kept repeating herself over and over. Has hx of absence sz , cut off DEPAKOTE x 3-4 years. Says she feels like she had a sz. 9/29/09 PCP medical records received DOS 8/5/2009. Assessment: Syncope. Call from patient''s mother. Patient felt light headed, stood and fainted. Kept repeating herself.

VAERS ID:353370 (history)  Vaccinated:2009-07-06
Age:16.0  Onset:2009-07-06, Days after vaccination: 0
Gender:Female  Submitted:2009-08-06, Days after onset: 31
Location:Ohio  Entered:2009-08-07, 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: Ibuprofen
Current Illness:
Preexisting Conditions: Vaccination adverse reaction; Aura; Blindness; Anxiety; Penicillin allergy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA00060
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0315Y0IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Aura, Blindness, Catatonia, Convulsion, Reaction to previous exposure to any vaccine
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a female with a history of experiencing aura of blindness and prevaccination anxiety after previous vaccines (unspecified which ones) and no known drug allergies, who on an unspecified date was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 659054/0315Y). Concomitant therapy included MENACTRA. "After receiving the vaccine", the patient started experiencing an aura of blindness and proceeded to have a catatonic movement that went into a seizure. The patient recovered shortly after. No lab tests were performed. The patient did not seek medical attention. Upon internal review seizure was determined to be other important medical events. Follow up information was received from a registered nurse. It was reported that the 16 year old female patient has an allergy to Amoxicillin (hives) and a history of the aura of blindness and feeling strange after her vaccination with ADACEL, 3 summers ago (date not provided). The patient''s mother reported that her daughter "last time" (3 summers ago) after she got a vaccine, she experienced the aura of blindness after they got out to the car. She did not loose consciousness, but felt really strange. The patient was administered GARDASIL (lot number 659054/0315Y, Expiration date 13-JUL-2010) on 06-JUL-2009. Concomitant medications included ibuprofen PRN and MENACTRA, also given on 06-JUL-2009. The patient was observed in the physician''s office saying she was having an aura of blindness, she could not see and then proceeded to become catatonic and the went into a seizure. The registered nurse reported that she recovered shortly after, and was able to go home with no problems. The registered nurse reported that as far as she knows, the patient had not experienced any more seizure activity since 06-JUL-2009. She further noted that as far as she knows, the patient has completely recovered and that she has not called into the office and has not been in to the office since 06-JUL-2009. Additional informatio

VAERS ID:353583 (history)  Vaccinated:2009-08-04
Age:16.0  Onset:2009-08-04, Days after vaccination: 0
Gender:Female  Submitted:2009-08-06, Days after onset: 2
Location:Kansas  Entered:2009-08-10, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia facial, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Arm pain followed by tingling in the arm/ hand. She then developed numbness/ tingling on some side face. Resolved overnight.

VAERS ID:353615 (history)  Vaccinated:2009-08-10
Age:16.0  Onset:2009-08-10, Days after vaccination: 0
Gender:Female  Submitted:2009-08-10, Days after onset: 0
Location:Ohio  Entered:2009-08-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: antibiotics s/p wisdom tooth extraction 5 days prior. I don''t know what they are as they didn''t know.
Current Illness: mild URI with runny nose for one day.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0658Y1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Contusion, Ear haemorrhage, Fall, Fatigue, Immediate post-injection reaction, Injury, Loss of consciousness, Syncope, Tearfulness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Immediately following HPV#2 and Varivax #2 (10:45 am) patient fainted and fell forward off of the exam table and hit her Left cheek, ear and knee on the ground. Her ear bled at the site of her earring. After being on the ground flat she regained consciousness within 45-60 seconds. She was confused for a few moments and tearful. Ice was applied to her cheek and she stayed and was observed for 15 minutes. She was told not to drive or go to work today and to call if she had vomiting, headaches or other changes. Mom is very upset. I called at 5:30 pm and patient is napping and other than having a bruise on her cheek (not swollen) and tired has no other worrisome signs. Mom wants a CT of brain and cheek done (she works in radiology at hospital). I do not think these are warrented at this time. She is angry I won''t order them now and is going to file a report with the hospital.(she says.)

VAERS ID:353744 (history)  Vaccinated:2009-08-03
Age:16.0  Onset:2009-08-03, Days after vaccination: 0
Gender:Female  Submitted:2009-08-03, Days after onset: 0
Location:Indiana  Entered:2009-08-11, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2733AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3249AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: C/o fainting

VAERS ID:353812 (history)  Vaccinated:2009-07-29
Age:16.0  Onset:2009-07-30, Days after vaccination: 1
Gender:Male  Submitted:2009-08-06, Days after onset: 7
Location:Maryland  Entered:2009-08-11, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0797Y1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Localized erythema/induration w/ spread.

VAERS ID:353901 (history)  Vaccinated:2009-08-06
Age:16.0  Onset:2009-08-06, Days after vaccination: 0
Gender:Female  Submitted:2009-08-06, Days after onset: 0
Location:Texas  Entered:2009-08-12, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None known
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB663AA UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA11092 UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0008Y UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2909AA UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3098BA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.D491Y UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness postural
SMQs:
Write-up: Patient rec''d 6 immunizations here in clinic. After standing waiting about 4 min. she felt dizzy, sat down, rested, wet paper towels on face and neck. Recovered well. She was dressed very warmly with scarfs on head. Foreign language, used language with her father.

VAERS ID:353913 (history)  Vaccinated:2009-08-06
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-12
Location:California  Entered:2009-08-12
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: N/A NEW PATIENT
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB343BA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB04764IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2866AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B040AB6IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0347Y1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: PT WAS GIVEN AN EXTRA IPV NAD TDAP BEFORE DUE

VAERS ID:354037 (history)  Vaccinated:2009-08-04
Age:16.0  Onset:2009-08-04, Days after vaccination: 0
Gender:Female  Submitted:2009-08-05, Days after onset: 1
Location:New Jersey  Entered:2009-08-13, Days after submission: 8
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 8/20/09 PCP note received DOS 8/4/09 Never experienced these symptoms with previous shots.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB249AD0UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0087Y0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Pulmonary hypertension (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: Vaccine was administered, patient became dizzy 30 seconds after shot. Patient was pale, diaphoretic & nauseous. Symptoms lasted about 45 minutes. BP dropped to 90/50 & pulse to 50/min. 8/20/09 PCP note received DOS 8/4/09. After shots pt became naseated, pale, diaphoretic, dizzy and had difficulty breathing. BP dropped to 90/50 and pulse into the 50''s. Sx lasted ~45 minutes with return to baseline. Vax record states pt "passed out".

VAERS ID:354057 (history)  Vaccinated:2009-07-23
Age:16.0  Onset:2009-07-23, Days after vaccination: 0
Gender:Female  Submitted:2009-07-23, Days after onset: 0
Location:Florida  Entered:2009-08-13, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB336AA1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1423X1UNLA
Administered by: Military     Purchased by: Military
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Patient experienced dizziness and nausea appox: 5 minutes after vaccination. Patient was placed on back w/legs raised for 15 minutes. Nausea and dizziness and nausea resolved with no further action.

VAERS ID:354084 (history)  Vaccinated:2009-08-10
Age:16.0  Onset:2009-08-10, Days after vaccination: 0
Gender:Unknown  Submitted:2009-08-13, Days after onset: 3
Location:Pennsylvania  Entered:2009-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0312Y2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Headache
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: pt had headace and stomache slef resolving after 24 hours

VAERS ID:355309 (history)  Vaccinated:2008-10-16
Age:16.0  Onset:2008-10-16, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Kansas  Entered:2009-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnant (10036586)
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0007279
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.    
Administered by: Public     Purchased by: Other
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: A non-serious report of inadvertently given FLUMIST has been received from a health department representative concerning a 16-year-old female, subsequent to FLUMIST. The patient''s past medical history included being 20 weeks pregnant. No concomitant medications were reported. On 16-Oct-2008 a patient who was 20 weeks pregnant was inadvertently administered FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during pregnancy.

VAERS ID:355759 (history)  Vaccinated:2009-01-06
Age:16.0  Onset:2009-01-06, Days after vaccination: 0
Gender:Female  Submitted:2009-02-05, Days after onset: 30
Location:Texas  Entered:2009-08-13, Days after submission: 188
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: MEDI0007890
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500552P IN 
Administered by: Military     Purchased by: Other
Symptoms: Expired drug administered
SMQs:
Write-up: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a 16-year-old female. The patients'' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.

VAERS ID:354342 (history)  Vaccinated:2009-07-27
Age:16.0  Onset:2009-07-27, Days after vaccination: 0
Gender:Female  Submitted:2009-08-14, Days after onset: 18
Location:Unknown  Entered:2009-08-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure, 07/27?/09, fine; diagnostic laboratory, 07/27?/09, heart rate: fine
CDC Split Type: WAES0908USA00788
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure normal, Heart rate normal, Nausea, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with the "first dose" of GARDASIL (injection, lot# not reported) in the "last week" (approximately 27-JUL-2009). Concomitant therapy included MENACTRA. The nurse stated that the patient received her first dose of GARDASIL and "2 minutes later the patient felt nauseated and she turned white, her lips were white". The nurse added that the patient looked like she maybe going into shock at that time. The nurse took blood pressure and checked her heart rate which were fine and they had the patient lie down for 5 to 10 minutes and then she started to feel better. The patient fully recovered after 20 to 30 minutes. The patient was given water and grapes. Upon internal review, shock was determined to be an other important medical events. Additional information has been requested.

VAERS ID:354400 (history)  Vaccinated:2009-07-18
Age:16.0  Onset:2009-07-18, Days after vaccination: 0
Gender:Female  Submitted:2009-08-17, Days after onset: 30
Location:Arkansas  Entered:2009-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin, OCP
Current Illness: no
Preexisting Conditions: ADHD
Diagnostic Lab Data: echocardiogram pending
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Public     Purchased by: Unknown
Symptoms: Cardiac murmur, Chest pain, Condition aggravated, Costochondritis, Echocardiogram
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Ongoing chest pain intermittently since the vaccine administration consistent with costochodritis, patient has a mvp that appears to have worsened with a louder murmur, will obtain echocardiogram

VAERS ID:354465 (history)  Vaccinated:2009-07-01
Age:16.0  Onset:2009-07-01, Days after vaccination: 0
Gender:Female  Submitted:2009-08-17, Days after onset: 47
Location:Kansas  Entered:2009-08-18, 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: None
CDC Split Type: WAES0908USA01957
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Grand mal convulsion, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female who in approximately July 2009 (about 1 month ago), was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported). The patient experienced a tonic-clonic seizure almost immediately after vaccination. Her symptoms resolved quickly in about 10 to 15 minutes. Unspecified medical attention was sought. No lab diagnostics studies were performed. On an unspecified date, the patient recovered. Upon internal review, tonic-clonic seizure was determined to be an other important medical event. Additional information has been requested.

VAERS ID:354482 (history)  Vaccinated:2009-08-11
Age:16.0  Onset:2009-08-11, Days after vaccination: 0
Gender:Female  Submitted:2009-08-12, Days after onset: 1
Location:Oregon  Entered:2009-08-18, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1604X1IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0650X0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2918AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypotonia, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: About 5 min after receiving the below 3 immunizations, pt. slumped fwd from sitting position on exam table, losing consciousness. M.D. caught upper body so didn''t fall off table & with mother''s help moved to supine position when awoke about 30 sec later (out about 30 sec). No post ictal state. NL neuro.

VAERS ID:354520 (history)  Vaccinated:2008-03-04
Age:16.0  Onset:2008-04-15, Days after vaccination: 42
Gender:Female  Submitted:2009-08-18, Days after onset: 490
Location:New York  Entered:2009-08-18
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: consistant extreme full body Uticaria
Preexisting Conditions: Same as #18. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. Persistant urticaria, penicillin allergy, allergy cat dander. /ksk
Diagnostic Lab Data: too many to list. would have to get medical records. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. LABS and DIAGNOSTICS: Cervical Lymph Node Biopsy - Abnormal, Hodgkin Lymphoma. CT Neck - Abnormal, diffuse cervic
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1487U0IMRA
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse reaction, Allergy test, Back pain, Biopsy bone marrow abnormal, Biopsy lymph gland, Biopsy lymph gland abnormal, Blood fibrinogen increased, Chemotherapy, Chest X-ray abnormal, Computerised tomogram abnormal, Condition aggravated, Ear pain, Epstein-Barr virus antibody positive, Haemoglobin decreased, Hepatitis B antibody, Hodgkin's disease nodular sclerosis stage II supradiaphragmatic, Hypertension, Idiopathic urticaria, Lymphadenitis, Lymphadenopathy, Mass, Neck pain, Obesity, Oestradiol decreased, Pain, Polydipsia, Positron emission tomogram abnormal, Pulmonary function test abnormal, Radiotherapy, Rash, Skin burning sensation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Malignant tumours (narrow), Hypersensitivity (narrow), Malignant lymphomas (narrow), Arthritis (broad)
Write-up: My daughter had been suffering from extreme full body Uticaria for three years and had been treated with benadryl, allergy medications, hydrocortisone creams and occasionally would be put on prednisone med pacs to control the uticaria. Two or Three weeks after her second vaccine of gardisil she noticed a lump on her neck. I took her to her pediatrician and was prescibed an antibiotic for possible glndular infection. After the course of the antibiotics were finished she came to me about 20 days later and said the lump never went away and now it was bigger. I immediately went back to my pediatricians office the next day. He sent her for an iimmediate cat scan. The cat scan results were enlarged lymph glands in her head neck and chest.We rushed her to the hospital rigth from his office where she was admitted. A biopsy was performed and she was diganosed with lymphoma cancer stage two.(Hodgkins) I am sure that this was caused by the gardisil vaccine. 8/25/09-record received for DOS 5/12/06-for allergy specialist visit for C/O difficulty controlling hives present since 9/05. Impression: idopathic urticaria. 8/24/09 PCP and oncology medical records received DOS 4/15/08 to 5/15/09. Assessment: Hodgkin Lymphoma Nodular Sclerosing Type, Stage IIAd. Patient presents with painful burning rash on extremities. Urticaria, obesity, polydipsia. Hypertension. Ear pain. Cervical lymphadenitis. Chemotherapy and radiation. Pain neck and back - resolving radiation reactions.

VAERS ID:354546 (history)  Vaccinated:2009-07-30
Age:16.0  Onset:2009-07-31, Days after vaccination: 1
Gender:Female  Submitted:2009-08-03, Days after onset: 3
Location:Mississippi  Entered:2009-08-18, Days after submission: 15
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.0493Y0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Itchy rash - of neck, trunk, arms.

VAERS ID:354638 (history)  Vaccinated:1998-06-18
Age:16.0  Onset:1998-07-01, Days after vaccination: 13
Gender:Female  Submitted:2009-08-19, Days after onset: 4067
Location:Florida  Entered:2009-08-19
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: Coombs test, CBC, others. 8/21/09 Hospital records received DOS 6/26/98 to 7/3/98. LABS and DIAGNOSTICS: CBC - RBC 1.07 M/MM3 (L) HGB 3.5 G/DL HCT 10.6% (L). Spherocytes. Reticulocyte Count 0.4% (L). Toxic Gran - Slight. WBC 21.1 K/MM3 (H) Bands 15% (H) Lymphocytes 13% (L) Monocytes 10% (H). LDH 450 IU/L (H). Positive Coombs'' test. Positive Target Cells. Negative monospot. Negative ANA. Haptoglobulin <5.8 mg/dl (L). Negative cold agglutinins. EKG - Abnormal heart rate. Epstein-Barr V AB-VCA IgM 2.28 Positive. Abdominal Ultrasound. Pelvic Ultrasound.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2 LA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaemia haemolytic autoimmune, Antinuclear antibody negative, Back pain, Balance disorder, Band neutrophil percentage increased, Blood lactate dehydrogenase increased, Cold agglutinins negative, Coombs test positive, Dizziness, Electrocardiogram abnormal, Epstein-Barr virus antibody positive, Fall, Fatigue, Feeling hot, Full blood count, Gait disturbance, Haematocrit decreased, Haemoglobin decreased, Haptoglobin decreased, Headache, Heart rate irregular, Jaundice, Loss of consciousness, Lymphocyte percentage decreased, Monocyte percentage increased, Mononucleosis heterophile test negative, Neutrophil toxic granulation present, Normochromic normocytic anaemia, Orthostatic hypotension, Pain, Pallor, Physical examination, Pyrexia, Red blood cell count decreased, Red blood cell target cells present, Reticulocyte count decreased, Spherocytic anaemia, Syncope, Tachycardia, Transfusion, Ultrasound abdomen, Ultrasound pelvis, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad)
Write-up: acute idiopathic autoimmune hemolytic anemia accompanied by high fever, fainting, jaundice, irregular heartbeat. 8/21/09 Hospital records received DOS 6/26/98 to 7/3/98. Assessment: Idiopathic hemolytic anemia. Patient c/o feeling tired, pains in lower back, headaches, feeling dizzy. Felt warm and having temperatures to 101. Continued body aches mostly in lower back and extremities. Saw physician, unremarkable PE. Subsequently was lightheaded, dizzy, off balance, fever of 103, stood up, blacked out, and fell to the floor. Could not walk very well. Presented at emergency room - extreme pallor, tachycardia. Severe normocytic anemia. Orthostatic hypotension. Blood transfusion.

VAERS ID:354753 (history)  Vaccinated:2009-08-12
Age:16.0  Onset:2009-08-14, Days after vaccination: 2
Gender:Female  Submitted:2009-08-14, Days after onset: 0
Location:Nevada  Entered:2009-08-20, 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: VYVANSE 20mg; ABILIFY 5mg
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0702X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2919AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0805Y1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Fall, Fatigue, 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), Accidents and injuries (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Mom states pt felt tired yesterday, light headed dizziness, fell out & lost conciosness for 30 seconds today!

VAERS ID:354795 (history)  Vaccinated:2009-08-18
Age:16.0  Onset:2009-08-19, Days after vaccination: 1
Gender:Female  Submitted:2009-08-20, Days after onset: 1
Location:Georgia  Entered:2009-08-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORAL CONTRACETIVES -ORTHO TRI CYCLEN LO
Current Illness: DENIES
Preexisting Conditions: DENIES
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3012AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAAC52B046AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0879Y1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received varicella, TDAP, MCV4 on 081809. Returns to clinic 082009 with edema, inflammation,hot to touch, pain at varicella injection site on right arm. Onset of symptoms 081909 am size of a "quarter" at onset. Edema and inflammation now 6cm x 5cm. Rub site with alcohol yesterday.

VAERS ID:354906 (history)  Vaccinated:2009-07-27
Age:16.0  Onset:2009-07-28, Days after vaccination: 1
Gender:Female  Submitted:2009-08-20, Days after onset: 23
Location:Kentucky  Entered:2009-08-21, 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: ORTHO EVRA
Current Illness: Migraine; Drug hypersensitivity
Preexisting Conditions: 8/28/09 ER records received DOS 7/29/09. Caffeine.
Diagnostic Lab Data: cardiac monitoring, results were fine; total heartbeat count, 07/29/09, 200, beats per minute; total heartbeat count, 07/29/09, 90, sinus rhythm. At discharge. 8/28/09 ER records received DOS 7/29/09. LABS and DIAGNOSTICS: Pulse 184. CBC
CDC Split Type: WAES0908USA02768
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arrhythmia, Aspartate aminotransferase decreased, Blood sodium decreased, Blood test, Cardiac monitoring normal, Cardioversion, Chest X-ray normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory normal, Full blood count normal, Heart rate increased, Palpitations, Sinus tachycardia, Supraventricular tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Chronic kidney disease (broad)
Write-up: Information has been received from a registered nurse and a certified medical assistant concerning a 16 year old female with migraine headaches and allergy to cephalosporin who on 27-JUL-2009 was vaccinated with a 0.5 ml IM first dose of GARDASIL (lot no. 661953/1130X). No other vaccines were given that day. Concomitant therapy included ORTHO EVRA. On 28-JUL-2009 the patient stated she developed a rapid heart rate "it feel like it was rushing out of my chest", standing cause her to loose her breath and dizziness. The symptoms continued through the entire day and into the next. On 29-JUL-2009 the patient was seen at emergency room and was diagnosed with supraventricular tachycardia (SVT) with a heart rate of 200 (bmp). The patient was not hospitalized. The patient underwent cardioversion and was released with heart rate in the 90''s (sinus rhythm). On an unspecified date, the patient recovered from supraventricular tachycardia. A blood work and a electrocardiogram (EKG) was performed (results not reported). The patient is being followed by a cardiologist and another physician who reported that holter monitor results were "fine." The reporter stated that supraventricular tachycardia was not related to therapy with GARDASIL. Supraventricular tachycardia was considered to be life threatening an other important medical event. A lot check has been initiated. No further information is available. 8/28/09 ER records received DOS 7/29/09. Assessment: Arrhythmia - Supraventricular tachycardia. Patient complains of palpitations and heart racing. Chest pain and difficulty breathing. 10/13/09 ICD-9 Codes received: 427.89 Other specified cardiac dysrhythmia, 780.4 dizziness, 786.05 paroxysmal nocturnal dyspnea, 785.1 palpitations, 785.0 Tachycardia unspecified.

VAERS ID:354974 (history)  Vaccinated:2009-08-18
Age:16.0  Onset:2009-08-18, Days after vaccination: 0
Gender:Male  Submitted:2009-08-22, Days after onset: 4
Location:Florida  Entered:2009-08-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3030AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Disturbance in attention, Dyskinesia, Erythema, Feeling hot, Listless, Pallor, Partial seizures, Presyncope, Reflexes abnormal
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Pt was given shot on 08/18/09 in Left deltoid IM. He was sitting in a chair. Approx 1-2 minutes after injection his left arm was flexed toward body his legs went straight out and his head was flexed backwards and his face became red and he seemend not to be aware. Apperaing to be a focal seizure lasting like 10-15 seconds maybe more but not more than a minute. He then awoke was okay than like 30sec-1 minute later he became pale and listless place pateint from chair to floor. His mouth was clamped shut could not access airway, felt for pulse. He had one. I laid on side then approx 20-30 seconds later he was aroused and became aware stating all was okay. He was still very pale. Pulse 64 BP 108/60 laying down. Complaining that he was hot placed fan on him. 911 was already called. He then wanted to sit up in chair was able to stand and sit in chair. Fire rescue arriving to scene with him in chair AAOx3. He was taken to Hospital ER via EMS. He ambulated out of clinic. He was discharged from Hospital same day with diagnosis of Vasal-Vagal as per family member Aunt.

VAERS ID:355016 (history)  Vaccinated:2009-07-28
Age:16.0  Onset:2009-07-28, Days after vaccination: 0
Gender:Female  Submitted:2009-08-14, Days after onset: 17
Location:Louisiana  Entered:2009-08-24, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Did X-Rays; CAT scans
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2928AA0IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Computerised tomogram, Contusion, Head injury, Immediate post-injection reaction, Loss of consciousness, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Immediately following vaccine (about 4 mins) patient passed out - hit her head on a table then concrete floor. health Unit called emergency and she was taken to local hospital. Doctor stated no internal injuries but she still has bruising on body and a lump on her head.

VAERS ID:355064 (history)  Vaccinated:2009-08-24
Age:16.0  Onset:2009-08-24, Days after vaccination: 0
Gender:Female  Submitted:2009-08-24, Days after onset: 0
Location:North Carolina  Entered:2009-08-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0671Y0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Pt became dizzy 20 min. after first Gardasil injection.

VAERS ID:355240 (history)  Vaccinated:2009-08-11
Age:16.0  Onset:2009-08-18, Days after vaccination: 7
Gender:Female  Submitted:2009-08-19, Days after onset: 1
Location:California  Entered:2009-08-25, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: None
Preexisting Conditions: 9/3/09 PCP medical records received DOS 4/1/08 to 8/18/09. Acne, myopia.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0312Y1UNLA
Administered by: Unknown     Purchased by: Public
Symptoms: Dizziness, Headache, Hypoaesthesia, Immunisation reaction, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)
Write-up: Pt had reaction after giving HPV vac. Pt complain of having headaches, dizziness, numbness on L arm and weakness on both legs. Pt was seen by Dr. on 8/18/09. 9/3/09 PCP medical records received DOS 4/1/08 to 8/18/09. Patient does not feel good. Dizziness, weakness, numbness.

VAERS ID:355243 (history)  Vaccinated:2009-08-18
Age:16.0  Onset:2009-08-18, Days after vaccination: 0
Gender:Male  Submitted:2009-08-18, Days after onset: 0
Location:Washington  Entered:2009-08-25, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB2861IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3013AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B0450IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: After receiving MENACTRA and Hep A injection. Pt c/o light headed, faint, nausea- Pale. Pt laid down - elevated feet - recovered - did fine.

VAERS ID:355482 (history)  Vaccinated:2009-07-30
Age:16.0  Onset:2009-08-11, Days after vaccination: 12
Gender:Female  Submitted:2009-08-26, Days after onset: 15
Location:Virginia  Entered:2009-08-26
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: History of pyelonephritis 9/25/09 Medical records received w/PMH: pyelonephritis. Allergy: amoxicillin.
Diagnostic Lab Data: cbc - WNL; glu 85; ekg: sinus bradycardia; other labs pending 9/25/09 Medical records received w/LABS: (+)ASO
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthropod bite, Blood glucose normal, Contusion, Electrocardiogram abnormal, Fatigue, Full blood count normal, Lymphadenopathy, Malaise, Nodule, Paraesthesia, Pharyngeal erythema, Presyncope, Sinus bradycardia, Streptococcus identification test, Streptococcus identification test positive, Streptococcal infection, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Initial near syncopal episode at time of vaccination on 7/30/09. Approximatley 8/11/09, she began to have intermittent problems with easy bruising, tingling, 9/25/09 Received PCP medical records which reveal patient in good general health on day of vaccination & had brief vasovagal syncope after shot. RTC 8/28 after symptoms began 8/11/09 of malaise, tiredness, easy bruising & near fainting episodes while driving. Exam revealed shotty cervical lymph nodes, erythematous throat, macular bruising on arms & nodule on right shin. 9/11 labs revealed + strep & had recent tick bite. Tx w/oral antibiotics.

VAERS ID:355527 (history)  Vaccinated:2009-08-21
Age:16.0  Onset:2009-08-21, Days after vaccination: 0
Gender:Female  Submitted:2009-08-22, Days after onset: 1
Location:Texas  Entered:2009-08-26, 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: She said it wasn''t bad (hurtful) then slouched soon after.
Preexisting Conditions:
Diagnostic Lab Data: Father and patient refused to be taken to hosp. Spoke to patient & dad at 7:30pm 8.21.09 & 8.22.09.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD199 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Headache. Momentarily passed out (opened her eyes and talked once laid down from slouching after covering shot with bandaid). Vomit, sweat said she was dizzy. Pale color after that. 911 came but all vital signs were OK.

VAERS ID:355686 (history)  Vaccinated:2009-08-24
Age:16.0  Onset:2009-08-24, Days after vaccination: 0
Gender:Male  Submitted:2009-08-25, Days after onset: 1
Location:Texas  Entered:2009-08-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EEG
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B046BA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blood pressure increased, Dyskinesia, Electroencephalogram, Loss of consciousness, Nausea, Pallor
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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: 30min after shot-BOOSTRIX mom returned to office with patient. She said he got nauseated in the car, became pale, flailed with his arms & passed out for short time. No loss of control. BP-113/73 pale, alert/cooperative. No V/tired. Rested on side in office for 30min. Appt for EEG made (negative). Appt with neurologist available.

VAERS ID:355690 (history)  Vaccinated:2009-08-17
Age:16.0  Onset:2009-08-19, Days after vaccination: 2
Gender:Female  Submitted:2009-08-21, Days after onset: 2
Location:New York  Entered:2009-08-27, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0698Y SCRA
Administered by: Private     Purchased by: Public
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Injection site shows a swollen lump 1 1/2" in diameter tender, itchy. Arm is weak, child fatigued.

VAERS ID:355701 (history)  Vaccinated:2009-04-09
Age:16.0  Onset:2009-04-11, Days after vaccination: 2
Gender:Female  Submitted:2009-08-27, Days after onset: 138
Location:Puerto Rico  Entered:2009-08-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: SKIN RASH AND VOMITING~HPV (Gardasil)~1~16~In Patient
Other Medications: ASPIRINE 81mg DAILY
Current Illness:
Preexisting Conditions: EPSTEIN ANOMALY (HEART MURMUR)
Diagnostic Lab Data:
CDC Split Type: PR-09-11
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1130X1IMUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2868AA0IMUN
Administered by: Private     Purchased by: Unknown
Symptoms: Pruritus, Rash, Tinea versicolour, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: MOTHER REFERS THE PATIENT PRESENTED WITH VOMITING, ITCHING AND RASH IN SKIN WHICH GOT WORSE. THE DERMATOLOGIST DIAGNOSED TINEA VERSICOLOR AND RECEIVED TREATMENT.

VAERS ID:355741 (history)  Vaccinated:2009-07-31
Age:16.0  Onset:2009-08-01, Days after vaccination: 1
Gender:Female  Submitted:2009-08-27, Days after onset: 26
Location:New Jersey  Entered:2009-08-27
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.1486U2IMRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Induration of 1 cm diameter at site of injection (induration still present 3 wks later).

VAERS ID:355743 (history)  Vaccinated:2009-08-25
Age:16.0  Onset:2009-08-25, Days after vaccination: 0
Gender:Female  Submitted:2009-08-25, Days after onset: 0
Location:Pennsylvania  Entered:2009-08-27, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMICTAL 25mg; PROZAC 10mg daily
Current Illness:
Preexisting Conditions: Depression
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500675P IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.0604Y0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0087X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 1118AM 3 minutes after shots were given, patient felt nauseous, became weak and fainted on the exam table. She responded immediately to ammonia inhalant; her BP 120/76. Ice pack was applied to her head. She was alert in a few minutes sitting up and ready to leave.

VAERS ID:355878 (history)  Vaccinated:2009-08-24
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-28
Location:Oklahoma  Entered:2009-08-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED02149211A IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: None noted

VAERS ID:355895 (history)  Vaccinated:2009-06-16
Age:16.0  Onset:2009-06-21, Days after vaccination: 5
Gender:Female  Submitted:2009-08-29, Days after onset: 69
Location:California  Entered:2009-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1129X1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: fainting, seizure about a week after vaccine given

VAERS ID:356010 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-08-28
Location:Unknown  Entered:2009-08-31, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0908USA03993
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Cerebrovascular accident, Dizziness, Gait disturbance, Nerve injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received via internet concerning a 16 year old female who on unspecified dates was vaccinated with the first two doses of GARDASIL. Subsequently the patient experienced fainting, stroke, memory loss which was devastating. The patient stated that she could barely walk, she was so dizzy that she would have to just sit down. The patient''s mother stated that physician diagnosed her daughter with nerve damage caused by GARDASIL. Upon internal review, stroke was considered an other important medical event. Additional information has been requested.

VAERS ID:356041 (history)  Vaccinated:2009-08-24
Age:16.0  Onset:2009-08-26, Days after vaccination: 2
Gender:Female  Submitted:2009-08-27, Days after onset: 1
Location:Arizona  Entered:2009-08-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0381X0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain, Nausea, Oropharyngeal pain, Pyrexia, Rash pruritic, Sinus congestion, Streptococcus identification test negative
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Developed fever of 100 last night and had left sided abd pain on Wednesday. 8/26/09. Woke up this AM 8/27/09 with rash on back of legs and waist that itch. Today has sore throat and some sinus congestion, some nausea. Strept screen negative. Given topical cream and XYZAL for itching.

VAERS ID:356097 (history)  Vaccinated:2009-08-27
Age:16.0  Onset:2009-08-28, Days after vaccination: 1
Gender:Female  Submitted:2009-08-31, Days after onset: 3
Location:New Jersey  Entered:2009-08-31
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2928AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Headache, fatigue. Local swelling, redness, & pain to site of injection.

VAERS ID:356102 (history)  Vaccinated:2009-08-17
Age:16.0  Onset:2009-08-21, Days after vaccination: 4
Gender:Female  Submitted:2009-08-25, Days after onset: 4
Location:North Carolina  Entered:2009-08-31, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergic to sulfa, KEFLEX, DURICEF
Diagnostic Lab Data: Hemoglobin performed on 8/21/09 - normal result per pts. mom. Influenza test - result pending.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.008741UNRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Chills, Fatigue, Haemoglobin normal, Headache, Influenza serology, Nausea
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Per pts. mother, pt. started experiencing extreme fatigue/weakness and some nausea in morning on 08/21/2009. Pt. was taken to PCP and Hgb check was done as pt. also started menses on 08/21/2009. Pt. felt fine all weekend and then on 8/25/09 started with headache, chills, nausea, and weakness, and was again taken to PCP and was at this time tested for influenza. Per mom, PCP is unsure of course of symptoms.

VAERS ID:356265 (history)  Vaccinated:2009-08-22
Age:16.0  Onset:2009-08-22, Days after vaccination: 0
Gender:Female  Submitted:2009-09-01, Days after onset: 10
Location:Florida  Entered:2009-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: MRI brain normal. 9/2/09 Consultant record received DOS 8/31/09. 9/17/09 Hospital records received DOS 8/31/09 to 9/1/09. LABS and DIAGNOSTICS Flu (-). LABS and DIAGNOSTICS: MRI Brain - Normal. Influenza A/B antigen (-) Throat Culture - No Growth.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB706AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.021641IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3012AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3158AA0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial culture negative, Drooling, Eyelid function disorder, Facial nerve disorder, Facial palsy, Facial paresis, Hypoaesthesia facial, Inflammation, Influenza serology negative, Nuclear magnetic resonance imaging brain normal, Throat lesion
SMQs:, Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)
Write-up: Bell''s palsy (unilateral). 9/2/09 Consultant record received DOS 8/31/09. Assessment: Bell''s Palsy. Patient presents with sudden onset (L) facial palsy / weakness. Feeling of weakness on (R) side. 9/17/09 Hospital records received DOS 8/31/09 to 9/1/09. Assessment: Bell''s Palsy. Patient visiting from Mexico, presents with 2 day history of right facial numbness. Could not close left eye, drooling from left side of mouth. Facial numbness. Peripheral facial nerve palsy, asymmetry of forehead wrinkles, mouth asymmetry. White exudates left peritonsillar recess. Patient immproved.

VAERS ID:356281 (history)  Vaccinated:2009-08-26
Age:16.0  Onset:2009-08-26, Days after vaccination: 0
Gender:Female  Submitted:2009-09-01, Days after onset: 6
Location:Colorado  Entered:2009-09-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: none known 9/22/09 Medical records received w/PMH: Left knee discomfort and left knee chondromalacia patella.
Diagnostic Lab Data: 9/22/09 Medical records received w/LABS: CT Head - Abnormal. CBC - WBC 14.8 3/uL (H) RBC 4.05 6/uL (L) Hematocrit 34.1% (L) Seg Neut 91.5% (H) Lymph 4.6% (L) Seg Neut ABS 13.5 (H) Lymph ABS 0.7 (L)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB296BA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1497X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Balance disorder, Computerised tomogram abnormal, Dizziness, Fall, Gait disturbance, Haematemesis, Haematocrit, Haemorrhage intracranial, Head injury, Headache, Loss of consciousness, Lymphocyte count decreased, Lymphocyte percentage decreased, Neutrophil count increased, Neutrophil percentage increased, Pain in extremity, Red blood cell count decreased, Skull fracture, Subdural haematoma, Syncope, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient administered Hep A and HPV vaccine. Sat in clinic room 10-15 minutes. Stated felt fine, color good. released to check out. stood 1-2 minutes and fell, possibly fainting, hitting head 9/22/09 ED and medical records received DOS 4/20/09 to 9/03/09. Assessment: Skull fracture and intracranial hemorrhage secondary to vasovagal syncope. Patient presents with headache and vomiting after syncope and a fall. Had felt light headed and lost consciousness, struck back of head on ground. Occipital skull fracture. Anterior intraparenchymal bleed and small subdural hemorrhage, occipital fracture, hematemesis. Pain left buttock and posterior left leg. Off balance gait. 10/2/09 Received ICD9 codes: 80121; 7802.

VAERS ID:356331 (history)  Vaccinated:2009-08-04
Age:16.0  Onset:2009-08-05, Days after vaccination: 1
Gender:Male  Submitted:2009-08-25, Days after onset: 20
Location:North Carolina  Entered:2009-09-02, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Amox allergy; asthma.
Diagnostic Lab Data: CBC & CRP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB343BA0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2933AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURUF484CA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0690Y1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Angioedema, C-reactive protein, Full blood count
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: Angioedema noted in right posterior arm.

VAERS ID:356448 (history)  Vaccinated:2009-08-13
Age:16.0  Onset:2009-08-14, Days after vaccination: 1
Gender:Female  Submitted:2009-09-03, Days after onset: 20
Location:Virginia  Entered:2009-09-03
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: HYPOTHYROIDISM
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1674X2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis, Pallor, Skin discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient claims that she felt lightheaded after standing for 10 mins and she had to be assisted with walking. She also claims that after feeling lightheaded and dizzy she sat down on cold floor at which point "everything was black" for approximately 10-20 mins. Patient never lost consciousness. People with patient noted that she was pale and lips greenish and was sweating profusely.

VAERS ID:356451 (history)  Vaccinated:2009-09-02
Age:16.0  Onset:2009-09-03, Days after vaccination: 1
Gender:Male  Submitted:2009-09-03, Days after onset: 0
Location:Pennsylvania  Entered:2009-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: None
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU2937BA5IMRA
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 104

VAERS ID:356454 (history)  Vaccinated:2009-08-31
Age:16.0  Onset:2009-08-31, Days after vaccination: 0
Gender:Female  Submitted:2009-09-03, Days after onset: 3
Location:Illinois  Entered:2009-09-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: fainted~HPV (Gardasil)~1~17~In Patient
Other Medications: none
Current Illness: none
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0575X1IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Dyskinesia, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: patient lying on exam table. While lying on exam table she fainted and arms flailed up. Nurse called patients name and she immediatley opened her eyes and was aware of surroundings. Nurse took pulse, B/P, and resp. All her vitals were within normal limits. Patient had fainted with the first HPV vaccination.

VAERS ID:356498 (history)  Vaccinated:2009-08-31
Age:16.0  Onset:2009-08-31, Days after vaccination: 0
Gender:Female  Submitted:2009-09-02, Days after onset: 2
Location:Colorado  Entered:2009-09-03, 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: Put on ibuprofen & diphenhydramine for rxn
Current Illness: None
Preexisting Conditions: No known
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB287AB IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2991AA IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3158AA IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Youth here today complaining of swelling, redness, pain, and itching over bilateral upper arms, where immunization shots were given yesterday. Pt states that she noticed some discomfort in the areas last night while sleeping when she would lie on her respective side. Then this morning she noticed the swelling and redness and has had intense itching in the area, worse over her R vs. L upper arm. Pt received immunizations yesterday and the affected area correlates with where her injections were given. Pt received the Tdap shot in her upper L (dominant) arm and a Hep A #1 and MENACTRA shot in her upper R arm. The more anterior shot appears to be the one reacting in her R arm, however, I am not certain if it was the Hep A or the MENACTRA that was given anteriorly in that arm. Pt also had a PPD placed in her volar R forearm yesterday. Pt has not tried any tx. She denies any fever, chills, or d/c. In further discussion regarding pt''s vaccinations, she states she thinks she did receive some vaccinations, although she does not remember which ones, about a year ago. We have no record of these vaccinations on file. Pt''s parents are currently out of the country and will not be returning until about 9/18/09. Pt states there is no other family members here who would know any further information on her vaccination status or who could obtain her previous medical records. She states she thinks she might have had a rxn to a vaccination in the past, but then she thinks it might have been a bee sting, she cannot remember which it was. Other ROS is WNL.

VAERS ID:356600 (history)  Vaccinated:2009-09-02
Age:16.0  Onset:2009-09-03, Days after vaccination: 1
Gender:Female  Submitted:2009-09-07, Days after onset: 4
Location:North Carolina  Entered:2009-09-07
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: Seizure 10/7/09 ER record received for date 9/3/09 Diagnostics/Lab: CT scan of head, UA.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0100Y1  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Feeling abnormal, Scan brain, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Gardasil vaccinations administered @ 4:30 p.m. 9/2/2009, was taken by ambulance to Hospital, @ 7:00 am on 29/3/2009. Diagnoses, seizure. 10/7/09 ER record received for date 9/3/09. Pt presented to ER with complaint from Mother that pt had 3 seizures while in shower and was "odd" for 5 minutes. Had HPV vaccine previous day. 12/17/09 GYN records received for DOS 9/02/09. Pt. presents for routine exam. YAZ prescribed. Gardasil Vax provided. Assessment: dysmenorrhea.

VAERS ID:356683 (history)  Vaccinated:2009-09-01
Age:16.0  Onset:2009-09-01, Days after vaccination: 0
Gender:Female  Submitted:2009-09-02, Days after onset: 1
Location:New York  Entered:2009-09-08, 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: WCE
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0229X UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEUR132058A UNLA
Administered by: Private     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt was given GARDASIL and ADACEL 100m /office approximately 10 minutes after injection, was found outside the building by police. Had syncope.

VAERS ID:356723 (history)  Vaccinated:2009-08-31
Age:16.0  Onset:2009-09-03, Days after vaccination: 3
Gender:Male  Submitted:2009-09-08, Days after onset: 5
Location:Michigan  Entered:2009-09-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TB test, Sanofi Pasteur, C3060AA, IM Left arm
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1678X0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2925AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B046AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Erythema and pain in upper deltoid area upper arm above elbow and trunk.

VAERS ID:356738 (history)  Vaccinated:2009-09-02
Age:16.0  Onset:2009-09-04, Days after vaccination: 2
Gender:Female  Submitted:2009-09-04, Days after onset: 0
Location:Ohio  Entered:2009-09-09, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0094Y0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Unevaluable event
SMQs:
Write-up: None Stated.

VAERS ID:356964 (history)  Vaccinated:2009-09-09
Age:16.0  Onset:2009-09-10, Days after vaccination: 1
Gender:Female  Submitted:2009-09-10, Days after onset: 0
Location:Alaska  Entered:2009-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Elevated WBC count
Preexisting Conditions:
Diagnostic Lab Data: WBC 22.3; GRAN 89.0 (Drawn 9/9/09 after visit)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97849P11IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0810Y0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Granulocyte count increased, Injection site erythema, Injection site swelling, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 6x7 cm erythema at injection site left arm. No temperature, swelling at injection site.

VAERS ID:356991 (history)  Vaccinated:2008-06-23
Age:16.0  Onset:2009-09-01, Days after vaccination: 435
Gender:Female  Submitted:2009-09-11, Days after onset: 10
Location:Kentucky  Entered:2009-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none, healthy
Preexisting Conditions: none 9/15/09 Received medical records w/Menactra, Lot #U2670AA, given LA on 6/24/2009.
Diagnostic Lab Data: Still doing tests. Will have mri and eeg. LABS and DIAGNOSTICS: Cranial CAT Scan Unremarkable. Cervical Spine CAT Scan Unremarkable. Blood Studies Unremarkable. 9/24/09 ER records received DOS 9/1/09. LABS and DIAGNOSTICS: Normal EKG. CHEM - CO2 20 MMOL/L (L) Anion Gap 19 (H) Alk Phos 106 IU/L (H). CBC - Neut 71.9% (H) Lymph 21.0% (L) Neut 7.6 X1C3 (H) Mono 0[[address]]Head - Demonstrates sinusitus, otherwise WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0181U2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amnesia, Anion gap increased, Blood alkaline phosphatase increased, Carbon dioxide decreased, Computerised tomogram abnormal, Computerised tomogram normal, Confusional state, Convulsion, Depressed level of consciousness, Dyskinesia, Electrocardiogram normal, Fall, Fatigue, Feeling abnormal, Feeling hot, Grand mal convulsion, Head injury, Headache, Laboratory test, Lymphocyte percentage decreased, Monocyte count decreased, Musculoskeletal stiffness, Neurological examination normal, Neutrophil count increased, Neutrophil percentage increased, Postictal state, Sinusitis, Swollen tongue, Tongue biting, Tongue discolouration
SMQs:, Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad)
Write-up: patient recieved Gardasil on 12/19/07, second dose on 2/20/08, and last dose on 6/23/2008. Extremely tired and at times seemed slow to respond.On 6/24/2009, went to family doctor to get menactra for college admission. That night patient had seizure during sleep. Bit tongue severely and had memory loss.Went to doctor, told to watch and wait. On 9/1/2009, patient suffered grand mal seizure at college and was taken to emergency room and evaluated. Sent to see neurologist next day and put on lamictal to control seizures. Following up on Sept 18 2009 with EEG and MRI.No family history at all of seizures and has been diagnosed with sudden onset seizures. 9/15/09 PCP and Neurology consult records received DOS 6/26/09 to 9/2/09. Assessment: Seizure disorder. Patient c/o ''feeling really weird'', woke up with discoloration and swelling left side of tongue. Trouble recalling things, took longer to remember things. Felt hot. Tongue bitten. Second seizure. Stiffening, jerking. Collapsed to floor. Taken to ER. Neurological exam WNL. 9/15/09 PCP and Neurology consult records received DOS 6/26/09 to 9/2/09. Assessment: Seizure disorder. Patient c/o ''feeling really weird'', woke up with discoloration and swelling left side of tongue. Trouble recalling things, took longer to remember things. Felt hot. Tongue bitten. Second seizure. Stiffening, jerking. Collapsed to floor. Taken to ER. Neurological exam WNL. 9/24/09 ER records received DOS 9/1/09. Assessment: New onset seizure. Seizure occuring just prior to arrival. Head injuries. Post-ictal headache and mild confusion. Sinusitis.

VAERS ID:357089 (history)  Vaccinated:2009-09-10
Age:16.0  Onset:2009-09-11, Days after vaccination: 1
Gender:Female  Submitted:2009-09-11, Days after onset: 0
Location:New York  Entered:2009-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3208AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1311X1IMRA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Feeling cold, Syncope, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fainting, feeling of coldness and weakness. Same reaction on 02/12/2009 but vaccine was given with other four.

VAERS ID:357228 (history)  Vaccinated:2009-09-09
Age:16.0  Onset:2009-09-09, Days after vaccination: 0
Gender:Female  Submitted:2009-09-10, Days after onset: 1
Location:Pennsylvania  Entered:2009-09-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: dizzy~HPV (no brand name)~2~0~Patient
Other Medications: No
Current Illness: No
Preexisting Conditions: Peanut allergy
Diagnostic Lab Data: That evening more HA + confusion. To ER. Head CT normal. Labs normal. Discharged with concussion diagnosis.
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3205CA2UNLA
HEPA: HEP A (VAQTA)MERCK & CO. INC.0604Y1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Computerised tomogram normal, Concussion, Confusional state, Fall, Head injury, Headache, Laboratory test normal, Loss of consciousness, Muscle twitching
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), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Received flu shot and Hep A. 3 minutes later standing at check out counter, fell backwards onto floor. Hit back of head on ground. Some twitching for 5 secs. Regained consciousness. Took water. Sat up after 5 minutes walked out after 15 mins.

VAERS ID:357362 (history)  Vaccinated:2009-09-14
Age:16.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-15, Days after onset: 1
Location:Florida  Entered:2009-09-15
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.OZ16Y2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Hypotension, Vision blurred
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)
Write-up: Dizzines,Hypotension,Blurred Vison,Quickly Recovered

VAERS ID:357365 (history)  Vaccinated:2008-03-17
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-15
Location:Tennessee  Entered:2009-09-15
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations: none~ ()~~0.00~Patient|none~ ()~~0.00~Sibling|none~ ()~~0.00~Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none. Dislocated shoulder, irregular periods. Migraine headaches, appendectomy.
Diagnostic Lab Data: EEG''s (5 or 6) only the last 2 have shown normal with medication. Tested on a regular basis since 8/15/2008. Labs and Diagnostics: EEG abnormal-c/w seizure d/o. Ct brain (-). WBCs 18K. BS 119. shoulder X-ray (+) dislocation and compr
CDC Split Type:
Vaccination
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HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U0UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood glucose increased, Compression fracture, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Epilepsy, Joint dislocation, Loss of consciousness, Muscle twitching, Myoclonic epilepsy, Myoclonus, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal, Presyncope, Scan brain, Syncope, White blood cell count increased, X-ray limb abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient had the 1st shot of Gardasil on 3/17/2008, she had the 2nd shot of Gardasil on 5/19/2008. She did not have the 3rd shot. She stated having twitching spells after awakening. We thought it was just maybe the way she was sleeping because it did not happen everyday. On 8/15/2008 she had a major seizure and was admitted to the hospital. She was diagnosised with EPILEPSY. She has had 5 major seizures since and sees a neurologist on a regular basis. Diagnosis of JUVENILE MYOCLONIC EPILEPSY. She now takes LAMICTAL 300mg twice daily. She has regular EEG''s. There is no history on either side of the family of a seizure disorder and she has never had any seizure history and no major illnesses. Via the Neurologist this may affect her for the rest of her life. DID THE GARDASIL CAUSE THIS??????? 9/29/09 MR received for DOS 8/15-16/2008 with D/C DX: Seizure activity. Right shoulder dislocation. Syncope. Pt presented after witnessed seizure activity. Pt found passed out in bathtub. Pt dislocated/fractured her shoulder during the episode. Reports pre-syncopal episodes for ~6 months. ICD9: 780.39, 812.09 10/2/09 Neurology consult records received DOS 9/14/09. Assessment: Juvenile myoclonic epilepsy. Seizures occur upon awakening, initial myoclonic jerks.

VAERS ID:357383 (history)  Vaccinated:2009-08-21
Age:16.0  Onset:2009-08-21, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Washington  Entered:2009-09-15
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: Penicillin; CECLOR; lymphangioma left orbital area
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
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Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2990AA0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Headache, Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 7:45 pm 8-21-09 nausea, headache not feeling well began vomiting 12:45 am which continued throughout the night given ondansetron ODT 4 mg tab at 6:15 am 8-22-09.

VAERS ID:357463 (history)  Vaccinated:2009-09-16
Age:16.0  Onset:2009-09-16, Days after vaccination: 0
Gender:Male  Submitted:2009-09-16, Days after onset: 0
Location:California  Entered:2009-09-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2877AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B036BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.026441SCLA
Administered by: Unknown     Purchased by: Public
Symptoms: Confusional state, Head injury, Headache, Loss of consciousness, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: patient got VZV/Tdap/MCV 4, and was sitting on bench for about 5 minutes for observation. on getting up, he experienced syncopal episode, hit the back of his head (occiput) with several seconds of loss of consciousness. after 10 minutes, he complained of headache,nausea, confusion, and vomited 1 time.

VAERS ID:357700 (history)  Vaccinated:2009-09-17
Age:16.0  Onset:2009-09-18, Days after vaccination: 1
Gender:Male  Submitted:2009-09-18, Days after onset: 0
Location:Georgia  Entered:2009-09-18
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
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Dose
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JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN236A0IMRA
Administered by: Military     Purchased by: Unknown
Symptoms: Eyelid oedema, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Pt was given JE-VAX yesterday at a facility/clinic at Kings Bay. He woke up today with swelling around eyelids and urticarial rash to arms and hips. No respiratory distress.

VAERS ID:357744 (history)  Vaccinated:2009-09-18
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-18
Location:Connecticut  Entered:2009-09-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN; HFA; PRN; CLARITIN 10 mg qd PCN
Current Illness: None
Preexisting Conditions: Asthma; Allergic Rhinitis due to pollen dust.
Diagnostic Lab Data: None
CDC Split Type:
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MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2812AA1IMRA
Administered by: Other     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: None. Student given a second MENACTRA vaccine. 1st MENACTRA given 4/24/08

VAERS ID:357758 (history)  Vaccinated:2009-09-15
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-15
Location:Wisconsin  Entered:2009-09-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
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FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA2591IMLA
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: None

VAERS ID:357777 (history)  Vaccinated:2009-06-02
Age:16.0  Onset:2009-07-21, Days after vaccination: 49
Gender:Female  Submitted:2009-09-21, Days after onset: 62
Location:Florida  Entered:2009-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: She has had blood test to see if it is Thyroid and the test was well within the standards and the only other thing she has done different is this vaccination that she did not want to begin with. Her Doctor and her father insisted she have
CDC Split Type:
Vaccination
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0000002IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Alopecia, Blood test, Emotional disorder, Fatigue, Pruritus, Scab
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Hypersensitivity (broad)
Write-up: Patient had her second injection of the Gardasil Shot in June 2009 and since then she has lost most of her hair. She is also getting scabs on her head also and itching. She is fatigued and very emotional. She continues to miss days at school because of the humiliation she faces at school with the loss of her hair.

VAERS ID:358013 (history)  Vaccinated:2009-09-08
Age:16.0  Onset:2009-09-09, Days after vaccination: 1
Gender:Female  Submitted:2009-09-23, Days after onset: 14
Location:Missouri  Entered:2009-09-23
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:
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TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Injection site rash, Injection site warmth, Pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Hot, raised at injection site, rash, fever of 100.4 degrees. Dizziness, trouble breathing, body aches. Diarrhea, vomiting.

VAERS ID:358126 (history)  Vaccinated:2009-09-23
Age:16.0  Onset:2009-09-23, Days after vaccination: 0
Gender:Female  Submitted:2009-09-23, Days after onset: 0
Location:California  Entered:2009-09-23
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: Seizure disorder (seizure free for 12 years)
Diagnostic Lab Data: N/A 10/5/09 Medical records received w/LABS: EEG abnormal.
CDC Split Type:
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HPV4: HPV (GARDASIL)MERCK & CO. INC.0053X0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysmenorrhoea, Electroencephalogram normal, Loss of consciousness, Postictal state, Presyncope, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Patient with history of chilhood seizure. Seizure free since 4 years of age. Patient had vaso-vagal episode briefly lost consciousness and had 5 to 6 seconds of clonic-tonic jerking arms and legs. Patient had post-ictal state for 2 hrs. 10/05/09 Received PCP medical records which included Neuro consults of 1998. FINAL DX: Generalized tonic seizure disorder. Records reveal that patient initially experienced night time seizure activity 4/98 followed by vomiting x 1 w/congestion & cough but no fever. Dx w/bronchitis & tx w/antibiotics. After 2nd abnormal EEG, started on antiseizure meds & did well. 10/6/09 Received Neuro medical records of 10/2/09. FINAL DX: syncopal attacks, likely vagal; hx of generalized seizrue disorder in childhood, treated & idiopathic; dysmenorrhea. Referred for EEG & if abnormal, an MRI. No further medical records available.

VAERS ID:358161 (history)  Vaccinated:2009-09-23
Age:16.0  Onset:2009-09-23, Days after vaccination: 0
Gender:Male  Submitted:2009-09-23, Days after onset: 0
Location:Florida  Entered:2009-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Viral URI
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
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FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3208AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Contusion, Dizziness, Fall, Mouth injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Ten minutes after receiving influenza vaccine felt dizzy and syncopal, he fell to the ground and bruised nose and cut lip. He was given O2 then transferred to ER and given IV fluids.

VAERS ID:358212 (history)  Vaccinated:2009-07-01
Age:16.0  Onset:2009-07-05, Days after vaccination: 4
Gender:Female  Submitted:2009-09-23, Days after onset: 80
Location:Missouri  Entered:2009-09-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI, given Septra day prior to vaccination.
Preexisting Conditions: None. Urine Culture (+). Tick bites. Tosillectomy.
Diagnostic Lab Data: diagnostic laboratory. PMH: CBC - WBC 1.7 K/uL (L) MCV 78.9 fL (L) MCH 26.8 pg (L) Platelet 121 K/uL (L) Bands 21% (H) Neutro 1.2 K/uL (L) Lymph 0.3 K/uL (L). Urinalysis - Hazy, Leukocyte Esterase trace, Protein 1+, Ketones 2+, Urobilinogen
CDC Split Type: WAES0909USA01991
Vaccination
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HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB238AA1UNRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0558X1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Bacteria urine identified, Band neutrophil percentage increased, Blood bilirubin increased, Blood creatinine increased, Blood culture negative, Blood sodium decreased, Contusion, Drug hypersensitivity, Dysuria, Haematuria, Headache, Heart rate increased, Laboratory test, Lymphocyte count decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Nausea, Neutrophil count decreased, Pain in extremity, Petechiae, Platelet count decreased, Protein urine present, Purpura, Pyrexia, Rash, Rash maculo-papular, Rickettsia antibody, Urinary sediment present, Urine abnormality, Urine ketone body present, Urine leukocyte esterase positive, Urobilin urine present, Vaccine positive rechallenge, Virus culture, Vomiting, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse and an office administrator concerning the nurse''s 16 year old daughter with no pertinent history who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot # 658271/0558X). Concomitant therapy include HAVRIX (unspecified) (lot# AHAVB238AA) with the first dose of GARDASIL. On 05-JUL-2009 the patient went to the emergency room with nausea, vomiting, fever, severe stomach pains and headaches. On 08-JUL-2009 the consumer called the office complaining of joint pain and ibuprofen was recommended. On 09-JUL-2009 the the consumer called the office again with complaint of increased joint pain It was reported that the patient could still eat food, but on 18-JUL-2009 the patient went to the emergency room since what she was experiencing was not getting better. The registered nurse also reported that the patient was admitted to hospital. At the hospital the patient was given fluids in case it was her kidney and also drew blood. The patient was also given SEPTRA which caused her to have tiny bruises on top of her two thighs. The registered reported that the patient was in the hospital for four days and was doing better after that. Then on 05-SEP-2009, the patient received her second dose of GARDASIL (Lot# 662404/0312Y) and then on 15-SEP-2009 (also reported as 11-SEP-2009) the patient started to experience severe stomach pains, nausea, vomiting, fever and headaches. No complaints of joint pain at that time. Therapy with GARDASIL was discontinued. The results of blood work were unknown. The registered nurse reported that they had called her physician, but the patient had not yet recovered. This is one of several reports from the same source. Additional information has been requested. 9/30/09 Hospital records, DC summary, received DOS 7/5/09 to 7/8/09. Assessment: Febrile illness, purpuric rash, maculopapular rash. Patient presents with a 3 day history of crampy abdominal pain aggravated by urination. Dysuria, vomiting, and hematuria. Red rash abdomen and

VAERS ID:358295 (history)  Vaccinated:2009-09-21
Age:16.0  Onset:2009-09-21, Days after vaccination: 0
Gender:Female  Submitted:2009-09-24, Days after onset: 3
Location:Indiana  Entered:2009-09-24
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: Told by guardian/translator that patient had a history of seizures. She had not had any seizures since coming to the US in 2/09. She saw a doctor and had blood work done on 9/21, but was on no meds a time of vaccinations. 10/7/09 ER records received for date 9/21/09. PMH: 3 previous sycopal episodes in past 3-4 yrs.
Diagnostic Lab Data: Patient transported by ambulance to PV ER. Testing done on blood (chemistries) and urine (UA and pregnancy test); all within normal limits other than slightly elevated Chloride level. No radiolgic testing done. Diagnosis was seizure vs.
CDC Split Type:
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HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB730AA0IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB327AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0672Y0IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA1109-20SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0449Y0SCRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3012AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B041BA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0999Y0SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal discomfort, Cold sweat, Convulsion, Dyskinesia, Gaze palsy, Immediate post-injection reaction, Laboratory test normal, Lethargy, Musculoskeletal stiffness, Opisthotonus, Pallor, Posturing, Pregnancy test negative, Syncope, Unresponsive to stimuli, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Immediately after receiving vaccinations, patient arched back, neck extended back and to the right, eyes fluttered and rolled back. Patient not responsive; not answering questions or talking. She was eased from the chair to the floor. Her body was stiff and jerking and had to be fully supported by 2 individuals. The jerking stopped within 2 minutes. Patient remained lethargic, eyes opened and then slowly closed repeatedly for the next ~15 minutes. Patient complained of upset stomach immediately following seizure-like activity, but denied needing to vomit. Skin was pale and moist. 10/7/09 ER records received for date 9/21/09. DC DX: seizure vs. syncope. Presenting sx: As pt was receiving vaccine, she arched her back, may have had loss of consciousness and/or seizure. Pt states in ER feeling fine. Assessment: PE WNL. ICD9 codes: 781.0, 780.39.

VAERS ID:358631 (history)  Vaccinated:2009-08-24
Age:16.0  Onset:2009-09-07, Days after vaccination: 14
Gender:Female  Submitted:2009-09-24, Days after onset: 17
Location:Pennsylvania  Entered:2009-09-29, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 PMH: none
Diagnostic Lab Data: Influenza (-); WBC = 1.6; Platelet count = 66; CMV +; EBV negative 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 Diagnostics/Labs: CT head(-), Lyme screen(-), CSF cx(-), WBC 1.6(L), bands 43%(H), CRP 92.5(H), RBC 3.95(L), platelets 66(L), HCT 35.7(L) neutrophils .5(L), LFT's abnormal-Albumin 2.9(L), protein 5.5(L), bili total .2(L), SGOT/AST 44(H), SGPT/ALT 35(H).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3173AA IMRA
Administered by: Private     Purchased by: Private
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Band neutrophil count increased, Blood albumin decreased, Blood bilirubin, Borrelia burgdorferi serology negative, C-reactive protein increased, CSF culture negative, Chills, Computerised tomogram normal, Cytomegalovirus test positive, Decreased appetite, Epstein-Barr virus test negative, Haematocrit decreased, Headache, Hyperhidrosis, Influenza serology negative, Leukopenia, Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Neutropenia, Neutrophil count decreased, Platelet count decreased, Protein total decreased, Pyrexia, Red blood cell count decreased, Thrombocytopenia, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever, headache. Thrombocytopenia, neutropenia. Admitted, no treatment. 10/7/09 Medical records received from dates 9/8/09 to 9/10/09 DC DX: Leukopenia, thrombocytopenia. Presenting SX: fever, neck pain/stiffness, myalgias, sweats, chills, HA, nausea, poor appetite. Symptoms occured x1 day after flu vaccine. ICD9 codes: 288.5, 287.5 11/30/2009 MR and DC summary for 9/10-9/11/2009 transfer to this facility for continued care, received IV ABX, DC Dx fever/headache, thrombocytopenia, neutropenia

VAERS ID:358667 (history)  Vaccinated:2009-06-30
Age:16.0  Onset:2009-09-14, Days after vaccination: 76
Gender:Female  Submitted:2009-09-28, Days after onset: 14
Location:North Carolina  Entered:2009-09-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Diagnostic laboratory, 09/19/09, Blood work was normal; Computed axial, 09/19/09, normal; Magnetic resonance, 09/19/09, abdominal: normal; Serum Epstein-Barr, 09/19?/09, positive
CDC Split Type: WAES0909USA03143
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Blood test normal, Computerised tomogram normal, Epstein-Barr virus test positive, Nuclear magnetic resonance imaging normal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a physician concerning his 16 year old daughter with no pertinent medical history and no known drug allergies who on 30-JUN-2009 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. On 14-SEP-2009 the patient experienced severe, crampy, intermittent left upper abdominal quadrant pain. On 19-SEP-2009 the patient was admitted to hospital. Blood work, computed axial tomography (CT) scan, and abdominal magnetic resonance imaging (MRI) were normal. The test results on the patient came back as positive for Epstein Barr virus. The patient received pain management with hydrocodone and intravenous morphine. The patient was discharged on 20-SEP-2009. At the time of the report, the patient had not recovered. Severe, crampy, intermittent left upper abdominal quadrant pain and positive for epstein barr virus were considered to be disabling. Additional information has been requested.

VAERS ID:358682 (history)  Vaccinated:2009-09-27
Age:16.0  Onset:2009-09-27, Days after vaccination: 0
Gender:Female  Submitted:2009-09-29, Days after onset: 2
Location:Michigan  Entered:2009-09-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS960304P IMLA
Administered by: Other     Purchased by: Private
Symptoms: Anxiety, Crying, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Patient said she felt dizzy, slight trouble breathing, crying. Did not turn into an allergic reaction. ER said patient probably had symptoms triggered by anxiety - did not suspect an allergic reaction.

VAERS ID:358744 (history)  Vaccinated:2009-01-09
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-28
Location:Unknown  Entered:2009-09-29, 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: Gastric disorder
Preexisting Conditions:
Diagnostic Lab Data: hematology, ?/?/09, blood panel: high on immunoglobulin E (131H) and Anti streptolysin O (208H)
CDC Split Type: WAES0909USA03482
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Alopecia, Asthenia, Back pain, Blood immunoglobulin E increased, Chest pain, Computerised tomogram normal, Diarrhoea, Dizziness, Dyskinesia, Dyspnoea, Feeling abnormal, Gastric disorder, Headache, Heart rate increased, Hypoaesthesia, Malaise, Nausea, Neck pain, Pain, Paraesthesia, Streptococcus identification test positive, Visual impairment, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Dyskinesia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from the patient''s mother via internet. The mother stated that her 16 year old daughter was injured by GARDASIL. On 09-JAN-2009, the patient was vaccinated with the first dose of GARDASIL and on 09-MAR-2008 with the second dose of GARDASIL. Before GARDASIL, she was happy, healthy and vibrant teenager. Since GARDASIL, the patient was sick every day of her life. She had dizziness, overall weakness, numbness and tingling in both legs and left arm, back pain, neck pain, pressure headaches, vision problems, breathing problems, chest pains, racing heartbeats, brain fog, stomach problems, nausea, diarrhea, weight loss, hair loss, jerking all over spells, the list goes on. She was and a/B student but failed her 10th grade year because she was too sick to retain what she was trying to learn (brain fog). she was no longer had energy to go off with her friends. Most days she lays in bed, in pain. The patient had been in the emergency room twice, once by ambulance for stopping breathing 3 times. She was seen several doctors. She had CT scan done. All tests come back normal (which is typical with all of the injured GARDASIL vaccine girls). Her blood panel showed high on immunoglobulin E (131H) and Anti streptolysin O (208H) which the doctor "thought" was rheumatic fever. Another doctor had said he did not believe she had rheumatic fever. Brain fog and energy increased were considered to be disability. This is one of several reports provided by the same source. No further information is available.

VAERS ID:358902 (history)  Vaccinated:2009-09-28
Age:16.0  Onset:2009-09-28, Days after vaccination: 0
Gender:Female  Submitted:2009-09-30, Days after onset: 2
Location:Missouri  Entered:2009-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM 20 mg, LUTERA birth control
Current Illness: No
Preexisting Conditions: Mild asthma, allergies to Sulfa drugs and black berries
Diagnostic Lab Data: Urine test at Hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97839P23IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Influenza like illness, Muscle twitching, Urine analysis
SMQs:, Dementia (broad), Dyskinesia (broad), Dystonia (broad)
Write-up: The 16 yo child described muscle twitching all over following vaccination (7pm same day). The mother took her to Hospital ER. They ran tests, which showed that nothing was wrong. The twitching was not witnessed in ER. The next day child experienced flu-like symptoms and stayed home from school. The day after 9-30-9 felt fine & returned to school, has not complained of any further muscle twitching.

VAERS ID:359042 (history)  Vaccinated:0000-00-00
Age:16.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-30
Location:Pennsylvania  Entered:2009-10-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 30 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0909USA04030
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Complex regional pain syndrome
SMQs:
Write-up: Information has been received from a physician concerning a 16 or 17 years old female who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced reflex sympathetic dystrophy within 1 day of administration of the vaccine. The patient was hospitalized for 1 month. The name of the hospital, dates of hospitalization, or patient specific information was not available. At the reporting time the patient had not recovered. Reflex sympathetic dystrophy was considered to be disabling. Additional information has been requested.

VAERS ID:359070 (history)  Vaccinated:2009-10-01
Age:16.0  Onset:2009-10-01, Days after vaccination: 0
Gender:Male  Submitted:2009-10-01, Days after onset: 0
Location:Pennsylvania  Entered:2009-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ceftriaxone
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3208AA1IMRA
Administered by: Unknown     Purchased by: Public
Symptoms: Blood pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Patient had syncopal episode with decrease in BP to 77 systolic, recovered given water subsequent BP systolic 106. Left without incident

VAERS ID:359106 (history)  Vaccinated:2009-03-11
Age:16.0  Onset:2009-05-01, Days after vaccination: 51
Gender:Female  Submitted:2009-09-30, Days after onset: 152
Location:Michigan  Entered:2009-10-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1312X1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Flushing, Madarosis
SMQs:, Anaphylactic reaction (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (broad)
Write-up: Mother states that patient was losing eye brows and eye lashes starting 2 months after GARDASIL. The eyelashes and eye brows growing back. Mother states that patient is feeling flushed. But patient denies recovering.

VAERS ID:359131 (history)  Vaccinated:2009-09-14
Age:16.0  Onset:2009-09-14, Days after vaccination: 0
Gender:Female  Submitted:2009-09-25, Days after onset: 11
Location:Pennsylvania  Entered:2009-10-02, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3212AA IMUN
Administered by: Private     Purchased by: Other
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: Per ER; allergic rxn - probably to flu shot.

VAERS ID:359184 (history)  Vaccinated:2009-10-01
Age:16.0  Onset:2009-10-01, Days after vaccination: 0
Gender:Female  Submitted:2009-10-02, Days after onset: 1
Location:Massachusetts  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair, flovent, Allegra, Astylin
Current Illness:
Preexisting Conditions: Celiac, asthma, seasonal allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3213AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site rash, Oxygen saturation normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Fluzone flu vaccine administered, as vaccine completed patient immediately developed a 6.5 x 5.5 cm flat round erythemic area with pruritis. No respiratory distress. O2 sat 100%. Given Benadryl 50mg po and monitored. Rash abated in 60 minutes.

VAERS ID:359204 (history)  Vaccinated:2009-09-30
Age:16.0  Onset:2009-10-01, Days after vaccination: 1
Gender:Male  Submitted:2009-10-02, Days after onset: 1
Location:Pennsylvania  Entered:2009-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Grinder abrasion to R thumb.
Preexisting Conditions: allergies:amoxil,pediazole,zithromax caps.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.088041SCLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site vesicles, Injection site warmth, Malaise, Sensation of heaviness, Sinus headache
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 10/1/09 afternoon developed swelling, heat and redness at site of injection. Feels general mailaise, sinus tenderness,L arm feels heavy and painful.Erythema and induration L upper arm at site of injection. One small blister at injection site.Is using ice at site of imflammation. To force fluids, use antipyretics and started on cefzil. diagnosis cellulitis/vaccine reaction moderate.

VAERS ID:359383 (history)  Vaccinated:2009-09-18
Age:16.0  Onset:2009-09-18, Days after vaccination: 0
Gender:Male  Submitted:2009-09-25, Days after onset: 7
Location:New York  Entered:2009-10-05, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOCALIN; CLONIDINE; RISPERIDAL; PROZAC
Current Illness: None ADHD/Depression
Preexisting Conditions: As in #18 (ADHD/depression) PMH: ADHD, Depresson Allergies: NKDA
Diagnostic Lab Data: Lyme titer 0.33 Lab: CBC, CMP WNL except for borderline low creatinine at 0.69, Cholesterol, UA, ESR WNL. Lyme titer 0.33 (negative). B Microtic and A phagocytophilum AB tests negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB715AA1IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2907BA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B029AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Blood cholesterol normal, Blood creatinine decreased, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Facial palsy, Full blood count normal, Red blood cell sedimentation rate normal, Urine analysis normal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: On 9/18/09, patient came in for well visit (annual P.E.) and received MENACTRA, BOOSTRIX, and Hep B vaccines. Later that evening, he started to experience left facial palsy. Seen in office on 9/21/09 L facial palsy still present. Concern of Lyme, DOXYCYCLINE prescribed for 1 month. Blood work obtained. As of 9/24/09, mother reports by phone that facial palsy still present, but better. 10/15/2009 received records from PCP for visit date 9/21/2009. Patient presents with sx of left facial palsy 3 days post vaccination. PE notes lt facial assymetry, unable to close lt eye fully, + eye tearing. Tx: Doxcycline, eye patch at night and Artificial tears.

VAERS ID:359387 (history)  Vaccinated:2009-09-28
Age:16.0  Onset:2009-09-28, Days after vaccination: 0
Gender:Female  Submitted:2009-09-28, Days after onset: 0
Location:Texas  Entered:2009-10-05, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: c/o of minor sore throat
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97840P10IMRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Dyskinesia, 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), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient received FLUVIRIN, then approximately, one minute later complained of lightheadedness, she sat down then lost consciousness for approximately 15 seconds, then had seizure like movement, for approximately 5 seconds. She then slowly woke up. Paramedics arrived and her vitals were normal.

VAERS ID:359576 (history)  Vaccinated:2009-09-29
Age:16.0  Onset:2009-09-29, Days after vaccination: 0
Gender:Male  Submitted:2009-09-30, Days after onset: 1
Location:Illinois  Entered:2009-10-06, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97846P2A IMLA
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt fainted after leaving pharmacy, in the parking lot, but got up before paramedics arrived. He was checked out in the ambulance. Paramedics said fainting was due to drop in blood pressure. Spoke to the father afterwards and was told the patient is fine.

VAERS ID:359737 (history)  Vaccinated:2009-09-23
Age:16.0  Onset:2009-09-24, Days after vaccination: 1
Gender:Female  Submitted:2009-09-30, Days after onset: 6
Location:California  Entered:2009-10-06, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Stress related headaches
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500677P IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.AHAVB326AA1UNLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0653X0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B046DA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Headache,