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Case Details (Sorted by Vaccination Date)

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VAERS ID:316277 (history)  Vaccinated:2008-06-13
Age:17.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 0
Location:Florida  Entered:2008-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Multiple sclerosis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1993BA5UNRA
Administered by: Public     Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Had TD vaccine given then patient was getting blood drawn. Patient passed out in chair - called 911, stabilized and went to hospital via ambulance.

VAERS ID:316252 (history)  Vaccinated:2008-06-13
Age:0.2  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-06-14, Days after onset: 1
Location:Virginia  Entered:2008-06-14
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
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURER   RL
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER   LL
Administered by: Private     Purchased by: Unknown
Symptoms: Crying, Diarrhoea, Hypersomnia, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)
Write-up: Initially she slept for 3 hrs. She awoke and immediately began crying for 3hrs continuously then on and off for the remainder of the day. She couldn''t sleep for more than 30 minutes. She also had diarrhea, vomiting, fussiness which is ongoing.

VAERS ID:316254 (history)  Vaccinated:2008-06-13
Age:11.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Male  Submitted:2008-06-14, Days after onset: 0
Location:Pennsylvania  Entered:2008-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: conjunctivitis, seasonal allergies
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER   RA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER   LA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Dysphonia, Headache, Pallor, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fever (102.2 at highest, hoarseness, paleness, weakness, headache

VAERS ID:316255 (history)  Vaccinated:2008-06-13
Age:40.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Male  Submitted:2008-06-15, Days after onset: 1
Location:New Hampshire  Entered:2008-06-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Lipitor
Current Illness: Puncture wound right middle finger
Preexisting Conditions: Hypothyoidism, alphaamitripsin, hypercholesterolemia
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2927AA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Fever, chills, rigors with generalizeed myalgia, arthralgia, malaise and severe localized pain on the day following vaccine administration. Fever, chills and rigors resolved the next day, though generalized myalgias still present 2 days after administration.

VAERS ID:316340 (history)  Vaccinated:2008-06-13
Age:23.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-06-16, Days after onset: 3
Location:Guam  Entered:2008-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: nkda, none
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1732SCLA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Cough, Nausea, Pain, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Fever, body aches, joint pain, cough, congestion, nausea, vomiting lasting more than 5 days after vaccine administered

VAERS ID:316385 (history)  Vaccinated:2008-06-13
Age:18.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-06-13, Days after onset: 0
Location:Missouri  Entered:2008-06-17, 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 - slight heart murmer
Diagnostic Lab Data:
CDC Split Type: MO200814
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2S61AA IM 
Administered by: Public     Purchased by: Public
Symptoms: Hypoaesthesia, Loss of consciousness, Palpitations, Visual disturbance
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), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Started seeing spots, combination heart racing, numb finger, "blacking out aware but not aware" until she blacked out

VAERS ID:317074 (history)  Vaccinated:2008-06-13
Age:30.0  Onset:2008-06-20, Days after vaccination: 7
Gender:Female  Submitted:2008-06-20, Days after onset: 0
Location:Utah  Entered:2008-06-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~Patient|None~ ()~~0.00~Sibling
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: spinal tap, 6/20/08, normal protein 7/14/08-records received- CT scan normal. Cultures no growth, CSF counts normal. WBC 11.9, segs 85.1 and absolute neutrophils 10.2. 8/13/08 Yellow Fever Lab Results from CDC lab:Day 0 CSF, RT-PCR and viral culture negative, negative for YF IgM Abs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD30013780PO 
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF301AA0SC 
Administered by: Private     Purchased by: Private
Symptoms: CSF protein normal, Chills, Computerised tomogram normal, Confusional state, Culture negative, Delirium, Diarrhoea, Lumbar puncture, Mental status changes, Neutrophil count increased, Neutrophil percentage increased, Polymerase chain reaction, Serology negative, Tremor, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)
Write-up: On Friday 6/18/08 at 10:00AM; patient got confused and progressively got worse. Also experienced shaking chills, diarrhea and vomiting. Patient didn''t know where she''s at at the time. Was taken to ER; where a spinal tap and Cat scan were done. Given DECADROM 10mg IV and 40mg qid p.o. Diagnosis: toxic encephalitis. 7/14/08-records received for DOS 6/21/08-DX: acute delirium resolving likely from yellow fever. Altered mental status, unable to state her location.

VAERS ID:317157 (history)  Vaccinated:2008-06-13
Age:4.0  Onset:2008-06-15, Days after vaccination: 2
Gender:Female  Submitted:2008-06-18, Days after onset: 3
Location:California  Entered:2008-06-24, 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: Proair inhaler
Current Illness: None
Preexisting Conditions: Asthma; Obstructive sleep apnea
Diagnostic Lab Data: None ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B049AA2IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01693SCLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1230U0SCRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 6/15/08: Office visit: patient came in for swollen arm due to immunization. MD notes: moderate swelling with erythema and tenderness, about 15 x 7 cm area around vaccination site of left upper arm. Patient/parent instruction given by MD: Can take Motrin every 6 hours to help with pain for a day or so.

VAERS ID:317265 (history)  Vaccinated:2008-06-13
Age:23.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Male  Submitted:2008-06-20, Days after onset: 7
Location:Louisiana  Entered:2008-06-24, 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: Over the counter Zinc for Acne
Current Illness:
Preexisting Conditions: Post-surgery for brain tumor (astrocytome), residual left hemiparesis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2408AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia, Sluggishness, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Fever, headache, nausea, vomiting. dizzy, sleepiness, sluggishness, pain at the injection site (could not raise R arm without pain).

VAERS ID:318340 (history)  Vaccinated:2008-06-13
Age:1.1  Onset:2008-06-14, Days after vaccination: 1
Gender:Female  Submitted:2008-06-26, Days after onset: 12
Location:New Mexico  Entered:2008-07-07, Days after submission: 11
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 BIOLOGICALSAHAVB216AA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1484U0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1893U0UNLL
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Rash noted one day after immunizations given.

VAERS ID:320014 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Female  Submitted:2008-07-15, Days after onset: 31
Location:New Jersey  Entered:2008-07-17, 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: Asthma
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08226
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthma, Axillary pain, Lymphadenopathy
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a 15 year old white female student with asthma who on 13-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660391/0063X) intramuscularly into left deltoid. Suspect therapy given the same day included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot #0063X) IM into left deltoid. On 14-JUN-2008 the patient developed left axillary adenopathy, left axillary pain and also asthma exacerbation. There was no illness at the time of vaccination. It was unknown by the reporter if the patient had recovered. Additional information has been requested.

VAERS ID:321909 (history)  Vaccinated:2008-06-13
Age:14.0  Onset:2008-06-27, Days after vaccination: 14
Gender:Female  Submitted:2008-08-12, Days after onset: 46
Location:California  Entered:2008-08-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: nonn
Current Illness: none
Preexisting Conditions: yes allergies (not as severe) She did have a severe preexisting allergy to beans of all kinds
Diagnostic Lab Data: We have been given an epi pen in case of emergency. She is on Zrytec, and inhalers and of couse Bendryl creams. Next is a round of steroids.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: My daughter has become severely allergic to many foods, very suddenly. It all started about two weeks after her first shot. My daughter does have allergies, but never to these new items, (nuts, she was a big peanut butter fan), (and new strange items, like sweet tarts, just gave her a horrible reaction) and never with such a severe reaction as now. She gets terrible hives, and difficulty breathing. I just connected the Gardasil shot and the onset of her severe allergies, because she is due to receive her next shot tommorow and I started thinking about when all this started! * Another daughter age 16 received her first shot the same day and has had no side effects*

VAERS ID:323236 (history)  Vaccinated:2008-06-13
Age:18.0  Onset:2008-06-18, Days after vaccination: 5
Gender:Female  Submitted:2008-08-25, Days after onset: 68
Location:Illinois  Entered:2008-08-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: XOPENEX inhaler; SINGULAIR; PHENTERMINE; ZYRTEC; MACROBID
Current Illness: None
Preexisting Conditions: hx of asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1740U0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: 5 days after receiving the vaccine-woke up, felt faint and had difficulty breathing, tightening of the chest-went to ER.

VAERS ID:528812 (history)  Vaccinated:2008-06-13
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2014-04-18
Location:Unknown  Entered:2014-04-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Viral titre, negative not provided
CDC Split Type: WAES1404USA008925
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Antibody test negative, Viral titre
SMQs:
Write-up: This spontaneous report was received from a registered nurse refers to a male patient of unknown age. On 13-JUN-2008 the patient was vaccinated with VARIVAX (dose strength was not reported) dose 2, subcutaneous. And on 27-AUG-1999 patient received dose 1 of VARIVAX. No concomitant medication was reported. Nurse reported that patient has negative titers after receiving 2 doses of VARIVAX. It was reported that patient sought medical attention and visited the office. There was no product quality complaint involved. The outcome of patient has negative titers after receiving 2 doses of VARIVAX was reported as not resolved. The relatedness between the VARIVAX and event was unknown. Additional information has been requested.

VAERS ID:316753 (history)  Vaccinated:2008-06-13
Age:23.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-06-20, Days after onset: 7
Location:Foreign  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Salbutamol sulphate; Fluticasone propionate
Current Illness: Asthma
Preexisting Conditions: Patient had no known allergies and no previous reactions to any vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: B0525101A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB077DD UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA0876 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dyspnoea, Malaise, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction in a 23-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), TYPHIM Vi. Concurrent medical conditions included asthma. Concurrent medications included Salbutamol and Flixotide. On 13 June 2008 the subject received 1st dose of TWINRIX (1 injection), unspecified dose of TYPHIM Vi (unknown). On 13 June 2008, minutes after vaccination with TWINRIX and TYPHIM Vi, the subject experienced anaphylactic reaction, could not breathe, pins and needles around mouth, pins and needles in all fingertips and did not feel well. The subject was treated with adrenaline and subsequently hospitalised. At the time of reporting the outcome of the events was unspecified. Verbatim text received: On th 16th June 2008 a nurse reported that on the 13 June 2008 a patient had been administered the first dose of a TWINRIX vaccination schedule and a TYPHIM Vi vaccination in separate arms. The nurse reported that a few minutes after the vaccination s the patient did not feel well, "couldn''t breathe" and had "pins and needles around mouth and in the tips of fingers". The patient was given adrenaline injection and started to initially feel better. Ten minutes after the adrenaline injection had been administered to the patient the patient developed the same symptoms and a second adrenaline injection was administered. The patient was then taken to hospital. The nurse stated that the patient had no known allergies and had not had any reactions to previous vaccinations. No further details were available at the time of reporting.

VAERS ID:317343 (history)  Vaccinated:2008-06-13
Age:  Onset:2008-06-14, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 10
Location:Foreign  Entered:2008-06-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: WBC count, 14Jun08, 13100/ul; Body temp, 14Jun08, 40 C; Serum C-reactive protein, 14Jun08, 0.01 mg/dl; WBC count, 15Jun08, 45400/ul; Body temp, 15Jun08, 40 C; Serum C-reactive protein, 15Jun08, 19.69 mg/dl; WBC count, 16Jun08, 45400/ul; Bod
CDC Split Type: WAES0806USA03471
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein increased, Erythema, Pyrexia, Swelling, Vomiting, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning a female patient who on 13-JUN-2008 was vaccinated with PNEUMOVAX 23. The patient was scheduled for splenectomy. On 14-JUN-2008 the patient developed pyrexia, swelling, redness and vomiting and was hospitalised. Laboratory findings revealed C-reactive protein (CRP) 0.01, white blood cell count (WBC) 13100/ul and body temperature of approximately 40 degrees centigrade (C). On 15-JUN-2008, the patient was treated with ceftriaxone sodium hydrate for suspected infection. Laboratory findings revealed CRP 19.69, WBC 45400/ul and body temperature of approximately 40 degrees C. On 16-JUN-2008 the patient had not recovered from pyrexia, swelling, redness and vomiting. Laboratory findings revealed CRP 23.83, WBC 45400/ul and body temperature of approximately 37 degrees C. The reporting physician felt that the pyrexia, swelling, redness and vomiting were definitely related to PNEUMOVAX 23 vaccine and considered the events to be serious due to hospitalization. Additional information has been requested.

VAERS ID:318253 (history)  Vaccinated:2008-06-13
Age:23.0  Onset:2008-06-13, Days after vaccination: 0
Gender:Female  Submitted:2008-07-04, Days after onset: 21
Location:Foreign  Entered:2008-07-07, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Flixotide; Salbutamol
Current Illness:
Preexisting Conditions: The patient had a medical history of asthma. The patient had no known allergies and had not had any reactions to previous vaccines.
Diagnostic Lab Data:
CDC Split Type: E200806040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB077DD0UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA0876 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Malaise, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)
Write-up: This case was initially reported to a foreign agency by the health authority on 25-Jun-2008. ADR 20277692. This case concerns a 23 year old female patient. The patient had a medical history of asthma. The patient had no known allergies and had not had any reactions to previous vaccines. The patient was taking concomitant Flixotide and Salbutamol for unknown indications. The patient received TYPHIM VI, batch number A0876-1, and the first dose of TWINRIX, batch number AHABB077DD, on 13-Jun-2008, in separate arms. On 13-Jun-2008, a few minutes post vaccinations, the patient did not feel well, "couldn''t breathe" and had "pins and needles around mouth and tips of fingers". The patient was given an adrenaline injection and started to initially feel better. Ten minutes after the injection had been administered the patient developed the same symptoms and a second adrenaline injection was administered. The patient was taken to hospital. The patient outcome was unknown. The event of anaphylactic reaction was coded by the MHRA.

VAERS ID:319650 (history)  Vaccinated:2008-06-13
Age:1.3  Onset:2008-07-08, Days after vaccination: 25
Gender:Female  Submitted:2008-07-17, Days after onset: 9
Location:Foreign  Entered:2008-07-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 07Jul08, 38 degrees C
CDC Split Type: WAES0807USA02705
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.WL000254770SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Depressed level of consciousness, Febrile convulsion, Hypotonia, Pharyngeal erythema, Pyrexia, Tympanic membrane hyperaemia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from an investigator concerning a 16 month old female patient with a family history of febrile seizures who entered a study. On 13-JUN-2008 at 11:26 the patient was vaccinated SC in the right deltoid with a first 0.5 mL dose of PROQUAD (Batch# WL00025477). On 07-JUL-2008, the patient developed a fever (38 degrees C). On 08-JUL-2008, 26 days after receiving the vaccination, the patient experienced a mild episode of depressed level of consciousness, decreased muscle tone, and vomiting. On 08-JUL-2008, the patient was admitted into the hospital''s emergency room and was diagnosed with a mild febrile seizure. However, the investigator did not agree with this diagnosis and considered the case as a depressed consciousness. The investigator considered these adverse events to be other important medical events. Exploratory findings revealed hyperemia of the throat and tympanic membranes that led to a suspected diagnosis of pharyngitis as the cause of the fever. Treatment for the event consisted of 5 mg STESOLID by rectal route on 08-JUL-2008 to treat febrile seizure. Relevant prior medications were APIRETAL to treat fever administered from 07-JUL-2008 to 08-JUL-2008, 15 mg by oral route. The patient recovered from the adverse events on the same day, 08-JUL-2008. The patient remained in the hospital emergency room for two hours for observation. After two hours, the patient was discharged. The reporting investigator felt that depressed level of consciousness, muscle tone decreased, fever and vomiting were possibly related to study therapy. The case is closed. Other business partner numbers include: 2007-002438-12 and E2008-06471.

VAERS ID:320681 (history)  Vaccinated:2008-06-13
Age:5.0  Onset:2008-06-14, Days after vaccination: 1
Gender:Unknown  Submitted:2008-07-28, Days after onset: 44
Location:Foreign  Entered:2008-07-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 200802366
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2733A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Joint swelling, Mobility decreased, Oedema peripheral, Pruritus, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case received from the Health Authorities on 21 July 2008. A 05-year-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of TRIPACEL, batch number C2733AB, on 13 June 2008. On 14 June 2008, i.e. the following day post-vaccination, the patient experienced very intense oedema of humeral joint, shoulder and cubital joint. The patient also developed urticaria, pruritus of the oedema area and decreased mobility of the humeral joint. The patient''s reaction lasted more than 3 days. The patient was hospitalized on unspecified dates. The patient''s symptoms were recovering at the time of the report.

VAERS ID:445737 (history)  Vaccinated:2008-06-13
Age:19.0  Onset:2008-07-03, Days after vaccination: 20
Gender:Female  Submitted:2011-12-16, Days after onset: 1261
Location:Foreign  Entered:2011-12-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01621
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NM132602IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abscess, Furuncle, Incisional drainage
SMQs:
Write-up: Case was received from the Health Authorities on 09-DEC-2011 under reference NC20110778. Case was medically confirmed. A 19 year old female patient received the first dose of GARDASIL (lot # 655127/0575F, batch # NE47400) on 13-SEP-2007. Second dose of GARDASIL (lot # 0275U, batch # NF54050) was received on an unspecified date. The third dose of (batch # NM13260) was received on 13-JUN-2008. As of 03-JUL-2008 she had been suffering from recurrent abscesses in the region of the underwear (buttock, perineum and sex). She underwent surgery 3 times for incision and drainage in 2009 and 2011. She was seen on 11-OCT-2011 for 6-day-lasting abscess, which was treated with unspecified medication. The diagnosis was chronic furunculosis. At the time of reporting, the patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the foreign method of assessment. Furunculosis was considered to be serious with serious criteria of hospitalization and disabling. Other business partner number included E2011-07908. No further information is available.

VAERS ID:517687 (history)  Vaccinated:2008-06-13
Age:24.0  Onset:2008-07-03, Days after vaccination: 20
Gender:Female  Submitted:2013-12-25, Days after onset: 2001
Location:Foreign  Entered:2013-12-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312FRA010579
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Cyst, Hidradenitis, Nodule, Pain
SMQs:, Dementia (broad)
Write-up: Information has been received from SPMSD (FR-1577272925-E2013-11145) on 23-DEC-2013. Case received via media press on 18-Dec-2013. A 24-year-old female patient had received the third dose of GARDASIL (batch number not reported) on 13-Jun-2008. On 03-Jul-2008, she presented with Verneuil''s disease with a first nodule on the same date. On an unspecified date she also developed cysts and daily pain. Her daily activities were also impaired. At the time of reporting, the outcome was not reported. According to the reporter, the reactions were related to the vaccination.

VAERS ID:316253 (history)  Vaccinated:2008-06-14
Age:0.5  Onset:2008-06-14, Days after vaccination: 0
Gender:Male  Submitted:2008-06-14, Days after onset: 0
Location:Texas  Entered:2008-06-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B054AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF232AD1IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0170-21SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC458921IMRL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: GAVE IMMUNIZATIONS TO A 6 MONTH OLD INFANT. INFANT HAD RECEIVED THE SAME IMMUNIZATION ON 05/01/2008 BUT A DIFFERENT LOT NUMBER. MOTHER AND FATHER NOTED THAT AROUND THE RT UPPER LEG WHERE THE PNEUMOCOCCAL CONJUGATE VACCINE 7-VALENT, PREVNAR A RED AREA WAS DEVELOPING THAT WAS IRREGULAR IN SIZE AND SLIGHTLY ELEVATED ABOUTN 4 INCHES BY 2 INCHES. THE AREA WAS ALSO SLIGHTLY SWOLLEN. THIS WAS NOTED 10 MINUTES AFTER THE INJECTION WAS GIVEN. THE SITE WAS WATCHED FOR INCREASING SEVERITY BUT DID NOT WORSEN WHILE THE FAMILY WAS AT THE CLINIC. THE FAMILY WAS ADVISED TO NOTIFY CLINIC IF THE SITE WORSENS AND TAKE INFANT TO PRIMARY CARE DOCTOR IF SITE WORSENS AND CHILD BECOMES IRRITABLE OR CHANGE IN MENTAL STATUS DEVELOPS. THE MOTHER STATES IT WAS NOT GETTING WORSE AND THE FAMILY LEFT THE CLINIC.

VAERS ID:316926 (history)  Vaccinated:2008-06-14
Age:4.0  Onset:2008-06-15, Days after vaccination: 1
Gender:Female  Submitted:2008-06-16, Days after onset: 1
Location:Illinois  Entered:2008-06-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC280AA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAV26BEA0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1890O1SCRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 16cm x 10cm red, sl. warm mild itchy local reaction.

VAERS ID:318330 (history)  Vaccinated:2008-06-14
Age:17.0  Onset:2008-06-15, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Missouri  Entered:2008-07-07
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
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURUE961AD0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Tenderness
SMQs:
Write-up: Tenderness x 25 hours at left arm (deltoid).

VAERS ID:318774 (history)  Vaccinated:2008-06-14
Age:23.0  Onset:2008-06-26, Days after vaccination: 12
Gender:Male  Submitted:2008-07-11, Days after onset: 15
Location:Wisconsin  Entered:2008-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None. PMH: chronic diarrhea with (-) scopes, MVA with head trauma 2005, cholecystectomy. NKDA
Diagnostic Lab Data: Clinical Dx Guillain-Barre. Progressive neurological weakness and respiratory distress. Sx improved with 5 day course of IVIG, discharged with some continued lower extremity weakness, improved respiratory function. Labs and Diagnostics: Head CT (-). CSF with protein 74.2 otherwise WNL. CSF cx (-). Pulmonary Vital capcity $g 3L. CPK 226. CKMB 9.4. CKMB Index 4.2. Lyme Ab screen (+).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB107AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal tenderness, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Blood product transfusion, Borrelia burgdorferi serology positive, CSF culture negative, CSF protein increased, Computerised tomogram normal, Dyspnoea, Facial palsy, Gait disturbance, Guillain-Barre syndrome, Heart rate increased, Hypogeusia, Hyporeflexia, Intercostal retraction, Muscular weakness, Pain, Paraesthesia, Peripheral coldness, Respiratory distress, Scan brain, Vital capacity, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow)
Write-up: Guillain-Barre syndrome. Sx beginning 12 days post vaccine. Hospitalized 6 days. 07/23/2008 MR received for DOS 7/4-9/2008 with D/C DX: Guillain-Barre Syndrome. Pt presented with 5 dya hx of paresthesias, weakness and pain to hands, face and legs, decreased taste sensation and progressive difficulty with walking and standing. Recent onset of SOB. PE (+) for pulse 116, accessory muscle use for breathing, diffuse abd tenderness, cold extremities, bilateral cranial nerve 7 palsy, weak DTRs, and bilateral weakness. TX with IVIG with good response in all but facial palsy. Able to ambulate with walker. D/C for outpt f/u and tx.

VAERS ID:327809 (history)  Vaccinated:2008-06-14
Age:65.0  Onset:2008-06-16, Days after vaccination: 2
Gender:Male  Submitted:2008-09-24, Days after onset: 100
Location:Oklahoma  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA00067
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness, Rash vesicular
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a 65 year old male consumer with no known drug allergies who on 14-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 16-JUN-2008 the patient experienced flu like symptoms and developed "chicken pox like rash" on legs below the knee. At the time of this report, the patient was recovering from the symptoms. The patient sought unspecified medical attention. Additional information has been requested.

VAERS ID:316970 (history)  Vaccinated:2008-06-14
Age:18.0  Onset:2008-06-15, Days after vaccination: 1
Gender:Female  Submitted:2008-06-20, Days after onset: 5
Location:Foreign  Entered:2008-06-23, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Neutrophil count, 15Jun08, 85%; Urinalysis, 15Jun08, blood in urine; Temperature measurement, 15Jun08, 38.6 centigrade; Temperature measurement, 15Jun08, 37.5 centigrade; WBC count, 4700; Temperature measurement, 39.6 centigrade.
CDC Split Type: WAES0806USA03514
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood urine present, Body temperature increased, Incorrect route of drug administration, Neutrophil count increased, Pyrexia, Urine analysis abnormal, Vomiting, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Initial information has been received from a health professional concerning an 18-19 year old female who on 14-JUN-2008 was inadvertently vaccinated by intravenous route with a 2nd dose of GARDASIL. On 15-JUN-2008 the patient presented fever (38.6 centigrade) and vomiting. The patient took motilium to treat vomiting and after attending the physician she was administered primperan to treat the vomits and Ibuprofen to treat fever. The patient breathed and urinated well. Follow up information was received. The patient continued with fever (39.6 centigrade). On 15-JUN-2008 the patient went to the clinic, she was vaccinated and there, they indicated her to continue the treatment with Ibuprofen. A blood test showed a neutrophyls deviation (85%). Leukocytes remained at normal levels (4700). Blood in urine was observed, but was not considered relevant as subject was menstruating. An internal medicine physician examined the patient and said that she had an hyperreactivity to a strange protein. In the afternoon, after contacting patient''s mother the health care professional reported that the patient did not feel worse during the night. She was being treated with Ibuprofen 600 mg/8 hour and paracetamol 500/8 hour (rotating medication every four hours). The patient presented mild fever on 15-JUN-2008 in the morning (37.5 centigrade). The health professional considered that these adverse events could also occur with the correct vaccine administration. The patient recovered. No further information is available. The case was closed. Other business partner numbers included E2008-05547.

VAERS ID:319284 (history)  Vaccinated:2008-06-14
Age:12.0  Onset:2008-06-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 31
Location:Foreign  Entered:2008-07-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807COL00003
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Oedema peripheral, Pyrexia, Somnolence
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)
Write-up: On 14-JUN-2008 a female of 12 year old assisted to a vaccination day and was placed on therapy with GARDASIL, 0.5 ml, first dose. On 14-JUN-2008 the patient experienced injection site pain, fever, nausea, headache, dizziness and somnolence. Subsequently, the patient recovered from fever, nausea, headache and dizziness. At the moment of the report, the patient presented injection site pain to the touch from the elbow to the shoulder and somnolence. She assisted to the emergency room and was prescribed with acetaminophen every 6 hours (dose unknown). Patient''s mother reported that the patient since the day of vaccination has been somnolent and her arm is swelled. The reporter felt that injection site pain, fever, nausea, headache and dizziness were related to therapy with GARDASIL. Additional information has been requested.

VAERS ID:320377 (history)  Vaccinated:2008-06-14
Age:40.0  Onset:2008-06-14, Days after vaccination: 0
Gender:Female  Submitted:2008-07-24, Days after onset: 40
Location:Foreign  Entered:2008-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Valproate sodium
Current Illness: EPILEPSY
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 14Jun2008, 12; Heart rate, 14Jun2008, 70bpm
CDC Split Type: B0529645A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB392AB SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure, Breath sounds abnormal, Heart rate normal, Immediate post-injection reaction, Loss of consciousness, Syncope
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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow)
Write-up: This case was reported by the regulatory authority (AFSSaPS, MA20081117, 08-2237) and described the occurrence of syncope in a 40-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included epilepsy treated with DEPAKINE. On 14 June 2008, while she had taken a substantial breakfast, at 09:38, the subject received a dose of ENGERIX B adult (20 mcg, subcutaneous, batch reference AHBVB392AB). It was noted that she spent a night at work a few days ago. On the following minute after the vaccination, she experienced syncope with loss of consciousness and noisy breathing. Blood pressure was 12 and heart rate was 70 bpm. She woke up soon. The subject was hospitalised but as the events resolved she was discharged the same day on the afternoon. The regulatory authority reported that the events were clinically significant (or requiring intervention). The AFSSaPS reported the events as probably related to ENGERIX B Adult vaccine.

VAERS ID:320210 (history)  Vaccinated:2008-06-15
Age:19.0  Onset:2008-07-15, Days after vaccination: 30
Gender:Female  Submitted:2008-07-22, Days after onset: 7
Location:Unknown  Entered:2008-07-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
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: WAES0807USA02927
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Head injury, Urinary incontinence
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a registered pharmacist a concerning a 19 or 20 year old of age female pharmacy technician who on an unspecified date was vaccinated with a first dose of GARDASIL and on approximately 15-JUN-2008, one month ago, was vaccinated with the second dose of GARDASIL. On 15-JUL-2008, the patient experienced a seizure after administration of second dose of GARDASIL. The technician hit her head and urinated on herself during the seizure. The seizure occurred while she was working. Paramedics treated her. At the time of reporting, she was alert and improving (recovering). The pharmacist did not know if she was hospitalized. The seizure was considered to be disabling by the reporter. Additional information has been requested.

VAERS ID:327743 (history)  Vaccinated:2008-06-15
Age:70.0  Onset:2008-06-17, Days after vaccination: 2
Gender:Male  Submitted:2008-09-24, Days after onset: 99
Location:Unknown  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOMAX (TAMSULOSIN)
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA03427
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning her father who is around 70 years old and on 15-JUN-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included (FLOMAX). The physician reported that her father received zoster vaccine live and on 17-JUN-2008, developed a red and swollen area at the injection site that was the size of his palm. The physician told her father to put on unspecified corticosteroid on it. The patient sought medical attention by phone. Additional information has been requested.

VAERS ID:335128 (history)  Vaccinated:2008-06-15
Age:26.0  Onset:2008-07-01, Days after vaccination: 16
Gender:Female  Submitted:2008-12-11, Days after onset: 163
Location:Foreign  Entered:2008-12-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: ethinyl estradiol (+) levonorgestrel
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: magnetic resonance imaging, ??08, brain and orbits: Foci of increased intensities seen. Demyelination cannot be excluded at this stage
CDC Split Type: WAES0812AUS00122
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Migraine, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Visual acuity reduced
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad)
Write-up: Information was obtained on request by the Company from the agency, via a Case Line Listing and Public Case Details Form, concerning a 26 year old female who on 15-JUN-2008 was vaccinated with GARDASIL, intramuscularly. Concomitant therapy included NORDETTE. In approximately July 2008, "within three weeks of vaccination", the patient developed left optic neuritis and migraine headache and was hospitalised. Results of Magnetic Resonance Imaging (MRI) of the patient''s brain and orbits were as follows: "Foci of increased intensities are seen within the periventricular deep white matter bilaterally. Demyelination cannot be excluded at this stage. The orbital contents define normally. Both optic nerves appear unremarkable." The patient was treated with prednisolone. On 21-AUG-2008 the patient had recovered, with sequelae (mild decreased vision), from optic neuritis and migraine. The agency considered that optic neuritis and migraine were possibly related to therapy with GARDASIL. The original reporting source was not provided. Additional information is not expected.

VAERS ID:316522 (history)  Vaccinated:2008-06-16
Age:69.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-18, Days after onset: 1
Location:Illinois  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Premarin; Crestor; Multi vitamin; Calcium; Glucosamine/Condroitin; ASA; Ibuprofen
Current Illness: None
Preexisting Conditions: Sulfa, codeine, dolubid allergies. Osteoarthritis, high cholesterol.
Diagnostic Lab Data: None at this time. Will see physician 6/18/2008.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0398X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Rash, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Began having itching 6/17/2008 on left hand; progressed to left arm, then chest and face. Having some facial swelling. Also have rash on hips and abdomen mostly on the left side. Right hand began with rash and itching in a.m. 6/18/2008.

VAERS ID:316529 (history)  Vaccinated:2008-06-16
Age:28.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-18, Days after onset: 1
Location:Missouri  Entered:2008-06-18
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: Sulfa
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1776U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Blister, Injection site erythema, Injection site mass, Injection site pruritus, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Client came to clinic 06/16/2008 for Varicella vaccine 3:30pm. Administered in R arm SQ. Pt. Phoned Health Department 06/18/2008 9:15am stating she was now out of town and her arm had a blistered rash with a knot the size of her fist. (Pt. stated she noticed 06/17/2008 @ 11:30pm after a 4 hour walk that site was red and itching with a slight knot). Instructed client to seek medical attention if condition worsened and she could take OTC Benadryl for reaction. (Client stated she has previously had chickenpox--needed titer for proof of disease for school--had decided to received vaccine)

VAERS ID:316532 (history)  Vaccinated:2008-06-16
Age:36.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-18, Days after onset: 1
Location:Indiana  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Naproxin 600 mg
Current Illness: none
Preexisting Conditions: Fractured neck healed wrong due to car wreck in 2007
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU2332BA2IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Burning sensation, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Aching,tingling,burning muscle went to Dr Diagnosed with Brachical Neuritis given prescription for steroids Referred to Neurologist on 6/20/08

VAERS ID:316538 (history)  Vaccinated:2008-06-16
Age:48.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 2
Location:Massachusetts  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin, Boniva, Amitriptyline, vicodin, singulair, albuterol MDI prn, loratidine, boniva, fluoxetine, clonazepam, temazepam, Vit B12
Current Illness: None
Preexisting Conditions: Multiple allergies: Bee venom, sulfa, latex, aspirin, NSAIDs, tetracycline, dust mite
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB530AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Developed redness and itching down entire arm and up neck to head that lasted for 2 days. Resolved with benadryl.

VAERS ID:316539 (history)  Vaccinated:2008-06-16
Age:29.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-18, Days after onset: 1
Location:Ohio  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown; also received second step TB mantoux on 6/16/08 in Right forearm
Current Illness: NA
Preexisting Conditions: Patient states she has a history of varicella infection as a child, but is unable to provide proof to her school and does not wish to provide titer; preferred to receive vaccination for varicella
Diagnostic Lab Data: NA
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H1924U SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURHC2766AA IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.H1008U SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Red, raised, itchy area (6.5 cm x 6 cm) developed approximately 24 hours after vaccination was administered, at varicella administration site.

VAERS ID:316579 (history)  Vaccinated:2008-06-16
Age:0.2  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-18, Days after onset: 1
Location:California  Entered:2008-06-18
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: None
Current Illness: None
Preexisting Conditions: None 7/14/08-records received-PMH: jaundice at birth.
Diagnostic Lab Data: Spinal tap, blood Cx & urine Cx 7/14/08-records received-Labs: specific gravity low 1.005, CSF normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Blood culture, CSF test normal, Convulsion, Culture urine, Gaze palsy, Pyrexia, Specific gravity urine decreased, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever and seizure on evening of the day he got vaccination. Pt. admitted in hospital. Got spinal tap & started on antibiotics. Also urine & blood cultures send. 7/14/08-records received for DOS 6/17/08-:Fever with possible seizure. Temp taken by parent 104, upon admission 99. This occurred night of vaccination. Eyes rolling to back of head, upper extremities shaking.

VAERS ID:316556 (history)  Vaccinated:2008-06-16
Age:3.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-19, Days after onset: 2
Location:Arizona  Entered:2008-06-19
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: febrile seizure at age 18 months not a result of vaccination
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER    
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anorexia, Convulsion, Crying, Drooling, Dyskinesia, Gaze palsy, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site rash, Irritability, Loss of consciousness, Screaming, Unresponsive to stimuli, Yawning
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), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: My son was administered 8 shots at once (4 sticks) on 6-16-08 and within two hours, began screaming, sweating, and crying uncontrollably for over an hour. He also complained that his arms hurt bad at the site of injection and there are red rashed on both arms. I gave him a dose of motrin and he took a nap. He was irritable and and had no appetite all night. In the a.m. 6-17-08 at 8:00am, he lost consciousness and had a seizure which lasted almost 15 minutes of jerking and staring blankly, eyes rolling back in his head, heavy drooling and then complete unresponsiveness. He was terrified and so was I. He was then transported by ambulance to hospital and the whole time he was yawning (which the paramedics told me was neurological) and staring blankly. He was monitored and then administered childrens tylenol. They released us at 11:00 am.

VAERS ID:316642 (history)  Vaccinated:2008-06-16
Age:5.0  Onset:2008-06-18, Days after vaccination: 2
Gender:Male  Submitted:2008-06-19, Days after onset: 1
Location:New Jersey  Entered:2008-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2953AB4UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08053UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1859U1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site abscess sterile, 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: Patient received DTAP, IPOL and VARIVAX vaccines on 6/16/08. Patient presented to office on 6/18/08 with painful, red, swelling of DTAP injection site. Diagnosed with sterile abscess - Duricef prescribed along with Tylenol and compresses to area.

VAERS ID:316724 (history)  Vaccinated:2008-06-16
Age:14.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-20, Days after onset: 4
Location:California  Entered:2008-06-20
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.197841IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Feeling abnormal, Gaze palsy, Headache, Hyperventilation, Hypotonia, Musculoskeletal stiffness, Pallor, Syncope, Syncope vasovagal, Tremor, Vaccine positive rechallenge
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: FIRST EVENT 4/9/08: RECEIVED HPV 1, TDAP, MCV4 - FAINTED SEVERAL SECONDS AFTER VACCINES GIVEN, EYES ROLLED BACK AND PT STIFFENED AND SHOOK FOR A FEW SECONDS, THEN RECOVERED QUICKLY. THOUGHT TO BE VAGAL EPISODE. WITNESSED BY MOM AND ASSISTED BY NURSE AND MD. SECOND EVENT 6/16/08: NERVOUS BEFORE SHOTS BC FAINTED LAST TIME. RECEIVED HPV 2. A FEW SEC LATER, FELT DIZZY AND UNABLE TO SEE, HEAD HURT THEN WENT LIMP, LEANED TO RIGHT AND STIFFENED AND ARMS AND LEGS SHOOK A LITTLE FOR APPROX 15 SEC, THEN PT WAS PALE, HYPERVENTILATING, EYES OPEN. SHE EVENTUALLY BECAME LUCID AND RESPONSIVE OVER ABOUT 3-5 MIN. BP STABLE THROUGHOUT. LUCID AND CONVERSATIONAL AFTER 5 MIN BUT QUIET AND STILL FELT "BAD". SHE RECOVERED COMPLETELY WITHIN 10 MINUTES. THIS ALSO WAS THOUGHT TO BE A VAGAL RESPONSE.

VAERS ID:316725 (history)  Vaccinated:2008-06-16
Age:59.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-20, Days after onset: 3
Location:Illinois  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glucophage 50 mg twice daily; Amaryl 4 mg daily; Lasix 40 mg daily; Restasis eye drops twice daily
Current Illness: none
Preexisting Conditions: Type II Diabetes; Glaucoma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1993AA IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site oedema, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Client complained of severe edema, redness, and generalized aching. This began by waking up the client at approximately 3 a.m. on the day following receiving the vaccine. Also c/o large baseball-sized lump at injection site. The site was this size when reported to the Health Department 4 days after the vaccine was received.

VAERS ID:316762 (history)  Vaccinated:2008-06-16
Age:70.0  Onset:2008-06-18, Days after vaccination: 2
Gender:Female  Submitted:2008-06-20, Days after onset: 2
Location:Michigan  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0298X0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Large hard "lump" at injection site - size of "baseball" - appeared 2 days after injection. Itched, very sore. After 2 days - lump is subsiding.

VAERS ID:316776 (history)  Vaccinated:2008-06-16
Age:1.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2008-06-20, Days after onset: 4
Location:North Carolina  Entered:2008-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
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 BIOLOGICALSAHAVB264BA0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0356X0SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1785U0SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Parents stated patient came out with hives that day, vaccines were the only new thing given that day.

VAERS ID:316875 (history)  Vaccinated:2008-06-16
Age:0.1  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2008-06-17, Days after onset: 1
Location:Arkansas  Entered:2008-06-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B156BA0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF262AA0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC650490UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0211X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Vaccine given to 27 day old due to incorrect birthdate.

VAERS ID:316878 (history)  Vaccinated:2008-06-16
Age:0.1  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 1
Location:Arkansas  Entered:2008-06-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B156BA0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF262AA0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC650490UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0211X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Vaccine given to 27 day old due to incorrect birthdate.

VAERS ID:316882 (history)  Vaccinated:2008-06-16
Age:0.1  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 1
Location:Arkansas  Entered:2008-06-23, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B156BA0UNLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF262AA0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC650490UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0211X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Vaccine given to 27 day old due to incorrect birthdate.

VAERS ID:316918 (history)  Vaccinated:2008-06-16
Age:5.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-18, Days after onset: 1
Location:Oregon  Entered:2008-06-23, 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: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHVB2346A0IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743SCLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0425U1SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Received DTaP/IPV left thigh 6/16/08. 24 hrs later red, swollen. Seen 6/18/08 upper site measures 9.5x8cm medial site measures 3.5x4.5cm.

VAERS ID:317064 (history)  Vaccinated:2008-06-16
Age:15.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-23, Days after onset: 7
Location:Pennsylvania  Entered:2008-06-23
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
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: Syncope- this pt actually passed out about 3 minutes after receiving the injection. We had to use an ammonia inhalant to help her come to.

VAERS ID:317156 (history)  Vaccinated:2008-06-16
Age:63.0  Onset:2008-06-18, Days after vaccination: 2
Gender:Female  Submitted:2008-06-19, Days after onset: 1
Location:Indiana  Entered:2008-06-24, 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: Not known
Current Illness: None
Preexisting Conditions: Patient-dx allergy: codeine (insomnia; hyperactivity)
Diagnostic Lab Data: Not taken
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0300X0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Vaccine given on 6/16/08. Patient called on 6/18/08 with complaint of her L arm swelling/bruising at injection site with some mild pain for past 12 hours. Also said area was warm.

VAERS ID:317170 (history)  Vaccinated:2008-06-16
Age:30.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-19, Days after onset: 2
Location:Iowa  Entered:2008-06-24, 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: NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB524AA0UNLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2899AA UNRA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Received Tdap vaccine rt. deltoid on 6/16/08. Received hepatitis-B vaccine lt. deltoid on 6/16/08. Became nauseated with vomiting on 6/17/08. Rt. hand and fingers numbness and tingling on 6/17/08.

VAERS ID:317213 (history)  Vaccinated:2008-06-16
Age:61.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-16, Days after onset: 1
Location:Kentucky  Entered:2008-06-24, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prilosec; Plavix; Alpravolum; ASA; Ranexa; Hydroapap; Phenergan
Current Illness: No
Preexisting Conditions: Codeine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB100AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Vomiting, diarrhea, weakness, started vomiting around 9:00 PM 6/17/08 and vomited til after 5:00 AM. Went to ER then back home at 8:00 AM. Appt with doctor 6/16/08.

VAERS ID:317216 (history)  Vaccinated:2008-06-16
Age:4.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-19, Days after onset: 2
Location:Georgia  Entered:2008-06-24, 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: Albuterol MDI
Current Illness: Asthma; Allergic rhinitis
Preexisting Conditions: Asthma; Allergic Rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)CONNAUGHT LABORATORIESU2397CA4UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02983UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0041X1UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1890U1UNLL
Administered by: Public     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 103.7

VAERS ID:317222 (history)  Vaccinated:2008-06-16
Age:23.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 7
Location:Virginia  Entered:2008-06-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1470F IMLA
Administered by: Military     Purchased by: Military
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Lymphadenopathy, Malaise, Mumps antibody test negative, Nasal congestion, Pharyngolaryngeal pain, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: MMR combination vaccination administered to childcare worker on 6/16/08 after request for mumps booster for negative mumps titer. Recipient reports the following day upon awakening she felt extremely "tired" and "throat started feeling tight" No breathing problems but glands in neck felt swollen and had a sore throat. Five days after vsaccination developed nasal congestion and some shortness of breath. Recipient is asthmatic but did not seek medical attention,and did not have her Albuterol inhaler,"lost it". Now 7 days later chest tightness is relieved but continues to have general malaise.

VAERS ID:317247 (history)  Vaccinated:2008-06-16
Age:16.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-06-24, Days after onset: 7
Location:Unknown  Entered:2008-06-24
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: Allergic to Sulfa, Codiene, and Omnicef
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1061U0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Oedema mouth, Rash pruritic, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)
Write-up: Within 24 hours of vaccine administration, patient developed an itchy rash, tongue and soft palate swelling. This reaction resulted in two additional doctor visits requiring and injection of steroids, and a prescription of a steroid dose pack.

VAERS ID:317372 (history)  Vaccinated:2008-06-16
Age:33.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2008-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0747U SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0783U SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Received phone call from doctor''s office. Client saw her PCP 6/18/08 due to increased pain and swelling to right arm after receiving vaccines at our health department. Per doctor, client''s injection site was swollen size of tennis ball with a dime size hard, red center. Client instructed to apply hydrocortisone cream as needed for itching. No other treatment required.

VAERS ID:317721 (history)  Vaccinated:2008-06-16
Age:11.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2008-06-18, Days after onset: 2
Location:Texas  Entered:2008-06-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2543AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2863AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pallor, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Fever, dizziness, headache, nausea, weakness, paleness.

VAERS ID:317729 (history)  Vaccinated:2008-06-16
Age:4.0  Onset:2008-06-18, Days after vaccination: 2
Gender:Male  Submitted:2008-06-18, Days after onset: 0
Location:Vermont  Entered:2008-06-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Eczema
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B0606AB4IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0390X1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Induration, Pallor, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Indurated wheal - 3 cm diameter around injection site and surrounding pale, pink swelling approximately 10 cm diameter.

VAERS ID:317921 (history)  Vaccinated:2008-06-16
Age:0.3  Onset:2008-06-19, Days after vaccination: 3
Gender:Male  Submitted:2008-06-30, Days after onset: 11
Location:New York  Entered:2008-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: X-ray; Ultrasound confirmation and fluroscopic enema procedure. 7/14/08-records received-X-rays: transverse colon consistent with intussusception and stool filled colon. Successful reduction of intussusception with barium enema. 7/25/08-records received- Stool occult blood negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2934AA UNLA
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.UF440AA SCLA
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURA0996 UNLA
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0210 PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal tenderness, Barium enema, Crying, Diet refusal, Discomfort, Intussusception, Lethargy, Occult blood negative, Oral intake reduced, Pain, Screaming, Ultrasound scan abnormal, Vomiting, X-ray, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Received Rotavirus vaccine on Monday morning (am) (June 16th 2008) by Thursday morning my son had not had regular bowel movements, was discomfort during sleeping hours nights prior, Thursday morning my son began to show signs of being lethargic, refusal to eat and what ever he did eat he began to vomit and scream in pain. (reportingly a neighbor called the local police to report a child screaming excessively). My son was taken to our pediatrician for examination Thursday (June 19th, 2008) morning at that point the pediatrician recommended my son be taken to a local hospital for an X-Ray & Ultrasound for what appeared to be "Intussusceptions"; Local Hospital confirmed via. x-ray/ultrasound scans "Intussusceptions" but the facilities were unequipped for this type of pediatric condition and recommended my son be taken to "Hospital" immediately where it was confirmed via. scan the Intussusceptions was positive. A procedure was performed via. an "Enema" technique to reduce the intestine. The procedure worked, my son was hospitalized for observation and released on June 21st, 2008. In less than 24 hrs my son was rushed back to "Medical Center" on June 22nd, 2008 for the same condition reoccurring. All the previous signs began in the early morning of the 22nd of June. A scan was performed confirming the Intussusceptions had occurred for the second time in less than a few days apart from the 1st occurrence. The same "Enema" procedure was performed and my son was hospitalized again from June 22nd - to - June 25th. 7/14/08-records received for DOS 6/19/08-DX:Intussusception. Presented with irritability and intermittent inconsolability. Tenderness right side of abdomen. Day prior non-bloody non-bilious emesis and 2 non-bloody stools.. 7/25/08-records received for DOS 6/22-6/25/08-DX:Intussusception with successful reduction with air enema. C/O abdominal pain decreased oral intake. Seen prior to this admission for intussusception. No fever, diarrhea, vomiting. Abdomen nondistended, non tender.

VAERS ID:318039 (history)  Vaccinated:2008-06-16
Age:4.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:North Carolina  Entered:2008-07-01
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: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSU2396BA4UNRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04903UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1669U1UNRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0175X1UNLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site induration, Injection site mass, 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: Day two after injection, large red bump developed. Approximate size of a half dollar. Hot, swollen, hard, and tender to touch. No fever; vitals good. Began course of Motrin and ice packs (20 minutes on/20 minutes off). Ama took 2 weeks to clear up.

VAERS ID:318060 (history)  Vaccinated:2008-06-16
Age:18.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-07-01, Days after onset: 14
Location:Georgia  Entered:2008-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR42416AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2730AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1577U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Local reaction(reddness) at site of varicella injectio. Appeared the next morning and was still noticable 3 days later when pt returned to clinic for TB Skin test reading. Recommended warm compresses and tylenol.

VAERS ID:318332 (history)  Vaccinated:2008-06-16
Age:1.5  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-26, Days after onset: 9
Location:Washington  Entered:2008-07-07, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2950AA3IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB234AA1IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1853U0SCRL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Raised red itchy area on patients injection site rt upper thigh.

VAERS ID:318360 (history)  Vaccinated:2008-06-16
Age:20.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-16, Days after onset: 0
Location:Wisconsin  Entered:2008-07-07, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB224CA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Injection site erythema, Injection site warmth, Local reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Gave patient 2nd Hep A shot at 2:00pm (6/16/08). Patient complained of numbness in left arm and tingling in left fingers. Observations of injection site showed localized reaction with hot, red areas. Dr interviewed patient and released patient with instructions to call if symptoms worsened. Vital signs were taken and were normal.

VAERS ID:318428 (history)  Vaccinated:2008-06-16
Age:17.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-06-26, Days after onset: 10
Location:Maryland  Entered:2008-07-07, Days after submission: 11
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: Illnesses at the time of vaccination and pre-existing medical history was not provided by the reporter.
Diagnostic Lab Data: Complete blood count revealed decreased white blood cells at 3.7.
CDC Split Type: 200802056
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2351A UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Full blood count, Headache, Pyrexia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad)
Write-up: Fever, headache.

VAERS ID:318524 (history)  Vaccinated:2008-06-16
Age:16.0  Onset:2008-06-23, Days after vaccination: 7
Gender:Female  Submitted:2008-06-26, Days after onset: 3
Location:Florida  Entered:2008-07-08, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CXR, -; pulse ox, 99% RA; R humerus X-ray, -; R shoulder X-ray, -
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0070X1UNRA
Administered by: Private     Purchased by: Private
Symptoms: Chest X-ray normal, Chest pain, Oxygen saturation normal, Pain in extremity, X-ray limb normal
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)
Write-up: Seen in office. 1 wk later 2nd HPV c/o, pain R arm and R side chest pain. Pain with deep insp & cough.

VAERS ID:318732 (history)  Vaccinated:2008-06-16
Age:5.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-07-02, Days after onset: 16
Location:Washington  Entered:2008-07-11, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA3IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB254BA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01703IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0238X1SCRA
Administered by: Public     Purchased by: Unknown
Symptoms: 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: L arm-upper painful, swollen and red - area of 7.5 cm x 7.5 cm measured and seen by provider 6/18/08. Advised ice packs/NSAIDS prn and return to clinic if worsens or not improved.

VAERS ID:318765 (history)  Vaccinated:2008-06-16
Age:8.0  Onset:0000-00-00
Gender:Male  Submitted:2008-07-11
Location:Washington  Entered:2008-07-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~NULL~~In Patient
Other Medications:
Current Illness: NONE.
Preexisting Conditions: NONE.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2935AA2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: NONE.

VAERS ID:318910 (history)  Vaccinated:2008-06-16
Age:4.0  Onset:2008-07-03, Days after vaccination: 17
Gender:Female  Submitted:2004-07-10, Days after onset: 1454
Location:Texas  Entered:2008-07-14, Days after submission: 1465
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: CBC - (complete blood count)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0346X1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Full blood count, Parotid gland enlargement, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Parotid swelling - left cheek anterior to pinna. Displaced pinna up & out. Fever 101.

VAERS ID:319034 (history)  Vaccinated:2008-06-16
Age:4.0  Onset:0000-00-00
Gender:Female  Submitted:2008-06-18
Location:California  Entered:2008-07-15, Days after submission: 27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B060AB4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA08053SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1310U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1467U1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swelling, red area on left upper arm, hot to touch - No pain, No fever - Redness and swelling 11.5cm x 11.5cm

VAERS ID:319528 (history)  Vaccinated:2008-06-16
Age:10.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Male  Submitted:2008-06-18, Days after onset: 1
Location:Washington  Entered:2008-07-17, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin; Poly-Viflor; Nasacort; Senokot
Current Illness: None
Preexisting Conditions: Nasal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1893U1SCUN
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient has golf ball sized soft swelling with erythema at site of Varicella injection.

VAERS ID:320041 (history)  Vaccinated:2008-06-16
Age:5.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2008-06-19, Days after onset: 3
Location:Ohio  Entered:2008-07-22, Days after submission: 33
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: Constipation
Diagnostic Lab Data: Cellulitis vs allergic response
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2953BA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04923IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0039X1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1891U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Gait disturbance, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Increase in swelling leg- 1 1/4" larger left leg; Extensive redness - most of thigh; Limping occurred within 6 hours after injection

VAERS ID:320439 (history)  Vaccinated:2008-06-16
Age:13.0  Onset:2008-06-30, Days after vaccination: 14
Gender:Female  Submitted:2008-07-24, Days after onset: 24
Location:Pennsylvania  Entered:2008-07-25, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA03571
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Borrelia burgdorferi serology, Brain oedema, Dysarthria, Encephalitis, Headache, Herpes simplex serology, Lethargy, Mumps antibody test, Mycoplasma serology, Nuclear magnetic resonance imaging brain, Rubella antibody test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a registered nurse concerning a 13 year old female patient who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 660387/1967U) IM. There was no concomitant medication. On 30-JUN-2008 the patient experienced headache, lethargy, slurred speech and brain swelling. The patient was diagnosed with acute cerebellitis (cerebellar encephalitis). The patient took an overseas trip when these symptoms occurred and was hospitalized. The patient will be on IV Acyclovir for 3 weeks and has been on Dexamethasone but is being weaned off. The patient was on acetazolamide and that was subsequently discontinued. The patient will be on ceftriaxone for 2 weeks and doxycycline for 28 days. The patient was considered to be recovering. The plan by the hospital was to discharge the patient on 17-JUN-2008 and have her on a flight back home by 19-JUL-2008 and to be directly admitted to a pediatric hospital. Lab Diagnostics studies performed were 3 MRIs to monitor brain swelling, serology for Lyme''s disease IGG, mycoplasma IGM, mumps IGG and IGM, rubella IGG and IGM, varicella IGG and IGM, parvovirus IGG and IGM, HSV IGG and IGM, however not results were reported. Acute cerebellitis was considered to be immediately life-threatening. The patient sought medical attention, called the physician''s office. Follow-up information was received which reported that on 19-JUL-2008, the patient was admitted to the hospital. The patient was subsequently discharged from the hospital on 22-JUL-2008. It was reported that the patient was sent home with a PICC line for antibiotics for the next several weeks. The registered nurse stated that the patient was stable. The registered nurse reported that the physician felt that the patient''s Encephalitis was related to GARDASIL (Lot # 660387/1967U) vaccination. Additional information has been requested.

VAERS ID:322403 (history)  Vaccinated:2008-06-16
Age:23.0  Onset:2008-06-23, Days after vaccination: 7
Gender:Female  Submitted:2008-08-15, Days after onset: 53
Location:Kansas  Entered:2008-08-18, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADDERALL TABLETS; hormonal contraceptives
Current Illness: Attention deficit disorder
Preexisting Conditions: PMH: ADHD, Acne. Oral contraceptives. NKDA.
Diagnostic Lab Data: magnetic resonance, 06/??/08 - revealed CVA. Labs and Diagnostics: Alk Phos 133, AST 57. ALT 75. Sed rate 46. ANA (-) on 7/1/08 reported as (+) by rheum. Lyme IgG, IgM (-). Ehrlichia (-). Hepatitis panel (-). Labs and Diagnostics: AP
CDC Split Type: WAES0808USA01846
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Activities of daily living impaired, Alanine aminotransferase increased, Amnesia, Angiogram, Anticoagulant therapy, Antinuclear antibody positive, Antiphospholipid antibodies positive, Antiphospholipid syndrome, Antithrombin III, Arthralgia, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased, Blood fibrinogen increased, Borrelia burgdorferi serology negative, Cerebrovascular accident, Contusion, DNA antibody positive, Ehrlichia serology, Epstein-Barr virus antibody positive, Fatigue, Gait disturbance, Hepatitis B test negative, Hepatitis C test negative, Hyperreflexia, Ischaemic stroke, Joint swelling, Memory impairment, Myalgia, Night sweats, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nystagmus, Oedema peripheral, Oral contraception, Pain in extremity, Personality change, Pituitary tumour benign, Pyrexia, Red blood cell sedimentation rate increased, Speech disorder, Strabismus, Systemic lupus erythematosus, Thrombin time, Tonsillar hypertrophy, Transaminases increased, Ultrasound Doppler abnormal, Vision blurred, Visual disturbance, Visual field defect, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Angioedema (broad), 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 (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), 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), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 13 year old female with attention deficit disorder and no history of drug reactions or allergies who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (LOT#: 659962/1740U) and on 16-JUN-2008 was vaccinated with the second dose of GARDASIL (LOT#: 660389/1968U). Concomitant therapy included oral birth control and ADDERALL. One week after the second vaccine (on approximately 23-JUN-2008) the patient developed joint pain that continued to get worse. She was not able to bath herself. She developed short term memory loss and blurred vision. The patient saw her primary physician and the physician ordered a magnetic resonance imaging (MRI) that revealed a cerebral vascular accident (CVA). The patient was hospitalized. Further diagnosis revealed the patient had lupus and antiphospholipid syndrome. As of 11-AUG-2008 the patient was recovering. Additional information has been requested. 08/25/2008 MR received from PCP from 6/13/08 to 8/7/08. Pt presented 6/13/08 for well check with normal exam and no c/o. Some recent weight loss due to increased activity while training for an athletic event. Seen again 7/1/08 with c/o 3 wk hx of arthalgias, myalgias, weight loss and fatigue. Pt reports poor memory. Subjective fever past weekend as well as swelling of R ankle. Recent ?tick bite. Seen again 7/10/08 with persistant arthralgias, fatigue, muscle aches and loss of vigor. Currently with night sweats and increased transaminases. Rheumatology consult 8/7/08 with DX: SLE characterized by a midbrain stroke and positive labs. On anticoagulants for the CVA. MD reports sx started after 2nd Gardasil dose. PE (+) for several areas of bruising, otherwise WNL. 9/10/2008 MR received for DOS 7/29-8/01/2008 with D/C DX: Antiphospholipid syndrome. Positive ANA, questionable reactive vs true Systemic Lupus Erythematosus. Ischemic stroke. Pituitary adenoma as an incidental finding on MRI. Pt presented with 5 week hx of myalgias, one week hx of vision changes as

VAERS ID:325575 (history)  Vaccinated:2008-06-16
Age:20.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 59
Location:Ohio  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA05154
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 20 year old female who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) in the upper left deltoid. After vaccination, she was asked to sit for 15 minutes before leaving the office, 10 minutes later, the patient experienced red blotches on her right and left thighs. She did not feel pain. The symptoms cleared and she called the office to set up an appointment for her second dose. Additional information has been requested.

VAERS ID:325703 (history)  Vaccinated:2008-06-16
Age:  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-08-14, Days after onset: 58
Location:Unknown  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA05513
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Injection site reaction, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a physician''s assistant concerning a female patient who on 16-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). On 17-JUN-2008 the patient experienced shortness of breath and tingling in the arm were the vaccination had been given. The patient was then sent to the emergency room to be evaluated. Additional information has been requested.

VAERS ID:326081 (history)  Vaccinated:2008-06-16
Age:18.0  Onset:2008-06-20, Days after vaccination: 4
Gender:Female  Submitted:2008-08-14, Days after onset: 55
Location:Unknown  Entered:2008-08-18, 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: doxycycline - mg
Current Illness: Chlamydial infection
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA02210
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with chlamydial infection who on approximately 16-JUN-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast). Concomitant therapy included doxycycline. The patient had experienced vomiting and nausea for the last three weeks (from approximately 20-JUN-2008). The patient''s vomiting and nausea persisted. No further information is provided. Additional information has been requested.

VAERS ID:326489 (history)  Vaccinated:2008-06-16
Age:16.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-08-14, Days after onset: 59
Location:Unknown  Entered:2008-08-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00038
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Menstruation delayed, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad)
Write-up: Information has been received from a consumer concerning her 16 year old daughter who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast). Subsequently the patient experienced nausea and fever. As of 31-JUL-2008 the patient had not gotten her period yet. The patient''s nausea and fever persisted. The patient didn''t seek medical attention. Additional information has been requested.

VAERS ID:326494 (history)  Vaccinated:2008-06-16
Age:  Onset:2008-07-28, Days after vaccination: 42
Gender:Female  Submitted:2008-08-14, Days after onset: 17
Location:Unknown  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00061
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Visual disturbance
SMQs:, Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Information has been received from a nurse practitioner (NP) concerning a female who on 16-JUN-2008 was vaccinated with a dose of GARDASIL vaccine (yeast). "This week", on approximately 28-JUL-2008 the patient went to emergency room with visual disturbances. The patient was not hospitalized. At the time of the report, it was unknown if the patient had recovered from visual disturbances. Additional information has been requested.

VAERS ID:325263 (history)  Vaccinated:2008-06-16
Age:0.2  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-09-12, Days after onset: 88
Location:Oregon  Entered:2008-09-16, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B153AA0IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF269AA0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC861380IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0209X0PO 
Administered by: Private     Purchased by: Private
Symptoms: Joint stiffness, Staring
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Mom says that after shots pt had stiff joints (wouldn''t move arms and legs well) and had a vacant stare for 2 weeks. Also she says that she and brother got gastro 2 weeks after rotavirus. At time of shot now 21 weeks

VAERS ID:325615 (history)  Vaccinated:2008-06-16
Age:91.0  Onset:2008-07-15, Days after vaccination: 29
Gender:Female  Submitted:2008-09-05, Days after onset: 52
Location:California  Entered:2008-09-19, 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: Isosorb 30mg; Forosemido 20mg; Atenolol 50mg; Fosinopril 10mg; Ecotrin
Current Illness: None
Preexisting Conditions: Codeine
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Dyspnoea, Herpes zoster, Pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: Got Shingles, occurred w/o rash. Shingles pain. Shortness of breath.

VAERS ID:327731 (history)  Vaccinated:2008-06-16
Age:65.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-09-24, Days after onset: 100
Location:Michigan  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension
Preexisting Conditions: Breast cancer
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA03072
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0300X0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles, Malaise, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 65 year old White female with a history of left breast cancer and hypertension and with no known drug allergy who on 16-JUN-2008 was vaccinate with a first dose of ZOSTAVAX (Oka/Merck) (lot# 659408/0300X) 0.65ml intradermally in her right forearm. The area of the forearm had a circle of fluid at the injection site and the 50 cent size rash caused pain. The patient felt achy and not well for the first week post vaccination. The arm finally was back to normal on approximately 21-JUL-2008 (also reported as approximately 21-JUL-2008). The patient will be getting re-immunized on 04-AUG-2008. The patient sought medical attention in office. Additional information is not expected.

VAERS ID:327747 (history)  Vaccinated:2008-06-16
Age:66.0  Onset:2008-06-17, Days after vaccination: 1
Gender:Female  Submitted:2008-09-24, Days after onset: 99
Location:California  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness:
Preexisting Conditions: Hypersensitivity
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA03824
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Stomach discomfort
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Information has been received from a consumer, who was allergic to dairy, with no previous medical history reported, who on 16-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65mL. Concomitant therapy included montelukast sodium (MSD). On 17-JUN-2008, the patient experienced dizziness and an upset stomach. No lot number was provided, at the time of the report, the patient had not recovered. The patient did not seek medical attention. There was no product quality complaint. Additional information has been requested.

VAERS ID:327748 (history)  Vaccinated:2008-06-16
Age:39.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-09-24, Days after onset: 100
Location:Texas  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA03837
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0298X SCUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a registered pharmacist, concerning a patient, with no previous medical history reported who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 659406/0298X) subcutaneously on 16-Jun-2008. On 16-JUN-2008, in the evening her arm became red and swollen to the "size of a softball" at the injection site. The pharmacist suggested that the patient see her physician. Sought medical attention: spoke with pharmacist. At the time at the report, the patient had not recovered. There was no product quality complaint. Additional information has been requested.

VAERS ID:327961 (history)  Vaccinated:2008-06-16
Age:80.0  Onset:2008-06-30, Days after vaccination: 14
Gender:Male  Submitted:2008-09-24, Days after onset: 86
Location:Connecticut  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Lipids abnormal; Benign prostatic hyperplasia
Preexisting Conditions: Arthritis; Herpes zoster
Diagnostic Lab Data: None
CDC Split Type: WAES0807USA03189
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCLA
Administered by: Private     Purchased by: Military
Symptoms: Arthralgia, Injection site nodule, Neuritis, Neuropathy peripheral, Pain in extremity
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a registered nurse concerning a physician with no pertinent medical history and no know drug allergies who on approximately 25-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml SC. In June 2008, the patient developed neuropathy within a day or 2 after vaccination. The patient''s neuropathy persisted. The patient sought medical attention and the patient was the prescriber. Follow up information was received from the physician (concerning himself) with arthritis, high blood pressure, lipid abnormal and Benign prostatic hyperplasia and a history of mild herpes zoster at age 35 who developed left arm neuritis after self administering the vaccine 0.65ml in left deltoid about 5 weeks ago on approximately 16-JUN-2008. There was no illness at the time of vaccination. The patient developed pain in the left elbow and a granulomatous lesion at the injection site in the left deltoid about 3 weeks ago on approximately 2 weeks after self injection the patient experienced mild sensory discomfort. The pain was described as extending from the elbow to the wrist on the volar side and was most bothersome at the antecubital fossa not related to use. There was no motor change and the pain was not constant, there was more time without discomfort than with. The pain severity was described as a one 1 of 10 and the pain was improving without treatment. There were not relevant diagnostic tests and laboratory data. The patient felt that the symptoms were "pre zoster" type changes recognized before appearance of zoster. No other symptoms or treatment reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008. Additional information is not expected.

VAERS ID:330675 (history)  Vaccinated:2008-06-16
Age:14.0  Onset:2008-06-19, Days after vaccination: 3
Gender:Female  Submitted:2008-10-14, Days after onset: 117
Location:Georgia  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown PMH: allergy: cephalasporin
Diagnostic Lab Data: Diagnostic laboratory 06/21/08 - low white count ; Diagnostic laboratory 06/20/08 - See narrative ; Diagnostic laboratory 06/23/08 - Erichiaa, West Nile and Rocky Mountain spotted fever negative ; Complete blood cell 06/20/2008 - no growth; Esptein-Barr virus 06/23/08 5.31; Complete blood cell 06/23/2008 - low white count, negative ANA and normal RF factor; Cytomegalovirus 06/23/2008 - High
CDC Split Type: WAES0809USA04952
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Bronchial hyperreactivity, C-reactive protein increased, Constipation, Croup infectious, Cytomegalovirus infection, Cytomegalovirus test positive, Epstein-Barr virus antibody positive, Fatigue, Full blood count normal, Hot flush, Idiopathic thrombocytopenic purpura, Laboratory test normal, Leukopenia, Lymphadenopathy, Malaise, Monocyte percentage increased, Myalgia, Nausea, Neutrophil percentage decreased, Papule, Pelvic pain, Petechiae, Platelet count decreased, Pyrexia, Rash, Rheumatoid factor negative, Splenomegaly, Urticaria, Viral infection, White blood cell count decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 14 year old female who on 14-APR-2008 was vaccinated with the first dose of GARDASIL. On 16-JUN-2008, the patient was vaccinated with a second dose of GARDASIL. Patient then went to the emergency room on 19JUN-2008. It was unspecified if the patient was hospitalized that day. The next day, on 20-JUN-2008, the patient came in the physician''s office with petechial rash, hot flashes and muscle pain. The office did a complete blood count, high mono, and esosithil count, and a high alcoholine phosphate count. The next visit was on 21-JUN-2008; the patient had no bleeding but had a low white count and petechial rash on legs. On 23-JUN-2008, the patient''s spleen tip was enlarged. The patient physician gave the patient a possible diagnosis of Ehrlichiosis. The patient was ordered a complete blood count(CBC), serum antinuclear antibodies test (ANA) and anti- DNA testing. The patient was tested for cytomegalovirus, rheumatoid factor, and Rocky Mountain spotted fever. A complete blood count showed low white count, negative serum antinuclear antibodies test (ANA) and normal rheumatoid factor (RF). Cytomegalovirus test (CMV) came back low white count; negative serum antinuclear antibodies test (ANA), and normal rheumatoid factor. Cytomegalovirus test (CMV) came back high, erichias, West Nile and Rocky Mountain spotted fever came back negative. Epstein-Barr came back high at 5.31. On 09-JUL-2008, the patient''s rash was still present. On 14-JUL-2008, the patient had hives on her arms, constipation, and positive cytomegalovirus test. At this point the patient was referred to the infectious disease specialist. On 23-JUL-2008, the infectious disease physician ordered the patient not to receive the third dose of GARDASIL. The patient''s history of persistent malaise, fatigue, and low platelet count had resolved by 09-JUL-2008. Additional information has been requested. 11/4/08 Reviewed PCP medical records of 6/16-7/29/2008. FINAL DX: none provided Records reveal patient received 2nd dose of vaccine 6/16/08. RTC 6/20 after experienced petechial rash, hot flashes, myalgias. Exam revealed enlarged lymph nodes. Dx w/possible viral syndrome. Labs ordered. Seen in Er 6/19/08 for rash & dx w/''low count''. Dx w/viral syndrome w/improving plt & wbc counts. RTC 6/23 w/hives all over, myalgias, fever. Dx w/possible erlichiocia & additional labs ordered. RTC 7/14 w/recurrent hives, malaise, constipation. Dx w/CMV & possible HPV reaction. Referred to ID on 7/23/08 for persistent fatigue, malaise, leukopenia. No dx provided & advised not to receive final vaccine. RTC 10/13 w/reactive airways disease, croupy cough. Tx w/nebs & antibiotics.

VAERS ID:334182 (history)  Vaccinated:2008-06-16
Age:19.0  Onset:2008-09-23, Days after vaccination: 99
Gender:Female  Submitted:2008-11-14, Days after onset: 52
Location:Kansas  Entered:2008-12-08, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug hypersensitivity; Sinusitis; Asthma
Preexisting Conditions: None
Diagnostic Lab Data: None; blood pressure, 124/6; total heartbeat count, 84; temperature measurement, 97.8
CDC Split Type: WAES0810USA02882
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0067X0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site atrophy, Injection site pain, Injection site swelling, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 19 year old female, who in February 2008, was vaccinated with the first dose of (dose and duration not reported). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the patient experienced an indentation at the injection site, it appeared that there was soft tissue or subcutaneous fat missing in an area of a centimeter and a half, and there was a little bit of swelling below that area. The patient indicated that the indentation was getting bigger and the indentation was painful at times. At the time of the report, the patient was not recovered. The patient sought medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a Licensed Practical Nurse concerning a 20 year old female with allergies and sinusitis who on 16-JUN-2008 was vaccinated with the first dose of GARDASIL (lot # 660393/0067X) IM into the left arm. Concomitant therapy included DESOGEN. 3 weeks prior to 14-OCT-2008, on 23-SEP-2008, the patient developed a dimple or indent of the skin on the left arm. There is slight pain with pressure at the injection site. The patient was seen in the office on 14-OCT-2008. The dimple had increased in size. At the time of the report the patient had not recovered. Follow-up information was received from the Licensed Practical Nurse which reported that the patient has a nickel allergy and mild asthma. It was reported that in 2002 the patient had a tetanus booster (manufacturer unknown). On 21-NOV-2008, the patient went to the doctor''s office complaining of dimpling of the left deltoid. The patient had no illness at the time of vaccination. A few weeks after vaccination, the patient had noted dimpling and pain at the injection site, she had no redness or sloughing in the skin, the patient had no fever and she believed the lesion was increasing in size and wanted to have this evaluated by an specialist. Patient weight: 134, blood pressure: 124/68 and temperature 97.8 F. Medical examination showed a stable appearing dimpling size 2.5 cm horizontally and 1 cm vertically. It appeared that there was lots of subcutaneous tissue. There was no evidence of secondary infection or sensory deficits at the site. The physician reported that dimpling and pain of left deltoid likely secondary to GARDASIL. No additional information is expected.

VAERS ID:336472 (history)  Vaccinated:2008-06-16
Age:67.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-12-27, Days after onset: 194
Location:Colorado  Entered:2009-01-05, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: HTN. anxiety. Depression. Allergies to PCN, sulfa, emycin, accupril
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0300X0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Joint range of motion decreased, Myalgia, Neck pain, Neurological examination normal, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pt got ZOSTAVAX shot 6-16-08. Has had restricted range of motion in that arm. If she immobilizes arm couple days the pain dissipates. Exercise makes it worse. 1/20/09 MR received from PCP. Undated TC from pt with c/o of arm pain following Zostavax given 6/18/09. Seen 10/9/08 with c/o shooting arm pain and neck pain. Neuro exam WNL. Assessment: HTN-not in great control. Myalgias. Chronic anxiety and depression-currently stable.

VAERS ID:347885 (history)  Vaccinated:2008-06-16
Age:11.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 333
Location:Ohio  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA08942
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2619AA UNUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC2937AA UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1857U1SCUN
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a 11 year old male patient with no known allergies or pertinent medical history who on 16-Jun-2008 was vaccinated SQ with 0.5ml of VARIVAX (Merck). Concomitant vaccination included MENACTRA and ADACEL. Subsequently, on 16-June-2008, within several hours of the vaccination the patient developed an injection site reaction where the vaccine was given that included warmth, swelling and redness. The patient also had a headache. Medical attention was sought in the office. There were no lab studies performed. It was reported that all symptoms resolved within 4 days. The patient was recovered on 20-Jun-2008. There was no product quality complaint involved. Follow-up information has been received from the physician''s office concerning this 11 year old male child with seasonal allergies who on 16-Jun-2008 at 12:30 was vaccinated in the left thigh with a second dose of VARIVAX (Merck) (lot# 660054/1857U). Concomitant vaccinations on the same day at 12:30 included MENACTRA (lot# U2519AA) in the right and ADACEL (lot# C2937AA) in the right thigh. There was no illness at the time of vaccination and no concomitant medications. Subsequently, on 16-Jun-2008 the patient developed swelling, erythema, and induration of the injection site. The patient also had a headache, myalgia, and low grade fever. There were no lab studies performed. The patient was treated symptomatically with Motrin, heat, and topical steroid cream. It was noted that the patient improved in 72 hours. At the time of the report, the patient recovered on 20-Jun-2008. Additional information is not expected.

VAERS ID:348047 (history)  Vaccinated:2008-06-16
Age:11.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 333
Location:Pennsylvania  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA03794
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a company representative concerning her 11 year old son with no pertinent medical history, drug reactions or allergies who on 16-JUN-2008 was vaccinated in the arm with a second dose of VARIVAX (Oka/Merck). On the same day the patient also received a dose of secondary suspect VAQTA. Other concomitant therapy included Meningococcal vaccine (unspecified) and Tetanus toxoid booster. On an unspecified date the patient developed large red patch on his arm at the injection site. It was reported that no reaction was reported with the first dose of VARIVAX (Oka/Merck). The patient was treated with KEFLEX. At the time of the report, it was unknown if the patient had recovered from the event. The patient went to physician. Additional information has been requested.

VAERS ID:348050 (history)  Vaccinated:2008-06-16
Age:11.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Male  Submitted:2009-05-15, Days after onset: 333
Location:South Carolina  Entered:2009-05-21, 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: ADDERALL TABLETS
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA03803
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNLL
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1911U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: 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: Information has been received from a healthcare worker concerning a 12 year old male with no known allergies who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck). the patient received the first dose at another location. on 16-JUN-2008 at 9:00 AM the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U) 0.5ml via subcutaneous route in the left leg. On the same day, the patient also received DTAP and MENACTRA. Concomitant therapy included ADDERALL TABLETS. The vaccines were all given in the left leg at the patient''s and mother''s request. All injections were spaced from one another. On 18-JUN-2008 the patient developed a very strong local reaction with swelling, redness and pain at the injection site. The patient was treated with MOTRIN (anti-inflammation) and resolved. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:348054 (history)  Vaccinated:2008-06-16
Age:9.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2009-05-15, Days after onset: 333
Location:South Carolina  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA03808
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1911U1SCRL
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial and follow-up information has been received from a healthcare worker concerning a 9 year old female with no known allergies who on 17-OCT-2000 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 16-JUN-2008 at 11:00 AM the patient was vaccinated subcutaneously into the right leg with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U). There was no concomitant medication. On an unspecified date the patient developed local reaction with erythematic, swelling and pain at the injection site. And the patient complained of fever. The local reaction progressed over 48 hours to induration. The patient was treated with antibiotics for a cellulitis. At the time of report, the patient was not recovered. This is one of several reports received from the same source. Additional information is not expected.

VAERS ID:353449 (history)  Vaccinated:2008-06-16
Age:64.0  Onset:2008-06-18, Days after vaccination: 2
Gender:Female  Submitted:2009-07-30, Days after onset: 407
Location:California  Entered:2009-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806USA07568
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1960U UNUN
Administered by: Other     Purchased by: Other
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: Information has been received from a physician concerning a 64 year old female who on 16-JUN-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 659487/1960U). On 18-JUN-2008 the patient experienced an injection site reaction after vaccination. She experienced redness, swelling and soreness at the site of injection. It was also noted that the swollen area was warm to touch. The patient sought medical attention at the office. At the time of the report, the outcomes of the injection site redness, swelling and swollen area was warm to touch were unknown. Additional information has been requested.

VAERS ID:353517 (history)  Vaccinated:2008-06-16
Age:18.0  Onset:2008-10-01, Days after vaccination: 107
Gender:Female  Submitted:2009-08-07, Days after onset: 310
Location:Illinois  Entered:2009-08-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None. 8/12/09 PCP records received DOS 6/16/08. Torn Achilles. DOS 6/16/08. Assessment: Routine Physical Exam. Contraception. Skin freckling. 8/24//09 Neurological consult records received DOS 5/14/09. Left foot benign tumor removal.
Diagnostic Lab Data: electroencephalography, 05/05/09, abnormal; magnetic resonance, 05/12/09, right frontal matter hyperintensity. 8/24//09 Neurological consult records received DOS 5/14/09. LABS and Diagnostics MRI Brain - abnormal, right frontal white matt
CDC Split Type: WAES0908USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1967U0UNUN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2566AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin, Confusional state, Convulsion, Drug level increased, Dyskinesia, Electroencephalogram abnormal, Loss of consciousness, Monocyte count increased, Monocyte percentage increased, Muscle twitching, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Partial seizures, Sensory loss, Tremor, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a consumer concerning her 18 year old daughter with no drug reactions/allergies who was vaccinated with the first dose of GARDASIL in "June 2008". The patient was vaccinated with meningococcal vaccine (manufacturer unknown) on the same day (Lot U2566AA). "Sometime in October 2008", the patient started having seizures. The patient was jerking sometimes and showing seizure episodes. The patient had some seizure attacks in "April 2009" and "June 2009". The patient was brought to the emergency room in "June 2009" and was not admitted in the hospital. The lab diagnostics studies performed: MRI, EEG, CAT SCAN. At the time of report the patient''s status was not recovered. Follow-up information was received from a registered nurse indicated the patient received GARDASIL (Lot #660387/1967U) on 16-JUN-2008. Concomitant therapy included meningococcal vaccine (manufacturer unknown) (Lot #U2566AA). Follow-up information was received from a nurse assistant indicated that the patient had an EEG which was reported as "abnormal EEG" on 05-MAY-2009. On 12-MAY-2009 the patient had a MRI which revealed "Right frontal matter hyperintensity". On 14-MAY-2009 the patient was seen by a doctor and was placed on therapy with KEPPRA 750mg BID. The patient was instructed to not drive. The patient was to repeat the EEG and MRI in 6 months. The patient was to move to another state (date unknown) and instructed to find a treating neurologist when she moved. On 18-JUN-2009 the patient went to the emergency room due to "convulsions". The patient was not admitted to the hospital. Convulsion was considered to be an other medical event. Additional information has been requested. 8/12/09 PCP records received. In for PE with normal exam. Vaccines administered. 8/24//09 Neurological consult records received DOS 5/14/09. Assessment: Focal Seizures with possible secondary generalization. Patient presents for assessment of abnormal EEG. First episode of syncope 2/09 or 3/09. Twitching of body. Blurry vision. 2 w

VAERS ID:383689 (history)  Vaccinated:2008-06-16
Age:17.0  Onset:2008-11-01, Days after vaccination: 138
Gender:Female  Submitted:2010-03-28, Days after onset: 512
Location:Illinois  Entered:2010-03-28
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None before Gardasil. After Gardasil, tried tranquilizer..didn''t help. Following hospitalization, on Lexapro and currently switching to Paxil (minor anxiety relief).
Current Illness: None.
Preexisting Conditions: None. PMH: Exercise-induced asthma.
Diagnostic Lab Data: Lab tests in hospital came back "normal," but so have numerous other girls who suffer the same condition.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0387U0UNRA
Administered by: Private     Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Chest discomfort, Dizziness, Eye pain, Fatigue, Laboratory test normal, Muscular weakness, Myalgia, Nausea, Palpitations, Panic attack, Paraesthesia, Suicidal ideation
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: heart pounds, chest tightness, dizzyness, nausea. I thought I was having panic attacks. experienced extreme fatigue and muscle weakness. Hospitalized 9/15/2009 because I was suicidal because I grew tired of living this way. I was put on an anti-depressant (Lexapro), which has helped a little with anxiety (which I never had until after Garadasil adverse side effects). It is now 3/28/10, and I experience tingling sensation in my legs almost constantly and sometimes in my lower arms. My chest is tight, and my muscles ache. I still have symptoms that feel like panic attacks, but the worst would be the fatigue. My eyes hurt, and pre-med major is difficult when so exhausted (let''s not forget the difficulty of working full-time as well, as I am an independent student). Since Gardasil, my life has become hell at a time when I should be in my prime.

VAERS ID:318071 (history)  Vaccinated:2008-06-16
Age:5.0  Onset:2008-06-16, Days after vaccination: 0
Gender:Female  Submitted:2008-07-01, Days after onset: 15
Location:Foreign  Entered:2008-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0526923A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B057BC IMLL
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SCLL
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Hypotonia
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: This case was reported by a regulatory authority (# 86620) and described the occurrence of decreased responsiveness in a 5-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. On 16 June 2008, the subject received unspecified dose of INFANRIX (intramuscular, unknown injection site), unspecified dose of MMR vaccine (subcutaneous, unknown injection site). On 16 June 2008, less than one day after vaccination with INFANRIX and MMR vaccine, the subject experienced hyporesponsiveness and hypotonia. This case was assessed as medically serious by GSK. On 16 June 2008, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and MMR vaccine.

VAERS ID:326528 (history)  Vaccinated:2008-06-16
Age:14.0  Onset:2008-06-24, Days after vaccination: 8
Gender:Female  Submitted:2008-09-29, Days after onset: 97
Location:Foreign  Entered:2008-09-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA04258
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0466U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonia, Muscle disorder, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a health professional concerning a 14 year old female with no reported relevant history who on 16-JUN-2008 was vaccinated intramuscularly into the upper arm with the first dose of GARDASIL (lot#: 0466U, batch #:NG34890). On 24-JUN-2008, the patient developed a sensation of paralysis and muscular tonus disorder in legs in particular in the thighs and less intensive in arms. The patient was hospitalized for 1 day (exact dates not reported). The patient recovered after 1 day. The reporting physician assessed the causal relation to the vaccine as probable. Other business partner numbers included: E2008-08704. No further information is available. File closed.

VAERS ID:327277 (history)  Vaccinated:2008-06-16
Age:  Onset:2008-06-20, Days after vaccination: 4
Gender:Female  Submitted:2008-10-08, Days after onset: 110
Location:Foreign  Entered:2008-10-07, 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: ANDROCUR, unk, unk; Estradiol, unk, unk
Current Illness: Major depression; Hirsutism
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory test, hepatic check up - normal; Sinus probe, normal; Abdominal ultrasound, normal; Pelvic ultrasound, normal; Epstein-Barr virus antibodies, negative; WBC count, normal; Serum TSH, normal; Red blood cell count, normal
CDC Split Type: WAES0809USA04872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Cytomegalovirus antibody negative, Epstein-Barr virus antibody negative, Liver function test normal, Musculoskeletal pain, Pain, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate normal, Ultrasound abdomen normal, Ultrasound pelvis normal, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a health authority (HA ref # DJ20080746) concerning an adult female with major depressant syndrome treated with ZOLOFT for several years and hirsutism treated with PROMAVES and ANDROCUR for at least 10 years. On 01-DEC-2007 the patient was vaccinated with the first dose of GARDASIL IM. In February 2008, the patient received the second dose of GARDASIL IM and on 16-JUN-2008 received the third dose of GARDASIL IM. Approximately since 20-JUN-2008, the patient was subfebrile at 37.8 C and 38 C, had asthenia and generalised pains especially at shoulder girdle punctually treated with EFFERALGAN. Clinical examination did not find any particularity. There was no evidence for focus infection. On biological standpoint, red and white blood cell count was normal, erythrocyte sedimentation rate was at 13 at first hour, hepatic check-up and thyrotropin were normal, cytomegalovirus and Epstein-Barr virus serologies were negative. Sinus scan and pelvic abdominal ultrasound did not find any particularity. At office visit date on 30-JUL-2008, it was observed that the patient was still febrile at 38 C and still presented pains. Symptoms did not regressed or worsened. The reporter considered the events to be other important medical events. Other business partner numbers included: E2008-08953. Additional information has been requested.

VAERS ID:327279 (history)  Vaccinated:2008-06-16
Age:  Onset:2008-06-20, Days after vaccination: 4
Gender:Female  Submitted:2008-10-06, Days after onset: 108
Location:Foreign  Entered:2008-10-07, 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: ANDROCUR, unk, unk; Estradiol, unk, unk
Current Illness: Depression; Hirsutism
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic laboratory test, hepatic check-up and thyroid stimulating hormone: normal; Diagnostic laboratory test, Epstein-Barr virus serologies: negative; Diagnostic procedure, sinus scan: did not find any particularity; Abdominal ultrasoun
CDC Split Type: WAES0809USA05046
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Cytomegalovirus test negative, Diagnostic procedure, Epstein-Barr virus test negative, Full blood count normal, Liver function test normal, Musculoskeletal pain, Pain, Pyrexia, Red blood cell sedimentation rate normal, Scan normal, Ultrasound abdomen normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from Health Authorities under reference number DJ20080746, concerning an adult female patient with depressive syndrome treated with ZOLOFT for several years and hirsutism treated with PROVAMCE and ANDROCUR for at least 10 years, who in December 2007, was vaccinated with the first dose of GARDASIL, in February 2008 was vaccinated with the second dose of GARDASIL and on 16-JUN-2008 was vaccinated with the third dose of GARDASIL IM. Concomitant therapy included estradiol and ANDROCUR. Approximately since 20-JUN-2008, the patient was subfebrile at 37.8 C and 38 C, had asthenia and generalized pains especially at shoulder girdle punctually treated with Efferalgan. Clinical examination did not find any particularity. There was no evidence for focus of infections. On biological standpoint, blood cell count was normal, erythrocyte sedimentation rate was at 13 at first hour, hepatic check-up and thyroid stimulating hormones were normal, cytomegalovirus and Epstein-Barr virus serologies were negative. Sinus scan and pelvic abdominal ultrasound did not find any particularity. At consultation on 30-JUL-2008, the patient was still febrile at 38 C and still presented pains. Symptoms did not regressed or worsened. Fever, asthenia and pain were considered to be other important medical events. Other business partner number included: E2008-08953. Additional information has been requested.

VAERS ID:328683 (history)  Vaccinated:2008-06-16
Age:0.2  Onset:2008-07-01, Days after vaccination: 15
Gender:Male  Submitted:2008-10-15, Days after onset: 106
Location:Foreign  Entered:2008-10-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data: Electroencephalogram, 00-Jul-2008, no abnormalities
CDC Split Type: NLWYEG02344808
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2752AA IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURC2752AA IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURC2752AA IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH254240IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Electroencephalogram normal, Gaze palsy, Hypertonia, Loss of consciousness, Myoclonus
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 (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding an 8-week-old male patient who experienced hypertonia, unconscious, crying, eyes rolled upwards and myoclonic jerks with arms and legs. The patient received the first dose on 16-Jun-2008. The patient has no relevant medical history. Additional suspect medication included PEDIACEL. The patient was not using concomitant medications. In Jul-2008, about 3 weeks after the vaccinations, the patient experienced an episode with hypertonia, unconscious, eyes rolled upwards and myoclonic jerks with arms and legs. The episode lasted for 30 seconds and afterwards the child started crying loudly. During the next 6 weeks, the child experienced similar episodes several times. The child was examined by a pediatrician and an EEG showed no abnormalities. The child has recovered. Electroencephalogram (results: no abnormalities) was done in Jul-2008. No additional information was available at the time of this report.

VAERS ID:329297 (history)  Vaccinated:2008-06-16
Age:0.3  Onset:2008-06-16, Days after vaccination: 0
Gender:Unknown  Submitted:2008-10-20, Days after onset: 126
Location:Foreign  Entered:2008-10-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported.
Diagnostic Lab Data:
CDC Split Type: 200803132
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906001 SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9711 IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1046 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Erythema, Injection site reaction, Mobility decreased, Musculoskeletal pain, Oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial report received from foreign health authorities on 8 October 2008 under the authority reference number: PL-URPL-OCR-20080820023. Seriousness criteria: Hospitalisation. A 4-month-old patient of unspecified gender and with no reported medical history developed injection site reaction, on 16 June 2008, the day of vaccination with intramuscular ACT-HIB, lot no: A9711-2, IMOVAX POLIO, lot no: Z-1046 and DTP administration on 16 June 2008. On the vaccination day, "a small oedema occurred", "redness in the right arm", then a pain whilst moving the shoulder joint (child was crying when moved "passive"). Later, on 20 June 2008, a significantly decreased mobility in the right upper limb was reported. The subject was admitted to hospital on 23 June 2008, on the following day, "no limits" in upper limb mobility were observed. The patient recovered within an unspecified time frame.

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